$CATB to Present Results, Open-Label Extension of the MoveDMD

CAMBRIDGE, Mass.

Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced that the Company will present results from the open-label extension of the MoveDMD trial following 24 and 36 weeks of edasalonexent treatment in boys with Duchenne Muscular Dystrophy (DMD) at the 22^nd International Congress of the World Muscle Society. The late breaking abstract and results will be available in the late breaking poster session starting at 10:30am CEST on Wednesday, October 4, 2017. The International Congress of the World Muscle Society is being held October 3 – 7, 2017, at the Palais du Grand Large in Saint Malo, France.

About Edasalonexent
Edasalonexent (CAT-1004) is an investigational oral small molecule that is being developed as a potential disease-modifying therapy for all patients affected by DMD, regardless of their underlying mutation. Edasalonexent inhibits NF-kB, a protein that is activated in DMD and drives inflammation and fibrosis, muscle degeneration and suppresses muscle regeneration. We are currently conducting the MoveDMD trial, a three-part clinical trial investigating the safety and efficacy of edasalonexent in boys enrolled at ages 4 – 7 affected with DMD (any confirmed mutation). The third part of the trial, an open-label extension with edasalonexent, is ongoing. The FDA has granted orphan drug, fast track and rare pediatric disease designations and the European Commission has granted orphan medicinal product designation to edasalonexent for the treatment of DMD. For a summary of clinical results reported to-date, please visit www.catabasis.com.

About Catabasis
At Catabasis Pharmaceuticals, our mission is to bring hope and life-changing therapies to patients and their families. Our SMART (Safely Metabolized And Rationally Targeted) Linker drug discovery platform enables us to engineer molecules that simultaneously modulate multiple targets in a disease. We are applying our SMART Linker^SM platform to build an internal pipeline of product candidates for rare diseases and plan to pursue partnerships to develop additional product candidates. For more information on the Company’s drug discovery platform and pipeline of drug candidates, please visit www.catabasis.com.

Investor and Media Contact
Catabasis Pharmaceuticals, Inc.
Andrea Matthews, 617-349-1971
amatthews@catabasis.com

$HALO & $BMY ENHANZE Global Collaboration and License Agreement

NEW YORK & SAN DIEGO

Bristol-Myers Squibb Company (NYSE:BMY) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced a global collaboration and license agreement to develop subcutaneously administered Bristol-Myers Squibb immuno-oncology medicines using Halozyme’s ENHANZE^® drug-delivery technology.

“We are excited to partner with Halozyme to pursue potential new approaches to how our medicines are delivered to patients,” said Murdo Gordon, chief commercial officer, Bristol-Myers Squibb. “Through our work with Halozyme, we hope to improve the patient treatment experience by developing flexible and convenient treatment delivery options.”

The Halozyme ENHANZE technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan — a glycosaminoglycan or chain of natural sugars in the body — to aid in the dispersion and absorption of other injected therapeutic drugs. This technology may allow for more rapid delivery of large volume injectable medications, such as medications that are currently delivered intravenously, through subcutaneous delivery.

“Bristol-Myers Squibb has one of the industry’s most advanced and extensive immuno-oncology portfolios with a clear commitment to patient-centered innovation,” said Dr. Helen Torley, president and chief executive officer of Halozyme. “Through this collaboration we are excited to explore the potential for ENHANZE to expand the number of cancer patients who may receive their therapies as a rapidly administered subcutaneous injection.”

Under the terms of the agreement, Halozyme will receive an initial $105 million for access to the ENHANZEtechnology. Bristol-Myers Squibb has designated multiple immuno-oncology targets including programmed death 1 (PD-1) and has an option to select additional targets within five years from the effective date. The collaboration may extend to a maximum of 11 targets. Halozyme has the potential to earn milestone payments of up to $160 million for each of the nominated collaboration targets and additional milestone payments for combination products, subject to achievement of specified development, regulatory and sales-based milestones. In addition, Bristol-Myers Squibb will pay Halozyme royalties on sales of products using the ENHANZE technology developed under the collaboration.

The agreement is subject to customary anti-trust clearance by the U.S. Justice Department and Federal Trade Commission pursuant to the Hart-Scott-Rodino Act.

For Bristol-Myers Squibb, the transaction is expected to be dilutive to Non-GAAP earnings per share (EPS) in 2017 and 2018 by approximately $0.01, and by approximately $0.05 in 2019.

About ENHANZE^® Technology

Halozyme’s proprietary ENHANZE^® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

About Bristol-Myers Squibb & Immuno-Oncology

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance the I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient’s tumor biology can be used as a guide for treatment decisions throughout their journey.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Halozyme

Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Bristol-Myers Squibb for its ENHANZE^® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

Halozyme Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE, the possible method of action of ENHANZE, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, the number of collaborative targets actually chosen, whether such products are ultimately developed or commercialized, whether milestones triggering milestone payments will be achieved, and statements concerning facilitating more rapid delivery of injectable medications through subcutaneous delivery that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in receipt of Hart-Scott-Rodino clearance, development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme’s most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development, and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the proposed technology or medicine delivery system will be successfully developed or approved for any of the indications described in this release. The actual financial impact of this transaction may differ from the expected financial impact described in this press release. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

$XXII to Speak at Global Tobacco & Nicotine Forum

CLARENCE, N.Y.

22nd Century Group, Inc. (NYSE American:XXII), a plant biotechnology company that is focused on tobacco harm reduction, announced today that officials from the Global Tobacco & Nicotine Forum (GTNF) have invited the Company’s Chief Executive Officer, Henry Sicignano, III, to participate on a GTNF panel entitled “Future Next Generation Products” on September 14, 2017 in New York City.

The Global Tobacco & Nicotine Forum is the world’s foremost exchange of ideas and information for tobacco technologies and products. Attendees to the forum include public health advocates, policymakers, scientists, and international tobacco industry executives. Visit www.gtnf-2017.com for more on GTNF. Also speaking at this year’s forum are:

Mitch Zeller, Director, US Food and Drug Administration’s Center for Tobacco Products. Together with FDA Commissioner, Dr. Scott Gottlieb, in August 2017, Mr. Zeller, released an article entitled, “A Nicotine-Focused Framework of Public Health.” Published in The New England Journal of Medicine (NEJM), the article spells out the FDA’s regulatory authority for mandating non-addictive levels of nicotine in combustible cigarettes.

Dr. Dorothy Hatsukami, Forster Family Chair in Cancer Prevention; Associate Director, Masonic Cancer Center; and Professor of Psychiatry, University of Minnesota. In 2016, together with two other prominent scientists, Dr. Dorothy Hatsukami wrote in Tobacco Control that failure to act on the World Health Organization (WHO) recommendation of mandating nicotine reductions in cigarettes to non-addictive levels could lead to the loss of millions of lives.

Dr. Michael Cummings, Professor, Medical University of South Carolina Department of Psychiatry & Behavioral Sciences; and Co-Director, Tobacco Policy and Control Program at Hollings Cancer Center. As an expert in tobacco policy, Dr. Cummings is often called upon to guide global tobacco control policy initiatives around the world. Earlier in 2017, Dr. Cummings gave the keynote address at 22nd Century’s Annual Meeting of Stockholders.

“Since the FDA announced its intention to mandate that all cigarettes have very low, non-addictive levels of nicotine, the public health community has focused much of its attention on 22nd Century,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “We look forward to working together with scientists and policymakers to make Very Low Nicotine cigarettes a public health reality in the United States and around the world.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on genetic engineering and plant breeding which allows the increase or decrease of the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in cannabis is to develop proprietary hemp/cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.com for more information.

Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2016, filed on March 8, 2017, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.

22nd Century Group
James Vail, 716-270-1523
Director of Communications
jvail@xxiicentury.com

$ZSAN Presents Data from ZOTRIP Study at International Headache Society

FREMONT, Calif., Sept. 13, 2017 — Zosano Pharma Corp. (NASDAQ:ZSAN) (“Zosano” or the “Company”) a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using our proprietary ADAM technology, presented data from its pivotal Phase 2/3 ZOTRIP study evaluating M207 as an acute treatment for migraine during the 18^th Annual Congress of the International Headache Society in Vancouver, BC. The data were presented by Dr. Don Kellerman, Vice President of Clinical Development and Medical Affairs.

As previously reported, the 3.8mg dose of M207 met both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours.  In addition, the 3.8mg dose showed durability of effect on pain freedom to 24 and 48 hours.

Two other poster presentations related to the results of the ZOTRIP study were presented at the meeting.  Dr. Pete Schmidt and co-authors presented an abstract entitled “Experience with Delayed Treatment of Migraine and Morning Migraine Treatment Using Intracutaneous Zolmitriptan (M207).” Dr. David Dodick and co-authors presented a poster based on an abstract entitled “Use of Most Bothersome Symptom as an Endpoint in an Acute Treatment of Migraine Trial.”

M207 is designed to rapidly deliver zolmitriptan during a migraine attack utilizing Zosano’s proprietary Adhesive Dermally-Applied Microarray, or ADAM technology.  Zosano’s ADAM technology consists of titanium microprojections coated with drug, and in the case of M207, our formulation of zolmitriptan.  Our ADAM technology delivers zolmitriptan by abrading the stratum corneum and allowing drug to be absorbed into the microcapillary system of the skin.

“Presenting our results in a rigorous scientific forum, and discussing them with world-class headache experts is very valuable for helping us understand the types of patients who might benefit most from our unique drug delivery method,” said Dr. Kellerman. “We continue to receive positive input from experts in the field about how this product could be valuable in the treatment paradigm for migraine, once it is available for patients.  We have been fortunate to work with a great group of Clinical Advisors who continue to provide valuable insight as we move forward with clinical development.”

Zosano’s novel delivery of zolmitriptan was confirmed by the results from the ZOTRIP study, where 41.5% of the patients treated with the 3.8mg dose of M207 achieved pain freedom at 2 hours, and the effect also appeared to be durable, with 31.7% and 26.8% of patients achieving sustained pain freedom from 2-24 hours and 2-48 hours respectively. In post-hoc analyses, M207 also demonstrated efficacy in traditionally difficult to treat established migraine headaches, as evidenced by a nearly identical therapeutic effect in those who treated prior to and after 2 hours. Additionally, 44 % of patients who awoke with their migraine headache were pain-free at 2 hours. Patients in this trial were instructed not to treat until their headache reached moderate to severe intensity and the mean time from headache onset to treatment was almost 5 hours.

The ZOTRIP Study

The ZOTRIP pivotal efficacy study was a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. Subjects were enrolled in the ZOTRIP trial at 36 centers across the United States. Those recruited into the trial had a history of at least one year of migraine episodes with or without aura. Upon recruitment, the subjects entered a run-in period that ensured they met the key eligibility criteria of 2-8 migraine attacks per month, which was documented using an electronic diary or an app on their cell phone. Subjects also identified their most bothersome symptom and indicated the presence or absence of nausea, phonophobia or photophobia, during the episodes in the run-in period. Successfully screened subjects were then randomized into the treatment/dosing period in which they had 8 weeks to confirm and receive blinded treatment for a single migraine attack, termed “qualifying migraine.” In which the most bothersome symptom had to be present.

During a qualifying migraine, subjects scored the severity of pain on a 4-point scale, and the presence or absence of migraine associated symptoms (photophobia, phonophobia or nausea), starting pre-dose and then at several intervals over 48 hours post-dose.

ZOTRIP Results

Five hundred and eighty nine subjects were enrolled in this study, of which 365 were randomized. Of those randomized, 333 subjects treated and are included in the safety analysis, and 321 qualified for the modified intent-to-treat (mITT) population. 51% of the subjects randomized were found to have severe migraine pain pre-treatment. Also at the time of treatment, 70% reported nausea, 37% aura, and 51% waking up with their migraine (morning migraine).  With the multiple doses and multiple endpoints in the trial, a sequential testing procedure was used beginning with the highest dose and the co-primary endpoints.  Since statistical significance was not achieved for most bothersome symptom in the 1.9 mg group, p-values for secondary endpoints should be considered nominal p-values.

The 3.8mg dose of M207 achieved statistical significance for both co-primary endpoints at two hours:

Furthermore, secondary endpoints measuring pain freedom at additional time points for the 3.8mg dose of M207 showed M207 superior to placebo with a nominal p-value less than 0.05:

M207 was well-tolerated with no SAEs

• Overall, 13 subjects (3.9%) reported pain at the application site; application site pain was reported as mild in all but 3 subjects;
• The most frequently reported adverse event was redness at the application site (18.3% of subjects).  All cases of redness resolved;
• Additionally, 5 (1.5%) patients across M207-treated groups reported dizziness vs 0% on placebo.

About Migraine

Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. Migraine symptoms can include moderate to severe headache pain combined with nausea and vomiting, or abnormal sensitivity to light and sound.  According to the Migraine Research Foundation, migraine affects 30 million men, women and children in the United States. Most migraines last between four and 24 hours, but some last as long as three days. According to published studies, 63% of migraine patients experience between one and four migraines per month. According to Decision Resources, prescription drug sales for migraine in the top seven countries were estimated to be $3.3 billion in 2015, and are expected to grow to $4.4 billion in 2020. Triptans, a family of tryptamine-based drugs first sold in the 1990s, account for almost 75% of anti-migraine therapies prescribed at office visits.

About M207

M207 is our proprietary formulation of zolmitriptan delivered utilizing Zosano’s proprietary Adhesive Dermally-Applied Microarray, or ADAM technology.  Zosano’s ADAM technology consists of titanium microprojections coated with drug, and in the case of M207, our formulation of zolmitriptan.  Our ADAM technology delivers drug by abrading the stratum corneum and allowing drug to be absorbed into the microcapillary system of the skin.  In February 2017, the Company announced statistically significant results from the ZOTRIP trial, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.

About Zosano Pharma

Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using our proprietary Adhesive Dermally-Applied Microarray, or ADAM technology.  The Company recently announced positive results from our ZOTRIP study that evaluated M207, which is our proprietary formulation of zolmitriptan delivered via our ADAM technology, as an acute treatment for migraine.  Zosano is focused on developing products where rapid administration of established molecules with known safety and efficacy profiles provides an increased benefit to patients, for markets where patients remain underserved by existing therapies. The Company anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” “unaudited,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K.. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.

Zosano Contact:
Georgia Erbez
Chief Business Officer and
Chief Financial Officer
510-745-1200

$NXTD Subsidiary FitPay & $BAC Collaborate; Wearable and IoT Payment

Agreement will enable Bank of America customers to use their debit or credit cards with a range of new devices

MELBOURNE, Florida, September 7, 2017 —

Bank of America (NYSE: BAC ) and FitPay, Inc., a wholly-owned subsidiary of NXT-ID, Inc. (NASDAQ: NXTD), today announced an agreement to extend contactless payment capabilities to a range of new devices, giving Bank of America customers more payment options and accelerating the adoption of new payment devices. This collaborative effort enables Bank of America customers to use their credit or debit cards to make secure contactless payments directly from devices that are integrated with the FitPay^[TM] payment platform at NFC-enabled point-of-sale locations and more than 9,000 Bank of America ATMs.

“As digital payments evolve, our goal is to give Bank of America customers access to payment options that are easy to use and highly secure,” said Mark Monaco, Head of Enterprise Payments at Bank of America. “Working with FitPay will allow our customers to use a range of new contactless payment devices to improve the payment experience, provide a high level of security, and fit seamlessly into any lifestyle.”

Under the agreement, Bank of America will participate in FitPay’s Digital Wallet Program, which enables manufacturers of Internet of Things (IoT) and wearable devices to add contactless payment capabilities to their product, making it possible for consumers to pay for goods and services at near-field communication-enabled (NFC) point-of-sale terminals with a simple tap. The platform uses tokenization, a payment security technology that replaces cardholders’ account information with a unique digital identifier (a ‘token’), to transact highly secure contactless payments.

“We are very pleased to be working with Bank of America to give their customers access to the latest payment technology,” said Michael Orlando, COO of NXT-ID and President of FitPay, Inc. “Broad adoption of digital payments requires fundamentally changing the payment experience and making new payments methods widely available. Our work with device manufacturers and Bank of America is driving both of these goals.”

Manufacturers of 15 IoT and wearable devices are currently integrating with the FitPay payment platform. Bank of America and FitPay are working together to enable Bank of America customers to use their credit or debit cards to make contactless payments or use NFC-enabled Bank of America ATMs with these devices. This collaboration includes ensuring that the devices meet Bank of America’s technical, usage, security, branding, and consumer experience requirements. Product announcements from the manufacturers of these devices are anticipated in 2017 and 2018.

Bank of America  
Bank of America is one of the world’s leading financial institutions, serving individual consumers, small and middle-market businesses and large corporations with a full range of banking, investing, asset management and other financial and risk management products and services. The company provides unmatched convenience in the United States, serving approximately 47 million consumer and small business relationships with approximately 4,500 retail financial centers, approximately 16,000 ATMs, and award-winning digital banking with approximately 34 million active users, including 23 million mobile users. Bank of America is a global leader in wealth management, corporate and investment banking and trading across a broad range of asset classes, serving corporations, governments, institutions and individuals around the world. Bank of America offers industry-leading support to approximately 3 million small business owners through a suite of innovative, easy-to-use online products and services. The company serves clients through operations in all 50 states, the District of Columbia, the U.S. Virgin Islands, Puerto Rico and more than 35 countries. Bank of America Corporation stock (NYSE: BAC) is listed on the New York Stock Exchange.

Visit the Bank of America newsroom for more Bank of America news, and click here to register for news email alerts.

NXT- ID, Inc. and FitPay, Inc.

NXT-ID, Inc. (NASDAQ: NXTD) provides a comprehensive platform of technology products and services that enable the Internet of Things (IoT). With extensive experience in access control, biometric and behavior-metric identity verification, security and privacy, encryption and data protection, payments, miniaturization and sensor technologies, NXT-ID develops and markets groundbreaking solutions for payment and IoT applications. Its industry-leading technology products and solutions include MobileBio®, a suite of biometric solutions that secure consumers’ mobile platforms, the Wocket™, a next-generation smart wallet and the Flye, a digital credit card developed in collaboration with WorldVentures. NXT-ID includes three mobile and IoT-related subsidiaries: LogicMark, LLC, a manufacturer and distributor of non-monitored and monitored personal emergency response systems (“PERS”) sold through dealers/distributors and the United States Department of Veterans Affairs; FitPay, Inc., a proprietary technology platform that delivers end-to-end solutions to device manufacturers for contactless payment capabilities, credential management, authentication and other secure services within the IoT ecosystem, and 3D-ID LLC, which is engaged in biometric identification and authentication. Learn more about NXT-ID at http://www.nxt-id.com . NXT-ID Inc. Corporate Contact: info@nxt-id.com . FitPay and the FitPay Payment Platform are trademarks of FitPay, Inc.

Forward-Looking Statements for NXT-ID: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company’s business strategy. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Such risks and uncertainties include, among other things, our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the availability of financing; the Company’s ability to implement its long range business plan for various applications of its technology; the Company’s ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission.

Media Contacts:

Bank of America
Betty Riess
+1-415-913-4416

FitPay, Inc. and NXT-ID
Chris Orlando
chris@fit-pay.com
+1-760-468-7273

D. Van Zant
press@nxt-id.com
+1-800-665-0411

$LOXO Initial LOXO-292 Clinical Data, Lung Cancer

STAMFORD, Conn., Sept. 13, 2017  — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced that its investigators will present initial clinical data for LOXO-292 at the International Association for the Study of Lung Cancer (IASLC) 18^th World Conference on Lung Cancer to be held October 15-18, 2017, in Yokohama, Japan. The oral presentation will include case reports for two patients with RET fusion lung cancer, previously treated with multikinase inhibitors (MKIs), who received LOXO-292, Loxo Oncology’s highly selective RET inhibitor.

