November 2017

15

NuCana Announces First Patients Enrolled in Phase 2 Study of Acelarin in a Platinum-Resistant Ovarian Cancer

EDINBURGH, United Kingdom, Nov. 15, 2017 (GLOBE NEWSWIRE) — NuCana plc (NASDAQ:NCNA) announced the enrollment of the first patients in both the United States and the United Kingdom in its PRO-105 study evaluating single-agent Acelarin (NUC-1031) in patients with platinum-resistant ovarian cancer.

Hugh Griffith, NuCana’s Chief Executive Officer, stated: “The initiation of this Phase 2 study of Acelarin in both the US and the UK is a major step in the expansion of the NuCana product pipeline and advances our strategy of rapidly developing our ProTides to benefit cancer patients globally. We are grateful to the patients and clinicians who are making this study possible.”

The PRO-105 study will enroll up to 64 patients with platinum-resistant ovarian cancer who have relapsed following three or more prior lines of chemotherapy. Patients will receive Acelarin on day 1, 8 and 15 of a 28-day cycle and will be treated to progression. The primary endpoint of the study will be Objective Response Rate, and secondary endpoints include Duration of Response, Progression-Free Survival, Overall Survival and safety parameters. Part one of the study will enroll up to 20 patients in each of two dose cohorts: 500mg/m2 and 750mg/m2. In part two of the study, NuCana will select one of these doses and enroll at least an additional 24 patients at the selected dose. NuCana expects to announce interim data from this study in 2018. More information about this study may be found at https://clinicaltrials.gov/ct2/show/NCT03146663.

Professor Bradley J. Monk of Arizona Oncology and co-Chief Investigator of PRO-105 stated: “Platinum-resistant ovarian cancer remains an area of significant unmet medical need and we are excited to participate in this study and advance Acelarin as a potential treatment for women with ovarian cancer. Acelarin’s ability to overcome key cancer cell resistance mechanisms resulting in significantly greater levels of the active anti-cancer metabolite differentiates it from other treatment approaches.”

Professor Charlie Gourley, of the University of Edinburgh and co-Chief Investigator of PRO-105, added: “Acelarin has shown meaningful clinical activity in advanced recurrent ovarian cancer and has been well-tolerated in clinical studies to date. We are pleased to be a part of this important clinical study.”

Acelarin is a potential first-in-class ProTide that has been evaluated in over 140 patients. In the first-in-human Phase 1 dose-ranging PRO-001 study in 49 evaluable patients with advanced metastatic solid tumors, Acelarin was well tolerated and achieved a 78% disease control rate. Acelarin achieved a disease control rate of 93% in a subset of 14 evaluable patients with advanced gynecological cancers in the PRO-001 study. This was followed by the Phase 1b dose-ranging PRO-002 study where Acelarin in combination with carboplatin achieved a 96% disease control rate and 39% response rate in 23 evaluable patients with recurrent ovarian cancer.

13

Apellis Pharmaceuticals Announces Closing of its Initial Public Offering

CRESTWOOD, Ky., Nov. 13, 2017 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (NASDAQ:APLS), a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, today announced the closing of its initial public offering of 10,714,000 shares of common stock at a public offering price of $14.00 per share. The total gross proceeds to Apellis were approximately $150.0 million, before deducting underwriting discounts and commissions and expenses payable by Apellis. All of the shares were sold by Apellis. In addition, Apellis granted the underwriters a 30-day option to purchase up to 1,607,100 additional shares of common stock at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any. The shares commenced trading on the NASDAQ Global Select Market under the ticker symbol “APLS” on Thursday, November 9, 2017.

Citigroup, J.P. Morgan and Evercore ISI acted as joint book-running managers for the offering.

A registration statement relating to the securities sold in this offering was declared effective by the Securities and Exchange Commission on November 8, 2017. The offering was made only by means of a prospectus. When available, copies of the final prospectus relating to the offering may be obtained by contacting: Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-800-831-9146, or email: prospectus@citi.com; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, telephone: (888) 474-0200, or email: ecm.prospectus@evercore.com.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Apellis

Apellis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade.

10

Aduro Biotech Announces Promising Preclinical Data that Validate Anti-CTLA-4 Antibody ADU-1604

BERKELEY, Calif., Nov. 10, 2017 (GLOBE NEWSWIRE) — Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced data from preclinical studies with ADU-1604, the company’s humanized anti-CTLA-4 monoclonal antibody. Data from these in vitro and in vivo studies demonstrate the potency of ADU-1604 and its ability to inhibit tumor growth and enhance T cell-dependent antibody responses. These data, which will be highlighted later today in a poster presentation (Poster #335) at the 32ND Annual Meeting of the Society for Immunotherapy of Cancer (SITC), underscore the potential application of ADU-1604 for the treatment of multiple cancer types, either as monotherapy or in combination with other therapies.

“These data from preclinical studies of ADU-1604, a novel anti-CTLA-4 product candidate derived from our proprietary B-select antibody platform, are encouraging and provide support to file an Investigational New Drug Application to advance ADU-1604 into clinical studies,” stated Andrea van Elsas, Ph.D., chief scientific officer of Aduro Biotech. “As a company with multiple programs and proprietary technology platforms, we are well positioned to leverage our product candidates, as monotherapies and in rational combinations, to develop new treatment options for patients in need.”

8

Synlogic Reports Positive Top-Line Phase 1 Data Demonstrating Safety and Tolerability and Proof of Mechanism in Healthy Volunteers for SYNB1020, a Synthetic BioticTM Medicine for the Treatment of Hyperammonemia

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 8, 2017– Synlogic, Inc.,(Nasdaq:SYBX) a clinical-stage drug discovery and development company applying synthetic biology to probiotics to develop novel Synthetic Biotic medicines, today announced positive top-line clinical data from its Phase 1 placebo-controlled single (SAD) and multiple ascending dose (MAD) clinical trial of SYNB1020 in healthy volunteers. The trial successfully met the primary objectives demonstrating safety and tolerability in healthy volunteers and identifying the maximum tolerated dose. Furthermore, proof of mechanism was demonstrated by a clear signal in a plasma nitrogen endpoint.

SYNB1020, is a novel, first-in-class, Synthetic Biotic medicine that is orally delivered and designed to treat elevated blood ammonia levels, or hyperammonemia, in genetic urea cycle disorders (UCD) or in chronic liver disease

“The positive data from our Phase 1 study in healthy volunteers, demonstrates that SYNB1020 was well-tolerated and had a statistically significant dose-dependent effect on the level of a nitrogen endpoint, providing evidence to support its mechanism of action,” said Aoife Brennan, M.B., B.Ch., Synlogic’s chief medical officer. “These data support the hypothesis that SYNB1020 treatment may provide clinical benefit in patients with UCDs or liver disease, and will inform dose selection in our planned Phase 1b/2a study of SYNB1020 in patients, which we expect to begin in the first half of 2018.”

“This first-in-human study represents a significant milestone for our new class of Synthetic Biotic medicines and demonstrates that they can operate from the gastrointestinal tract to metabolize systemic toxins,” said JC Gutiérrez-Ramos, Ph.D., Synlogic’s president and chief executive officer. “We look forward to evaluating SYNB1020 in patients, and to moving our second program, SYNB1618 for the treatment of phenylketonuria into clinical trials in 2018.

SYNB1020 was safe and well tolerated in subjects in multiple ascending dose cohorts who received total daily doses of up to 1.5×1012 CFU for 14 days. There have been no serious adverse events (SAEs), and no cases of infection with the bacteria in this study. While the study is ongoing, there is no evidence of colonization by SYNB1020 as all subjects who have completed follow-up have cleared the bacteria from their systems within the expected timeframe.

In the MAD component of the Phase 1 study, daily dosing of SYNB1020 over 14 days in healthy volunteers enabled identification of a dose-response relationship between SYNB1020 oral administration and changes in a nitrogen endpoint in plasma which was found to be statistically significant in the highest dose cohort compared to placebo. In addition, viability and evidence of mechanistic activity of the Synthetic Biotic was demonstrated in feces of subjects who received SYNB1020, but not in control subjects. As expected, SYNB1020 did not lower blood ammonia levels in these healthy individuals who had normal blood ammonia levels at baseline. Collectively, the data support the hypothesis that SYNB1020 treatment may enable metabolism of potentially neurotoxic blood levels of ammonia in patients with hyperammonemia stemming from UCDs or liver damage.

October 2017

26

This ‘Uber’ Of Staffing App Could Revolutionize The Hospitality Industry

Jitjatjo is a new app specifically designed to solve temporary hospitality staffing problems. Catering companies, event planners and restaurateurs can use Jitjatjo (which sounds like tic tac toe) to ease their “supply and demand” challenges of staffing. In one week managers might need to hire staff to accommodate an intimate black-tie dinner party for 30 diners, a 3,000-person corporate event and a promotional cocktail hour for 300 people. Finding talented workers during busy periods, retaining them during slow periods, is both stressful and time consuming.

“How can I get part-timers that come in and give me the available supply to satisfy the demand?” asks Ron McCulloch rhetorically in his strong Scottish accent. Jitjatjo’s co-founder and Executive Chairman, 64-year-old McCulloch sits in his Manhattan office that overlooks Soho, explaining that his 25+ years in the hospitality industry, including the colossal Home Nightclub in Sydney where he lived for 17 years, taught him the elastic nature of hospitality staffing.

“So rather than just taking someone off the street and say, ‘Come and work for me for one night,’” says McCulloch, demonstrating the level of desperation some managers feel when looking for hospitality staff, especially last-minute; instead he suggests, managers turn to the more efficient and targeted Jitjatjo app, which launched 11 months ago.

McCulloch, along with co-founder and CEO Tim Chatfield, play down the comparison, Jitjatjo is arguably the Uber of temporary hospitality staffing. If a catering company suddenly needs five extra servers and a bartender for an event in two hours, they input the specifics of the job through the Jitjatjo app and its algorithm books the most qualified workers available within minutes.

For better or worse, servers and clients don’t choose each other, Jitjatjo’s algorithm makes the match. “People in hospitality have so many things to do,” says McCulloch, “they want simple solutions.”

ENYO Pharma opens a new subsidiary in Australia as a new managing center for clinical trials

Lyon, October 26, 2017. ENYO Pharma, a biopharmaceutical company developing new molecules with an innovative approach inspired by viruses, made a strategic decision and has recently decided to open its first wholly owned subsidiary in Melbourne, Australia, because of its excellent clinical trials development capabilities and attractive conditions offered by the government. The Australian Government is very supportive of biotech startups and the Victorian Government Business Office provides good business development networking. This office will be the new ENYO Pharma center to manage EYP001 (an FXR agonist) clinical trials in the Asia-Pacific region for chronic Hepatitis B. A Phase 1b study of EYP001 is currently submitted in 4 countries and two new Australian centers in Sydney and Perth have joined the study and started recruitment.

ENYO Pharma bases its innovation on mimicking viral strategies to discover new cellular targets and is currently developing drug candidates in therapeutic areas such as infectious and metabolic diseases. One of the company’s leading programs is a new drug EYP001, against chronic Hepatitis B which is a major public health concern in the Asia-Pacific region. More than a half of the global population infected worldwide by Hepatitis B are located in this region, representing 129 million patients.

“ENYO Pharma is currently looking forward to working in this region as the well-established clinical expertise in this part of the world adds important value to ENYO Pharma R&D efforts and specifically our expeditious development of EYP001” commented Pietro Scalfaro, M.D., Chief Medical Officer of ENYO Pharma SA.

“Melbourne’s strong biotechnology sector is the leading research and clinical trial hub in the Asia Pacific region. ENYO Pharma is a leading biotechnology innovator in infectious diseases and the Government of Victoria is proud to welcome their new research subsidiary into Melbourne, Australia.” said the Minister for Innovation and Trade, Minister Philip Dalidakis.

24

Innovative Alzheimer’s Disease Combination Therapy Trial Supported By New Joint Funding Initiative

NEW YORK AND CHICAGO, Oct. 24, 2017 /PRNewswire-USNewswire/ — The Alzheimer’s Association and Alzheimer’s Drug Discovery Foundation (ADDF) are collaborating to jointly fund a new combination therapy clinical trial for Alzheimer’s disease to be conducted by Amylyx Pharmaceuticals. The $1.85 million grant is the first award under an initiative created by the Alzheimer’s Association and the ADDF to fund combination therapies.

The grant will support a phase 2 clinical trial of AMX0035, a combination of sodium phenylbutyrate (PB) and tauroursodeoxycholic-acid (TUDCA). The trial, expected to begin in the first half of 2018, will include approximately 50 people with mild cognitive impairment or mild-to-moderate Alzheimer’s disease and test the drug’s effectiveness at slowing or stopping brain cell death.

“Combination therapies hold great potential to slow the progression of Alzheimer’s,” said Howard Fillit, MD, the ADDF’s founding executive director and chief science officer. “The innovation of Amylyx’s combination therapy is that it targets multiple causes of brain cell loss, and the two drugs given in tandem create additional protective effects. The ADDF was an early supporter of innovative targets for Alzheimer’s, and we believe combination therapies are a critical next step in finding effective treatments for the disease.”

Alzheimer’s is a complex disease with multiple, interrelated causes. A growing number of experts believe combination therapy—with two or more drugs, or drugs and lifestyle interventions—will be required to effectively treat it.

“We have witnessed the success of combination therapy in HIV/AIDS, cancer, and heart disease. There is strong reason to believe that to successfully address Alzheimer’s, and its extraordinary complexity, we need to attack the disease on multiple fronts,” said Maria Carrillo, PhD, Alzheimer’s Association chief science officer. “Meetings convened in 2015 by the Alzheimer’s Association (proceedings published in 2016) and the ADDF led the two organizations to recognize the potentially important role of combination therapies in Alzheimer’s and paved the way for this exciting partnership and initial clinical trial funding.”

New approaches to Alzheimer’s are urgently needed, as deaths from the disease continue to rise precipitously as more and more Baby Boomers reach the age of greatest risk.

The grant was made through the Alzheimer’s Combination Therapy Opportunities (ACTO) program, a joint research funding initiative created by the Alzheimer’s Association and the ADDF to support clinical trials combining multiple treatment approaches. The ACTO program specifically called for study proposals using repurposed drugs that have been determined safe for use in treating other conditions. Repurposing may speed the drug development process because researchers can often begin with phase 2 trials including outcome measures of effectiveness, rather than phase 1 safety tests.

The drug to be tested, AMX0035, is a proprietary oral formulation of two existing therapeutics. PB is an FDA-approved therapy—currently prescribed for urea-cycle disorders—that activates genes responsible for protecting brain cells from toxic unfolded proteins. TUDCA is an acid produced in small amounts by the body that targets cellular energy loss. In preclinical studies conducted by the company and with academic collaborators, combination dosing of PB and TUDCA protected brain cells from inflammation and oxidation. Amylyx received FDA clearance for AMX0035’s Investigational New Drug application in April 2017 and has an ongoing multicenter clinical study of the compound in people with amyotrophic lateral sclerosis (ALS).

“We are very grateful for the support from the Alzheimer’s Association and the Alzheimer’s Drug Discovery Foundation, and we’re honored to partner with them in this new combination therapy initiative,” said Kent Leslie, Amylyx chief scientific officer. “Through a combination approach targeting two different and independent pathways, AMX0035 is designed to benefit both neurodegeneration and neuroinflammation, key drivers of Alzheimer’s and ALS. The biomarker-focused trial design will assist in translating the promising preclinical effects observed in models of Alzheimer’s to an improved understanding of the potential of AMX0035 to help individuals living with this disease.”

Synlogic Receives Orphan Drug Designation for SYNB1618, a Synthetic BioticTM Medicine for the Treatment of Phenylketonuria

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct. 24, 2017– Synlogic (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel living medicines, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to SYNB1618, Synlogic’s preclinical-stage drug candidate for the treatment of phenylketonuria (PKU) , an inborn error of metabolism (IEM) caused by a mutation in the gene that breaks down the amino acid phenylalanine (Phe). Phe accumulation in the blood and brain can lead to neurocognitive abnormalities and treatment currently requires severe dietary protein restriction.

SYNB1618, an orally administered medicine, is designed to complement the missing function in patients with PKU by providing alternative metabolic pathways to consume Phe. Synlogic plans to file an investigational new drug application (IND) with the FDA for SYNB1618 for the potential treatment of PKU in early 2018.

“We believe our Synthetic Biotic medicines could transform the treatment of PKU,” said Aoife Brennan, M.B., B.Ch., Synlogic’s chief medical officer. “Consequently, we were pleased to receive the FDA’s orphan drug designation which validates our approach and represents an important step toward achieving our goal of bringing novel treatments to the patients and families affected by this challenging disease.”

16

‘Farm in a Box’ Could Protect Food Supplies After Extreme Weather Events

Boston-based Freight Farms has developed what it calls the Leafy Green Machine, a method for vertical, hydroponic farming inside a shipping container.

BY MOLLY FOSCO OCTOBER 16, 2017 3:53 PM EDT – Vertical and hydroponic farming has gained popularity in recent years. And with the frequency and intensity of some extreme weather events on the rise, innovative techniques offer enticing solutions to some agricultural problems.

Boston-based company Freight Farms is offering one approach: It’s helping people grow food inside shipping containers 365 days a year, no matter the weather conditions.

Brad McNamara and Jon Friedman started Freight Farms in 2010 with the goal of making it easier for anyone to grow food on a commercial scale. “We really focused on putting farming into the hands of regular people so that you can have a manageable footprint but still produce at a commercial level,” McNamara, the company’s CEO, told Seeker. “We were really inspired by what’s becoming possible with new technology and the fact that no one had changed their thinking yet from big agriculture and large-scale farms.”

McNamara and Friedman wanted to create something small that could still produce large crop yields. The result is the Leafy Green Machine, a produce farm that operates inside a shipping container that is forty feet long, eight feet wide, and nine and a half feet high. The LGM uses a vertical, hydroponic farming method that allows leafy greens like kale, lettuce, and cabbage, as well as herbs like basil, mint, and oregano, to be harvested once a week, year round. It grows 2-4 tons of produce annually using less than 10 gallons of water per day. Its water, air, and nutrient inputs can be monitored and controlled remotely using a software called “farmhand.”

The LGM costs about $85,000 and around $13,000 to operate annually. Freight Farms offers financing options, as well as video tutorials and two-day, in-person trainings at their Boston headquarters on how to operate an LGM.

4

Forensic Logic Announces Acquisition of COPLINK Platform from IBM

The acquisition will create the nation’s largest network of law enforcement users, information, and technology

WALNUT CREEK, CA and TUCSON, AZ – October 4, 2017 – Forensic Logic, the premier provider of network search technology and cloud-based information services to law enforcement, today announced it has acquired the COPLINK suite of products from IBM. COPLINK is a leading public safety information sharing platform and provider of analytical, tactical and operational software for law enforcement. The acquisition will deliver an unprecedented level of information access and technological interoperability to the U.S. law enforcement community, while greatly streamlining data integration, product acquisition, and customer service among their customer base.

Created in 1998, COPLINK provides public safety software and services to over 5100 law enforcement jurisdictions throughout the United States. In addition to its core analysis platform, the COPLINK system offers an integrated array of software solutions for investigations, operations, and compliance.
Founded in 2003, Forensic Logic has become one of the fastest-growing public safety technology providers in the country built on the success of its search engine optimized for public safety. The acquisition will further Forensic Logic’s strategy to deploy a fully integrated suite of world-class information access technology across the widest possible network of public safety agencies.

“The COPLINK acquisition reinforces our commitment to bring a compelling combination of technological capabilities to this market,” said Bob Batty, CEO of Forensic Logic. “Our customers will no longer have to choose between the best search capability, the finest analytical tools, and the richest network of data – once the integration is done they will all be on one platform.”

2

Stealth BioTherapeutics Granted Orphan Drug Designation of Elamipretide for Treatment of Patients with Primary Mitochondrial Myopathy

BOSTON – October 2, 2017 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation to Stealth’s investigational drug candidate, elamipretide, for the treatment of patients with primary mitochondrial myopathy (PMM).

“We are thrilled to achieve this key regulatory milestone for the treatment of PMM, a debilitating condition characterized by muscle weakness and fatigue with no FDA-approved treatments,” said Reenie McCarthy, Stealth’s chief executive officer. “We will continue to work closely with the FDA as we advance into our Phase 3 trial of elamipretide in patients with PMM.”

The Orphan Drug Act was enacted in 1983 to encourage development of drugs for rare diseases, which are diseases that affect fewer than 200,000 persons in the United States. Once granted, Orphan Drug Designation provides various development benefits for an investigational drug, including seven-year exclusivity after marketing approval is received.

In June 2017, Stealth announced results from MMPOWER-2, a Phase 2 continuation trial evaluating safety, tolerability and efficacy of treatment with elamipretide for PMM, which showed benefit of elamipretide across multiple endpoints assessed and supports a Phase 3 trial in this patient population. Stealth is currently recruiting for the RePOWER trial, an observational study of patients with PMM. Patients enrolled in RePOWER may have the opportunity to participate in the Phase 3 trial to further evaluate the potential efficacy, safety and tolerability of elamipretide for patients with PMM.

NuCana Plc Announces Closing Of Initial Public Offering Of ADSs And Exercise Of Underwriters’ Option To Purchase Additional ADSs

EDINBURGH, United Kingdom, Oct. 02, 2017 (GLOBE NEWSWIRE) — NuCana plc (Nasdaq:NCNA), a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for cancer patients by applying its ProTide™ technology to transform some of the most widely prescribed chemotherapy agents into more effective and safer medicines, announced today the closing of its initial public offering of 7,596,505 American Depositary Shares (“ADSs”) at a price to the public of $15.00 per ADS, which includes 929,505 shares sold upon partial exercise of the underwriters’ option to purchase additional ADSs, for total gross proceeds of approximately $114 million, before deducting underwriting discounts and commissions. Each ADS represents one ordinary share of NuCana. The ADSs began trading on the NASDAQ Global Select Market on September 28, 2017 under the ticker symbol “NCNA.” All ADSs were offered by NuCana.

Citigroup, Jefferies and Cowen acted as joint book-running managers for the offering, and William Blair acted as co-manager for the offering. A registration statement on Form F-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission (the “SEC”) and was declared effective on September 27, 2017. Copies of the registration statement can be accessed by visiting the SEC’s website at www.sec.gov.

The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by phone at (800) 831-9146, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340 or by e-mail at Prospectus_Department@Jefferies.com, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention Prospectus Department or by phone at (631) 274-2806.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

September 2017

27

Aduro Biotech Announces First Patient Dosed in Phase 1 Clinical Trial of Personalized Immunotherapy pLADD Based on Proprietary Neoantigen Technology

Trial has begun in Patients with Metastatic Colorectal Cancer Who Have Few Treatment Options

BERKELEY, Calif., Sept. 27, 2017 (GLOBE NEWSWIRE) — Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that the first patient has been dosed in the Phase 1 clinical trial (see www.clinicaltrials.gov, identifier NCT03189030) designed to evaluate the safety and tolerability of a personalized live, attenuated double-deleted Listeria monocytogenes (pLADD) immunotherapy for adults with metastatic colorectal cancer that is microsatellite stable (MSS). The personalized immunotherapy has been engineered with patient-specific neoantigens that were identified and selected using state-of-the-art neoantigen identification technology developed by Hanlee Ji, M.D., associate professor of medicine at the Stanford University School of Medicine.

“Our pLADD program leverages our extensive capabilities relating to the use of Listeria as a delivery mechanism for cancer antigens and Dr. Ji’s innovative neoantigen technology used to identify immunogenic antigens specific for an individual patient,” said Natalie Sacks, M.D., chief medical officer of Aduro Biotech. “Together, we believe these two cutting edge technologies represent a new approach to treating patients who have relapsed following prior chemotherapy. We look forward to evaluating initial proof-of-concept in this Phase 1 clinical trial.”

Clinical Design of Phase 1 PLADD Trial in Adults with Metastatic Corlorectal Cancer
The Phase 1 clincial single-arm trial is designed to evaluate the safety and tolerability of a personalized immunotherapy made using patient-specific antigens and Aduro’s proprietary live, attenuated, double-deleted Listeria monocytogenes platform technology. The trial is seeking to enroll approximately 10 patients with metastatic colorectal cancer that is MSS. Patients will receive their patient-specific immunotherapy once every three weeks.

NuCana plc Announces Pricing of Initial Public Offering

EDINBURGH, United Kingdom, Sept. 27, 2017 (GLOBE NEWSWIRE) — NuCana plc (Nasdaq:NCNA), a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for cancer patients by applying its ProTide ™ technology to transform some of the most widely prescribed chemotherapy agents into more effective and safer medicines, announced today the pricing of its initial public offering of 6,667,000 American Depositary Shares (“ADSs”) at a price to the public of $15.00 per ADS, for total gross proceeds of approximately $100.0 million, before deducting underwriting discounts and commissions. Each ADS represents one ordinary share of NuCana.

In addition, NuCana has granted the underwriters a 30-day option to purchase up to 1,000,050 additional ADSs at the initial offering price to cover over-allotments, if any. All of the ADSs are being offered by NuCana.

NuCana’s ADSs have been approved for listing on the NASDAQ Global Select Market and are expected to begin trading under the symbol “NCNA” on September 28, 2017. The offering is expected to close on October 2, 2017, subject to customary closing conditions.

Citigroup, Jefferies and Cowen are acting as joint book-running managers for the offering, and William Blair is acting as co-manager for the offering.

A registration statement on Form F-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission (the “SEC”) and was declared effective on September 27, 2017. Copies of the registration statement can be accessed by visiting the SEC’s website at www.sec.gov.

This offering is being made only by means of a prospectus. A copy of the final prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by phone at (800) 831-9146, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340 or by e-mail at Prospectus_Department@Jefferies.com, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention Prospectus Department or by phone at (631) 274-2806.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

26

Aduro Biotech Announces Advancement of ADU-S100 into Global Combination Trial With PDR001 for the Treatment of Solid Tumors and Lymphomas

First Patient Dosed in Phase 1b Clinical Trial

BERKELEY, Calif., Sept. 26, 2017 (GLOBE NEWSWIRE) — Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that the first patient has been dosed in the Phase 1b dose escalation and dose expansion clinical trial (see www.clinicaltrials.gov, identifier NCT03172936) designed to evaluate the safety and efficacy of ADU-S100 (also known as MIW815), a novel STING pathway activator, in combination with PDR001, Novartis’ investigational PD-1 checkpoint inhibitor, for the treatment of advanced/metastatic solid tumors or lymphomas. The trial, which is being conducted in collaboration with Aduro’s partner, Novartis, is expected to enroll approximately 175 patients at sites located in the United States, Europe, Canada, Australia and Japan.

“We are pleased with our early progress in the ongoing Phase 1 dose escalation trial of ADU-S100 as a single agent and are eager to expand our investigation into a separate clinical trial to evaluate the effect of ADU-S100 used in combination with the PDR001 checkpoint inhibitor,” said Natalie Sacks, M.D., chief medical officer of Aduro Biotech. “As a leader in STING activation, we look forward to gaining more insight into the potential therapeutic application of this novel combination therapy.”

Clinical Design of Phase 1b ADU-S100 (MIW815)/PDR100
The Phase 1b multi-center, open-label study is designed to evaluate the safety and efficacy of ADU-S100 (MIW815) in combination with PDR001 in patients with accessible solid tumors or lymphomas. The trial will evaluate two treatment schedules of ADU-S100 in dose escalation. One group will receive a fixed dose of intravenous PDR001 on day 1 and an intratumoral injection of ADU-S100 three times in a 28-day cycle. Another group will receive a fixed dose of intravenous PDR001 on day 1 and intratumoral injection of MIW815 (ADU-S100) on day 1 of every 28-day cycle. Once the maximum tolerated dose and/or recommended dose for expansion is determined, the expansion part of the study will open.

19

Amylyx Pharmaceuticals Receives FDA Orphan Drug Designation for AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis

September 19, 2017 09:00 AM Eastern Daylight Time
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Amylyx Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AMX0035, an oral therapeutic in clinical development for the treatment of amyotrophic lateral sclerosis (ALS). The Company recently began a Phase 2 clinical study, the CENTAUR trial, to evaluate the safety and efficacy of AMX0035 in ALS patients.

The U.S. Orphan Drug Act provides incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. Orphan drug designation by the FDA conveys up to seven years of marketing exclusivity if the compound receives regulatory approval, and offers various development incentives, including tax credits related to clinical trial expenses, an exemption from the FDA-user fee, and FDA assistance in clinical trial design.

Background on AMX0035
AMX0035 is a combination of two small molecules, sodium phenylbutyrate (PB) and tauroursodeoxycholic acid (TUDCA). Each compound has demonstrated strong efficacy in several cellular and animal models of ALS. When individually tested in ALS clinical trials, PB and TUDCA have both shown safety, tolerability, and preliminary signs of efficacy. In preclinical trials, Amylyx has demonstrated a synergistic effect between the two compounds, suggesting that the combination may have improved efficacy compared to the individual agents.

About the CENTAUR Trial
CENTAUR is a 24-week, randomized, double-blind, placebo-controlled Phase II clinical trial in 132 participants with ALS. The trial’s primary objectives are to evaluate the safety and tolerability of AMX0035 and assess the drug’s impact on disease progression as measured by the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) over the 24-week study period. The trial will also evaluate the impact of AMX0035 on isometric strength as measured by ATLIS, respiratory function, and exploratory biomarkers. There will also be an open label extension to the trial so that all enrolled patients will have the option of continuing treatment once the 24-week treatment period concludes.

18

Green Biologics’ Renewable Chemicals Granted Kosher and Halal Certification

Company’s n-butanol and acetone can now serve as ingredients for the growing markets for kosher and halal consumer goods

Ashland, Virginia and Abingdon, Oxfordshire U.K. (September 18, 2017) – Green Biologics, Inc., the U.S. subsidiary of Green Biologics Ltd., a U.K. industrial biotechnology and renewable chemicals company, announced today that it has achieved kosher and halal certification for the 100 percent biobased n-butanol and acetone, produced at the company’s commercial facility in Little Falls, Minnesota. These certifications enable Green Biologics’ chemicals to serve as ingredients for personal, homecare and food products.

“The kosher and halal certifications that have been granted to our Little Falls, MN manufacturing facility will further enable us to build partnerships within the major food, cleaning and cosmetic brands, to name a few,” said David Anderson, Vice President of Marketing at Green Biologics. “These certifications are becoming popular, not only for those with religious motivations, but also to the wider market as they are being used as an effective method for identifying high quality goods.”

The recent certifications are an important milestone for Green Biologics’ BioPure™ n-butanol and acetone, which are entirely produced using renewable feedstocks. Consumers and retailers are increasingly demanding products produced from natural or sustainable ingredients. Both n-butanol and acetone can also serve as additives and solvents in personal care, cosmetic, and both household and industrial cleaning products. For cosmetics, while acetone is most often used as a nail polish remover, BioPure™ n-butanol can be combined with acids derived from natural plant based oilsto produce a wide array of 100 percent renewable butyl esters. These esters can be utilized in natural lipsticks, moisturizers, and nail polishes. Butyl esters are also utilized as aroma chemicals in fragrance products and flavor additives within the food industry.

In addition to the kosher and halal certifications, provided by the respective OK Kosher and Islamic Services of America certifying bodies, Green Biologics is also a member of the American Chemistry Council (ACC), and its commercial facility, Central MN Renewables LLC, participates in the ACC’s Responsible Care® program. The company’s n-butanol and acetone have received 100 percent biobased, USDA BioPreferred® certification.

13

NuCana Announces Interim Data from First-In-Human Study of Transformative Anti-Cancer Agent, NUC-3373

Received Best Poster Presentation Award at ESMO 2017

Edinburgh, United Kingdom, September 13, 2017 (GLOBE NEWSWIRE) – NuCana plc announced the presentation of interim first-in-human data from a Phase 1 clinical study of NUC-3373, its ProTide transformation of the active anti-cancer metabolite of 5-fluorouracil (5-FU), at the European Society for Medical Oncology (ESMO) 2017 Congress held earlier this week in Madrid, Spain.

Interim pharmacokinetic (PK) and pharmacodynamic (PD) data were presented at ESMO 2017, and the presentation was awarded “Best Poster” status by the organizing committee. Key findings from the study included PK and PD data from 21 patients with 10 different advanced solid tumor cancer types and indicated that NUC-3373 has the potential to have greater activity and an improved safety profile as compared to 5-FU. The results indicated a linear and reproducible dose-response across all dose ranges as well as a well-tolerated safety profile. After a short administration, plasma half-life of NUC-3733 was 9.7 hours, as compared to the 8 to 14 minute half-life associated with 5-FU. Evidence of rapid and efficient intracellular activity were noted, with high levels of FUDR-MP, the active anti-cancer metabolite of 5-FU detectable in cells 5 minutes after infusion and still detectable after 48 hours. NUC-3373 bound to and inhibited the target enzyme, thymidylate synthase, and depleted the pool of dTMP, a nucleotide necessary for DNA replication, 2 to 4 hours after administration. Additionally, NUC-3373 did not generate the key toxic metabolites of 5-FU (F-BAL or dhFU) intracellularly or in the patient’s plasma.

“NUC-3373 appears to have considerable advantages over 5-FU, with much higher levels of the active, anti-cancer metabolite, that may overcome key cancer resistance pathways and allow for a more favourable safety profile and a more convenient dosing regimen,” said Dr. Sarah Blagden, Associate Professor of Experimental Cancer Medicine at the University of Oxford and Chief Investigator of the study. “5-FU remains one of the most important and widely used anti-cancer drugs in the world. This interim analysis of NUC-3373’s Phase 1 data strongly supports its continued development.”

Hugh Griffith, NuCana’s Chief Executive Officer, said: “NUC-3373 is our second product candidate that uses our proprietary ProTide technology with the goal of improving the efficacy and safety of important anti-cancer agents. We are excited to see these interim data and especially gratified that it was chosen
for a Best Poster award at ESMO 2017. These data support that NUC-3373 may have a key role to play in the treatment of cancer and we look forward to continuing its rapid development, along with the development of other product candidates in our pipeline.”

12

NuCana Announces Positive Results of NUC-1031 (Acelarin®) in Advanced Ovarian Cancer at ESMO 2017

Acelarin combination with carboplatin achieved 96% disease control rate and 39% response rate in patients with recurrent ovarian cancer

Edinburgh, United Kingdom, September 12, 2017 (GLOBE NEWSWIRE) – NuCana plc, a clinical-stage biopharmaceutical company developing a portfolio of novel anti-cancer medicines called ProTides™, announced the presentation of data from its recently completed trial of its lead product candidate, NUC-1031 (Acelarin®), at the European Society for Medical Oncology (ESMO) 2017 Congress held September 8th-12th, 2017 in Madrid, Spain. Results from NuCana’s Phase 1b trial showed that Acelarin, when combined with carboplatin, was well tolerated and demonstrated clinical activity in women with recurrent platinum-resistant and platinum-sensitive ovarian cancer. An overall response rate of 39% was observed amongst the 23 evaluable patients, including 1 (4%) who achieved a complete response, 8 (35%) with partial responses, and 13 (57%) with stable disease that lasted at least 12 weeks. This yielded an overall disease control rate of 96% (22 patients). The responses were durable, with an average progression free survival of 7.4 months. The most common adverse events across all dose levels were neutropaenia, leukopaenia and thrombocytopaenia. No unexpected adverse events were observed with the combination to date.

All patients in the study were previously treated with an average of three prior chemotherapy regimens. Seventeen of the evaluable patients were either refractory or resistant to their last platinum-containing regimen.

“The fact that the Acelarin combination with carboplatin achieved these results in heavily pre-treated and platinum-resistant patients clearly demonstrates Acelarin is a very active agent,” said Dr. Sarah Blagden, Associate Professor of Experimental Cancer Medicine at the University of Oxford and Chief Investigator of the Phase 1b study. Professor Blagden added, “importantly, the favorable toxicity profile of Acelarin enabled us to combine it with carboplatin at AUC 5, whereas with gemcitabine, carboplatin has to be given at AUC 4. Thus, we are able to deliver both Acelarin and carboplatin at their optimal dose.”

Hugh Griffith, NuCana’s Chief Executive Officer, said: “The high disease control rate and durable responses achieved with the combination of Acelarin and carboplatin are exciting. We remain focused on advancing Acelarin’s development for the treatment of patients with ovarian cancer as well as exploring its use for the treatment of other solid tumours.”

7

Project ALS and Amylyx Enter Collaboration to Test AMX0035

Pre-clinical studies at Columbia University’s Motor Neuron Center Complement Amylyx Phase 2 Clinical Studies of Lead Therapeutic Compound

New York, NY and Cambridge, MA (September 7, 2017) – Project ALS and Amylyx Pharmaceuticals today announced a collaboration to undertake pre-clinical studies with Amylyx’s oral compound AMX0035 to advance the understanding of the compound’s neurobiological effects. The studies to be conducted at the Project ALS Pre-Clinical Core at Columbia University’s Motor Neuron Center will complement the company’s recently initiated Phase 2 clinical program of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS).

The Project ALS Pre-Clinical Core at the Columbia University’s Motor Neuron Center has established a unique integrated and standardized platform for the testing and validation of new therapeutic strategies in recognized experimental models of ALS and for biomarker discovery. The Core, developed in collaboration with Project ALS, will accelerate the translation of new promising therapies to patients by facilitating speedy testing of new therapeutic leads discovered by laboratories studying motor neuron biology, genetics and genomics.

“The collaboration will bring together a promising therapeutic candidate for a devastating disease with leading edge, fundamental neuroscientific research at Columbia,” said Valerie Estess, director of research for Project ALS. “The studies in this collaboration will provide greater insight into the neurobiological effects of AMX0035, and hopefully optimize its beneficial effects.”

The collaboration is an outgrowth of previous studies by The Project ALS Pre-Clinical Core at Columbia University of tauroursodeoxycholic acid (TUDCA), one of the components of AMX0035. “We look forward to evaluating AMX0035 in models of ALS. It is exciting that TUDCA has independently shown promise in both our labs and in studies conducted by the company,” said Drs. Hynek Wichterle and Serge Przedborski, co-directors of The Project ALS Pre-Clinical Core and tenure faculty in the Departments of Pathology and Neurology at Columbia University.

AMX0035 is a combination of two drugs, sodium phenylbutyrate (PB) and tauroursodeoxycholic acid (TUDCA). Previous studies of PB and TUDCA as individual agents demonstrated efficacy in cellular and animal models of ALS. AMX0035 has been shown to synergistically prevent nerve cell death and neurotoxic inflammation, hallmarks of ALS, in preclinical models. In addition, PB and TUDCA have been individually tested in ALS clinical trials and each demonstrated safety, tolerability, and preliminary signs of efficacy. AMX0035 recently entered Phase 2 clinical development to evaluate its safety and efficacy in ALS. The trial, called CENTAUR, is a 24-week, randomized, double-blind, placebo-controlled study in 132 participants with ALS. More information on the CENTAUR trial can be found at www.clinicaltrials.gov, NCT03127514 and at www.Amylyx.com/Trials.

“Amylyx is very excited to partner with Project ALS and the researchers at Columbia’s Motor Neuron Center to advance these experiments. We hope these studies will provide valuable insights into both AMX0035 and ALS biology that will ultimately improve the lives of patients with ALS,” said Kent Leslie, Chief Scientific Officer of Amylyx.

5

CellCentric exploring CCS1477 and p300/CBP inhibition for haematological cancers

September 5th 2017

CellCentric has signed an agreement with Laura Pasqualucci, Professor of Pathology and Cell Biology at Columbia University Medical School, New York USA, to explore the relevance of the company’s drug Candidate, CCS1477, in treating certain haematological cancers. This is in addition to existing collaborations with Professor Tim Somervaille, Consultant Haematologist and Senior Group Leader at the Cancer Research UK Manchester Institute and Professor Brian Huntly, Consultant Haematologist and Professor of Leukaemia Stem Cell Biology at the Cambridge Stem Cell Institute.

CCS1477 is a novel, potent and highly selective p300/CBP inhibitor candidate drug. The compound is progressing to the clinic with a lead indication for the aggressive form of prostate cancer (CRPC).

Additionally, it has been known for some time that inhibiting p300/CBP has relevance to treating other tumour types, including blood, bladder and lung cancers. However, to date, there has been a lack of clinical-quality compounds with which to explore such new applications.

CellCentric has been exploring a range of potential clinical indications for CCS1477 through its own research, as well as through multiple collaborations with leading academic groups. The latest agreement will see Laura Pasqualucci test CCS1477 in a series of in-house haematological cancer models. She has a long-standing interest in epigenetic-related targets and their role in cancer. Alongside Riccardo Dalla-Favera, she originally identified p300/CBP as common target mutations in both diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL).

Tim Somervaille separately, is exploring the potential for CCS1477 in acute myeloid leukaemia (AML). Tim has a long-standing interest in the mechanisms and therapies in myeloid malignancies. Brian Huntly is an internationally recognised expert in the role of p300/CBP in haematopoietic stem cell function and will be researching the effects of CCS1477 in his unique collection of haematological cancer models.

CellCentric is also collaborating with academic groups for CCS1477’s primary indication, castrate resistant prostate cancer. Inhibiting p300/CBP drives down levels of the androgen receptor, its adaptive splice variants, as well as key biomarkers including PSA. Further mechanistic aspects are being explored by CellCentric with Karen Knudsen (Director, Kimmel Cancer Center, Thomas Jefferson University); Johann de Bono (Drug Development Unit Director, ICR, Royal Marsden, London); and Luke Gaughan (NICR, University of Newcastle).

CCS1477 is in the final stages of toxicological evaluation prior to submission of a Clinical Trial Application (European equivalent of an IND) to initiate human testing. First patient dosing is anticipated early in 2018, under the leadership of Johann de Bono.

Commenting, Nigel Brooks, CellCentric’s Director of Translational Science, said ‘Recent data has strongly supported the potential of CCS1477 and p300/CBP inhibition for the treatment of tumours beyond castrate resistant prostate cancer. We are delighted to be investigating these further with multiple world-leading researchers. We look forward to further validating our strategy for testing CCS1477 for multiple tumour types, as CellCentric moves to the clinic.’

Archive

November 2017

15

NuCana Announces First Patients Enrolled in Phase 2 Study of Acelarin in a Platinum-Resistant Ovarian Cancer

EDINBURGH, United Kingdom, Nov. 15, 2017 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced the enrollment of the first patients in both the United States and the United Kingdom in its PRO-105 study evaluating single-agent Acelarin (NUC-1031) in patients with platinum-resistant ovarian cancer. Hugh Griffith, NuCana’s Chief Executive Officer, stated: “The initiation of this Phase 2 study of Acelarin in both the US and the UK is a major step in the expansion of the NuCana product pipeline and advances our strategy of rapidly developing our ProTides to benefit cancer patients globally. We are grateful to the patients and clinicians who are making this study possible.” The PRO-105 study will enroll up to 64 patients with platinum-resistant ovarian cancer who have relapsed following three or more prior lines of chemotherapy. Patients will receive Acelarin on day 1, 8 and 15 of a 28-day cycle and will be treated to progression. The primary endpoint of the study will be Objective Response Rate, and secondary endpoints include Duration of Response, Progression-Free Survival, Overall Survival and safety parameters. Part one of the study will enroll up to 20 patients in each of two dose cohorts: 500mg/m2 and 750mg/m2. In part two of the study, NuCana will select one of these doses and enroll at least an additional 24 patients at the selected dose. NuCana expects to announce interim data from this study in 2018. More information about this study may be found at https://clinicaltrials.gov/ct2/show/NCT03146663. Professor Bradley J. Monk of Arizona Oncology and co-Chief Investigator of PRO-105 stated: “Platinum-resistant ovarian cancer remains an area of significant unmet medical need and we are excited to participate in this study and advance Acelarin as a potential treatment for women with ovarian cancer. Acelarin’s ability to overcome key cancer cell resistance mechanisms resulting in significantly greater levels of the active anti-cancer metabolite differentiates it from other treatment approaches.” Professor Charlie Gourley, of the University of Edinburgh and co-Chief Investigator of PRO-105, added: “Acelarin has shown meaningful clinical activity in advanced recurrent ovarian cancer and has been well-tolerated in clinical studies to date. We are pleased to be a part of this important clinical study.” Acelarin is a potential first-in-class ProTide that has been evaluated in over 140 patients. In the first-in-human Phase 1 dose-ranging PRO-001 study in 49 evaluable patients with advanced metastatic solid tumors, Acelarin was well tolerated and achieved a 78% disease control rate. Acelarin achieved a disease control rate of 93% in a subset of 14 evaluable patients with advanced gynecological cancers in the PRO-001 study. This was followed by the Phase 1b dose-ranging PRO-002 study where Acelarin in combination with carboplatin achieved a 96% disease control rate and 39% response rate in 23 evaluable patients with recurrent ovarian cancer.

13

Apellis Pharmaceuticals Announces Closing of its Initial Public Offering

CRESTWOOD, Ky., Nov. 13, 2017 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS), a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, today announced the closing of its initial public offering of 10,714,000 shares of common stock at a public offering price of $14.00 per share. The total gross proceeds to Apellis were approximately $150.0 million, before deducting underwriting discounts and commissions and expenses payable by Apellis. All of the shares were sold by Apellis. In addition, Apellis granted the underwriters a 30-day option to purchase up to 1,607,100 additional shares of common stock at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any. The shares commenced trading on the NASDAQ Global Select Market under the ticker symbol “APLS” on Thursday, November 9, 2017. Citigroup, J.P. Morgan and Evercore ISI acted as joint book-running managers for the offering. A registration statement relating to the securities sold in this offering was declared effective by the Securities and Exchange Commission on November 8, 2017. The offering was made only by means of a prospectus. When available, copies of the final prospectus relating to the offering may be obtained by contacting: Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-800-831-9146, or email: prospectus@citi.com; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, telephone: (888) 474-0200, or email: ecm.prospectus@evercore.com. This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Apellis Apellis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade.

10

Aduro Biotech Announces Promising Preclinical Data that Validate Anti-CTLA-4 Antibody ADU-1604

BERKELEY, Calif., Nov. 10, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced data from preclinical studies with ADU-1604, the company’s humanized anti-CTLA-4 monoclonal antibody. Data from these in vitro and in vivo studies demonstrate the potency of ADU-1604 and its ability to inhibit tumor growth and enhance T cell-dependent antibody responses. These data, which will be highlighted later today in a poster presentation (Poster #335) at the 32ND Annual Meeting of the Society for Immunotherapy of Cancer (SITC), underscore the potential application of ADU-1604 for the treatment of multiple cancer types, either as monotherapy or in combination with other therapies. “These data from preclinical studies of ADU-1604, a novel anti-CTLA-4 product candidate derived from our proprietary B-select antibody platform, are encouraging and provide support to file an Investigational New Drug Application to advance ADU-1604 into clinical studies,” stated Andrea van Elsas, Ph.D., chief scientific officer of Aduro Biotech. “As a company with multiple programs and proprietary technology platforms, we are well positioned to leverage our product candidates, as monotherapies and in rational combinations, to develop new treatment options for patients in need.”

