$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).

http://www.globenewswire.com/NewsRoom/AttachmentNg/94e771da-19d6-41b9-a8db-7ad9b0e38b63

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).

http://www.globenewswire.com/NewsRoom/AttachmentNg/bfc0d503-7d2b-4596-aeca-8865d75a4b38

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).

http://www.globenewswire.com/NewsRoom/AttachmentNg/458094aa-2cbb-48fa-99fb-b185d03c4777

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

http://www.globenewswire.com/NewsRoom/AttachmentNg/bf6cf439-0645-4b94-9ea1-738037f9f036

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).

http://www.globenewswire.com/NewsRoom/AttachmentNg/1b540a6d-9d9b-44ed-8154-4e275efb6dee

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.

__________________________________

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
Vice President of Investor Relations & Corporate Communications
857-259-5353
mosborne@vygr.com  

Media:            
Katie Engleman
Pure Communications, Inc.
910-509-3977
Katie@purecommunicationsinc.com

$VSTM Positive Top-line Data, Pivotal Phase 3 DUO™ Study in Leukemia Lymphoma

Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, today reported positive top-line results from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib, a first in class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Regarding the DUO study’s primary endpoint of progression free survival (PFS) as determined by Independent Review Committee (IRC), oral duvelisib monotherapy showed superiority over ofatumumab, an approved standard of care treatment for patients with CLL/SLL, achieving a statistically significant improvement in median PFS of 13.3 months, compared to 9.9 months for ofatumumab with a hazard ratio (HR) of 0.52 (p<0.0001), representing a 48% reduction in the risk of progression or death. Median PFS in the subset of patients with 17p deletion randomized to duvelisib was also significantly higher (12.7 months compared to 9.0 months for ofatumumab; HR of 0.41, p=0.0011).

“Although the treatment of CLL/SLL has advanced in recent years, there remains a substantial unmet need with many patients progressing or relapsing following the available therapies,” commented Ian Flinn, MD, PhD, Director of the Blood Cancer Research Program at Sarah Cannon Research Institute and the Lead Investigator on the DUO study. “These positive results from the randomized DUO study demonstrate that duvelisib prolongs progression-free survival (PFS) with a manageable safety profile in patients with relapsed or refractory CLL/SLL, including in high risk patients with the 17p deletion. For our patients with CLL/SLL, and for the physicians who treat them, a convenient, oral monotherapy that is taken at home would be a valuable addition to the treatment landscape.”

Verastem plans to share these clinical data with the U.S. Food and Drug Administration (FDA) with the goal of filing a New Drug Application (NDA) with the FDA during the first half of 2018. The duvelisib NDA submission will be supported by favorable results from both the DUO study in CLL/SLL and the DYNAMO™ study in indolent non-Hodgkin’s lymphoma (iNHL), which also achieved its primary endpoint with an ORR of 46% (p<0.0001).

In the Phase 3 DUO study, 319 patients were randomized 1:1 to receive either duvelisib 25mg twice daily until disease progression or unacceptable toxicity or ofatumumab, an approved standard of care treatment for use in CLL/SLL, per its label with an initial infusion of 300 mg followed by 7 weekly infusions and 4 monthly infusions of 2,000 mg. In addition to the primary endpoint of PFS in the ITT population a stratification factor to evaluate the outcome in the patients with 17p deletion CLL/SLL, a known poor prognostic subgroup, was conducted. PFS and other efficacy endpoints were analyzed using response determinations per the IRC using modified iwCLL/IWG criteria.

Duvelisib monotherapy had a manageable safety profile, with results from this study consistent with the well-characterized safety profile of duvelisib monotherapy in patients with advanced hematologic malignancies. Verastem intends to submit detailed results from the Phase 3 DUO study for publication in a peer-reviewed medical journal and for presentation at an upcoming scientific meeting.

“We are extremely grateful to the patients, caregivers, and investigators who participated in the DUO study and we are pleased to be that much closer to delivering on our mission to develop drugs that improve the lives of patients with cancer,” said Robert Forrester, President and Chief Executive Officer of Verastem. “Duvelisib was an important strategic acquisition for Verastem. Both of our late-stage trials with duvelisib monotherapy (DUO and DYNAMO) have now achieved their primary endpoints, highlighting the significant potential of duvelisib in the treatment of advanced hematologic malignancies. We anticipate sharing these results with the FDA in preparation for a potential NDA filing during the first half of 2018 and look forward to exploring subsequent development opportunities for duvelisib in additional cancers.”