The schedule for the late-breaking oral presentation is as follows:

Presentation Date: October 18, 2017
Title: LOXO-292, a potent, highly selective RET inhibitor, in MKI-resistant RET fusion-positive lung cancer patients with and without brain metastases
Session Title: Emerging Genomic Targets
Presenter: Vamsidhar Velcheti, M.D.

About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancer, and a subset of colon and other cancers. RET point mutations account for approximately 60% of medullary thyroid cancer. Both RET fusion and select RET mutated cancers are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as “oncogene addiction,” renders such tumors highly susceptible to small molecule inhibitors targeting RET. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in a Phase 1 trial. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email clinicaltrials@loxooncology.com.

About Loxo Oncology
Loxo Oncology is a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers. Our pipeline focuses on cancers that are uniquely dependent on single gene abnormalities, such that a single drug has the potential to treat the cancer with dramatic effect. We believe that the most selective, purpose-built medicines have the highest probability of maximally inhibiting the intended target, thereby delivering best-in-class disease control and safety. Our management team seeks out experienced industry partners, world-class scientific advisors and innovative clinical-regulatory approaches to deliver new cancer therapies to patients as quickly and efficiently as possible. For more information, please visit the company’s website at www.loxooncology.com.

Contacts for Loxo Oncology, Inc.

Company:
Jacob S. Van Naarden
Chief Business Officer
jake@loxooncology.com

Investors:
Peter Rahmer
The Trout Group, LLC
646-378-2973
prahmer@troutgroup.com

Media:
Dan Budwick
1AB Media
973-271-6085
dan@1abmedia.com

$QTNT Latest MosaiQ Performance Evaluation Studies Quite Positive

• Performance evaluation studies confirm required concordance levels for all assays
• Verification and validation studies to commence shortly
• European field trials still expected to be completed in CY17

JERSEY, Channel Islands, Sept. 12, 2017 — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today reported progress on performance evaluation studies for MosaiQ.

“Our latest performance evaluation results represent a key final step prior to commencing our verification and validation studies, allowing us to reaffirm our goal of completing planned field trials in Europe for MosaiQ during the second half of this year,” said Paul Cowan, Chairman and Chief Executive Officer of Quotient.

Assay Performance

Results of internal performance evaluation studies for the MosaiQ IH Microarray (the initial blood grouping microarray) and the MosaiQ SDS Microarray (the initial disease screening microarray) indicate that MosaiQ achieved the required targeted performance compared with predicate technologies. The performance evaluation data were derived using microarrays manufactured in Quotient’s validated, high-volume manufacturing facility and run on field trial-ready instruments. Final internal verification and validation studies for the MosaiQ IH Microarray and MosaiQ SDS Microarray are the next step in preparation for European field trials later this year.

MosaiQ IH Microarray – Antigen Typing

A summary of the most recent performance evaluation data derived in our ongoing study for antigen typing is set out below:

In this study 571 donor samples were tested.

MosaiQ IH Microarray – Antibody Detection

The most recent performance evaluation data for the antibody detection assay achieved 99.1% concordance compared with the predicate technology.  In these studies, 788 donor samples and 28 known positive samples were tested.

MosaiQ SDS Microarray

The most recent performance evaluation study for the MosaiQ SDS Microarray achieved 100% sensitivity and 98% specificity for CMV and 100% sensitivity and 100% specificity for syphilis.

Regulatory and Commercial Milestones – For Next Twelve Months are Confirmed

• European Field Trials – Quotient expects to complete European field trials during CY17
• European Regulatory Approval – Upon the successful completion of European field trials Quotient expects to file promptly for European regulatory approval for MosaiQ
• European Commercialization – Quotient has commenced the commercialization of MosaiQ in Europe, where it has already received invitations to participate in tenders to be awarded in the middle of CY18
• U.S. Field Trials and subsequent Regulatory Filing will follow the successful completion of European field trials.

MosaiQ Platform

MosaiQ, Quotient’s next-generation platform is designed to deliver fast, comprehensive antigen typing, antibody detection and disease screening results, using a single low volume sample in a high throughput automated format. MosaiQ represents a transformative and highly disruptive unified testing platform for transfusion diagnostics. Feasibility has also been demonstrated with respect to the detection of nucleic acids (DNA or RNA) using the MosaiQ platform. Through MosaiQ, Quotient expects to deliver substantial value to donor testing laboratories worldwide by providing affordable, routine comprehensive characterization and screening of blood products, on a single automated instrument platform designed to radically reduce labor costs and complexity associated with existing practice.

About Quotient Limited

Quotient is a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and serological disease screening, Quotient is developing its proprietary MosaiQ^TM technology platform to offer a breadth of tests that is unmatched by existing commercially available transfusion diagnostic instrument platforms. The Company’s operations are based in Edinburgh, Scotland; Eysins, Switzerland and Newtown, Pennsylvania.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include delays or denials of regulatory approvals or clearances for products or applications; market acceptance of our products; the impact of competition; the impact of facility expansions and expanded product development, clinical, sales and marketing activities on operating expenses; delays or other unforeseen problems with respect to manufacturing, product development or field trial studies; adverse results in connection with any ongoing or future legal proceeding; continued or worsening adverse conditions in the general domestic and global economic markets; as well as the other risks set forth in the Company’s filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-looking statements.

The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.

CONTACT: Chris Lindop, Chief Financial Officer – chris.lindop@quotientbd.com; +41 22 545 52 26

$AEMD Expedited Access Pathway Designation from FDA for Hemopurifier®

SAN DIEGO, Sept. 12, 2017  — Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company focused on unmet needs in global health and biodefense, announced today that it has received an Expedited Access Pathway (EAP) designation from the United States Food and Drug Administration (FDA) to support the advancement of the Aethlon Hemopurifier® to treat life-threatening viruses. The FDA EAP program was established to facilitate more rapid patient access to breakthrough technologies with the potential to address life threatening disease conditions for which no approved or cleared treatment alternatives exist.

“We are honored to have our Hemopurifier® designated to the Expedited Access Pathway and additionally are pleased that FDA has also allowed our proposed “indication for use,” which provides the possibility of treating a wide-range of life-threatening viruses versus a single disease condition,” said Jim Joyce, Chairman and CEO of Aethlon Medical.

Aethlon proposed the following “indication for use” in its EAP submission; “The Hemopurifier is a single-use device indicated for the treatment of life-threatening highly glycosylated viruses that are not addressed with an approved treatment.” To date, the Hemopurifier has been validated to capture a broad-spectrum of viruses that are highly glycosylated, including life-threatening strains of pandemic influenza viruses, mosquito-borne viruses as well as hemorrhagic viruses that are not addressed with an approved treatment.

The FDA established the EAP program for medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), premarket notification (510[k]) or requests for De Novo designation. Under EAP, the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA’s PMA approval standard of reasonable assurance of safety and effectiveness.

About Aethlon Medical, Inc.
Aethlon Medical is focused on addressing unmet needs in global health and biodefense. The Aethlon Hemopurifier® was designed to reduce the presence of life-threatening viral pathogens from the circulatory system of infected individuals. The technology provides a first-line candidate defense against viruses that are not addressed with approved therapies, including a broad-spectrum of naturally occurring pandemic threats and agents of bioterrorism. Aethlon Medical is also investigating the potential use of the Hemopurifier® to reduce the presence of tumor-derived exosomes, which contribute to immune-suppression and the spread of metastasis in cancer patients. Aethlon Medical is the majority owner of Exosome Sciences, Inc. (ESI), which is a diagnostic company focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disorders, including Alzheimer’s disease (AD) and Chronic Traumatic Encephalopathy (CTE). Additional information can be found online at www.AethlonMedical.com and www.ExosomeSciences.com. You can also connect with us on Twitter, LinkedIn, Facebook and Google+.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as “may,” “believe,” “anticipate,” “expect,” “intend,” “plan,” “project,” “will,” “projections,” “estimate,” or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that may contribute to such differences include, without limitation, the Company’s ability to maintain its listing on the Nasdaq Capital Market, or any other national securities exchange, that the Company or its subsidiary will not be able to commercialize its products, that the FDA will not approve the initiation or continuation of the Company’s clinical programs or provide market clearance of the Company’s products, the Company’s ability to raise capital when needed, the Company’s ability to complete the development of its planned products, the Company’s ability to manufacture its products either internally or through outside companies, the impact of government regulations, patent protection on the Company’s proprietary technology, the ability of the Company to meet the milestones contemplated in its contract with DARPA, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2017, and in the Company’s other filings with the Securities and Exchange Commission. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

Company Contact:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
858-489-7800 x3300
Jfrakes@aethlonmedical.com

Media Contact:
David Schull or Maggie Beller
Russo Partners, LLC
David.Schull@RussoPartnersLLC.com
Maggie.Beller@RussoPartnersLLC.com
212-845-4271

Investor Relations:
John Marco
CORE IR
516 222 2560
johnm@coreir.com

$ALDX Announces Positive Results from Dry Eye Disease Phase 2a Clinical Trial

Statistically and Clinically Significant Improvement Across Multiple Sign and Symptom Endpoints Onset of Action Observed Within One Week of Therapy Phase 2b Clinical Trial Expected to be Initiated in the First Half of 2018

LEXINGTON, Mass., Sept. 12, 2017 — Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a clinical-stage biotechnology company devoted to treating inflammation, inborn errors of metabolism, and other diseases related to endogenous aldehyde toxicity, today announced positive results from a Phase 2a clinical trial of topical ocular ADX-102 in patients with dry eye disease.

“ADX-102 is a promising agent for the treatment of dry eye disease, a persistently challenging condition for many people worldwide,” commented John Sheppard, M.D., Professor of Ophthalmology, Eastern Virginia Medical School. “The evidence of rapid-onset activity and the tolerability profile demonstrated in the Phase 2a clinical trial suggests that ADX-102 could provide important patient benefits relative to existing therapies.”

The randomized, dose-ranging, parallel-group, double-masked Phase 2a clinical trial investigated three formulations of ADX-102 (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid formulation) in 51 dry eye disease patients (17 per arm) treated for 28 days. The results from the pooled data over the 28-day treatment period demonstrated statistically significant improvement from baseline in Symptom Assessment in Dry Eye (SANDE) Score (p=0.003), Ocular Discomfort Score (p=0.00002), Overall Four-Symptom Score (p=0.0004), Schirmer (tear volume) Test (p=0.008), tear osmolarity (p=0.003), and Lissamine Green ocular surface staining score (p=0.002).  Improvements in dry eye disease signs and symptoms were evident within one week of therapy. A modest dose-response was observed, and activity increased over the duration of therapy, supporting evidence of the effect of drug. Levels of malondialdehyde, a pro-inflammatory aldehyde mediator sequestered by ADX-102, were significantly reduced in the tears of patients (p=0.009), supporting the differentiated mechanism of action relative to other therapies in dry eye disease.

The primary objective of the trial was to select a formulation and dose range for a Phase 2b clinical trial. Based on consistent statistically and clinically significant activity across multiple sign and symptom endpoints, and tolerability consistent with that of standard of care, 0.1% ADX-102 was nominated for advancement. Relative to baseline, improvement after 28 days of 0.1% ADX-102 therapy was statistically significant or approached statistical significance for Ocular Discomfort Score (p=0.002), the dryness component of the Four-Symptom Score (p=0.01), Overall Four-Symptom Score (p=0.048), SANDE Score (p=0.09), Schirmer Test (p=0.04), tear osmolarity (p=0.06), and tear aldehyde levels (p=0.007). Effect sizes generally correlated with clinical significance for patient-reported outcomes.

There were no safety concerns observed for any of the formulations of ADX-102, and no serious adverse events were reported.

“These data represent the fourth set of positive Phase 2 results with ADX-102 in ocular inflammation. The breadth of activity across noninfectious anterior uveitis, allergic conjunctivitis, and now dry eye disease confirms the potential of ADX-102 as an important and differentiated therapy in ophthalmology,” commented Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “We are particularly excited about the potential of ADX-102 in the dry eye disease population, which is generally perceived to be inadequately treated but accounted for approximately $1.8 billion in prescription sales in the United States in 2016. We look forward to the initiation of a Phase 2b clinical trial in dry eye disease in the first half of 2018.”

Conference Call
Aldeyra will hold a conference call on September 12, 2017 at 8:00 a.m. ET to discuss results of the clinical trial. The dial-in numbers are 1-877-870-4263 for domestic callers and 1-412-317-0790 for international callers.   A live webcast of the conference call will also be available on the investor relations page of Aldeyra’s corporate website at ir.aldeyra.com. After the live webcast, the event will remain archived on Aldeyra’s website for one year.

About Aldeyra Therapeutics
Aldeyra Therapeutics, Inc. is a biotechnology company devoted to improving lives by inventing, developing and commercializing products that treat diseases thought to be related to endogenous aldehydes, a naturally occurring class of pro-inflammatory and toxic molecules.  Aldeyra’s lead product candidate, ADX-102, is an aldehyde trap in development as topical eye drops for the treatment of ocular inflammation. ADX-102 has now been tested in over 250 patients in Phase 2 clinical trials in dry eye disease, allergic conjunctivitis, and noninfectious anterior uveitis. A dermatologic form of ADX-102 is in late-stage clinical development for the treatment of ichthyosis due to Sjögren-Larsson Syndrome, an inborn error of aldehyde metabolism. ADX-102 has not been approved for sale in the U.S. or elsewhere.

About Dry Eye Disease
Dry eye disease is a common inflammatory disease estimated to affect approximately 20 million people in the United States, and is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, and in severe cases, decreased vision. Among physicians and patients, existing therapy for dry eye disease is generally regarded as inadequate. In patients with dry eye disease, pro-inflammatory aldehyde mediators may contribute to ocular inflammation. By diminishing aldehyde levels, Aldeyra’s topical ocular aldehyde trap platform represents a novel and differentiated approach for the treatment of dry eye disease.

Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra’s plans and expectations for the development of ADX-102 and the timing thereof; the potential of ADX-102 as an agent for the treatment of dry eye disease; the ability of ADX-102 to provide important patient benefits and a differentiated mechanism of action relative to existing therapies; and estimates of the market size for Dry Eye Disease. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “aim,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Aldeyra’s forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra’s clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra’s continuing review and quality control analysis of clinical data, Aldeyra’s ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities, the ability to obtain and maintain regulatory approval to conduct clinical trials and to commercialize Aldeyra’s product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Aldeyra’s product candidates; the size and growth of the potential markets for Aldeyra’s product candidates and the ability to serve those markets; Aldeyra’s expectations regarding Aldeyra’s expenses and revenue, the sufficiency of Aldeyra’s cash resources and needs for additional financing; the rate and degree of market acceptance of any of Aldeyra’s product candidates; Aldeyra’s expectations regarding competition; Aldeyra’s anticipated growth strategies; Aldeyra’s ability to attract or retain key personnel; Aldeyra’s ability to establish and maintain development partnerships; Aldeyra’s expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra’s ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra’s business and the market in which it operates; and other factors that are described in the “Risk Factors ” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations ” sections of Aldeyra’s Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, which are on file with the Securities and Exchange Commission(SEC) and available on the SEC’s website at www.sec.gov. All of Aldeyra’s development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials.

In addition to the risks described above and in Aldeyra’s other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Corporate Contact:
Stephen Tulipano
Aldeyra Therapeutics, Inc.
Tel: +1 781-761-4904 ext. 205
stulipano@aldeyra.com

Investor Contact:
Chris Brinzey
Westwicke Partners
Tel: 339-970-2843
Chris.brinzey@westwicke.com

Media Contact:
Cammy Duong
MacDougall Biomedical Communications
781-591-3443
cduong@macbiocom.com

$CIIX FY17 Financials, 76% YoY Increase in Revenues & More

SAN GABRIEL, California, September 12, 2017 —

ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, today provides an update on its financial and business achievements for the fiscal year of 2017, as well as its outlook for fiscal year 2018. At the same time, Warren Wang, founder and CEO of CIIX, comments on the recent stock price volatility as it may relate to recent news in the Digital Currency Industry.

The fiscal year ended May 31, 2017 represents a significant milestone in the Company’s 18-year history as both its long established Financial Services/Media Division, and the more recently established Consumer Division, have made substantial progress this year.

Financial Highlights:

Financial Services Business Highlights:

• Upgraded the US stocks live video platform and revealed details of real-money trading conducted by all analysts to paid VIP subscribers.
• Announced plans to launch a Cryptocurrency Education and Trading Subscription Service and the first Chinese daily video news broadcast from the NYSE covering digital currency and blockchain technology before the end of 2017.

Hemp Oil Business Highlights:

• Established CBD Biotechnology Co., Ltd., a wholly-owned foreign enterprise in Shanghai, China; appointed Summer Yun as Chief Executive Officer (CEO); and announced plans to launch of its hemp-infused skin care line in China before end of 2017.
• Established ChineseHempOil.com, Inc., a wholly-owned subsidiary in the US; launched its first hemp oil product line “OptHemp;” and appointed Keevin Gillespie as President.
• Engaged Launch Haus, LLC, a venture building firm and digital holding company specializing in direct response marketing including digital, E-commerce and direct sales channels.
• Retained Buyopsy, LLC, a wholly owned subsidiary of Launch Haus, LLC responsible for handling direct to consumer implementations and staff augmentation, and its Principal Chris J Snook (effective September 1, 2017) to provide day-to-day leadership in growth and E-commerce for ChineseInvestors.com, Inc., ChineseHempOil.com and CBD Biotechnology Co., Ltd.

“I am very pleased about the Company’s significant increase in revenue in the fiscal year ended May 31, 2017,” says Wang. “Although the blueprint of our Company’s business strategy has expanded through its entrance into the Hemp Industry, our core subscription and investors relations services remain strong with significant growth rates. I am thankful for the investors who have supported our ongoing development plans and look forward to a prosperous year ahead.”

Looking forward, Wang states, “although the business of our Consumer Division is still in the early stages, the recently launched ‘OptHemp’ product line is gaining popularity among Chinese consumers in the US, and the Company’s first hemp-infused skin care product line will launch in China in the coming months. We believe that through the efforts of our business strategists such as Buyopsy, LLC and its principal Chris Snook, our E-commerce partners such as Elevated.com and Quiverr.com, and our talented management team, we will generate substantial revenues in FY 2018 via sales of our hemp-based products in the United States and China. Our overall goal in 2018 is for the Company is to achieve annual revenue growth of more than 100%, while cutting costs and achieving profitability.”

The Company recently announced that its Financial Services/Media Division will also be providing ancillary services in the popular Digital Currency Industry.  Digital Currency has attracted a lot of attention in recent years from the creation of Bitcoin, the world’s first decentralized digital currency, to blockchain technology, which allows digital currency to transfer value across the globe without resorting to traditional intermediaries such as banks.  This industry has also created new phenomena such as currency mining, trading, tender, and storage related businesses and has paved the way for companies such as ChineseInvestors.com, Inc. to provide its educational subscription services to the many market investors that see the unique opportunity that digital currency poses and that desire to capitalize on this market opportunity. These interested investors may not have a full understanding of the concept of digital currency or access to the latest market news; therefore the Company sees this as an opportunity to provide fundamental knowledge to Chinese speaking newcomers to digital currency, including straightforward explanations of the basics of digital currency, how to buy it and straightforward trading guidelines.  For those with digital currency experience, the Company will provide more detailed information regarding currency mining, blockchain technology, stock trends and ETFs. As part of its plan to enter the Digital Currency Industry, the Company also recently announced its plans to launch a Chinese Daily Video News Broadcast from the NYSE floor covering the Digital Currency Market.