08

Synlogic Reports Positive Top-Line Phase 1 Data Demonstrating Safety and Tolerability and Proof of Mechanism in Healthy Volunteers for SYNB1020, a Synthetic BioticTM Medicine for the Treatment of Hyperammonemia

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 8, 2017-- Synlogic, Inc.,(Nasdaq:SYBX) a clinical-stage drug discovery and development company applying synthetic biology to probiotics to develop novel Synthetic Biotic medicines, today announced positive top-line clinical data from its Phase 1 placebo-controlled single (SAD) and multiple ascending dose (MAD) clinical trial of SYNB1020 in healthy volunteers. The trial successfully met the primary objectives demonstrating safety and tolerability in healthy volunteers and identifying the maximum tolerated dose. Furthermore, proof of mechanism was demonstrated by a clear signal in a plasma nitrogen endpoint. SYNB1020, is a novel, first-in-class, Synthetic Biotic medicine that is orally delivered and designed to treat elevated blood ammonia levels, or hyperammonemia, in genetic urea cycle disorders (UCD) or in chronic liver disease "The positive data from our Phase 1 study in healthy volunteers, demonstrates that SYNB1020 was well-tolerated and had a statistically significant dose-dependent effect on the level of a nitrogen endpoint, providing evidence to support its mechanism of action," said Aoife Brennan, M.B., B.Ch., Synlogic’s chief medical officer. "These data support the hypothesis that SYNB1020 treatment may provide clinical benefit in patients with UCDs or liver disease, and will inform dose selection in our planned Phase 1b/2a study of SYNB1020 in patients, which we expect to begin in the first half of 2018." “This first-in-human study represents a significant milestone for our new class of Synthetic Biotic medicines and demonstrates that they can operate from the gastrointestinal tract to metabolize systemic toxins,” said JC Gutiérrez-Ramos, Ph.D., Synlogic’s president and chief executive officer. “We look forward to evaluating SYNB1020 in patients, and to moving our second program, SYNB1618 for the treatment of phenylketonuria into clinical trials in 2018. SYNB1020 was safe and well tolerated in subjects in multiple ascending dose cohorts who received total daily doses of up to 1.5x1012 CFU for 14 days. There have been no serious adverse events (SAEs), and no cases of infection with the bacteria in this study. While the study is ongoing, there is no evidence of colonization by SYNB1020 as all subjects who have completed follow-up have cleared the bacteria from their systems within the expected timeframe. In the MAD component of the Phase 1 study, daily dosing of SYNB1020 over 14 days in healthy volunteers enabled identification of a dose-response relationship between SYNB1020 oral administration and changes in a nitrogen endpoint in plasma which was found to be statistically significant in the highest dose cohort compared to placebo. In addition, viability and evidence of mechanistic activity of the Synthetic Biotic was demonstrated in feces of subjects who received SYNB1020, but not in control subjects. As expected, SYNB1020 did not lower blood ammonia levels in these healthy individuals who had normal blood ammonia levels at baseline. Collectively, the data support the hypothesis that SYNB1020 treatment may enable metabolism of potentially neurotoxic blood levels of ammonia in patients with hyperammonemia stemming from UCDs or liver damage.

October 2017

26

This 'Uber' Of Staffing App Could Revolutionize The Hospitality Industry

Jitjatjo is a new app specifically designed to solve temporary hospitality staffing problems. Catering companies, event planners and restaurateurs can use Jitjatjo (which sounds like tic tac toe) to ease their “supply and demand” challenges of staffing. In one week managers might need to hire staff to accommodate an intimate black-tie dinner party for 30 diners, a 3,000-person corporate event and a promotional cocktail hour for 300 people. Finding talented workers during busy periods, retaining them during slow periods, is both stressful and time consuming. “How can I get part-timers that come in and give me the available supply to satisfy the demand?” asks Ron McCulloch rhetorically in his strong Scottish accent. Jitjatjo’s co-founder and Executive Chairman, 64-year-old McCulloch sits in his Manhattan office that overlooks Soho, explaining that his 25+ years in the hospitality industry, including the colossal Home Nightclub in Sydney where he lived for 17 years, taught him the elastic nature of hospitality staffing. “So rather than just taking someone off the street and say, ‘Come and work for me for one night,’” says McCulloch, demonstrating the level of desperation some managers feel when looking for hospitality staff, especially last-minute; instead he suggests, managers turn to the more efficient and targeted Jitjatjo app, which launched 11 months ago. McCulloch, along with co-founder and CEO Tim Chatfield, play down the comparison, Jitjatjo is arguably the Uber of temporary hospitality staffing. If a catering company suddenly needs five extra servers and a bartender for an event in two hours, they input the specifics of the job through the Jitjatjo app and its algorithm books the most qualified workers available within minutes. For better or worse, servers and clients don’t choose each other, Jitjatjo’s algorithm makes the match. “People in hospitality have so many things to do,” says McCulloch, “they want simple solutions.”

26

ENYO Pharma opens a new subsidiary in Australia as a new managing center for clinical trials

Lyon, October 26, 2017. ENYO Pharma, a biopharmaceutical company developing new molecules with an innovative approach inspired by viruses, made a strategic decision and has recently decided to open its first wholly owned subsidiary in Melbourne, Australia, because of its excellent clinical trials development capabilities and attractive conditions offered by the government. The Australian Government is very supportive of biotech startups and the Victorian Government Business Office provides good business development networking. This office will be the new ENYO Pharma center to manage EYP001 (an FXR agonist) clinical trials in the Asia-Pacific region for chronic Hepatitis B. A Phase 1b study of EYP001 is currently submitted in 4 countries and two new Australian centers in Sydney and Perth have joined the study and started recruitment. ENYO Pharma bases its innovation on mimicking viral strategies to discover new cellular targets and is currently developing drug candidates in therapeutic areas such as infectious and metabolic diseases. One of the company’s leading programs is a new drug EYP001, against chronic Hepatitis B which is a major public health concern in the Asia-Pacific region. More than a half of the global population infected worldwide by Hepatitis B are located in this region, representing 129 million patients. “ENYO Pharma is currently looking forward to working in this region as the well-established clinical expertise in this part of the world adds important value to ENYO Pharma R&D efforts and specifically our expeditious development of EYP001” commented Pietro Scalfaro, M.D., Chief Medical Officer of ENYO Pharma SA. “Melbourne’s strong biotechnology sector is the leading research and clinical trial hub in the Asia Pacific region. ENYO Pharma is a leading biotechnology innovator in infectious diseases and the Government of Victoria is proud to welcome their new research subsidiary into Melbourne, Australia.” said the Minister for Innovation and Trade, Minister Philip Dalidakis.

24

Innovative Alzheimer’s Disease Combination Therapy Trial Supported By New Joint Funding Initiative

NEW YORK AND CHICAGO, Oct. 24, 2017 /PRNewswire-USNewswire/ — The Alzheimer’s Association and Alzheimer’s Drug Discovery Foundation (ADDF) are collaborating to jointly fund a new combination therapy clinical trial for Alzheimer’s disease to be conducted by Amylyx Pharmaceuticals. The $1.85 million grant is the first award under an initiative created by the Alzheimer’s Association and the ADDF to fund combination therapies. The grant will support a phase 2 clinical trial of AMX0035, a combination of sodium phenylbutyrate (PB) and tauroursodeoxycholic-acid (TUDCA). The trial, expected to begin in the first half of 2018, will include approximately 50 people with mild cognitive impairment or mild-to-moderate Alzheimer’s disease and test the drug’s effectiveness at slowing or stopping brain cell death. “Combination therapies hold great potential to slow the progression of Alzheimer’s,” said Howard Fillit, MD, the ADDF’s founding executive director and chief science officer. “The innovation of Amylyx’s combination therapy is that it targets multiple causes of brain cell loss, and the two drugs given in tandem create additional protective effects. The ADDF was an early supporter of innovative targets for Alzheimer’s, and we believe combination therapies are a critical next step in finding effective treatments for the disease.” Alzheimer’s is a complex disease with multiple, interrelated causes. A growing number of experts believe combination therapy—with two or more drugs, or drugs and lifestyle interventions—will be required to effectively treat it. “We have witnessed the success of combination therapy in HIV/AIDS, cancer, and heart disease. There is strong reason to believe that to successfully address Alzheimer’s, and its extraordinary complexity, we need to attack the disease on multiple fronts,” said Maria Carrillo, PhD, Alzheimer’s Association chief science officer. “Meetings convened in 2015 by the Alzheimer’s Association (proceedings published in 2016) and the ADDF led the two organizations to recognize the potentially important role of combination therapies in Alzheimer’s and paved the way for this exciting partnership and initial clinical trial funding.” New approaches to Alzheimer’s are urgently needed, as deaths from the disease continue to rise precipitously as more and more Baby Boomers reach the age of greatest risk. The grant was made through the Alzheimer’s Combination Therapy Opportunities (ACTO) program, a joint research funding initiative created by the Alzheimer’s Association and the ADDF to support clinical trials combining multiple treatment approaches. The ACTO program specifically called for study proposals using repurposed drugs that have been determined safe for use in treating other conditions. Repurposing may speed the drug development process because researchers can often begin with phase 2 trials including outcome measures of effectiveness, rather than phase 1 safety tests. The drug to be tested, AMX0035, is a proprietary oral formulation of two existing therapeutics. PB is an FDA-approved therapy—currently prescribed for urea-cycle disorders—that activates genes responsible for protecting brain cells from toxic unfolded proteins. TUDCA is an acid produced in small amounts by the body that targets cellular energy loss. In preclinical studies conducted by the company and with academic collaborators, combination dosing of PB and TUDCA protected brain cells from inflammation and oxidation. Amylyx received FDA clearance for AMX0035’s Investigational New Drug application in April 2017 and has an ongoing multicenter clinical study of the compound in people with amyotrophic lateral sclerosis (ALS). “We are very grateful for the support from the Alzheimer’s Association and the Alzheimer’s Drug Discovery Foundation, and we’re honored to partner with them in this new combination therapy initiative,” said Kent Leslie, Amylyx chief scientific officer. “Through a combination approach targeting two different and independent pathways, AMX0035 is designed to benefit both neurodegeneration and neuroinflammation, key drivers of Alzheimer’s and ALS. The biomarker-focused trial design will assist in translating the promising preclinical effects observed in models of Alzheimer’s to an improved understanding of the potential of AMX0035 to help individuals living with this disease.”

24

Synlogic Receives Orphan Drug Designation for SYNB1618, a Synthetic BioticTM Medicine for the Treatment of Phenylketonuria

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 24, 2017-- Synlogic (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel living medicines, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to SYNB1618, Synlogic’s preclinical-stage drug candidate for the treatment of phenylketonuria (PKU) , an inborn error of metabolism (IEM) caused by a mutation in the gene that breaks down the amino acid phenylalanine (Phe). Phe accumulation in the blood and brain can lead to neurocognitive abnormalities and treatment currently requires severe dietary protein restriction. SYNB1618, an orally administered medicine, is designed to complement the missing function in patients with PKU by providing alternative metabolic pathways to consume Phe. Synlogic plans to file an investigational new drug application (IND) with the FDA for SYNB1618 for the potential treatment of PKU in early 2018. “We believe our Synthetic Biotic medicines could transform the treatment of PKU,” said Aoife Brennan, M.B., B.Ch., Synlogic’s chief medical officer. “Consequently, we were pleased to receive the FDA’s orphan drug designation which validates our approach and represents an important step toward achieving our goal of bringing novel treatments to the patients and families affected by this challenging disease.”

16

‘Farm in a Box’ Could Protect Food Supplies After Extreme Weather Events

Boston-based Freight Farms has developed what it calls the Leafy Green Machine, a method for vertical, hydroponic farming inside a shipping container. BY MOLLY FOSCO OCTOBER 16, 2017 3:53 PM EDT - Vertical and hydroponic farming has gained popularity in recent years. And with the frequency and intensity of some extreme weather events on the rise, innovative techniques offer enticing solutions to some agricultural problems. Boston-based company Freight Farms is offering one approach: It’s helping people grow food inside shipping containers 365 days a year, no matter the weather conditions. Brad McNamara and Jon Friedman started Freight Farms in 2010 with the goal of making it easier for anyone to grow food on a commercial scale. “We really focused on putting farming into the hands of regular people so that you can have a manageable footprint but still produce at a commercial level,” McNamara, the company’s CEO, told Seeker. “We were really inspired by what’s becoming possible with new technology and the fact that no one had changed their thinking yet from big agriculture and large-scale farms.” McNamara and Friedman wanted to create something small that could still produce large crop yields. The result is the Leafy Green Machine, a produce farm that operates inside a shipping container that is forty feet long, eight feet wide, and nine and a half feet high. The LGM uses a vertical, hydroponic farming method that allows leafy greens like kale, lettuce, and cabbage, as well as herbs like basil, mint, and oregano, to be harvested once a week, year round. It grows 2-4 tons of produce annually using less than 10 gallons of water per day. Its water, air, and nutrient inputs can be monitored and controlled remotely using a software called "farmhand." The LGM costs about $85,000 and around $13,000 to operate annually. Freight Farms offers financing options, as well as video tutorials and two-day, in-person trainings at their Boston headquarters on how to operate an LGM.

04

Forensic Logic Announces Acquisition of COPLINK Platform from IBM

The acquisition will create the nation’s largest network of law enforcement users, information, and technology WALNUT CREEK, CA and TUCSON, AZ – October 4, 2017 – Forensic Logic, the premier provider of network search technology and cloud-based information services to law enforcement, today announced it has acquired the COPLINK suite of products from IBM. COPLINK is a leading public safety information sharing platform and provider of analytical, tactical and operational software for law enforcement. The acquisition will deliver an unprecedented level of information access and technological interoperability to the U.S. law enforcement community, while greatly streamlining data integration, product acquisition, and customer service among their customer base. Created in 1998, COPLINK provides public safety software and services to over 5100 law enforcement jurisdictions throughout the United States. In addition to its core analysis platform, the COPLINK system offers an integrated array of software solutions for investigations, operations, and compliance. Founded in 2003, Forensic Logic has become one of the fastest-growing public safety technology providers in the country built on the success of its search engine optimized for public safety. The acquisition will further Forensic Logic’s strategy to deploy a fully integrated suite of world-class information access technology across the widest possible network of public safety agencies. “The COPLINK acquisition reinforces our commitment to bring a compelling combination of technological capabilities to this market,” said Bob Batty, CEO of Forensic Logic. “Our customers will no longer have to choose between the best search capability, the finest analytical tools, and the richest network of data – once the integration is done they will all be on one platform.”

02

Stealth BioTherapeutics Granted Orphan Drug Designation of Elamipretide for Treatment of Patients with Primary Mitochondrial Myopathy

BOSTON – October 2, 2017 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation to Stealth’s investigational drug candidate, elamipretide, for the treatment of patients with primary mitochondrial myopathy (PMM). “We are thrilled to achieve this key regulatory milestone for the treatment of PMM, a debilitating condition characterized by muscle weakness and fatigue with no FDA-approved treatments,” said Reenie McCarthy, Stealth’s chief executive officer. “We will continue to work closely with the FDA as we advance into our Phase 3 trial of elamipretide in patients with PMM.” The Orphan Drug Act was enacted in 1983 to encourage development of drugs for rare diseases, which are diseases that affect fewer than 200,000 persons in the United States. Once granted, Orphan Drug Designation provides various development benefits for an investigational drug, including seven-year exclusivity after marketing approval is received. In June 2017, Stealth announced results from MMPOWER-2, a Phase 2 continuation trial evaluating safety, tolerability and efficacy of treatment with elamipretide for PMM, which showed benefit of elamipretide across multiple endpoints assessed and supports a Phase 3 trial in this patient population. Stealth is currently recruiting for the RePOWER trial, an observational study of patients with PMM. Patients enrolled in RePOWER may have the opportunity to participate in the Phase 3 trial to further evaluate the potential efficacy, safety and tolerability of elamipretide for patients with PMM.

02

NuCana Plc Announces Closing Of Initial Public Offering Of ADSs And Exercise Of Underwriters' Option To Purchase Additional ADSs

EDINBURGH, United Kingdom, Oct. 02, 2017 (GLOBE NEWSWIRE) -- NuCana plc (Nasdaq:NCNA), a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for cancer patients by applying its ProTide™ technology to transform some of the most widely prescribed chemotherapy agents into more effective and safer medicines, announced today the closing of its initial public offering of 7,596,505 American Depositary Shares ("ADSs") at a price to the public of $15.00 per ADS, which includes 929,505 shares sold upon partial exercise of the underwriters' option to purchase additional ADSs, for total gross proceeds of approximately $114 million, before deducting underwriting discounts and commissions. Each ADS represents one ordinary share of NuCana. The ADSs began trading on the NASDAQ Global Select Market on September 28, 2017 under the ticker symbol "NCNA." All ADSs were offered by NuCana. Citigroup, Jefferies and Cowen acted as joint book-running managers for the offering, and William Blair acted as co-manager for the offering. A registration statement on Form F-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on September 27, 2017. Copies of the registration statement can be accessed by visiting the SEC's website at www.sec.gov. The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by phone at (800) 831-9146, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340 or by e-mail at Prospectus_Department@Jefferies.com, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention Prospectus Department or by phone at (631) 274-2806. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

September 2017

27

Aduro Biotech Announces First Patient Dosed in Phase 1 Clinical Trial of Personalized Immunotherapy pLADD Based on Proprietary Neoantigen Technology

Trial has begun in Patients with Metastatic Colorectal Cancer Who Have Few Treatment Options BERKELEY, Calif., Sept. 27, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that the first patient has been dosed in the Phase 1 clinical trial (see www.clinicaltrials.gov, identifier NCT03189030) designed to evaluate the safety and tolerability of a personalized live, attenuated double-deleted Listeria monocytogenes (pLADD) immunotherapy for adults with metastatic colorectal cancer that is microsatellite stable (MSS). The personalized immunotherapy has been engineered with patient-specific neoantigens that were identified and selected using state-of-the-art neoantigen identification technology developed by Hanlee Ji, M.D., associate professor of medicine at the Stanford University School of Medicine. “Our pLADD program leverages our extensive capabilities relating to the use of Listeria as a delivery mechanism for cancer antigens and Dr. Ji’s innovative neoantigen technology used to identify immunogenic antigens specific for an individual patient,” said Natalie Sacks, M.D., chief medical officer of Aduro Biotech. “Together, we believe these two cutting edge technologies represent a new approach to treating patients who have relapsed following prior chemotherapy. We look forward to evaluating initial proof-of-concept in this Phase 1 clinical trial.” Clinical Design of Phase 1 PLADD Trial in Adults with Metastatic Corlorectal Cancer The Phase 1 clincial single-arm trial is designed to evaluate the safety and tolerability of a personalized immunotherapy made using patient-specific antigens and Aduro’s proprietary live, attenuated, double-deleted Listeria monocytogenes platform technology. The trial is seeking to enroll approximately 10 patients with metastatic colorectal cancer that is MSS. Patients will receive their patient-specific immunotherapy once every three weeks.

27

NuCana plc Announces Pricing of Initial Public Offering

EDINBURGH, United Kingdom, Sept. 27, 2017 (GLOBE NEWSWIRE) -- NuCana plc (Nasdaq:NCNA), a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for cancer patients by applying its ProTide ™ technology to transform some of the most widely prescribed chemotherapy agents into more effective and safer medicines, announced today the pricing of its initial public offering of 6,667,000 American Depositary Shares ("ADSs") at a price to the public of $15.00 per ADS, for total gross proceeds of approximately $100.0 million, before deducting underwriting discounts and commissions. Each ADS represents one ordinary share of NuCana. In addition, NuCana has granted the underwriters a 30-day option to purchase up to 1,000,050 additional ADSs at the initial offering price to cover over-allotments, if any. All of the ADSs are being offered by NuCana. NuCana's ADSs have been approved for listing on the NASDAQ Global Select Market and are expected to begin trading under the symbol "NCNA" on September 28, 2017. The offering is expected to close on October 2, 2017, subject to customary closing conditions. Citigroup, Jefferies and Cowen are acting as joint book-running managers for the offering, and William Blair is acting as co-manager for the offering. A registration statement on Form F-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on September 27, 2017. Copies of the registration statement can be accessed by visiting the SEC's website at www.sec.gov. This offering is being made only by means of a prospectus. A copy of the final prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by phone at (800) 831-9146, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340 or by e-mail at Prospectus_Department@Jefferies.com, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention Prospectus Department or by phone at (631) 274-2806. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

26

Aduro Biotech Announces Advancement of ADU-S100 into Global Combination Trial With PDR001 for the Treatment of Solid Tumors and Lymphomas

First Patient Dosed in Phase 1b Clinical Trial BERKELEY, Calif., Sept. 26, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that the first patient has been dosed in the Phase 1b dose escalation and dose expansion clinical trial (see www.clinicaltrials.gov, identifier NCT03172936) designed to evaluate the safety and efficacy of ADU-S100 (also known as MIW815), a novel STING pathway activator, in combination with PDR001, Novartis’ investigational PD-1 checkpoint inhibitor, for the treatment of advanced/metastatic solid tumors or lymphomas. The trial, which is being conducted in collaboration with Aduro’s partner, Novartis, is expected to enroll approximately 175 patients at sites located in the United States, Europe, Canada, Australia and Japan. “We are pleased with our early progress in the ongoing Phase 1 dose escalation trial of ADU-S100 as a single agent and are eager to expand our investigation into a separate clinical trial to evaluate the effect of ADU-S100 used in combination with the PDR001 checkpoint inhibitor,” said Natalie Sacks, M.D., chief medical officer of Aduro Biotech. “As a leader in STING activation, we look forward to gaining more insight into the potential therapeutic application of this novel combination therapy.” Clinical Design of Phase 1b ADU-S100 (MIW815)/PDR100 The Phase 1b multi-center, open-label study is designed to evaluate the safety and efficacy of ADU-S100 (MIW815) in combination with PDR001 in patients with accessible solid tumors or lymphomas. The trial will evaluate two treatment schedules of ADU-S100 in dose escalation. One group will receive a fixed dose of intravenous PDR001 on day 1 and an intratumoral injection of ADU-S100 three times in a 28-day cycle. Another group will receive a fixed dose of intravenous PDR001 on day 1 and intratumoral injection of MIW815 (ADU-S100) on day 1 of every 28-day cycle. Once the maximum tolerated dose and/or recommended dose for expansion is determined, the expansion part of the study will open.

19

Amylyx Pharmaceuticals Receives FDA Orphan Drug Designation for AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis

September 19, 2017 09:00 AM Eastern Daylight Time CAMBRIDGE, Mass.–(BUSINESS WIRE)–Amylyx Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AMX0035, an oral therapeutic in clinical development for the treatment of amyotrophic lateral sclerosis (ALS). The Company recently began a Phase 2 clinical study, the CENTAUR trial, to evaluate the safety and efficacy of AMX0035 in ALS patients. The U.S. Orphan Drug Act provides incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. Orphan drug designation by the FDA conveys up to seven years of marketing exclusivity if the compound receives regulatory approval, and offers various development incentives, including tax credits related to clinical trial expenses, an exemption from the FDA-user fee, and FDA assistance in clinical trial design. Background on AMX0035 AMX0035 is a combination of two small molecules, sodium phenylbutyrate (PB) and tauroursodeoxycholic acid (TUDCA). Each compound has demonstrated strong efficacy in several cellular and animal models of ALS. When individually tested in ALS clinical trials, PB and TUDCA have both shown safety, tolerability, and preliminary signs of efficacy. In preclinical trials, Amylyx has demonstrated a synergistic effect between the two compounds, suggesting that the combination may have improved efficacy compared to the individual agents. About the CENTAUR Trial CENTAUR is a 24-week, randomized, double-blind, placebo-controlled Phase II clinical trial in 132 participants with ALS. The trial’s primary objectives are to evaluate the safety and tolerability of AMX0035 and assess the drug’s impact on disease progression as measured by the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) over the 24-week study period. The trial will also evaluate the impact of AMX0035 on isometric strength as measured by ATLIS, respiratory function, and exploratory biomarkers. There will also be an open label extension to the trial so that all enrolled patients will have the option of continuing treatment once the 24-week treatment period concludes.

18

Green Biologics’ Renewable Chemicals Granted Kosher and Halal Certification

Company’s n-butanol and acetone can now serve as ingredients for the growing markets for kosher and halal consumer goods Ashland, Virginia and Abingdon, Oxfordshire U.K. (September 18, 2017) – Green Biologics, Inc., the U.S. subsidiary of Green Biologics Ltd., a U.K. industrial biotechnology and renewable chemicals company, announced today that it has achieved kosher and halal certification for the 100 percent biobased n-butanol and acetone, produced at the company’s commercial facility in Little Falls, Minnesota. These certifications enable Green Biologics’ chemicals to serve as ingredients for personal, homecare and food products. “The kosher and halal certifications that have been granted to our Little Falls, MN manufacturing facility will further enable us to build partnerships within the major food, cleaning and cosmetic brands, to name a few,” said David Anderson, Vice President of Marketing at Green Biologics. “These certifications are becoming popular, not only for those with religious motivations, but also to the wider market as they are being used as an effective method for identifying high quality goods.” The recent certifications are an important milestone for Green Biologics’ BioPure™ n-butanol and acetone, which are entirely produced using renewable feedstocks. Consumers and retailers are increasingly demanding products produced from natural or sustainable ingredients. Both n-butanol and acetone can also serve as additives and solvents in personal care, cosmetic, and both household and industrial cleaning products. For cosmetics, while acetone is most often used as a nail polish remover, BioPure™ n-butanol can be combined with acids derived from natural plant based oilsto produce a wide array of 100 percent renewable butyl esters. These esters can be utilized in natural lipsticks, moisturizers, and nail polishes. Butyl esters are also utilized as aroma chemicals in fragrance products and flavor additives within the food industry. In addition to the kosher and halal certifications, provided by the respective OK Kosher and Islamic Services of America certifying bodies, Green Biologics is also a member of the American Chemistry Council (ACC), and its commercial facility, Central MN Renewables LLC, participates in the ACC’s Responsible Care® program. The company’s n-butanol and acetone have received 100 percent biobased, USDA BioPreferred® certification.

13

NuCana Announces Interim Data from First-In-Human Study of Transformative Anti-Cancer Agent, NUC-3373

Received Best Poster Presentation Award at ESMO 2017 Edinburgh, United Kingdom, September 13, 2017 (GLOBE NEWSWIRE) – NuCana plc announced the presentation of interim first-in-human data from a Phase 1 clinical study of NUC-3373, its ProTide transformation of the active anti-cancer metabolite of 5-fluorouracil (5-FU), at the European Society for Medical Oncology (ESMO) 2017 Congress held earlier this week in Madrid, Spain. Interim pharmacokinetic (PK) and pharmacodynamic (PD) data were presented at ESMO 2017, and the presentation was awarded “Best Poster” status by the organizing committee. Key findings from the study included PK and PD data from 21 patients with 10 different advanced solid tumor cancer types and indicated that NUC-3373 has the potential to have greater activity and an improved safety profile as compared to 5-FU. The results indicated a linear and reproducible dose-response across all dose ranges as well as a well-tolerated safety profile. After a short administration, plasma half-life of NUC-3733 was 9.7 hours, as compared to the 8 to 14 minute half-life associated with 5-FU. Evidence of rapid and efficient intracellular activity were noted, with high levels of FUDR-MP, the active anti-cancer metabolite of 5-FU detectable in cells 5 minutes after infusion and still detectable after 48 hours. NUC-3373 bound to and inhibited the target enzyme, thymidylate synthase, and depleted the pool of dTMP, a nucleotide necessary for DNA replication, 2 to 4 hours after administration. Additionally, NUC-3373 did not generate the key toxic metabolites of 5-FU (F-BAL or dhFU) intracellularly or in the patient’s plasma. “NUC-3373 appears to have considerable advantages over 5-FU, with much higher levels of the active, anti-cancer metabolite, that may overcome key cancer resistance pathways and allow for a more favourable safety profile and a more convenient dosing regimen,” said Dr. Sarah Blagden, Associate Professor of Experimental Cancer Medicine at the University of Oxford and Chief Investigator of the study. “5-FU remains one of the most important and widely used anti-cancer drugs in the world. This interim analysis of NUC-3373’s Phase 1 data strongly supports its continued development.” Hugh Griffith, NuCana’s Chief Executive Officer, said: “NUC-3373 is our second product candidate that uses our proprietary ProTide technology with the goal of improving the efficacy and safety of important anti-cancer agents. We are excited to see these interim data and especially gratified that it was chosen for a Best Poster award at ESMO 2017. These data support that NUC-3373 may have a key role to play in the treatment of cancer and we look forward to continuing its rapid development, along with the development of other product candidates in our pipeline.”

12

NuCana Announces Positive Results of NUC-1031 (Acelarin®) in Advanced Ovarian Cancer at ESMO 2017

Acelarin combination with carboplatin achieved 96% disease control rate and 39% response rate in patients with recurrent ovarian cancer Edinburgh, United Kingdom, September 12, 2017 (GLOBE NEWSWIRE) – NuCana plc, a clinical-stage biopharmaceutical company developing a portfolio of novel anti-cancer medicines called ProTides™, announced the presentation of data from its recently completed trial of its lead product candidate, NUC-1031 (Acelarin®), at the European Society for Medical Oncology (ESMO) 2017 Congress held September 8th-12th, 2017 in Madrid, Spain. Results from NuCana’s Phase 1b trial showed that Acelarin, when combined with carboplatin, was well tolerated and demonstrated clinical activity in women with recurrent platinum-resistant and platinum-sensitive ovarian cancer. An overall response rate of 39% was observed amongst the 23 evaluable patients, including 1 (4%) who achieved a complete response, 8 (35%) with partial responses, and 13 (57%) with stable disease that lasted at least 12 weeks. This yielded an overall disease control rate of 96% (22 patients). The responses were durable, with an average progression free survival of 7.4 months. The most common adverse events across all dose levels were neutropaenia, leukopaenia and thrombocytopaenia. No unexpected adverse events were observed with the combination to date. All patients in the study were previously treated with an average of three prior chemotherapy regimens. Seventeen of the evaluable patients were either refractory or resistant to their last platinum-containing regimen. “The fact that the Acelarin combination with carboplatin achieved these results in heavily pre-treated and platinum-resistant patients clearly demonstrates Acelarin is a very active agent,” said Dr. Sarah Blagden, Associate Professor of Experimental Cancer Medicine at the University of Oxford and Chief Investigator of the Phase 1b study. Professor Blagden added, “importantly, the favorable toxicity profile of Acelarin enabled us to combine it with carboplatin at AUC 5, whereas with gemcitabine, carboplatin has to be given at AUC 4. Thus, we are able to deliver both Acelarin and carboplatin at their optimal dose.” Hugh Griffith, NuCana’s Chief Executive Officer, said: “The high disease control rate and durable responses achieved with the combination of Acelarin and carboplatin are exciting. We remain focused on advancing Acelarin’s development for the treatment of patients with ovarian cancer as well as exploring its use for the treatment of other solid tumours."

07

Project ALS and Amylyx Enter Collaboration to Test AMX0035

Pre-clinical studies at Columbia University’s Motor Neuron Center Complement Amylyx Phase 2 Clinical Studies of Lead Therapeutic Compound New York, NY and Cambridge, MA (September 7, 2017) – Project ALS and Amylyx Pharmaceuticals today announced a collaboration to undertake pre-clinical studies with Amylyx’s oral compound AMX0035 to advance the understanding of the compound’s neurobiological effects. The studies to be conducted at the Project ALS Pre-Clinical Core at Columbia University’s Motor Neuron Center will complement the company’s recently initiated Phase 2 clinical program of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The Project ALS Pre-Clinical Core at the Columbia University’s Motor Neuron Center has established a unique integrated and standardized platform for the testing and validation of new therapeutic strategies in recognized experimental models of ALS and for biomarker discovery. The Core, developed in collaboration with Project ALS, will accelerate the translation of new promising therapies to patients by facilitating speedy testing of new therapeutic leads discovered by laboratories studying motor neuron biology, genetics and genomics. “The collaboration will bring together a promising therapeutic candidate for a devastating disease with leading edge, fundamental neuroscientific research at Columbia,” said Valerie Estess, director of research for Project ALS. “The studies in this collaboration will provide greater insight into the neurobiological effects of AMX0035, and hopefully optimize its beneficial effects.” The collaboration is an outgrowth of previous studies by The Project ALS Pre-Clinical Core at Columbia University of tauroursodeoxycholic acid (TUDCA), one of the components of AMX0035. “We look forward to evaluating AMX0035 in models of ALS. It is exciting that TUDCA has independently shown promise in both our labs and in studies conducted by the company,” said Drs. Hynek Wichterle and Serge Przedborski, co-directors of The Project ALS Pre-Clinical Core and tenure faculty in the Departments of Pathology and Neurology at Columbia University. AMX0035 is a combination of two drugs, sodium phenylbutyrate (PB) and tauroursodeoxycholic acid (TUDCA). Previous studies of PB and TUDCA as individual agents demonstrated efficacy in cellular and animal models of ALS. AMX0035 has been shown to synergistically prevent nerve cell death and neurotoxic inflammation, hallmarks of ALS, in preclinical models. In addition, PB and TUDCA have been individually tested in ALS clinical trials and each demonstrated safety, tolerability, and preliminary signs of efficacy. AMX0035 recently entered Phase 2 clinical development to evaluate its safety and efficacy in ALS. The trial, called CENTAUR, is a 24-week, randomized, double-blind, placebo-controlled study in 132 participants with ALS. More information on the CENTAUR trial can be found at www.clinicaltrials.gov, NCT03127514 and at www.Amylyx.com/Trials. “Amylyx is very excited to partner with Project ALS and the researchers at Columbia’s Motor Neuron Center to advance these experiments. We hope these studies will provide valuable insights into both AMX0035 and ALS biology that will ultimately improve the lives of patients with ALS,” said Kent Leslie, Chief Scientific Officer of Amylyx.

05

CellCentric exploring CCS1477 and p300/CBP inhibition for haematological cancers

September 5th 2017 CellCentric has signed an agreement with Laura Pasqualucci, Professor of Pathology and Cell Biology at Columbia University Medical School, New York USA, to explore the relevance of the company’s drug Candidate, CCS1477, in treating certain haematological cancers. This is in addition to existing collaborations with Professor Tim Somervaille, Consultant Haematologist and Senior Group Leader at the Cancer Research UK Manchester Institute and Professor Brian Huntly, Consultant Haematologist and Professor of Leukaemia Stem Cell Biology at the Cambridge Stem Cell Institute. CCS1477 is a novel, potent and highly selective p300/CBP inhibitor candidate drug. The compound is progressing to the clinic with a lead indication for the aggressive form of prostate cancer (CRPC). Additionally, it has been known for some time that inhibiting p300/CBP has relevance to treating other tumour types, including blood, bladder and lung cancers. However, to date, there has been a lack of clinical-quality compounds with which to explore such new applications. CellCentric has been exploring a range of potential clinical indications for CCS1477 through its own research, as well as through multiple collaborations with leading academic groups. The latest agreement will see Laura Pasqualucci test CCS1477 in a series of in-house haematological cancer models. She has a long-standing interest in epigenetic-related targets and their role in cancer. Alongside Riccardo Dalla-Favera, she originally identified p300/CBP as common target mutations in both diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL). Tim Somervaille separately, is exploring the potential for CCS1477 in acute myeloid leukaemia (AML). Tim has a long-standing interest in the mechanisms and therapies in myeloid malignancies. Brian Huntly is an internationally recognised expert in the role of p300/CBP in haematopoietic stem cell function and will be researching the effects of CCS1477 in his unique collection of haematological cancer models. CellCentric is also collaborating with academic groups for CCS1477’s primary indication, castrate resistant prostate cancer. Inhibiting p300/CBP drives down levels of the androgen receptor, its adaptive splice variants, as well as key biomarkers including PSA. Further mechanistic aspects are being explored by CellCentric with Karen Knudsen (Director, Kimmel Cancer Center, Thomas Jefferson University); Johann de Bono (Drug Development Unit Director, ICR, Royal Marsden, London); and Luke Gaughan (NICR, University of Newcastle). CCS1477 is in the final stages of toxicological evaluation prior to submission of a Clinical Trial Application (European equivalent of an IND) to initiate human testing. First patient dosing is anticipated early in 2018, under the leadership of Johann de Bono. Commenting, Nigel Brooks, CellCentric’s Director of Translational Science, said ‘Recent data has strongly supported the potential of CCS1477 and p300/CBP inhibition for the treatment of tumours beyond castrate resistant prostate cancer. We are delighted to be investigating these further with multiple world-leading researchers. We look forward to further validating our strategy for testing CCS1477 for multiple tumour types, as CellCentric moves to the clinic.’

August 2017

28

Synlogic Completes Merger with Mirna Therapeutics

- Synlogic Commences Trading on NASDAQ Capital Market under Ticker Symbol “SYBX” - Combined Company has Approximately $100 Million in Cash and Cash Equivalents Following Transaction Close - Company Strengthens Board of Directors with addition of Michael Powell, Ph.D., and Richard Shea CAMBRIDGE, Mass. & AUSTIN, Texas--(BUSINESS WIRE)--Aug. 28, 2017-- Synlogic, Inc. and Mirna Therapeutics, Inc. today announced that the proposed merger of the two companies has closed following the approval of Mirna’s stockholders received on August 24, 2017. The merged company will operate as Synlogic, Inc. and will focus on advancing Synlogic’s platform for development of Synthetic Biotic™ medicines, which are designed using synthetic biology to genetically reprogram probiotic bacteria to treat metabolic and inflammatory diseases and cancer. Synlogic will commence trading on the NASDAQ Capital Market today, August 28, 2017, under the ticker symbol “SYBX”. “The close of this merger, in combination with our recent financing, provides Synlogic with significant resources to move forward as a public company and realize our goal of developing a new class of living medicines that have the unique potential to compensate for dysfunctional pathways in serious diseases,” said Jose Carlos Gutiérrez-Ramos, Ph.D., Synlogic’s president and chief executive officer. “Earlier this year we initiated the first human clinical trial of our lead Synthetic Biotic investigational medicine for hyperammonemia, and in the first half of 2018 we expect to initiate clinical trials of a second Synthetic Biotic medicine candidate for the treatment of phenylketonuria (PKU). Our solid financial position enables us to continue to execute on advancing our novel development programs through the clinic to demonstrate the therapeutic potential of our Synthetic Biotic platform.” The combined company’s cash and cash equivalents, as of immediately following the closing of the merger, is approximately $100 million. This includes proceeds from a Series C financing that closed immediately prior to the signing of the merger agreement in which Synlogic raised approximately $42 million from leading biotechnology investors, including Aju IB Investment, Ally Bridge Group, Arctic Aurora LifeScience, CLI Ventures, Perceptive Advisors, Rock Springs Capital, and other undisclosed new investors. Existing investors, Atlas Venture, Deerfield, New Enterprise Associates (NEA), and OrbiMed also participated in the financing. As a result of the closing of the merger, Synlogic stockholders and option holders own, or have rights to acquire, approximately 82 percent of the combined company, and former Mirna stockholders own approximately 18 percent of the combined company.

24

Apellis Pharmaceuticals Announces that APL-2 Met its Primary Endpoint in a Phase 2 Study in Patients with Geographic Atrophy, an Advanced Form of Age-Related Macular Degeneration

Statistically Significant Slowing of Disease Progression Seen at 12 Months LOUISVILLE, KY., August 24, 2017 - Apellis Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a platform of novel therapeutic compounds for the treatment of autoimmune diseases, today announced that its complement C3 inhibitor, APL-2, met its primary endpoint in a Phase 2 clinical trial (FILLY) in patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD). At 12 months, APL-2, administered monthly via intravitreal injection, showed a 29% (p=0.008) reduction in the rate of GA lesion growth compared to sham. With every other month administration, a 20% (p=0.067) reduction was observed. Additionally, in a post hoc analysis, a greater effect was observed during the second six months of the study: a reduction in growth rate of 47% (p<0.001) with monthly administration, and a reduction of 33% (p=0.01) with every other month administration. The most frequently reported adverse events in the study eye were associated with the injection procedure. A higher incidence of exudative AMD was observed in the treatment groups, predominantly in subjects with a history of exudative AMD in the fellow eye, and was managed with the administration of standard-of-care therapies. “We are very excited about the results of this study,” said Cedric Francois, MD, PhD, founder and chief executive officer of Apellis. “In addition to demonstrating a statistically significant slowing of disease over 12 months, APL-2’s effect appears to increase in the second six months of the study, slowing down the rate of degeneration by almost half. We plan to move forward with Phase 3 studies as soon as possible.” David Boyer, MD, of Retina-Vitreous Associates Medical Group, said, “These results are very exciting for all people afflicted with dry AMD with geographic atrophy. It is currently an untreatable condition, and the reduction of the progression of atrophy in this trial offers new hope for vision maintenance for our patients.” Results, including an analysis of genetic markers, will be presented at an upcoming major medical meeting.

11

Aiming at Soliris, Apellis loads for PNH phase III with $60M series E

By Marie Powers, News Editor, BioWorld Apellis Pharmaceuticals Inc. extended its string of financings with a $60 million series E preferred stock round led by Sectoral Asset Management that included new investors Sofinnova, Vivo Capital, F-Prime Capital Partners, investment funds advised by Clough Capital Partners LP and Venbio Select. Existing investors Morningside Ventures, Cormorant Asset Management, Venbio Global Strategic Fund and Epidarex Capital also participated in the financing. In conjunction with the financing, Maha Katabi, private equity partner at Sectoral Asset Management, is set to join the Apellis board, chaired by Morningside co-founder Gerald Chan. The raise represents the largest to date for the Louisville, Ky.-based company, topping last year’s $47 million series D. Late in 2015, Apellis considered a run at the public markets to fund development of its lead program, APL-2, but the timing was “unfortunate,” according to Cedric Francois, co-founder, president and CEO, with the company’s S-1 dropping at about the same time the markets were doing the same. Still, Apellis, founded in 2009, has had little trouble securing the funds to keep moving forward, raising $92 million prior to the series E. “The real purpose of this round was to broaden our existing syndicate by bringing in investors that can help us take this company to the next level,” Francois told BioWorld. The round, which came together in less than three months, positions Apellis to move its complement C3 inhibitor into a phase III program in paroxysmal nocturnal hemoglobinuria (PNH) and to advance studies in other indications. A synthetic cyclic peptide conjugated to a polyethylene glycol polymer that binds specifically to C3 and C3b, APL-2 blocks all three pathways of complement activation (classical, lectin and alternative) with a particularly high potency against the alternative pathway. In December 2016, Apellis disclosed interim results from two phase Ib open-label, dose-escalation trials of the self-injected APL-2, reporting that the drug reduced the breakdown of red blood cells in patients when given daily as a monotherapy or as an add-on to standard-of-care therapy, the intravenous Soliris (eculizumab) from Alexion Pharmaceuticals Inc., of Cheshire, Conn. At the time of the report, 15 patients dosed across the two trials had completed a month of dosing, and five had completed more than three months of treatment. With APL-2 (270 mg) as a monotherapy, three of three PNH patients achieved a reduction in levels of the biomarker lactate dehydrogenase (LDH) to below the standard for control in PNH (500 U/L). With APL-2 (270 mg) as a Soliris add-on, six of six previously transfusiondependent PNH patients did not require transfusions during the study, and five of six achieved hemoglobin levels within the normal range for healthy people. “We might be on to something,” Francois said at the time. (See BioWorld Today, Dec. 5, 2016.) The phase III program will help to advance that thesis by confirming whether inhibition of C3 offers advantages over drugs like Soliris, which targets complement C5. Apellis plans to begin enrolling the first phase III in PNH in the fourth quarter, “where, ultimately, the goal will be to find out if APL-2 can be superior to Soliris in its mechanism of action,” Francois said.

10

Apellis Pharmaceuticals Announces $60 Million Series E Financing

Funding Will Advance Trials of APL-2 in Paroxysmal Nocturnal Hemoglobinuria LOUISVILLE, KY., August 10, 2017 - Apellis Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a platform of novel therapeutic compounds for the treatment of autoimmune diseases, today announced the closing of a $60 million Series E preferred stock financing led by Sectoral Asset Management. New investors include Sofinnova, Vivo Capital, F-Prime Capital Partners, certain investment funds advised by Clough Capital Partners L.P., and venBio Select. Existing investors Morningside Ventures, Cormorant Asset Management, venBio Global Strategic Fund, and Epidarex Capital also participated in the financing. The proceeds of the financing will be used to initiate Phase 3 trials with APL-2 in paroxysmal nocturnal hemoglobinuria (PNH), a rare, chronic, life-threatening blood disorder, and advance development in other indications. Positive Phase 1b results in PNH were recently reported, and, later in 2017, results are expected from a Phase 1 study in autoimmune hemolytic anemia and a Phase 2 study in geographic atrophy, an advanced form of age-related macular degeneration. “Data generated to date with APL-2 across a range of clinical indications support our belief that C3 inhibition has great potential to deliver novel and commercially successful treatments,” commented Cedric Francois, MD, PhD, founder and Chief Executive Officer of Apellis. "This group of top tier investors supports our vision of developing APL-2 to its full potential, and of providing a range of differentiated treatments to patients with serious unmet medical needs,” he added. “The remainder of this year will see significant milestones for Apellis.” As part of this financing, Maha Katabi, PhD, CFA, Partner, Private Equity at Sectoral Asset Management will join Apellis’ Board of Directors. “APL-2 is a molecule with the potential to disrupt current treatment paradigms in a range of complement-mediated conditions,” noted Dr. Katabi. "We are pleased to support Apellis, and help the Company reach its next growth objectives.”

09

Aduro Biotech Bolsters Intellectual Property Position in STING Field with Two New Patents

BERKELEY, Calif., Aug. 09, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced that the United States Patent and Trademark Office has issued two patents to Aduro related to the activation of the STING (Stimulator of Interferon Genes) Pathway. The first, U.S. Patent 9,724,408, jointly owned with the University of California and licensed to Aduro Biotech, covers ADU-S100 (MIW815), an investigational STING Pathway Activator being developed as a cancer therapy, and certain methods for its use. The second patent, U.S. Patent 9,695,212, claims methods of using certain additional cyclic dinucleotides (CDNs) to induce STING-dependent immune responses. “As leaders in cutting edge research and development of STING technologies, it is imperative that we protect our discoveries and expertise related to the modulation of the STING pathway,” said Stephen T. Isaacs, chairman, president and CEO of Aduro Biotech. “These issued patents strengthen and broaden the intellectual property coverage for fundamental aspects of our clinical CDN, ADU-S100, in addition to protecting our innovative research recognizing the importance of STING as a central mediator in triggering the development of tumor-specific immunity. We have demonstrated preclinically that activating STING promotes an inflamed tumor phenotype, which led to a profound anti-cancer immune response. ADU-S100 is the first STING Pathway Activator to enter into the clinic and is in an ongoing Phase 1 dose escalation study in patients with cutaneously accessible tumors.” The issued patents bolster our patent portfolio for STING, where Aduro owns and licenses families of patents and patent applications for compounds that target the STING receptor, which would expire, or if issued would expire, between 2025 and 2038. These include both U.S. and international patent applications.

08

Amylyx Pharmaceuticals Doses First Patient in Phase II Clinical Trial of AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis

Cambridge, MA, August 8, 2017 – Amylyx Pharmaceuticals, Inc., in collaboration with The ALS Association, ALS Finding a Cure®, and the Massachusetts General Hospital, today announced that the first patient was dosed in the CENTAUR study, a Phase II clinical trial assessing the efficacy and safety of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The Neurological Clinical Research Institute (NCRI) at the Massachusetts General Hospital (MGH) and the Northeast ALS Consortium (NEALS) will oversee the trial, and 25 NEALS member medical centers across the United States will participate. CENTAUR (“Combination of Phenylbutyrate and Tauroursodeoxycholic Acid”), which will enroll 132 participants nationwide, was designed in collaboration with patients and caregivers along with clinical leaders in ALS. The design is intended to facilitate trial access, ease of trial site visits, patient engagement, and to measure both functional and biochemical changes over time. Amylyx plans to provide an open label extension to people who participate in CENTAUR. “The CENTAUR trial builds on promising results with AMX0035 in preclinical studies and clinical experience with the drug’s two components,” said Sabrina Paganoni, M.D., Ph.D., Principal Investigator for the study and physician at the Massachusetts General Hospital and Spaulding Rehabilitation Hospital. “The team at NCRI worked closely with Amylyx to design an innovative trial that will evaluate AMX0035’s safety and efficacy, advance our understanding of several biomarkers, and provide insights into ALS disease biology.” Merit Cudkowicz, M.D. MSc, Chief of Neurology at MGH, added, “The design and launch of the CENTAUR trial reflects a close collaboration between academia, industry, ALS organizations, and patients. Collaborative efforts among key stakeholders is essential to developing treatments for this complex and serious disease.” The study will be the first multi-center, interventional trial to utilize ATLISTM (“Accurate Test of Limb Isometric Strength”), a novel technology developed by Pat Andres, DPT, to quantitatively assess changes in patients’ muscle strength. PET imaging of neuroinflammation and blood-based markers of neurodegeneration will also be utilized to assess changes in disease pathology. Support for CENTAUR comes in part from a $2.96 million grant from The ALS Association and ALS Finding A Cure®. Amylyx CEO and co-founder, Joshua Cohen commented, “We are tremendously grateful for the support we have received from the ALS community.” Justin Klee, President and co-founder added, “The study reflects the outstanding progress the Amylyx team and our collaborators made to build a strong clinical program aimed at ultimately improving the lives of patients with this devastating disease.” The Amylyx therapeutic candidate, AMX0035, is an oral combination of sodium phenylbutyrate (PB) and tauroursodeoxycholic acid (TUDCA) that works synergistically to reduce neuronal death and inflammation. Both PB and TUDCA have been individually tested in previous ALS clinical trials; both compounds demonstrated safety, tolerability, and preliminary signs of efficacy.