Conference Call Information

The Verastem management team will host a conference call today, Wednesday, September 6, 2017, at 8:00 AM (ET). The call can be accessed by dialing 1-877-341-5660 (toll-free) or 1-315-625-3226 (international) five minutes prior to the start of the call and providing the passcode 81095627.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

About Duvelisib

Duvelisib is an investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.^1,2,3 Duvelisib is currently being evaluated in late- and mid-stage clinical trials, including DUO™, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory CLL/SLL,⁴ and DYNAMO™, a single-arm, Phase 2 monotherapy study in patients with refractory iNHL.⁵ Both DUO and DYNAMO achieved their primary endpoints upon topline analysis of efficacy data. Duvelisib is also being evaluated for the treatment of other hematologic malignancies, including T-cell lymphoma, through investigator-sponsored studies.⁶ Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About Verastem, Inc.

Verastem, Inc. (NASDAQ:VSTM) is a biopharmaceutical company focused on discovering and developing drugs to improve outcomes for patients with cancer. Verastem is currently developing duvelisib, a dual inhibitor of PI3K-delta and PI3K-gamma, which has successfully met the primary endpoints in both a Phase 2 study in double-refractory iNHL and a Phase 3 clinical trial in patients with relapsed/refractory CLL/SLL. In addition, Verastem is developing the FAK inhibitor, defactinib, which is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types, including pancreatic, ovarian, non-small cell lung cancer, and mesothelioma. Verastem’s product candidates seek to treat cancer by modulating the local tumor microenvironment, enhancing anti-tumor immunity and reducing cancer stem cells. For more information, please visit www.verastem.com.

Verastem, Inc. forward-looking statements notice:

This press release includes forward-looking statements about Verastem’s strategy, future plans and prospects, including statements regarding the development and activity of Verastem’s investigational product candidates, including duvelisib and defactinib, and Verastem’s PI3K and FAK programs generally, the structure of our planned and pending clinical trials and the timeline and indications for clinical development. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that the full data from the DUO study will not be consistent with the top-line results of the study; that the preclinical testing of Verastem’s product candidates and preliminary or interim data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials; that even if data from clinical trials is positive, regulatory authorities may require additional studies for approval and the product may not prove to be safe and effective; that the degree of market acceptance of product candidates, if approved, may be lower than expected; that the timing, scope and rate of reimbursement for our product candidates is uncertain; that there may be competitive developments affecting our product candidates; that data may not be available when expected; that enrollment of clinical trials may take longer than expected; that our product candidates will cause unexpected safety events or result in an unmanageable safety profile as compared to their level of efficacy; that duvelisib will be ineffective at treating patients with lymphoid malignancies; that Verastem will be unable to successfully initiate or complete the clinical development of its product candidates; that the development of Verastem’s product candidates will take longer or cost more than planned; that Verastem may not have sufficient cash to fund its contemplated operations; that Verastem or Infinity Pharmaceuticals, Inc. will fail to fully perform under the duvelisib license agreement; that Verastem will not pursue or submit regulatory filings for its product candidates; and that Verastem’s product candidates will not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients. Other risks and uncertainties include those identified under the heading “Risk Factors” in Verastem’s Annual Report on Form 10-K for the year ended December 31, 2016 and in any subsequent filings with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Verastem’s views as of the date of this release, and Verastem does not undertake and specifically disclaims any obligation to update any forward-looking statements.

References

¹ Winkler et al. PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models. Chem Biol 2013; 20:1-11.
² Reif et al. Cutting Edge: Differential roles for phosphoinositide 3 kinases, p110-gamma and p110-delta, in lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.
³ Schmid et al. Receptor tyrosine kinases and TLR/IL1Rs unexpectedly activate myeloid cell PI3K, a single convergent point promoting tumor inflammation and progression. Cancer Cell 2011;19:715-727.
⁴ www.clinicaltrials.gov, NCT02004522
⁵ www.clinicaltrials.gov, NCT01882803
⁶ www.clinicaltrials.gov, NCT02783625, NCT02783625, NCT02158091

Verastem, Inc.
Brian Sullivan, 781-292-4214
Director, Corporate Development
bsullivan@verastem.com

$MKGI Prepares for Nasdaq Application, Convertible Debt Elimination & Divesting Non-Core

$SKLN Enters Innovative Technology Partnership with Intalere for STREAMWAY® System

Provides access to more than 90,000 members, including 3,733 hospitals

MINNEAPOLIS, Sept. 05, 2017 — Skyline Medical Inc. (NASDAQ:SKLN) (“Skyline” or “the Company”), producer of the FDA-approved STREAMWAY® System for automated, direct-to-drain medical fluid disposal, announces that the Company has entered into an innovative technology partnership with Intalere for the STREAMWAY System. Intalere is a professional supply chain company offering a comprehensive suite of services to empower healthcare providers to better manage their entire spend and ultimately deliver superior care.