“The Company is excited about the opportunity to enter the Digital Currency Market as an ancillary service provider,” says Wang. “Although the Company’s stock price may have recently been affected short term due to recent news in the Digital Currency Industry, as an ancillary service provider the Company does not anticipate that it will be affected long term by the ban prohibiting Chinese exchanges from providing digital currency trading services, Chinese regulators’ efforts to limit the use of digital currencies, the recent release by Chinese authorities declaring initial coin offerings (“ICOs”) illegal in China, or the US SEC’s warnings that securities laws apply to ICOs.  While these regulatory measures and the recent global news surrounding digital currency exchanges may slow the interest surrounding digital currency and ICOs, they may also make the terrain more reliable and safer for investors. Moreover, with large investors becoming more involved in the Digital Currency Market, we believe that the need to overcome the limitations of digital currency exchanges has become imperative. Although CIIX does not currently have plans for an ICO, we are excited about the opportunity to expand our subscription services and media services division on the opportunities that we expect to emerge from the Digital Currency Market.”

“However, CIIX has neither set up a cryptocurrency exchange in China, nor raised capital through an ICO. Some investors have a misunderstanding of our business,” clarifies Wang.

About ChineseInvestors.com (OTCQB: CIIX)

Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail, online and direct sales of hemp-based products and other health related products.

For more information visit ChineseInvestors.com

Subscribe and watch our video commentaries: https://www.youtube.com/user/Chinesefncom

Follow us on Twitter for real-time Company updates: https://twitter.com/ChineseFNEnglsh

Like us on Facebook to receive live feeds: https://www.facebook.com/Chinesefncom;

https://www.facebook.com/Chineseinvestors.com.english

Add us on WeChat: Chinesefn or download iPhone iOS App: Chinesefn

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776

Investor Relations:
Alan Klitenic
+1-214-636-2548

Corporate Communications:
NetworkNewsWire (NNW)
New York, New York
http://www.NetworkNewsWire.com
+1-212-418-1217 Office
Editor@NetworkNewsWire.com

$SMMT $62 Million BARDA Contract, Ridinilazole for C. difficile Infection

CAMBRIDGE, Mass. and OXFORD, United Kingdom, Sept. 11, 2017 – Summit Therapeutics (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection (‘CDI’), today announces that the Biomedical Advanced Research and Development Authority (‘BARDA’), an agency of the US government’s Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, has awarded Summit a contract worth up to $62 million. The funds will support the clinical and regulatory development of ridinilazole for the treatment of CDI, including Summit’s planned Phase 3 development program.

Ridinilazole is a highly selective, novel class antibiotic aimed at both treating the initial infection and reducing recurrent disease, which is the key clinical issue in the treatment of CDI. In a Phase 2 proof of concept clinical trial conducted in North America, ridinilazole was shown to be highly preserving of the microbiome of patients compared with the standard of care, vancomycin, and achieved a substantial reduction in rates of recurrent disease.

The Centers for Disease Control and Prevention highlighted C. difficile as one of three pathogens that pose an immediate public health threat. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the United States.

“CDI is a serious public health threat that is a significant burden on the US population, and BARDA has committed to the development of innovative treatments capable of addressing all aspects of this serious illness, including recurrent disease. BARDA’s selection of ridinilazole for an award is testament to ridinilazole’s promising clinical and preclinical data package that indicate its potential as a front-line treatment of CDI that could reduce recurrent disease,” commented Glyn Edwards, Chief Executive Officer of Summit. “This non-dilutive funding award begins to deliver on our strategy of maximizing the value of ridinilazole for patients with CDI, Summit and our shareholders, and we look forward to initiating the Phase 3 clinical program of ridinilazole.”

The BARDA contract provides for a cost-sharing arrangement under which BARDA would fund a specified portion of estimated costs for specified activities related to the continued clinical and regulatory development of ridinilazole for CDI. Under the terms of the contract, Summit is initially eligible to receive from BARDA $32 million to fund, in part, obtaining regulatory approval for and commencing enrollment and dosing into Summit’s two planned Phase 3 clinical trials of ridinilazole.  In addition, Summit is eligible for additional funding under the contract pursuant to three independent option work segments, which may be exercised by BARDA in its sole discretion upon the achievement of certain development and other milestones for ridinilazole. If the three option work segments are exercised in full, Summit would be eligible for an additional $30 million from BARDA. Activities in these three option work segments include the completion of enrollment and treatment in the two planned Phase 3 clinical trials and other activities related to the preparation for the potential submission of application for marketing approval for ridinilazole in the United States.

With this contract award, Summit remains on track to initiate two Phase 3 clinical trials of ridinilazole for CDI in the first half of 2018. The Company continues to explore various funding options for completion of its Phase 3 clinical development program, with these including entering into a collaboration with a third party, equity financing or securing additional non-dilutive funding from government entities and philanthropic, non-government and not for profit organizations.

This project will be funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600002C.

Summit will file on Form 6-K with the US Securities and Exchange Commission (‘SEC’) additional information about the agreement with BARDA. A copy of the Form 6-K will be available to download, from the date of this press release, either from the Investors section of the Company’s website at www.summitplc.com, or from the SEC website at www.sec.gov.

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR).

About BARDA
BARDA, within the HHS Office of the Assistant Secretary for Preparedness and Response, makes available medical countermeasures to address public health emergencies arising from natural and intentional threats through an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools. For more information about BARDA, visit www.phe.gov/about/BARDA/Pages/default.aspx.

About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community with over one million estimated cases of CDI each year in the United States and Europe. There are an estimated 29,000 death per year from CDI in the United States alone. The Centers for Disease Control and Prevention highlighted C. difficile as one of three pathogens that pose an immediate public health threat. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the United States.

CDI is a bacterial infection of the colon that produces toxins that cause inflammation and severe diarrhea, and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that can cause widespread damage to the natural gastrointestinal (gut) flora and allow overgrowth of C. difficile bacteria. Existing CDI treatments are predominantly broad spectrum antibiotics, and these cause further damage to the gut flora and are associated with high rates of recurrent disease. Recurrent disease is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.

About Ridinilazole
Ridinilazole is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In this trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. The Phase 2 trial was conducted in North America with the majority of sites located in the United States. Ridinilazole has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.

About Summit Therapeutics
Summit Therapeutics is a biopharmaceutical company with operations in the United States and United Kingdom and is focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.Summitplc.com and Summit can be followed on Twitter (@Summitplc).

For more information, please contact:

Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including but not limited to, statements about the potential benefits and future operation of the BARDA contract, including any potential future payments thereunder, the clinical and preclinical development of our product candidates and the potential for their commercialization, the therapeutic potential of our product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, any other potential third-party collaborations, expectations regarding the sufficiency of our cash resources to fund operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the ability of BARDA to terminate our contract for convenience at any time, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, laws and regulations affecting government contracts, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that we make with the Securities and Exchange Commission, including our Annual Report on Form 20-F for the fiscal year ended 31 January 2017. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.

$TEAR to Present at the 19th Annual Rodman and Renshaw Global Investment Conference

SAN DIEGO, Sept. 11, 2017 — TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (the “Company”), today announced that the company will be featured as a presenting company at the 19th Annual Rodman & Renshaw Global Investment Conference being held September 10-12, 2017 at the Lotte New York Palace Hotel in New York, NY.

TearLab’s management will provide a corporate overview and business update on the company during the presentation at the conference.

Details of the presentations are as follows:

The presentation will be webcast and available for replay in the Investor Section of TearLab’s website www.tearlab.com.

About TearLab Corporation

TearLab Corporation (www.tearlab.com) develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve standard of care by objectively and quantitatively testing for disease markers in tears at the point-of-care. The TearLab Osmolarity Test, for diagnosing Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System.  TearLab Corporation’s common shares trade on the NASDAQ Capital Market under the symbol ‘TEAR’ and on the Toronto Stock Exchange under the symbol ‘TLB’.

Investor Contact:

The Ruth Group

Lee Roth

Tel: 646-536-7012

lroth@theruthgroup.com

$PPHM Appointment of Roger J. Lias, Ph.D. as President of Avid Bioservices

Senior Executive with More Than Two Decades of CDMO Management Experience to Also Join Peregrine’s Board of Directors

TUSTIN, Calif., Sept. 11, 2017 — Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and through its proprietary R&D pipeline, today announced the appointment of Roger J. Lias, Ph.D., as the new president of Avid Bioservices, the company’s wholly-owned contract development and manufacturing organization (CDMO) subsidiary.  Dr. Lias, who has more than 20 years of CDMO management experience, will also join Peregrine’s board of directors. In conjunction with this appointment, Steven King will step down from his role as president of Avid on September 25, 2017 and remain as president and chief executive officer of Peregrine.

“We have been in the process of transforming the company from a research and development focused organization offering CDMO services to a pure play CDMO.  We have been looking for someone with a breadth of experience in the biologics contract development and manufacturing industry.  We are very pleased to have the opportunity to bring someone with Roger’s impressive track record within the CDMO industry to help guide expansion and growth of the business,” said Mr. King. “Roger has a solid track record of success in driving business expansion, growing revenues and building stockholder value.  We are looking forward to seeing the positive impact Roger can have on the Avid business and I look forward to closely working with him to maintain the continuity of the business during the coming transition.”

Throughout his career, Dr. Lias has held senior management positions at several leading CDMOs including Cytovance Biologics, KBI BioPharma, Diosynth RTP (formerly Covance Biotechnology Services) and Lonza Biologics. At each of these companies, he was primarily charged with overseeing commercial operations, including growing and diversifying their respective client bases. During this time, Dr. Lias’ achievements ranged from building start-up Cytovance’s contract process development and biopharmaceutical cGMP production business, to increasing revenues at Diosynth from $16 million to $120 million over a four-year period. Additionally, he has built a reputation as a highly regarded CDMO industry advocate who has contributed to the acceptance and growth of the biologics contract manufacturing market. Dr. Lias earned his Ph.D. from Clare College at the University of Cambridge in the United Kingdom.

“As someone with a long history in the CDMO space, I was impressed by the level of sophistication of the current Avid operation ranging from the recently opened state-of-the-art Myford facility to the industry leading services and capabilities available to its clients,” said Dr. Lias. “The Avid team has successfully put the key pieces in place to allow the company to become a significant player in the rapidly expanding CDMO industry. I am excited work to build upon that foundation and help the company take the next important step in establishing itself as the CDMO of choice for high quality cGMP clinical and commercial manufacturing services.”

Dr. Lias most recently served as executive director, head of global biologics business development for Allergan plc., where he was responsible for developing and executing strategies designed to support the company’s business development activities related to innovative biologics, biosimilars and complex injectable products. In this role, he was instrumental in identifying, structuring and negotiating a biosimilars co-development collaboration with Amgen for four oncology biosimilar monoclonal antibody products.  Prior to Allergan, Dr. Lias was president and group commercial director for Eden Biodesign, an established biopharmaceutical contract manufacturer and consultancy and wholly-owned subsidiary of Eden Biopharma Group. During his time with Eden Biodesign, he successfully transitioned the company’s CDMO client base from early-stage biotechnology companies to established biotechnology and multinational pharmaceutical companies, while also playing a key role in the eventual sale of Eden Biopharma Group to Watson Pharmaceuticals (now Allergan).

“We recently initiated a search for individuals with relevant biologics contract manufacturing experience as part of our efforts to expand and change the makeup of the board of directors as we move toward a focus on growing the Avid CDMO business.  We were fortunate to identify Roger as an ideal candidate early in the process and he quickly established himself as the clear choice for not only joining the board but also as the candidate for president.  He has had a long and successful career in the CDMO space, as well as a clear vision for achieving success for Avid in the near and long-term,” said David H. Pohl, member of the Peregrine board of directors and head of the company’s nominating committee. “We look forward to having Roger join the board and the contributions he can make to the continued success of the business.”

Avid Bioservices was established out of Peregrine’s internal biologics manufacturing and development capabilities and began formal operations in January 2002.  The company has grown from an internal support operation to a full service CDMO that manufactures bulk drug substance for products that are approved and marketed in over 18 countries by leading biopharma companies. Avid was recently recognized as a leading CDMO by Life Science Leader as a recipient of multiple 2017 Contract Manufacturing Leadership Awards for Quality, Reliability, Capabilities, Expertise and Compatibility. The company has an outstanding regulatory inspection history and state-of-the-art cGMP manufacturing facilities. Mr. King has served as president of Avid since its formation in addition to his role as president and CEO of Peregrine Pharmaceuticals since 2003.

About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development and manufacturing organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products.  Peregrine’s in-house CDMO services, including cGMP manufacturing and development capabilities, are provided through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. The company is also working to evaluate its lead immunotherapy candidate, bavituximab, in combination with immune stimulating therapies for the treatment of various cancers, and developing its proprietary exosome technology for the detection and monitoring of cancer.  For more information, please visit www.peregrineinc.com.

About Avid Bioservices, Inc.
Avid Bioservices, a wholly owned subsidiary of Peregrine Pharmaceuticals, provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 20 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid’s services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit www.avidbio.com.

Contacts:
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com	

Tim Brons (Media)	
Vida Strategic Partners	
415-675-7402
tbrons@vidasp.com

$MRNS Successful Clinical Trial Results Ganaxolone Focused on CDKL5 Disorder

Substantial and Durable Anti-Seizure Efficacy Shown in Patients Suffering From Severe,

Rare Genetic Epilepsy

Marinus to Host Conference Call and Webcast Today at 9:00 am EDT

RADNOR, Pa., Sept. 11, 2017 –  Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), today announced that top-line data from the Phase 2 open-label study in patients with CDKL5 disorder support advancing ganaxolone into a definitive late-stage clinical trial. Oral ganaxolone, in addition to baseline treatment, showed a sizable and durable seizure-frequency reduction in the majority of patients, with some achieving an increase in the number of seizure-free days and reporting behavioral benefits. CDKL5 disorder is a severe, rare genetic epilepsy that results in early-onset, treatment-refractory seizures, pervasive neuro-developmental delay and disabling behavioral issues. There are no approved or effective available treatment options. Marinus plans to meet with regulatory agencies to obtain agreement on the clinical development plan that would be needed for approval of ganaxolone for CDKL5 disorder.

Orrin Devinsky, MD, Director of the NYU Langone Medical Center’s Comprehensive Epilepsy Center and Principal Investigator in the current study, commented, “I am impressed with the magnitude of seizure reduction and gain in seizure-free days seen with ganaxolone treatment in children with this highly refractory epilepsy. The durable anti-epileptic effect seen in several children distinguishes ganaxolone’s efficacy from the more than 20 currently available anti-epileptic drugs that provide limited seizure control lasting a few weeks to months. When treating children with the severest forms of epilepsy such as CDKL5 disorder, there is a desperate need for new drugs that are well-tolerated, efficacious and easy to administer with no need for special monitoring. With no other treatment showing this degree of promise, I am excited to lead the effort to advance ganaxolone into potentially the first, late-stage clinical trial in children with CDKL5 disorder.”

Top-line Data:

• The median change in 28-day seizure frequency from baseline in the ITT (intent-to-treat) population (primary endpoint) was a decrease of 43% (n=7).
• The median change from baseline in seizure-free days in the ITT population (key secondary endpoint) was an increase of 78% (n=5; two subjects cannot be calculated due to 0 baseline seizure-free days).
• Five of the seven children experienced a meaningful seizure reduction compared to baseline; median reduction of 65% (range 24% – 85%).
• Three children have so far met the criteria to enter the one year study extension (completed 26-weeks of treatment with excellent seizure control) and continue to experience a median seizure reduction of 70% and median increase in seizure-free days of 75%.
• The Clinical Global Impression Scale rated by Investigators (CGI-I) and Caregivers (CGI-P) were consistent with seizure control for all the children. Children with a 43% or higher seizure reduction were rated as “much improved” or “very much improved” by the Investigators and Caregivers.
• Investigators and Caregivers reported improvements in attention, mood, behavior and sleep via investigator narratives.
• Ganaxolone was generally safe and well-tolerated with no serious adverse events. To date, there have been no adverse event reports of somnolence or dizziness.
• One child has not yet reached the 26-week visit and two children discontinued prior to completing the 26-week treatment due to lack of efficacy.

Nicola Specchio, MD, PhD, Principal Investigator at the Ospedale Pediatrico Bambino Gesù in Rome, commented, “I am very impressed with the improvement my patients experienced while on ganaxolone. They showed a sizeable decrease in seizure frequency and increase in attention associated with a calmer demeanor, which exceeded my expectations. Ganaxolone’s safety profile and effect on seizure and non-seizure related comorbidities, common in children with CDKL5 disorder, makes it an exciting potential therapeutic for this rare patient population that critically needs an effective and lasting treatment option.”

Marinus is planning to submit the full CDKL5 disorder data set for publication or presentation at a medical conference.  Earlier this year, Marinus received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) to develop ganaxolone for the treatment of CDKL5 Disorder.

“We believe that the efficacy and safety profile of ganaxolone in this study provide compelling evidence that a definitive study in patients with CDKL5 disorder should be undertaken as soon as possible,” commented Dr. Lorianne Masuoka, Chief Medical Officer of Marinus Pharmaceuticals.  “The tolerability and complete lack of dose regimen-limiting safety concerns, as compared to the most widely used anti-epileptic drugs for this condition, could make ganaxolone an exceptional option for patients with CDKL5 disorder.”

The study enrolled seven children between the ages of 2 and 16 at three sites within the U.S. and Italy.  Following screening and baseline evaluations, children received up to 1,800 mg/day of oral ganaxolone in addition to their current treatment regimen for up to 26-weeks. The primary efficacy measure was percent change from baseline in the 28-day seizure frequency over 26-weeks. The key secondary outcome measure was percent change from baseline in seizure-free days. Safety and tolerability were secondary objectives of the study. Patients responding to therapy were given the option to enroll into a 52-week extension program.

In addition to the CDKL5 disorder cohort of patients, Marinus evaluated a cohort of Lennox-Gastaut syndrome (LGS) patients.  Based upon these robust CDKL5 disorder clinical results and etiologic fit with ganaxolone’s mechanism of action, Marinus has prioritized CDKL5 disorder as its lead pediatric orphan program for advancement into later stage clinical development.

Conference Call and Webcast Details
Marinus will host a conference call today at 9:00 a.m. EDT. Stockholders and other interested parties may participate in the call by dialing 844-277-9448 (domestic) or 336-525-7135 (international) and referencing conference ID number 79335646. The live webcast can be accessed on the investor page of Marinus’ website at http://ir.marinuspharma.com/events.cfm. A replay will be available on Marinus’ website approximately two hours after completion of the event and will be archived for up to 30 days.

About CDKL5 Disorder

CDKL5 disorder is a serious and rare genetic disorder that is caused by a mutation of the cyclin-dependent kinase-like 5 (CDKL5) gene, located on the X chromosome. It predominantly affects girls and is characterized by early-onset, difficult-to-control seizures and severe neuro‑developmental impairment. The CDKL5 gene encodes a protein essential for normal brain function.  Most children affected by CDKL5 cannot walk, talk, or care for themselves. Many also suffer from scoliosis, visual impairment, gastrointestinal difficulties, and sleeping disorders. CDKL5 disorder is among the epileptic encephalopathies that are most refractory to treatment.  Currently, there are no approved therapies for CDKL5 Disorder.

About Ganaxolone

Ganaxolone, a positive allosteric modulator of GABA_A, is being developed in three different dose forms (intravenous, capsule, and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Unlike benzodiazepines, ganaxolone exhibits anti-seizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABA_A receptors.  Ganaxolone has been studied in more than 1,500 subjects, both pediatric and adult, at therapeutically relevant dose levels and treatment regimens for up to two years. In these studies, ganaxolone was generally safe and well-tolerated. The most commonly reported adverse events were somnolence, dizziness and fatigue.

About Marinus Pharmaceuticals

Marinus Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development of ganaxolone, which offers a new mechanism of action, demonstrated efficacy and safety, and convenient dosing to improve the lives of patients suffering from epilepsy and neuropsychiatric disorders. Ganaxolone is a positive allosteric modulator of GABA_A that acts on a well-characterized target in the brain known to have both anti-seizure and anti-anxiety effects. Ganaxolone is being developed in three different dose forms (IV, capsule and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Marinus is currently evaluating ganaxolone in women with postpartum depression and in orphan pediatric indications for the treatment of genetic seizure and behavior disorders, and preparing to initiate a Phase 2 study in status epilepticus, an orphan indication. For more information visit www.marinuspharma.com. Please follow us on Twitter: @MarinusPharma.