02

CollegeVine Completes First Six Months of 2017 With Accelerating Momentum

CAMBRIDGE, Mass., Aug. 2, 2017 /PRNewswire/ -- CollegeVine, a national online provider of student mentoring and college admissions guidance for high schoolers and their families, today reported company growth and capital raises through the first half of 2017. CollegeVine doubled its Series A to $6.7m in March with $3.6m additional funds from Morningside Technology Ventures and University Ventures. "Our momentum is a direct result of addressing the changes needed in the college admissions process," said Jon Carson, CollegeVine CEO and 30 year edtech entrepreneur veteran. "Our platform and process of having near-peer mentors (college students) work with high schoolers and their families helps lessen the stress of the college admissions process. This year is extremely pivotal in our progress because we are disrupting the industry with the use of data to help students match with schools that are best for them. " These milestones help validate CollegeVine's value proposition and proliferation in the edtech industry, but what particularly highlights its success is the amount of students CollegeVine has helped find and be admitted to the best schools for them, exceeding the market acceptance rate close to four times. "One of the most important things CollegeVine was able to provide for my family and my teenager was a sense of regaining control over a stressful process," said Denise Hoffner, parent of a CollegeVine student from the 2017 admissions class. "Navigating the college admissions process is tough when you have little to no guidance from the high school, but CollegeVine helped my son stay organized and created a path to help him get admitted to some of his top choice schools. Having stellar, incisive assistance took pressure off of us individually and collectively." Continuing to demonstrate its leadership, innovation, and commitment to high school students and their families, CollegeVine has made major strides in achievements including: Doubled capital raise: CollegeVine closed an additional $3.6 million Series A funding round in April to bring its total series A financing to 6.7M. Release of Mentorship 2.0: To better serve the growing needs of its customer base, CollegeVine extended its mentorship program by increasing the number of meetings between mentors and mentees, providing students with access to more interest-specific resources such as exclusive office hours with experts in a student's particular field of interest. Total offering of scholarship dollars: CollegeVine's robust client base has received a total offering of $14,500,000 in scholarship dollars for the 2016-17 college acceptance season. Progressive pro bono program: The company's ongoing devotion to its pro bono program saw a 90 percent acceptance rate to a top 50 school, as well as a 71 percent acceptance rate to Ivy League or equivalent schools. Company recognition: CollegeVine has been recognized as one of top 50 startups to watch by Built in Boston, slated to make a huge impact in tech over the next 12 months. The company's momentum has been featured in key media outlets including The Wall Street Journal, Business Insider and Boston Business Journal. Incremental inbound inquiries and website traffic: CollegeVine has seen a steady uptick in website traffic by 3.5 times and a six-time growth in inbound inquiries over the previous year. Expansion of leadership: The company has grown its leadership team with the addition of Aaron Rissler, who previously ran sales at 2020 Onsite. Upon joining CollegeVine at the beginning of the year, Aaron has led the team to beating the sales plan every month so far in 2017. CollegeVine also recently added Stephen Smith, co-founder of Naviance, to its Advisory Board. Smith joins Doug Williams, CTO of iSpecimen on the Advisory Board, and will provide guidance for continued growth of CollegeVine as a strategic advisor.

01

Voicebox Launches Linguistic Code-Switching Capability

The technology allows speech systems to draw from one language to learn another. By Phillip Britt - Posted Aug 1, 2017 Semantic parsing and similar techniques can revolutionize natural language processing, according to Phil Cohen, chief scientist for artificial intelligence at Voicebox, a provider of voice technology for the automotive, mobile, home, and internet-connected devices markets. However, acquiring training data for each domain in each supported language remains cumbersome and expensive. This limitation has become increasingly significant as companies demand intelligent, conversational voice applications to support their global product strategies. Late last week, Voicebox's Advanced Technologies Team announced a significant innovation that reduces the burden of data collection. More important, the innovation helps overcome the challenge of parsing multilanguage utterances, known in linguistic circles as code-switching. Voicebox's approach applies the learning of one language to another. The team evaluated utterances in German, English, and a mix of both in a single utterance. They developed a neural network model, trained on both English- and German-only sentences. As part of a single semantic parsing process, this model transfers information from one language to the other, thus leveraging English data to reduce the amount of data needed for German. As a result, performance on each language improved. The team also evaluated utterances that could contain a mix of both languages and weren't in any of the training data. Results were similarly impressive. "We're excited about the ground-breaking benefits this innovation brings to users," Cohen says. To date, voice navigation systems, for example, have struggled with multilingual use cases. This has been a serious usability issue in multilanguage regions, such as Europe or Asia, where code-switching is common. For example, a French person driving through Germany might ask a question in French. A person who is multi-lingual might ask a question or phrase a sentence in a mix of languages, using the language that best describes what he or she is discussing. "My grandmother did this constantly," Cohen says. "She said, 'It sounds better this way.'" Being able to offer multiple language speakers a multilanguage speech recognition solution in connected cars has been a problem for automotive companies ever since the first inception of connected cars at the end of the last decade, according to Cohen. But the Voicebox development is only the first step in providing a true multilinguistic speech recognition system, he adds. A large company specializing in voice recognition would need to develop a comprehensive voice recognition system that then the auto manufacturers would need to add to their systems. The new voice recognition systems come out every two years, according to Cohen. The new 2017 versions are out now. So the next versions will be out in 2019, with the next generation after that out in 2021. Cohen says it is possible for a multilanguage voice recognition system to be ready for the 2019 models, and hinted that a company like Voicebox could develop it. While he wouldn't go as far to say that customers were demanding such a system, he says that once such a system is available, customers will come to expect they have a car equipped with that capability.

July 2017

30

Talking Cars like Toyota and Can Now Talk in Multiple Languages with help from VoiceBox

July 30, 2017 by Lynn Walford Voicebox Advanced Technologies Team announced an innovation that reduces the burden of data collection while producing impressive, industry-leading results. More importantly, the innovation helps overcome the challenge of parsing multi-language utterances, known in linguistic circles as “code-switching.” Voicebox software is shipping in all new 2018 Toyota cars. Voicebox’s approach applies the ‘learning’ of one language to another. The team evaluated utterances in German, English and a mix of both in a single utterance. They developed a neural network model, trained on both English- and German-only sentences. As part of a single semantic parsing process, this model transfers information from one language to the other, thus leveraging English data to reduce the amount of data needed for German. As a result, performance on each language improved, yielding state-of-the-art accuracy comparable to the likes of Google. The team also evaluated utterances that could contain a mix of both languages and weren’t in any of the training data. Results were similarly impressive.

27

Voicebox Announces Pioneering Work in AI to Streamline Development Process and Improve User Experience

Innovative transfer learning method using multiple languages to be presented at the prestigious Conference on Natural Language Learning (Association for Computational Linguistics) July 27, 2017 09:10 PM Eastern Daylight Time BELLEVUE, Wash.--(BUSINESS WIRE)--AI techniques such as semantic parsing hold the promise of revolutionizing natural language processing. However acquiring training data for each domain in each supported language remains cumbersome and expensive. This limitation has become increasingly significant as companies demand intelligent, conversational voice applications to support their global product strategies. Today, the Voicebox Advanced Technologies Team announced a significant innovation that reduces the burden of data collection while producing impressive, industry-leading results. More importantly, the innovation helps overcome the challenge of parsing multi-language utterances, known in linguistic circles as “code-switching.” Voicebox’s approach applies the ‘learning’ of one language to another. The team evaluated utterances in German, English and a mix of both in a single utterance. They developed a neural network model, trained on both English- and German-only sentences. As part of a single semantic parsing process, this model transfers information from one language to the other, thus leveraging English data to reduce the amount of data needed for German. As a result, performance on each language improved, yielding state-of-the-art accuracy comparable to the likes of Google. The team also evaluated utterances that could contain a mix of both languages and weren’t in any of the training data. Results were similarly impressive. “We are excited to present this innovation at CoNLL,” said Dr. Phil Cohen, Chief Scientist, AI at Voicebox. “And we’re more excited about the ground-breaking benefits this innovation brings to users.” To date, voice navigation systems, for example, have struggled with multi-lingual use cases. This has been a serious usability issue in multi-language regions, such as Europe or Asia where code-switching is common. For example, a French person driving in Germany may say, “Wie viele Universitäten ont Paris?” (How many universities does Paris have?) Similarly, it is very common for a person in China to ask, “播放歌曲 Let It Be.” “At the end of the day,” Cohen added, “the goal of Voicebox Advanced Technologies research is to bring practical value and a better experience to users.”

25

Kezar Life Sciences Announces Successful Completion of Phase 1a Study and Secures $50 Million in Series B Financing

Funding to support continued development of KZR-616, a first-in-class immunoproteasome inhibitor, and advance discovery program targeting the protein secretion pathway SOUTH SAN FRANCISCO, Calif., July 25, 2017 /PRNewswire/ -- Kezar Life Sciences, a private, clinical-stage biopharmaceutical company developing novel small molecule therapeutics targeting the immunoproteasome and the protein secretion pathway, announced today that it has closed an oversubscribed Series B investment round of $50 million led by Cormorant Asset Management and Morningside Venture. New investors participating in the financing include Cowen Healthcare Investments, Pappas Capital, Chiesi Venture Fund, Qiming Venture Partners and Bay City Capital, joined by additional existing investors EcoR1 Capital, Omega Funds, and Aju IB Investment. Kezar has now raised a total of $73 million since its inception in 2015. Kezar also announced the successful completion of the Company's Phase 1a healthy volunteer study with their lead drug candidate, KZR-616, a first-in-class selective immunoproteasome inhibitor. The placebocontrolled study enrolled a total of eighty-two subjects, sixty-one of which received single or multiple doses at varying dose levels. The trial identified multiple doses that resulted in desired levels of inhibition of the immunoproteasome and that were well tolerated with repeat dose administration. Additional results from the study are anticipated to be presented at the American College of Rheumatology's Annual Meeting in San Diego in November. "We are pleased with the results of our healthy volunteer study, and grateful for the support of such an excellent group of investors to finance our upcoming clinical trials," said John Fowler, CEO of Kezar Life Sciences. "The strong demand for this financing reflects growing excitement for the potential of immunoproteasome inhibition in treating autoimmune disorders and recognizes the clear leadership position enjoyed by Kezar." Christopher Kirk PhD, President and CSO, added, "These initial clinical trial results demonstrate that KZR-616 is achieving the desired levels of immunoproteasome inhibition that correlate with anti-inflammatory activity seen in laboratory models. By selectively targeting the immunoproteasome, we believe we can avoid the toxicities associated with dual proteasome inhibitors like VELCADE™ and KYPROLIS™, as exhibited by the early safety findings from this study."

19

Stealth BioTherapeutics Initiates Phase 2/3 Study of Elamipretide in Patients with Barth Syndrome

Study will evaluate elamipretide in rare genetic mitochondrial disease characterized by muscle weakness, cardiac abnormalities, recurrent infections and delayed growth BOSTON – July 19, 2017 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced the initiation of TAZPOWER, a Phase 2/3 study evaluating elamipretide in patients with Barth syndrome. Barth syndrome is a rare genetic mitochondrial disease, caused by mutations in the TAZ gene, and characterized by cardiac abnormalities, skeletal muscle weakness, recurrent infections and delayed growth. “The severe problems experienced by patients with Barth syndrome are caused by misshapen and dysfunctional mitochondria, which reduce the energy production in the affected tissues. The resulting muscle weakness can lead to severe fatigue, heart failure and death,” said Stealth Chief Medical Officer Doug Weaver. “In this study, we hope to show that elamipretide may have clinical benefit by improving function in these affected mitochondria.” TAZPOWER is a randomized, double-blind, placebo-controlled crossover study that will evaluate the effects of daily elamipretide treatment in a minimum of 12 patients with genetically confirmed Barth syndrome. Patients will be randomized to one of two sequence groups: 12 weeks of single daily subcutaneous injections of elamipretide in Treatment Period 1, followed by 12 weeks of treatment with placebo in Treatment Period 2, with a four-week wash-out period between periods, or vice versa. The primary endpoint is change in distance walked during the six-minute walk test. Secondary endpoints include functional assessments, patient-reported outcomes and safety. “Our understanding of Barth syndrome and how it manifests has evolved significantly, but current treatment efforts are still limited to the management of symptoms,” said Hilary Vernon, M.D., Ph.D., assistant professor of Pediatrics at McKusick-Nathans Institute of Genetic Medicine at Johns Hopkins University and the primary investigator for the study. “The initiation of TAZPOWER represents an important milestone in the potential development of a disease-specific treatment option.” TAZPOWER builds upon Stealth BioTherapeutics’s existing rare disease and cardiorenal programs, including three ongoing Phase 2 studies in adults with heart failure (IDDEA-HF, PROGRESS-HF, RESTORE-HF). “This study underscores our commitment to develop elamipretide for the treatment of rare genetic mitochondrial diseases,” said Stealth Chief Executive Officer Reenie McCarthy. “The cardiovascular and skeletal muscle symptoms affecting this population share a common thread with symptoms experienced in diseases commonly associated with aging, such as heart failure, in which mitochondrial dysfunction contributes to the clinical pathology.”

19

STEALTH BIOTHERAPEUTICS SHARES PROMISING DATA FROM MITOCHONDRIAL MYOPATHY TRIAL

July 19, 2017 - Recently, at the 2017 UMDF Mitochondrial Medicine Symposium, Stealth BioTherapeutics shared very encouraging results from its second clinical trial for primary mitochondrial myopathy, the MMPOWER-2 study. Stealth is a Boston-based biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction; its lead drug under investigation is elamipretide (previously known as Bendavia). Primary mitochondrial myopathy (PMM) is a genetically-acquired mitochondrial disease characterized by signs and symptoms of myopathy (debilitating muscle weakness, easy fatigability, exercise intolerance and pain). The Phase 2 MMPOWER-2 trial was conducted to evaluate safety, tolerability and efficacy of treatment using elamipretide in 30 adult (ages 16-65) patients with PMM. An overall assessment of the top-line MMPOWER-2 results showed benefit across multiple endpoints and is supportive of continuation toward a Phase 3 study in this patient population. Patients enrolled in MMPOWER-2 previously participated in Stealth’s MMPOWER trial, designed to assess dosing, which demonstrated a dose-dependent improvement in distance walked in the 6-Minute walk test (6MWT) after 5 days of once daily intravenous administration of elamipretide or placebo. In MMPOWER-2, patients were randomized to once daily subcutaneous administration of elamipretide or placebo for a longer period of time (four weeks), and then, after a washout period, received the opposite treatment during a second four-week dosing period. Patients, their doctors and investigators at Stealth were unaware of which group patients belonged to during the trial and the subsequent assessments. This type of study design, known as a randomized, double-blind, placebo-controlled crossover study, is considered a “gold standard” in clinical trials evaluating investigational drugs. Randomized controlled trials can be challenging in rare and orphan diseases because there simply are not as many patients available to participate, and there tend to be as many differences as there are similarities between patients who may have the same diagnosis (also known as heterogeneity). Multiple endpoints, or outcomes, were considered and evaluated during the MMPOWER-2 trial in addition to the 6MWT, including the Neuro-QoL (Quality of Life in Neurological Disorders) measurement system, and a new patient-reported outcome tool, the Primary Mitochondrial Myopathy Symptom Assessment (PMMSA), developed by Stealth specifically for this patient population. Other tools and measures for safety, tolerability and functional assessment were also applied. Chuck Mohan, Executive Director of the United Mitochondrial Disease Foundation, comments “Clinical trials for rare diseases are challenging and we are very supportive of Stealth for their efforts to evaluate potential therapeutics in a meaningful, rigorous and scientific manner. The progress of the MMPOWER-2 trial provides hope to our global mitochondrial disease community. ” The primary objective of the study was to evaluate the effect of a single daily subcutaneous dose of elamipretide for four weeks on a PMM patient’s walking distance, as measured by the 6MWT. Patients receiving elamipretide walked an average of 20 meters more than those receiving placebo at the end of the 4-week dosing period. In addition, those patients who were the most impaired at baseline demonstrated the greatest improvement. Data gathered and analyzed for several other secondary endpoints is also informative and promising. Treatment with elamipretide resulted in statistically significant and clinically meaningful improvements in the Neuro-QOL Fatigue Short Form score and in the PMMSA Total Fatigue score. In other words, patients showed overall improvement in fatigue and in symptoms which impacted their daily quality of life and functional abilities. Patients also reported a statistically significant improvement in the PMMSA identified symptom most bothersome to them individually, such as tiredness, muscle weakness, muscle pain, abdominal discomfort, vision problems, or balance problems. Data also continued to demonstrate safety and tolerability of elamipretide, with the most common side effect being redness or itching at the injection site. Kira Mann, CEO of MitoAction, is enthusiastic about these findings. “These results are very promising for patients struggling with fatigue, pain, and weakness due to mitochondrial myopathy. On behalf of patients and families with mitochondrial disease, we are excited about this data and continue to be supportive of future elamipretide studies.” Stealth continues to be committed to developing mitochondrial therapeutics and engaging with the mitochondrial disease clinician and patient/family community. In March of 2017, Stealth initiated RePOWER, a prospective, observational study of patients with mitochondrial myopathy. RePOWER will assess approximately 300 PMM patients, ages 16-65, and will gather information about current symptoms, quality of life, functional abilities and medical history. Findings from MMPOWER, MMPOWER-2 and RePOWER will together help establish and inform a Phase 3 trial to continue to evaluate the potential efficacy, safety and tolerability of elamipretide. Stealth plans to launch its Phase 3 trial around the end of this year. The executive director of the Foundation for Mitochondrial Medicine, Laura Stanley, has a child with mitochondrial disease. She states, “Results such as these demonstrate why it is so important for every patient and family with primary mitochondrial disease to be involved in these very important and groundbreaking studies. Together we are pioneering this field.”

13

UK’S SILICON PHOTONICS CONSORTIUM WELCOMES £4.8 MILLION BOOST TO R&D INNOVATION FUNDING

Rockley Photonics matches government funding from the Engineering and Physical Research Council (EPSRC) in a ‘Prosperity Partnership’ with the University of Southampton Oxford, UK, 13 July 2017 – Rockley Photonics Limited, the UK’s leading integrated technology and systems innovator for next-generation networks, will, over the next five years, match government funding from the EPSRC, and form a ‘Prosperity Partnership’ with the University of Southampton’s Optoelectronics Research Centre (ORC). An official announcement about this partnership, and additional projects involving 10 universities and businesses operating in key areas of innovation, will be made today at 18:00hrs (Thursday 13th July) by Jo Johnson, Minister of State for Universities, Science, Research and Innovation at a special event at BT’s HQ, 81 Newgate Street, London. The money, totalling around £4.8 million, will be used to support research into how silicon photonics technology can be used to improve data centre communication networks and support a new integrated photonics platform for broader mass market applications. Dr Andrew Rickman, founder, CEO and chairman of Rockley Photonics said: “We are honoured to have our technology and business endeavors supported and recognised by the EPSRC in this extraordinary funding initiative.” He continued: “Rockley Photonics and The University of Southampton team has a long-standing history of working together. Our partnership, built up over many years, demonstrates the value of relationships between academia and commercial enterprises such as ours. It gives us the ability to combine resources and academic excellence and focus on ground-breaking, early-stage technologies, such as silicon photonics. “Research in to this area is progressing quickly, and in the very near future, this game-changing, disruptive technology will soon have a huge impact on the future architecture design of large data centres; improve the power and compute capacity of new consumer devices and provide robust sensing solutions in a variety of industry sectors, such autonomous vehicles and biomedical. All this at dramatically lower cost and with considerably less power requirements.” Graham Reed, Professor of Silicon Photonics at Southampton, commented: “Andrew Rickman, Chief Executive Officer of Rockley Photonics, is the world’s leading entrepreneur in this field. We have a long history of working together and this collaboration is almost the perfect fit for the remit of the Prosperity Partnerships – a truly mutual relationship between university and industry. “At Southampton, our expertise and facilities offer a unique environment for silicon photonics research and innovation. One of the world’s most pressing problems is how to handle our relentless desire for more data and we are striving to make significant improvements.”Professor Nigel Titchener-Hooker, Professor of Biochemical Engineering at UCL, who chaired the panel that approved the Prosperity Partnerships projects, said: “The quality of the applications we reviewed was outstanding. The breadth of applications too speaks to the diversity of UK industry and to the alignment between the UK’s very best academic teams and our industrial base. “The grants promise to create a series of exciting avenues of research leading to industrial implementation. It's a wonderful new example of how, in partnership, we can harness our collective capabilities to strengthen our economy and once again underscores the importance of ongoing investment in the higher education research base.”

13

Aduro Announces Milestone Achieved Relating to Collaboration with Merck for Development of Anti-CD27 Antibody for the Treatment of Cancer

Investigational Immunotherapy on Track to Enter Clinical Development in 2018 BERKELEY, Calif., July 13, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that the company has earned a $2.0 million milestone payment under its worldwide licensing agreement with Merck (known as MSD outside the United States and Canada) for work supporting the preparation of an Investigational New Drug Application (IND) for its anti-CD27 antibody. “We are pleased with the progress being made on the pre-clinical development of the anti-CD27 antibody, which was created with our proprietary B-select monoclonal antibody technology and selected by Merck for continued development,” stated Hans van Eenennaam, Ph.D., chief operational officer, Aduro Biotech Europe. “Aduro’s anti-CD27 antibody targets the CD27 co-stimulatory pathway, an important component in stimulating an anti-cancer immune response. We look forward to working closely with Merck in their effort to advance this promising and novel approach in the field of immunotherapy into clinical development.” About CD27 and Aduro’s Anti-CD27 Antibody CD27 is a co-stimulatory receptor expressed on different immune cells, such as T-lymphocytes and NK (natural killer) cells. It has been recognized as having an important role in priming, enhancing and sustaining a productive anti-cancer (CD8 T-cell) adaptive immune response. In preclinical studies, anti-CD27 activation in combination with immune checkpoint inhibition has demonstrated the ability to achieve complete tumor eradication. In 2014, Merck, through a subsidiary, entered into a worldwide license agreement for the development and commercialization of CD27 antibody agonists. Aduro’s anti-CD27 antibody, which was identified with its proprietary B-select monocolonal antibody technology, targets a functional epitope on CD27 demonstrating potent activation of the CD27 co-stimulatory pathway in pre-clinical studies. As a part of the worldwide license agreement, and in addition to payments received, including the $15 million up-front payment, Aduro is eligible to receive future development, commercial and net sales milestone payments. In addition, Aduro is eligible to receive royalties in the mid-single digits to low teens based on any net sales of the product, if it is approved for marketing.

11

Why These Harvard Dropouts Hired a 60-Year-Old Yale-Educated CEO

A trio of college entrepreneurs were hauling in $100,000 a month from their Ed Tech startup. They dropped out and gave up the CEO role to a 60 year old serial entrepreneur. Here's why it's working. By Peter Cohan, Founder, Peter S. Cohan & Associates@petercohan Just because you drop out of Harvard it doesn't mean you're the next Bill Gates or Mark Zuckerberg. And a group of mostly Harvard undergraduates who dropped out to run their startup realized that they'd be better off picking as their CEO a 60-year-old serial entrepreneur who had sold three of his companies for about $200 million. In so doing, their startup is riding the crest of a breaking wave that could propel them all to great success. This comes to mind in considering my July 10 conversation with Jon Carson who since January 2016 has been CEO of CollegeVine, a service that connects undergraduate so-called Near-Peer Mentors (NPMs) with high school students seeking college admissions and their parents. As Carson explained, "CollegeVine is a virtual high school guidance platform that enables families of public school students to supplement their high school guidance to get the same quality of guidance as students at private schools.The company has been growing revenue at 3.5 times per year and between 2015 and 2017, the number of NPMs it employs has [skyrocketed] from 80 to 600," Carson said. CollegeVine's "secret sauce is connecting high schoolers and their families to a network of highly talented college students at a range of top schools. These consultants have expertise in navigating the high school journey, proven academic success, and successfully completed the college admissions process. Due to age proximity they relate easily to teenagers. These consultants go through intensive training and are leveraged by proprietary, data-driven decision making tools," he explained. Carson was a startup mentor at the Harvard Innovation Lab (iLab) where he met the Harvard undergraduates who were running CollegeVine. "We had a speed dating session in which 10 mentors met with 10 startup teams. We chose each other. CollegeVine was doing $100,000 in revenue a month from their dorm room. I thought they had something special and helped them to think through the trade-offs of whether they should drop out of college to pursue the idea," said Carson. The CollegeVine founders were three friends from New Jersey who met in seventh grade. Two of them were at Harvard and one was at U. Chicago. They did not get much help from their high school college counselors but with help from slightly older students they figured out what they needed to do to get into these elite schools. Others asked for their help and their reputation spread. In the fall of 2015, they had to leave the iLab and they decided to take a leave from Harvard to work on CollegeVine -- in January 2016 they made Carson its CEO. Why drop out of Harvard? "As our company grew, we found ourselves continuously making tradeoffs between the business and school. There simply wasn't enough time in the day to really get the most out of Harvard and also achieve our goals for the company. My co-founders and I decided we wanted to focus on one thing, and at the time we were all in agreement that we were onto something pretty interesting with the company because of the strong revenue traction and clear market signals we had caught a wave. We all felt like we had stumbled upon a rare opportunity we just couldn't pass up." Perkins and his cofounders trust Carson and he trusts them. As Perkins said, "The relationship only works because there is strong mutual trust; we respect Jon's extensive experience and intelligence; Jon sees us as equals and gives us full autonomy in everything we do, with a healthy dose of his own mentorship." "The juxtaposition is incredibly powerful. We met Jon as we were approaching a pretty critical juncture for the company. The business was completely taking off and our aspirations for what it could be were scaling well beyond what any of us had possibly imagined. Jon started off as a volunteer mentor with us at the iLab," Perkins continued. Perkins believes the company is better off with Carson as CEO. "After working with Jon for a few months, we all came to appreciate a really strong team dynamic; Jon's part was to help synthesize our vision and define the trajectory for the incredible momentum we were building in all aspects of the business. From our perspective, we were onto something so powerful that we wanted someone at the table that had seen the movie a few times to add a new perspective," concluded Perkins. Carson has learned a valuable lesson from his decades of entrepreneurial experience. "It is much better to work for a startup that's catching a wave. It's easy to tell -- customers are seeking out its product and revenues are growing." That is clearly the case with CollegeVine.

07

OMNI FACILITATES THE SHARING OF STORED ITEMS

San Francisco – On-demand storage start-up Omni enables users to rent out their stored items to the local community. Omni creates an inventory of all the items stored by subscribers, photographing, identifying and categorising each one. ‘Omni gives you the ability to make any of your items available to your friends or the local community,’ Ryan Delk, vice-president of product and growth at Omni, tells TechCrunch. The items are categorised as ‘personal’ by default, but subscribers can re-label their belongings to enable them to be shared with ‘friends’ added to the platform’s network, or members of the wider Omni community. Users looking to borrow an item send a request to the item owner and state the desired dates. Users pay a monthly fee of £0.38 ($0.50, €0.44) per item to store small items and £2.3 ($3, €2.6) per item for larger pieces. There is currently no system in place at Omni that enables users to make money off their unused goods, but the company is considering whether to monetise the service, with Omni taking a proportion of the rentals. According to Omni, 29% of items in its inventory are classified as home goods and tools, 25% as apparel and 13% as sports and recreation.

June 2017

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Far from the big hubs, Apellis is steering its rival to Alexion’s Soliris into a PhIII program

A Kentucky biotech says they’re laying the foundation for a pivotal program for their C3 inhibition therapy, which execs believe can replace Soliris in treating PNH. Louisville-based Apellis has been making progress on its lead drug far away from the spotlight that concentrates attention on the big biotech hubs. But it’s been well funded, with a $47 million D round that dropped early last year after they gave up on an IPO in chilly market waters. And the company says they’ve been nailing down hard human evidence that by moving upstream from C5 inhibition, where Soliris hits, they can do a better job in controlling anemia and transfusion dependence among patients with this extremely rare condition. This week, Apellis is reporting on two tiny studies of 3 and 6 patients. In 3 patients never treated with Soliris, investigators reported that all of them experienced a quick correction on a key biomarker for lactate dehydrogenase, or LDH. In 6 patients not responding well to Soliris, the average hemoglobin level was brought up an average of 36%, LDH was corrected and transfusions dropped from 3.4/month on eculizumab monotherapy to 0.3/month when APL-2 was added to eculizumab. And the biotech raised no unusual red flags on the safety side. As one of the world’s most expensive therapies, Soliris has inspired a range of rivals all looking to replace it with their own drug. Companies like Ra Pharmaceuticals and Akari have been on the trail, while Soliris’ manufacturer, Alexion, has been making advances with a second-gen product for their key moneymaker. ALXN1210 — an anti-C5 antibody that inhibits terminal complement for patients with paroxysmal nocturnal hemoglobinuria (PNH) — was about the only experimental product that earned much respect from new CEO Ludwig Hantson when he took over earlier this year. Apellis has attracted considerable financial support for its work. At the time it filed its S-1, the biotech reported that Morningside Venture Investments owned 32.6% of the company, making the VC their biggest investor. And they say that they’re just getting started with a lead focus on PNH, with a range of other diseases that they believe can be treated through the same pathway. CEO Cedric Francois said he found the data encouraging as he steers the company to a Phase III study in a few months. We believe that C3-inhibitor APL-2 can be the next generation PNH treatment offering patients a powerful solution to meaningfully improve their quality of life.

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Stealth casts a wide net with experimental treatment for mitochondrial diseases

Jun 30, 2017 at 1:55 PM - At first glance, primary mitochondrial diseases are an incredibly hard target for biopharma companies to pursue. There are literally hundreds of different subtypes, caused by mutations in either nucleic DNA (nDNA) or mitochondrial DNA (mDNA). Even within that, patients that carry the same mutations (genotypes) often have variable symptoms and disease characteristics (phenotypes). Perhaps that’s why there are no targeted therapies currently approved for primary forms of the disease and thus, a huge unmet need. But it doesn’t stop there. Secondary mitochondrial dysfunction is implicated in some of the greatest public health burdens facing us to do, from Parkinson’s and Huntington’s disease to heart failure. In this light, there’s a dire need to better understand and develop therapies for the cellular battery packs we call mitochondria. Boston, Massachusetts-based Stealth Biotherapeutics has a good shot at making in-roads. Its lead program seeks to address a common denominator across all primary subtypes — skeletal muscle weakness (myopathy). “Based on epidemiology, our best guess is that approximately 40,000 patients in the U.S. have what we would consider primary mitochondrial myopathy,” said Jim Carr, Stealth’s chief clinical development officer, by phone. According to Carr, myopathy, “seems to be a primary feature and you could say, chief complaint of patients with primary mitochondrial diseases.” Skeletal muscle requires huge amounts of energy when the individual exerts him or herself, which is why patients with these conditions fatigue very easily. In Stealth’s first trial, dubbed MMPOWER, participants were given the experimental drug elamipretide intravenously every day, for five days. A six-minute walk test was then conducted at the end of treatment, which registered clinically meaningful gains in the patient endurance. The major aim, however, was to determine the optimal dose. Stealth was also able to gather additional safety data, which Carr said gave the team confidence to progress. In a subsequent trial, MMPOWER-2, the same participants were invited back to build on those results. Thirty out of 36 patients signed up for a second round. “The primary objective of MMPower-2 was to find identify additional endpoints to take into Phase 3,” Carr explained. Stealth went to great lengths to understand what symptoms really impact the patients and what metrics would correlate with actual improvements in quality of life — an approach FDA encourages with rare conditions. The results from MMPOWER-2 were presented this week at the United Mitochondrial Disease Foundation (UMDF) Symposium in Washington D.C. “We were very gratified with what we saw,” Carr said. “We found additional endpoints that seemed to be very sensitive to the changes that occurred in response to the molecule.” Stealth’s drug elamipretide is a four-amino acid peptide with an affinity for cardiolipin, found in the membrane of the many mitochondria functioning within our cells. Elamipretide’s mechanism of action has not been fully elucidated, but Carr believes it has to do with the stabilization of the mitochondrial membrane. “When there’s disease, the membrane tends to lose some of it integrity and those complexes drift apart,” he explained, which comprises the mitochondria’s electronic transfer chain. “So what we think happens is that the molecule associates with cardiolipin and helps to pull the complexes together and restore normal electronic flow.” Carr said the company has also demonstrated with repeat dosing in different animal models that the drug can improve the morphology of the mitochondria, “making very sick-looking mitochondria look normal again.” With its affinity for cardiolipin, elamipretide is readily absorbed by cells. However, it doesn’t appear to impact healthy mitochondria. “It associates with mitochondria whether there is disease or not, but the drug really only has activity if the mitochondria are dysfunctional. So it’s a built-in safety mechanism,” Carr noted. The toxicity profile has been favorable thus far. In the second study, which moved from IV dosing to subcutaneous injections, a majority (80%) of patients suffered localized effects (itching, redness) at the site of administration. According to Carr, there were no serious events. “We don’t view that as a safety concern. If anything, it may affect compliance and adherence going on, so we’re very conscious of that.” It’s manageable, but one major question remains: How much of an impact will the therapy really have? It’s a very relevant question in this day and age, following the approval of some rare disease drugs that barely move the needle. In some cases, insurers are reluctant to cover them. “Of course we have to prove this definitively, but we think it’s going to make a fairly significant difference, a fairly meaningful difference to patients,” Carr said. “In fact, that’s one of the reasons we wanted to develop the patient reported outcomes; because the patients need to tell us that. To me, that’s the most important deliverable for patients with this molecule, to help them feel better and live a more normal life.” In the MMPOWER-2 study, patients improved on the six-minute walk test — albeit less emphatically than in the first trial. But they also reported less overall fatigue, less fatigue associated with activity, less muscle pain, and less muscle weakness, with “persuasive P-valuations” as Carr put it. The average age of patients in the study was 40. Imagine living for 40 years with extreme fatigue and severe physical limitations. There’s no promise of a miracle gene therapy-like effect, but a five or 10 percent improvement in energy could make a profound difference to their lives. Those patients are now rolling over into an open-label extension, Carr said, to gauge the effects of longer-term treatment. “Our hope is, certainly when we give the drug for even longer, the effects will be intensified.” The continuation is a testament to the relationship Stealth has built with U.S. and international mitochondrial patient advocacy groups. They’re all on the front line of a pivotal battle in the wider war against disease, given how important our tiny cellular energy packs are. To that end, planning for a Phase 3 trial of elamipretide is well underway.

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Elamipretide Shows Therapeutic Potential for Primary Mitochondrial Myopathy in Latest Trial Results

JUNE 30, 2017 - The investigational drug elamipretide has therapeutic potential to improve the physical capacity of patients with primary mitochondrial myopathy (PMM), according to the latest results of the Phase 2 MMPOWER-2 study. The positive results support the further clinical development of the drug to tackle this medical condition that lacks therapeutic options. These and other findings of the clinical trial were presented at the Mitochondrial Medicine Symposium 2017 held by the United Mitochondrial Disease Foundation (UMDF) in Washington DC from June 28 to July 1. “The lives of patients with primary mitochondrial myopathy, for which there are no FDA-approved treatment options, can be significantly impaired by the debilitating muscle weakness and fatigue they experience daily,” Dr. Amel Karaa, trial investigator, internist, and clinical geneticist at Massachusetts General Hospital said in a press release. “We have seen improvements associated with elamipretide in MMPOWER-2 which merit study in a Phase 3 trial.” The injectable therapy, also known as Bendavia or MTP-131, was developed by Stealth BioTherapeutics and designed to target dysfunctional mitochondria. Elamipretide restores the ability of mitochondria to serve as the cell’s power source and reduces the levels of damaging oxidative stress produced by its previous dysfunctional activity. The efficacy, safety, and tolerability of elamipretide are being evaluated in the randomized, placebo-controlled MMPOWER-2 (NCT02805790) clinical trial. All 30 participants with diagnosed mitochondrial disease included in this study had previously completed Stealth BioTherapeutics ‘s first clinical trial MMPOWER (NCT02367014). In the first trial, the distance patients were able to walk in six minutes (6MWT) improved after five days of treatments with elamipretide. This beneficial effect was found to be dose-dependent. In the ongoing MMPOWER-2, increasing the time of treatment to four weeks was associated with patients improving their 6MWT distance by an average of 20 meters compared to those receiving a placebo, although this endpoint did not reach statistical significance. However, a detailed analysis additionally showed that the treatment seemed to most benefit those who presented great physical impairment at baseline (able to walk less than 450 meters). These patients were able to walk an average additional 24 meters compared to an additional 8 meters observed in the group of patients with better physical capacity at the beginning of the trial. This observation was consistent with previous results of MMPOWER. During the trial, elamipretide treatment significantly improved Neuro-Quality of Life Fatigue Short Form score, and the Primary Mitochondrial Myopathy Symptom Assessment Total Fatigue Score — a Stealth BioTherapeutics proprietary patient-reported outcome tool — compared to the placebo group. No serious treatment-associated adverse events were reported during the trial. The most common side effect reports were mild redness or itching at the injection site. “We are highly encouraged by the MMPOWER-2 trial’s identification of endpoints to measure changes in both skeletal muscle function and quality of life issues, which are so crucial in this patient population,” said Reenie McCarthy, chief executive officer at Stealth. “These findings confirm the potential of elamipretide for these patients and help us establish and validate critical details for our planned Phase 3 study. We look forward to working closely with U.S. and European regulatory officials to finalize the design of our Phase 3 trial, which will enroll patients with primary mitochondrial myopathy caused by a variety of genetic mutations,” McCarthy added.

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Storage company Omni now lets users share their belongings with friends

Posted Jun 29, 2017 by Ryan Lawler (@ryanlawler) On-demand storage startup Omni wants to make it easier for you to have access to your favorite items without them taking up space in your closet. But now the company is taking a huge step toward making those items available to your friends, and to other people in your local community. Omni is hardly alone in the market for on-demand storage, with companies like Clutter, MakeSpace and Trove bringing those services online. But where Omni seeks to differentiate from other storage startups is in providing item-level categorization and access to its users’ stuff. When you store your stuff with Omni, it doesn’t just sit in a box or crate collecting dust in a warehouse somewhere. The company goes through the process of photographing, identifying, categorizing and adding each item to an inventory that can be managed in a mobile app. Users can choose to take items out of storage at any time, so long as they give the company at least two hours notice. That allows Omni users who like to surf or bike or golf on the weekends to keep their sporting gear in storage when they’re not using it and take it out only when they need it. But now that the company has accrued a kind of critical mass of items, it wants to allow users to make them available to friends and other people in their local community. “What we’re launching is the ability for you as the item owner to make any of your items available to your friends or to the local community,” Omni VP of product and growth Ryan Delk says. For Omni, which has itemized more than 100,000 goods in the 18 months since launch, this was always part of its master plan. “We positioned ourselves as a storage company knowing that was a Trojan horse,” Delk told me. According to him, Omni was able to accomplish this because “everything happens on the item level.” In retrospect, the plan probably should have been obvious. After all, why go through the trouble of building infrastructure required to pick up items for storage, individually tag and categorize them, and add them to a cloud database of goods unless you would then allow users to actually do something with them? Omni allows users to store small goods for $0.50 per item per month and large items for $3 a month. It also charges pick-up and delivery fees based on how soon a user wants to access something in their inventory. While it’s free to have goods picked up — unless it’s a real rush (3 hours or less) — Omni charges a $3 delivery fee for items that will be dropped off next day and $20 for items needed within 2 hours. Due to the economics of its business, the stuff you store with Omni would probably not be the same type of thing you’d throw into a box and forget about at your local self-storage warehouse. Based on its own categorization, Omni says that 29 percent of items fall in the “home goods and tools” bucket, with apparel making up another 25 percent and sports and recreation accounting for 13 percent of all goods. From those three categories alone, you could imagine an Omni user making a set of power tools available to a neighbor, letting a friend borrow a dress for an event or sharing camping or other outdoor equipment. Omni has already been testing this concept with a limited number of beta users in the Bay Area, and is now opening it up to others. All items a user has stored will by default remain private, but if they would like to share with friends or make their stored goods available to the community at large they can now easily do so.

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Stealth BioTherapeutics Presents Phase 2 Data From MMPOWER-2 Continuation Trial Supporting Phase 3 Development of Elamipretide in Primary Mitochondrial Myopathy

BOSTON ­- JUNE 29, 2017- Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced results from MMPOWER-2, a Phase 2 continuation trial evaluating safety, tolerability and efficacy of treatment with elamipretide for primary mitochondrial myopathy (PMM). Detailed results from the trial were presented today at Mitochondrial Medicine Symposium 2017, the United Mitochondrial Disease Foundation (UMDF) symposium. “The lives of patients with primary mitochondrial myopathy, for which there are no FDA-approved treatment options, can be significantly impaired by the debilitating muscle weakness and fatigue they experience daily,” said Dr. Amel Karaa, trial investigator, internist and clinical geneticist at Massachusetts General Hospital. “We have seen improvements associated with elamipretide in MMPOWER-2 which merit study in a Phase 3 trial.” The overall assessment of the top-line MMPOWER-2 results shows benefit across multiple endpoints assessed and is supportive of a Phase 3 trial in this patient population. The 30 patients enrolled in MMPOWER-2 previously completed MMPOWER, Stealth’s first clinical trial in this patient population, which demonstrated a dose-dependent improvement in distance walked in the six-minute walk test (6MWT) after five days’ treatment with elamipretide. In MMPOWER-2, a longer, four-week treatment period with elamipretide was associated with an average 20 additional meters walked versus placebo during the 6MWT (p=0.08), the primary endpoint. Although the 6MWT efficacy endpoint did not reach significance, a pre-specified analysis showed that patients who were more impaired at baseline (pre-treatment 6MWT less than 450 meters) experienced a greater improvement with elamipretide (24 meters on average) than patients who were less impaired at baseline (pre-treatment 6MWT more than 450 meters; eight meters on average). This finding is consistent with observations from MMPOWER. MMPOWER-2 was instrumental in identifying additional endpoints for a Phase 3 trial. At four weeks, treatment with elamipretide resulted in statistically significant improvements in Neuro-QoL Fatigue Short Form score (4 units versus placebo; p=0.01), a validated patient-reported scale for fatigue in neurologic disorders, and in the Primary Mitochondrial Myopathy Symptom Assessment (PMMSA, formerly the Mitochondrial Disease Symptom Assessment) Total Fatigue Score (1.7 units; p=0.0006), a proprietary patient-reported outcome tool developed by Stealth specifically for this patient population. Several other PMMSA assessments also showed significant improvements for elamipretide-treated patients, including improvement in the most bothersome symptom reported by each patient (p=0.01). The triple Timed-Up-and-Go test (3TUG; p=0.8), measuring the time it takes to stand from seating, walk six meters, sit and repeat three times, was completed in less than one minute, which may be insufficient to measure endurance-related skeletal muscle weakness and fatigue. The 3TUG test will not be included in Phase 3. Treatment with elamipretide appeared to be well tolerated, with no serious adverse events. The most common side effect was injection-site reactions (80 percent with elamipretide versus 17 percent with placebo); most were mild redness or itching. “We are highly encouraged by the MMPOWER-2 trial’s identification of endpoints to measure changes in both skeletal muscle function and quality of life issues, which are so crucial in this patient population,” said Stealth Chief Executive Officer Reenie McCarthy. “These findings confirm the potential of elamipretide for these patients and help us establish and validate critical details for our planned Phase 3 study. We look forward to working closely with U.S. and European regulatory officials to finalize the design of our Phase 3 trial, which will enroll patients with primary mitochondrial myopathy caused by a variety of genetic mutations.” In March of this year, Stealth initiated RePOWER, a multi-national pre-trial registry of patients with PMM. RePOWER will assess approximately 300 patients, ages 16-65, at a single enrollment visit, where they will complete questionnaires about their current symptoms and quality of life, perform functional assessments and share data from clinical records. Findings from MMPOWER, MMPOWER-2 and RePOWER will together help inform a Phase 3 trial to further evaluate the potential efficacy, safety and tolerability of elamipretide.

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Green Biologics Achieves REACH Certification, Sets Sights on Europe

Compliance with stringent REACH regulations positions company to further expand market share internationally Ashland, Virginia and Abingdon, Oxfordshire U.K. (June 29, 2017) – Green Biologics, Inc., the U.S. subsidiary of Green Biologics Ltd., a U.K. industrial biotechnology and renewable chemicals company, announced today that it has received REACH certification, a regulation of the European Union that promotes protection of human and environmental health from risks posed by chemicals. By registering with REACH, which stands for Registration, Evaluation, Authorisation of Chemicals, Green Biologics is now able to supply Europe with larger bulk quantities of its bio-based n-butanol. The company has also obtained pre-registration for its bio-based acetone and various derivatives, allowing it to ship up to 100 tonnes of these chemicals to Europe through June 1, 2018. This achievement underlines Green Biologics’ commitment to embracing a global view on customers and business. It also enables the company to solidify its long-term position as a supplier to customers and markets in Europe. “Although Green Biologics’ first manufacturing site is based in North America, as the only producer of bio-based n-butanol and acetone in the world there are a wide range of opportunities for our products to be adopted across Europe as replacements to their traditional petroleum-based counterparts,” said Sean Sutcliffe, Chief Executive at Green Biologics. “Europe will be a key growth market for our company and the REACH registration of our n-butanol will help us navigate the many complex regulatory requirements associated with importing chemicals into the region.” The result of more than 100 years of research and development, Green Biologics’ fermentation platform utilizes a robust library of Clostridium microbial strains as biocatalysts to produce its 100 percent biobased n-butanol and acetone. The company has plans to offer a full suite of BioPure™, 100 percent biobased, high purity, products through its patented Advanced Fermentation Process™ and third-party partnerships. Currently, all Green Biologics chemical products are being produced at the company’s commercial facility, Central Minnesota Renewables, located in Little Falls, MN, which officially began operations in December of last year. Green Biologics is a member of the American Chemistry Council (ACC) and its commercial facility, Central MN Renewables LLC, has been built to meet Responsible Care® standards. The company’s n-butanol and acetone have received 100 percent bio-based, USDA BioPreferred® certification.

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Positive Data from APL-2 Studies Show Rapid and Durable Improvements in LDH and Hemoglobin Levels in PNH

LOUISVILLE, Ky., June 29, 2017 – Apellis Pharmaceuticals, Inc. today provided an update on clinical outcomes in its two ongoing Phase 1b clinical trials with APL-2, a complement C3 inhibitor, in the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare, acquired, potentially life-threatening disease characterized by complement-mediated hemolytic anemia. Apellis is developing APL-2 as a next generation monotherapy, with the goal of resolving anemia and transfusion dependency in PNH patients on standard of care. APL-2 is being developed for newly diagnosed PNH patients as well as for patients who suffer from anemia while receiving standard of care intravenous infusions of eculizumab. Eculizumab is a complement C5 inhibitor that improves anemia in patients with PNH, but leaves up to 75% of PNH patients anemic and 35-40% transfusion-dependent. APL-2 is being evaluated in two Phase 1b clinical trials. PADDOCK is an open label safety and efficacy study of 270mg of APL-2 administered daily by subcutaneous injection to PNH patients (n=3) who have never received eculizumab. In PADDOCK, in the first month, all three patients treated with APL-2 monotherapy experienced rapid corrections in lactate dehydrogenase (LDH), a key marker of hemolytic activity in PNH, from an average of 1,615 U/L to an average of 275 U/L (1.1x upper limit of normal), a decline of 83%. PHAROAH is an open label safety and efficacy study of 270mg of APL-2 administered daily by subcutaneous injection as a complementary therapy to suboptimal responders to eculizumab (n=6), defined as hemoglobin levels (Hb) of less than 10 g/dL at screening or a history of at least one transfusion in the previous year. In the first month, average Hb levels in the six patients increased from 8.8 g/dL to 11.9 g/dL, an increase of 36%. During this period, patients also experienced rapid corrections in LDH from an average of 280 U/L (1.3x upper limit of normal) to an average of 163 U/L (0.8x upper limit of normal), a decline of 42%. After six months, the average Hb level was 11.4 g/dL, and the average LDH level continued to be normal at 184 U/L (0.9x upper limit of normal). During that same period, the average transfusion rate dropped from 3.4/month on eculizumab monotherapy to 0.3/month when APL- 2 was added to eculizumab. Notably, five of six patients on baseline were receiving higher than normal dosing with eculizumab in the form of 1,200 mg every two weeks or 900 mg every week, as opposed to the normal 900 mg every two weeks. There have been no significant drug-related safety concerns and overall APL-2 was well tolerated in both PADDOCK and PHAROAH during the six months of dosing. None of the patients experienced episodes of breakthrough hemolysis, which can occur in patients treated with C5 inhibitors. Both open label studies are ongoing and are designed to support cross-over from eculizumab to APL-2 after a brief period of add-on dosing. Later in 2017, the Company plans to switch from daily to twice per week dosing.