This contract includes STREAMWAY in Intalere’s Innovation and New Technology category, indicating STREAMWAY demonstrates unique capabilities compared to existing products on contract or available in the market. Preferred pricing for more than 90,000 Intalere members extends to 3,733 acute care hospitals, 3,715 ambulatory surgery centers and 175 hospital-based physicians.

“This partnership with Intalere is very exciting and is further validation of the STREAMWAY technology,” said Dr. Carl Schwartz, chief executive officer of Skyline Medical.  “Intalere is an organization that is committed to discovering appropriate innovative and new technology companies that are interested in partnering with healthcare group purchasing organizations to remain competitive in delivering optimal cost, quality and clinical outcomes for its members. STREAMWAY continues to be recognized for its unique advantages over other products in the market, now for the benefit of Intalere members. As we work towards expanding our presence and increasing sales around the country, this partnership will continue to introduce new avenues to reach member organizations as potential customers for STREAMWAY.”

About Intalere

Intalere’s mission focuses on improving the operational health of America’s healthcare providers by designing tailored, smart solutions that deliver optimal cost, quality and clinical outcomes. We strive to be the essential partner for operational excellence in healthcare through customized solutions that address customers’ individual needs. We assist our customers in managing their entire spend, providing innovative technologies, products and services, and leveraging the best practices of a provider-led model. As Intalere draws on the power of our owner Intermountain Healthcare’s nationally-recognized supply chain expertise and leadership in technology, process improvement and evidence-based clinical and business best practices, we are uniquely positioned to be the innovation leader in the healthcare industry. Visit www.intalere.com to learn more.

About the STREAMWAY System

Skyline’s revolutionary, FDA-cleared STREAMWAY System is the first true direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures. It connects directly to a facility’s plumbing system to automate the collection, measurement and disposal of waste fluids.  As of June 30, 2017, Skyline Medical customers have installed 101 STREAMWAY Systems in 52 facilities across 20 states, and in Canada.

The STREAMWAY minimizes human intervention for better safety and improves compliance with Occupational Safety and Health Administration (OSHA) and other regulatory agency safety guidelines. It also provides unlimited capacity for increased efficiency in the operating room, which leads to greater profitability. Furthermore, the STREAMWAY eliminates canisters to reduce overhead costs and provides greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the U.S.  For a demonstration please visit www.skylinemedical.com or call 855-785-8855.

About Skyline Medical

Skyline Medical produces a fully automated, patented, FDA-cleared waste fluid disposal system that virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods that require hand carrying and emptying filled fluid canisters present an exposure risk and potential liability. Skyline Medical’s STREAMWAY System fully automates the collection, measurement and disposal of waste fluids and is designed to: 1) reduce overhead costs to hospitals and surgical centers; 2) improve compliance with OSHA and other regulatory agency safety guidelines; 3) improve efficiency in the operating room, and radiology and endoscopy departments, thereby leading to greater profitability; and 4) provide greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills each year in the U.S.  For additional information, please visit www.skylinemedical.com.

Forward-looking Statements

Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company’s business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include risks related to our proposed merger with CytoBioscience, Inc., including the fact that we may not complete the merger; we do not have complete information about CytoBioscience, including audited financial statements; the combined company will not be able to continue operating without additional financing; possible failure to realize anticipated benefits of the merger; costs associated with the merger may be higher than expected; the merger may result in disruption of the Company’s and CytoBioscience’s existing businesses, distraction of management and diversion of resources; delay in completion of the merger may significantly reduce the expected benefits; and the market price of the Company’s common stock may decline as a result of the merger. Other risks and uncertainties relating to the Company include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; 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 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, which are available for review at www.sec.gov.  This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company’s financial position. See the Company’s most recent Annual Report on Form 10-K, and subsequent reports and other filings at www.sec.gov.

Contacts:

Skyline Medical
Carl Schwartz, Chief Executive Officer
(651) 389-4800
cschwartz@skylinemedical.com

Investors
LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com

$RNN to Present Updated Clinical and Preclinical Data at 2017 #ESMO

ROCKVILLE, Md., Sept. 05, 2017 — Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing innovative, targeted therapeutics for the treatment of cancer, today announced that it will present updated preliminary data from the Phase IIa study of RX-3117 in advanced and metastatic bladder cancer and also the final data on the Supinoxin™ Phase I clinical study at the 2017 European Society for Medical Oncology (ESMO) Congress, which is being held September 8-12, 2017 in Madrid, Spain. Rexahn will also present the data from preclinical studies evaluating RX-3117 in combination with other anticancer agents including Abraxane® and immuno-oncology agents.