Forward-Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Words such as “may”, “will”, “expect”, “anticipate”, “estimate”, “intend”, “believe”, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.  Examples of forward-looking statements contained in this press release include, among others, statements regarding our interpretation of preclinical studies, development plans for our product candidate, including the development of dose forms, the clinical trial testing schedule and milestones, the ability to complete enrollment in our clinical trials, interpretation of scientific basis for ganaxolone use, timing for availability and release of data, the safety, potential efficacy and therapeutic potential of our product candidate and our expectation regarding the sufficiency of our working capital. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements.  Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of future clinical trials, the timing of the clinical trials, enrollment in clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, the attainment of clinical trial results that will be supportive of regulatory approvals, and other matters, including the development of formulations of ganaxolone, and the availability or potential availability of alternative products or treatments for conditions targeted by the company that could affect the availability or commercial potential of our drug candidates.  Marinus undertakes no obligation to update or revise any forward-looking statements.  For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see filings Marinus has made with the Securities and Exchange Commission.

CONTACT:
Lisa M. Caperelli
Executive Director, Investor & Strategic Relations
Marinus Pharmaceuticals, Inc.
484-801-4674
lcaperelli@marinuspharma.com

$CIIX Retains Bestselling Author Chris J. Snook’s Biopsy, LLC for E-Commerce Growth

SAN GABRIEL, California, September 11, 2017  —

ChineseInvestors.com, Inc. (OTCQB: CIIX) (‘CIIX’ or the ‘Company’) today announced that has retained Biopsy, LLC managed by Chris J Snook effective September 1, 2017 to provide leadership in growth and E-Commerce. Biopsy, LLC will be the architect of the digital infrastructure and go-to-market strategy for ChineseInvestors.com, Inc., its wholly owned subsidiary ChineseHempOil.com and its wholly owned foreign enterprise CBD Biotechnology Co., Ltd. reporting directly Warren Wang, CEO of ChineseInvestors.com, Inc., to Keevin Gillespie, President of ChineseHempOil.com, Inc. and to Summer Yun, CEO of CBD Biotechnology Co., Ltd.

Snook will work closely with the entire ChineseInvestors.com, Inc. team developing the strategy for and managing the execution of all internal and external communications related to IT, digital marketing, agency vendors, and the E-commerce, network marketing and retail divisions. Biopsy, LLC’s role will include informing and exciting consumers throughout Canada and the United States and Mainland China about ChineseInvestors.com, Inc.’s brands. Biopsy, LLC will oversee commerce initiatives, underlying data governance and digital architecture, go-to-market strategy, product and brand creation, and business development initiatives. As the managing member of Biopsy, LLC, Snook will also be directly involved with the Company’s media relations and executive and financial communications.

ChineseInvestors.com, Inc.’s decision to retain Biopsy, LLC comes at an important time as the Company has established several new relationships that will be managed by Biopsy, LLC including its selection of Elevated.com as its new digital agency of record in August and its recent agreement with Quiverr.com to drive sales of its hemp health products on the Amazon Channel. ChineseInvestors.com, Inc. plans to hire additional marketing talent that will assist to develop and manage its Chinese-American digital marketing strategy in the coming months. The Company’s objective is to add $1m in new net revenues from these efforts in the coming 12 months.

With over 18 years in the early stage and digital marketing, technology, and E-commerce industries, Snook’s experience spans a variety of sectors including media, technology, private equity, and direct-to-consumer product distribution. Notably, Snook is the bestselling author of the 2017 Wiley & Sons book Digital Sense which Forbes calls ‘A book every marketer must read in 2017’, also listed by Mashable as ‘The marketing must read of the year’. The Consumer Technology Association (producer of The Consumer Electronics Show (‘CES’)) also invited Snook join their collaboration of 12 ‘Thought Leaders’ for the official 2018 program under their long-running ‘Gary’s Book Club Initiative’. Snook was also invited as one of 12 honored guests to the Association’s ‘Leaders In Technology Annual Dinner’.

“ChineseInvestors.com, Inc. is fortunate to be able to contract with Biopsy, LLC as Chris’ unique skill and experience will enhance the Company’s ability to effectively emerge as a leader in the CBD Biotechnology Industry, while also strengthening and expanding the market reach and value of the Company’s core financial media business,” said Warren Wang, CEO and Founder of ChineseInvestors.com. Inc. “Moreover, I’d like congratulate Chris on the success of his bestseller Digital Sense and his emergence as a leading voice on consumer experience, E-commerce operations, blockchain technology and the internet 3.0. Online purchases by Chinese consumers now exceed that of US consumers and global online sales are expected to grow 20% annually. ChineseInvestors.com, Inc. is committed to building the necessary platforms to capitalize on this growth trend and to emerge as a market leader.”

“I am honored to work with ChineseInvestors.com, Inc. at such an exciting time for both the Company and the E-commerce and Direct-to-Consumer Personal Care Products Industries at large,” said Snook. “I look forward to contributing to the Company’s future successes. I thank Mr. Wang for giving me the opportunity to join such a talented and innovative team.”

Snook is an award winning entrepreneur, an international bestselling author and thought leader and more information can be found on him at http://www.chrisjsnook.com.

About ChineseInvestors.com (OTCQB: CIIX)

Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail, online and direct sales of hemp-based products and other health related products.

For more information visit ChineseInvestors.com

Subscribe and watch our video commentaries: https://www.youtube.com/user/Chinesefncom

Follow us on Twitter for real-time Company updates: https://twitter.com/ChineseFNEnglsh

Like us on Facebook to receive live feeds: https://www.facebook.com/Chinesefncom;

https://www.facebook.com/Chineseinvestors.com.english

Add us on WeChat: Chinesefn or download iPhone iOS App: Chinesefn

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776

Investor Relations:
Alan Klitenic
+1-214-636-2548

Corporate Communications:
NetworkNewsWire (NNW)
New York, New York
http://www.NetworkNewsWire.com
+1-212-418-1217 Office
Editor@NetworkNewsWire.com

$IGC Alzheimer’s Drug Candidate New Molecular Pathway for THC to Inhibit Aβ40 Production

BETHESDA, Md., Sept. 11, 2017 — India Globalization Capital, Inc. (NYSE American:IGC) today provides an update on compelling in vitro data compiled from genetically engineered cell lines, confirmed by Dr. Chuanhai Cao, an IGC Senior Advisor and Associate Professor of Pharmaceutical Sciences at USF’s College of Pharmacy, which shows that at varying concentrations of THC, the production of Aβ40 protein decreases by as much as 50% over a 48-hour period.

It is believed that Alzheimer’s disease is caused by two types of legions in the cerebral cortex and hippocampus: 1) senile plaque composed of amyloid beta peptides (Aβ plaque), and 2) neurofibrillary tangle, composed of highly phosphorylated Tau protein. Amyloid Protein Precursor (APP), on the surface of neurons, is normally cleaved by enzymes to free up Aβ peptide composed of 36-43 amino acids that is then cleared by the body.

In patients with Alzheimer’s, an imbalance causes Aβ to be unregulated, resulting in the abnormal buildup into insoluble fibroles depositing as senile plaques. Aβ monomers aggregate to form oligomers and then into fibril Aβ. It is believed that extracellular misfolded oligomers are toxic to nerve cells.

IGC’s Alzheimer’s drug candidate, IGC-ADI, works through a molecular pathway that allows low doses of THC to: 1) inhibit Aβ protein production, 2) inhibit Aβ protein aggregation 3) reduce protein phosphorylation, 4) restore mitochondria function and 5) redirect the immune system.

The summary data indicates that at a 25nM THC concentration, Aβ40 production decreased by 30% over a 6-hour period; 35% over a 24-hour period; and 40% over a 48-hour period.  At a 2.5 μM concentration of THC, Aβ40 production decreased by 30% over a 6-hour period; 40% over a 24-hour period; and 55% over a 48-hour period.

Aβ40 and Aβ42 play a key role in amyloid plaques and have been implicated in the pathogenesis of Alzheimer’s disease.  The studies done by Dr. Cao at USF led to the filing of a patent by USF entitled, “THC as a Potential Therapeutic Agent for Alzheimer’s Disease.”

“IGC acquired the exclusive right to this patent filing and we plan to advance this technology through medical trials that can potentially bring much needed relief for patients suffering from AD,” says IGC’s CEO, Ram Mukunda.

About Alzheimer’s Disease
Alzheimer’s Disease (AD) is a form of dementia.  It is known as America’s most expensive disease, with an estimated cost to the U.S. economy of $236 billion.  AD currently affects more than 5.3 million Americans.  Over the next 20 years, the number of those afflicted with the disease is expected to double.  The forecast is staggering, considering that to date, no effective cure has been found.

About IGC
IGC is engaged in the development of cannabis based combination therapies to treat Alzheimer’s, pain, nausea, eating disorders, several end points of Parkinson’s, and epilepsy in dogs and cats.  IGC has assembled a portfolio of patent filings and four lead product candidates addressing these conditions. The company is based in Maryland, USA.

For more information please visit www.igcinc.us
Follow us on Twitter @IGCIR and Facebook.com/IGCIR/

Forward-looking Statements
Please see forward looking statements as discussed in detail in IGC’s Form 10K for fiscal year ended March 31, 2017, and in other reports filed with the U.S. Securities and Exchange Commission.

Investors Contact:
Claudia Grimaldi
301-983-0998
www.igcinc.us
info@igcinc.us

$PULM to Present at Rodman & Renshaw Global Investment Conference Sept. 11

LEXINGTON, Mass., Sept. 8, 2017 — Pulmatrix, Inc. (NASDAQ: PULM) will present at the Rodman & Renshaw 19th Annual Global Investment Conference on Monday, September 11, 2017 at 10:25 AM EDT in the Lotte New York Palace Hotel in New York City. As part of the presentation, William Duke, Jr., Chief Financial Officer for Pulmatrix, will provide an update on the Company’s business and its pipeline of inhaled therapeutics.

The presentation will highlight Pulmatrix’s recent in-licensing of narrow spectrum kinase inhibitors (NSKI) from RespiVert Ltd., a wholly owned subsidiary of Janssen Biotech, Inc., and provide updates on the lead pipeline programs.

About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF) and severe asthma, and PUR1800, a narrow spectrum kinase inhibitor for patients with COPD. In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for COPD.  Pulmatrix’s product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

FORWARD-LOOKING STATEMENTS
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K filed by the Company with the Securities and Exchange Commission on March 10, 2017, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

$ARRY Phase 3 BEACON CRC Safety Lead-In Results in Colorectal Cancer

41% confirmed ORR for patients on combination of binimetinib, encorafenib and cetuximab – – Median duration of treatment was 5.6 months at time of analysis and 76% of patients remain on study treatment – – Generally well-tolerated with attractive safety profile – – Array to host investor reception and webcast during ESMO on September 9 –

BOULDER, Colo., Sept. 8, 2017 — Array BioPharma (Nasdaq: ARRY) and Pierre Fabre today announced safety results and initial clinical activity from the safety lead-in of the Phase 3 BEACON CRC study evaluating binimetinib, a MEK inhibitor, encorafenib, a BRAF inhibitor and Erbitux® (cetuximab), an anti-EGFR antibody, in patients with BRAF-mutant colorectal cancer (CRC) whose disease has progressed after one or two prior regimens in the metastatic setting.  BRAF-mutant CRC represents a difficult-to-treat subtype of colorectal cancer that impacts 10 to 15% of CRC patients. These data were presented as an e-poster on September 8 at the 2017 European Society for Medical Oncology Congress in Madrid, Spain (Abstract No. #517P).

As of August 9, 2017, 30 patients were treated in the safety lead-in and received the triplet combination of binimetinib, encorafenib and cetuximab (BINI 45 mg twice daily, ENCO 300 mg daily and CETUX per label). Out of the 30 patients, 29 had a BRAF^V600E mutation.  Microsatellite instability-high (MSI-H) (resulting from defective DNA mismatch repair) was detected in only one patient.  The triplet demonstrated good tolerability, supporting initiation of the randomized portion of the study.  In addition, promising initial clinical activity was observed, with a confirmed overall response rate (ORR) of 41%, including a complete response, in patients with the BRAF^V600E mutation, a group of patients with historically poor outcomes. The observed ORR was 59% in the 17 patients with the BRAF^V600E mutation with only one prior therapy.  Out of 28 patients with both a BRAF^V600E mutation and a post-baseline assessment, 27 showed tumor regression.

“The BRAF mutation carries a very poor prognosis for patients with advanced colorectal cancer, and is particularly unresponsive after first-line therapy,” said Scott Kopetz, M.D., Ph.D., FACP, Associate Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. “In the safety lead-in, the triplet combination showed impressive results with a confirmed overall response rate of 41%.  Several patients also showed prolonged stable disease, with 76% of patients overall continuing on therapy after a median duration of exposure of 5.6 months. These results are unprecedented for this patient population based on existing standards of care.”

In the safety lead-in, the triplet combination was generally well-tolerated. The most common grade 3 or 4 adverse events (AEs) seen in at least 10% of patients were nausea (10%), vomiting (10%), increased blood creatine kinase (10%) and urinary tract infection (10%).  Three patients discontinued treatment due to AEs with only one considered related to treatment.  At the time of the analysis, 76% of patients remain on study treatment after a median duration of treatment of 5.6 months (range 1.0 – 9.3 months).

With these encouraging results, Array continues to enroll the randomized portion of the BEACON CRC study, assessing the efficacy of encorafenib in combination with cetuximab with or without binimetinib compared to cetuximab and irinotecan-based therapy.

“There has been a long-standing need to find improved treatment options for patients with BRAF-mutant colorectal cancer, and we are encouraged that data from the safety lead-in show binimetinib, encorafenib and cetuximab may have this potential,” said Axel Grothey, M.D., Professor of Oncology, Mayo Clinic College of Medicine and Science. “We hope these promising findings, with the impressive response rates, including a complete response, and early signs of durability, will bring us one step closer to addressing this high unmet medical need.”

ARRAY INVESTOR RECEPTION AND WEBCAST:  Array will host an investor reception during ESMO 2017 where key opinion leaders in the colorectal cancer field, including Dr. Scott Kopetz, M.D. Anderson and Dr. Axel Grothey, Mayo Clinic, who will give presentations covering the BRAF-mutant colorectal cancer landscape and data from the BEACON CRC safety lead-in. The presentations will be webcast (live and replay), for those who wish to participate remotely.

About Colorectal Cancer
Worldwide, colorectal cancer is the third most common type of cancer in men and the second most common in women, with approximately 1.4 million new diagnoses in 2012. Of these, nearly 750,000 were diagnosed in men, and 614,000 in women. Globally in 2012, approximately 694,000 deaths were attributed to colorectal cancer. In the U.S. alone, an estimated 135,430 patients will be diagnosed with cancer of the colon or rectum in 2017, and approximately 50,000 are estimated to die of their disease. [1] In the United States, BRAF mutations are estimated to occur in 10% to 15% of patients with colorectal cancer and represent a poor prognosis for these patients.[2-5]  Based on recent prospective historical data, the prevalence of MSI-H in tumors from patients with metastatic BRAF-mutant CRC ranged from 14% in a recent Phase 1b/2 trial (NCT01719380) (Array, data on file) and 18% a recent Southwestern Oncology Group (SWOG) randomized phase 2 study.[6]

About Binimetinib and Encorafenib
MEK and BRAF are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is a late-stage small molecule MEK inhibitor and encorafenib is a late-stage small molecule BRAF inhibitor, both of which target key enzymes in this pathway. Binimetinib and encorafenib are being studied in clinical trials in advanced cancer patients, including the Phase 3 BEACON CRC trial.

BEACON CRC was initiated based on results from a Phase 2 study which included the combination of encorafenib and cetuximab in 50 patients with advanced BRAF-mutant CRC.  These results were presented at the 2016 ASCO annual meeting. In this arm, median overall survival for these patients exceeded one year, which is more than double several separate historical standard of care published benchmarks for this population. [7-12] The objective response rate (ORR) was 22%; historical published benchmarks in this patient population using standard of care regimens range between 4% to 8%. [10-13]

On July 5, 2017, Array announced that it submitted two NDAs to the FDA to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. Array completed its NDA submissions based on findings from the pivotal Phase 3 COLUMBUS trial.  In addition, Array’s European partner, Pierre Fabre, announced on August 28, 2017 that the European Medicines Agency (EMA) has validated the review of the Marketing Authorization Applications for binimetininb and encorafenib.

Binimetinib and encorafenib are investigational medicines and are not currently approved in any country.

Array BioPharma retains exclusive rights to binimetinib and encorafenib in key markets including the U.S., Canada and Israel.  Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America.  The BEACON CRC trial is being conducted with support from Pierre Fabre and Merck  KGaA, Darmstadt, Germany (support is for sites outside of North America).

About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer.  Eight registration studies are currently advancing related to seven Array-owned or partnered drugs: binimetinib (MEK162), encorafenib (LGX818), selumetinib (partnered with AstraZeneca), danoprevir (partnered with Roche), ipatasertib (partnered with Genentech), larotrectinib (partnered with Loxo Oncology) and tucatinib (partnered with Cascadian Therapeutics).

About Pierre Fabre
With a portfolio representing a continuum of activities spanning from prescription drugs and consumer healthcare products to dermo-cosmetics, Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies. Its portfolio includes several global brands and franchises among which Eau Thermale Avène – the worldwide dermo-cosmetic market leader – Klorane, Ducray, René Furterer, A-Derma, Galénic, Elancyl, Naturactive, Pierre Fabre Health Care, Pierre Fabre Oral Care, Pierre Fabre Dermatologie and Pierre Fabre Oncologie.

In 2016, Pierre Fabre generated 2,282 million euros in revenues, of which 60% came from its international business and 59% from its dermo-cosmetics division. Pierre Fabre, which has always been headquartered in the South-West of France, counts more than 13,000 employees worldwide, owns subsidiaries and offices in 47 countries and enjoys distribution agreements in over 130 countries. In 2016, Pierre Fabre dedicated ca. 195 million euros to its R&D efforts, split between oncology, central nervous system, consumer healthcare, dermatology and dermo-cosmetics.

Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan.

The independent French certification group AFNOR audited Pierre Fabre for its corporate social responsibility policy at the “exemplary” level, according to the ISO 26000 standard for CSR.