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Aduro Biotech Announces Initiation of Phase 2 Clinical Trial of CRS-207 in Combination with KEYTRUDA® (pembrolizumab) for the Treatment of Previously-Treated Gastroesophageal Adenocarcinoma

BERKELEY, Calif., June 29, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced  the initiation of the Phase 2 clinical study designed to evaluate the tolerability, safety and efficacy of CRS-207, Aduro’s lead listeria-based immunotherapy construct (LADD), in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy marketed by Merck (known as MSD outside the United States and Canada), for the treatment of patients with gastroesophageal adenocarcinoma who have failed two prior chemotherapy treatments. Clinical trial sites have been activated and the study is open for enrollment.

“Gastroesophageal adenocarcinoma is an aggressive, difficult to treat cancer for which there is currently no FDA-approved therapy for those in need of a third-line treatment option,” stated Natalie Sacks, M.D., chief medical officer of Aduro Biotech. “We are pleased to be evaluating the CRS-207/KEYTRUDA combination in this Phase 2 clinical trial for late-stage gastroesophageal cancer patients and hope to see similar synergistic anti-cancer activity as observed in preclinical studies with this investigational treatment regimen.”

The multicenter, single-arm, open-label Phase 2 study is designed to evaluate the safety and efficacy of CRS-207 with KEYTRUDA in adults with gastric, gastroesophageal junction, or esophageal adenocarcinoma who have received two prior systemic chemotherapy treatment regimens for advanced disease.  The trial will be conducted at up to 15 sites and will enroll approximately 70 patients. The primary efficacy endpoint is objective response rate, defined as the proportion of patients with either complete or partial responses.  For additional information about the study, please visit www.clinicaltrials.gov (search identifier NCT03122548).

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Newton biotech says drug targeting cell's energy center shows promise

Jun 29, 2017, 8:30am EDT - A Newton biotech says it has moved one step closer to developing the first treatment for rare genetic diseases of the mitochondria — the powerhouses of the cell that create 90 percent of the human body’s energy. Privately held Stealth BioTherapeutics on Thursday unveiled what it characterized as positive data from a Phase 2 study of its potential treatment for "mitochondrial myopathy," muscle weakness caused by a broad class of diseases. The 50-employee company, which has raised around $200 million since being founded in 2007, said that patients who received the drug fared better in a six-minute walking test than those taking a placebo. While improvement on that metric was not statistically significant, Stealth said the trial helped it to identify other potential endpoints, or objectives, for a Phase 3 study later this year. Those endpoints include the level of fatigue felt by patients, which was markedly greater for those taking the placebo. There were no serious side effects, Stealth said. In an interview, Stealth CEO Reenie McCarthy said that mitochondria have long been an intriguing target for drugmakers because of the important role they play in the body. But targeting mitochondria, which have multiple membranes, can be difficult, and many earlier approaches have produced toxic side effects. Most patients with mitochondrial myopathy are prescribed cocktails of vitamins and put on a diet high in antioxidants (think blueberries or red wine). Stealth’s drug is designed to permeate mitochondria and bind to a part of the inner membrane that plays a pivotal role in energy metabolism, McCarthy said. In June 2016, Stealth had unveiled positive data from a Phase 2 trial of the drug, called "elamipretide." The trial data reported on Thursday examined the same patients for a longer period. The company now plans to work with regulators in the U.S. and Europe to finalize the design of the Phase 3 trial, which could begin by the end of the year, McCarthy said. “With this data, we really do feel like we’ve substantially de-risked and prepared for our Phase 3 program,” she said. “We’re very encouraged by the data in a population for which there are no approved treatments.”

28

Aduro Biotech Announces First Patient Dosed in Phase 2 Clinical Trial of CRS-207 in Combination with KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Previously Treated Malignant Pleural Mesothelioma

BERKELEY, Calif., June 28, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced that the first patient has been dosed in the company’s Phase 2 clinical trial in malignant pleural mesothelioma (MPM). The trial, which will involve approximately 35 patients, will evaluate the tolerability, safety and efficacy of CRS-207, Aduro’s LADD (live, attenuated double-deleted) based immunotherapy, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy marketed by Merck (known as MSD outside the United States and Canada), for the treatment of patients with MPM whose disease progressed following prior treatment.

“We are excited to initiate this Phase 2 trial to evaluate the combination of CRS-207 and pembrolizumab, an anti-PD-1 therapy, which we believe has the potential to be a synergistic combination therapy for patients with malignant pleural mesothelioma,” said Natalie Sacks, M.D., chief medical officer at Aduro. “Mesothelioma is an aggressive cancer with a poor prognosis and limited treatment options; currently, there are no FDA-approved therapies indicated for second- or third-line treatment. We have received Orphan Drug Designation in the U.S. and E.U. for CRS-207 for this indication, and we are committed to doing all that we can to bring new treatment options to patients facing this difficult disease.”

The multicenter, single-arm, open-label Phase 2 study is designed to evaluate the safety and efficacy of CRS-207 with pembrolizumab in adults with previously treated MPM. The trial will be conducted at up to 10 sites and will enroll approximately 35 patients who have failed one to two prior treatments. The primary efficacy endpoint is objective response rate, defined as the proportion of patients with either complete or partial responses. For additional information about the study, please visit www.clinicaltrials.gov (NCT03175172).

Earlier this year, Aduro announced a clinical collaboration with Merck, through a subsidiary, relating to the investigation of CRS-207 used in combination with pembrolizumab for the treatment of MPM. This is the second clinical collaboration formed this year between the two companies, with the first announced in January 2017 relating to the investigation of CRS-207 used in combination with pembrolizumab for the treatment of gastric cancer.

27

Human Cell-Expressed Interferon beta for Stem Cell Research and Regenerative Medicine Applications

Chicago, IL. — June 27, 2017 HumanZyme Inc., a leading supplier of novel recombinant human proteins and growth factors expressed in human cells, today announced the launch of HumanKine® Interferon beta (IFN beta) expressed from HEK293 cells. IFN beta is a member of the type I family of interferons whose function is inhibiting viral infection, along with the regulation and activation in immune responses against bacteria, parasites and tumor cells. IFN beta is deficient in multiple sclerosis, and is currently used in injectable form as a treatment for this disease. According to Scott Coleridge, CEO at HumanZyme, “We are proud to be the only commercial supplier of high-quality, tag-free recombinant human Interferon beta expressed in human cells for research purposes. Our proprietary HEK293 expression system allows us to express difficult proteins in a human cell line to provide the most authentic recombinant products possible. The new IFN beta further expands our animal component-free HumanKine product line, is priced competitively, is and is also available in bulk.” Glycosylation of the Interferon beta protein by a single asparagine-linked sugar chain has been shown to be essential to its activity and stability, both in vitro and in vivo. HumanZyme’s IFN beta expressed in human cells assures native processing, glycosylation and folding of the purified protein compared to other expression systems such as bacterial, mammalian cell lines, or insect cells, preserving its biologic function and activity. HumanZyme’s HumanKine proteins are also animal-derived product free, xeno-free and carrier-free.

15

Stealth BioTherapeutics to Present Top-Line Data From MMPOWER-2 Phase 2 Continuation Trial at Mitochondrial Medicine Symposium 2017

MMPOWER-2 assessed once daily dosing, tolerability and efficacy of elamipretide in patients who completed the MMPOWER clinical trial Company to feature presentation from primary mitochondrial myopathy program BOSTON – June 15, 2017 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced the presentation from the Company’s primary mitochondrial myopathy (PMM) program will be featured at Mitochondrial Medicine Symposium 2017, the United Mitochondrial Disease Foundation (UMDF) symposium, from June 28 – July 1, 2017 in Washington D.C. The presentation will include top-line results from MMPOWER-2, a Phase 2 continuation trial evaluating the safety, tolerability and efficacy of treatment with elamipretide for PMM in patients with genetically confirmed mitochondrial disease previously treated in the MMPOWER study. Data from the MMPOWER-2 trial will be presented at the UMDF symposium on Thursday, June 29 at 8:00 a.m. EDT. “People with PMM, for which there are no FDA-approved therapies, experience debilitating muscle weakness and severe fatigue that can make even simple daily tasks challenging. We are focused on developing products designed to address this unmet medical need with our mitochondrial medicine platform,” said Stealth Chief Executive Officer Reenie McCarthy. “We look forward to discussing the progress of our clinical programs and the MMPOWER-2 data at the UMDF symposium. The findings, together with our learnings from the MMPOWER study, will be critical in informing our plans for a Phase 3 program in this patient population.” For additional information on Stealth’s program in PMM or elamipretide, please refer to Stealth’s website. About MMPOWER-2 MMPOWER-2 is a Phase 2, randomized, double-blind, placebo-controlled crossover study to evaluate the safety, tolerability and efficacy of four weeks’ treatment with once-daily subcutaneous (SC) injections of elamipretide or placebo in thirty patients with PMM previously treated in the MMPOWER study. Subjects treated in the MMPOWER-2 study were randomized (1:1) to receive either four weeks of treatment with 40 mg elamipretide administered once daily SC in the first treatment period followed by four weeks of treatment with placebo administered once daily SC in the second treatment period, or vice versa. The two treatment periods were separated by a four-week washout period. The primary efficacy endpoint is change in distance walked in six minutes at the end of each four-week treatment period. Secondary endpoints include safety and tolerability assessments, patient-reported outcomes and global impression scales.

14

ENYO Pharma SA announces successful completion of EYP001 first in man Phase 1 study

June 14, 2017 - ENYO Pharma SA, a privately held biopharmaceutical company currently focused on developing treatments for viral infections, today announced that the Phase 1a single and multiple ascending dose trial evaluating EYP001 in healthy subjects has been completed. The results show that EYP001 was safe and well-tolerated at all doses studied in 80 subjects. The safety, pharmacokinetics (PK) and pharmacodynamic (PD) analysis are in line with established FXR biology and reported results from other early stage compounds that are in development for NASH. In particular, the levels and pattern of plasma concentrations changes of C4 (7αhydroxy4cholesten3one) and fibroblast growth factor 19 (FGF19) are consistent with FXR agonism over the dose range of 60mg up to 500mg of multiple single doses administered over 15 days. These clinical results were presented at the international liver conference in Amsterdam earlier this year. In addition, in vitro data were presented confirming that EYP001 inhibits HBV particle release similarly to Tenofovir (TFV) or Entecavir (ETV), with an additive effect when combined. Moreover, EYP001 alone inhibited viral protein (HBsAg and HBeAg) production, reduced cccDNA and pgRNA, while TFV or ETV mono-treatment had negligible effect on these HBV markers in vitro. EYP001 is a synthetic farnesoid X receptor (FXR) agonist with a favorable profile for oral therapy. The first Phase 1 study was designed to determine the safety, tolerability and pharmacokinetics of EYP001 in healthy subjects. Another ongoing Phase 1 study evaluates the safety, food effect and PK of EYP001 in subjects with chronic HBV infection. Jacky Vonderscher, Ph.D., Chief Executive Officer of ENYO Pharma SA commented: “We are pleased with the profile emerging in our Phase 1 development with EYP001. We look forward to bringing the compound into further clinical development and believe EYP001 has the potential to be explored in additional indications such as NASH.” “Throughout the clinical program completed thus far, EYP001 has demonstrated an excellent tolerability and safety profile. By using the novel approach of enriched digitized ECG analysis we also showed that EYP001 does not impact QT. This supports our focus to progress swiftly with efficacy trials, while advancing the required regulatory clinical package.” added Pietro Scalfaro, M.D., Chief Medical Officer of ENYO Pharma SA.

08

Voicebox’s Advanced Technologies Team Tackles Natural Language Understanding With New Semantic Parsing Methods

Although Voicebox Technologies offers best-of-breed Automated Speech Recognition (ASR) products, speech recognition alone does not make for a voice interface. Natural Language Understanding (NLU), the process by voice-driven systems understand and respond to a user’s commands, are what make each Voicebox product a success. For Voicebox’s Advanced Technologies team, semantic parsing is essential to building an accurate next-generation NLU system. Semantic parsing is a method of mapping a user’s language to its meaning, even in cases with complex phrasing. In other words, semantic parsing is how a voice-enabled device knows the difference between such similar commands as “what is close” and “what is the closest.” Mark Johnson, Chief Scientist of Voicebox Australia, described semantic parsing as an important advance beyond rule-based NLUs of the past. “Semantic parsing is a crucial component for Conversational Intelligence, as it permits users to say what they want the device to do—for example, ‘Send this photo to all the people in it’—rather than [forcing them] conform to a fixed set of templates or patterns.” The Advanced Technologies team at Voicebox aims to solve some of the greatest obstacles facing current NLU technology, from mixed-language speech, to rare and complex utterances. Some of these obstacles were addressed in the team’s recent research paper on multilingual semantic parsing, which Voicebox is proud to say has been accepted for presentation at the CoNLL 2017 conference. The team’s approach to multilingual parsing handles utterances known in research circles as “code-switching,” which contain a mixture of languages. For Voicebox, which has offered monolingual solutions for years, this research is essential to developing multilingual NLU technology that better serves an increasingly multi-cultural world. The research team conducted a series of code-switching experiments in semantic parsing systems, where commands were given in German, English, or a mixture of both languages in the same utterance. The researchers developed a model which transfers information from a source language to a target language in a single semantic parsing process that speeds up the overall training. They combined data from both languages, including low-frequency words, to train the model to overcome lexical complexities and understand utterances in two languages. They also tested deep-learning neural networks on code-switching data and saw similar results. Their approach achieved state-of-the art accuracy comparable to that of Google’s NLU system. The system reached 85.7% and 83% accuracy respectively, on English and German utterances. More surprisingly, the code-switching model achieved 78% exact-match accuracy on multi-lingual utterances—more than 60% better than a corresponding monolingual model—even though it was never trained on code-switching data. “[We asked] can we use the information we learned from one language to make it easier to build semantic parsers in other languages?” Mark Johnson said. “Our goal was to see if having a semantic parser in one language could reduce the amount of data required for a second or even a third language. We were able to show that we could, and significantly so.” Voicebox is tackling the fundamental research necessary to provide reliable NLU products in a variety of languages, dialects, and multi-lingual settings. Since many users are multilingual and mix foreign words into their everyday speech, the ability of NLU technology to accommodate complex speech around the world is key to building more capable and accessible conversational systems.

08

Voicebox Technologies Releases Talisman Embedded Speech Recognition Software

Voicebox Technologies, an innovator of natural language voice applications, recently released Talisman, the latest iteration of its Embedded Automatic Speech Recognition (ASR) product for automotive and embedded IoT applications. The Talisman ASR is designed for small and mid-range embedded platforms like those found in cars, smartphones, and smart appliances. It supports large recognition grammars that can handle thousands of phrases. Historically, Voicebox has worked with third-party ASR solutions. With a high-quality, robust, in-house ASR solution, Voicebox can now double its language catalogue for the Embedded ASR platform over what it introduced in 2016. New languages will include Korean, Dutch, and Portuguese, and others. The expanded catalogue will also offer improved recognition for British, Australian, and Indian English dialects. When asked about the significance of the Talisman ASR Dan Carter, Vice President of Speech for Voicebox, said “the Talisman ASR enables us to deliver the entire end-to-end voice experience, from audio to understanding what the user said, to executing their request without the engineering overhead of integrating components from multiple suppliers.” Voicebox’s Embedded ASR utilizes deep neural networks (DNN), which uses vast quantities of collected data to generate probabilistic text outputs. Voicebox trains its speech models using a GPU compute cluster to include a wide range of speakers, ensuring their voice commands won’t be compromised due to differences in pronunciation or accent. What is remarkable with Talisman ASR is that it uses the latest techniques previously found on high end server based ASR solutions on a low memory embedded platform. Combining Talisman’s excellent on-board performance in embedded systems with Voicebox’s Hybrid SDK provides the additional power of cloud-computing. When network connectivity is available we can leverage Voicebox’s cloud ASR and capture usage and performance data from Talisman. This data can be used to train better models, improving accuracy.

07

InCarda Therapeutics Announces Positive Clinical Data Supporting Development of Inhaled Flecainide for the Treatment of Symptomatic Acute Events of Paroxysmal Atrial Fibrillation (PAF)

Flecainide administered via oral inhalation is well tolerated and elicits ECG changes suggestive of rapid drug delivery to heart

Brisbane, California, June 7, 2017 – InCarda Therapeutics, Inc. (InCarda), a privately held biopharmaceutical company developing therapies for acute cardiovascular conditions via the inhalation route, today announced positive top-line clinical data from a Phase 1 study for its lead investigational product, InRhythmTM (inhaled flecainide), demonstrating rapid drug delivery to the systemic circulation to treat symptomatic acute episodes of PAF.

“Patients with PAF experience acute episodes of heart palpitations, lightheadedness, fatigue and shortness of breath caused by fast heart rate and irregular rhythm, and are at increased risk of strokes.  Many require hospital procedures such as electrical cardioversion (shock), to restore normal heart rhythm,” explained Luiz Belardinelli, MD, chief medical officer of InCarda. “The clinical study results are consistent with our preclinical findings, which suggest that InRhythmTMcould restore normal heart rate and rhythm in patients with PAF.”

InRhythmTM delivers flecainide via inhalation to achieve more rapid delivery of the drug to the heart via the lungs.  Delivery of flecainide via inhalation offers the potential for faster conversion to normal sinus rhythm and more rapid relief of PAF symptoms than either intravenous (IV) or oral flecainide.  Flecainide is approved as an oral anti-arrhythmic drug for first-line therapy of patients with PAF.  An IV formulation of flecainide is approved as first-line therapy in the EU and in selected countries for acute cardioversion of recent onset PAF.

The Phase 1 clinical study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of flecainide delivered via inhalation and was conducted in two parts. The first part was a double-blind placebo controlled single sequential ascending dose study evaluating three doses of inhaled flecainide or placebo in 34 healthy volunteers. The second part was a two-period crossover study comparing delivery of flecainide via inhalation with delivery via IV infusion in six healthy volunteers.

The study met its endpoints of safety and tolerability; all doses of inhaled flecainide administered (estimated lung doses of 20 to 60 mg) were found to be safe and well tolerated. Inhalation of flecainide rapidly delivered the drug into systemic circulation (within one to three minutes), yielding venous plasma levels sufficient to elicit its expected electrophysiological effects, in keeping with the therapeutic activity of flecainide.

“We are excited about these results and the potential for inhaled flecainide to safely restore normal heart rate and rhythm as well as relieve symptoms from episodes of PAF within minutes after inhalation without the need to go to a hospital or emergency room,” stated Dr. Belardinelli.

“In the US alone, atrial fibrillation affects over five million patients and results in an annual expenditure of over $26B.  Providing patients a way to treat their episodes of PAF soon after the onset of symptoms, whether at home, at work or anywhere else, should markedly improve their quality of life, make the overall management of PAF more efficient, and reduce healthcare utilization and costs,” stated Grace E. Colon, Ph.D., chief executive officer and president of InCarda. “With these exciting data in hand, we are actively preparing for a Phase 2 trial.”

01

Aduro Biotech Announces FDA Clearance of Investigational New Drug Application to Evaluate the Combination of ADU-S100 with PDR001 for the Treatment of Solid Tumors and Lymphomas

Early Phase 1 Dose Escalation Signals Support Advancement into Phase 1b in Second Half of 2017

BERKELEY, Calif., June 01, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for ADU-S100 (also known as MIW815), a novel STING pathway activator, to be evaluated in combination with PDR001, Novartis’ investigational anti-PD-1 checkpoint inhibitor, for the treatment of advanced/metastatic solid tumors or lymphomas.  The Phase 1b study is expected to be initiated in the second half of 2017.

“The initial insights we have gained from the ongoing trial of ADU-S100, coupled with preclinical data that suggests an anti-cancer synergy between an anti-PD-1 checkpoint inhibitor and ADU-S100, underscores the importance of evaluating these two novel approaches to treating cancer in combination with one another,” stated Natalie Sacks, M.D., chief medical officer of Aduro.  “With the IND now cleared, working with Novartis, our STING program collaborator, we look forward to initiating a Phase 1b trial in the second half of the year to gain clinical insights into the STING/anti-PD-1 inhibitor combination for the treatment of multiple tumor types. At the same time, we will continue to evaluate the potential of ADU-S100 as a monotherapy in cutaneously accessible tumors as well as viscerally accessible tumors.” The open label, global, multicenter Phase 1b study is designed to evaluate the safety and efficacy of ADU-S100 administered by intratumoral injection with PDR001 to patients with advanced/metastatic solid tumors or lymphomas.  

May 2017

24

Liquidia Technologies Announces Positive Phase 1 Data for LIQ865, Sustained-Delivery PRINT® Formulation of Bupivacaine for Post-Surgical Pain Relief

RESEARCH TRIANGLE PARK, NC – May 24, 2017

Liquidia Technologies, Inc., today announced initial data from its LIQ865 internal clinical development program, which is a PRINT® formulation for the sustained-delivery of free base bupivacaine for post-surgical pain relief. The phase 1 trial, marking the first evaluation of LIQ865 in humans, was a randomized, controlled, double-blind study evaluating the safety, pharmacokinetic profile and pharmacodynamic response of a single-ascending dose in healthy adult males. Topline data indicate that LIQ865 doses were well tolerated and the pharmacodynamic response was consistent with a local anesthetic effect lasting for three or more days.

“According to the National Institute on Drug Abuse, a component of the National Institutes of Health, 2.1 million people in the United States suffer from substance use disorders related to prescription opioid pain relievers, many of whom began taking opioids as post-surgical patients,” said Mike Royal, M.D., LIQ865 Program Leader and Senior Vice President, Clinical Development at Liquidia. “Our intent with LIQ865 is to increase the options for long-lasting, safe, effective post-operative pain relief that can reduce the need for opioids in the early days following surgery.”

Liquidia is developing LIQ865 with the goal of providing at least three days of post-surgical pain relief with a single administration, potentially minimizing or avoiding the need for opioid analgesics. There are over 80 million inpatient and outpatient surgeries performed every year, with the majority of surgeries requiring opioids to treat moderate to severe post-operative pain.i,ii  A minority of these individuals will become long-term users and have the potential for opioid misuse and addiction.iiiiv 

“The phase 1 clinical trial results for LIQ865 further validate the remarkably broad applicability of the PRINT technology across virtually any therapeutic area,” said Neal Fowler, Chief Executive Officer at Liquidia.  “We look forward to providing additional updates on our PRINT technology-enabled clinical programs throughout 2017.”

 

17

Aduro Biotech Announces Clinical Collaboration with Merck to Evaluate the Combination of Aduro’s CRS-207 with Merck’s KEYTRUDA® (Pembrolizumab) for the Treatment of Mesothelioma

Second Phase 2 Clinical Collaboration between the Two Companies to Evaluate CRS-207/Pembrolizumab Combination

BERKELEY, Calif., May 17, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today the expansion of its clinical collaboration with Merck (known as MSD outside the United States and Canada) to include an additional Phase 2 clinical trial. The companies will investigate the combination of CRS-207, Aduro’s LADD (live, attenuated double-deleted) based immunotherapy, with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with malignant pleural mesothelioma (MPM) whose disease progressed following prior treatment. Earlier this year, Aduro announced a Phase 2 clinical collaboration with Merck, through a subsidiary, to evaluate the combination of CRS-207 with pembrolizumab for the treatment of gastric cancer.

“Data from our ongoing Phase 1 clinical trial of CRS-207 with standard chemotherapy as frontline treatment for malignant pleural mesothelioma have been very encouraging, including disease control in 94 percent of patients treated with the CRS-207/chemotherapy combination,” said Natalie Sacks, M.D., chief medical officer at Aduro.  “Based on these clinical data, as well as data from preclinical studies that demonstrate synergistic activity of CRS-207 and anti-PD-1 therapy, we look forward to initiating a Phase 2 trial to evaluate the CRS-207/pembrolizumab combination in patients with malignant pleural mesothelioma who have failed prior treatment.”

The multicenter, single-arm, open-label Phase 2 study is designed to evaluate the safety and efficacy of CRS-207 with pembrolizumab in adults with previously treated MPM.  The trial is expected to involve approximately 35 patients who have failed one to two prior treatments.

11

DNAtrix Oncolytic Myxoma Virus Eliminates Treatment-Resistant Cancer

Houston, TX – May 11, 2017 – DNAtrix, a clinical stage biotechnology company developing oncolytic viruses for cancer, today announced a podium presentation on the use of DNAtrix’s oncolytic myxoma virus for treatment-resistant cancer at the upcoming 2017 Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) in Washington, DC.

Grant McFadden, PhD, Director of the Biodesign Center for Immunotherapy, Vaccines and Virotherapy at Arizona State University, will present his pre-clinical results showing that ex vivo treatment of stem cells with myxoma virus prior to transplantation efficiently eliminates residual chemotherapy-resistant myeloma cells that remain in the transplant recipient.

Myxoma virus is an oncolytic poxvirus with the ability to selectively kill cancer cells without infecting or perturbing normal cells. More importantly, it can exploit T-cells and other white blood cells as virus “carriers,” which can be systemically delivered to target and destroy tumors.

“This report by Dr. McFadden represents years of research to uncover the remarkable cancer-targeting properties of this virus,” said Frank Tufaro, PhD, CEO of DNAtrix.  “It appears that myxoma virus could be especially effective in combination with T-cell-based therapies, such as CAR-T therapy and stem cell transplantation.”

09

Apellis Receives EMA Orphan Drug Designation for APL-2 in PNH

C3 inhibitor is in development for the treatment of PNH, both in patients not previously treated with eculizumab, and in patients who continue to experience hemolysis and require red blood cell transfusions despite receiving treatment with eculizumab LOUISVILLE, Ky.May 9, 2017 /PRNewswire/ -- Apellis Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on inhibition of the complement system, announced today that the European Medicines Agency (EMA) has granted orphan medicinal product ("Orphan Drug") designation to APL-2, a complement C3 inhibitor, in the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare, acquired, potentially life-threatening disease characterized by complement-mediated hemolytic anemia.

To qualify for EMA orphan designation, a sponsor must establish that the product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than 5 in 10,000 persons in the European Union (EU), and that there exists no satisfactory method of treatment of the condition that has been authorized in the EU or, if such method exists, that the product will be of significant benefit to those affected by the condition.
An orphan designation by EMA will allow Apellis to benefit from several incentives offered by the EU to companies developing medicines for rare diseases, including protocol assistance, access to the centralized authorization procedure, and market exclusivity once the medicine is on the market. Cedric Francois, M.D., Ph.D., chief executive officer of Apellis, said: "This is another important milestone for the APL-2 program. We believe that APL-2 has the potential to offer an important, and hopefully improved, new treatment option for patients suffering with PNH.  The granting of orphan designation by the EMA and the resulting incentives will benefit us, both in the near term, as we continue to advance our clinical programs, and in the longer term, as we prepare to bring APL-2 to market."

08

Green Biologics Honored with Biorenewable Deployment Consortium’s Commercialization Achievement Award

Ashland, Virginia and Abingdon, Oxfordshire U.K. (May 8, 2017) – The Biorenewable Deployment Consortium (BDC) honored Green Biologics, Inc., the U.S. subsidiary of Green Biologics Ltd., a U.K. industrial biotechnology and renewable specialty chemicals company, with the organization’s Spring 2017 Commercialization Achievement Award at its spring meeting in Des Moines on May 2, 2017. Green Biologics is recognized for its leadership in the biorenewable industry and successful commercialization of renewable alternatives to n-butanol, acetone and its associated derivatives. These chemicals serve as vital components to downstream products across various industries, including CASE (coatings, adhesives, sealants and elastomers), HI&I (household, industrial & institutional cleaners), PCI (personal care intermediates), food ingredients and energy chemicals. “The Biorenewable Deployment Consortium is proud to honor Green Biologics with its Spring 2017 Commercialization Achievement Award,” said BDC Chairman and Co-Founder Ben Thorp. “Green Biologics is a great example of a company that is effectively using its technology platform to produce a wide range of sustainable feedstocks into high performance green chemicals and industrial products. Its commercial plant in Little Falls, MN is the reason that BDC has recognized Green Biologics and awarded its global team for its continued success.” Green Biologics officially began customer shipments at its first commercial facility in Little Falls, MN, in December 2016, marking the culmination of a years’-long effort to create a robust, global network of customers and partners. These relationships have enabled the company to bring its 100 percent bio-based products to numerous downstream markets and specialty applications. As a result, Green Biologics has further strengthened its position as a global renewable specialty chemicals company, and reinforced its ability to meet the needs of today’s producers and consumers, who are demanding environmentallyconscious alternatives to longstanding products. “We’re pleased to be recognized by the Biorenewable Deployment Consortium for these achievements,” said Tim Staub, Green Biologics’ Global VP Business Development, who received the award on behalf of the company. “Our global team’s tireless efforts and dedication to a greener, cleaner tomorrow made all that we have accomplished possible, and we thank all involved for their hard work. It makes us very proud to follow in the footsteps of companies like DuPont Industrial Biosciences, which received this honor last year, and we’ll continue to work hard to bring new products and innovative solutions to market.”

02

Stealth BioTherapeutics Initiates Phase 1/2 Trial of SBT-20 in Patients With Early Stage Huntington’s Disease

SBT-20 is the second investigational compound from Stealth’s mitochondrial platform

Trial results to inform development plan for targeting mitochondrial dysfunction in neurodegenerative diseases

BOSTON – May 2, 2017 – Stealth BioTherapeutics Inc. (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced the initiation of CHALLENGE-HD, a Phase 1/2 trial evaluating SBT-20 in patients with early stage Huntington’s disease. SBT-20 is an investigational tetrapeptide aimed at improving mitochondrial function by restoring the physical and biochemical properties of dysfunctional mitochondria.

“Huntington’s disease is a fatal genetic disorder in which nerve cells in the brain deteriorate over time, causing patients to have progressively limited physical and mental abilities. Research shows that mitochondrial dysfunction may play a central role in this deterioration, making the mitochondria a prime target for study,” said Stealth’s Chief Clinical Development Officer Jim Carr. “This trial examines the safety and tolerability of SBT-20 at various doses and begins to explore the possible benefit of the compound in addressing mitochondrial dysfunction in Huntington’s disease.”

CHALLENGE-HD is a two-part, randomized, double-blind, placebo-controlled trial being conducted at a single clinical site, the Centre for Human Drug Research (CHDR) in the Netherlands.  The trial is evaluating the safety, tolerability and efficacy of daily subcutaneous injections of SBT-20 in adult patients with early stage Huntington’s disease (genetically confirmed disease with Unified Huntington’s Disease Rating Scale [UHDRS] Total Motor Score of five or more and Total Functional Capacity Score of seven or more). During part one, patients are administered SBT-20 subcutaneously for seven days at one of three ascending doses (5, 15 and 25 mg). The findings will be used to select a dose for the second part of the trial, in which SBT-20 will be administered subcutaneously for 28 days. The trial aims to enroll 24 patients, all of whom will participate in both part one and part two of the trial. The trial’s primary endpoints are safety and tolerability, and secondary endpoints will measure the effect of SBT-20 on mitochondrial and motor function as well as its pharmacokinetic profile.

“The initiation of CHALLENGE-HD is a significant milestone for Stealth as our second drug candidate enters human trials in a new therapeutic area. As a leader in mitochondrial medicine, we want to pursue the full potential of mitochondria-targeted therapies, in rare primary mitochondrial diseases, common diseases of aging and now in neurodegenerative disorders. We plan to use the results from this trial to better inform our SBT-20 pipeline development plan and the broader potential of our platform in neurodegenerative disorders,” said Stealth Chief Executive Officer Reenie McCarthy.

02

Aduro Biotech Reports First Quarter 2017 Financial Results

Ten Product Candidates Advancing with $356 Million in Total Cash

BERKELEY, Calif., May 02, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (NASDAQ:ADRO) today reported financial results for the first quarter ended March 31, 2017. Net loss for the first quarter of 2017 was $21.8 million, or $0.32 per share, compared to a net loss of $28.8 million, or $0.45 per share for the same period in 2016.

Cash, cash equivalents and marketable securities totaled $356.0 million at March 31, 2017, compared to $361.9 million at December 31, 2016.

“This will be an important year for Aduro, as we generate data in our ongoing ADU-S100/STING monotherapy trial and our planned Phase 2 trial in mesothelioma, as well as look for data from Janssen’s Phase 1 trials in lung and prostate cancers evaluating LADD therapeutic candidates,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “We also plan to advance our STING program into additional clinical studies in collaboration with Novartis, and the first antibody from our B-select platform, the novel anti-APRIL antibody, is expected to be cleared for clinical testing this year. With ten product candidates in our diversified portfolio and a healthy balance sheet, we are in a strong position to continue to advance our pipeline and build a leading immunotherapy company."

April 2017

24

Precision Intratumoral Delivery of DNX-2401 with the Alcyone MEMS Cannula

Houston, TX & Lowell, MA – April 24, 2017 – DNAtrix, a clinical stage biotechnology company developing virus-based immunotherapies for cancer, and Alcyone Lifesciences, a leader in neural intervention systems and advanced drug delivery, will reveal clinical data demonstrating the precise administration of DNX-2401, an oncolytic adenovirus, into brain tumors using Alcyone’s MEMS Cannula (AMCTM) at the Annual Meeting of the American Association of Neurological Surgeons (AANS) in Los Angeles, CA.

Neurosurgeon Frederick Lang, MD, FACS, FAANS, will present results from a Phase 1b study confirming reproducible delivery of DNX-2401 by the AMC into recurrent glioblastoma tumors. Infusion accuracy was determined using the “aura method,” the displacement of DNX-2401 by gadolinium.

DNX-2401 is a potent oncolytic adenovirus that replicates in tumors and activates an anti-tumor immune response. The AMC is a dual-channel, MRI-safe cannula with the smallest-in-class micro-tip, ensuring optimal and consistent drug distribution while eliminating backflow.

“The AMC cannula standardizes the efficient delivery of DNX-2401 into the tumor of patients with recurrent glioblastoma.” said Frank Tufaro, PhD, CEO of DNAtrix. “Based on these results, neurosurgeons in the US and Canada are using the AMC in our Phase 2 clinical trial of DNX-2401 with pembrolizumab (KEYTRUDA®).”

“The lessons learned from more than a decade of attempts at exploiting convection enhanced delivery (CED) for brain cancer treatment weighed critically on the design, development, and implementation of the AMC delivery platform. The drawbacks centered around sub-optimally designed devices that have poor bio-distribution characteristics as well as surgeons' inability to monitor the distribution of these drugs within the tumor,” said PJ Anand, CEO of Alcyone Lifesciences. “It is our vision that the AMC intraparenchymal delivery platform will make this modality of treatment a permanent addition to clinical management of brain malignancies.”

March 2017

31

LUQA PHARMACEUTICALS PARTNERS WITH POLICHEM SA (An Almirall Company) TO DISTRIBUTE MACMIROR (Nifuratel) IN THE PEOPLES REPUBLIC OF CHINA

March 31st 2017 Hong Kong, PRC – Luqa Pharmaceuticals (“Luqa” or the “Company”), the China focused specialty pharmaceutical company, announces that it has entered into an exclusive long-term agreement for the distribution rights of MACMIROR (Nifuratel). MACMIROR (Nifuratel) is a product used for the polyvalent therapy of vulvovaginal infections due to pathogenic micro-organisms: Candida, Trichomonas and Bacteria. The product is used in the treatment of a wide range of infections of the genito-urinary tract. The product is already registered in the Peoples Republic of China and Luqa will be responsible for the sales, marketing and distribution, with initial commercialization expected during the second half of 2017. Luqa is already firmly established in the women’s health market with both its prescription and aesthetic dermatology portfolio, which is actively promoted and distributed by the Company’s own sales force across China. Robert Braithwaite, Luqa’s CEO commented, “Coming after our recent acquisition of Arista- which expanded our commercial footprint in China, we are very pleased to announce this transaction, which extends Luqa’s growing women’s health portfolio with the commercial rights for a registered prescription drug, used in various public and private hospital settings”.

27

Cognoa raises $11.6M to continue validation, FDA submission for child development assessment app

By Heather Mack | March 27, 2017

Palo Alto, California-based Cognoa, which makes an app to assess child development, has raised $11.6 million in a round led by existing investor Morningside. This brings the company’s total funding to over $20 million.

By analyzing parent-provided information and videos of a child’s natural behavior, the Cognoa app uses machine learning to provide an assessment of whether that child is developing at the right pace, as well as to evaluate their behavioral health. The app is intended for use in children aged 18 months to 7 years old, and while it does not provide a diagnosis, parents can take the evaluation to the pediatrician. The company has completed several clinical validation studies and has been used by 300,000 families.

“The trend of using patient-reported outcomes (PROs) and machine learning to provide diagnoses has grown exponentially in the healthcare field, and Cognoa is a leader in the area of assessments for developmental and behavioral conditions” Dr. Isaac Cheng, an investor at Morningside, said in a statement. “We believe Cognoa can significantly improve the standard of care for child behavioral development and are committed to supporting the clinical validation and FDA approval of the first machine learning-based diagnostic for early diagnosis of developmental delays.”

The latest funding will be used to for additional validation studies on the path towards FDA submission as well as to expand the app's use with pediatricians, employers and insurers.

22

Launch of the HBI-120 handheld backscatter imager

Heuresis Corp., a privately held U.S., company specializing in advanced x-ray instrumentation, is pleased to announce the launch of the HBI-120 handheld backscatter imager. Heuresis’ HBI-120 is the world’s first one-piece handheld backscatter x-ray imager; it supports mission-critical requirements for customs and border protection, narcotics interdiction, bomb squads, VIP security, and other “soft target” protection missions. With optimum scan speeds of 15 cm (6”) per second, the HBI-120 provides one-sided x-ray images of bulk narcotics, hidden currency, explosives, ammunition and other contraband through up to 2.5 mm of steel; typical steel motor vehicle body panels are no more than 1 mm-thick. In prison environments, improvised weapons hidden in in bedding materials can be found quickly. HBI‐120 images objects with a miniaturized, shielded, 5 Watt, 120 keV, 42 microAmp, x‐ray generator and proprietary optics that makes a raster‐scanning pencil beam of x-rays to scan objects of interest. As the HBI-120 is moved over an object, a two‐dimensional backscatter x‐ray image of the object is displayed in real‐time on the imager’s high‐resolution transflective LCD touchscreen and saved in the instrument’s memory. Complete with an Android™ operating system for a broad feature set, the HBI-120 includes built-in Wi-Fi, Bluetooth™, GPS, laser scan guides, and a flashlight, all designed to help you gather and document scan images and share results quickly. Designed for the harshest work environments, the battery-operated HBI-120 is rated for use from –40 °C (–40 °F) to 60 °C (140 °F); the unit it is splash and dustproof, and rated to IP54. “The HBI-120 makes it possible for the first time to quickly find threats and contraband when much larger and more expensive truck and portal-based x-ray imaging systems are not practical or affordable. With its 120 keV x-ray generator, built-in display and ergonomic design, the HBI-120 gives law enforcement officers, customs agents and others a new tool to help them identify anomalies in vehicles, cargo and baggage.” Mr. Grodzins continued: “We have generated a lot of excitement wherever the HBI-120 has been used, particularly by narcotics interdiction teams and customs and border protection agents. From narcotics and currency to hidden weapons and bulk explosives, the HBI-120 is designed to support the global law enforcement community in their ongoing efforts to fight terrorism and combat contraband trafficking.

15

Aduro Biotech to Host Research and Development Day in New York

Company Also Invited to Ring the Opening Bell at the NASDAQ Stock Market

BERKELEY, Calif., March 15, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (NASDAQ:ADRO) today announced that the Aduro management team will host a Research and Development Day in New York City, New York, on Monday, March 27, 2017, at 8:30 a.m. Eastern Time, to review its three distinct immunotherapy platform technologies and related clinical programs.  Leading immunotherapy expert Thomas Gajewski M.D., Ph.D., leader of the Immunology and Cancer program at the University of Chicago Comprehensive Cancer Center, Director of Melanoma Oncology, and a Professor in the Ben May Department for Cancer Research, will present on the STING (Stimulator of Interferon Genes) pathway as an important new therapeutic target and speak on its potential for groundbreaking innovation in immunotherapy.

The following day, on Tuesday, March 28, Stephen T. Isaacs, chairman, president and chief executive officer of Aduro, and members of management, will ring the opening bell at the Nasdaq Stock Market.

14

InCarda Therapeutics Announces Abstract Acceptances for the Heart Rhythm 2017 Conference

San Francisco, California, March 14, 2017 – InCarda Therapeutics, Inc. (InCarda), a privately held biopharmaceutical company focused on the development and commercialization of therapies for acute cardiovascular conditions via the inhalation route, today announced the acceptance of two abstracts for poster presentations at the Heart Rhythm Society’s 38th Annual Scientific Sessions (HRS) to be held in Chicago, IL from May 10 – 13, 2017. The abstracts are:

    • Rapid Cardioversion of Acute-Onset Atrial Fibrillation with Pulmonary Delivery of Flecainide in Anesthetized Dogs; Authored by Luiz Belardinelli, M.D., and colleagues of InCarda Therapeutics.
     
    • Accelerated Conversion of Atrial Fibrillation to Sinus Rhythm by Intratracheal Delivery of Flecainide Acetate in a Porcine Model; Authored by Richard L. Verrier, Ph.D., and colleagues of Beth Israel Deaconess Medical Center, Harvard Medical School.
Dr. Verrier is a well-known expert in preclinical models of cardiac arrhythmia.  He is also collaborating on InCarda’s clinical research program. “As we continue to advance the clinical development of InRhythm™ (inhaled flecainide) for acute cardioversion of recent onset atrial fibrillation (AF) in patients with paroxysmal atrial fibrillation, we are increasingly optimistic about the future of this exciting product candidate,” stated Luiz Belardinelli, M.D., chief medical officer of InCarda. “We believe that by delivery of flecainide via inhalation, we can develop a safe and effective product. We are looking forward to presenting our results at the HRS as well as at future medical conferences.” InCarda’s Lead Product for PAF Paroxysmal atrial fibrillation (PAF), the most common type of cardiac arrhythmia (abnormal heart rhythm) is characterized by rapid and irregular heartbeats that often lead to palpitations and other disabling symptoms (e.g., fatigue). Orally administered flecainide is a commonly prescribed antiarrhythmic drug. InCarda is evaluating an inhaled formulation of this drug to treat symptomatic recent onset AF.  Inhaled delivery through the lung and pulmonary vein directly to the heart offers the potential for faster conversion of PAF to sinus rhythm with rapid relief of symptoms associated with PAF, both in and out-of-hospital, along with enhanced safety.  

13

Stellar Biotechnologies and Matrivax Sign Agreement to Transfer Vaccine Technology

LOS ANGELES and BOSTON, March 13, 2017 /PRNewswire/ -- Stellar Biotechnologies, Inc. (Nasdaq: SBOT), a leading manufacturer of a key protein utilized in immunotherapy development pipelines, and Matrivax Inc., a vaccine biotechnology company, today announced that the companies have entered into a technology transfer and purchase agreement related to Stellar's proprietary Clostridium difficile technology. Under the terms of the agreement, Stellar will transfer its proprietary rights and know-how of immunogens and vaccine technology for a life-threatening pathogenic bacteria known as Clostridium difficile (C. diff). Stellar advanced this technology through exploratory preclinical studies completed under an exclusive license of the patented immunotherapy technology from the University of Guelph, Canada. Stellar President and CEO Frank Oakes said that Matrivax's acquisition of Stellar's interest in C. diff technology underscores the importance of developing immunotherapy treatments for C. diff infections (CDI). "We are pleased with this endorsement of our vision for therapeutic vaccines to fight C. diff. This arrangement provides Stellar the opportunity to advance promising technology and share in successful milestones, without further capital investments," said Mr. Oakes. Matrivax CSO Kevin P. Killeen, PhD, said that, "Matrivax is excited to advance the C. diff prophylactic and therapeutic vaccine technology to the clinic. A key company goal is to develop novel therapeutic and preventative interventions targeting CDI that direct the immune system against both the pathogen and toxins, unlike many alternative approaches that only impact toxin-mediated disease symptoms. By acquiring rights to this enabling protective antigen technology, we can now advance research designed to disrupt the fundamental pathways of C. diff pathogenesis and transmission," said Dr. Killeen. For termination of its exclusive license to the patent rights, and transfer of know how related to its development work, Stellar will receive an upfront fee from Matrivax as well as a percentage of certain fees, milestone payments, sublicensing income and royalties that are paid by Matrivax to the University of Guelph in consideration of the license granted to Matrivax under the patent rights. As part of the arrangement, Stellar and the University of Guelph terminated their existing license agreement, effective March 6, 2017. The succeeding license agreement directly between the  University of Guelph and Matrivax became effective the same date. C.difficile has been categorized as an urgent threat by the Centers for Disease Control. According to published research reports, treatment costs in the United States and Europe are estimated at $7 billion annually.

10

Aduro Biotech Awarded East Bay Innovation Award for its Contributions in Life Sciences and the San Francisco East Bay Community

BERKELEY, Calif., March 10, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today the receipt of the East Bay Economic Development Alliance’s (East Bay EDA) East Bay Innovation Award for its innovation within the life science industry and unique contributions to the East Bay’s prosperity and culture of innovation.

“We are honored to have been recognized by the East Bay EDA for our innovative approach to the treatment of cancer and for our efforts to support and nurture the continued prosperity and rich culture that makes the East Bay what it is today,” stated Stephen Isaacs, chairman, president and chief executive officer of Aduro. “It is the diversity of our community—the people, the academic institutions, and businesses—that support us in our mission to bring innovative new therapies to individuals battling cancer.  We are grateful to be in the position to make a positive difference in the lives of others, within the East Bay and beyond.”

07

Green Biologics Named No. 12 in Biofuels Digest’s 50 Hottest Companies in the Advanced Bioeconomy

Renewable chemicals company rises 10 spots in annual industry rankings Ashland, Virginia and Abingdon, Oxfordshire U.K. (March 7, 2017) – Green Biologics, Inc., the U.S. subsidiary of Green Biologics Ltd., a U.K. industrial biotechnology and renewable chemicals company, announced today that it was named the No. 12 hottest company in this year’s 50 Hottest Companies in the Advanced Bioeconomy (Hot 50). The rankings, which are compiled by Biofuels Digest, a leading daily news publication on the pulse of the biofuels and biochemical industries, were announced last week in Washington D.C. at ABLC 2017 and mark a significant advancement for the company as compared to last year’s competition, in which Green Biologics held the No. 22 spot. “We’re very excited about this notable rise in the rankings,” said Sean Sutcliffe, CEO of Green Biologics. “This recognition is a true testament to the progress we have made toward establishing ourselves as the speciality chemicals provider of choice for numerous global markets. In just the past year alone, we have strengthened and expanded our network of industry partners, started operations and shipments at our first commercial plant, and launched our first sustainable, consumer-facing product. This year’s ranking is proof that the industry has taken notice of our achievements and has confidence in what’s to come.” Considered an industry staple, this longstanding annual listing recognizes companies leading the charge in innovation and achievement throughout the fuels and biobased chemicals and materials industries. The rankings are developed based on a system that weights inputs from an invited panel of distinguished industry selectors, composed of CEOs, scientists and media among others, with votes from registered subscribers to The Digest and those cast through social media. This recognition is the latest in a string of prestigious industry accolades the company has received in recent months, which include being named in the 2017 Global Cleantech 100 and recognized by the 2016 Global Clean Energy Awards as the Best Renewable Speciality Chemical Company in the UK.