Title: RX-3117, An Oral Hypomethylating Agent to Treat Advanced Solid Tumors (ST): Interim results from an Ongoing Phase 2a Study in Advanced Urothelial Cancer
Abstract #: 873P
Session Date/Time: Sunday, September 10, 2017 1:15– 2:15 pm CET, Hall 8
Authors: Drs M.C. Maia, S.K. Pal, S.T. Tagawa, V. Chung, J. Picus, S. Gupta and Rexahn Pharmaceuticals

Title: Phase 1 study of RX-5902, a novel Orally Bioavailable Inhibitor of Phosphorylated P68, which prevents β-catenin Translocation in Advanced Solid Tumors
Abstract #: 258P
Session Date/Time: Monday, September 11, 2017 1:15– 2:15 pm CET, Hall 8
Authors: Drs.J. Diamond, G. Eckhardt, W. Larry Gluck, Martin Gutierrez and Rexahn Pharmaceuticals

Title: A Novel Small Molecule Nucleoside Analog, RX-3117, Shows Potent Therapeutic Activity in Combination with Nab-paclitaxel and Checkpoint Inhibitors in Xenograft Models
Abstract #: 413P
Session Date/Time: Monday, September 11, 2017 1:15– 2:15 pm CET, Hall 8
Authors: Drs. J Frank, D.J. Kim, E Benaim, Rexahn Pharmaceuticals

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals Inc. (NYSE MKT:RNN) is a clinical stage biopharmaceutical company dedicated to developing novel, best-in-class therapeutics for the treatment of cancer. The Company’s mission is to improve the lives of cancer patients by developing next generation cancer therapies that are designed to maximize efficacy while minimizing the toxicity and side effects traditionally associated with cancer treatment. Rexahn’s product candidates work by targeting and neutralizing specific proteins believed to be involved in the complex biological cascade that leads to cancer cell growth. The Company has a broad oncology pipeline that includes three anti-cancer compounds currently in Phase II clinical development: Supinoxin^™, RX-3117, and Archexin^®, and a novel nanopolymer-based drug delivery platform technology that may increase the bio-availability of FDA-approved chemotherapies. For more information about the Company and its oncology programs, please visit www.rexahn.com.

Safe Harbor
To the extent any statements made in this press release deal with information that is not historical, these are forward looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about Rexahn’s plans, objectives, expectations and intentions with respect to cash flow requirements, future operations and products, enrollments in clinical trials, the path of clinical trials and development activities, and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Rexahn’s actual results to be materially different than those expressed in or implied by Rexahn’s forward-looking statements. For Rexahn, particular uncertainties and risks include, among others, understandings and beliefs regarding the role of certain biological mechanisms and processes in cancer; drug candidates being in early stages of clinical development; the timing of completion of clinical trials; the ability to initially develop drug candidates for orphan indications to reduce the time-to-market and take advantage of certain incentives provided by the U.S. Food and Drug Administration; and the ability to transition from our initial focus on developing drug candidates for orphan indications to candidates for more highly prevalent indications. More detailed information on these and additional factors that could affect Rexahn’s actual results are described in Rexahn’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. Rexahn undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:
LifeSci Advisors, LLC
Michael Rice 
mrice@lifesciadvisors.com 
(646) 597-6979 	

LifeSci Advisors, LLC
Ashley Robinson
arr@lifesciadvisors.com 
(646) 597-6979

$AKCA Expands Leadership Team in Preparation for First Commercial Launch

Expansion of Akcea Leadership Further Strengthens Financial, Clinical and Commercial Foundation

CAMBRIDGE, Mass., Sept. 05, 2017 — Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc. focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders, announced today the appointment of four experienced pharmaceutical and biotech industry leaders to key leadership roles including:

• Michael MacLean, chief financial officer
• Mustafa Noor, M.D., FACP, chief development officer
• Samuel Yonren, MB BS, MRCPI, vice president and head of pharmacovigilance and drug safety
• Kyle Jenne, U.S. commercial head

“We are excited to welcome Mike, Mustafa, Sam and Kyle to the Akcea team at such a paramount time for the company. Each of these individuals brings a strategic and critical set of skills to the organization as we prepare for the global commercial launch of volanesorsen and continue to advance our pipeline,” said Paula Soteropoulos, president and chief executive officer of Akcea Therapeutics. “As a newly public company approaching the commercialization of our first product, we believe this expansion of our leadership team strengthens our position to achieve success in the near and long term.”