To find out more about Pierre Fabre, please go to www.pierre-fabre.com

References

[1] Cancer Facts & Figures 2017. American Cancer Society.  Available at: https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2017.html (link is external).  Accessed July 2017.
[2] Saridaki Z, et al. (2013) BRAFV600E Mutation Analysis in Patients with Metastatic Colorectal Cancer (mCRC) in Daily Clinical Practice: Correlations with Clinical Characteristics, and Its Impact on Patients’ Outcome. PLoS ONE 8(12): e84604. doi:10.1371/journal.pone.0084604
[3] Sorbye H, et al. (2015) High BRAF Mutation Frequency and Marked Survival Differences in Subgroups According to KRAS/BRAF Mutation Status and Tumor Tissue Availability in a Prospective Population-Based Metastatic Colorectal Cancer Cohort. PLoS ONE 10(6): e0131046. doi:10.1371/journal.pone.0131046
[4] Loupakis F, et al. (2009) KRAS codon 61, 146 and BRAF mutations predict resistance to cetuximab plus irinotecan in KRAS codon 12 and 13 wild-type metastatic colorectal cancer. British Journal of Cancer 101(4), 715 – 721
[5] Vecchione, et al. (2016) A Vulnerability of a Subset of Colon Cancers with Potential Clinical Utility. Cell 165, 317–330
[6] Kopetz et al. J Clin Oncol. 2017;35:520-20
[7] Ulivi et al., J Transl Med. 2012
[8] Saridaki et al., PLoS One. 2013
[9] Loupakis et al., Br J Cancer. 2009
[10] De Roock et al., Lancet Oncol, 2010
[11] Peeters et al., ASCO 2014
[12] Kopetz et al., ASCO 2017
[13] Seymour et al., Lancet Oncol, 2013 (supplementary appendix)

Array BioPharma Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the future development plans of binimetinib and encorafenib, and the timing of the announcement of further results of clinical trials for binimetinib and encorafenib; expectations regarding the timing of regulatory filings for binimetinib and encorafenib and regarding approval of binimetinib and encorafenib for BRAF-mutant melanoma; expectations that events will occur that will result in greater value for Array; and the potential for the results of current and further clinical trials to support regulatory approval or the marketing success of binimetinib and encorafenib. Specifically, there is no assurance that results from the BEACON CRC study will satisfy the requirements of regulatory authorities necessary to file an application for marketing approval, or that if such application is accepted, that it will be approved.  These statements involve significant risks and uncertainties, including those discussed in our most recent annual report filed on Form 10-K, in our quarterly reports filed on Form 10-Q, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, the determination by the FDA, EMA or other regulatory agencies that results from clinical trials are not sufficient to support registration or marketing approval of binimetinib and encorafenib; our ability to effectively and timely conduct clinical trials in light of increasing costs and difficulties in locating appropriate trial sites and in enrolling patients who meet the criteria for certain clinical trials; risks associated with our dependence on third-party service providers to successfully conduct clinical trials and to manufacture drug substance and product within and outside the United States; our ability to grow and successfully develop commercialization capabilities; our ability to achieve and maintain profitability and maintain sufficient cash resources; and our ability to attract and retain experienced scientists and management. We are providing this information as of September 8, 2017. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.

$EGLT New Data at PAINWEEK on ARYMO ER Deterring Opioid Abuse

Additional Study Examined Reasons Why Opioid Abusers Progress to More Dangerous Routes of Administration Beyond Oral Abuse

WAYNE, Pa., Sept. 8, 2017 — Egalet Corporation (Nasdaq: EGLT) (“Egalet”), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, yesterday presented findings from two studies at PAINWeek 2017 in Las Vegas. One study showed that the reduction in abuse potential of ARYMO^® ER (morphine sulfate) extended-release (ER) tablets, as measured by drug liking and other pharmacodynamic (PD) endpoints, strongly correlated to the pharmacokinetic (PK) results. Another study showed the majority of abusers progress to more dangerous routes of abuse after taking opioids orally.

“An analysis from the clinical abuse deterrence studies for ARYMO ER demonstrated a correlation between the PK data and the PD results, supporting its potential to help deter opioid abuse,” said Jeffrey Dayno, MD, chief medical officer at Egalet. “In addition, another study looked at the motivation behind individuals progressing from oral abuse, which is particularly relevant given the ongoing opioid epidemic, and one for which there is little data. The study showed that the majority of abusers do progress to more dangerous, non-oral routes of abuse. This is why we believe ARYMO ER and other abuse-deterrent opioids could play an important role in deterring opioid abuse.”

Misuse/abuse of opioids often involves manipulation (eg. chewing, crushing or dissolving) of the drug to get it into an abuseable form for alternative routes of administration (eg. intranasal or intravenous) and/or to achieve a quicker and more potent euphoric effect. To make manipulation more difficult, abuse-deterrent (AD) formulations, such as ARYMO ER, were developed. ARYMO ER is a U.S. Food and Drug Administration (FDA) approved AD opioid indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

In a study led by Ben Vaughn, principal statistical scientist from Rho Inc., the objective was to better understand the PK/PD relationship using results from the oral and intranasal human abuse potential (HAP) studies of ARYMO ER. Evaluation of the relationship between PK and PD results can elucidate time points that coincide with the onset, peak and duration of the effects for intact and manipulated products. Such PK/PD evaluations may allow for a better understanding of how barriers to deter abuse affect the PK properties of AD opioids, and how changes in PK influence the PD outcomes. Highlights from the study included:

• All PD assessments of opioid abuse potential significantly correlated with Cmax, Tmax and abuse quotient in the anticipated directions, reinforcing literature suggesting that rate and degree of drug absorption influence abuse potential; and
• PK parameters were most effective in predicting Drug Liking Emax, followed by Overall Drug Liking and Take Drug Again.

“Understanding the PK/PD properties of an opioid is critical because the rate and degree of drug absorption correlates to the potential for abuse,” said Mr. Vaughn. “The data presented at PAINWeek illustrate that abuse-deterrent products, such as ARYMO ER, may provide barriers to misuse or abuse. When prescribing an opioid, healthcare providers should consider medicines with abuse-deterrent features.”

A second study led by Stacey McCaffrey, PhD, research scientist at Inflexxion, Inc., looked at the motivation for change in route of administration during the course of opioid abuse. Oral ingestion of intact pills is the most frequently reported route of misuse and abuse for many prescription opioids, but alternative routes of administration (RoA) such as intranasal and intravenous are also common. Traditionally, the opioid misuse or abuse pathway has been described as follows: an initial oral opioid exposure in a genetically susceptible person induces a “high” or euphoric feeling, which may then trigger a desire to intensify the euphoric effect through chewing pills, snorting, or injecting the opioid. No research has evaluated the motivation for these changes in RoA over the course of opioid abuse. Dr. McCaffrey et. al studied adult patients entering an opioid abuse treatment center with the purpose of understanding the natural history of opioid abuse and motivation for changes in RoA. The data regarding motivations for changing RoA include:

• 75% of the patients began prescription opioid abuse by swallowing pills intact, and 80% of those patients progressed to chewing, snorting, or injecting during the course of their abuse;
• Euphoria was the most common motive for change in RoA from oral to more dangerous, non-oral routes;
  • Nearly all (92.3%) “achieved desired effect” motivation statements were associated with a progression from swallowing to a more dangerous RoA;
• Most (80.0%) patients reporting social influences motivation began their abuse as “recreational abusers” (i.e., without a legitimate prescription written for them by a physician); and
• The majority (83.0%) of “social influences: pressure/encouragement” motivation statements were associated with transitioning to a more dangerous RoA.

The following posters were presented yesterday, including the two discussed above, during the PAINWeek 2017 poster session from 6:30 pm – 8:30 pm PT:

• The Relationship Between the Pharmacokinetics of Morphine Abuse-Deterrent, Extended-Release, Injection-Molded Tablets and Pharmacodynamic Outcomes in Oral and Intranasal Human Abuse Potential Studies. Authors: Ben Vaughn, MS, Colville Brown, MD, John Lawler, BS, Karsten Lindhardt, MSc, PhD, DBE, Gwendolyn Niebler, DO, Jeffrey M. Dayno, MD.
• Motivation for Change in Route of Administration during the Course of Opioid Abuse. Authors: Stacey McCaffrey, PhD, ; Kelly Manser, BA, ; Colville Brown, MD, ; Gwendolyn Nieber, DO.
• A Responders Analysis of Morphine Abuse-Deterrent, Extended Release, Injection-Molded Tablets in Oral and Intranasal Human Abuse Potential Studies. Author: Lynn R. Webster, MD, Michael D. Smith, PharmD, Ben Vaughn, MS, Colville Brown, MD, John Lawler, BS, Karsten Lindhardt, MSc, PhD, DBE, Gwendolyn Niebler, DO, Jeffrey M. Dayno, MD.
• A Harm Reduction Model to Quantify Potential Misuse/Abuse Reduction and Abuse Related Events Avoided from Abuse Deterrent Opioids. Authors: Alan White, PhD; Tim Spittle BS; Gwendolyn Niebler, DO; Jeffrey Dayno, MD; Colville Brown, MD, Nathaniel Katz, MD, MS.
• Bioequivalence of Immediate-Release (IR) Oxycodone with Aversion Technology Compared with a Non–Abuse-Discouraging Formulation of IR Oxycodone. Authors: Sean Gill, MA, John Lawler, BS, Gwendolyn Niebler, DO, Colville Brown, MD, Jeffrey M. Dayno, MD.

About ARYMO ER
ARYMO ER was developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ARYMO ER is the first approved product developed using Egalet’s proprietary Guardian™ Technology—a physical and chemical barrier approach to abuse deterrence without the use of an opioid antagonist—creating tablets that are difficult to manipulate for the purpose of misuse and abuse. Results from in vitro testing demonstrated that ARYMO ER tablets, in comparison to non-abuse-deterrent morphine sulfate extended-release tablets, have increased resistance to cutting, crushing, grinding or breaking using a variety of tools. Due to its physical and chemical properties, ARYMO ER is expected to make abuse by injection difficult. Abuse of ARYMO ER by injection, as well as by the oral and nasal routes, is still possible. Please see important safety information on ARYMO ER below.

About Egalet
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. Egalet has three approved products: ARYMO^® ER (morphine sulfate) extended-release tablets for oral use —CII, developed using Egalets proprietary Guardian™ Technology, OXAYDO^® (oxycodone HCI, USP) tablets for oral use only –CII and SPRIX^® (ketorolac tromethamine) Nasal Spray. Using Guardian Technology, Egalet is developing a pipeline of clinical-stage, product candidates including Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple active pharmaceutical ingredients with similar or different release profiles. For full prescribing information on ARYMO ER, including the boxed warning and medication guide, please visit arymoer.com. For full prescribing information on SPRIX, including the boxed warning and medication guide, please visit sprix.com. For full prescribing information on OXAYDO, including the boxed warning and medication guide, please visit oxaydo.com.

IMPORTANT SAFETY INFORMATION ABOUT ARYMO ER

Indications

ARYMO ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use

• Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve ARYMO ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
• ARYMO ER is not indicated as an as-needed (prn) analgesic.

Contraindications

ARYMO ER is contraindicated in patients with:  significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days, known or suspected gastrointestinal obstruction, including paralytic ileus; hypersensitivity (e.g., anaphylaxis) to morphine.

Warnings and Precautions

Addiction, Abuse, and Misuse: ARYMO ER contains morphine, a Schedule II controlled substance. As an opioid, ARYMO ER exposes its users to the risks of addiction, abuse, and misuse. As extended-release products such as ARYMO ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of morphine present.

Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status. Carbon dioxide (CO₂) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of ARYMO ER, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases with ARYMO ER.

To reduce the risk of respiratory depression, proper dosing and titration of ARYMO ER are essential. Overestimating the ARYMO ER dose when converting patients from another opioid product can result in a fatal overdose with the first dose.

Accidental ingestion of even one dose of ARYMO ER, especially by children, can result in respiratory depression and death due to an overdose of morphine.

Neonatal Opioid Withdrawal Syndrome: Prolonged use of ARYMO ER during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of ARYMO ER with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics.

Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: The use of ARYMO ER in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.

Patients with Chronic Pulmonary Disease: ARYMO ER-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of ARYMO ER.

Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients.

Monitor such patients closely, particularly when initiating and titrating ARYMO ER and when ARYMO ER is given concomitantly with other drugs that depress respiration. Alternatively, consider the use of non-opioid analgesics in these patients.

Interaction with Monoamine Oxidase Inhibitors: Monoamine oxidase inhibitors (MAOIs) may potentiate the effects of morphine, including respiratory depression, coma, and confusion. ARYMO ER should not be used in patients taking MAOIs or within 14 days of stopping such treatment.

Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.

Severe Hypotension: ARYMO ER may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating the dose of ARYMO ER. In patients with circulatory shock, ARYMO ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use ARYMO ER in patients with circulatory shock.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: In patients who may be susceptible to the intracranial effects of CO₂ retention (e.g., those with evidence of increased intracranial pressure or brain tumors), ARYMO ER may reduce respiratory drive, and the resultant CO₂ retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with ARYMO ER.

Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of ARYMO ER in patients with impaired consciousness or coma.

Difficulty in Swallowing and Risk for Obstruction in Patients at Risk for a Small Gastrointestinal Lumen: Moistened ARYMO ER tablets may become sticky leading to difficulty in swallowing the tablets. Patients could experience choking, gagging, regurgitation and tablets stuck in the throat. Instruct patients not to pre-soak, lick, or otherwise wet ARYMO ER tablets prior to placing in the mouth, and to take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth.

Tablet stickiness and swelling may also predispose patients to intestinal obstruction and exacerbation of diverticulitis. Patients with underlying GI disorders such as esophageal cancer or colon cancer with a small gastrointestinal lumen are at greater risk of developing these complications. Consider use of an alternative analgesic in patients who have difficulty swallowing and patients at risk for underlying GI disorders resulting in a small gastrointestinal lumen.

Risks of Use in Patients with Gastrointestinal Conditions: ARYMO ER is contraindicated in patients with gastrointestinal obstruction, including paralytic ileus. The morphine in ARYMO ER may cause spasm of the sphincter of Oddi. Opioids may cause increases in the serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Increased Risk of Seizures in Patients with Seizure Disorders: The morphine in ARYMO ER may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during ARYMO ER therapy.

Withdrawal: Avoid the use of mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who have received or are receiving a course of therapy with a full opioid agonist analgesic, including ARYMO ER. In these patients, mixed agonists/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.

When discontinuing ARYMO ER, gradually taper the dose. Do not abruptly discontinue ARYMO ER.

Risks of Driving and Operating Machinery: ARYMO ER may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of ARYMO ER and know how they will react to the medication.

Adverse Reactions

In clinical trials, the most common adverse reactions with morphine sulfate extended-release formulations were constipation, dizziness, sedation, nausea, vomiting, sweating, dysphoria, and euphoric mood.

Additional Drug Interactions

Serotonergic Drugs: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: May reduce the analgesic effect of ARYMO ER and/or precipitate withdrawal symptoms; avoid concomitant use.

Muscle Relaxants: Morphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Cimetidine: The concomitant use of cimetidine can potentiate morphine effects and increase risk of hypotension, respiratory depression, profound sedation, coma, and death.

Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.

Anticholinergic Drugs: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

P-Glycoprotein (P-gp) Inhibitors: The concomitant use of P-gp inhibitors can increase the exposure to morphine by about two-fold and can increase risk of hypotension, respiratory depression, profound sedation, coma, and death.

Use in Specific Populations

Pediatrics: The safety and effectiveness in pediatric patients below the age of 18 have not been established.

Geriatrics: The pharmacokinetics of ARYMO ER have not been studied in elderly patients. Elderly patients (aged 65 years or older) may have increased sensitivity to morphine.

Hepatic Impairment: Morphine pharmacokinetics have been reported to be significantly altered in patients with cirrhosis. Start these patients with a lower than usual dosage of ARYMO ER and titrate slowly while monitoring for signs of respiratory depression, sedation, and hypotension.

Renal Impairment: Morphine pharmacokinetics are altered in patients with renal failure. Start these patients with a lower than usual dosage of ARYMO ER and titrate slowly while monitoring for signs of respiratory depression, sedation, and hypotension.

Overdosage

Acute overdosage with morphine can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations.

Safe Harbor
Statements included in this press release (including but not limited to upcoming milestones) that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, and are subject to known and unknown uncertainties and risks. Actual results could differ materially from those discussed due to a number of factors, including, but not limited to: the success of Egalet’s clinical trials, including the timely recruitment of trial subjects and meeting the timelines therefor; Egalet’s ability to obtain and maintain regulatory approval of Egalet’s products and  product candidates and any regulatory action involving Egalet’s products; Egalet’s ability to maintain the intellectual property position of Egalet’s products and product candidates; Egalet’s ability to identify and reliance upon qualified third parties to manufacture its products; Egalet’s ability to service its debt obligations; Egalet’s ability to find and hire qualified sales professionals; the receptivity in the marketplace and among physicians to Egalet’s products; the success of products which compete with Egalet’s that are or become available; general market conditions; and other risk factors described in Egalet’s filings with the United States Securities and Exchange Commission. Egalet assumes no obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by law.

Investor and Media Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: bcs@egalet.com
Tel: 484-259-7370

$FNHC Postpones Annual Shareholders Meeting Due to Hurricane Irma

SUNRISE, Fla., Sept. 08, 2017 – Federated National Holding Company (the “Company”) (NASDAQ:FNHC), an insurance holding company, is providing updates regarding Hurricane Irma, which  is currently located in the Atlantic Ocean and is projected to make landfall in South Florida this weekend.

The Company’s annual shareholders meeting was previously scheduled for Tuesday, September 12, 2017 in South Florida.  Due to the pending arrival of Hurricane Irma, we are announcing that this meeting has been re-scheduled to Tuesday, September 19, 2017 at 11:00 A.M. (Eastern time) at the DoubleTree Hotel at 13400 West Sunrise Boulevard, Sunrise, FL 33323.  This action has been taken to ensure the safety of all, including our employees, Board of Directors, and shareholders at a time when hazardous weather conditions may be in the area.

Summarized information regarding the Company’s reinsurance programs follows.  See the Company’s Form 8-K dated July 3, 2017 for further information.

The Company has two insurance subsidiaries, Federated National Insurance Company (“Federated National”), which is a wholly owned subsidiary, and Monarch National Insurance Company (“Monarch National”), of which we own 42.4%, both write homeowners insurance in Florida.

Federated National and Monarch National purchase reinsurance to reimburse them for elevated single-event property losses under their respective homeowners’ insurance policies.  This reinsurance affords protection to our policyholders and shareholders in the event of one or more catastrophic events such as a Hurricane Irma.  Each company purchases its own separate reinsurance program.  Federated National’s reinsurance program covers both Florida and Non-Florida exposures and all private layers of protection have prepaid automatic reinstatement protection, which affords Federated National additional coverage for subsequent events.  The combination of private and FHCF reinsurance treaties will afford Federated National approximately $2.19 billion of aggregate coverage with a maximum single event coverage totaling approximately $1.56 billion, exclusive of retentions.  Federated National’s single event pre-tax retention for a catastrophic event in Florida is $18 million.  In addition, Federated National purchases separate Non-Florida excess of loss reinsurance treaties that could decrease our pre-tax retention from $18 million to as low as $6.5 million when we have both Florida and Non-Florida losses in the same event.

Similarly, Monarch National’s reinsurance program covers Florida exposures and all private layers of protection have prepaid automatic reinstatement protection which affords Monarch National additional coverage for subsequent events.  The combination of private and FHCF reinsurance treaties will afford Monarch National approximately $109.8 million of aggregate coverage with a maximum single event coverage totaling approximately $68.9 million, exclusive of retentions.  Monarch National’s single event pre-tax retention for a catastrophic event in Florida is $3.4 million.  All Federated National and Monarch National private treaties are with reinsurers that currently have an AM Best or Standard & Poor’s rating of “A-” or better, or have fully collateralized their maximum potential obligations in dedicated trusts.

Federated National and Monarch National stands ready to help our policyholders through this event with a devoted team of experienced field adjusters and emergency response partners.  Our policyholders can reach us at any time via our First Report Line at (800) 293-2532 or can report a claim online at FedNat.com.  Policyholders can also visit our Claims Center at FedNat.com, which lists our preferred contractors, who are on call and available to assist with repairs and recovery efforts.

About the Company

The Company is authorized to underwrite, and/or place through our wholly owned subsidiaries, homeowners’ multi-peril, commercial general liability, federal flood, personal auto and various other lines of insurance in Florida and various other states.  The Company also serves as managing general agent for its joint venture, Monarch National Insurance Company.  The Company markets and distributes its own and third-party insurers’ products and our other services through a network of independent agents. The Company also utilizes a select number of general agents for the same purpose.