06

ROCKLEY PHOTONICS RECEIVES GLOBAL TECHNOLOGY INNOVATION AWARD FOR BREAKTHROUGH DATA CENTER TECHNOLOGY

Frost & Sullivan recognises Rockley’s ground breaking R&D which is poised to transform the future design of ‘hyper-scale’ data centers

Pasadena, CA and Oxford, UK, 6 March 2017 – Rockley Photonics Limited, an integrated technology and systems innovator for next-generation networks, has been recognised by leading analyst firm, Frost & Sullivan, for its ground breaking R&D in networking infrastructure technology.

Dr Andrew Rickman, Rockley’s founder and CEO, will receive the prestigious Frost & Sullivan 2017 Global Technology Innovation Award for Data Center Networking Infrastructure at a ceremony in London on 14th March.

The proliferation of Internet of Things (IoT), connected living and artificial intelligence is set to dramatically increase the demand for cloud services and faster computing capabilities within data centers. Rockley’s integrated networking technology is designed to enable large data centers to upscale their networking infrastructure so that the projected growth in compute power can be met.

Experts have suggested that data traffic in cloud data centers may require 1000 times more bandwidth than that deployed today in order to keep up with demand for internet services over the next 10 years.

According to Frost & Sullivan, Rockley is poised to play a transformational role in the future design of ‘hyper-scale’ data centers.

03

Luqa Acquires Arista, strengthening its position in China medical aesthetics market

March 3rd, 2017 Hong Kong, China - Luqa Pharmaceuticals (“Luqa”) today announced that it has entered into a definitive agreement under which Luqa will acquire all of the outstanding common stock of Arista, a company focused on aesthetic and surgical solutions. This transaction advances Luqa’s strategy of becoming a China leader in the fast growing, multi-billion dollar aesthetic market and a provider of innovative medical solutions. The new Luqa will be distinguished in the marketplace by its ability to offer a broad suite of solutions to enable healthcare professionals to achieve excellent patient results and satisfaction. The acquisition will bring the flagship product Aethoxysklerol® for the treatment of varicose veins. Luqa will offer healthcare providers a broader range of high quality treatment options, further enhancing Luqa’s customer relationships, its competitive position and enable Luqa to capitalize on opportunities to effectively launch new products from its product pipeline. “Today’s announcement is a significant next step in our journey to become the leader in China’s aesthetics market. These additions to Luqa’s strong platform strengthen our operating foundation and build on Luqa’s mission of providing innovative and effective products with customer centric solutions for the medical community and the patients we serve,” Robert Braithwaite, CEO of Luqa, said. “We are extremely pleased with this transaction, which has been strongly supported by Luqa shareholders. It ensures even greater potential for future growth in the fast growing aesthetics and medical business we focus on. With this acquisition we expand our product offering, increase our direct commercial presence in China and expand our reach to the whole of the Greater China region.” Zona Yim, Managing Director of Arista, “We are pleased to join Luqa. I believe this combination offers a platform for future growth as well as expanded opportunities for our company as a whole. I am confident that with Luqa’s energy, resources, product portfolio and robust pipeline, we will be better positioned to develop and market the solutions our customers need. ”

02

Stealth BioTherapeutics Initiates Observational Study of Patients With Mitochondrial Myopathy

BOSTON – March 2, 2017 – Stealth BioTherapeutics Inc. (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced the initiation of RePOWER, a prospective, observational study and pre-trial registry of patients with mitochondrial myopathy (MM). This study will be conducted in North America, Europe and Australia.

“We expect to use this study to help us design an interventional Phase 3 trial and further our understanding of elamipretide’s potential in this patient population,” said Jim Carr, Stealth’s Chief Clinical Development Officer. “Since mitochondrial disease has a heterogeneous clinical presentation, the results of this study will help us better characterize the disease burden impacting patients who may participate in our upcoming Phase 3 trial, as well as add to the scientific understanding of the disease. We hope that our scientific collaboration with the investigators will add to the work of others, and further the knowledge needed to find effective treatments for this disease.”

“As our mission is to be the leader in mitochondrial medicine, we’re committed to help fill the significant treatment gaps in primary mitochondrial disease, as well as in more common diseases associated with aging in which mitochondrial dysfunction is a contributory or causal factor,” said Stealth’s Chief Executive Officer Reenie McCarthy. “Severe fatigue and muscle weakness, or MM, is among the most common clinical presentations of primary mitochondrial disease, making it difficult for patients to complete simple daily tasks. Our goal with our MM program, as with all our programs, is to design clinical trials as thoughtfully as possible taking into account the clinical burden of disease on the patient population. We believe this study will help guide us as we work to develop therapies for MM and other primary mitochondrial diseases.”

February 2017

21

Frequency Therapeutics Announces a Revolutionary Small-molecule Approach to Restore Hearing Published in Cell Reports

Frequency Therapeutics, a company spearheading the movement to restore hearing by harnessing the regenerative potential of progenitor cells in the body, today announced that a team led by Frequency’s scientific co-founders published research highlighting a breakthrough small-molecule approach to regenerate inner ear sensory hair cells. Frequency is advancing the approach to develop a potentially restorative treatment for chronic noise-induced hearing loss. The paper titled, “Clonal Expansion of Lgr5-Positive Cells from Mammalian Cochlea and High-Purity Generation of Sensory Hair Cells,” is a cover feature in the journal Cell Reports, and can be accessed in the current online edition.

16

CellCentric’s novel p300/CBP inhibitor, CCS1477 advancing to the clinic

CellCentric has developed a potent, selective, orally bioavailable small molecule inhibitor of p300/CBP. These targets are key regulators of cancer cells, and specifically play a critical role in the progression of the aggressive form of prostate cancer.  Key pre-clinical efficacy data on CellCentric’s compound CCS1477 is presented today at GU-ASCO, Orlando. GU-ASCO poster 2017: http://www.cellcentric.com/gu-asco-poster-2017 Castrate resistant prostate cancer (CRPC) remains a significant unmet need, despite recent advances including the adoption of new agents such as Enzalutamide and Abiraterone.  CRPC is driven by functional androgen receptor (AR) proteins, and modified AR-splice variants that emerge. Data shared today shows that CellCentric’s candidate drug CCS1477 lowers AR and AR-splice variants, as well as the key cancer regulator c-Myc, causing complete inhibition of prostate tumour growth in vivo (22Rv1 xenograft).  PSA levels are completely suppressed, a well-known biomarker of prostate cancer, as well as AR-regulated genes such as TMPRSS2.  CellCentric is now advancing CCS1477 in to the clinic. p300/CBP are twin (paralogue) proteins that act as transcriptional co-activators, which help govern which genes are used or not used within cells. They are also active acetyl transferases that play a role in turnover of proteins within cells, including AR.  CellCentric’s drug compound CCS1477 binds to a common conserved bromodomain of p300 and CBP. Separate from prostate cancer, certain tumours develop loss of function mutations in either p300 or CBP.  It has been shown that when this occurs, the cancer cell becomes dependent on the non-mutated paralogue3.  Inhibition of the non-mutated protein can drive cancer cell death – known as synthetic lethality. Specific p300 and CBP mutations can be detected to identify patients that could benefit from a targeted drug such as CCS1477.  This opportunity represents up to 20% of lung cancer sufferers (both small cell and non-small cell) and 25% of patients with bladder cancer, as well as up to 30% of haematological cancers. These are significant areas of unmet clinical need.

14

New membrane, Giga-module to be piloted

Clean Membranes, a US-based membrane company founded to commercialize technology developed at MIT, told WDR that it will pilot its Neophil UF membrane at the town of Amherst, Massachusetts. The test will be conducted in cooperation with the department of civil and environmental engineering at the University of Massachusetts, Amherst.   According to Michael Grossman, Clean Membrane’s sales engineering manager, the Neophil membrane is a foulingresistant, PVDF hollow fiber membrane that operates in an outside-in, dead-end filtration mode. Developed jointly with Polymem and Arkema, the fibers are arranged in bundles (elements) and potted for mounting within a Gigamem module. A 24-inch (61cm) diameter Gigamem module contains 52 individual elements, while a 14-inch (36cm) diameter element contains 18 elements.   With recent water restrictions due to severe drought conditions across the state, Amherst is interested in investigating UF as a means for recovering municipal wastewater for beneficial reuse purposes, with a particular focus on the irrigation of town’s recreation fields. The pilot system will filter secondary effluent from the Amherst Wastewater Treatment Plant to demonstrate its ability to generate Class A reuse quality water.

13

ASLAN Pharmaceuticals announces first patient enrolled in phase 1 study of varlitinib in Japan

Singapore, 13 February 2017 – ASLAN Pharmaceuticals (ASLAN), a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, today announced that they are initiating enrolment of the first patient in the phase 1 clinical trial for varlitinib (ASLAN001) in biliary tract cancer in Japan. Varlitinib is a potent reversible small molecule inhibitor of the HER-family of receptor tyrosine kinases (RTKs). The study is expected to enrol up to 36 Japanese patients. Designed in collaboration with Japanese medical experts, the open-label study is open to all patients with solid tumours and biliary tract cancer. The primary study objective is to characterise the safety and tolerability of varlitinib as monotherapy and in combination with capecitabine in Japanese patients with biliary tract cancer. This will make possible for Japanese patients join the global study in varlitinib in biliary tract cancer. Enrolment is planned at two clinical sites in Japan.

06

CollegeVine Reports Accelerating Growth, Achieves Key Milestones In 2016

CAMBRIDGE, Mass., Feb. 6, 2017 /PRNewswire/ -- CollegeVine, a national provider of student mentoring and college admissions guidance, today reported steady growth in 2016, wrapping up its fourth admissions cycle in business with the achievement of several key milestones. CollegeVine revenue grew by 326 percent from 2015—a strong indicator of the growing demand for the company's specialized services and appeal of its unique, near-peer mentorship program. Beyond the significant growth of its revenue, CollegeVine achieved numerous milestones in 2016, including: Paid Client Results – The number of CollegeVine clients rose by 300 percent over 2015, with students applying Early Action and Early Decision achieving a 46 percent acceptance rate to the Ivy League and equivalent schools – more than twice the national average; Pro Bono Program – The company continued its pro bono program, identifying and selecting 21 deserving students, who were accepted into schools such as Princeton, Caltech, and University of Michigan, Ann Arbor; Leadership Expansion – Edtech veteran Jon Carson joined CollegeVine as CEO in 2016, and the company tapped former Zipcar CTO Doug Williams and Harvard Business School professor Deepak Malhotra to join its Board of Advisors and Board of Directors, respectively; Capital Raise – CollegeVine completed a $3.1 million Series A funding round led by Morningside Technology Ventures with participation by New York-based University Ventures, after which Morningside's founder Gerald Chan also joined the CollegeVine board; Staff Growth – The company expanded its network of near-peer consultants from 80 to more than 300 college students at the nation's top universities. The company expanded its recruiting reach from a dozen campuses to over 20; Mentorship Program Launch – CollegeVine launched a robust near-peer mentorship program for high school students, with customized services for freshmen, sophomores and juniors to develop their interests and get the most out of their high school experience; New SAT Tutoring Program – To better prepare students for the SAT while addressing changes implemented by the College Board in March 2016, CollegeVine updated its SAT tutoring program, making it one of the most comprehensive in the nation; New ACT Tutoring Program – To better prepare students for the ACT, CollegeVine updated its ACT tutoring program, making it one of the most comprehensive in the nation as well; Thought Leadership – In 2016, CollegeVine management was invited to speak at multiple sessions including a keynote at GSV/ASU, the premier edtech thought leadership conference. In addition, CollegeVine founders were widely quoted as industry experts in such media outlets as U.S. News & World Report, TeenVOGUE, The Boston Globe and many others; and Successful Blogs – CollegeVine launched its Zen blog in 2016 to address the growing stress families experience throughout the admissions process, and continued its industry-leading CollegeVine blog as well, with up to 100 high-density posts per month.

03

ENVISIA THERAPEUTICS RELEASES INTERIM ENV515 (travoprost XR) PHASE 2 DATA DEMONSTRATING 11-MONTH DURATION-OF-ACTION AFTER A SINGLE DOSE IN PATIENTS WITH GLAUCOMA

RESEARCH TRIANGLE PARK, NC – FEBRUARY 3, 2017 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today released an interim analysis of the second cohort of its ENV515 (travoprost XR) phase 2 trial in patients with glaucoma showing a clinically meaningful reduction in intraocular pressure (IOP) for the entire 11-month evaluation period following a single administration. ENV515 also demonstrated an IOP lowering effect comparable to prestudy topical prostaglandin analogs (XALATAN® and LUMIGAN®) and in-study topical timolol maleate 0.5% ophthalmic solution (daily eye drops). Glaucoma is the leading cause of preventable vision loss and blindness due largely in part to poor patient compliance with once-daily eye drops. “A clinically meaningful reduction in IOP over the initial 11 months indicates that ENV515 has the potential to become a once a year therapy for glaucoma patients,” said Benjamin Yerxa, President of Envisia. “We continue to enroll patients into the next cohort of the study where we are studying ENV515 dose levels that have the potential to demonstrate a duration-of-action longer than the current 11 months.”

January 2017

25

Green Biologics Recognized as a Clean Technology Leader by Two Prestigious Industry Awards

Ashland, Virginia and Abingdon, Oxfordshire U.K. (January 25, 2017) – Green Biologics, Inc., the U.S. subsidiary of Green Biologics Ltd., a U.K. industrial biotechnology and renewable chemicals company, today announced that it has been named to the prestigious 2017 Global Cleantech 100 and recognized in the 2016 Global Clean Energy Awards as the Best Renewable Specialty Chemical Company – UK. Both highly-selective awards programs honor companies worldwide for efforts aimed at tackling today’s energy challenges and contributions to a more sustainable future. Green Biologics was recognized for its Clostridium fermentation platform, which uses sustainable feedstocks to produce high-performance chemicals, such as n-butanol and acetone. These high-value chemicals provide a renewable alternative to conventional petrochemical-based commodities for a growing number of consumer and industrial applications. “We are extremely proud to receive these two distinguished clean technology recognitions that acknowledge our tireless efforts in bringing renewable chemical alternatives to market,” said Sean Sutcliffe, Chief Executive of Green Biologics. “Both accolades reinforce the industry’s confidence in our technology and are a testament to the significant progress we’ve made over the past year in strengthening our position as a global renewable speciality chemicals company.”

19

HD Biosciences Merges with WuXi AppTec

Shanghai, China – January 19th, 2017 HD Biosciences Co., Ltd. (HDB), a leading biology-focused preclinical drug discovery contract research organization (CRO), today announces its merge with WuXi AppTec, a leading global pharmaceutical, biotechnology and medical device open-access capability and technology platform. After completion of acquisition, HD Biosciences will become a wholly-owned subsidiary of WuXi, and will continue to focus on growing its core competences and providing greater services. The acquisition will further strengthen WuXi's R&D capability from target validation to lead discovery and optimization, improving and expanding WuXi's open-access enabling service platform. Founded in 2002, HD Biosciences is headquartered in Shanghai with operating facilities in Beijing and San Diego, USA. As a leading biology and preclinical service provider, its plate-based pharmacology & screening capability and AGMTM based target validation are industry leading platforms with great reputation. The company also provides hit identification, lead discovery, in vivo pharmacology and other related services. HD Biosciences has long established close and strategic partnerships with major multinational pharmaceutical companies, biotechs and research institutions worldwide. Over the years, HD Biosciences has been providing award winning services to its worldwide clients, and has won a leading position among the biology CROs in China. "We are excited about this acquisition and the great opportunities it brings along. HB Biosciences has a long-standing mission to grow into a major global player with distinctive core competences that could create special value for our clients. Merging with WuXi AppTec, a clear industry leader in drug R&D enabling services with enormous global exposure, resources and vision, will greatly speed up the process. We are confident that the integration will elevated our services to a new height and will enable us to better meet our growing customer needs," said Dr. Xuehai Tan, Chairman and CEO of HD Biosciences. "We are very pleased to welcome HD Biosciences to WuXi," said Dr. Ge Li, Chairman and Chief Executive Officer of WuXi AppTec. "During the past 14 years, HD Biosciences has developed into a global company with wide recognition, and this business combination is an important step in strengthening WuXi's biology and preclinical service capability. At WuXi, our commitment is to build the most comprehensive capability and technology platform in industry to enable anyone, and any company to discover and develop better medicines and healthcare products for patients, and to realize our vision that every drug can be made and every disease can be treated."

19

Aduro Biotech Enters into Exclusive License Agreement for Proprietary Neoantigen Identification Technology

BERKELEY, Calif., Jan. 19, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced an exclusive license agreement with Stanford University for state-of-the-art neoantigen identification technology developed by Dr. Hanlee Ji, associate professor of medicine at Stanford.  Aduro will leverage its proprietary live, attenuated double-deleted Listeria (LADD) immunotherapy platform to engineer personalized LADD-based cancer therapies (pLADD) encoding multiple neoantigens identified through this technology.  The company plans to initially evaluate pLADD for the treatment of cancers of the gastrointestinal tract, including colorectal cancer, with a Phase 1 clinical trial expected to be initiated in 2017.

Pursuant to the terms of the agreement, Aduro received an exclusive license to the proprietary bioinformatics algorithms and computational workflows for neoantigen identification and selection. The accurate identification of neoantigens, tumor markers that are unique to an individual’s tumor, is believed to be critical in the development of a patient-specific cancer treatment.  Aduro’s LADD technology, which has been shown in clinical studies to remodel the tumor microenvironment, will be used to create a patient-specific immunotherapy that is engineered to enable the presentation of multiple selected neoantigens in dendritic cells, with the aim of inducing a targeted, robust anti-cancer immune response.

“We are excited to leverage the strength of Aduro’s LADD program with this new expertise in identifying a patient’s unique repertoire of cancer antigens to make personalized immunotherapies a reality for patients in need,” said Thomas Dubensky Jr., Ph.D., chief scientific officer of Aduro. “We look forward to applying the discoveries made possible with this highly sophisticated computational approach to neoantigen identification, with the aim to initiate a Phase 1 clinical trial later this year.”

09

Aduro Biotech Announces Clinical Collaboration with Merck to Evaluate the Combination of Aduro’s CRS-207 with Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Gastric Cancer

BERKELEY, Calif., Jan. 09, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today a clinical collaboration with Merck (known as MSD outside the United States and Canada). The companies will investigate the combination of CRS-207, Aduro’s LADD (live, attenuated double-deleted) based immunotherapy, with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of gastric cancer.

“CRS-207 has demonstrated the ability to induce an anti-tumor immune response in clinical trials in other tumor types that over express the tumor antigen, mesothelin,” said Dirk G. Brockstedt, Ph.D., executive vice president of Research and Development at Aduro.  “Gastric cancer is an immune-sensitive mesothelin-expressing tumor where PD-1 checkpoint inhibitors have shown some activity. The combination of inducing an immune response through CRS-207, while simultaneously suppressing the cancer’s ability to evade the immune system through a PD-1 checkpoint inhibitor, has resulted in synergistic anti-tumor activity in pre-clinical studies. We aspire to reproduce this activity in the clinic in patients with gastric cancer.”

The multicenter Phase 1 study, planned to begin in the first half of the year, will enroll patients with metastatic gastric cancer who have failed at least two prior therapies to receive the combination of CRS-207 and pembrolizumab.

About LADD and CRS-207 LADD is Aduro's proprietary platform of live, attenuated double-deleted Listeria monocytogenes strains that have been engineered to generate a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity.

CRS-207 is one of a family of product candidates based on Aduro's LADD immunotherapy platform that has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.

December 2016

20

Paroxysmal Nocturnal Hemoglobinuria Treatment Receives Fast Track Designation

RDR Staff; Published Online: Tuesday, Dec 20, 2016 Apellis Pharmaceuticals announced that their orphan drug APL-2, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) received Fast Track Designation by the FDA. APL-2 is designed for patients who experience hemolysis and require RBC transfusions even while taking eculizumab. APL-2 currently in two Phase Ib clinical trials. One trial assessing doses APL-2 administered by daily subcutaneous injection (SC) in patients with PNH who have not received the standard of care in the past, and the other is assessing doses of APL-2 as an add on with standard care. Results APL-2 doses of 180mg and 270mg significantly reduced hemolytic activity as early as eight days after the start of dosing, and this inhibition was maintained through the dosing period. About APL-2 APL-2 is a synthetic cyclic peptide conjugated to a polyethylene glycol (PEG) polymer that binds specifically to C3 and C3b, effectively blocking all three pathways of complement activation (classical, lectin, and alternative) with a particularly high potency against the alternative pathway.  About PNH Paroxysmal nocturnal hemoglobinuria (PNH) is a rare disorder in which red blood cells break apart prematurely. It is an acquired hematopoietic stem cell disorder. Some hematopoietic stem cells in individuals with PNH are defective and consequently produce defective blood cells. These defective red blood cells of PNH are extremely susceptible to premature destruction by a particular part of a person’s own immune system called the complement system.  About Fast Track Designation  The FDA’s Fast Track program is designed to facilitate and expedite development and review of new drugs. Through the Fast Track program, a product may be eligible for priority review at the time of BLA and may be eligible to submit sections of the BLA on a rolling basis as data become available. APL-2 doses of 180mg and 270mg significantly reduced hemolytic activity as early as eight days after the start of dosing, and this inhibition was maintained through the dosing period.

16

ENYO Pharma SA announces successful initiation of the Phase 1 clinical programme with EYP001, its lead candidate for the treatment of Chronic Hepatitis B Virus infection

Lyon, December 16, 2016 - ENYO Pharma SA, a privately held biopharmaceutical company currently focused on developing treatments for viral infections, today announced that the Phase 1 single and multiple ascending dose trial evaluating EYP001 in healthy subjects has been initiated, and that single dose escalation has been completed. The results have shown that EYP001 is safe and well-tolerated at all doses studied in 46 healthy subjects. The safety and pharmacokinetics (PK) analysis of these first Phase 1 data will be complete by Q2 2017. EYP001 is a synthetic farnesoid X receptor (FXR) agonist with a favorable profile for oral therapy. The first Phase 1 study was designed to determine the safety, tolerability and pharmacokinetics of EYP001 in healthy subjects. ENYO Pharma also announced that next Phase 1 clinical studies of EYP001 are already planned during 2017 to test the safety, PK and initial antiviral activity of EYP001 in subjects with chronic HBV infection.

13

Green Biologics Begins Customer Shipments at First Commercial Plant

Little Falls, MN, facility produces 100 percent bio-based n-butanol and acetone Ashland, Virginia USA and Abingdon, Oxfordshire U.K. (December 13, 2016) – Green Biologics, Ltd., a UK industrial biotechnology and renewable specialty chemicals company, announced today the start of commercial shipments of bio-based n-butanol and acetone from its manufacturing facility in Little Falls, Minnesota. Over the past year, Green Biologics has built a robust pipeline of domestic and export customers combined with multiple partnerships to bring its products to downstream markets. These include distribution agreements with Acme Hardesty, Nexeo Solutions, and Caldic as well as a strategic partnership with HOC Industries, a custom blender, packager and distributor of consumer and government products. The company is collaborating with other industry leaders in a range of specialty markets and applications where performance and sustainability drive value. “The start of our first commercial facility is a critical milestone in building our position within the industry as a global renewable speciality chemicals company,” said Sean Sutcliffe,Chief Executive of Green Biologics. “We’re very proud to announce the start of shipments to key customers in highvalue markets and look forward to working with existing and new collaborators to bring a wide range of sustainable, environmentally-friendly products to shelves.” Offered as a high-performance, high purity, fully-sustainable alternative to conventional petrochemical-based commodities, Green Biologics’ speciality chemicalsaim to drive value in customer applications and downstream markets ranging from specialty coatings, pharmaceuticals, cosmetics, personal care and consumer products. Both butanol and acetone products carry the brand name BioPure™ and have receivedUSDA BioPreferred® status. As a member of the American Chemistry Council (ACC), Green Biologics’ commercial facility is actively working towards meeting Responsible Care® standards.

07

Cognito Therapeutics Launched with Exclusive License to Promising Alzheimer’s Research from The Massachusetts Institute of Technology

Boston, Mass. and San Francisco, Calif. — December 7, 2016 – Cognito Therapeutics announced today that the company has secured an exclusive worldwide license to the intellectual property developed from scientific discoveries by Li-Huei Tsai, Ph.D., and Ed Boyden, Ph.D., professors in the Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology (MIT). The company was launched earlier this year with Series A financing from Morningside Venture. The scientific discoveries are featured in the December 8th issue of Nature. Working with mouse models of Alzheimer's disease, the team of scientists showed that by using a unique and totally non-invasive method of stimulation, they were able to restore gamma oscillation in the brains of the mice, which in turn activated the microglia cells to remove beta amyloid plaques in the brains. These plaques are characteristic of the brains of Alzheimer's disease patients, which are also deficient in gamma oscillation. “These results have opened up new doors to our understanding of Alzheimer’s,” said Prof. Tsai, Picower Professor of Neuroscience at MIT and co-founder of Cognito Therapeutics. “By demonstrating the underlying importance of these brain wave signatures, we have potentially uncovered a key to solving this disease in humans.” Tsai and Boyden co-founded Cognito Therapeutics to translate their findings into a treatment for Alzheimer’s patients. The company has filed an extensive portfolio of patents covering the applications of this novel approach to treating a variety of neurological disorders. "This is truly breakthrough science," said Gerald Chan, ScD, founder of Morningside and board member of Cognito Therapeutics. "It has the potential of being a game changer in our struggle to find an effective treatment for Alzheimer's disease. The social impact of such a treatment, if successful, would be enormous, as dementia is becoming the leading medical problem of an aging population." Cognito Therapeutics is based in Cambridge, Massachusetts, and at the San Francisco incubator TheraNova, a medical device developer with expertise in accelerating time-to-market for innovative medical technologies. “A device-based approach to Alzheimer’s is novel,” said Daniel Burnett, M.D., chief technology officer of Cognito Therapeutics and founder of TheraNova. “We are excited to be working with Morningside, which has shown an unwavering commitment to bringing this technology all the way into the clinic.”

06

Aduro Biotech Europe’s Hans van Eenennaam, Ph.D. and John Dulos, Ph.D. Honored with the Intellectual Property Owners Education Foundation’s 43rd Inventor of the Year Award for Contributions in the Discovery of KEYTRUDA® (pembrolizumab)

December 06, 2016 5:00 a.m. ET

BERKELEY, Calif. and OSS, The Netherlands, Dec. 06, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that Hans van Eenennaam, Ph.D., chief operational officer and executive director of Aduro Biotech Europe, and John Dulos, Ph.D., principal scientist, will be honored tonight by the Intellectual Property Owners Education Foundation (IPOEF) as winners of the 43rd Inventor of the Year Award for their work relating to the discovery of KEYTRUDA® (pembrolizumab). KEYTRUDA is marketed by Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the U.S. and Canada) and is the first FDA-approved PD-1 inhibitor for the treatment of select cancers.

“It is an honor to have been part of the team whose work led to the discovery of KEYTRUDA and positively impacted the lives of many cancer patients,” said Dr. van Eenennaam. “Now as part of Aduro Biotech Europe, where we are focused on developing novel B-select antibodies to modulate the immune system, we are pleased to be collaborating once again with the MSD team on what we believe to be the best-in-class anti-CD27 therapeutic antibody.” Dr. Dulos, principal scientist and project team lead for Aduro’s anti-APRIL BION-1301 program, commented, “As a scientist, it is incredibly satisfying to have been part of a team whose discoveries today are having a meaningful impact on the lives of many patients with several cancer types.  We thank the Intellectual Property Owners Education Foundation for this honor and will continue to leverage our knowledge and discoveries in the field of immuno-oncology with the aim of helping cancer patients in need.”  

05

ENYO Pharma receives a €2.5 million grant from EU under the Horizon2020/SME Instrument Phase 2 programme for its project MIMESIS

• MIMESIS will accelerate and enable large scale development of ENYO Pharma’s novel discovery approach aimed at identifying new preclinical assets against infectious diseases and cancer from innovative drug discovery starting points inspired by viruses. Lyon, December 5, 2016 - ENYO Pharma, a biopharmaceutical company currently focused on developing treatments for viral infections, today announced that it has received a grant of €2.5 million in response to its application to the highly competitive SME Instrument Phase 2 funding programme (6% success rate). The SME Instrument is part of Horizon 2020, the EU framework programme dedicated to innovation and research managed by the European Commission. It belongs to the pillar “Industrial Leadership” of H2020 and aims to support high growth and highly innovative SMEs with global ambitions. ENYO Pharma’s MIMESIS project applied for the June 2016 cut-off under the topic “Dedicated support to biotechnology SMEs closing the gap from lab to market”. MIMESIS has been selected by an independent jury of four experts recognised for their scientific and business expertise. The company will receive 2.5 M€ corresponding to the financing of 70% of the total project budget (€3.6 million). After a feasibility Phase that generated ENYO’s internal drug development programme on an autophagy target, MIMESIS will be expanded to an industrialised scale to accelerate the discovery of new therapeutic targets and innovative new chemical entities against infectious diseases and cancer. Dr Eric Meldrum, ENYO Pharma's Chief Scientific Officer commented, "We are very honoured to receive the recognition from the Horizon 2020 jury in what was a highly competitive process. MIMESIS represents a real paradigm shift in the development of new innovative drugs for pathologies where the medical need is immense. This financing will enable us to screen our library of original peptides and small molecules on hundreds of intracellular human targets previously untapped by the pharmaceutical industry.” For this project ENYO Pharma has designed a proprietary library of 10’000 small molecules to modulate host cell biology and also capable of disrupting protein:protein interactions (PPIs) between pathogens and the host. This library of developable chemical templates will be screened in phenotypic assays for inhibitors of the replication cycle of several viruses (Influenza, RSV, HRV, Zika) and a mycobacterium (TB). As this library is designed to modulate host cell biology, it will also be screened for inducers of Immunogenic Cell Death (ICD) in tumors. With €3.6 million over 24 months, most promising chemistries will be the starting point for numerous hit to lead optimisation programmes funded within the EU grant. Those optimisation efforts focused on novel intracellular targets will generate valuable Intellectual Property. Upon completion of MIMESIS, ENYO Pharma will further optimise its best chemical series either internally or in collaboration with other pharmaceutical companies up to clinical proof of concept. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement n° 739086- MIMESIS

05

Aduro Biotech Announces Anti-CD27 Agonist, an Investigational Anti-Cancer Immunotherapy, Advancing in Collaboration with MSD

December 05, 2016 4:00 a.m. ET

Expected Filing of Investigational New Drug (IND) Application in 2017

Company to Host Conference Call Today to Provide Program Update, Including STELLAR, at 5:30 a.m. PT/ 8:30 a.m. ET

BERKELEY, Calif. and OSS, The Netherlands, Dec. 05, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that an anti-CD27 antibody developed by Aduro Biotech Europe and derived from its proprietary B-select technology has been selected to be advanced into clinical development by Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the U.S. and Canada), through a subsidiary.  CD27 has been recognized as having a critical role in activating a productive anti-cancer immune response and has demonstrated the potential to be combined with checkpoint inhibitors in pre-clinical studies.

“Pre-clinical studies have shown that an anti-CD27 agonist can induce a T cell-mediated anti-cancer immune response, and in combination with PD-1 immune checkpoint inhibitors complete tumor eradication can be achieved,” said Hans van Eenennaam, Ph.D., chief operational officer, Aduro Biotech Europe.

The CD27 antibody was licensed by MSD to advance as a part of their successful immunotherapy development program and was identified in close collaboration with Prof. Jannie Borst, Ph.D., professor at the University of Amsterdam and division head at the Netherlands Cancer Institute, through Aduro’s B-select monoclonal antibody technology. This technology includes a proprietary ultra-selective functional screening process to identify antibodies with unique binding properties against a broad repertoire of targets that can modulate the innate and adaptive arms of the immune system.

  “In 2014, prior to the acquisition by Aduro Biotech, BioNovion entered into a worldwide license agreement with MSD that covers the product candidate’s development and advancement through commercialization,” said Andrea van Elsas, Ph.D., chief scientific officer of Aduro Biotech Europe. “Both companies recognized the significant potential of targeting CD27 as a new and distinct mechanism in cancer immunotherapy, especially in the context of PD-1 checkpoint inhibitors, and were strongly committed to accelerate a quality candidate into the clinic.”

03

Aduro Biotech Presents Preclinical Data Supporting Clinical Development of its Anti-APRIL Antibody, BION-1301, for the Treatment of Multiple Myeloma

December 03, 2016 12:00 p.m. ET

Poster #2112 to be Presented at the 58th American Society of Hematology Annual Meeting and Exposition

BERKELEY, Calif. and OSS, The Netherlands, Dec. 03, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced the presentation of data from preclinical studies supporting the clinical development of the company’s proprietary monoclonal antibody (mAb) BION-1301, a humanized anti-APRIL (A PRoliferation-Inducing Ligand) antibody for the treatment of multiple myeloma.  Data from these in vivo and in vitro preclinical studies demonstrated that BION-1301 effectively neutralized APRIL, preventing its binding to BCMA (B cell maturation antigen), an essential receptor expressed on multiple myeloma cells.  Based on the mechanism of action and anti-tumor activity observed in earlier preclinical studies with the parental anti-APRIL antibody, hAPRIL.01A, BION-1301 has the potential to inhibit multiple myeloma tumor growth, survival and chemoresistance.  These data, which will be highlighted in a poster presentation (Poster #2112) at the 58th American Society of Hematology Annual Meeting and Exposition, further underscore the potential application of BION-1301 for use as a single agent, or in combination with current standard of care therapies, for the treatment of multiple myeloma.

“In patients with multiple myeloma, there is an overabundance of APRIL, a ligand which plays a critical role in the proliferation of multiple myeloma cells,” stated Andrea van Elsas, Ph.D., chief scientific officer of Aduro Biotech Europe. “With BION-1301, which was derived from Aduro’s proprietary B-select antibody platform, we are blocking APRIL from binding to its target receptor, thereby inhibiting the growth and survival of multiple myeloma cells.” Dr. van Elsas continued, “Based on the data to be presented later today, we believe BION-1301 represents a novel antibody with a novel mechanism of action that has potential in the treatment of multiple myeloma, alone or in combination regimens.  We look forward to advancing BION-1301 into clinical development in the coming year in our effort to bring much needed new treatment options to patients with multiple myeloma.”  

02

Apellis Reports Positive Interim Results from Phase Ib Clinical Trials of APL-2 in PNH

C3 inhibitor reduces hemolysis in patients with PNH, is generally well tolerated LOUISVILLE, Ky., December 2, 2016 – Apellis Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on inhibition of the complement system, today will present positive interim results from two ongoing Phase Ib open-label, dose-escalation clinical trials of APL-2, a complement C3 inhibitor, in paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare, acquired, potentially lifethreatening disease characterized by complement-mediated hemolytic anemia. Interim results suggest that APL-2 reduces hemolysis in patients with PNH who receive daily subcutaneous injections of APL-2 as monotherapy or as an add-on to the standard of care, eculizumab. With APL-2 (270 mg) as monotherapy, three out of three (3/3) PNH patients achieved a reduction in lactate dehydrogenase (LDH) levels to below the standard for control in PNH (500 U/L). With APL-2 (270 mg) as add-on to eculizumab, six out of six (6/6) previously transfusion-dependent PNH patients did not require transfusions during the study and five out of six (5/6) PNH patients achieved hemoglobin levels within the normal range for healthy individuals. All 15 PNH patients who have been dosed across the two trials to date have completed at least one month of dosing, with five having received more than three months of dosing. Based on preliminary assessment, APL-2 is generally well tolerated. “Establishing that systemic inhibition of C3 is feasible with daily subcutaneous injections of APL-2 in patients with PNH is a significant achievement that validates C3 as a target in the complement pathway,” said Cedric Francois, M.D., Ph.D., chief executive officer of Apellis. “APL-2’s unique ability to target C3 and block all three pathways of the complement system is indicative of its potential to be an effective treatment for multiple complement-driven diseases. We are encouraged by the preliminary results APL-2 has demonstrated, as well as the favorable safety data observed thus far in the Phase Ib trials and our previous studies in healthy volunteers. All patients in the Phase Ib trials will have completed three months of dosing in January 2017.” Apellis will present the Phase Ib interim results today at the International PNH Interest Group (IPIG) Annual Scientific Assembly and will present the poster “APL-2, a Complement C3 Inhibitor for the Potential Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH): Phase I Data from Two Completed Studies in Healthy Volunteers” tomorrow at the American Society of Hematology (ASH) Annual Meeting.

02

Why High School Students Should Seek Out Peer Mentors for College Applications

Find out how CollegeVine's near peer mentors can help high school students successfully apply for college. DEC 2, 2016 2:59PM EST -- When Ling Ritter applied early decision one of her top college choices, she had doubts about her ability to get in, but her guidance counselor told her she had a strong enough profile that the school would either accept or defer her, but not deny. So, when she received a rejection from that school, she was flummoxed. Ling, now 19, went back to that counselor who, this time, told her the rejection was an “indicator of [her] competitiveness,” and that she should remove any other “reach” schools she was planning to apply to. She didn’t listen. Instead, she added a few “safe” schools, and applied to her “reach” options as well — and was accepted to 13 out of 17, including Princeton University, where she’s currently a sophomore politics major. Ling’s college application process was rocky, perhaps in part because her main source of guidance was an adult counselor who was also responsible for helping out all of her classmates. After all, according to CollegeVine, the average public school student receives only 38 minutes with her school’s guidance department over the course of four years. But, Ling is determined to make it better for other high schoolers. She now works as a “Near-Peer Mentor” with CollegeVine, which pairs high schoolers with college students who not only still have the application process fresh in their minds, but also can lend insight on actual, current college life. As part of her one-on-one relationships with her mentees, Ling (who went through training with CollegeVine for the job) helps with their school selections, applications, and essays, managing deadlines and timelines, and more. And she’s not alone. CollegeVine’s college mentors attend schools around the country, and represent more than 20 different majors, extracurriculars, and individual experiences. We caught up with Ling to find out even more about the program — and why it’s awesome for both the mentors and the mentees. Teen Vogue: How do you think having a near-peer mentor would have changed your college application experience? Ling Ritter: Near-peer mentors help make college applications less of a guessing game. There is no silver bullet, no magic formula. However, after joining the CollegeVine team and going through their consultant training program, I now understand that there are ways mentors can help students authentically maximize their strengths in order to stand out in the applicant pool. TV: What do you wish a college student would have or could have told you during that process? LR: One piece of advice high school seniors frequently hear during the application process is, “Just be yourself.” I want to double down on that. You don’t need to be anyone else to succeed — you need to know that you are enough. But I also want to expand on this idea: Be yourself and understand who you are. Colleges are looking for individuals who demonstrate that they have been thinking about the intersections of their different identities, extracurricular interests, and academic pursuits, and that they are exploring how they can apply their unique perspectives to the world around them. An application is a very condensed representation of you, so seek out ways to add complexity and color. TV: As a mentor, what kind of advice do you give? What aspects of your college experience do you share? LR: Although [we follow a] curriculum, I will share anything about my college experience that my student wishes to know. CollegeVine’s pairing process is very specific, so I have thus far always been paired with a student who either is really interested in Princeton or has many shared passions in common with me (or both). This often leads to all sorts of great conversations [and questions, like], “Should I submit an arts supplement?” [or] “How do I begin to navigate the myriad career paths that stem from my interests?” TV: Do you have any moments from your mentoring experiences with high school students that especially stand out to you? LR: My favorite thing to hear from a student is, “Oh! I didn’t think I could do that.” Many students come in believing that college applications have to be weighty, and serious, and formal. While it’s important to demonstrate diligence, it’s equally important to convey personality. The times in which I was able to help students discover new and creative ways of expressing themselves, or showcasing quirky hobb[ies] that [don’t] fit within the confines of a traditional resume are definitely special moments for me. TV: What's the best part about being a near-peer mentor? LR: Getting to know my students has been incredible. They are all such kind hearted, multifaceted, and spirited individuals. I am rooting for them in their college searches, and I know that, when spring comes around, the tables will turn, and they will be the ones choosing college[s] that fill them with pride and excitement for the future. TV: How does mentoring high school students affect your current college life and path? LR: Mentoring gives my college life a sense of purpose. Being raised by immigrant grandparents instilled in me the importance of not only being thankful for the resources available to me, but also using those resources to help future generations obtain the same opportunities. CollegeVine gives me a platform to do so on a very personal level. TV: What about your confidence and outlook as a student and a person? LR: Working with CollegeVine has given me insight into some of the potential reasons...behind my own admittance to Princeton. This, coupled with hard work paying off in the classroom, has really helped me prove to myself that I belong here. TV: If you could give one piece of advice to students beginning the college application process, what would it be? LR: The weight of a hundred rejections is still less than that of refusing to try and always wondering if things could be different. Rub some dirt on it and get back to being awesome.

November 2016

30

MicuRx Initiates Phase 1 Clinical Trial in U.S. for Novel Antibiotic Agent MRX-4

HAYWARD, Calif. and SHANGHAI, China – November 30, 2016 – MicuRx Pharmaceuticals, Inc. today announced the start of a Phase 1 clinical trial of a new antimicrobial agent, MRX-4, for the treatment of infections caused by Gram-positive bacteria including methicillin-resistant S. aureus (MRSA) and vancomycin-resistant Enterococci (VRE). MRX-4 is a prodrug form of the oral antibiotic MRX-1, presently in Phase 3 clinical trials in China for the treatment of complicated skin infections.

This comprehensive Phase 1 trial, now enrolling patients at a single center in the United States, will evaluate safety, tolerability, pharmacokinetics and bioavailability of the oral formulation of MRX-4. The study will enroll 122 healthy subjects in nine single- and four multiple-ascending dose cohorts. Concurrently, the safety, tolerability, and pharmacokinetics of the intravenous formulation of MRX-4 will be evaluated in 60 healthy subjects of five single- and four multiple-ascending dose cohorts, along with an oral to IV crossover study.

“We anticipate that success in this Phase 1 trial would enable a rapid transition into advanced clinical studies in the U.S. for this new means of efficient delivery of our antibiotic systemically,” stated Zhengyu Yuan, Ph.D., president and CEO of MicuRx.

MRX-1 is a next-generation oxazolidinone agent that has shown notably improved hematopoietic safety compared to first-generation antibiotics, such as linezolid, while maintaining excellent efficacy characteristics for this class. The prodrug form of MRX-1, named MRX-4, serves to expand its utility into both intravenous and enhanced oral applications.

29

Green Biologics Receives USDA Certification

Renewable Specialty Chemicals Company Receives Certification Under USDA BioPreferred® Program Ashland, Virginia and Abingdon, Oxfordshire U.K. (November 29, 2016) – Green Biologics, Inc., the U.S. subsidiary of Green Biologics Ltd., a U.K. industrial biotechnology and renewable chemicals company, announced today that its high purity bio-based n-butanol and acetone have received official certification under the USDA BioPreferred® program. The products are now certified as 100 percent bio-based and are marketed under the BioPure™ brand. “Having our n-butanol and acetone named as USDA Certified BioBased Products is yet another milestone that we can point to when demonstrating the value and differentiation of our products from conventional petrochemical-based commodities,” said David Anderson, Global Vice President of Marketing for Green Biologics.

21

Partial Clinical Hold Lifted and Enrollment Resumes for Aduro Biotech LADD Clinical Trials

November 21, 2016 8:00 a.m. ET

Company’s Ongoing Clinical Trials with LADD-based Therapies Include Mesothelioma and Ovarian Cancers as well as Personalized LADD (pLADD)

BERKELEY, Calif., Nov. 21, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on its clinical trials evaluating the LADD (live, attenuated double-deleted) immunotherapy platform, enabling patient enrollment to resume in all Aduro-sponsored clinical studies.

“We are pleased to come to a rapid agreement with the FDA to resume new patient enrollment in our LADD clinical studies,” said Stephen T. Isaacs, chairman, president and CEO of Aduro Biotech. “With slight protocol modifications implemented, we remain on track to initiate a Phase 2 clinical study using our LADD-based therapy CRS-207 in combination with an anti-PD-1 compound for patients with mesothelioma in the first half of 2017. Additionally, we continue to make significant progress with our STING Pathway Activator and B-select Antibody programs and with our three diverse immunotherapy platforms, we believe we are uniquely positioned to bring innovative therapies to patients with late-stage cancers.” In agreement with the FDA, Aduro’s LADD-based clinical trial protocols have been modified to include extended patient surveillance, to exclude patients with certain prosthetic devices that are not easily removed, and to add guidance to administer prophylactic antibiotics following LADD-based treatment for patients who may receive immune-suppressive treatments.  

18

Stealth BioTherapeutics Announces Positive Phase 2 Clinical Trial Findings for Patients Undergoing Renal Angioplasty

Data support company’s cardiorenal program, including three ongoing heart failure trials

Single elamipretide infusion improves kidney microvasculature and function after renal artery angioplasty

BOSTON – November 18, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today presented results from the EVOLVE trial, which demonstrated that a single dose of elamipretide prior to renal artery angioplasty and stenting procedures improved kidney function and blood flow for three months post-procedure. The data were presented as a late-breaking poster at the American Society of Nephrology (ASN) Kidney Week 2016 in Chicago.

“Patients undergoing renal angioplasty and stenting, intended to open up kidney arteries blocked by atherosclerosis, often fail to regain normal kidney function due to tissue damage during the procedure, possibly due to the sudden replenishment of oxygen to starved tissues,” said Dr. Stephen Textor, the principal investigator for the trial. “The study results validate our preclinical findings and our underlying hypothesis that elamipretide may help prevent acute kidney injury by preserving mitochondrial function in cells and ultimately improve measures of kidney function in these patients.”

15

SKSpruce Technologies Finalist WBA Awards

San Jose, CA, November 15, 2016—SKSpruce Technologies, an emerging Silicon Valley leader in carrier-class Wi-Fi, is a finalist for the Wireless Broadband Alliance (WBA) “Best Next Gen Wi-Fi Network Infrastructure” award, recognizing and celebrating excellence in wireless innovation. The WBA recently announced the shortlist for its annual WBA Industry Awards 2016, taking place at the Wireless Global Congress, November 16-17 in San Jose, California. The finalist entry recognizes SKSpruce’s Wi-Fi solution used in the largest integrated Wi-Fi/cellular system in the world, deployed in Japan by SoftBank, a leading global carrier with more than 100 million subscribers. The SoftBank Mobile Wi-Fi system has 460,000 access points throughout the country seamlessly integrated into their 4G LTE network providing transparent uninterrupted handover between 4G LTE and Wi-Fi, delivering a superior user experience. SoftBank Mobile’s entire Wi-Fi network is controlled by the SKSpruce SKG10000 gateway, and its integration to the core mobile network is provided by SKSpruce.

14

Stealth BioTherapeutics Initiates Phase 1 Study of Elamipretide in Dry Age-Related Macular Degeneration

Top-line data from study evaluating elamipretide in patients with dry age-related macular degeneration expected mid-year 2017

BOSTON – November 14, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced the initiation of ReCLAIM, a Phase 1 study evaluating elamipretide in intermediate age-related macular degeneration (AMD). Top-line data are expected mid-year 2017.

“There are currently no FDA-approved treatment options for dry AMD, so we are eager to better understand the effect that elamipretide may have in treating these roughly 13 million patients,” said Dr. Scott Cousins, the trial investigator, and Professor of Ophthalmology and Director of the Duke University Center for Macular Diseases. “Mitochondrial dysfunction that stems from various environmental toxins may be an important causative factor in dry AMD, and in laboratory models, elamipretide appears to prevent mitochondrial dysfunction in the retinal pigment epithelium.”

ReCLAIM is an open-label study to evaluate the safety and tolerability of 12 weeks’ treatment with daily subcutaneous injections of elamipretide in patients, age 55 and above who have at least one eye with intermediate AMD, and have either: a) high-risk protein deposits (drusen) on the retina without any geographic atrophy (GA), a characteristic of advanced AMD which can result in the loss of photoreceptor cells or b) GA with an unaffected central fovea (noncentral GA). The study’s primary endpoints are safety and tolerability, and the secondary endpoints are changes from baseline in physical/ophthalmic examinations and feasibility of subcutaneous injections in this patient population.