Forward-Looking Statements /Safe Harbor Statements

Safe harbor statement under the Private Securities Litigation Reform Act of 1995:

Statements that are not historical fact are forward-looking statements that are subject to certain risks and uncertainties that could cause actual events and results to differ materially from those discussed herein. Without limiting the generality of the foregoing, words such as “anticipate,” “believe,” “budget,” “contemplate,” “continue,” “could,” “envision,” “estimate,” “expect,” “guidance,” “indicate,” “intend,” “may,” “might,” “plan,” “possibly,” “potential,” “predict,” “probably,” “pro-forma,” “project,” “seek,” “should,” “target,” or “will” or the negative thereof or other variations thereon and similar words or phrases or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements might also include, but are not limited to, one or more of the following:

• Projections of revenues, income, earnings per share, dividends, capital structure or other financial items or measures;
• Descriptions of plans or objectives of management for future operations, insurance products/or services;
• Forecasts of future insurable events, economic performance, liquidity, need for funding and income; and
• Descriptions of assumptions or estimates underlying or relating to any of the foregoing.

The risks and uncertainties include, without limitation, risks and uncertainties related to estimates, assumptions and projections generally; the nature of the Company’s business; the adequacy of its reserves for losses and loss adjustment expense; claims experience; weather conditions (including the severity and frequency of storms, hurricanes, tornadoes and hail) and other catastrophic losses; reinsurance costs and the ability of reinsurers to indemnify the Company; raising additional capital and our potential failure to meet minimum capital and surplus requirements; potential assessments that support property and casualty insurance pools and associations; the effectiveness of internal financial controls; the effectiveness of our underwriting, pricing and related loss limitation methods; changes in loss trends, including as a result of insureds’ assignment of benefits; court decisions and trends in litigation; our potential failure to pay claims accurately; ability to obtain regulatory approval applications for requested rate increases, or to underwrite in additional jurisdictions, and the timing thereof; the impact that the results of the Monarch joint venture may have on our results of operations; inflation and other changes in economic conditions (including changes in interest rates and financial markets); pricing competition and other initiatives by competitors; legislative and regulatory developments; the outcome of litigation pending against the Company, and any settlement thereof; dependence on investment income and the composition of the Company’s investment portfolio; insurance agents; ratings by industry services; the reliability and security of our information technology systems; reliance on key personnel; acts of war and terrorist activities; and other matters described from time to time by the Company in releases and publications, and in periodic reports and other documents filed with the United States Securities and Exchange Commission.

In addition, investors should be aware that generally accepted accounting principles prescribe when a company may reserve for particular risks, including claims and litigation exposures. Accordingly, results for a given reporting period could be significantly affected if and when a reserve is established for a contingency. Reported results may therefore appear to be volatile in certain accounting periods.

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made.  We do not undertake any obligation to update publicly or revise any forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements are made.

CONTACT:
Michael H. Braun, CEO (954) 308-1322,
Ronald Jordan, CFO (954) 308-1363,
or Erick A. Fernandez, CAO (954) 308-1341
Federated National Holding Company

$ONS Announces Strategic Partnership With GMS Tenshi Holdings Pte. Limited

Up to $50 million in combination of equity, warrants and license fees

CRANBURY, N.J., Sept. 08, 2017 – Oncobiologics, Inc. (NASDAQ:ONS) today announced that it entered into a Purchase Agreement on September 7, 2017 with GMS Tenshi Holdings Pte. Limited (“GMS Tenshi”), providing for the private placement of up to $25.0 million of Oncobiologics’ Series A Convertible Preferred Stock (“Series A”), as well as warrants to acquire up to an additional 16,750,000 shares of its common stock (the “Warrants”) having an aggregate exercise price of approximately $15 million.

In connection with the entry into the Purchase Agreement, Oncobiologics and GMS Tenshi also entered into a Joint Development and License Agreement (the “License”), providing for the license to GMS Tenshi of rights to ONS-3010 (HUMIRA® biosimilar) and ONS-1045 (AVASTIN® biosimilar) in emerging markets, excluding China, India and Mexico. The License supersedes and replaces a previous strategic license agreement entered into on July 25, 2017 with GMS Tenshi, which licensed only ONS-1045, and which resulted in payments totaling $2.5 million in up-front and milestone fees to Oncobiologics.  The License includes an aggregate $2.5 million of additional upfront payments due in part at signing and upon initial closing of the sale of Series A under the Purchase Agreement, as well as potential additional milestones of up to $5.0 million and a net profit share.

Oncobiologics has also entered into an agreement with an existing investor and holder of senior secured notes of Oncobiologics to exchange $1.5 million of its senior secured notes for non-voting Series B Convertible Preferred Stock and forgive the unpaid interest on such exchanged notes.

Oncobiologics Chairman and CEO, Pankaj Mohan, Ph.D., commented, “This investment by GMS Tenshi represents the culmination of our efforts to align with a strategic financial partner with a global strategy to accelerate commercialization of our biosimilar candidates and enhance our partnering and licensing capabilities.  The principals of GMS Tenshi are internationally known biopharma entrepreneurs with the know-how to rapidly deliver critically needed biosimilars to emerging markets around the globe.  We believe that we now have a partner with the necessary financial and global commercial pharmaceutical expertise that, when combined with our unique BioSymphony™ Platform, will allow us to realize our vision to bring affordable biologic drugs to patients in need around the world.”

Oncobiologics intends to use the net proceeds from the private placement primarily for the initiation of Phase 3 clinical trials for its lead biosimilar candidate, ONS-3010, and for working capital and general corporate purposes.  ONS-3010 has successfully completed Phase 1 clinical trials and is preparing to enter Phase 3 in 2018. Oncobiologics is developing ONS-3010 as a differentiated HUMIRA® biosimilar with a unique formulation and an innovative Phase 3 clinical program designed to prove biosimilarity to, and interchangeability with, HUMIRA® in a single study population.

GMS Tenshi is a Singapore based joint-venture between Tenshi Life Sciences Private Limited – the private investment vehicle of Arun Kumar, and GMS Holdings, a private investment company headquartered in Amman, Jordan owning a portfolio of diversified businesses globally.  Arun Kumar is the founder of the Strides Group of companies, including India-based pharmaceutical company Strides Arcolab Limited (currently Strides Shasun Limited) and Stelis Biopharma Limited, a company engaged in the development of biotherapeutic drugs (including biosimilars).  GMS Holdings is a founder and major shareholder in MS Pharma, a leading branded generics company in the Middle East and North Africa region.  In the United States, GMS Holdings was a co-founder of and majority shareholder in Alvogen, Inc. a specialty generic pharmaceutical company, which it sold in 2014.  Together with Strides Shasun and Tenshi Life Sciences, GMS Holdings is a strategic investor in Stelis Biopharma.

A statement issued by GMS Tenshi noted, “We believe that bringing affordable biosimilars to emerging markets where they are so desperately needed is of critical importance to global healthcare.  As pharma specialists, we also recognize the technical challenges in developing and manufacturing complex biologics, and we saw that the Oncobiologics team and its BioSymphony™ Platform offered the scientific and engineering capabilities required to accomplish this. GMS Tenshi is excited to invest in Oncobiologics to accelerate the commercialization of its flagship biosimilar product candidates (namely ONS-3010 and ONS-1045), as well as other pipeline and new product candidates. Our objective is to help Oncobiologics prepare ONS-3010 so that it can be launched alongside other first-wave HUMIRA® biosimilars with potentially improved tolerability compared to the originator product as reported in the successful Phase 1 trial.”

Under the Purchase Agreement, Oncobiologics will initially sell 32,628 shares of its Series A to GMS Tenshi for approximately $3.3 million of cash upon satisfaction of certain initial closing conditions, and enter into an Investor Rights Agreement in connection therewith.  Under the Investor Rights Agreement, Oncobiologics will grant GMS Tenshi certain registration rights with respect to the shares of its common stock issuable upon conversion of the Series A and exercise of the Warrants. Effective upon the closing of the initial sale of Series A to GMS Tenshi, Oncobiologics’ Board also will elect Faisal G. Sukhtian and Joe Thomas, each of whom will be designated by GMS Tenshi under the Investor Rights Agreement, to its Board of Directors, which individuals will fill vacancies on the Board created by the resignations of Robin Smith Hoke and Donald J. Griffith, which will also be effective as of the closing of the initial sale of Series A to GMS Tenshi.  Oncobiologics also entered into an Exchange and Purchase Agreement on September 7, 2017 with an existing investor and agreed to exchange $1.5 million aggregate principal amount of the outstanding senior secured notes held by such investor for 1,500,000 of Oncobiologics’ non-voting, Series B Convertible Preferred Stock (“Series B”) concurrent with the issuance of the remaining 217,372 shares of Series A.  Oncobiologics and the holders of its senior secured notes also agreed to amend the terms of such notes to extend the maturity date by 12 months, among other items.

The closing of the sale of the additional 217,372 remaining shares of Series A and the Warrants is subject to a number of additional closing conditions, including receipt of stockholder approval and other customary closing conditions. Under the Investor Rights Agreement, GMS Tenshi will have the right to designate up to two additional directors in connection with the closing of the sale of such remaining securities. Oncobiologics will also grant GMS Tenshi certain information rights, a right of first offer over certain future issuances of securities, as well as a right of participation in certain future securities issuances.  In the event that the final closing does not occur, Oncobiologics has agreed to pay GMS Tenshi, under certain circumstances, $12.5 million in liquidated damages in addition to other expenses, and GMS Tenshi will have a right to put all of the Series A purchased at the initial closing to Oncobiologics.

Oncobiologics intends to file a proxy statement with the U.S. Securities and Exchange Commission for its Annual Meeting of Stockholders, pursuant to which it will seek stockholder approval of the issuance of the Series A and Warrants to GMS Tenshi, change of control of Oncobiologics, along with election of directors and other items to be set forth therein.

This news release shall not constitute an offer to sell or a 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 Oncobiologics, Inc. and its BioSymphony™ Platform
Oncobiologics is a clinical-stage biopharmaceutical company focused on identifying, developing, manufacturing and commercializing complex biosimilar therapeutics. Its current focus is on technically challenging and commercially attractive monoclonal antibodies (mAbs) in the disease areas of immunology and oncology. Oncobiologics is advancing its pipeline of biosimilar products, two of which are currently in clinical development. Led by a team of biopharmaceutical experts, Oncobiologics operates from an in-house state-of-the-art fully integrated research and development, and manufacturing facility in Cranbury, New Jersey. Oncobiologics employs its BioSymphony™ Platform to address the challenges of biosimilar development and commercialization by developing high quality mAb biosimilars in an efficient and cost-effective manner on an accelerated timeline. For more information, please visit www.oncobiologics.com.

Forward-Looking Statements
This press release contains forward-looking statements.  All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend” or “continue,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning.  These include statements about whether or not the closing of the sale of the Series A and Warrants to GMS Tenshi will occur, our ability to receive potential additional upfront and milestone payments under the License Agreement, the effects of partnering with GMS Tenshi on our ability to continue development of, and potentially commercialize, our biosimilar product candidates, and the exchange of senior secured notes for Series B, among others. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this presentation. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

CONTACTS:

Oncobiologics:
Lawrence A. Kenyon
Chief Financial Officer
LawrenceKenyon@oncobiologics.com

Media & Investors: 
Alex Fudukidis
Russo Partners, LLC
alex.fudukidis@russopartnersllc.com

$CIIX Announces Publication on Advancements and Applications of Cryptocurrency

$KEYW $18 Million Task Order for DOD

HANOVER, Md., Sept. 07, 2017 — The KeyW Holding Corporation (NASDAQ:KEYW) today announced that its wholly-owned subsidiary, Sotera Defense Solutions, Inc., was awarded a three-year, $18 million Task Order to provide business systems software engineering and sustainment services to the U.S. Army Communications-Electronics Command (CECOM) Software Engineering Center (SEC). This is the fifth Task Order awarded to the combined company under the $7 billion Software and Systems Engineering Services Next Generation (SSES NexGen) indefinite delivery/indefinite quantity contract.

For this contract, awarded during the second quarter of the company’s fiscal year, KeyW will support software engineering, development and sustainment, business consulting, IT infrastructure, procurement management and administrative services for the CECOM SEC Enterprise Information Systems Directorate (EISD).

EISD’s mission is to execute program management and lifecycle sustainment functions within cost, schedule and performance for all assigned enterprise resource planning, logistics IT, satellite communications and Department of Defense/Department of the Army enterprise business applications.

“KeyW is mission-focused,” said Bill Weber, KeyW’s chief executive officer. “And we’re honored to continue this work that ultimately supports the Army’s mission to provide quality software solutions for Warfighters.”

About KeyW

KeyW is a pure-play national security solutions provider for the Intelligence, Cyber and Counterterrorism Communities’ toughest challenges. We support the collection, processing, analysis and dissemination of information across the full spectrum of their missions. We employ and challenge more than 2,000 of the most talented professionals in the industry with solving such complex problems as preventing cyber threats, transforming data into intelligence and combating global terrorism.

Forward-Looking Statements: Statements made in this press release that are not historical facts constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to: statements about our future expectations, plans and prospects; statements regarding  our strategies, plans, and operations; and other statements containing the words “estimates,” “believes,” “anticipates,” “plans,” “expects,” “will,” “potential,” “opportunities,” and similar expressions. Our actual results, performance or achievements or industry results may differ materially from those expressed or implied in these forward-looking statements. These statements involve numerous risks and uncertainties, including but not limited to those risk factors set forth in our Annual Report on Form 10-K, dated and filed March 15, 2017 with the Securities and Exchange Commission (SEC) as required under the Securities Act of 1934, and other filings that we make with the SEC from time to time. Due to such uncertainties and risks, readers are cautioned not to place undue reliance on such forward-looking statements. KeyW is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events or otherwise.

Contacts:
Heather Williams
Corporate Media Relations 
443.733.1613
communications@keywcorp.com

Investor Relations
443.733.1600
investors@keywcorp.com

$CDXC TRU NIAGEN™ Retail Launch, Partnered with Asia’s Top Health & Beauty Shop, Watsons

Hong Kong will be the Initial Market Launch, Soon to be Followed by Additional Asian Locations

IRVINE, Calif., Sept. 07, 2017 — ChromaDex Corp. (NASDAQ:CDXC), an innovator of science-based, proprietary health and wellness consumer products and ingredient technologies that promote health longevity announced today its new partnership with Hong Kong based retailer, A.S. Watson, for the launch of the U.S. made TRU NIAGEN^™ dietary supplement (www.truniagen.com) in Asia.

With over 6,000 stores in 11 Asian and European markets, Watsons is the leading health and beauty retailer in Asia and Europe.  On September 15, Watsons will launch TRU NIAGEN^™ in over 100 stores in Hong Kong and online in eStore at www.watsons.com.hk.

Frank Jaksch, Jr., CEO and Co-founder of ChromaDex stated, “We’re excited to have a premier partner in Watsons, for the launch of TRU NIAGEN^™ in Asia. They are globally renowned for offering a market-leading product range, and exceptional personalized consultation to educate their consumers.”

Ms. Diane Cheung, General Manager of Watsons Hong Kong shared, “Our innovative consumers are looking for nutritional support to help them age better.  Watsons prides itself on bringing breakthrough health and nutrition technologies to its consumers.  TRU NIAGEN^™ is a proven, safe and effective way to significantly boost NAD+, which may help our consumers achieve health longevity.”

NAD+ plays an essential role in cellular metabolism and maintaining healthy cellular function. Published research suggests that declines in NAD+ are linked to a variety of challenges associated with aging.

Robert Fried, President, and Chief Strategy Officer of ChromaDex, added, “This critical milestone is the first step in executing our broader expansion plans for TRU NIAGEN^™. With the science continually reinforcing just how important NAD+ and this nutrient are to health, we recognize our responsibility to distribute it widely, safely and with the finest partners around the globe.”

Soon after the premiere in Hong Kong, Watsons plans to launch TRU NIAGEN^™ in additional retail outlets in Macau and in other Asian countries in the near future. TRU NIAGEN^™ will be available with a single bottle priced at HK$388.  Annual subscriptions and multi bottle packs will also be offered online soon.

To date, ChromaDex has invested millions in analytical research, toxicology studies and human clinical trials supporting the safety and efficacy of TRU NIAGEN^™.  It has initiated over 120 collaborative studies with leading universities and research institutions such as the National Institute of Aging, MIT and the Scripps Research Institute, representing an estimated $50+ million in additional nicotinamide riboside research.

For more information on ChromaDex, visit: https://www.chromadex.com/.

About NAD+
NAD+ activates cellular metabolism and energy production within the cell’s “power stations,” the mitochondria. Our mitochondria are constantly working to convert the food we eat into the energy necessary to power all bodily systems as well as help us stay healthy. The challenge is that both NAD+ levels and mitochondrial functions decline as we age. This reduction in NAD+ is believed by scientists to be linked to a wide variety of age-related challenges.

About TRU NIAGEN^™
TRU NIAGEN™ is a branded dietary supplement brought to market by key nicotinamide riboside innovator and patent holder, ChromaDex.  NIAGEN^® nicotinamide riboside (NR), also supplied by ChromaDex, is the feature ingredient in TRU NIAGEN^™.  Research published in Nature Communications demonstrates it is clinically proven to boost NAD+ (nicotinamide adenine dinucleotide) levels, which decline with age. Only NIAGEN^® nicotinamide riboside has Generally Recognized as Safe (GRAS) status and a New Dietary Ingredient Notification (NDIN), both reviewed by FDA.

About ChromaDex:
ChromaDex leverages its complementary business units to discover, acquire, develop and commercialize patented and proprietary health and wellness consumer products and nutritional ingredient technologies that promote healthy longevity. In addition to our consumer product and ingredient technologies units, we also have business units focused on natural product fine chemicals (known as “phytochemicals”), and product regulatory and safety consulting. As a result of our relationships with leading universities and research institutions, we are able to discover and license early stage, IP-backed ingredient technologies. We then utilize our in-house chemistry, regulatory and safety consulting business units to develop commercially viable ingredients. Our consumer product and ingredient portfolio are backed with clinical and scientific research, as well as extensive IP protection. Our portfolio of patented ingredient technologies includes NIAGEN^® nicotinamide riboside; pTeroPure^® pterostilbene; PURENERGY^®, a caffeine-pTeroPure^® co-crystal; IMMULINA^™, a spirulina extract; and AnthOrigin^®, anthocyanins derived from a domestically-produced, water-extracted purple corn husk. To learn more about ChromaDex, please visit www.ChromaDex.com.

About Watsons:
Watsons is Asia’s leading health and beauty retailer, currently operating over 6,000 stores – more than 1,500 of which are pharmacies, in 11 Asian and European markets, including China (Mainland China, Hong Kong, Taiwan and Macau), Singapore, Thailand, Malaysia, the Philippines, Indonesia, Turkey and Ukraine. Watsons operates over 220 stores in Hong Kong and Macau, of which over 50 have in-store pharmacies, making Watsons the No. 1 Pharmacy Network in Hong Kong.

Watsons has a professional team of pharmacists, dieticians, Chinese medicine practitioners, health & fitness advisors, beauty consultants, an experienced mother & baby advisor and a nurse. They are devoted to serving customers, and offer the longest pharmacy operating hours in Hong Kong.

Watsons continually sets the highest standards in the health, wellness and beauty market, providing personalized advice and counseling in health, beauty and personal care on top of its market-leading product range, making customers LOOK GOOD, FEEL GREAT every day. Since 2009, Watsons has been the No. 1 Pharmacy/ Drugstore brand in Asia*. In Europe, Watsons is also the leading Health & Beauty retailer in Ukraine.

*Campaign Asia-Pacific/ Nielsen’s “Asia’s Top 1,000 Brands” Online Study 2017 of over 6,000 respondents across 13 markets in Asia Pacific region

About A.S. Watson Group:
Established in Hong Kong in 1841, A.S. Watson Group is the largest international health and beauty retailer in Asia and Europe with over 13,500 stores in 24 markets. Each year, over three billion customers and members shop with A.S. Watson’s 13 retail brands, both in stores and online.

In Hong Kong, A.S. Watson operates more than 600 stores under four retail brands – Watsons, PARKnSHOP, FORTRESS, and Watson’s Wine. In addition, A.S. Watson manufactures and distributes high quality drinking water brand Watsons Water, as well as the famous juice drinks Mr. Juicy and Sunkist.

For the fiscal year 2016, A.S. Watson Group recorded revenue of HKD151.5 billion. A.S. Watson has over 130,000 employees worldwide, including 12,900 in Hong Kong.

A.S. Watson Group is also a member of the world-renowned multinational conglomerate CK Hutchison Holdings Limited, which has five core businesses ‐ ports and related services, retail, infrastructure, energy and telecommunications in over 50 countries.

Please visit www.aswatson.com for more in-depth information about A.S. Watson Group and its brands. You may also stay in touch with A.S. Watson via its digital presence (eCommerce, social media, mobile app & more); more details are at http://www.aswatson.com/our-customers/digitalasw/.

Forward-Looking Statements:
This release contains forward-looking statements relating to ChromaDex and ChromaDex’s business within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements related to the timing and expansion plans of launching TRU NIAGEN^™ in Asia, the ability of ChromaDex to execute on expanding TRU NIAGEN^™ sales, whether science will reinforce how important NAD+ and TRU NIAGEN^™ are to health, the health benefits of TRU NIAGEN^™, including whether TRU NIAGEN^™ can help consumers achieve health longevity, the amount ChromaDex will invest in trials supporting the safety and efficacy of TRU NIAGEN^™, the price of TRU NIAGEN^™ to consumers in Asia and whether a reduction in NAD+ is linked to age-related challenges. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as “expects”, “anticipates”, “intends”, “estimates”, “plans”, “potential”, “possible”, “probable”, “believes”, “seeks”, “may”, “will”, “should”, “could” or the negative of such terms or other similar expressions. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, ChromaDex’s Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

ChromaDex Public Relations Contact:
Breah Ostendorf, Director of Marketing 
949-537-4103
breaho@chromadex.com

ChromaDex Investor Relations Contact:
Andrew Johnson, Director of Investor Relations 
949-419-0288
andrewj@chromadex.com

$KURA Positive Phase 2 Study for Tipifarnib in HRAS

Four of the first six HRAS mutant HNSCC patients enrolled on study achieve confirmed RECIST partial responses

Durable responses greater than one year observed

SAN DIEGO, Sept. 07, 2017  — Kura Oncology, Inc., (Nasdaq:KURA) a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced positive topline results from a Phase 2 trial for its lead product candidate, tipifarnib, in patients with HRAS mutant relapsed or refractory squamous cell carcinomas of the head and neck (HNSCC). The Phase 2 trial achieved its primary endpoint prior to the completion of enrollment.

The trial protocol requires four confirmed, partial responses, per RECIST 1.1 criteria, out of 18 patients to meet its primary endpoint. Four confirmed, partial responses and two patients with disease stabilization have been observed among the first six evaluable HNSCC patients enrolled in the trial. In addition, objective responses greater than one year in duration have already been observed in two patients. All patients joined the study upon progression on prior therapy, including chemotherapy, cetuximab or immune therapy. Kura will continue to enroll HRAS mutant HNSCC patients and plans to present data from the study at an upcoming scientific or medical conference.

“We have observed rapid and, in some cases, dramatic responses in patients with relapsed and/or refractory HNSCC who do not appear to benefit from other therapies,” said Antonio Gualberto, M.D., Ph.D., Chief Medical Officer of Kura Oncology. “Based on these very encouraging results, we are exploring available options to advance the development of tipifarnib in this patient population as quickly as possible.”

About HRAS Mutant HNSCC

Head and neck cancer is one of the leading causes of cancer-related deaths worldwide, with squamous cell carcinomas accounting for most head and neck cancers. Response rates for the three agents approved for treatment of HNSCC in the second line, including cetuximab and immune therapy agents, are in the range of 13-16%, and median overall survival is up to 7.5 months. HRAS is a proto-oncogene that has been implicated in the development and progression of HNSCC and has been established to be uniquely farnesylated.

About Kura Oncology

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, which is currently being studied in multiple Phase 2 clinical trials. Kura’s pipeline also includes KO-947, an ERK inhibitor, currently in a Phase 1 trial, and KO-539, an inhibitor of the menin-MLL protein-protein interaction, currently in preclinical testing. For additional information about Kura Oncology, please visit the company’s website at www.kuraoncology.com.

Forward-Looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of tipifarnib, progress and expected timing of Kura Oncology’s tipifarnib drug development program and clinical trials and plans regarding future clinical trials and development activities. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura Oncology may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise, ” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura Oncology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT INFORMATION

INVESTOR CONTACT:
Robert H. Uhl
Managing Director
Westwicke Partners, LLC
(858) 356-5932
robert.uhl@westwicke.com

CORPORATE COMMUNICATIONS CONTACT:
Mark Corbae
Vice President
Canale Communications
(619) 849-5375
mark@canalecomm.com

$FRTA Charlie Brown Joins Forterra as Executive Vice President and Chief Financial Officer

IRVING, Texas, Sept. 07, 2017 — Forterra, Inc. (“Forterra” or the “Company”) (NASDAQ:FRTA), a leading manufacturer of water infrastructure pipe and products in the United States and Eastern Canada, today announced the appointment of Charlie Brown as Executive Vice President and Chief Financial Officer, to begin his employment on or before September 25, 2017. Mr. Brown is an industry veteran with over 25 years of experience driving growth and improvement at manufacturing and construction materials companies. Mr. Brown will report to Chief Executive Officer Jeff Bradley and serve on the Company’s executive leadership team. He will succeed Matt Brown, who has resigned from the Company to pursue other opportunities.

Charlie Brown previously served as Chief Financial Officer of Oldcastle Materials Company, the North American materials division of CRH plc with $8 billion in 2016 revenue, where he led over 500 associates in over 1,200 locations, including finance, accounting, risk management and real estate personnel. During his tenure, he led implementation of enhanced financial systems, including SOX compliance, and improved business reporting capabilities and internal controls. In addition to his core responsibilities as CFO, Mr. Brown was active in Oldcastle’s operational management and acquisition activities, having completed over 100 deals during his time as CFO of the company and led efforts to enhance the procurement function and cost savings initiatives.

Mr. Brown joined Oldcastle Materials as Vice President of Finance in 2003 and was promoted to Senior Vice President of Finance in 2007 and Chief Financial Officer in 2008.  Prior to Oldcastle Materials, he held various finance and senior management roles of increasing responsibility at Vulcan Materials from 1996 to 2003 and at PPG Industries from 1990 to 1996. Mr. Brown holds a Bachelor of Arts in International Economics from The George Washington University in Washington, D.C., and Master of Management from Northwestern University (Kellogg) in Evanston, Illinois.

“We are pleased to announce Charlie’s appointment as Forterra’s CFO,” said Mr. Bradley. “Charlie brings a strong background in finance and proven leadership capabilities, with over nine years serving as a CFO of Oldcastle Materials Company. I look forward to working alongside him to leverage his skills, expertise and experience as we focus on executing our growth strategy and delivering value to our shareholders.  I also want to thank Matt for his contributions to Forterra over the past two years. We wish him well in his future endeavors.”

Matt Brown’s decision to resign was not motivated by any disagreements over financial statements or disclosures.

About Forterra, Inc.
Forterra is a leading manufacturer of pipe and products in the U.S. and Eastern Canada for a variety of water-related infrastructure applications, including water transmission, distribution, drainage and stormwater management. Based in Irving, Texas, Forterra’s product breadth and scale help make it a preferred supplier to a wide variety of customers, including contractors, distributors and municipalities. For more information on Forterra, please visit www.forterrabp.com.

Cautionary Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on historical information available at the time the statements are made and are based on management’s reasonable belief or expectations with respect to future events, and are subject to risks and uncertainties, many of which are beyond the Company’s control, that could cause actual performance or results to differ materially from the belief or expectations expressed in or suggested by the forward-looking statements. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update any forward-looking statement to reflect future events, developments or otherwise, except as may be required by applicable law. Investors are referred to the Company’s filings with the Securities and Exchange Commission for additional information regarding the risks and uncertainties that may cause actual results to differ materially from those expressed in any forward-looking statement.

Company Contact Information:
David Lawrence
Vice President and Treasurer 
469-299-9113
IR@forterrabp.com

$NLNK Updated Data for Indoximod Plus KEYTRUDA® in Melanoma

AMES, Iowa

NewLink Genetics Corporation (NASDAQ: NLNK) today announced updated data from the ongoing Phase 2 NLG2103 study of indoximod, NewLink Genetics’ IDO pathway inhibitor, in combination with the PD-1 pathway inhibitor, KEYTRUDA (pembrolizumab). These data will be highlighted in an oral presentation at the Third International Cancer Immunotherapy Conference in Frankfurt/Mainz, Germany, on September 9, 2017 by Yousef Zakharia, M.D., Assistant Professor of Medicine, Division of Hematology, Oncology and Blood & Marrow Transplantation at the University of Iowa and Holden Comprehensive Cancer Center.

Indoximod plus pembrolizumab data from Phase 2 trial in advanced melanoma (Graphic: Business Wire)

The presentation entitled, “Combined Inhibition of the IDO and PD-1 Pathways Improves the Response Rate for Patients with Advanced Melanoma”, showed an improvement over previously reported results presented at the AACR Annual Meeting 2017 for both the Complete Response rate (CR) and the Overall Response Rate (ORR) for patients¹ who received indoximod plus pembrolizumab. Evaluable patients were defined as those having at least one on-treatment imaging study.

Key findings in the updated data reported today:

• Improvement in Complete Response (CR) to 20% (10/51 patients) compared to CR of 12% (6/51 patients)
• The Progression-Free Survival (PFS) by RECIST criteria was 56% at one year with median PFS (mPFS) of 12.9 months

“We are encouraged by the progression-free survival and the improvement in complete responses observed in the trial,” said Charles J. Link, Jr., M.D., Chairman, Chief Executive Officer, and Chief Scientific Officer. “The updated data further support our decision to initiate a pivotal trial for patients with advanced melanoma.”

Indoximod in combination with pembrolizumab was well-tolerated. The most common all-grade adverse events were fatigue, headache, and nausea. Three patients experienced grade 3 serious adverse events (SAE) possibly attributed to indoximod. Three patients experienced SAEs that led to discontinuation of treatment. There were no treatment related deaths.

Pivotal Trial of Indoximod in Advanced Melanoma to Include Both PD-1 Inhibitors, KEYTRUDA (pembrolizumab) and OPDIVO (nivolumab)

The pivotal trial has been designed as a large-scale (600 patients) trial in Stage III unresectable and metastatic stage IV melanoma. The trial will have a one to one randomization between indoximod plus KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab) compared to single agent PD-1 inhibitor. The co-primary endpoints of the study are PFS by RECIST criteria and Overall Survival (OS).

“Our team is excited to move forward with this pivotal trial,” said Eugene Kennedy, M.D., Vice President of Clinical and Medical Affairs. “We believe that allowing physicians the choice of either pembrolizumab or nivolumab accurately reflects current clinical care and should aid in enrolling the trial by the end of 2018.”

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape.

NewLink Genetics is currently evaluating indoximod in multiple combination studies for patients with various types of cancer including melanoma, acute myeloid leukemia, pancreatic cancer and prostate cancer.

About NewLink Genetics Corporation

NewLink Genetics is a late-stage biopharmaceutical company focusing on discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics’ IDO pathway inhibitors are designed to harness multiple components of the immune system to combat cancer. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1 agents, cancer vaccines, and chemotherapy across multiple indications such as melanoma, prostate cancer, acute myeloid leukemia, and pancreatic cancer. For more information, please visit http://www.newlinkgenetics.com.

KEYTRUDA® is a registered trademark of Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

OPDIVO® is a registered trademark of Bristol-Myers Squibb Company.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of NewLink Genetics that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,” “will,” “could,” “should,” “seek” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include any statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink Genetics makes due to a number of important factors, including those risks discussed in “Risk Factors” and elsewhere in NewLink Genetics’ Annual Report on Form 10-K for the year ended December 31, 2016 and other reports filed with the U.S. Securities and Exchange Commission (SEC). The forward-looking statements in this press release represent NewLink Genetics’ views as of the date of this press release. NewLink Genetics anticipates that subsequent events and developments will cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing NewLink Genetics’ views as of any date subsequent to the date of this press release.

$SRPT Positive Results for Gene Expression Study in DMD

— Study achieved statistical significance on all primary and secondary biological endpoints —

— Results further validate the Company’s exon-skipping platform for the treatment of DMD —

CAMBRIDGE, Mass., Sept. 06, 2017 — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicines to treat rare neuromuscular diseases, today announced muscle biopsy results from its 4053-101 study, a Phase 1/2 first-in-human study conducted in Europe to assess the safety, tolerability, pharmacokinetics, and efficacy of golodirsen in 25 boys with confirmed deletions of the DMD gene amenable to skipping exon 53. The study comprised two parts. In Part 1, 12 patients were randomized to receive a dose titration of golodirsen (8 patients) or placebo (4 patients).  At the end of Part 1 (dose titration), all 12 patients continued on golodirsen and an additional 13 patients started golodirsen (Part 2).  In Part 2, all 25 patients were treated for an additional 48 weeks at the time of muscle biopsy. The analysis included biopsies of the bicep muscle at baseline and on-treatment at the Part 2 Week 48 time point. All 25 participants displayed an increase in skipping exon 53 (p < 0.001) over baseline levels, representing a 100 percent response rate as measured by RT-PCR and demonstrating proof of mechanism. Mean dystrophin protein increased to 1.019 percent of normal compared to a mean baseline of 0.095 percent of normal (p < 0.001) as measured by Western blot, the primary biological endpoint in the study, representing a 10.7 fold increase from baseline. The study also showed a statistically significant increase in dystrophin immunofluorescence as measured by immunohistochemistry (IHC), the secondary biological endpoint in the study, confirming sarcolemma-associated protein expression and distribution.

Francesco Muntoni, principal investigator for this study and Pediatric Neurologist, Great Ormond Street Hospital for Children NHS Foundation Trust and the UCL Great Ormond Street Institute of Child Health, said, “All treated boys showed the anticipated exon skipping after treatment and this resulted in a mean increase of dystrophin protein, as measured by Western blot, from 0.095 percent at baseline to 1.019 percent of normal after at least one-year of treatment with golodirsen.”

“These data were also supported by the highly statistically significant increase of dystrophin expression at the sarcolemma, as measured by recently developed validated methodology. This is now the second exon-skipping agent to have shown a statistically significant increase in dystrophin production, validating the exon-skipping approach to treating DMD boys with amenable mutations.”

Professor Muntoni is also Director of the Dubowitz Neuromuscular Center, a leading clinical and research institution for children affected by neuromuscular disorders, and Deputy Director, for the MRC Neuromuscular Translational Research Centre at University College London.

“These data demonstrate statistically significant exon skipping, dystrophin production and localization, which further validate the broad application of our exon-skipping platform and aligns with our strategic imperative to expand and improve the treatment choices for the majority of patients with DMD,” said Douglas Ingram, Sarepta Therapeutics’ president and chief executive officer. “Additionally, the rigor with which we designed our methods and executed this study speaks to our commitment to continuous improvement and scientific excellence.”

The full biological results from the 4053-101 study will be presented at an upcoming medical meeting or scientific conference. Golodirsen is one of the investigational candidates currently being evaluated in the ESSENCE study, a global, randomized double-blind, placebo-controlled study evaluating efficacy and safety in patients amenable to skipping exons 45 or 53.

Dystrophin is a protein found in muscle cells that, while present in extremely small amounts (about 0.002 percent of total muscle protein), is crucial in strengthening and protecting muscle fibers. A devastating and incurable muscle-wasting disease, DMD is associated with specific errors in the gene that codes for dystrophin, a protein that plays a key structural role in muscle fiber function. Progressive muscle weakness in the lower limbs spreads to the arms, neck and other areas of the body. The condition is universally fatal, and death usually occurs before the age of 30 generally due to respiratory or cardiac failure.

Golodirsen uses Sarepta Therapeutics’ proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 53 of the DMD gene. Golodirsen is designed to bind to exon 53 of dystrophin pre-mRNA, resulting in exclusion, or “skipping”, of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 53 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein.

About the 4053-101 Study

The 4053-101 study was conducted as part of the SKIP-NMD project, which was originally funded by a European Union grant that allowed the completion of the first phase of the Phase 1/2 4053-101 study. In addition, the SKIP-NMD international project was coordinated by Professor Muntoni and involved a consortium of 10 academic partners across Europe (UK, France, Belgium and Italy) and the U.S. Several companies including Sarepta Therapeutics, Consultants for Research and Imaging (CRIS), and SYSNAV (expertise in indoor/outdoor robust navigation and positioning systems) provided new advances and techniques in translational Duchenne research, as did six patient organizations: Action Duchenne, Association Française contre les Myopathies, Duchenne Family Support Group, Duchenne Parent Project France, Duchenne Parent Project Onlus, and Muscular Dystrophy UK.

The study is titled, “2-Part, Randomized, Double-Blind, Placebo-Controlled, Dose-Titration, Safety, Tolerability, and Pharmacokinetics Study (Part 1) Followed by an Open-Label Efficacy and Safety Evaluation (Part 2) of SRP-4053 in Patients With Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping.”

Part 1 is a randomized, placebo-controlled dose-titration to assess safety, tolerability and pharmacokinetics of four dose levels of SRP-4053 in genotypically-confirmed DMD patients with deletions amenable to exon 53 skipping.

Part 2 is an open-label evaluation of SRP-4053 in patients from Part 1, along with newly enrolled DMD patients with deletions amenable to exon 53 skipping. Paired muscle biopsies of the biceps brachii at baseline and on-treatment were obtained to evaluate the biological endpoints from 25 patients treated with 30 mg/kg of SRP-4053 administered weekly by intravenous infusion during Part 2 of the trial. The study is scheduled to continue for 144 weeks to evaluate safety and clinical endpoints.

About Duchenne Muscular Dystrophy

DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. One of the most common fatal genetic disorders, DMD affects approximately one in every 3,500 – 5,000 male births worldwide.

About Sarepta Therapeutics

Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicines to treat rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying Duchenne muscular dystrophy (DMD) drug candidates. For more information, please visit www.sarepta.com.

Forward-Looking Statements

This press release contains “forward-looking statements”. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the safety and efficacy of golodirsen (SRP-4053); study data achieving statistical significance on endpoints and validating Sarepta’s exon-skipping platform and approach for the treatment of DMD boys with amendable mutations; the data demonstrating statistically significant exon skipping, dystrophin production and localization, which further validate the broad application of Sarepta’s exon-skipping platform and align with Sarepta’s strategic imperative to expand and improve the treatment choices for the majority of patients with DMD; the rigor with which Sarepta designed the methods and executed this study speaking to Sarepta’s commitment to continuous improvement and scientific excellence; the full biological results being presented at an upcoming medical meeting or scientific conference; golodirsen continued evaluation as part of the ESSENCE study and its designed mechanism of action.

These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: the results of our ongoing research and development efforts and clinical trials for golodirsen (SRP-4053) and our other product candidates may not be positive or consistent with these or prior results or demonstrate a safe clinical benefit; the data presented in this release may not be consistent with the final data set and analysis thereof or result in a safe or effective treatment benefit; there may be delays in Sarepta’s projected development or regulatory timelines for golodirsen (SRP-4053) and its other products candidates for various reasons, some of which may be outside of Sarepta’s control, including regulatory, court or agency decisions, and any or all of Sarepta’s product candidates may fail in development or may not receive required regulatory approvals for commercialization; and those risks identified under the heading “Risk Factors” in Sarepta’s 2016 Annual Report on Form 10-K or and most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect Sarepta’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the Company’s filings with the SEC. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Internet Posting of Information

We routinely post information that may be important to investors in the ‘For Investors’ section of our website at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

Source: Sarepta Therapeutics, Inc.

Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
iestepan@sarepta.com 
or
W2O Group
Brian Reid, 212-257-6725
breid@w2ogroup.com

$FRED Names Heath Freeman Chairman of the Board

MEMPHIS, Tenn.

Fred’s, Inc. (“Fred’s” or “Company”) (NASDAQ:FRED) today announced that it has appointed Heath Freeman Chairman of the Board of Directors, effective immediately. Mr. Freeman succeeds Thomas J. Tashjian, who is retiring from the Board.

“Heath brings significant retail, turnaround, and financial expertise and we determined that as Chairman, Heath will bring invaluable insights and experience as the Company continues to execute its turnaround strategy,” said Michael K. Bloom, Chief Executive Officer and Member of the Board. “Additionally, as President of Alden, the Company’s largest investor, Heath brings a strong shareholder perspective to the role of Chairman. I am confident that under his leadership, coupled with the oversight of our high-quality and experienced Board, we will be well positioned to drive Fred’s long-term success.”

Mr. Freeman commented, “I am pleased to assume the role of Chairman of the Fred’s Board. Fred’s has a strong platform and I look forward to continuing to work together with our Board members to support the management team as it executes the Company’s strategy to drive free cash flow and generate value for all shareholders.”

Mr. Bloom added, “On behalf of the Board of Directors, I want to thank Tom for his dedicated service and many contributions to Fred’s over the past 16 years. Our Board and management team have significantly benefited from Tom’s exemplary leadership and we wish him the best in his well-deserved retirement.”

Mr. Freeman was added to Fred’s Board on August 14, 2017 in connection with the execution of an Amended and Restated Cooperation Agreement between Alden Global Capital LLC (”Alden”) and Fred’s, dated August 11, 2017.

About Heath Freeman

Mr. Freeman is the President and a Founding Member, of Alden Global Capital LLC, a New York-based investment firm focused on deep value, catalyst driven investing. He has been with the firm since its founding in 2007, and has been its President since 2014. Mr. Freeman currently serves as Vice Chairman of MediaNews Group, Inc. (‘MNG”), the second largest newspaper business in the United States by circulation, owning newspapers such as The Denver Post, San Jose Mercury News and Orange County Register. At MNG he leads the strategic review committee and serves on the compensation committee. Mr. Freeman is a co-founder and serves on the board of SLT Group, Inc. a private boutique fitness business founded in 2011. In addition, Mr. Freeman also co-founded City of Saints Coffee Roasters in 2013, a third wave coffee roaster, wholesaler and retailer. Prior to Alden, Mr. Freeman worked as an Investment Analyst at Smith Management, a private investment firm. Mr. Freeman began his career as an analyst at Peter J. Solomon Company, a boutique investment bank with a focus on Retail and Consumer, where he worked on mergers and acquisitions, restructurings and refinancing assignments. Currently, Mr. Freeman serves as Chairman of the Advisory Board for Jewish Life at Duke University’s Freeman Center. He is a graduate of Duke University.

About Fred’s Pharmacy

Tracing its history back to an original store in Coldwater, Mississippi, opened in 1947, today Fred’s Pharmacy is headquartered in Memphis, Tennessee, and operates 600 pharmacy and general merchandise stores, which includes 14 franchised Fred’s Pharmacy locations and an additional three specialty pharmacy-only locations. With a unique store format and strategy that combines the best elements of a healthcare-focused drug store with a value-focused retailer, Fred’s Pharmacy stores offer more than 12,000 frequently purchased items that address the healthcare and everyday needs of its customers and patients. This includes nationally recognized brands, proprietary Fred’s Pharmacy label products, and a full range of value-priced selections. The Company has two distribution centers, one in Memphis, Tennessee, and Dublin, Georgia.

For more information about the Company, visit Fred’s website at www.fredsinc.com.

Forward-Looking Statements

Comments in this news release that are not historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. A reader can identify forward-looking statements because they are not limited to historical facts or they use such words as “outlook,” “guidance,” “may,” “should,” “could,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “forecast,” “goal,” “intend,” “committed,” “continue,” or “will likely result” and similar expressions that concern the Company’s strategy, plans, intentions or beliefs about future occurrences or results. These risks and uncertainties include, but are not limited to, those associated with the Company’s announced strategic plan, the success of announced acquisition activities and future growth trends in businesses acquired; general economic trends; changes in consumer demand or purchase patterns; delays or interruptions in the flow of merchandise between the Company’s distribution centers and its stores or between the Company’s suppliers and same; a disruption in the Company’s data processing services; cyber-security threats; costs and delays in acquiring or developing new store sites; and the factors listed under “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any subsequent quarterly filings on Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements speak only as of the date made. The Company undertakes no obligation to release revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unforeseen events, except as required to be reported under the rules and regulations of the Securities and Exchange Commission.

$VYGR Positive Results Phase 1b Trial of VY-AADC01 in Parkinson’s

VY-AADC01 improved multiple measures of patients’ motor function and activities of daily living in Cohorts 2 and 3

Robust and durable clinical effects achieved with substantial reductions in daily oral levodopa use and other Parkinson’s medications; one-time administrations of VY-AADC01 well-tolerated out to 24 months

Pivotal Phase 2-3 program on track to begin during late 2017 and to dose the first patient during the first half of 2018

Conference call scheduled for today at 8:00 a.m. EDT

CAMBRIDGE, Mass., Sept. 06, 2017 — Voyager Therapeutics, Inc. (NASDAQ:VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, today announced positive results from its ongoing Phase 1b trial of VY-AADC01 in advanced Parkinson’s disease. The results demonstrated durable, dose-dependent and time-dependent improvements across multiple measures of patients’ motor function after a one-time administration of the gene therapy.  These measures include patient-reported diaries, Parkinson’s disease rating scales, and activities of daily living.

“We are very pleased with the updated results from our dose-escalation trial. By six months in Cohort 3, patients achieved the clinically meaningful improvements in motor symptoms that were observed in Cohort 2 and with even lower doses of their oral Parkinson’s medications, including levodopa,” said Bernard Ravina, M.D., M.S., chief medical officer of Voyager Therapeutics. “These data suggest that higher doses of VY-AADC01 result in greater AADC activity, increasing the patient’s capacity to produce dopamine and, therefore, reducing their need for oral Parkinson’s medications. As a result, patients in the trial are spending more time during the day with good motor function, less time with poor motor function, and are experiencing less disability.  For patients in Cohort 2 at 12 months, this meant an average increase during the day of four hours of on-time without dyskinesia, which is a very meaningful change.  We believe the distinct mechanism of action of VY-AADC01 that allows patients to achieve this motor function improvement while markedly reducing their Parkinson’s medications to this extent and duration reflects a pattern that has not been seen in previous Parkinson’s gene therapy trials and does not exist with current or emerging treatments.”

Steven Paul, M.D., Voyager’s president and chief executive officer added, “These encouraging results continue to de-risk the program and support the use of either dose of VY-AADC01 administered in Cohort 2 or Cohort 3 for our planned pivotal trial. We continue to be impressed with the Cohort 2 data out to 12 months, namely, the increase in diary on-time of four hours without dyskinesia, decrease in off-time of 54%, supported by a 56% reduction in UPDRS-III motor scores while on medication.  In addition, preliminary results from our posterior delivery trial suggest that even greater coverage of the putamen, the brain region we are targeting, can be achieved and with shorter administration times. We are excited to continue to follow the patients in this Phase 1b trial, particularly patients in Cohort 3 from six to 12 months, and those in the posterior delivery trial, as we approach the start of the pivotal Phase 2-3 program later this year.”

About the Phase 1b Trial

In advanced Parkinson’s disease, the putamen is depleted of dopamine and of the enzyme aromatic L-amino acid decarboxylase (AADC) that is responsible for converting levodopa to dopamine. VY-AADC01 is Voyager’s gene therapy vector that contains the gene that encodes the AADC enzyme. A single administration of VY-AADC01 into the putamen could offer advanced patients’ improved motor function while reducing their requirements for oral levodopa and other dopaminergic medications and their associated behavioral and motor side effects.

• The Phase 1b, open-label trial includes 15 patients with advanced Parkinson’s disease and disabling motor fluctuations, treated with a single administration of VY-AADC01.
• The primary objective of the trial is to assess the safety and distribution of ascending doses of VY-AADC01 administered under magnetic resonance imaging (MRI) guidance to the putamen, a region of the brain associated with impaired motor function in Parkinson’s disease.
• Secondary objectives include assessment of AADC expression and activity in the putamen measured by positron emission tomography (PET) using [¹⁸F] fluorodopa (or ¹⁸F-DOPA), which reflects the capacity to convert levodopa to dopamine. Other secondary measures include assessments of motor function and activities of daily living, as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS-III and UPDRS-II, respectively), quality of life, and a patient-completed (Hauser) diary. Daily requirements for levodopa and related medications are also measured.

Biomarker and Clinical Results Summary

Today’s interim results include data from all 15 patients treated in Cohorts 1, 2 and 3 (five patients in each Cohort) including data from patients in Cohort 1 at 24 months, Cohort 2 at 12 months and Cohort 3 at six months. Patients enrolled in Cohort 3 received similar infusion volumes of VY-AADC01 compared to Cohort 2 (up to 900 µL per putamen), but three-fold higher vector genome concentrations. This volume and concentration for Cohort 3 represents up to a three-fold higher total dose of up to 4.5×10¹² vector genomes (vg) of VY-AADC01 compared to patients in Cohort 2 who received a total dose of up to 1.5 × 10¹² vg. Patients in Cohort 1 received lower volumes (up to 450 µL per putamen) and lower vector genome concentrations for at a total dose of up to 7.5×10¹¹ vg.

Patients enrolled in Cohorts 1, 2 and 3 were:

• On average, 58 years of age with a Parkinson’s disease diagnosis for an average of 10 years.
• Candidates for surgical intervention including deep-brain stimulation due to disabling motor complications despite treatment with optimal anti-Parkinsonian medication.
• At baseline, the average patient diary on-time without troublesome dyskinesia was 10.5 hours, average UPDRS-III on medication score was 13.5, average diary off-time was 4.6 hours and average UPDRS-II activities of daily living off medication score was 16.5.
• At baseline, patients were treated with maximal levels of multiple dopaminergic medications including, in many cases, amantadine for the treatment of dyskinesia, or uncontrolled or involuntary movements. Patients’ average amount of Parkinson’s disease medications at baseline was 1,526 mg of oral levodopa equivalents per day.

Putamen Coverage, AADC Activity and Daily Doses of Oral Levodopa

• The use of real-time, MRI-guided delivery and increasing infusion volumes resulted in 21% mean coverage of the volume of the putamen with VY-AADC01 in Cohort 1, 34% mean coverage in Cohort 2, and 42% mean coverage in Cohort 3.
• VY-AADC01 treatment resulted in a 13% increase, a 56% increase, and a 79% increase in mean putaminal AADC enzyme activity in Cohort 1, 2, and 3, respectively at six months relative to baseline as measured by ¹⁸F-DOPA PET scans (Figure 1).  Coverage of the putamen and AADC enzyme activity were highly correlated (r=0.84, p=0.0002)
• VY-AADC01 treatment resulted in reduced daily doses of oral levodopa and related medications to achieve optimal motor control, suggesting a greater capacity for patients to make more dopamine but with less need for oral levodopa.  Patients’ Parkinson’s medications were reduced by a mean of 208 mg (14%), 553 mg (34%) and 618 mg (42%) for Cohorts 1, 2 and 3, respectively, at six months compared with baseline (Figure 1).

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Clinical Motor Function, Activities of Daily Living Data Summary

Treatment with VY-AADC01 resulted in dose-dependent (Cohorts 2 and 3 versus Cohort 1) and time-dependent clinically meaningful improvements in patients’ motor function in diary on-time without troublesome dyskinesia (Figure 2). This included an increase in diary on-time without dyskinesia of 4.0 hours from baseline to 12 months for patients in Cohort 2 and a reduction in patients’ on-time with troublesome dyskinesia (data not shown in Figure 2).

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Scores for UPDRS-III, the physician-rated motor examination, also improved (reduced scores) while patients were on their medication in a dose-related manner (Cohorts 2 and 3 versus Cohort 1).  These changes in self-reported diary on-time and UPDRS-III on medication are consistent with an enhanced response to oral levodopa and related medications (Figure 3).

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In addition, VY-AADC01 reduced patients’ off-time as self-reported by diary (Figure 4).

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VY-AADC01 demonstrated dose-dependent and time-dependent improvements in patients’ activities of daily living as measured by reductions in the UPDRS-II off medication score, including a change in mean score from baseline of -2.4 for Cohort 2 at 6 months compared with a change in score from baseline of -3.6 for Cohort 3 at 6 months (Figure 5).

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Safety Data from Cohorts 1, 2 and 3

The infusion was successfully completed in all 15 patients and infusions of VY-AADC01 have been well-tolerated with no vector-related serious adverse events (SAEs).  Fourteen of the 15 patients were discharged from the hospital within two days following surgery. As previously reported, one patient experienced two SAEs: a pulmonary embolism or blood clot in the lungs, and related heart arrhythmia or irregular heartbeat. The patient was treated with an anti-coagulant and symptoms associated with the SAEs have completely resolved. Investigators determined that this was most likely related to immobility during the administration and subsequent formation of a blood clot, or deep vein thrombosis (DVT), in the lower extremity. Consequently, DVT prophylaxis was added to the protocol and no subsequent events have been observed.

Phase 1b Posterior Trajectory Trial Completes Additional Patient Dosing

Investigators recently completed dosing additional patients in a separate Phase 1 trial designed to further optimize the intracranial delivery of VY-AADC01. This planned Phase 1 trial explores a posterior, or back of the head, delivery approach, compared to Cohorts 1 through 3 from the ongoing Phase 1b trial that used a transfrontal, or top of the head, delivery approach into the putamen. A posterior approach better aligns the infusion of VY-AADC01 with the anatomical structure of the putamen to potentially reduce the total procedure time and increase the total coverage of the putamen.

Administration of VY-AADC01 with this posterior approach was well-tolerated by the three patients dosed since the start of the trial. No serious adverse events were reported, and patients were discharged from the hospital the day after surgery. The posterior approach resulted in greater average putaminal coverage (approximately 50%) and reduced average administration times compared with the transfrontal approach of Cohorts 1 through 3. Voyager continues to expect to enroll more patients in this trial prior to the start of the pivotal Phase 2-3 program.

Pivotal Phase 2-3 Program on Track to Begin During Late 2017

Voyager remains on track to begin the pivotal Phase 2-3 program for VY-AADC01 late this year and dose the first patient during the first half of 2018. The company will continue to follow patients from Cohorts 1 through 3, and those in the posterior trajectory trial, and plans to report updated results from these trials during the first quarter of 2018, prior to the start of patient enrollment in the pivotal program.

Conference Call Information

Voyager will host a conference call and webcast today at 8:00 a.m. EDT. The live call may be accessed by dialing (877) 851-3834 for domestic callers or +1 (631) 291-4595 for international callers, and referencing conference ID number 80581781. A live audio webcast of the conference call will be available online from the Investors & Media section of Voyager’s website at www.voyagertherapeutics.com. The webcast will be archived for 30 days.

About Parkinson’s Disease and VY-AADC

Parkinson’s disease is a chronic, progressive and debilitating neurodegenerative disease that affects approximately 700,000 people in the U.S.¹ and seven to 10 million people worldwide². It is estimated that up to 15% of the prevalent population with Parkinson’s disease, or approximately 100,000 patients in the U.S., have motor fluctuations that are refractory, or not well-controlled, with levodopa. While the underlying cause of Parkinson’s disease in most patients is unknown, the motor symptoms of the disease arise from a loss of neurons in the midbrain that produce the neurotransmitter dopamine.  Declining levels of dopamine in this region of the brain, the putamen, leads to the motor symptoms associated with Parkinson’s disease including tremors, slow movement or loss of movement, rigidity, and postural instability.  Motor symptoms during the advanced stages of the disease include falling, gait freezing, and difficulty with speech and swallowing, with patients often requiring the daily assistance of a caregiver.

There are currently no therapies that effectively slow or reverse the progression of Parkinson’s disease. Levodopa remains the standard of care treatment, with its beneficial effects on symptom control having been discovered over 40 years ago³. Patients are generally well-controlled with oral levodopa in the early stages of the disease, but become less responsive to treatment as the disease progresses. Patients experience longer periods of reduced mobility and stiffness termed off-time, or the time when medication is no longer providing benefit, and shorter periods of on-time when their medication is effective.

The progressive motor symptoms of Parkinson’s disease are largely due to the death of dopamine neurons in the substantia nigra, a part of the midbrain that converts levodopa to dopamine, in a single step catalyzed by the enzyme AADC.  Neurons in the substantia nigra release dopamine into the putamen where the receptors for dopamine reside.  In advanced Parkinson’s disease, neurons in the substantia nigra degenerate and the enzyme AADC is markedly reduced in the putamen, which limits the brain’s ability to convert oral levodopa to dopamine⁴. The intrinsic neurons in the putamen, however, do not degenerate in Parkinson’s disease^5,6. VY-AADC, comprised of the adeno-associated virus-2 capsid and a cytomegalovirus promoter to drive AADC transgene expression, is designed to deliver the AADC gene directly into neurons of the putamen where dopamine receptors are located, bypassing the substantia nigra neurons and enabling the neurons of the putamen to express the AADC enzyme to convert levodopa into dopamine.  The approach with VY-AADC, therefore, has the potential to durably enhance the conversion of levodopa to dopamine and provide clinically meaningful improvements by restoring motor function in patients and improving symptoms following a single administration.

About Voyager Therapeutics

Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of adeno-associated virus (AAV) gene therapy through innovation and investment in vector engineering and optimization, manufacturing and dosing and delivery techniques. Voyager’s pipeline focuses on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of ALS, Huntington’s disease, Friedreich’s ataxia, frontotemporal dementia, Alzheimer’s disease and severe, chronic pain.  Voyager has broad strategic collaborations with Sanofi Genzyme, the specialty care global business unit of Sanofi, and the University of Massachusetts Medical School.  Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager Therapeutics is headquartered in Cambridge, Massachusetts.  For more information, please visit www.voyagertherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws.The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “undoubtedly,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding the initiation, timing, progress and reporting of results of its preclinical programs and clinical trials and its research and development programs; its ability to advance its AAV-based gene therapies into, and successfully initiate, enroll, and complete, clinical trials; the potential clinical utility of its product candidates; its ability to continue to develop its product engine; its ability to add new programs to its pipeline; its ability to enter into new partnerships or collaborations; its expected cash, cash equivalents and marketable debt securities at the end of a fiscal year and anticipation for how long expected cash, cash equivalents and marketable debt securities will last; and the timing or likelihood of its regulatory filings and approvals are forward looking. All forward-looking statements are based on estimates and assumptions by Voyager’s management that, although Voyager believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected.  Such risks and uncertainties include, among others, those related to the initiation and conduct of preclinical studies and clinical trials, the availability of data from clinical trials and the expectations for regulatory submissions and approvals; the continued development of the product engine; Voyager’s scientific approach and general development progress; the availability or commercial potential of Voyager’s product candidates; the sufficiency of cash resources; and need for additional financing. These statements are also subject to a number of material risks and uncertainties that are described in Voyager’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

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¹ Willis et al, Neuroepidemiology.2010;34:143–151

² www.pdf.org/en/parkinson_statistics

³ Poewe W, et al, Clinical Interventions in Aging.2010;5:229-238.

⁴ Lloyd, J Pharmacol Exp Ther. 1975;195:453-464, Nagatsu, J Neural Transm Suppl.2007

⁵ Cold Spring Harb Perspect Med 2012;2:a009258

⁶ Braak et al, Cell Tissue Res.2004;318:121-134

Investor Relations:    
Matt Osborne
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857-259-5353
mosborne@vygr.com  

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Katie Engleman
Pure Communications, Inc.
910-509-3977
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