“ReCLAIM will build upon our ongoing ophthalmic program to help us better understand the potential of elamipretide to treat back of the eye diseases as well as the effects of the treatment to slow the aging process in eye tissue,” said Stealth Chief Executive Officer Reenie McCarthy. “We look forward to evaluating initial results of this study mid-year 2017.”

12

Aduro Biotech Highlights Positive Clinical Results from Second Cohort of Phase 1b Mesothelioma Clinical Trial

November 12, 2016 8:02 a.m. ET

Data Presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting Continues to Show Clinical Activity of CRS-207

Two Additional Poster Presentations Detailing Promising Preclinical Results of STING and pLADD Programs

BERKELEY, Calif., Nov. 12, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced highlights from a poster presentation at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held in National Harbor, Maryland on the preliminary safety and efficacy of its novel immunotherapy, CRS-207, being evaluated in unresectable malignant pleural mesothelioma. These data were from the second cohort of patients in an ongoing Phase 1b clinical trial of CRS-207 in combination with standard of care chemotherapy and immune-modulating doses of cyclophosphamide (Cy) as a first-line treatment.

Preliminary results as of October 2016 from the 22 patients in the second cohort in the Phase 1b clinical study (Abstract #261) showed that 82 percent (18/22) of patients had disease control, with 55 percent (12/22) of patients achieving a partial response (PR) and 27 percent (6/22) with stable disease. Tumor shrinkage was observed in 77 percent (17/22) of patients. Of these patients, 36 percent (8/22) experienced tumor shrinkage after two doses of immunomodulatory doses of cyclophosphamide combined with CRS-207 (Cy/CRS-207), but prior to initiation of standard of care chemotherapy. Fourteen percent (3/22) of these patients achieved a partial response. No treatment-related serious adverse events or unexpected toxicities were observed. Median duration on study was 9.7 months at the time of data cutoff. Treatment continues, with immune response evaluations and survival follow up ongoing.

Of note, analysis of paired tumor biopsies obtained from two patients showed a marked infiltration of immune effector cells into the tumor microenvironment (TME) following two doses of Cy/CRS-207, as compared to baseline. Post-therapeutic changes included an increase in CD8+ cytotoxic T cells as well as an increase in other immune cell types that are thought to be essential for effective immunotherapy, including dendritic cells and natural killer cells. Together, these data suggest that the Cy/CRS-207 remodeling of the TME may be an important component of the clinical responses observed in this cohort of patients.

“The data from the second cohort, which is a patient population with more advanced disease compared to the first cohort, demonstrate that the addition of immunomodulatory doses of cyclophosphamide, which has been shown to inhibit negative regulatory T cell populations, to the combination of CRS-207 and chemotherapy results in encouraging disease control and tolerability for patients with mesothelioma,” said Dirk G. Brockstedt, Ph.D., executive vice president of research and development of Aduro. “Importantly, we believe these data, together with the results from the first cohort, support further investigation of CRS-207 in mesothelioma, and we intend to initiate a Phase 2 study of CRS-207 used in combination with an anti-PD-1 therapy as an immune-modulator in patients with mesothelioma who have failed at least one prior therapy.”

 

09

Aduro Biotech’s Personalized LADD Therapy Featured in an Oral Presentation at SITC’s New Cancer Immunotherapy Agents in Development Program

November 09, 2016 4:01 p.m. ET

-- Personalized LADD, or pLADD, is being developed utilizing patient-specific neoantigens --

BERKELEY, Calif., Nov. 09, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced that Tom Dubensky Jr., Ph.D., chief scientific officer of Aduro, presented today about the company’s personalized LADD technology at the Society for Immunotherapy of Cancer (SITC) distinct session titled New Cancer Immunotherapy Agents in Development being held in conjunction with the SITC annual meeting.

LADD is Aduro's proprietary platform of live, attenuated double-deleted Listeria monocytogenes strains that have been engineered to express tumor-associated antigens to induce an innate immune response and tumor-specific T cell-mediated immunity.  Personalized LADD, or pLADD, is a second generation LADD technology that is being designed for individualized, patient-specific immunotherapy.  The pLADD approach leverages the immune activating activity of the Listeria bacterial vector in combination with neoantigens, or the tumor markers specific to an individual’s cancer, which are derived from the patient’s own unique tumor cells. Once administered, pLADD therapies are expected to mobilize the immune system through first an immediate recognition of the presence of Listeria as being foreign and then second a specific and customized immune attack on cells containing the tumor neoantigens presented by pLADD.  An Investigational New Drug (IND) application has been accepted, and a Phase 1 trial evaluating the safety and immunogenicity of pLADD in patients with advanced gastro-intestinal cancers is planned. “There is tremendous excitement in the oncology field to develop personalized therapies as the next new wave in immunotherapy to specifically customize treatment for each patient based on neoantigens that are unique to a patient’s tumor,” said Tom Dubensky Jr., Ph.D., chief scientific officer of Aduro. “We are excited about the potential of our pLADD program, which has been shown to induce anti-tumor immune responses specific to tumor neoantigens and correlate with longer survival in preclinical models. Additionally, in these models, we observed a synergistic anti-tumor effect when pLADD was combined with an anti-PD-1 antibody, resulting in a significant reduction in tumor volume and increased survival.”  

08

DNAtrix Licenses Myxoma Virus for New Immunotherapy Platform

Houston, TX – November 8, 2016 – DNAtrix, a clinical stage biotechnology company developing virus-driven immunotherapies for cancer, announced it has entered into an exclusive license agreement with the University of Florida, Gainesville to develop a novel oncolytic virus platform.  The platform is based on myxoma virus, a poxvirus that has been shown to have beneficial features for treating cancers.

A major advantage of the myxoma virus is its ability to attach to T lymphocytes and other white blood cells, which are then delivered to the patient to trigger tumor cell killing and antitumor immunity.  Myxoma virus can be armed with multiple immune stimulatory genes, a feature shared by other large DNA virus such as herpes simplex and adenovirus.

“The myxoma virus has unique properties for attacking cancer,” said CEO Frank Tufaro, Ph.D. “We think this technology platform provides a new modality for delivery of a potent oncolytic virus to tumors by co-administering it along with T cells.  We look forward to testing this “Trojan horse” strategy in the clinic.”

“The myxoma virus is a novel oncolytic candidate that does not infect normal human cells but has a unique ability to identify the damaged signaling pathways found in the majority of human cancers; thus, resulting in productive infections in the patient’s cancer cells,” stated Grant McFadden, Ph.D., Professor in the Department of Molecular Genetics & Microbiology at the University of Florida, College of Medicine.

08

CellCentric wins Innovate UK award to expand use of p300/CBP inhibitors in cancer

November 8th 2016

CellCentric is developing first in class drug compounds against a key regulator of cancer. P300/CBP are twin (paralogue) histone acetyltransferase proteins, that act as transcriptional co-factors. When inhibited they cause the down regulation of the androgen receptor (AR) and its variants. It also decreases c-Myc, another key cancer driver.

CellCentric has been focusing the use of its new potent, specific, orally deliverable compounds for the aggressive form of prostate cancer, CRPC, where AR and AR-splice variants play a key role.

Recent scientific publications have shown that cancer cells can gain mutations in p300 or CBP. When this happens, the cell becomes dependent, or addicted, to the corresponding paralogue protein. Inhibition of p300/CBP with drug compounds can then drive synthetic lethality – cancer cell death. This potential new way to treat certain types of cancer occurs is application to up to 20% of lung cancers (both small cell and non-small cell, NSCLC) as well as bladder cancer (up to 25%) and leukaemia (up to 18%).

CellCentric has won an award from the UK’s innovation agency, Innovate UK, to expand its work, to investigate the use of p300/CBP inhibitors beyond prostate cancer. The funds will be used to confirm the synthetic lethality mechanism in lung cancer. It will go on to validate if p300 and CBP mutations can be readily detected in circulating tumour cells, thus allowing clinicians to easily identify patients that will benefit from the new inhibitor drugs that are being developed.

Lung cancer accounts for 25% of all cancer deaths. Despite other new targeted approaches (e.g. EGFR and ALK inhibitors for NSCLC), over 50% of lung cancers are not molecularly defined. Thus p300/CBP inhibitors offer a significant new opportunity, either as single agents or used in combination with existing or other developmental drugs. This is also a significant commercial opportunity. The lung cancer drug market is set to reach $14.3bn by 2024. Even a small segment such as that representing ALK positive tumours (4-8% of total) are predicted to have sales of $1.2bn.

07

Stealth BioTherapeutics Announces Acceptance of Late-Breaking Clinical Trial Poster at American Society of Nephrology Kidney Week 2016

Late-breaking poster presents data from elamipretide clinical trial in chronic kidney disease patients at risk of acute kidney injury

BOSTON – November 7, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced that the abstract, “Phase 2a Clinical Trial of Mitochondrial Protection (Elamipretide) during Stent Revascularization in Patients with Atherosclerotic Renal Artery Stenosis” has been accepted as a late-breaking clinical trial poster at the American Society of Nephrology (ASN) Kidney Week 2016 taking place in Chicago, November 15-20, 2016.

“The EVOLVE trial underscores our commitment to our cardiorenal program,” said Stealth’s Chief Executive Officer Reenie McCarthy. “We are pleased to present the details of these results both in the context of our three ongoing Phase 2 heart failure studies, as well as to inform our approach to other diseases of aging in which mitochondrial dysfunction is a contributing factor.”

EVOLVE was a double-blind, placebo-controlled study that evaluated 14 patients ages 40 to 80 with chronic kidney disease (CKD) at risk of acute kidney injury (AKI). The primary endpoint was change in kidney function, and the secondary endpoint was a change in renal blood flow and cortical perfusion.

07

Aduro Biotech Presents Preclinical Data Demonstrating Acute and Systemic Immune Activation through STING Pathway Stimulation with ADU-S100

Combination of ADU-S100 and PD-1 Blockade Resulted in Complete Eradication of Local and Distal Tumors

BERKELEY, Calif., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today highlighted an oral presentation given by the company’s chief scientific officer, Thomas Dubensky Jr., Ph.D., at the 4th European Society of Medical Oncology (ESMO) Symposium on Immuno-Oncology held last week in Lausanne, Switzerland.  The data, generated from multiple preclinical models, demonstrated important changes in the tumor microenvironment and the activation of acute and systemic tumor-specific immune cell responses following intratumoral administration of ADU-S100 (also known as MIW815), an investigational STING (Stimulator of Interferon Genes) Pathway Activator immunotherapy.  Importantly, these preclinical data underscore the ability for ADU-S100 to induce tumor-specific memory mediated by immune cells (e.g. T-cells and NK-cells) whereby the immune system is able to eliminate specific cancerous cells upon their reintroduction without further therapy. Additionally, the anti-tumor efficacy achieved with ADU-S100 was enhanced by combination with an anti-PD-1 immune checkpoint inhibitor, and resulted in the complete eradication of local and distal tumors.

“We are pleased to have further validated, through multiple preclinical models, our previous discoveries regarding the potential mechanism of action of the STING Pathway and the role it serves in stimulating a robust and systemic T-cell immune response,” stated Dr. Dubensky. “We look forward to working in partnership with Novartis on translating our preclinical findings to a clinical experience as we continue to make progress with our ongoing Phase 1 study of ADU-S100.”

02

CollegeVine Secures $3.1 Million In Series A Funding

CAMBRIDGE, Mass., Nov. 2, 2016 /PRNewswire/ -- CollegeVine, the fast-growing EdTech startup specializing in high school mentoring for college applications, has closed a $3.1 million Series A funding round led by Morningside Technology Ventures ("Morningside") with participation by New York-based University Ventures. Morningside is a private equity and venture capital firm. Gerald Chan, its co-founder, has joined CollegeVine's Board of Directors. University Ventures is a specialty venture capital fund that exclusively focuses on promising ideas in the higher education space. The announcement was made today by Jon Carson, the CEO of CollegeVine. CollegeVine was started by two Harvard University students and one University of Chicago student working out of the Harvard iLab. The company uses a near peer model of matching talented college students with high schoolers to help them with the college application process. CollegeVine's services quickly earned a reputation for its outstanding college admissions results. Two years ago, the company employed 20 college students as consultants; today it employs almost 300. "There is a huge unmet need for high school students to get proper guidance and mentoring in their planning for college and their application for admission. The fast growth of CollegeVine's business validates that its services are exactly what high school students are looking for. Optimizing the college application process is beneficial both to the applicants and to the universities," said Chan. "With the backing of Morningside and support from University Ventures, we are now positioned to grow the company to meet consumer demand. We plan to use the Series A investment to build out our technology platform and product suite, grow the team, and accelerate our growth," said Carson. "We are pleased to have Gerald join our Board as he has been a valued partner and mentor over several ventures. I am honored, to be working with him on another new and exciting EdTech venture." Morningside was the primary backer of FamilyEducation Network where Carson was both the founder and CEO. FamilyEducation Network became the largest K-12 online network when it was acquired by Pearson Plc for $175 million in 2000. CollegeVine has recently strengthened its management team with the addition of former Zipcar executive Doug Williams as chief technical advisor and Harvard Business School professor Deepak Malhotra as a member of the board of directors.

01

DNAtrix Announces First Patients Treated in Phase 2 Trial with DNX-2401 and KEYTRUDA

Houston, TX – November 1, 2016 – DNAtrix, a clinical stage biotechnology company developing virus-driven immunotherapies for cancer, announced that the first patients have been treated in a multicenter Phase 2 trial investigating its oncolytic adenovirus, DNX-2401, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with recurrent glioblastoma.

The CAPTIVE trial is evaluating the potential effect of DNX-2401 and KEYTRUDA in patients with recurrent glioblastoma, a disease for which there is neither a cure nor adequate treatment. Leading medical centers in the United States and Canada are participating.

DNX-2401 is a potent conditionally replicative oncolytic adenovirus that targets and kills cancer cells, while leaving normal cells intact. Multiple clinical studies have shown that DNX-2401 has a favorable safety profile, strong tumor-killing potential and can trigger an antitumor immune response.

KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2.  This activity enhances the T cell response and leads to effective tumor destruction. KEYTRUDA is currently approved in the United States for advanced melanoma, metastatic non-small cell lung cancer (NSCLC), and advanced head and neck squamous cell cancer (HNSCC).

“Glioblastoma is a difficult disease to treat with conventional therapies,” said Frank Tufaro, Ph.D., Chief Executive Officer of DNAtrix. “Based on remarkable preclinical data, we anticipate that the addition of KEYTRUDA to DNX-2401 therapy will provide even more benefit to patients with recurrent disease.”

October 2016

31

Myanmar HTI Project Formally Launched

October, 2016 - SKSpruce Technologies formally launched the Myanmar Carrier-grade Wi-Fi project. A dedicated project team led by Henry Wu (VP of Product, SE & Product Marketing) was set up to ensure the smooth implementation of this project. The project marks the inaugural collaboration between SKSpruce and Myanmar HTI. Aimed at providing excellent data communication services and comprehensively improving user experience, the project will deploy the world-class carrier-grade Wi-Fi solution of SKSpruce in major areas of Yangon. During this project, over ten thousand APs will be deployed in 22 towns (10 towns in phase I) of Yangon to provide Wi-Fi services to 6 million Yangon citizens, in order to improve the data communication capacity of Yangon public areas, and to bring great economic profits and social benefits to Myanmar. Myanmar HTI project is SKSpruce’s largest project in Southeast Asia this year. Meanwhile, it indicates that SKSpruce is making a significant move to expand Southeast Asian market. SKSpruce is attracting an increasing number of international clients with its continuous product innovation, solution optimization, and technology development.

25

Stealth BioTherapeutics Initiates Phase 2 Study of Elamipretide in Patients Hospitalized with Congestive Heart Failure

Top-line results anticipated in second half of 2017

BOSTON – October 25, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction associated with common diseases of aging and genetic mitochondrial diseases, today announced the initiation of IDDEA-HF, a Phase 2 study evaluating elamipretide in patients hospitalized due to congestive heart failure. Heart failure causes more than two million hospitalizations in the U.S. and Europe each year.

“In heart failure, mitochondrial dysfunction may not only be a causative factor, but may also contribute to the progression of the disease and the associated fluid build-up that causes congestion, due to muscle weakness from a lack of energy production,” said Stealth Vice President of Clinical Development Jim Carr. “In line with our findings in elderly patients enrolled in the   trial, we hope to demonstrate the ability of elamipretide to increase energy production to help the heart muscle work better, subsequently relieving congestion in the body.”

IDDEA-HF is a randomized, double-blind, placebo-controlled study to evaluate the cardiac and renal effects of daily treatment with elamipretide in patients who have been hospitalized with congestive heart failure. Up to 300 patients will be randomized within 72 hours of presentation to receive 20 mg daily elamipretide or placebo intravenously for up to seven days. The primary endpoint is change in NT-proBNP, a cardiac biomarker reflecting the level of congestion. Secondary endpoints include change in clinical status and safety and tolerability.

“IDDEA-HF is a key step in our development of therapies for common diseases of aging. These patients have failed current therapies, experiencing an episode of acute decompensation, which highlights the intense need for new options within the heart failure treatment paradigm where we believe elamipretide can have a significant impact,” said Stealth Chief Executive Officer, Reenie McCarthy. “The data from this study, together with our other ongoing trials in heart failure, will help inform our projected Phase 3 heart failure program as well as our approach to other common diseases of aging for which elamipretide may have therapeutic potential.”

24

Aduro Biotech Reports Partial Clinical Hold to Pause Enrollment in LADD Trials

BERKELEY, Calif., Oct. 24, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that trials with investigational agents based on its LADD (Listeria-based immunotherapy construct) platform have been placed on partial clinical hold to pause new patient enrollment. Patients currently receiving a LADD-based agent (except one currently identified patient, due to the presence of a pacemaker) are continuing to receive treatment, with several of these patients having been on study drug for six months or longer. The partial hold was initiated following notification to the FDA that a blood culture sample from an indwelling port of a metastatic pancreatic cancer patient who presented with gastrointestinal symptoms tested positive for Listeria, which is suspected to be CRS-207. The patient was administered intravenous antibiotics, subsequent blood cultures tested negative for Listeria, and the patient was reported to be doing well.

Aduro is working with the FDA to lift the partial hold so as to resume new patient enrollment in its LADD clinical trials. The company is revising study protocols in accordance with feedback from the agency, including the modification of antibiotic administration following treatment, extended patient surveillance, and, as a pre-emptive measure, exclusion of patients who are on or will receive certain immune-suppressive treatments or who have certain prosthetic devices. Aduro will be providing proposed revisions to the protocols, patient consent forms, and investigator brochures to the agency later this week.

This partial hold does not impact any ongoing development of Aduro’s two other distinct platform technologies, STING pathway activators and B-select monoclonal antibodies.

 

17

ENVISIA THERAPEUTICS RELEASES ENV515 (travoprost XR) PHASE 2 DATA SHOWING NINE-MONTH DURATION OF ACTION AFTER A SINGLE DOSE IN PATIENTS WITH GLAUCOMA

Results Provide Encouraging Outlook for Extended Treatment of Glaucoma Patients RESEARCH TRIANGLE PARK, NC – OCTOBER 17, 2016 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today released an interim analysis of its ENV515 (travoprost XR) phase 2 trial in glaucoma patients showing clinically meaningful reduction in intraocular pressure (IOP) for the entire nine-month evaluation period following a single administration. ENV515 also demonstrated an IOP lowering effect comparable to prestudy topical prostaglandin analogs (XALATAN® and LUMIGAN®) and in-study topical timolol maleate 0.5% ophthalmic solution (daily eye drops). Glaucoma is the leading cause of preventable vision loss and blindness due largely in part to poor patient compliance with once-daily eye drops. “ENV515 continues to show great potential with a favorable safety profile and a sustained, clinically meaningful reduction in IOP over the initial nine months,” said Benjamin Yerxa, President of Envisia. “We plan to initiate enrollment in a new cohort of this phase 2 trial by year-end, which will enable us to evaluate the high dosage form of ENV515 that has been formulated with the goal of achieving efficacy comparable to TRAVATAN Z® with a duration greater than 9 months.”

12

New app helps workers track child development, identify autism early

By Amanda Eisenberg, Published October 12 2016, 1:41am EDT --

As employers struggle with retention rates across the board, healthcare technology company Cognoa is trying to keep a specific population employed: parents of children with developmental disorders.

The Palo Alto-based company recently launched Cognoa for Employers, a mobile app that screens children as young as 18 months for developmental disorders, to assist with early detection and cut down on future healthcare costs and missed workdays. The app would be included in a benefits package for parents to assess how their young children are reaching developmental benchmarks and screens for autism, speech delays and ADHD.

With one in six children in the United States diagnosed with a developmental disorder, according to the Centers for Disease Control and Prevention, the impact affects parents who work full-time.

“There is a greater pressure on one of the parents to leave the workforce and stay home with the child,” says Cognoa CEO Brent Vaughan. “The key benefit is it allows valuable employees to be happy and focused at work.” The company built the parent-facing app to encourage early detection and intervention; the average age of an autism diagnosis is age 4, according to nonprofit Autism Speaks. An earlier diagnosis, says Vaughan, could be “the difference between attending special or normal schools” and could create a “lifelong change for a family.”

“We hear from parents constantly who are unable to keep a job,” says Wendy Fournier, president of the National Autism Association. “Many get frequent calls to pick up their kids from school, or have lots of medical appointments and need to take time off. It’s difficult for a lot of us to be dependable employees because caring for a child with autism can be volatile: Some days are fine, some are disastrous.”

Cognoa’s machine learning-based platform, which has been running for two years and has data from more than 140,000 children screened by the app, attempts to minimize the number of doctor’s visits that could leave an employee to take time off, says Vaughan.

Parents are asked to fill out a questionnaire that details their child’s play habits, eye contact, stomach and sleep problems, sensitivity to noise, and body and verbal language. They are also able to record videos of their children for a home-based, parent-selected evaluation, which is then compared to other videos and information in the system. The data is kept password protected and has rigorous data encryption that meet or exceed HIPAA compliance, Vaughan says.

“In the detailed assessments, parents receive descriptions of specific behavioral areas where their child is meeting developmental milestones, as well as areas that correspond with any elevated risk for delay,” he says. “The assessment reports also include the links to the videos the parent provided of the child’s actual behavior that corresponds with the assessment. We have found that both parents and clinicians find it valuable to see the videos of the child’s natural behavior at home.”

Vaughan says the app’s main competitor is standard care. However, not all pediatricians screen for developmental disorders, which is where the app bridges the gap in care for parents who might not be able to pay the co-pay or bring their child to the doctor’s office.

September 2016

28

ACD Launches BaseScope™ Suite of Tissue Analysis Assays Enabling Breakthrough Advances in Molecular Pathology

The BaseScope assay is unique in enabling spatial localization of splice variants, point mutations and highly homologous sequences within tissue samples NEWARK, Calif., Sept. 28, 2016 /PRNewswire/ -- Advanced Cell Diagnostics (ACD), a brand of Bio-Techne Corporation, announces the release of a breakthrough RNA in situ hybridization (ISH) assay delivering the unprecedented capability of detecting RNA transcripts at single base resolution. The BaseScope™ assay is available commercially as a kit for use in laboratories worldwide and via ACD's Pharma Assay Services. As one of the offerings of the Pharma Assay Services portfolio, BaseScope provides highly sensitive and specific detection of exon junction/splice variants, SNPs, small insertions/deletions, and short targets, including complex and highly homologous gene families such as MAGE and ILT in just four weeks. Dr. Yuling Luo, Founder and President of ACD, explained the significance of the launch: "BaseScope is a truly revolutionary assay providing groundbreaking insights into biological and disease mechanisms not possible with other technologies – again demonstrating our pioneering position in molecular pathology. Before the launch of the BaseScope assay, it was simply not possible to detect a specific exon-exon junction or a point mutation in situ with morphological context."

27

Aduro Biotech Presents Encouraging Preclinical Data Showing Combination Synergy of its Immunotherapy and Checkpoint Inhibitors to Increase Antitumor Efficacy

BERKELEY, Calif., Sept. 27, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today highlighted two posters presented at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CRI-AACR) in New York. The preclinical data demonstrate positive changes in the tumor microenvironment and induction of a tumor-specific immune response by Aduro’s LADD (listeria-based immunotherapy construct) and STING (Stimulator of Interferon Genes) Pathway Activator immunotherapy platform technologies. Importantly, adding a PD-1 blockade to either immunotherapy regimen significantly bolstered antitumor efficacy. “These preclinical data demonstrate the underlying mechanisms by which our LADD and STING immunotherapy platforms activate the immune system and induce robust innate immunity, facilitating a change in the tumor microenvironment which results in effective destruction of cancer cells in several preclinical models,” said Thomas Dubensky, Jr., Ph.D., chief scientific officer of Aduro. “Importantly, the combination data are even more impressive, showing increased efficacy when our LADD and STING platforms are combined with an anti-PD1 checkpoint inhibitor to combat the tumor’s ability to hide from the immune system. These data support our strategy to combine our immunotherapy regimens with checkpoint inhibitors for greater anti-tumor activity, looking toward the ultimate goal of better, more effective patient care.”

26

MicuRx Closes $55 Million Series C Financing to Support Development of Next-Generation Antibiotic MRX-I

Funds to Support Phase 3 Clinical Trials in U.S. and China HAYWARD, Calif. and SHANGHAI, Sept. 26, 2016 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc. today announced the close of its $55 million Series C financing. Led by GP Healthcare Capital, the round included new investors GP TMT Capital, 3E Bioventures Capital, and Delian Capital. Mr. Yu Miao of GP Healthcare Capital will join the board of directors. "Our investors have recognized the unique benefits that our next-generation antibiotic, MRX-I, offers to patients who need better tolerated, more convenient oral and intravenous antibiotics to treat MRSA," commented Zhengyu Yuan, Ph.D., president and CEO of MicuRx. "We are very pleased to have the solid support of such a strong syndicate which will fund MicuRx through our first New Drug Application (NDA) filing in China. The fast growing pharmaceuticals market in China, presents an excellent opportunity for MRX-I. In parallel, we are pursuing development in the U.S. and other global markets." Funding from Series C financing will be used to continue development of MRX-I in both the United States and China. With the funds, the company expects to complete its Phase 3 trial using oral MRX-1 to treat complicated skin and skin structure infections (cSSSI) in China, complete one pivotal US Phase 3 trial with oral and intravenous formulations of the drug for the indication of acute bacterial skin and skin structure infections (ABSSSI) as well as file a Chinese NDA for cSSSI. The BFC group provided financial advice to MicuRx.

19

Stealth BioTherapeutics Reports Elamipretide Improved Skeletal Muscle Bioenergetics in the Elderly

Trial evaluating treatment with investigational drug, elamipretide, demonstrated improved mitochondrial function by increasing energy production after single treatment BOSTON – September 19, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced results from the MOTION Trial. This clinical trial evaluated the systemic delivery of elamipretide on skeletal muscle function in elderly subjects with reduced mitochondrial function, and demonstrated improved mitochondrial energy production after treatment. This increase in mitochondrial bioenergetics was comparable to the improvement resulting from six months of exercise training, shown in a similar patient population in other trials. The data from this trial were presented at the Late Breaker Poster Session of the Heart Failure Society of America Annual Scientific Meeting in Orlando, Florida on Saturday, September 17. MOTION was a Phase 2 randomized, double-blind, placebo-controlled study that evaluated 40 patients ages 60-85 with demonstrated mitochondrial dysfunction to determine the effect of elamipretide on skeletal muscle energetics and performance. The primary endpoint showed improved mitochondrial energy production (ATPmax) which increased by 30% over baseline as compared to a 10% change in the placebo group (p=0.055). The improved bioenergetics were associated with greater skeletal muscle function (p=0.004). Furthermore elamipretide was well tolerated with no treatment-emergent adverse events (TEAEs) identified.

13

Kezar Life Sciences Announces Initiation of Phase 1 Clinical Program for Lead Candidate KZR-616, a First-in-Class Immunoproteasome Inhibitor

SOUTH SAN FRANCISCO, Calif., Sept. 13, 2016 /PRNewswire/ -- Kezar Life Sciences, a company focused on the discovery and development of drugs targeting protein homeostasis, announced today the initiation of its Phase 1 randomized, double-blind clinical program for KZR-616, a selective inhibitor of the immunoproteasome. Since enrollment of the first cohort on August 9, Kezar has completed dosing of 24 subjects across three cohorts in the single ascending dose (SAD) portion of the Company's Phase 1a study, which includes both SAD and multiple ascending dose (MAD) portions. The study is expected to enroll a total of 64-80 subjects, with key endpoints including pharmacokinetics and biomarkers of target engagement, as well as safety and tolerability. In the Phase 1 program, KZR-616 is administered once-weekly as a subcutaneous injection. Pending progress of the study, the Company anticipates that it will report topline pharmacokinetics, safety, and target engagement data by the end of 2016. Additionally, in the first half of 2017 the Company anticipates commencing a Phase 1b study of KZR-616, which is expected to enroll up to 40 patients with autoimmune disorders and include a cohort with a placebo control. "We are proud to be the first company to move a selective inhibitor of the immunoproteasome into the clinic," said John Fowler, Kezar's Chief Executive Officer and Co-Founder. "The Kezar scientific team is unparalleled in its understanding of the unique biology and therapeutic potential of the immunoproteasome, and has done a tremendous job moving our lead program rapidly into the clinic.  We look forward to demonstrating the safety profile and target engagement of KZR-616 in the coming months, and launching Phase 1b and 2 trials in patients in 2017."

12

Stealth BioTherapeutics Initiates Phase 2 Study of Elamipretide in Primary Mitochondrial Disease

Study will evaluate the long-term safety, tolerability and efficacy of elamipretide in patients who completed the Phase 2 MMPOWER study BOSTON – September 12, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced the initiation of a longitudinal extension trial for evaluating elamipretide in primary mitochondrial disease. The study, MMPOWER-2, will be limited to patients who completed the initial MMPOWER Phase 2 study. Positive data from MMPOWER were announced in June 2016 showing statistically significant improvement in distance walked in six minutes. “Patients with rare primary mitochondrial diseases have no FDA-approved treatment options to address their needs,” said Stealth Chief Executive Officer Reenie McCarthy. “We’re committed to helping fill these significant gaps in care through our study of elamipretide. Following the promising results from our Phase 2 MMPOWER study, we’re happy to announce the initiation of MMPOWER-2, which will help us better understand the effects of longer treatment with elamipretide for these patients, who often face severe challenges completing even simple daily activities.” MMPOWER-2 is a randomized, double-blind, placebo-controlled crossover study to evaluate the safety, tolerability and efficacy of four weeks’ treatment with once-daily subcutaneous injections of elamipretide in patients with genetically confirmed mitochondrial disease. All patients in this study have previously completed the MMPOWER study.

01

ASLAN PHARMACEUTICALS AND A*STAR ENTER RON ANTIBODY LICENSING AND RESEARCH COLLABORATION AGREEMENT

Singapore, 1 September 2016 – ASLAN Pharmaceuticals (ASLAN), a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, today announced the licensing of a novel immuno-oncology antibody, targeting RON (Recepteur d’Origine Nantais), from Singapore’s Agency for Science, Technology and Research (A*STAR) which ASLAN will develop and commercialise worldwide. RON is a receptor tyrosine kinase, and an overexpression of RON leads to increased tumour metastasis. Consequently, RON activation in tumour cells promotes aggressive disease. The RON antibody licensed by ASLAN was developed by A*STAR’s p53 Laboratory and is currently in preclinical development. The antibody has demonstrated preclinical efficacy in a range of in vivo models of human cancer. Under the terms of the agreement, ASLAN will gain global rights to develop the RON antibody and intends to commence clinical studies in 2018. Commercial terms were not disclosed. To further advance the project towards clinical trials, ASLAN and A*STAR have also entered a three-year research collaboration. ASLAN will be responsible for the design of innovative clinical development programmes, in close collaboration with A*STAR’s p53 Laboratory which will continue to be responsible for the preclinical development of the antibody assets.

August 2016

31

InCarda Therapeutics Initiates Enrollment of Phase 1 Clinical Trial of Inhaled Flecainide for the Treatment of Cardiac Arrhythmias

San Francisco, California, August 31, 2016 – InCarda Therapeutics, Inc. (InCarda), a privately-held biopharmaceutical company pioneering a novel approach of treating cardiovascular conditions by delivering medications via the inhalation route, today announced that it has initiated a Phase 1 clinical trial for its lead product intended to treat recent onset atrial fibrillation (AF). The single-center trial will evaluate the safety and tolerability of inhaled flecainide in a randomized, double-blind, placebo-controlled design consisting of single ascending doses of inhaled active solution, or inhaled placebo solution, in multiple cohorts of healthy volunteers. This study is being conducted at CMAX, a division of IDT Australia. “This is an important step in advancing InCarda’s lead product into clinical development,” stated Narsi Rangachari, co-founder and chief operating officer of InCarda Therapeutics. “With its novel delivery approach, InCarda is uniquely positioned to develop this rapid-onset treatment for patients with paroxysmal AF.”

23

Backed by a biotech legend, two young entrepreneurs tackle one of the Holy Grails of R&D

ENDPOINTS NEWS - It’s not often that two recent college grads can come up with enough cash and connections to run a Phase II study of a new combination drug for a tough and deadly disease like ALS. But with some backing by biotech legend Henri Termeer and $8 million in venture cash and grant money, Justin Klee and Josh Cohen say they’re ready to turn what started out as an undergraduate science project at Brown into a clinical reality in a matter of months at a startup dubbed Amylyx. The key component in all this, the money to start dosing patients, comes from a $5 million Series A led by Morningside Venture with contributions from the ALS Investment Fund and former Genzyme CEO Termeer. Combined with a $3 million grant from the ALS Accelerated Therapeutics Initiative and some discount pricing from a network of hospitals engaged in ALS work, and Klee and Cohen say they’ve reached the threshold of a mid-stage trial that will look for both efficacy and safety data. “It is atypical,” Klee allows in our telephone interview this morning. But the two young entrepreneurs are preparing to take a shot at ALS on a budget that most Big Pharmas would spend on preclinical work. And they say their work could have applications for Alzheimer’s, another devastating disease that has so far burned billions of dollars in largely wasted research efforts.

22

Amylyx Nabs $5M to Take Aim at Nerve Cell Death in ALS Patients

Xconomy Boston - While the cause of amyotrophic lateral sclerosis, or ALS, remains a mystery, many researchers are trying to develop a cure by stopping its effect—the death of nerve cells that leads to muscle deterioration and the patient’s eventual death. One Cambridge, MA-based drug developer, Amylyx Pharmaceuticals, has received a $5 million Series A financing to take its nerve cell-targeting treatment, AMX0035, into a Phase 2 trial for ALS patients. The treatment is a combination of sodium phenylbutyrate, a drug commonly used to remove ammonia from the body, and tauroursodeoxycholic acid, a derivative of stomach bile acid. With the two drugs combined into one, the company believes it can possibly block nerve cell death and neurotoxic inflammation, two potential causes of ALS. The company expects the trial to begin in late 2016 or early 2017. The funding was provided by Morningside Venture, the ALS Investment Fund, and former Genzyme CEO Henri Termeer. Since selling Genzyme to Sanofi for $20 billion in 2011, Termeer has been an active investor and advisor to startup biotechs, including Moderna Therapeutics, Lysosomal Therapeutics, Aura Biosciences, and X4 Pharmaceuticals. The $5 million funding follows a $3 million grant for the Phase 2 trial that Amylyx received from the ALS Accelerated Therapeutics Initiative, which is a collaboration between the ALS Association and ALS Finding a Cure. Amylyx says it has raised $10 million for its drug, called AMYX0035.

22

Amylyx Announces $5 Million Series A Financing to Support Phase II Clinical Trial of AMX0035 for Treatment of Amyotrophic Lateral Sclerosis

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals Inc. announced today that it has completed a $5 million Series A financing to support its upcoming Phase II trial in patients with Amyotrophic Lateral Sclerosis (ALS). Morningside Venture led the financing and was joined by the ALS Investment Fund and former Genzyme CEO Henri Termeer, as well as new and previous private investors. The financing adds to a recently awarded $2.96 million grant to support the clinical trial from the ALS Accelerated Therapeutics Initiative, which is a collaboration between the ALS Association and ALS Finding a Cure. Overall, Amylyx has raised $10 million in grant funding and private financing to advance AMX0035. The IND for this Phase II trial is on schedule for the fourth quarter of 2016 and the trial will start shortly thereafter. Over 20 clinical sites across the United States have already expressed interest in participating.

10

BRISTOL-MYERS SQUIBB REACQUIRES RIGHTS TO ASLAN002 (BMS777607) IN ASIA FROM ASLAN

Agreement validates ASLAN’s strategy and development capabilities Singapore, 10 August 2016 – ASLAN Pharmaceuticals (ASLAN), a biotech company focused on the development of immunotherapies and targeted agents for Asia-prevalent tumour types, today announced that Bristol-Myers Squibb will reacquire the rights to ASLAN002 (BMS777607) in China, Australia, Korea, Taiwan and other Asian territories. ASLAN002 is a potent small-molecule dual inhibitor of the cMET receptor tyrosine kinase and RON immune checkpoint. ASLAN in-licensed ASLAN002 in the above-mentioned markets from Bristol-Myers Squibb in November 2011 and has successfully completed a phase 1 study, in which ASLAN002 was shown to be safe and well tolerated. The phase 1 data demonstrated that inhibition of RON resulted in potent inhibition of plasma biomarkers of RON activity. ASLAN will receive an upfront payment of US$10 million and is eligible to receive development and regulatory milestones in excess of US$50 million. In addition, ASLAN is eligible to receive royalty payments on future worldwide sales of ASLAN002. Bristol-Myers Squibb resumes responsibility for all development and commercialisation activities and expenses. Commenting on the agreement, Dr Carl Firth, Chief Executive Officer of ASLAN Pharmaceuticals, said: “The acquisition of ASLAN002 by Bristol-Myers Squibb supports ASLAN’s strategy to in-license investigational programmes and apply the unique development expertise of our team to accelerate the generation of high-quality data and significantly increase the value of a programme. The commercial terms of the agreement further strengthen ASLAN’s financial position following the closing of our recent financing rounds; we are in a very strong position to continue to build our proprietary pipeline of novel clinical programmes.”

08

Green Biologics: Selling commodities as specialties

August 8, 2016 - Industrial biotechnology company Green Biologics Ltd. (GBL; Abingdon, United Kingdom) produces n-butanol and acetone by fermenting sugars from renewable feedstocks. The two products are drop-in alternatives to petroleum-based chemicals and find use in a variety of applications. Although n-butanol and acetone are typical examples of commodity chemicals, sold on volume and price, GBL is effectively selling its versions of the products as specialties. “What I think is interesting around Green Biologics is how we are developing a specialty chemicals market in what is effectively a commodities space,” says Sean Sutcliffe, CEO at GBL. “We’re not really competing with our friends at BASF [SE] or Dow [Chemical Co]. They focus on volume, price, and supply chains. We’re focusing on similar molecules but on a different sector entirely, where it’s performance and downstream value that count.” The company’s objective is to apply synthetic biology and modern process technology to the clostridium microbial fermentation process to develop and produce renewable biobased products. “It’s a specialty chemicals business but with perhaps a stronger intellectual property [(IP)] base than usual,” says Sutcliffe. ”Our IP base is particularly strong in this sector, with the technology underpinning the strategy. Our key strategy is bringing specialty chemical applications that provide a mixture of higher performance and natural ingredients ... . There is a strong market drive towards green, natural, sustainable ingredients.” GBL says that its competitive advantage straddles the biology, the process, right through to the end market. “Our business model is that we develop the technology; we own, operate, make, and sell the product, and work [closely] with customers,” Sutcliffe says.

04

DNAtrix Awarded FDA Orphan Products Development Grant for DNX-2401

Houston, TX – August 4, 2016 – DNAtrix, a clinical stage biotechnology company developing virus-driven immunotherapies for cancer, announced the award of a $2 million research grant from the FDA’s Office of Orphan Products Development to support its Phase 2 clinical trial evaluating DNX-2401 with the checkpoint inhibitor pembrolizumab for patients with recurrent glioblastoma. This FDA grant program supports the development of medicines for rare diseases or conditions where no current therapy exists. Approximately 100 applications are received per year from which roughly 10 are selected for funding following rigorous scientific review. DNX-2401 is a potent oncolytic adenovirus that targets and kills cancer cells, while leaving normal cells intact. Multiple clinical studies in patients with recurrent glioblastoma and gynecologic cancer have shown that DNX-2401 has a favorable safety profile, strong tumor-killing potential and can trigger an antitumor immune response. DNX-2401 has already received Orphan Drug Designation and Fast Track Designation by the FDA and PRIME Designation by the EMA. Frank Tufaro, Ph.D., Chief Executive Officer of DNAtrix said, “We are delighted by the FDA’s continued recognition of DNX-2401 as a promising treatment for glioblastoma by awarding this grant to further support our product development strategy. This is an important accomplishment for the company and another significant step toward bringing DNX-2401 to patients with devastating brain tumors.”

01

Corn-to-Butanols Project On Track

The renewables group aims to ramp up production from its US facility through 2017 as it looks for partners for further expansions Will Beacham, Barcelona - 1-14 August, 2016 - Green Biologics, the UK-headquartered producer of renewable-based n-butanol and acetone, is on track to complete the retrofit of a commercial scale US ethanol facility by the end of 2016, its CEO Sean Sutcliffe says. The company set out plans at the beginning of 2015 to retrofit the 21m gallon ethanol facility at Little Falls, Minnesota, for the production of high-purity n-butanol and acetone, and the project is progressing on schedule, according to Sutcliffe. The company also has a 1/30 scale demonstration plant that has been running since August 2014 to prove its Clostridium microbial fermentation technology and ensure consistent quality is deliverable. This allows high-purity n-butanol and acetone to be produced, which is benzene-free and with low water content compared to petrochemical-derived alternatives, he claims. “We’ve had interest from people looking for these advantages. One major producer of butanol derivatives said it’s the best quality they’d ever sampled. People are rightly cautious as they need high-quality product,” he adds.

01

Bio-Techne Corporation Completed its Acquistition of Advanced Cell Diagnostics

MINNEAPOLIS, August 01, 2016 / PRNewswire/ –– Bio-Techne Corporation (NASDAQ: TECH) today announced it has completed its acquisition of Advanced Cell Diagnostics of Newark, CA. This represents the 9th acquisition for Bio-Techne in the last three years. With these acquisitions, Minneapolis-based Bio-Techne has grown from approximately 650 employees in 2013 to nearly 1,700 staff worldwide and has expanded its global reach with subsidiaries in every major geographic market. Organically, we continue to develop and launch in excess of 1,500 new products to market on a yearly basis which enable researchers to address new and more complex questions in the life science field. This latest acquisition of ACD is consistent with our strategic plan, which includes both organic growth and acquisitions that fill portfolio gaps.

July 2016

27

DNAtrix Receives European Medicines Agency PRIME Designation

Houston, TX – July 27, 2016 – DNAtrix, a clinical stage biotechnology company developing virus-driven immunotherapies for cancer, announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation for DNX-2401 as a promising new treatment for recurrent glioblastoma. The PRIME initiative was launched by the EMA in March of 2016 to accelerate the regulatory approval of breakthrough therapies that target an unmet medical need. By offering prompt interaction with Sponsors developing innovative therapies, the objective is to provide patients who have few treatment options with early access to priority medicines that could provide significant benefit. DNX-2401 is a potent oncolytic adenovirus that targets and kills cancer cells, while leaving normal cells intact. Multiple clinical studies in patients with recurrent glioblastoma and gynecologic cancer have shown that DNX-2401 has a favorable safety profile, strong tumor-killing potential and can trigger an antitumor immune response. “We are pleased and honored that the European Medicines Agency has recognized the potential of our oncolytic immunotherapy DNX-2401 to make a positive impact on glioblastoma,” said Joanna Peterkin, M.D., M.S., Chief Medical Officer of DNAtrix. “We look forward to working with the EMA on this important development program for DNX-2401, with the goal of improving the quality of life of patients with brain tumors.”

21

DNAtrix Announces Successful Intratumoral Delivery of DNX-2401 via Alcyone’s MEMS Cannula for the Targeted Treatment of Recurrent Glioblastoma

Houston, TX & Lowell, MA – July 21, 2016 – DNAtrix, a clinical stage, biotechnology company developing virus-driven immunotherapies for cancer, announced the successful intratumoral administration of DNX-2401 with the Alcyone MEMS Cannula (AMC) to patients with recurrent glioblastoma. A substudy is being performed as part of a larger multicenter study to evaluate DNX-2401 as treatment for recurrent glioblastoma, a disease for which there is neither a cure nor adequate treatment. DNX-2401 is a potent oncolytic adenovirus that targets and kills cancer cells, while leaving normal cells intact. Multiple clinical studies in patients with recurrent glioblastoma and gynecologic cancer have shown that DNX-2401 has a favorable safety profile, strong tumor-killing potential and can trigger an antitumor immune response. The AMC is a dual-lumen MRI-safe neuro-ventricular cannula with the smallest-in-class micro-tip and patented design features that ensure optimal and consistent drug distribution while eliminating backflow. Analysis of intraoperative MRI from the pilot study demonstrates that the AMC delivers DNX-2401 precisely and accurately into the tumor. Neurosurgeons participating in the study have also praised the cannula’s ease of use. “The Alcyone MEMS Cannula is a compelling technology that ensures a complete dose of DNX-2401 is delivered directly to the brain tumor and provides a standard, reliable and consistent method of virus administration. We are excited to incorporate this technical advantage into our development program to combat this devastating disease,” said Frank Tufaro, Ph.D., Chief Executive Officer of DNAtrix.

11

2020 On-site Optometry Raises $3 Million, Plans for Rapid Growth

BOSTON--(BUSINESS WIRE)--2020 On-site Optometry raised $3 million in an extension to its Series A-1, bringing 2020 On-site’s total fundraising to $7.9 million. 2020 On-site, a Boston-based start-up, delivers comprehensive vision care (eye exams, glasses, contacts) to offices and schools via their state-of-the-art mobile vision centers (MVCs). 2020 is the U.S.’s largest provider of mobile vision centers for corporate wellness, with more than 10,000 exams performed on a 2020 MVC at over 230 corporations. This fundraising round includes investments from Morningside Ventures; Andrew Balson, CEO of Match Beyond; John Connolly, Senior Advisor of Bain Capital Ventures; RoAnn Costin, Board Member of Lululemon Athletica; Lee Linden, former Head of Commerce of Facebook; Mark Nunnelly, former Managing Director of Bain Capital; and David Sanderson, Partner of Bain & Co; among others. When asked why he invested in 2020, Mr. Balson commented, “2020 has solved a problem for companies and their employees by providing high-quality optometry in a convenient and low-cost setting. We will see more MVCs parked at companies and more eyes cared for as the 2020 team grows their presence. This is investing in a company that will do well by doing good.” On-site eye exams are becoming a new standard in corporate wellness at a time when companies are looking for ways to drive employee engagement and help employees stay on top of their health. Operating in Boston and Atlanta today, 2020 launches in Chicago this fall.

07

Bio-Techne to Acquire Advanced Cell Diagnostics for Up to $325M

Bio-Techne said it has agreed to acquire molecular pathology test developer Advanced Cell Diagnostics (ACD) for up to $325 million in a deal that expands the buyer’s offerings into genomics technology, as well as its presence within clinical labs. Founded in 2006 by President and CEO Yuling Luo, Ph.D., and COO Steve Chen, Ph.D., ACD develops cell- and tissue-based diagnostic tests for personalized medicine. ACD’s products and services are based on its proprietary RNA in situ hybridization, or RNA ISH, technology, a proprietary target hybridization and signal amplification technology enabling the detection of single RNA molecules in single cells and commercialized under the RNAscope® brand name. According to ACD, RNA ISH could provide pathologists with reagents capable of specifically detecting transcripts of expressed genes, noncoding RNAs, as well as more subtle genetic details, such as gene splice variants, gene fusions, copy number variations, and single-nucleotide polymorphisms. “With broader adoption of the technology in the diagnostic arena, it has the potential to revolutionize the choice of reagents in diagnostic practices, such as oncology, infectious diseases, and others,” Bio-Techne President and CEO Charles R. Kummeth said in a statement. “As we continue to expand the portfolio of products and technologies we bring to our customers, we view the leading-edge ACD products as a natural and complementary extension of the Bio-Techne product offering.”

06

BIO-TECHNE ANNOUNCES AGREEMENT TO ACQUIRE ADVANCED CELL DIAGNOSTICS

Minneapolis/July 6, 2016/--Bio-Techne Corporation (NASDAQ: TECH) announced today that it has agreed to acquire Advanced Cell Diagnostics (ACD) for $250 million in cash plus contingent consideration of $75 million due upon the achievement of certain milestones. The transaction is expected to close on or about August 1, 2016, with closing subject to the satisfaction of customary closing conditions. The transaction will be financed through a combination of cash on hand and a revolving line of credit facility that Bio-Techne expects to obtain prior to the closing of the acquisition. Charles R. Kummeth, President and Chief Executive Officer of Bio-Techne, commented, “We are very pleased to have ACD as part of Bio-Techne Corporation. First of all, ACD marks Bio-Techne’s entry into the genomics field and market. Second, and more importantly, its innovative and versatile technology has the potential to change pathology practices. RNA-ISH is a transformative technology facilitating and improving the monitoring of gene expression patterns at the single cell level––while retaining the morphological context of the tissue being analyzed. ACD’s technology serves both research and diagnostic markets, expanding Bio-Techne’s presence in the clinical lab setting. With broader adoption of the technology in the diagnostic arena, it has the potential to revolutionize the choice of reagents in diagnostic practices, such as oncology, infectious diseases and others. As we continue to expand the portfolio of products and technologies we bring to our customers, we view the leading-edge ACD products as a natural and complementary extension of the Bio-Techne product offering, with the ultimate goal to more completely address our customers’ varied needs in the research and clinical space."

June 2016

29

Argos Therapeutics Announces Closing of $29.8 Million Second Tranche of March 2016 Financing

DURHAM, N.C., June 29, 2016 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of truly individualized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced that it had completed the closing of the second tranche of its private placement financing under the Company's previously announced March 2016 securities purchase agreement. In the closing of the second tranche, Argos sold, for a total purchase price of $29,824,520, a total of 5,478,672 shares of common stock and warrants to purchase a total of 4,109,005 shares of common stock (0.75 shares of common stock for each share of common stock purchased), based on a purchase price per share of common stock and accompanying warrant equal to $5.44375. The closing of the second tranche was triggered by the previously announced recommendation from the Company's independent data monitoring committee ("IDMC") that the Company continue its pivotal ADAPT Phase 3 clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma based on results of the IDMC's scheduled interim data review.

28

Luqa Pharmaceuticals and Daewoong Pharmaceuticals to launch a Strategic Collaboration in the Aesthetics Field

June 28, 2016 - Luqa Pharmaceuticals, a China specialty company, has announced it has signed a Letter of Intent with leading Korean company Daewoong Pharmaceuticals for the commercialization and promotion of innovative products in the aesthetics field. Through this collaboration, Daewoong will continue the ambitious international expansion of its aesthetics portfolio, building on landmark agreements with leading companies in Europe, USA and Latin America. In words of Mr. Robert Braithwaite, CEO of Luqa Pharma: “We look forward to this collaboration with Daewong to continue to expand our aesthetics portfolio for Greater China. Daweong’s high quality products are a perfect complement to our current range therapies, allowing us to provide a complete range of solutions for dermatologists, aesthetics doctors and our patients.”

27

Stealth BioTherapeutics Initiates Two Phase 2 Trials Evaluating Elamipretide for the Treatment of Heart Failure

Trials to evaluate potential treatment option for heart failure patients with either reduced or preserved ejection fraction BOSTON – June 27, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced the initiation of two Phase 2 studies evaluating elamipretide in heart failure: PROGRESS-HF in patients with heart failure with reduced ejection fraction and RESTORE-HF in those with preserved ejection fraction. Top-line data from each are expected in the second half of 2017. “The heart’s reduced ability to relax and contract during heart failure may be linked to mitochondrial dysfunction and a resulting lack of energy in heart muscle,” said Stealth Vice President of Clinical Development Jim Carr. “Since muscle is required for both pumping and re-filling the heart, we believe elamipretide could address this lack of energy in the heart muscle in the two major forms of heart failure by improving mitochondrial function.” “Our initiation of these Phase 2 trials marks an important milestone for Stealth and the progression of our cardiorenal program for elamipretide. Following the promising findings from our Phase 1 PREVIEW trial in heart failure, we hope to demonstrate improvements in heart function across both types of heart failure with longer-term dosing,” said Stealth Chief Executive Officer Reenie McCarthy.

24

NPIC Achieves SQF Level 2 Certification

Dallas, TX — NPIC is proud to announce that they have increased their grade of SQF certification. This grade increase comes after an in-depth audit process which took place in May of 2016. The audit consisted of a thorough review of all processes, including training, sanitation and manufacturing. The SQF audit process is run by the SQF Institute, an organization that sets the standard for food manufacturers in the United States, Canada and Mexico. Their mission is “to deliver consistent, globally recognized food safety and quality certification programs based on sound scientific principles, consistently applied across all industry sectors and valued by all stakeholders.” The SQF program is recognized by retailers and food service providers around the world and is the only program of its kind that integrates a quality component as well as food safety.

23

Apellis Announces Positive Results from Phase 1 Clinical Trials of APL-2, a C3 Complement Inhibitor

LOUISVILLE, Ky., June 23, 2016 /PRNewswire/ -- Apellis Pharmaceuticals, Inc. today announced positive results from two Phase 1 clinical trials of its complement C3 inhibitor, APL-2. The trials were randomized, double-blind, placebo-controlled, single and multiple ascending dose studies designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of subcutaneous injection in healthy adult volunteers. Forty subjects were administered APL-2 subcutaneously (SC) either as a single dose (ranging from 45 to 1,440mg) or repeated doses for 28 consecutive days (ranging from 30 to 270 mg/day). Both studies concluded that pharmacological doses of APL-2 were safe and well tolerated and that APL-2's PK / PD profile supports daily SC administration. In addition, complement-mediated hemolysis (destruction of the red blood cells) was assessed and daily APL-2 doses of 180mg and 270mg significantly reduced hemolytic activity as early as eight days after the start of dosing, and this inhibition was maintained throughout the dosing period. "We are pleased to have accomplished this major milestone in the clinical development of APL-2. Targeting C3 is very challenging as it is the most abundant complement protein in the body. It is the first time that a study demonstrates that inhibiting complement at the C3 level can be safely achieved in a clinical study," said Cedric Francois, M.D., Ph.D., Chief Executive Officer of Apellis.

17

Stealth BioTherapeutics Reports Positive Elamipretide Data in First-Of-Its-Kind Primary Mitochondrial Myopathy Trial

Positive Phase 2 data in rare disease trial lead to extension study and planning for Phase 3 BOSTON – June 17, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced the presentation of positive results from MMPOWER, a Phase 2 trial evaluating the systemic delivery of elamipretide for the treatment of primary mitochondrial myopathy, or muscle weakness, in patients with a genetically confirmed mitochondrial disease. The findings demonstrated statistically significant improvements with elamipretide in distance walked in six minutes, the study’s primary efficacy endpoint and an accepted measurement of functional exercise capacity. The results were presented at Mitochondrial Medicine 2016, the United Mitochondrial Disease Foundation (UMDF) symposium, in Seattle at 8:10 a.m. PT. “The muscle weakness, exercise intolerance and heightened fatigue experienced by patients with primary mitochondrial disease can make simple daily tasks very challenging,” said Dr. Amel Karaa, trial investigator, internist and clinical geneticist at Massachusetts General Hospital. “These findings demonstrate the potential for elamipretide to help improve their ability to perform everyday activities. We look forward to further study of this compound in upcoming trials of primary mitochondrial disease.”

13

Independent Data Monitoring Committee Recommends Continuation of ADAPT Phase 3 Clinical Trial of AGS-003 in Metastatic Renal Cell Carcinoma Following Interim Data Review

DURHAM, N.C., June 13, 2016 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of truly individualized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced that the independent data monitoring committee (IDMC) for the Company's pivotal Phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) has recommended the continuation of the trial based on results of the IDMC's scheduled interim data review. The next IDMC meeting is being planned to coincide with the Genitourinary Cancers Symposium in February 2017. "As the largest global Phase 3 trial ever performed in newly diagnosed, intermediate and poor risk mRCC patients, the ADAPT trial continues to progress," said Dr. Robert Figlin, the Steven Spielberg Family chair in hematology oncology, professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute and the co-principal investigator for the ADAPT trial. "With all the excitement regarding the clinical benefit of the emerging immuno-oncology therapies, a positive outcome of the ADAPT trial, because of AGS-003's novel mechanism of action, could be a game changer in the treatment of mRCC." AGS-003 is an individualized immunotherapy that captures both mutated and variant antigens that are unique to each patient's tumor, and, therefore, specifically designed to induce an immune response targeting that patient's particular tumor antigens. In an open-label Phase 2 trial, treatment with AGS-003 plus sunitinib resulted in median overall survival of more than 30 months in newly diagnosed, intermediate and poor risk mRCC patients. We have enrolled a total of 462 mRCC patients in our ongoing pivotal, randomized Phase 3 ADAPT trial evaluating AGS-003 in combination with standard targeted therapy, which has a primary endpoint of overall survival. AGS-003 is Argos' most advanced Arcelis®-based product candidate.

08

Are Shipping Containers the Future of Farming?

The startup Freight Farms is using repurposed freight containers and LED lights to grow acres’ worth of produce in a fraction of the space. Inside the cavernous interior of a former Boston-area taxi depot—walls covered in graffiti, pools of water on the concrete floors—three gleaming green-and-white containers sit side by side. The steel boxes are former “reefers”—refrigerated shipping containers used to transport cold goods. Bone-chilling rain is falling outside, but inside the 320-square-foot boxes, it’s a relatively balmy 63 degrees, and the humid air is heavy with the earthy smell of greens. Filling each box are 256 neat vertical towers of plants, bathed in a noonday-intense pink light. The crops being cultivated here—lettuce, herbs and other leafy greens—are not what we’ve come to expect from this kind of operation. But the company behind this agricultural innovation owes a large debt to America’s pot farmers. Freight Farms was founded in 2010, its existence predicated on a bet that LEDs would soon become efficient enough for farming as if the sun had disappeared—without breaking the bank. Co-founder Brad McNamara puts it this way: “Traditional research said, yeah, LEDs are good, but the more important research was that they were improving at a Moore’s-Law rate.” Moore’s Law, used to describe the exponential increase in computing power over the past 50 years, can be applied to LEDs thanks in part to the needs—and considerable resources—of marijuana growers. In addition to 128 LED strips, each “farm” has a water circulation system, 8 gallon-size tanks of liquid fertilizer and a propane tank for producing supplemental CO2—all running on as little as 10 gallons of water and 80 kWh of energy per day. Under the right conditions, a grower can go from seeds to sellable produce within six weeks. According to data pooled by the company, an average Freight Farms box can produce 48,568 marketable mini-heads of lettuce a year—the growing power of two acres of farmland. Freight Farms is part of a rapidly expanding field: Food and agricultural technology startups received $4.6 billion in investment in 2015, almost double the $2.36 billion that poured into the sector in 2014, according to a report from agriculture investment platform AgFunder. Companies like John Deere and Monsanto have long invested in new technology for conventional farming, but we’re now seeing a disruption of farming itself.

08

VOICEBOX LAUNCHES NEXTGEN VOICE AI FOR AUTO MAKERS

Fully Integrated Software Development Kit v5.0 Provides Platform for Superior In-Car Voice Systems Detroit, MI (June 8, 2016)__VoiceBox Technologies, the award-winning innovator of Contextual Natural Language Understanding (CNLU) and next gen Voice Artificial Intelligence (AI) announced the new VoiceBox Automotive Software Development Kit (v5.0), now available for Windows, Linux and Android platforms. With full integration of the VoiceBox Embedded Automatic Speech Recognition (ASR) engine and the company’s patented context management, VoiceBox continues to offer auto makers a single solution for powering the next generation of in-car voice systems. The company’s Automotive SDK is the first of its kind to offer Deep Neural Networks (DNN) which enables the processing of complex, contextual conversations. It is also the only Voice AI technology to include parallel hybrid processing with machine learning. This allows user queries to be simultaneously processed in both embedded and cloud systems to optimize the delivery of results. “The new VoiceBox Platform is a reflection of our technology’s continuous evolution, and features the natural and personal VoiceBox AI experience by leveraging DNN processing, machine learning, and patented hybrid architecture,” said Rich Kennewick, President and Cofounder of VoiceBox.

07

InCarda Therapeutics Elects Dr. Norbert Bischofberger to Board of Directors

San Francisco, California, June 7, 2016 – InCarda Therapeutics, Inc. (InCarda), a privately-held biopharmaceutical company focused on the development of therapies for cardiovascular conditions via the inhalation route, today announced the election of Norbert Bischofberger, Ph.D., to the company’s board of directors. Dr. Bischofberger has spent over 25 years at Gilead Sciences, where he currently serves as the company’s chief scientific officer and executive vice president of research and development. “Dr. Bischofberger has been a key driver of Gilead’s success, and we’re very pleased to have his unique acumen and insights advising InCarda on product and pipeline development,” said Grace E. Colon, Ph.D., President and Chief Executive Officer of InCarda Therapeutics. “We are deeply honored to have him join our Board and help guide InCarda as a developer of paradigm-shifting therapies for cardiovascular conditions.” “InCarda has an exciting therapy for atrial fibrillation and a novel approach that I believe has potential to significantly improve the treatment of acute cardiac conditions. I look forward to contributing to the development of important medications by this promising company,” stated Dr. Bischofberger.

06

NuCana’s Acelarin achieves high clinical activity and durable disease control in patients with recurrent ovarian cancer

Synergy with carboplatin and positive Phase 1b data presented at ASCO 2016 Chicago, IL, 6th June 2016: NuCana today presented positive interim results of a Phase 1b clinical study of Acelarin (NUC-1031) in combination with carboplatin in patients with late-stage recurrent ovarian cancer at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO). NuCana is a clinical stage biopharmaceutical company developing and commercializing a portfolio of novel anti-cancer medicines based on their proprietary ProTide technology. Acelarin is NuCana’s first ProTide to be advanced into the clinic and a range of new anti-cancer agents are being developed from this platform technology. ProTides represent a new class of medicines capable of bypassing specific drug resistance mechanisms and generating high intracellular levels of the anti-cancer agent in tumour cells. At ASCO today the Phase 1b study results were presented from the first 22 patients, of which 20 were evaluable. Significant clinical activity was achieved with an overall response rate of 30%, including 1 (5%) complete response, 5 (25%) partial responses and 13 (65%) with stable disease. The overall disease control rate was 95%, which was durable, with a progression free survival already at 6.6 months and ongoing. The Acelarin combination was well tolerated and no unexpected adverse events were reported.

06

Stealth BioTherapeutics Reports Positive Results for Primary Mitochondrial Myopathy Trial

Trial evaluating treatment with elamipretide in rare disease meets efficacy and safety endpoints Data to be presented at Mitochondrial Medicine 2016 on Friday, June 17 at 8:10 a.m. PT BOSTON – June 6, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced positive results from MMPOWER, a Phase 2 trial evaluating the systemic delivery of elamipretide for the treatment of primary mitochondrial myopathy, or muscle weakness, in patients with a genetically confirmed mitochondrial disease. Data from the MMPOWER trial will be presented at , the United Mitochondrial Disease Foundation (UMDF) symposium, on Friday, June 17 at 8:10 a.m. PT.

04

Aduro Biotech Presents Encouraging Anti-Tumor Response Data From Ongoing Phase 1b Study in Malignant Pleural Mesothelioma at ASCO

BERKELEY, Calif., June 04, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced the presentation of updated data from an ongoing Phase 1b clinical trial of its immunotherapy product candidate CRS-207 in combination with pemetrexed and cisplatin (standard of care chemotherapy) as front-line treatment for patients with unresectable malignant pleural mesothelioma (MPM). The results from the first of two cohorts were presented today in a poster presentation at the 2016 American Society of Clinical Oncology Meeting (ASCO) held in Chicago. Of the 36 evaluable patients, disease control was observed in 94% (34/36), including 3% (1/36) with a complete response, 56% (20/36) with partial responses and 36% (13/36) experiencing stable disease following treatment with CRS-207 and chemotherapy. Prior to receiving chemotherapy, 31% (11/36) of patients experienced some tumor shrinkage (range: -1% to -43%) after receiving CRS-207 alone. The estimated median overall survival was 16.4 months (95% CI: 11.0 – 20.6 months). CRS-207 was generally well-tolerated with no treatment-related serious adverse events or cumulative toxicities when administered with chemotherapy. "The observed responses with the combination of CRS-207 and standard chemotherapy are unprecedented in mesothelioma," said Dean Fennell, Ph.D., F.R.C.P., professor of Thoracic Medical Oncology at the University of Leicester and president of the International Mesothelioma Interest Group (iMig). "Pleural mesothelioma is a devastating disease, and these data suggest that immunotherapy has the potential to advance treatment options for these patients." Dirk G. Brockstedt, Ph.D., executive vice president of Research and Development at Aduro added, "These results demonstrate that CRS-207 induces anti-tumor activity in patients with malignant pleural mesothelioma. We are looking forward to the results from the study’s second cohort, which is evaluating the addition of immune modulating doses of cyclophosphamide to the CRS-207 chemotherapy combination. Preclinical data suggest that the simultaneous inhibition of regulatory T-cells through the addition of a checkpoint inhibitor may amplify the tumor response and overall survival seen with CRS-207. As such, the combination of CRS-207 with a checkpoint inhibitor could be the regimen we advance in our mesothelioma program going forward.”

01

Stealth BioTherapeutics Initiates Phase 2 Study of Elamipretide in Leber’s Hereditary Optic Neuropathy

Trial augments ongoing clinical development program for rare genetic mitochondrial diseases BOSTON – June 01, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs for treating mitochondrial dysfunction, today announced the initiation of ReSIGHT, a phase 2 clinical study evaluating the topical eye drop delivery of elamipretide (formerly known as Ocuvia) for the treatment of patients with Leber’s Hereditary Optic Neuropathy (LHON). Affecting approximately 35,000 people worldwide, LHON is an inherited mitochondrial disease that causes central vision loss stemming from the damage to retinal ganglion cells due to dysfunction of energy-producing complexes in the mitochondria. The disease, which can lead to legal blindness, affects more men than women and often strikes patients in their late teens and early 20s. “Elamipretide offers hope for patients suffering from this rare ophthalmic disease, for which there is no FDA-approved treatment. The loss of vision can be sudden and devastating, often occurring in both eyes within a few weeks’ time. Unfortunately, the resulting vision loss is usually permanent, underscoring the desperate need for effective treatment options,” said Alfredo Sadun, M.D., Ph.D., UCLA Doheny Eye Institute, the primary investigator for the study.

May 2016

19

Edyn debuts smart water valve to put home gardens on autopilot

Oakland, Calif.-based Edyn started selling a new, smart gardening device this week: an Internet-connected water valve that lets users irrigate their gardens or lawns automatically. The Edyn Water Valve uses data from the company’s Edyn Garden Sensor, a soil sensor, along with local weather systems, to adjust the moisture levels in the soil. If a user wants, they can adjust their irrigation systems via the Edyn smartphone app. Sold for $69, the Edyn Water Valve weighs less than eight ounces, is solar-powered, Wi-Fi-enabled and fits a standard garden hose. The Edyn system was designed to be small enough for use with a hose that’s connected to a kitchen sink, and a window box garden if desired.

12

Aduro Biotech Announces First Patient Dosed in Phase 1 Study of ADU-S100 for the Treatment of Cutaneously Accessible Tumors

BERKELEY, Calif., May 12, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that the first patient has been dosed in a Phase 1 trial for ADU-S100 (also known as MIW815), a novel STING (Stimulator of Interferon Genes) pathway activator. Activation of the STING pathway in tumors has been shown to be a critical step to initiate an innate response that may lead to a systemic adaptive tumor-specific immune response. Novartis, Aduro’s collaborator for STING pathway activator compounds in the field of oncology, is conducting the study. The achievement of this milestone triggers a $35 million milestone payment from Novartis to Aduro. “We are thrilled to embark on this landmark Phase 1 study, which we believe is the first clinical trial to specifically target the STING pathway. ADU-S100 (MIW815) has the potential to induce an anti-tumor immune response that is unique to the treated individual, an approach that potentially offers the benefits of a personalized therapy but using an off-the-shelf small molecule,” said Thomas Dubensky, Jr., Ph.D., chief scientific officer of Aduro. “ADU-S100 is the first compound to enter the clinic under our collaboration with Novartis, and through this Phase 1 study, we look forward to gaining insight into the safety, tolerability and initial efficacy for several different types of cancer. We have now advanced two differentiated immuno-oncology platforms into the clinic: ADU-S100, with the start of this trial, and our LADD listeria-based immunotherapy strains in clinical studies in multiple indications, including pancreatic, ovarian, lung and prostate cancers, mesothelioma and glioblastoma.”

03

Envisia Therapeutics Announces Positive Three-Month Interim Results of Low Dose ENV515 in Patients with Glaucoma

RESEARCH TRIANGLE PARK, NC – May 3, 2016 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today reported positive results from an interim three-month analysis of an ongoing 12-month safety and efficacy evaluation of the low dosage form of ENV515 XR (travoprost). ENV515, the Company’s lead product candidate, is an extended-release formulation of travoprost that could offer sustained reduction in intraocular pressure (IOP) for more than six months after a single dose. “We are excited to report positive results for the low dosage form of ENV515, which demonstrated a favorable safety profile and a sustained, clinically meaningful reduction in IOP over the entire three months,” said Benjamin Yerxa, President of Envisia. “These results enable us to move forward with the dose escalation study later this year, evaluating the high dosage form of ENV515 that has been formulated with the goal of achieving efficacy comparable to TRAVATAN Z with a duration greater than six months.” Previously, a 28-day evaluation of the low dosage form of ENV515 demonstrated a reduction in IOP comparable to topical timolol, while the high dosage form of ENV515 demonstrated results comparable to topical once-daily TRAVATAN Z® (travoprost ophthalmic solution). This second cohort of the ongoing phase 2 trial was a 12-month safety and efficacy evaluation of the low dosage form of ENV515 that was designed as an open-label trial that enrolled five glaucoma patients at sites within the U.S. The low dosage form of ENV515, administered once on Day 1, achieved the interim efficacy endpoint in this 3-month analysis, time-matched 8 AM IOP over the three-month post-dose period, with -7.1 mmHg or -27% change from IOP baseline that was comparable to topical timolol 0.5% twice daily with -7.4 mmHg or -28% change from IOP baseline, administered to the non-study eye. ENV515 was well tolerated and there were no serious adverse events, no changes in corneal endothelial cell counts evaluated by an independent reading center, and no changes in corneal thickness. The most common adverse event was early-onset transient hyperemia,oreye redness,related to the dosing procedure. “Envisia’s extended delivery approach, leading to sustained IOP control without any loss of efficacy over time, may dramatically change the way we treat glaucoma in the majority of our patients,” said Dr. Thomas Walters, MD, the lead investigator for cohort 2 of the ENV515 phase 2 trial. “The current results position Envisia as one of the leaders in the field of ophthalmology.”

03

BioScale Announces Company Name Change to ProterixBio and New Focus on Pulmonary Diagnostics and Disease Management

Billerica, MA, May 3, 2016 – BioScale, Inc. today announced that the company is changing its name to ProterixBio, Inc. The name change reflects a new strategic direction centered on high value clinical applications including diagnostics products and disease management services. ProterixBio is developing innovative products to transform the management of chronic diseases, with the initial applications focusing on pulmonary diseases such as chronic obstructive pulmonary disease (COPD), cystic fibrosis and idiopathic pulmonary fibrosis (IPF).

April 2016

28

Aduro Biotech Announces Key Preclinical Data Published Highlighting New Approach to Treat Multiple Myeloma

Studies Demonstrated that BION-1301 anti-APRIL Monoclonal Antibody Blocks Multiple Myeloma Cell Proliferation, Drug Resistance and Immunosuppression in the Tumor Microenvironment BERKELEY, Calif., April 28, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced the publication of a pivotal paper elucidating the roles of B cell maturation antigen (BCMA) and its ligand A PRoliferation-Inducing Ligand (APRIL) in multiple myeloma, highlighting the potential of its proprietary monoclonal antibody (mAb) BION-1301 targeting APRIL. The authors demonstrated through in vivo and in vitro preclinical studies that the APRIL/BCMA ligand/receptor pair drives multiple myeloma tumor growth and survival, and activates immunosuppressive mechanisms that allow the tumor to thrive. Importantly, the studies demonstrated that BION-1301 halts tumor growth and overcomes drug resistance to chemotherapeutic agents lenalidomide and bortezomib in preclinical models. The study, entitled “APRIL and BCMA promote human multiple myeloma growth, chemoresistance, and immunosuppression in the bone marrow microenvironment,” was published by Kenneth Anderson, M.D. Ph.D., and Yu-Tzu Tai, Ph.D. of the Dana-Farber Cancer Institute. The article appears online ahead of print in the peer-reviewed journal Blood. “For the first time, we have identified several different molecular mechanisms by which APRIL activates BCMA to promote multiple myeloma progression in vivo,” said Dr. Anderson, program director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics at Dana-Farber and Kraft Family Professor of Medicine at Harvard Medical School. “Understanding the mechanism of tumor progression and resistance allowed us to test a novel approach to potentially combat disease advancement by using an anti-APRIL antibody. BION-1301 blocks the APRIL-induced signal cascade at a critical juncture, and represents a new potential mechanism to both achieve disease response and restore immune function, even in patients with myeloma resistant to current therapies.”

20

Genocea Congratulates Dr. George Siber, 2016 Albert B. Sabin Gold Medal Award Recipient

CAMBRIDGE, Mass., April 20, 2016 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, is delighted to congratulate Dr. George R. Siber, board member and chair of Genocea's scientific advisory boards, on being awarded the 2016 Albert B. Sabin Gold Medal Award by the Sabin Vaccine Institute. The award recognizes his research contributions in the development of innovative vaccines, including the first pneumococcal conjugate vaccine, the first meningococcal conjugate vaccine and the first antibody for the prevention of RSV infections. He was also involved in development of the first rotavirus vaccine and live attenuated influenza vaccine. This prestigious honor — the highest scientific honor granted by the Sabin Vaccine Institute and one of the most important in the field of vaccinology — is awarded annually to a distinguished member of the public health community who has pioneered work in vaccinology or a complementary field. "We have been fortunate over the years to benefit from George's leadership and expertise, and congratulate him on this very well deserved honor," commented Chip Clark, president and chief executive officer of Genocea. "The impact on humanity of the vaccines he has helped to develop has been profound and his contributions to the scientific community and to the body of knowledge about vaccine development will continue to have a positive impact on the lives of millions of patients."

18

InSilixa Developing Drug-Resistance TB Test Showcasing Potential for Hundreds of Targets

Apr 18, 2016 | Madeleine Johnson -- The TB test is intended to showcase the firm’s core technology, which can perform highly multiplexed nucleic acid amplification and analysis of hundreds of targets simultaneously. InSilixa received a two-year, $1.5 million Phase II Small Business Innovation and Research grant from the National Human Genome Research Institute in 2013. The company also received $224,764 in funding from the National Institutes of Health last month to develop a point-of-care test for cancer-causing strains of human papillomavirus. In addition to a total of about $3 million in NIH funding overall, InSilixa has won $1.4 million in early seed funding and completed a $13 million Series A financing round in 2014. The firm is now seeking $35 million in Series B funding. InSilixa CEO Arjang Hassibi told GenomeWeb in an interview that the general area of focus for the firm’s technology is infectious diseases. Specifically, the firm is exploring “applications in which you require an actionable test in a quick amount of time … a complex test looking at drug resistivity with different strains, where the level of multiplexing is beyond simple PCR platforms that are out there.” The InSilixa technology uses semi-conductor-based chips for solid-phase array-based detection as the amplification is happening. It’s not a microarray, but it overcomes a bottleneck other technologies encounter with the detection step of NAAT testing, Hassibi said. “The problem of multiplex PCR has been you can always increase the level of multiplexing — the record for sequencing is up to a few thousand — so, you can create multiple amplifications, but the challenge is detecting them in parallel,” he said. By using optical methods, with different colors and channels for detection, other technologies can multiplex to a certain level. But, Hassibi said, commercial multiplex panels often divide samples and do multiple reactions to get the required number of targets. InSilixa’s method instead uses multiplex PCR to amplify all the regions in which mutations exist in one reaction chamber, and then it uses a CMOS, or complementary metal-oxide semiconductor, chip to capture and detect during the reaction, and perform a melt curve analysis in parallel. The melt curve component is able to distinguish single-base pair changes and provides “the sensitivity of sequencing,” Hassibi said. The firm’s first chip, the Hydra 1K, can examine 1,024 mutations in parallel, and the company envisions this technology will be unique in the white space between sequencing and individual PCR tests or small multiplex PCR panels.

07

Green Biologics Selects Nexeo Solutions as its U.S. Distribution Partner

Logistics and Distribution Key Focus of Renewables Collaboration Ashland, Virginia and Abingdon, Oxfordshire U.K. (April 7, 2016) – Green Biologics, Inc., the U.S. subsidiary of Green Biologics Ltd., a U.K. industrial biotechnology and renewable chemicals company, announced today a distribution agreement with Nexeo Solutions, a Texas (U.S.) based global distribution company. Nexeo Solutions will become Green Biologics’ national distributor of renewable n-butanol and acetone to U.S. customers in a number of key markets including CASE (coatings, adhesives, sealants and elastomers), HI&I (household, industrial & institutional cleaners), PCI (personal care intermediates) and energy chemicals. “Nexeo Solutions is a superb partner for Green Biologics,” said Timothy G. Staub, Global Vice President of Business Development for Green Biologics. “With decades of distribution experience, particularly in high value solvents, Nexeo Solutions brings a unique combination of logistical capabilities and market knowledge along with a critical presence both in key markets and geographies important to our customers.” Green Biologics is currently constructing its first commercial production facility for renewable n-butanol and acetone in Little Falls, Minn., and aims to start up the plant in late 2016 with shipments to customers by Q4. Green Biologics is a new member of the American Chemistry Council (ACC) and is building its new green solvents facility to meet Responsible Care™ standards.

05

InCarda Therapeutics Appoints Dr. Luiz Belardinelli as Chief Medical Officer

San Francisco, California, April 5, 2016 – InCarda Therapeutics, Inc. (InCarda), a privately-held biopharmaceutical company focused on the development of therapies for cardiovascular conditions via the inhalation route, today announced that the company has appointed Luiz Belardinelli, M.D., to the position of Chief Medical Officer. Dr. Belardinelli joins InCarda for this position half-time and plans to also continue in his role at Gilead Sciences where he serves as a Senior Advisor for the Cardiovascular Therapeutic Area of Gilead. Previously Luiz was Senior Vice President for Cardiovascular Therapeutics for Gilead. He brings highly relevant cardiovascular experience having been a major contributor to the discovery and development of three cardiovascular products, Adenocard, Lexiscan and Ranexa. “We are thrilled to have Dr. Belardinelli join our team. As a recognized global expert in cardiac arrhythmias (such as atrial fibrillation) we will benefit from his preclinical and clinical knowledge and regulatory experience—both in the U.S. and abroad—as well as his vast network of colleagues in this space,” stated Grace E. Colon, Ph.D., President and Chief Executive Officer of InCarda. “Dr. Belardinelli joins us at an important time, as we are on track to initiate a Phase 1 clinical trial in Q2 of this year to evaluate our inhaled formulation of flecainide for treatment of patients with recent onset paroxysmal atrial fibrillation.”

03

Stealth BioTherapeutics announces presentation of elamipretide data at ACC. Trial results support further study of elamipretide in heart failure.

BOSTON – April 3, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs for treating mitochondrial dysfunction, announced promising results from the Phase 1 PREVIEW trial evaluating elamipretide (formerly known as Bendavia) in heart failure patients with reduced ejection fraction. The results showed elamipretide to be safe and well tolerated with demonstrated improvements in key secondary efficacy measures. The data were presented today at the American College of Cardiology’s 65th Annual Scientific Session (ACC.16) in Chicago during the Novel Therapies in Heart Failure moderated poster session, South Hall A1, from 12:30-1:45 PM CT. Heart failure affects approximately six million people in the U.S. and continues to be the leading cause of hospitalization, despite available therapies. “The heart requires a significant amount of energy to both contract and relax, and targeting the mitochondrial dysfunction affecting the heart’s energy supply in this population is a new approach to treating the disease,” said Melissa Daubert, M.D., Duke University Health System and the trial’s primary investigator for echocardiography. “Based on the improvement in heart function seen after just one high-dose treatment, we are very excited to explore the benefits of elamipretide after repeated dosing.”

March 2016

31

Genital Herpes Immunotherapy GEN-003 Shows Sustained Reduction of Viral Shedding Rate, Durable Impact on Clinical Disease 12 Months Post-Dosing

CAMBRIDGE, Mass., March 31, 2016 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive 12 month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. GEN-003 demonstrated sustained and statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing across multiple dose groups as well as sustained efficacy at multiple dose levels across secondary endpoints measuring the impact on clinical disease. GEN-003 was safe and well tolerated by patients, with no serious adverse events related to the vaccine in the trial. "We are very pleased with these data, which show that GEN-003 has strong and durable effects on both HSV-2 viral activity and genital herpes clinical disease, supporting our belief that GEN-003 could become a cornerstone treatment for patients affected by this serious disease. Specifically, a single course of treatment of GEN-003 may offer benefits similar to a full year of daily administration of oral antivirals - but with greatly improved convenience," said Chip Clark, president and chief executive officer of Genocea. "We anticipate reporting virologic efficacy data for GEN-003 from our recently-initiated Phase 2b study in the third quarter of 2016, clinical efficacy data at 6 months post dosing around the end of 2016 and conducting our end of Phase 2 meeting with the FDA in the first quarter of 2017." "These 12 month data highlight the potential of GEN-003 to significantly enhance the genital herpes treatment landscape," said Lori A. Panther, M.D., MPH, infectious diseases specialist at Beth Israel Deaconess Medical Center and Assistant Professor of Medicine at Harvard Medical School. "Because of the physical and psychological impact of this disease, both patients and treating physicians would be eager to use an effective treatment that more conveniently improves control of outbreaks. The reduction in viral shedding, which is thought to cause the epidemic spread of genital herpes, is also encouraging."

29

VoiceBox Launches New Offering To Enable In-Car Digital Assistants

Mar 29, 2016 - New Technology for Automobile Manufacturers Simplifies Development of Superior In-Car Voice Systems VoiceBox Technologies, a global provider of contextual voice and natural language understanding (NLU) technologies for automotive, mobile and IoT products, today announced the availability of the company’s new Embedded Automatic Speech Recognition (ASR) product for automotive applications. Integrated with the company’s award-winning NLU technology, VoiceBox’s Embedded ASR now offers auto makers a single solution for powering the next generation of in-car voice systems. “In-car systems have long been held back by their lack of available alternatives in ASR software,” said Tom Freeman, SVP of Kymeta Corporation which was recently showcased at the North American International Auto Show. “By providing their DNN enhanced ASR together with their superior NLU, VoiceBox now offers Automotive companies the opportunity to advance their in-car solutions to better meet the voice experience consumers want.” Designed to convert speech into text, which is then processed through NLU, VoiceBox’s Embedded ASR supports more than 20 languages. The company’s Embedded ASR solution is the first of its kind to offer Deep Neural Networks (DNN) which enable the processing of complex, contextual conversations. It is also the only ASR technology to include parallel hybrid processing with machine learning. This allows user queries to be simultaneously processed in both embedded and cloud systems to optimize the delivery of results. VoiceBox’s Embedded ASR technology is available now for use in automotive information and entertainment units and is also used in VoiceBox mobile and IoT solutions.

28

Aduro Biotech and UC Berkeley Launch Industry-Leading Immunotherapeutics and Vaccine Research Initiative

BERKELEY, Calif., March 28, 2016 (GLOBE NEWSWIRE) -- The University of California (UC) Berkeley, in collaboration with Aduro Biotech, Inc. (Nasdaq:ADRO), today launched an innovative Immunotherapeutics and Vaccine Research Initiative (IVRI). IVRI is UC Berkeley’s first-ever immunotherapy-focused initiative and, in partnership with Aduro, will combine UC Berkeley’s extensive research capabilities with the company’s expertise in immunotherapy discovery and development to identify and advance new treatment options and preventive modalities for cancer, infectious disease and autoimmune disease. IVRI is designed to explore the unique synergy between cancer and infectious disease research and to accelerate breakthrough discoveries in both areas. IVRI researchers are working closely with collaborators and sponsors with the shared goal of discovering and advancing immunotherapeutics and vaccine strategies. “In the last several years, we have learned so much about the role of the immune system in treating disease, and we look forward to harnessing that information across both research and industry to develop innovative new treatment options to improve patient care,” said David Raulet, Faculty Director of the IVRI and a Professor of Immunology and Pathogenesis at University of California, Berkeley. “Through this initiative, we will leverage our powerful research networks to understand how we can better engage the immune system in treating cancer, infectious disease and autoimmune disease. By doing this, we hope to develop new methods for targeting and effectively controlling many different cancers, autoimmune and infectious diseases. Our goal is for these findings to pave the way for the development of innovative new treatment options.”

24

Aduro Biotech Announces First Patient Dosed in Combination Clinical Trial of CRS-207 and Epacadostat to Treat Ovarian Cancer

BERKELEY, Calif., March 24, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that the first patient has been dosed in SEASCAPE, the Phase 1/2 clinical study designed to evaluate the safety, tolerability and preliminary efficacy of CRS-207, Aduro’s lead listeria-based immunotherapy construct (LADD), in combination with epacadostat (INCB24360), Incyte Corporation’s (Nasdaq:INCY) selective IDO1 inhibitor, in patients with ovarian cancer. “By combining two immuno-oncology therapies which we believe have synergistic mechanisms of action, we andIncyte look forward to potentially advancing new treatment options for patients with ovarian cancer that could result in more effective therapy than either therapy alone,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “Combination therapy is rapidly emerging as a new paradigm for immuno-oncology. With our three diverse technology platforms – LADD (listeria-based therapy), STING pathway activators and monoclonal antibodies – we intend to continue to identify new opportunities to improve patient care.” SEASCAPE (Study of Epacadostat and CRS-207 in Adults with Platinum Resistant Ovarian Cancer), co-funded byIncyte and Aduro, is designed to establish a recommended dose based on safety and tumor biomarkers for CRS-207 and epacadostat in Phase 1 followed by expansion into Phase 2 which will evaluate the combination at the recommended (or identified) dose level compared to CRS-207 alone. Aduro plans to enroll up to 40 patients in Phase 1 and up to 86 patients in Phase 2 with platinum-resistant ovarian, fallopian or peritoneal cancers. For more information about the study, visit www.clinicaltrials.gov and search identifier NCT02575807.

23

Argos Therapeutics Announces Initiation of a Phase 2 Clinical Trial of AGS-003 for the Treatment of Non-small Cell Lung Cancer in Combination with Standard-of-Care Chemotherapy

DURHAM, N.C., March 23, 2016 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of truly individualized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced the initiation of an investigator-sponsored Phase 2 clinical trial ofAGS-003 in combination with standard platinum-doublet chemotherapy with or without radiation in patients with newly diagnosed Stage 3 non-small cell lung cancer (NSCLC). The study is being conducted at the Cancer Research Network of Nebraska (CRNN) and is expected to enroll 20 patients. AGS-003 will be administered either concurrently with chemotherapy and with or without radiation or sequentially with chemotherapy and with or without radiation, according to the subject's assigned treatment arm. "The standard of treatment of NSCLC has been chemotherapy after surgery, but now we can offer this exciting new option of individualized immunotherapy," said Dr. Stephen Lemon, co-principal investigator and president of Oncology Associates, Omaha, Nebraska, a CRNN collaborating practice. "We are thrilled to participate in this exciting study and are hopeful that AGS-003will be safe and effective, and help our patients fight this terrible disease."

23

ENVISIA THERAPEUTICS SECURES $16.5 MILLION IN ADDITIONAL SERIES A FINANCING

RESEARCH TRIANGLE PARK, NC – March 23, 2016 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today announced a $16.5 million investment from existing investors to support the accelerated development of the Company’s pipeline of innovative extended-release ocular therapies for the three leading causes of preventable vision loss and blindness. “We are very pleased with the rapid progress we have made in the development of a portfolio of promising therapeutics and grateful for the continued support of our investors,” said Benjamin Yerxa, President. “This financing will be used to continue the clinical evaluation of our lead product, ENV515 for glaucoma, through phase 2 studies and to advance two other products in our pipeline through key data milestones.” Envisia is focused on the development of novel ocular therapeutics, with current programs in glaucoma, diabetic macular edema (DME) and age-related macular degeneration (AMD).

23

VoiceBox Announces Scientific Advisory Board

Mar 23, 2016 - Distinguished Researchers Bring Expertise and Strategic Guidance to Help Advance VoiceBox’s Technology Development VoiceBox Technologies, a global provider of contextual voice technologies and natural language understanding (NLU) for automotive, mobile and IoT products, today announced the formation of a Scientific Advisory Board. The diverse, world-class roster represents VoiceBox’s continued investment in its broader strategy to become a unifying interface for the Internet of Things. Board members include distinguished researchers in the fields of Artificial Intelligence (AI), multimodal human-computer interaction, biometrics, speech recognition, natural language understanding and dialog processing technologies. “Our vision of a common, intelligent interface – multi-device, cross-device and multi-user – integrates exciting new technologies to supplement our comprehensive, advantaged voice offerings,” said Mike Kennewick, VoiceBox’s CEO. “By integrating world-renowned talent regardless of location, we are able to build a team the expertise of which rivals the largest companies in our industry.”

16

ARCHITIZER A+ POPULAR CHOICE AWARDS AND PUBLIC VOTING

The IrisVR Mobile App has been selected as a Finalist in the Architizer A+ Awards for the Technology: Apps category. We're thrilled to be in the running. Help us win by voting here. Not to be outdone, the IrisVR Prospect Desktop App has been selected as a Special Mention for the Technology: Apps category. Out of thousands of submissions, it scored in the top 15% of entrants to achieve this special honor.

11

HD Biosciences Received Numerous "Vendor Appreciation and Special Contribution" Awards from Its Partners and Clients for the Impacts to Their Drug Discovery Portfolio Development

Shanghai, China – March 11, 2016 - HD Biosciences Co., Ltd. (HDB), a leading biology-focused preclinical Contract Research Organization (CRO), discloses today that, for the past three months, several project teams, business managers and a few dozens of scientists have received various awards from HDB’s partners and clients to recognize exceptional performance and valuable deliveries on collaboration. "Various awards and appreciations presented from our partners are strong demonstration of our high quality services and commitments of our staff to the jobs that they are associated with. These are also indications that the company business strategy to focus on value impacts of our services to clients' portfolio being paid off." Dr. Xuehai Tan, President & CEO of HDB commented in his remark. "We will continue to firmly stick to our core competences and invest on our teams to build a special global CRO, with which, partners and clients can develop their expectations." The awards from clients mainly cover the areas including plate-based pharmacology, target validation, anti-infectious disease, preclinical candidate (PCC) development, safety profiling, and project management, logistics supports etc.

09

InSilixa Inc. and DNA Software Inc. enter into agreement to develop state-of-the-art high-multiplex infectious disease panels for commercialization on InSilixa’s CMOS biochip platform

Sunnyvale, CA – March 9th, 2016. InSilixa Inc., the pioneer in the use of CMOS biochip technology for molecular diagnostics (MDx) and DNA Software Inc., a leader in DNA diagnostic design and analysis solutions, announces a joint agreement to develop Infectious disease assays specifically for InSilixa’s sample-to-answer CMOS biochip platform. InSilixa’s proprietary sample-to-answer CMOS biochip technology enables rapid detection, quantification, and genotyping of pathogens (viruses and bacteria) in clinical samples and the simultaneous identification of their drug resistance profiles using a highly-multiplexed targeted mutation detection technique. The first generation of InSilixa’s products will focus on infectious diseases MDx applications in near-patient and point-of-care (POC) settings, including the comprehensive analysis of seasonal respiratory infection outbreaks, rapid detection of MDR bacteria (“super bugs”) in urgent care settings and the detection, quantification and comprehensive drug resistance genotyping of the human immunodeficiency virus (HIV) in blood samples from patients with HIV/AIDS. The multiplexed PCR designs provided by DNAS Software will leverage their algorithms for signature sequence identification, ThermoBLASTTM for scanning oligonucleotides against collections of genomic sequences, and their PCR design software. “We are very excited to work with Dr. SantaLucia and his industry leading team at DNA Software to realize the full potential of our unique platform” said Dr. Arjang Hassibi, CEO of InSilixa Inc. “The agreement between InSIlixa and DNAS is a tremendous complement of technologies that will result in multiplexed detection of a wide variety of pathogens with outstanding sensitivity and specificity” said Dr. John SantaLucia, CEO of DNA Software, Inc.

08

Stealth BioTherapeutics Initiates Phase 2 Clinical Study of Elamipretide in Fuchs’ Corneal Endothelial Dystrophy

BOSTON – March 8, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing drug candidates for treating mitochondrial dysfunction, today announced the initiation of ReVEAL, a Phase 2 clinical study evaluating the topical eye drop formulation of elamipretide (formerly known as Ocuvia) for the treatment of patients with Fuchs’ corneal endothelial dystrophy (FCED). Top-line data from the study are expected in the third quarter of 2016. Fuchs’ is a late-onset, progressive disease of the cornea characterized by a reduction of endothelial cells, and can lead to edema or even blindness in more advanced cases. Elamipretide targets the inner mitochondrial membrane to help preserve mitochondrial energetics, loss of which is thought to lead to the onset of Fuchs’. “Many severe ocular diseases, including Fuchs’, are linked to dysfunctional mitochondria and are characterized by a state of increased oxidative stress and impaired energetic components of the eye. We are aiming to safely restore these energetics and to show a clinical benefit with elamipretide in visual acuity and other functional measures,” Stealth BioTherapeutics Chief Scientific Officer Mark Bamberger said. “This new trial furthers our ongoing commitment to uncovering the role mitochondrial dysfunction plays in ocular disorders, and how we might address unmet needs across several indications where impaired energetics are a final common pathway.”

01

HumanZyme Launches New XKine™ Recombinant Protein Line For Stem Cell Research and Regenerative Medicine Applications

March 1, 2016 -- HumanZyme Inc., a leading supplier of novel human proteins and growth factors to academic and biopharmaceutical customers enabling stem cell research and regenerative therapy applications, launched the new XKine™ product line broadening the company’s product offering. The new XKine™ human recombinant proteins are manufactured utilizing EColi or Chinese Hamster Ovary (CHO) host cell lines, expanding the number of research applications supported by HumanZyme. “The new XKine products are priced competitively selected carefully to support current pathway analysis, allowing our customers to purchase these products from HumanZyme, without the need to go to a 3rd party supplier as previously required, ” said Scott Coleridge, CEO at HumanZyme. The new XKine recombinant human protein line includes IL-11, IL-15, IL-34, IL35, IL5, IL8(CxXL8), LIF, Neurturin, PDGF-BB, Rantes(CCL5) sCD40 ligand, sTrail/apo2L, BDNF, CTGF, EGF and FGF-acidic etc. We will keep adding more recombinant proteins and cytokines to this growing product line.

February 2016

22

VoiceBox and Samsung announce partnership for S Voice technology

February 22, 2016 - Language technology startup VoiceBox announced a partnership with Samsung to use VoiceBox’s Natural Language Understanding (NLU) technology for Samsung’s S Voice services, including Samsung’s intelligent personal assistant. Currently, S Voice can assist Samsung mobile users with placing calls, sending texts, making appointments, updating social network websites, opening apps, and navigation. It also offers automatic activation features — for example, starting your car engine from outside the car — and can respond to questions. The new deal with Bellevue, Wash.-based VoiceBox is aimed at helping S Voice keep up with artificial intelligence competitors, like Apple’s Siri, Microsoft’s Cortana, and Amazon’s Alexa.

18

VoiceBox Technologies’ Solutions to be Leveraged Across Samsung’s Mobile Devices

BELLEVUE, USA – February 18, 2016 –VoiceBox Technologies Corporation today announced a strategic partnership with Samsung to use VoiceBox’s Natural Language Understanding (NLU) technology for Samsung’s voice services. The companies have been working closely together to build an intelligent assistant powered by VoiceBox’s NLU technology. “We are proud to have been selected to power the voice services on a range of existing and new Samsung mobile devices,” said Mike Kennewick, CEO of VoiceBox. “We look forward to collaborating on other opportunities with Samsung, particularly relative to our Smart Home and Internet of Things initiatives.” “Samsung understands that voice is a critical technology for its future. We are pleased to partner with VoiceBox and this collaboration will enable us to provide users with a powerful voice experience,” said Peter Koo, Senior Vice President Samsung Mobile.

18

Idibon AI processes world-scale text data … on a single computer!

Idibon News / Rob Munro/Thursday, February 18th, 2016 Idibon is announcing the launch of a new Machine Learning library, IdiML, for ultra-low latency text analytics at scale. Artificial Intelligence has become common in business, especially in big data processing. For most companies, it has simply been impossible to process the amount of data produced by large scale text processes like social media services, or to apply fast machine learning for real-time human interaction. We are aiming to solve this for everyone. IdiML is so fast, you can process the entire Twitter Firehose in real-time on the CPU of a single laptop, still leaving half the CPU capacity free! The breakthrough comes from intelligent in-memory processing that allows the information to be extracted without expensive database or file lookups. IdiML intelligently pre-compiles information from deep-learning, feature extraction, and client-defined semantic libraries, making the knowledge highly available through compression and in-memory data structures. At the point of processing, this allows a minimum number of passes to be made over the text, with our artificial intelligence extracting information continuously over the stream of data at breakneck speeds.

12

Apellis Completes $47 Million Series D Financing

LOUISVILLE, Ky., Feb. 12, 2016 /PRNewswire/ -- Apellis Pharmaceuticals, Inc., today announced that it has completed a $47.1 million Series D preferred stock financing, co-led by new investors Cormorant Asset Management, Hillhouse Capital Group and venBio Global Strategic Fund, joining existing investors Morningside Venture Investments, AJU IB Investment, and Epidarex Capital. The proceeds of the financing will be used to further advance clinical trials in the Company's ongoing complement immunotherapy programs, including paroxysmal nocturnal hemoglobinuria (PNH) and geographic atrophy (GA), an advanced form of dry type age-related macular degeneration (AMD), as well as chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF). "Our unique approach to broadly inhibit complement C3, the central protein in the complement cascade, is designed to significantly transform the treatments of patients with autoimmune and inflammatory diseases," commented Cedric Francois, M.D., Ph.D., founder and Chief Executive Officer of Apellis. "This financing allows us to advance our broad pipeline, resulting in up to three clinical programs by the end of 2016. We are excited to welcome three new investors to the Apellis team," he added. Robert Adelman, M.D., of venBio and Bihua Chen of Cormorant joined the Board of Directors.

09

DNAtrix's Oncolytic Immunotherapy, DNX-2401, Awarded EU Orphan Medicine Designation for Treating Malignant Brain Tumors

HOUSTON, Feb. 9, 2016 /PRNewswire/ -- DNAtrix, a clinical stage, biotechnology company developing virus-driven immunotherapies for cancer, announced that its lead product, DNX-2401, has been designated by the European Commission as an orphan medicinal product for the treatment of glioma. Glioblastoma, the deadliest form of glioma, strikes approximately 25,000 people a year in the US and EU. Sponsors who obtain orphan designation benefit from a number of incentives, including protocol assistance, scientific advice specific for designated orphan medicines, and market exclusivity once the medicine is on the market. "We are pleased that the European Commission has recognized the potential benefits of our immunotherapy product for the treatment of brain tumors," said Frank Tufaro, Ph.D., CEO of DNAtrix, "We plan to continue our aggressive development program in the EU."

03

ENYO Pharma announces closing of a €22 million funding round

Lyon, 3 February 2016. ENYO Pharma, a biopharmaceutical company focused on developing treatments for acute and chronic viral infections, today announced that it has secured a €22 million Series A financing round. The investment is intended to help the company roll out its clinical hepatitis-B programme more quickly. The deal was led by Sofinnova Partners, alongside Morningside and Bpifrance via its fund InnoBio, and should enable ENYO Pharma to conduct Phase I trials in the first half of 2016, and phase II trials on chronic hepatitis B sufferers should follow by 2017.

01

Coming to Atlanta – Eye Exams at the Office!

BOSTON--(BUSINESS WIRE)--For today’s workforce, it’s hard to squeeze in important medical appointments, and in general, find that elusive work-life balance. According to the Center for Disease Control and Prevention, an estimated 61 million adults in the US are at risk for vision loss, yet only half had gone to the eye doctor in the previous 12 months. New this spring, Atlanta employers can help make getting an eye exam faster and easier for their employees. Why make thousands of people commute to the eye doctor when the eye doctor can simply come to them? That’s how Boston-based 2020 On-site Optometry is revolutionizing eye care. Having launched their first Mobile Vision Center in 2014, 2020 On-site has partnered with over 160 corporate clients and seen over 8,000 patients in the Boston area. “We are incredibly excited to be entering the Atlanta market,” said 2020 On-site CEO Howard Bornstein. “Traction at major, national employers based throughout the US with offices in Atlanta, Boston and elsewhere makes it apparent that we are solving a broad, latent need.”

01

Aduro Biotech Receives $22.4 Million in Clinical Development Milestone Payments From Janssen

BERKELEY, Calif., Feb. 01, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that the company received $22.4 million in clinical development milestone payments from Janssen Biotech, Inc., the company’s license partner for ADU-214, ADU-741 and other products using Aduro’s LADD technology platform for the treatment of specific cancers. Janssen is responsible for all clinical development for the product candidates within the license agreements. “Our relationship with Janssen has been exceptionally productive, with ADU-214 for the treatment of lung cancer and ADU-741 for the treatment of prostate cancer advancing in clinical studies,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “We believe these therapeutics may offer important alternatives for patients suffering from these aggressive cancers.”

January 2016

29

Green Biologics Named in the 2015 Global Cleantech 100

Gahanna, Ohio and Abingdon, England (January 29, 2016) – Green Biologics Ltd., a U.K. based industrial biotechnology and renewable chemicals company, today announced it has once again been named to the prestigious 2015 Global Cleantech 100, produced by Cleantech Group, a leading global research and advisory firm. Green Biologics was recognized for its Clostridium fermentation platform, which converts a wide range of sustainable feedstocks into high performance green chemicals such as n-butanol and acetone for use by the growing consumer and industrial products industries. The Global Cleantech 100 is a comprehensive list of the private companies poised to make the most significant impact on the cleantech industry through innovative and promising technologies aimed at addressing tomorrow’s clean technology challenges. The list is collated by sifting through thousands of nominations and combining proprietary Cleantech Group research data, with weighted qualitative judgments, and specific inputs from a global 100-person Expert Panel. We are pleased to once again be recognized as a leading clean technology company through inclusion in the Cleantech 100, said Sean Sutcliffe, Chief Executive of Green Biologics, Ltd. ͞During this past year, we’ve made significant progress on our path to becoming an industry-leading renewable specialty chemicals company. We began 2015 by securing significant financing and are proud of the progress that has been made toward the construction on our 100 percent renewable, bio-based n-butanol and acetone plant in Little Falls, MN.

26

LEICA BIOSYSTEMS AND ADVANCED CELL DIAGNOSTICS PARTNER TO DEVELOP AND COMMERCIALIZE RNASCOPE-BASED DIAGNOSTIC AND COMPANION DIAGNOSTIC TESTS

NEWCASTLE UPON TYNE, UK & HAYWARD, CALIFORNIA, USA, January 26, 2016 – Leica Biosystems, a global leader in anatomical pathology solutions & workflow automation, and Advanced Cell Diagnostics, Inc. (ACD), a world leader in RNA biomarker analysis for precision medicine, today announced a comprehensive partnership to develop and commercialize tissue-based diagnostic tests based on ACD's RNAscope in situ hybridization (ISH) assays on Leica Biosystems' BOND clinical advanced staining instruments. The agreement supports Leica Biosystems' development and commercialization of fully automated RNAscope-based companion diagnostic (CDx) tests in partnership with biopharmaceutical companies. The combination of ACD's RNAscope technology with Leica Biosystems' fully automated pathology solutions allows the companies and laboratories in clinical markets to integrate the power of new RNA-based biomarker tests into the existing pathology workflow. These tests will be co-branded and commercialized exclusively by Leica Biosystems for use in clinical labs around the world. The market-leading RNAscope LS probes and reagents running on the Research Use Only BOND RX instrument will also be upgraded as ready-to-use kits with streamlined software, to make the system more robust and easy to use. The RNAscope LS products will continue to be branded and commercialized exclusively by ACD. The availability of RNAscope technology on both research and clinical advanced staining platforms provides a seamless path for diagnostic test developers to translate their research to the clinic.

20

VoiceBox Technologies Agrees to Acquire Speech Product Unit, Telisma

BELLEVUE, WA, USA/ FRANCE— January 20, 2016 — VoiceBox Technologies Corporation, a global leader in intelligent, contextual voice solutions for connected things, has agreed to acquire the speech product unit Telisma from OnMobile S.A. The transaction is expected to close January 31, 2016. Founded as a spinoff of France Telecom in 2000, Telisma provides speech recognition technology to numerous leading companies and brings an additional 14 years of expertise in embedded and server Automatic Speech Recognition (ASR) to VoiceBox. The industry award winning interactive voice response (IVR) solution teliSpeech™ is deployed around the world and currently handles more than one billion IVR calls per year in many different languages. “We’ve been collaborating with Telisma on a robust embedded ASR solution for the automotive market for a couple years now,” said Mike Kennewick, CEO of VoiceBox. “This acquisition represents a natural extension of VoiceBox solutions to global IVR markets and further expands our ability to deliver full voice services to current and future customers.”

12

Envisia Therapeutics Announces First Patient Dosed in Second Cohort of Novel Phase 2 Program Evaluating ENV515 in Patients with Glaucoma

RESEARCH TRIANGLE PARK, NC – January 12, 2016 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today announced it has dosed its first patient in the second cohort of the phase 2 clinical program evaluating the Company’s lead product candidate, ENV515. ENV515 is an extended-release formulation of travoprost that could offer sustained reduction in intraocular pressure (IOP) for more than six months after a single dose. “We are encouraged by our initial clinical experience with ENV515 in glaucoma patients and have rapidly moved into the second cohort of our phase 2 program for advanced testing, which will provide more data in early 2016 to guide next steps for a larger, multi-center, masked trial,” said Benjamin Yerxa, President of Envisia. “The progress of the ENV515 program further supports the potential of the proprietary PRINT® technology platform to accelerate drug development for front and back of the eye diseases.” “Envisia’s novel approach may dramatically change the way we treat glaucoma, especially since poor patient adherence with eye drops is associated with blindness and visual impairment from glaucoma,” said Steven L. Mansberger, MD, MPH, Vice-Chair, Director of Glaucoma Services at Devers Eye Institute and lead investigator for the ENV515 phase 2a trial. “This study may provide evidence that one-to-two injections per year of ENV515 in the doctor’s office could control the IOP in most glaucoma patients without the need for them to apply daily eye drops.”

07

Stealth BioTherapeutics Receives FDA Fast Track Designation for Rare Disease Indication

Boston- January 7, 2016- Stealth BioTherapeutics (Stealth), a biopharmaceutical company developing drug candidates for treating mitochondrial dysfunction, today announced that the U.S Food and Drug Administration (FDA) has granted Fast Track designation for MTP-131 (also known as Bendavia) for the treatment of primary mitochondrial myopathy, characterized by muscle weakness in patients with genetic mitochondrial diseases. MTP-131 is currently being studied for the treatment of primary mitochondrial myopathy in its MMPOWER trial, with results expected midyear. Genetic mitochondrial diseases are a diverse group of rare inherited disorders characterized by systemic mitochondrial dysfunction that impairs patient health and well-being. MTP-131 is an investigational drug targeting the inner mitochondrial membrane to help preserve mitochondrial energetics and restore the healthy physiology which is often impaired in many rare and common diseases.

December 2015

29

New Mitochondrial Therapy Based on Bioenergetics Advancing in Range of Clinical Trials | Stealth BioTherapeutics' MTP-131 under study for skeletal muscle and cardio-renal ills linked to mitochondrial dysfunction

In the pipeline at Stealth BioTherapeutics is a new therapy, MTP-131, with the potential to treat individuals with mitochondrial disease and other diseases affected by mitochondrial dysfunction. The systemic version of MTP-131 (also known as Bendavia) is in clinical trials for skeletal muscle and cardio-renal diseases. The topical eye drop version (also known as Ocuvia) is on track to initiate clinical trials into Fuchs’ corneal endothelial dystrophy and Leber’s hereditary neuropathy in early 2016. “Our lead compound, MTP-131, is being tested in therapeutic areas where mitochondria have the highest impact: heart, skeletal muscle, and the eye,” said Dr. Mark Bamberger, chief scientific officer of Stealth BioTherapeutics. “In collaboration with mitochondrial experts, we are looking at the organs with the most mitochondria (e.g., the heart) or that produce the most energy (e.g., muscle tissue and the eye). Mitochondrial function is involved in many different diseases. The key is which disease areas to focus.”

21

Aduro Biotech Announces Initiation of Phase 1 Study of ADU-741 for the Treatment of Prostate Cancer

BERKELEY, Calif., Dec. 21, 2015 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that the first patient in the Phase 1 study of ADU-741 (also known as JNJ-64041809), a LADD immunotherapy product candidate for the treatment of prostate cancer, has been dosed. Janssen Biotech, Inc., is Aduro’s license partner for ADU-741. Janssen is conducting the study. “Janssen has deep expertise in the development of therapeutics for prostate cancer and we are extremely pleased with the rapid advancement of ADU-741 into clinical trials,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “ADU-741 represents a highly-specific, multifaceted approach to stimulate the immune system to fight cancer and we believe it may offer a new and unique treatment alternative to improve the outcome of men suffering from metastatic castration-resistant prostate cancer. We are particularly excited about ADU-741, which represents a significant advancement of our LADD technology and utilizes our proprietary methods to express multiple antigens that are relevant to prostate cancer. By engaging in productive agreements with partners like Janssen, Novartis and Incyte, we expand the reach of our novel immuno-oncology platform and offset the development costs of our internal therapies, all of which we pursue for the ultimate goal of bringing new treatments to patients in need.” The Phase 1 study will enroll approximately 40 patients with metastatic castration-resistant prostate cancer. The initial dose escalation portion of the trial, with two dose levels of ADU-741, will evaluate safety and immunogenicity. The trial will then expand to further characterize safety and preliminary immunological and clinical activity. Additional information may be found at clinicaltrials.gov, using identifier NCT02625857.

14

Aduro Biotech Receives Orphan Drug Designation in the European Union for CRS-207 and GVAX Pancreas for the Treatment of Pancreatic Cancer

BERKELEY, Calif., Dec. 14, 2015 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation to CRS-207 and GVAX for the treatment of pancreatic cancer. “We are extremely pleased to receive Orphan Drug Designation in the EU for CRS-207 and GVAX pancreas, which, taken together with our Breakthrough Designation granted by the U.S. Food and Drug Administration in the U.S., represent important regulatory milestones in our global strategy to develop new immunotherapies for this underserved population,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “As an integral step in our pursuit to bring this combination to patients with pancreatic cancer, we expect to report topline results from the ongoing Phase 2b ECLIPSE study evaluating this combination in the first half of 2016.”

10

Independent Data Monitoring Committee Recommends Continuation of ADAPT Phase 3 Clinical Trial of AGS-003 for Metastatic Renal Cell Carcinoma Following Second Planned Interim Analysis

DURHAM, N.C., Dec. 10, 2015 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immunooncology company focused on the development and commercialization of fully individualized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced its independent data monitoring committee (IDMC) has recommended the continuation of the company's pivotal phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) based on results of the committee's second planned interim data analysis. "The ADAPT phase 3 trial to evaluate AGS-003 in front line mRCC, the largest global trial ever performed in newly diagnosed, unfavorable risk mRCC patients, continues to progress nicely," said Dr. Figlin, the Steven Spielberg Family chair in hematology oncology, professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute and the principal investigator for the ADAPT trial. "We anticipate that we are approaching the mid-point for the expected number of events and look forward to the next interim review of the trial data in approximately six months."

10

Aduro Biotech Announces First Patient Dosed in Phase 1 Study of ADU-214 for the Treatment of Lung Cancer

BERKELEY, Calif., Dec. 10, 2015 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced the start of the Phase 1 study of ADU-214 (also known as JNJ-64041757), a LADD immuno-oncology therapy for the treatment of lung cancer, with the dosing of the first patient in the trial. Janssen Biotech, Inc., Aduro’s license partner for ADU-214, is conducting the multi-center study. “We are extremely pleased to see the first immuno-oncology therapy resulting from our license agreement with Janssen enter the clinic,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “With more than 200,000 new diagnoses this year and over 400,000 people living with lung cancer in the United Statesalone, new therapeutics are desperately needed. We believe ADU-214 may offer new hope to patients suffering from this aggressive disease.”

02

Green Biologics Starts Construction in Little Falls, MN

Gahanna, Ohio and Abingdon, England (December 2, 2015) – Green Biologics Ltd., a U.K. based industrial biotechnology and renewable chemicals company, is moving forward with the construction of its 100 percent renewable, bio-based n-butanol and acetone manufacturing facility in Little Falls, MN. The existing manufacturing site, formerly known as The Central MN Ethanol Cooperative (CMEC), was acquired by Green Biologics in December 2014 and re-named Central MN Renewables (CMR). Permitting was completed in late August and the construction began on September 1, 2015. Commercial production is scheduled to commence in 2016. The commencement of this construction project marks a significant milestone in our commitment to becoming a world class renewable specialty chemicals company, said Sean Sutcliffe, Chief Executive of Green Biologics, Ltd. In November, Green Biologics gained membership to the American Chemistry Council and started implementation of a comprehensive Responsible Care® initiative.

November 2015

23

Aduro Biotech Receives Orphan Drug Designation in the European Union for CRS-207 for the Treatment of Mesothelioma

BERKELEY, Calif., Nov. 23, 2015 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation to CRS-207 for the treatment of malignant pleural mesothelioma (MPM). “The receipt of Orphan Drug Designation in the European Union (EU) for CRS-207 for the treatment of MPM marks a significant regulatory milestone for Aduro, as we expand our operations in Europe and advance our therapies closer to the commercial marketplace,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “We look forward to working with the EMA to expeditiously advance CRS-207 through development with the goal of bringing this potential therapy to patients throughout Europe suffering from mesothelioma.” To receive Orphan Drug Designation from the EMA, a therapy must be intended for the treatment of a life-threatening or chronically debilitating rare condition with a prevalence of less than five in 10,000 in the European Union. Orphan Drug Designation provides incentives designed to facilitate development, including protocol assistance and scientific advice and importantly, may provide up to ten years of market exclusivity in the EU following product approval.

09

Aduro Biotech Announces Five Poster Presentations at the Society of Immunotherapy of Cancer Annual Meeting

BERKELEY, Calif. – November 9, 2015 - Aduro Biotech, Inc. (Nasdaq: ADRO) today announced five posters highlighting ongoing clinical trials and pre-clinical programs investigating its novel immunotherapies in development for the treatment of cancer were presented at the Society for Immunotherapy of Cancer Annual Meeting held in National Harbor, Maryland last week. In a poster presented on Saturday, November 7, 2015 by Nitya Nair, Ph.D., scientist at Aduro, updated safety and efficacy data were shared from the Phase 2a clinical trial of Aduro’s novel immunotherapy CRS-207 in combination with GVAX Pancreas in patients with metastatic pancreatic cancer. Seven patients treated with this regimen survived for over three years, with one patient continuing to receive the combination regimen. In addition, the poster highlighted key biomarker findings in 38 patients from the 93-patient trial which demonstrated a statistically significant correlation between levels of certain immune cells in the peripheral blood and overall survival. Specifically, the data showed elevated subsets of CD8+ immune T cells at baseline and at seven weeks after treatment initiation resulted in better performance outcomes. Conversely, an increase in subsets of certain myeloid cells (CD14+) at the same time points was associated with worse outcomes.

03

MicuRx Reports Positive Top-Line Results From Phase 2 US Clinical Trial For Novel Antibiotic MRX-I

HAYWARD, Calif. and SHANGHAI, Nov. 3, 2015 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced positive top-line results from its second Phase 2 clinical study of the drug candidate MRX-I. MRX-I is an oral oxazolidinone antibiotic designed to treat drug-resistant bacteria such as MRSA and VRE, while offering a safer and better tolerated oxazolidinone antibiotic therapy. "We are very pleased that results of MRX-I in the second Phase 2 clinical study performed in USA validate the therapeutic potential of this novel agent," said Dr. Zhengyu Yuan, president and CEO of MicuRx Pharmaceuticals, lnc. "For over 220 patients treated in US and China with MRX-I to-date, the response rates are consistently high. Importantly, MRX-I has not caused myelosuppression, the key limiting side effect of currently available oxazolidinone drugs."

October 2015

22

Chimerix Initiates Phase 3 SUSTAIN and SURPASS Trials of Brincidofovir for Prevention of Cytomegalovirus Disease in Kidney Transplant Recipients

Durham, N.C. – October 22, 2015 – Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced initiation of dosing in SURPASS (ClinicalTrials.gov ID: NCT02439957), one of the two Phase 3 trials in the brincidofovir kidney transplant program. Both the SUSTAIN (ClinicalTrials.gov ID: NCT02439970) and SURPASS trials are evaluating brincidofovir for the prevention of cytomegalovirus (CMV) disease in kidney transplant recipients; both trials are now actively enrolling. Brincidofovir is an oral nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including herpesviruses and adenovirus, and demonstrated a clinically and statistically significant reduction in CMV infection in a Phase 2 trial in hematopoietic cell transplant (HCT) recipients. Based on that successful study, Chimerix designed and conducted the pivotal SUPPRESS trial for the prevention of clinically significant CMV infection in patients undergoing HCT which completed enrollment in June. Topline data from SUPPRESS are anticipated in early 2016.

21

Amgen Wins EU Green Light for First Virus-Based Cancer Drug

LONDON (Reuters) - A first-in-class drug from Amgen (formerly Morningside portfolio project Biovax) based on a tumour-killing virus was given a green light by European regulators on Friday, paving the way for its approval within a couple of months. The decision is a further milestone for a technology that has long fascinated scientists but has previously proved difficult to harness. The European Medicines Agency (EMA) said its experts had recommended approval of Imlygic, also known as talimogene laherparepvec or "T-Vec", for treating melanoma, making it another option among several new drugs for the most deadly form of skin cancer.

20

CellCentric secures funding to take its prostate cancer programme to IND

Further investment from Morningside Venture Investments Ltd and Providence Investment Company Ltd will see the company take its small molecule drug discovery programme for the most aggressive form of prostate cancer (CRPC) through candidate finalisation and IND-enabling studies. CellCentric’s proprietary compounds target a histone acetyl transferase (HAT) that is key in androgen receptor regulation. For 10-20% of those with prostate cancer, long term survival prospects are poor. The aggressive form of the disease, castrate-resistant prostate cancer (CRPC), has a median survival time of 14 months. Two newer drugs on the market have some benefit, but cancer cells have multiple adaptive mechanisms that limit their effectiveness.

15

CellCentric successfully completes InnovateUK programme

CellCentric is developing small molecule inhibitors for the most aggressive form of prostate cancer (CRPC). In March 2013, the company secured support from InnovateUK, combined with venture capital investment, to develop novel small molecule modulators of the androgen receptor pathway. This programme has now completed, on time and on budget. Castrate resistant prostate cancer is a significant unmet clinical need. It effects up to 20% of prostate cancer suffers, and is rapidly lethal. The pharmaceutical market for drugs in this space is significant. Existing therapies, which have limited effectiveness, are project to be worth over $9.5bn by 2020. Through its deep foundation in epigenetics, CellCentric identified novel ways to address CRPC, by targeting the androgen receptor pathway – key to the progression of the disease. The company won a significant award from InnovateUK through its BioMedical Catalyst scheme, to translate the scientific concept and early research data, through to small molecule inhibitors that could be advanced as drugs and tested in the clinic.

06

GSK obtains rights to inhaled nanoparticles made using Liquidia's PRINT platform

GlaxoSmithKline ($GSK) now has rights to develop inhaled therapeutics using Liquidia's PRINT particle engineering technology. The development builds on a drug delivery alliance between the two companies that commenced in 2012. In addition to the upfront payment made in 2012, Research Triangle Park, NC's Liquidia receives an additional option fee from GSK, continued R&D funding, and the opportunity to earn regulatory and milestone payments down the road. Liquidia retains its ability to independently develop an inhaled therapy for a particular disease field, according to a release. "We are very pleased with the progress that has been made over the past three years in our collaboration with GSK. They are a great partner in our exploration of inhaled therapeutic options using our novel PRINT technology," said Liquidia CEO Neal Fowler in a statement. "GSK's decision to exercise this option initiates a new and exciting chapter in our relationship. We remain confident in the strength of this collaboration to navigate the path ahead to develop novel inhaled therapies."

06

Envisia Therapeutics' Lead Product Candidate, ENV515, Achieves Primary Efficacy Endpoint in Phase 2A Glaucoma Clinical Trial

RESEARCH TRIANGLE PARK, NC – OCTOBER 6, 2015 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today reported results from its first clinical trial of the Company’s lead product candidate, ENV515 (travoprost XR). In this phase 2a trial, ENV515 achieved its primary efficacy endpoint by demonstrating a statistically significant and clinically meaningful reduction in intraocular pressure (IOP) with results comparable to topical once-daily TRAVATAN Z® (travoprost ophthalmic solution). ENV515 is engineered as a proprietary, fully biodegradable PRINT® (Particle Replication In Non-Wetting Templates) travoprost formulation that could offer sustained reduction in IOP for more than six months after a single dose.

01

Merck and DNAtrix Announce Phase 2 Immuno-Oncology Collaboration in Patients with Aggressive Form of Brain Cancer

KENILWORTH, N.J. & HOUSTON, Oct.1, 2015 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, and DNAtrix today announced they have entered into an oncology clinical study collaboration to evaluate the efficacy and safety of DNX-2401, DNAtrix’s oncolytic immunotherapy, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD- 1 therapy, in a Phase 2, multi-centered study of patients with recurrent glioblastoma, the most aggressive form of brain cancer for which there is no cure. DNX-2401 is a conditionally replicative oncolytic adenovirus designed to specifically target cells defective in the Retinoblastoma (Rb) pathway, which is present in many cancers. Several DNX-2401 clinical studies have demonstrated a favorable safety profile and strong tumor-killing potential in patients with recurrent glioblastoma. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. KEYTRUDA is currently approved in the United States for certain types of advanced metastatic melanoma.

September 2015

24

Aduro Biotech Enters Into Definitive Agreement to Acquire Premier Antibody Portfolio and Engineering Capabilities Through Purchase of BioNovion

BERKELEY, Calif. and OSS, The Netherlands, Sept. 24, 2015 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) and BioNovion Holding B.V. announced today that they have entered into a definitive agreement for Aduro to acquire BioNovion, a privately held monoclonal antibody discovery and development company based in The Netherlands. The acquisition will further strengthen and expand Aduro's immunotherapy capabilities to now encompass monoclonal antibodies, including preclinical assets that inhibit clinically validated immune checkpoint pathways. Such immune checkpoint inhibitors could potentially be used alone or in combination with Aduro's LADD and CDN platforms to increase immunotherapy potency and durability. In addition, BioNovion has a rich pipeline of novel preclinical monoclonal antibodies which inhibit or activate unique immune response pathways that have a role in controlling the progression of diverse malignancies.

August 2015

04

Genocea Biosciences, Inc. Announces Closing of $50 Million Public Offering of Common Stock

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced the closing of the previously announced public offering of 3,850,000 shares of its common stock, at the public offering price of $13.00 per share, before underwriting discounts. In addition, Genocea has granted the underwriters a 30-day option to purchase up to an additional 577,500 shares of common stock at the same price. The net proceeds to Genocea from this offering are expected to be approximately $47 million.

June 2015

29

Aduro Biotech Announces Immunotherapy Regimen Successfully Passes Futility Analysis in Phase 2b ECLIPSE Trial in Metastatic Pancreatic Cancer

BERKELEY, Calif., June 29, 2015 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that an independent Data Monitoring Committee (DMC) recommended that the Phase 2b ECLIPSE trial of its novel LADD and GVAX immunotherapies continue as planned without modification based on the successful outcome of a pre-specified futility analysis. The DMC assessment included an evaluation of interim primary efficacy and safety data from over half of the anticipated patient population enrolled in the trial.

18

Advanced Cell Diagnostics Completes $22 Million Series C Equity Financing

Hayward, CA – June 18, 2015 – Advanced Cell Diagnostics, Inc. (ACD), a world leader in the field of in situ nucleic acid detection for life science research and clinical diagnostics, announced today that it has raised $22 million in Series C equity financing, led by growth equity investor Summit Partners with participation from Kenson Ventures and existing investors, Morningside Ventures and New Leaf Venture Partners.

16

Kezar Life Sciences Closes $23M Series A Financing

SOUTH SAN FRANCISCO, Calif., June 16, 2015 /PRNewswire/ -- Kezar Life Sciences, a company focused on the discovery and development of drugs targeting protein homeostasis for autoimmune disorders, announced the completion of a Series A financing totaling $23 million. The capital raised in the Series A will be used to advance Kezar's lead immunoproteasome inhibitor candidate into Phase 1a and 1b clinical trials, with the goal of demonstrating safety and efficacy in patients with autoimmune disease. Kezar also intends to advance drug discovery programs targeting protein secretion.

10

Chimerix Prices Public Offering of Common Stock

DURHAM, N.C., June 10, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the pricing of an underwritten public offering of 3,775,000 shares of its common stock at a price to the public of $39.75 per share. The gross proceeds to Chimerix from this offering, before deducting underwriting discounts and commissions and other offering expenses payable by Chimerix, are expected to be approximately $150 million. The offering is expected to close on or about June 16, 2015, subject to customary closing conditions. Chimerix anticipates using the net proceeds from the offering to fund its research and development efforts and for general corporate purposes, including working capital.

09

Luqa Pharmaceuticals Completes US$15M Series A Financing

Hong Kong, S.A.R., June 9, 2015 – Luqa Pharmaceuticals, a China specialty care company that markets innovative solutions in dermatology and other specialty areas, announces the completion of a US$15 million round of fund raising. The new financing was led by Morningside Ventures. Proceeds will be used to expand, develop and fund on-going operations and commercialization of Luqa’s product range.

May 2015

26

Stealth BioTherapeutics Announces Positive Results in Bendavia Heart Failure Study: The PREVIEW Trial

BOSTON – May 26, 2015 – Stealth BioTherapeutics (Stealth), a biopharmaceutical company developing drug candidates for treating mitochondrial dysfunction, today announced positive heart failure results from its PREVIEW study showing Bendavia improved cardiac function for patients. The results were presented at the European Society of Cardiology (ESC) Heart Failure Congress in Seville, Spain, during a symposium focused on mitochondria’s role in chronic heart failure (CHF).

22

BioScale Launches New ViBE® Software v3 For Use On ViBE Platform To Further Increase Productivity And Cost-Efficiency In Drug Development

Billerica, Mass. — May 22, 2015 — BioScale, Inc., a leading supplier of novel protein measurement technology to accelerate the development of diagnostic and clinical applications, and biological and pharmaceutical products, today announced the launch of a new ViBE software v3 allowing use of the platform in GLP and drug development labs. The new software, enabling faster plate read times of one hour, lower reagent consumption, FDA 21 CFR Part 11 tools and LIMS connectivity, was introduced at the recently concluded Protein Engineering Summit (PEGS) conference in Boston.

19

Alcyone Lifesciences and DNAtrix Enter Clinical Collaboration for Brain Cancer

Lowell, MA and Houston, TX – May 19, 2015. Alcyone Lifesciences, Inc., a leader in neural intervention systems for neurological conditions and targeted drug delivery, and DNAtrix Inc., a privately held biotechnology company and a leader in oncolytic virus therapy, have entered into an exclusive clinical collaboration. Under the agreement, DNAtrix will utilize Alcyone’s MEMS Cannula (AMC) targeted delivery platform for the intratumoral delivery of DNX-2401, an oncolytic adenovirus and DNAtrix’s lead product for the treatment of the most aggressive form of brain cancer, glioblastoma (GBM).

April 2015

28

InCarda Therapeutics Completes Over $5 Million Private Financing

San Francisco, California, April 28, 2015 – InCarda Therapeutics, Inc. (InCarda), a privately-held biotechnology company focused on the development and commercialization of therapies for acute cardiovascular conditions via the inhalation route, today announced the completion of a Series A financing. In this financing, InCarda raised over $5 million with potential tranches totaling an additional $1.5 million. The lead investor in the financing was Morningside. Other investors include a consortium of physicians and other health care and high tech professionals. Reenie McCarthy, representing Morningside, will join InCarda’s board of directors. Proceeds from the financing will be used to further the company’s lead cardiovascular program for an inhaled therapy intended to treat paroxysmal atrial fibrillation (PAF).

27

Stealth BioTherapeutics Expands Ocuvia’s Clinical Development into Rare Mitochondrial Optic Neuropathies

BOSTON – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing drug candidates for mitochondrial dysfunction, today announced expansion of its ophthalmology program with FDA granting a Type B meeting for inherited optic neuropathies. Optic neuropathies include a diverse group of genetic diseases characterized by vision loss due to mitochondrial dysfunction. Affecting more than 1 in 10,000 individuals, optic neuropathies are common to more than 20 inherited mitochondrial diseases. Stealth’s ophthalmology program is led by Ocuvia, an investigational drug targeting mitochondrial dysfunction to treat common and rare eye diseases. Ocuvia is currently being studied in patients with diabetic macular edema and dry age-related macular degeneration.

20

Aduro Biotech Announces Close of Initial Public Offering, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares, and Concurrent Private Placement

BERKELEY, Calif.--(BUSINESS WIRE)-- Aduro Biotech, Inc. (Nasdaq: ADRO) today announced the closing of its initial public offering of 8,050,000 shares of common stock at a price to the public of $17.00 per share, which included 1,050,000 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares. Aduro estimates the net proceeds from the public offering were approximately $124.3 million after deducting the underwriting discount and estimated offering expenses. Aduro also today announced the closing of its concurrent private placement of 1,470,588 shares of common stock at a price of $17.00 per share, for estimated net proceeds of approximately an additional $25.0 million.

14

Aduro Biotech Announces Pricing of Its Initial Public Offering

BERKELEY, Calif.--(BUSINESS WIRE)--Apr. 14, 2015-- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced the pricing of its initial public offering of 7,000,000 shares of common stock at a price to the public of $17.00 per share. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 1,050,000 shares of common stock at the initial public offering price, less the underwriting discount. Aduro’s common stock is expected to begin trading on The NASDAQ Global Select Market under the symbol “ADRO” on April 15, 2015. The offering is expected to close on April 20, 2015, subject to customary closing conditions. Aduro estimates net proceeds from the offering will be approximately $107.7 million (assuming no exercise of the underwriters’ option to purchase additional shares of common stock), after deducting the underwriting discount and estimated offering expenses payable by Aduro. Aduro’s net proceeds from a concurrent private placement at a price of $17.00 per share are expected to be $25.0 million.

01

New Platform Investment in Long Range Product Tankers

Morningside Private Investors (MPI) has purchased, along with management, two long range product tankers (LR1s) to transport refined product globally. Our Singapore-based ship management partners have experience managing different types of tankers ranging from smaller, specialized chemical tankers up to medium range product tankers. Our backing of this team allows them to enter a new market in the Panamax sized (75k DWT) shipping category hauling clean products such as diesel, gasoline, jet fuel and naptha.

March 2015

30

Aduro Biotech Establishes Collaboration with Novartis for Research and Development of Immuno-Oncology Products

BERKELEY, Calif.--(BUSINESS WIRE)--Aduro Biotech, Inc. today announced the establishment of a major collaboration with Novartis for the worldwide research, development and commercialization of novel immuno-oncology products derived from Aduro’s cyclic dinucleotide (CDN) approach to target the STING (Stimulator of Interferon Genes) receptor, that, when activated, is known to initiate broad innate and adaptive tumor-specific immune responses. Aduro will receive $200M upfront, equity stake and future potential milestones collectively totaling up to $750M, plus profit sharing in the collaboration.

26

Aduro Receives Orphan Drug Designation for CRS-207 in Mesothelioma

BERKELEY, Calif.--(BUSINESS WIRE)-- Aduro Biotech, Inc. today announced that the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CRS-207, a novel immuno-oncology product candidate, for the treatment of mesothelioma. This designation potentially allows Aduro seven years of limited marketing exclusivity in the United States if it is the first to obtain FDA marketing approval for mesothelioma, and qualifies the company for grant funding to offset the cost of clinical testing as well as tax credits for certain research and a waiver of the Biologics License Application user fee. The FDA previously granted orphan designation to CRS-207 and GVAX Pancreas for the treatment of pancreatic cancer.

17

Genocea Biosciences, Inc. Announces Closing of $51.7 Million Public Offering of Common Stock and Exercise in Full of Underwriters' Option to Purchase Additional Shares

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced the closing of the previously announced public offering of common stock, including the exercise in full by the underwriters of their option to purchase an additional 818,181 shares of common stock, at the public offering price of $8.25 per share. The exercise of the underwriters' option brought the total number of shares of common stock sold by Genocea to 6,272,726 shares and increased the total gross proceeds raised in this offering to $51.7 million, before deducting the underwriting discounts and commissions. The net proceeds to Genocea from this offering were approximately $48.4 million.

12

Genocea Biosciences, Inc. Announces Pricing of $45 Million Public Offering

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced the pricing of its public offering of 5,454,545 shares of its common stock at a public offering price of $8.25 per share, before underwriting discounts. In addition, Genocea has granted the underwriters a 30-day option to purchase up to an additional 818,181 shares of common stock at the same price. The offering is expected to close on or about March 17, 2015, subject to satisfaction of customary closing conditions.

February 2015

25

MicuRx Initiates U.S. Phase 2 Clinical Trial For Novel Antibiotic MRX-I

HAYWARD, Calif. and SHANGHAI, Feb. 25, 2015 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced that it has received the approval from the U.S. Food and Drug Administration (FDA) to initiate Phase 2 clinical study in the United States for its lead drug candidate MRX-I. MRX-I, which demonstrated an enhanced safety profile over the market-leading comparator in Phase 1 studies, is an oral oxazolidinone antibiotic designed to treat infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).

17

Stealth BioTherapeutics Initiates a Clinical Study of Bendavia for the Treatment of Orphan Mitochondrial Diseases

BOSTON – Feb. 17, 2015 – Stealth BioTherapeutics (Stealth) today announced the initiation of a clinical study of Bendavia in patients with Mitochondrial Myopathy (MM). This study will investigate Bendavia for the treatment of myopathy (muscle weakness) in patients with genetic mitochondrial diseases. Genetic mitochondrial diseases are a diverse group of rare inherited disorders characterized by systemic mitochondrial dysfunction that impairs patient health and wellbeing. Bendavia is an investigational drug that targets the inner mitochondrial membrane to treat diseases both common and rare, including cardio-renal diseases and orphan mitochondrial diseases.

12

Chimerix Presents Update on Preliminary Data From AdVise Study of Brincidofovir for Adenovirus Infection at BMT Tandem Meetings

DURHAM, N.C., Feb. 12, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX) announced the presentation of preliminary data from the open-label, Phase 3 AdVise trial of brincidofovir for adenovirus infection showing a short-term mortality rate of less than 40 percent. The current analysis is based on the first 85 subjects enrolled and supports the trend seen in the first 48 subjects as presented at the meeting of the Infectious Diseases Society of America (IDSA), IDWeek. Historic mortality rates as high as 80 percent for disseminated adenovirus disease have been reported. These data will be presented today at 4:45 p.m. PT at the 2015 BMT Tandem Meetings, the combined annual meetings of the Center for International Blood and Marrow Transplant Research and the American Society of Blood and Marrow Transplantation, taking place in San Diego, CA. Final trial results will be reported at a later date and will comprise clinical outcomes for trial subjects as compared to matched historical controls.

January 2015

29

Green Biologics to Convert Minnesota Ethanol Plant to N-Butanol and Acetone Facility

Green Biologics, a UK-based renewable chemicals company, has embarked on a major redevelopment process to turn a U.S. ethanol plant into an n-butanol and acetone facility to cater for the growing renewables-based paints and coatings industries. “Our strategy is to focus on supplying the renewable paints and coatings industry and other high value formulations markets and not fuels. We have now acquired an ethanol plant which will produce n-butanol and acetone from renewable sources,” Tim Staub, global vice president for Business Development said.

27

Envisia Therapeutics Initiates Phase 2a Clinical Trial for ENV515 in Patients with Glaucoma

RESEARCH TRIANGLE PARK, NC – JANUARY 27, 2015 – Envisia Therapeutics today announced that it has initiated a phase 2a clinical trial to investigate the safety and tolerability of its lead product, ENV515, in patients with glaucoma. ENV515 is a proprietary, fully biodegradable PRINT® (Particle Replication In Non-Wetting Templates) particle formulation of a prostaglandin analog, travoprost, with the potential for sustained intraocular pressure (IOP) reduction over as many as six months. ENV515 offers the potential to significantly address the poor compliance that exists among glaucoma patients today to limit disease progression and vision loss.

20

Aduro Biotech Reports Long-term Survival and Immune Biomarker Data From Phase 2 Clinical Trial of Its Immuno-oncology Regimen in Patients With Pancreatic Cancer

BERKELEY, Calif. -- Aduro Biotech, Inc. today announced that seven pancreatic cancer patients treated with its combination immuno-oncology regimen in a 93-patient Phase 2a clinical trial continue in survival follow-up, with two of those patients remaining on the company’s combination therapy for more than two years with no evidence of cumulative toxicity. Furthermore, the company reported data from ongoing immune monitoring analyses of the trial that show a statistically significant correlation in the breadth and quantity of patients’ antigen-specific CD8 T cell responses to treatment with overall survival. The analyses also identified a subset of cytokines that, when measured prior to treatment, correlated with longer overall survival. The data were presented at the American Society of Clinical Oncology (ASCO) 2015 Gastrointestinal Cancers Symposium in San Francisco.

09

Stealth Biotherapeutics Expands Clinical Development for Mitochondrial Therapies

Boston, MA January 9, 2015—(BUSINESS WIRE)—Stealth BioTherapeutics (formerly Stealth Peptides), a clinical-stage biopharmaceutical company developing drug candidates for the treatment of diseases involving mitochondrial dysfunction, today detailed its clinical development program in both common and rare diseases for its lead compounds, Bendavia and Ocuvia. Stealth is expanding its mitochondria-targeted therapies into several core areas, including cardio-renal diseases, ophthalmic disorders and orphan mitochondrial diseases. Stealth also announced that funding from its lead investor, Morningside, has surpassed $100M. The funding advances Stealth’s clinical development program for Bendavia and Ocuvia, and will help broaden its mitochondrial platform to include additional clinical candidates in 2015.

05

Aduro Biotech Closes $51.4 Million Series D Financing

BERKELEY, Calif. -- Aduro Biotech, Inc., a clinical-stage immuno-oncology company, today announced the closing of a $51.4 million Series D preferred stock financing. Eleven new investors participated in the round, including OrbiMed , Janus Capital Management LLC, funds managed by Franklin Advisers, Inc., Jennison Associates LLC (on behalf of certain clients), Foresite Capital Management LLC, certain private investment funds advised by Clough Capital Partners L.P., and other healthcare investors. The Morningside group and certain of the company’s existing investors also participated in the financing. Leerink Partners LLC acted as the exclusive placement agent for the financing.

December 2014

23

Green Biologics Closes Acquisition of Ethanol Plant in Minnesota

Gahanna, Ohio and Abingdon UK (December 23, 2014) - Green Biologics Inc. today announced the successful closing of its acquisition of the assets of Central MN Ethanol Cooperative LLC (CMEC). Green Biologics intends to repurpose the operation, which includes a 21 million gallon per year ethanol plant, to produce renewable nbutanol and acetone, utilising its proprietary advanced fermentation process (AFP™) technology platform. Green Biologics Inc. is a wholly owned U.S. subsidiary of Green Biologics Ltd., a UK industrial biotechnology and renewable chemicals company. The acquisition was make through Central MN Renewables LLC. (CMR), an affiliate of Green Biologics Inc. Current management and employees will continue with CMR. The plant is scheduled to begin production of renewable n-butanol and acetone in 2016, and will continue to produce ethanol until the repurposing is completed. The purchase was in accordance with an asset purchase agreement with CMEC previously announced on December 2, 2013. CMEC was represented in the transaction by Ocean Park Advisors, LLC.

03

Aduro Biotech Announces Preclinical Data Presented at American Association for Cancer Research Tumor Immunology and Immunotherapy Conference

ORLANDO, Fla.--(BUSINESS WIRE)-- Aduro Biotech, Inc., a leader in the development of therapies for immuno-oncology, today announced data demonstrating potent anti-tumor activity in preclinical models treated with ADU-S100, a proprietary molecule based on the company’s cyclic dinucleotide (CDN) platform technology. The data were presented by Thomas W. Dubensky, Jr., Ph.D., chief scientific officer of Aduro, at the American Association for Cancer Research Tumor Immunology and Immunotherapy Conference being held in Orlando this week.

02

Apellis Pharmaceuticals Raises $33M to Fund its Complement Immunotherapy Programs

LOUISVILLE, Ky., Dec. 2, 2014 /PRNewswire/ -- Apellis Pharmaceuticals, Inc., a leading biotechnology company applying immunotherapy to autoimmune disease, today announced that it has completed a $33M private placement of its Series C Preferred Stock. The financing was led by Morningside Ventures and AJU IB Investment Co., Ltd. with Epidarex Ventures participating with follow-on funding. The proceeds will be used to fund three new complement immunotherapy programs entering clinical proof-of-concept stage.

November 2014

20

Apellis Pharmaceuticals to Acquire Potentia Pharmaceuticals

CRESTWOOD, Ky., Nov. 20, 2014 /PRNewswire/ -- Apellis Pharmaceuticals announced today that it entered into an agreement to acquire Potentia Pharmaceuticals. As part of the acquisition agreement, Apellis obtained the necessary intellectual property rights to develop its complement inhibitor drug compound (APL-2) in ophthalmology and plans its first clinical trial in dry age-related macular degeneration (dry AMD).

14

Chimerix's Brincidofovir Selected for Use in Ebola Clinical Trial in West Africa by International Consortium

DURHAM, N.C., Nov. 13, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that its investigational broad-spectrum antiviral brincidofovir has been selected as one of two investigational agents to be evaluated in a clinical study in patients with confirmed Ebola Virus Disease in west Africa. Chimerix and the University of Oxford are in the process of finalizing a definitive agreement for supplying brincidofovir for the planned clinical trial.

09

Mobile optometry service puts eye on convenience

By Cindy Atoji Keene GLOBE CORRESPONDENT NOVEMBER 09, 2014 The Boston startup Project 2020 aims to make it easier to get annual eye exams and basic preventive care, using the mobile clinic housed in its “eye truck” to bring services to the patients. It avoids all sorts of hassles, including having to drive after pupils have been dilated, said Alexa Baggio, director of operations. “We take a headache-inducing process and reduce it to 15 minutes, while increasing the quality of care,” said Baggio. Is this the next step in a broadly defined “mobile health”? We’re living in a convenience economy. Whether it’s mobile car detailers, manicures, or pet groomers, it’s easier to bring services directly to homes or businesses. Project 2020 is onsite optometry; the eye doctor comes to your office.