Michael MacLean, Chief Financial Officer
“I am thrilled to be joining Akcea at this pivotal moment for the company as they prepare to commercialize volanesorsen globally,” said Michael MacLean, chief financial officer of Akcea Therapeutics. “I look forward to working closely with the high-caliber leadership team to provide financial insight to advance the Company’s key business strategies and drive shareholder value.”

As chief financial officer, Mr. MacLean will be responsible for the strategic leadership of Akcea’s financial imperatives. He comes to Akcea with more than a decade of leadership experience in the life sciences industry across a range of commercial, research and development (R&D), and manufacturing environments globally, including North America and Europe. Mr. MacLean will bring to Akcea a deep financial understanding as the Company develops its global operating models to advance its corporate objectives. He has also built finance teams, scaled up infrastructure and processes for companies in high growth mode, as well as progress fundraising for programs and other initiatives. Most recently, he worked at PureTech Health as inaugural chief financial officer immediately following PureTech’s initial public offering. Previously, Mr. MacLean served as senior vice president of finance and chief accounting officer of Biogen Inc. where he led the Company’s worldwide finance organization, as well as evaluated financial implications of commercial, R&D and other expansion strategies.

Mustafa Noor, M.D., FACP, Chief Development Officer
“Having the ability to work at a company with a late-stage pipeline of four novel drugs is a remarkable opportunity,” said Dr. Mustafa Noor, chief development officer of Akcea Therapeutics. “There still remains severe unmet need for therapies tackling largely unaddressed drivers of cardiometabolic disease. I am excited to play a role in Akcea’s dedication to advance its promising drugs targeting these poorly addressed lipid risk factors, which include APOCIII, Lp(a) and ANGPTL3, to patients who need these medicines most.”

As chief development officer, Dr. Noor will be responsible for the integrated activities of Clinical Development and Development Operations at Akcea. In this role, Dr. Noor will report to Louis O’Dea, chief medical officer and head of regulatory affairs. Dr. Noor brings to Akcea over 20 years of experience in cardiovascular and metabolic clinical research and development in the industry. He joined the industry at Bristol-Myers Squibb and over the next 17 years has advanced his career through GSK and Pfizer Inc., principally in cardiovascular and metabolic medicine. Dr. Noor also worked at Ipsen Group where he was therapeutic area head for endocrinology global clinical development. Most recently, he was chief medical officer at Rugen Therapeutics. Dr. Noor holds a medical degree (M.D.) from the Pritzker School of Medicine, University of Chicago. He completed his residency in Internal Medicine at the Scripps Clinic, La Jolla, CA and his Fellowship in Endocrinology and Metabolism at the University of California, San Francisco, CA. Dr. Noor is a Fellow of the American College of Physicians.

Samuel Yonren, MB BS, MRCPI, Vice President and Head of Pharmacovigilance and Drug Safety
As vice president and head of pharmacovigilance and drug safety, Dr. Yonren will serve as the global safety leader responsible for all medical aspects of safety assessment and safety risk management strategy across Akcea‘s pipeline. In this role, Dr. Yonren will report to Louis O’Dea, chief medical officer and head of regulatory affairs. Dr. Yonren brings to Akcea expertise in data systems that support effective pharmacovigilance and a depth of leadership experience in cardiometabolic clinical development and  postmarketing safety. After a number of years of training and practice in internal medicine and infectious diseases at academic centers including New York University, Dr. Yonren came to industry as a clinical research physician at Pfizer Inc. in the U.K. and soon afterwards moved into drug safety at GSK. He came to the U.S. as senior director of safety at Millennium Pharmaceuticals Inc. and gathered further years of experience in safety and pharmacovigilance at Medimmune, Ovation Pharmaceuticals, Inc., Alcon/Novartis Pharma AG and most recently Aegerion Pharmaceuticals, where, as head of drug safety, he supervised safety programs for lomitapide and metreleptin. Dr. Yonren holds a medical degree (MB BS) from the University of Lagos and a Membership in the Royal Colleges of Physicians of Ireland (MRCPI) in Internal Medicine.

Kyle Jenne, U.S. Commercial Head
As U.S. commercial head, Mr. Jenne will be responsible for building and leading Akcea’s customer-facing organization in the U.S., including all teams that will directly engage with U.S. health care providers (HCPs), patients and payers to support improved diagnosis and treatment of patients with familial chylomicronemia syndrome (FCS). In his role, Mr. Jenne will report to Molly Harper, vice president, global commercial development. Mr. Jenne brings to Akcea more than 18 years of commercial leadership experience in the industry, including the build-out and leadership of organizations in therapeutic areas including cardiovascular and lipid-driven diseases, rare diseases, and oncology. He previously held sales and marketing leadership roles at Acorda Therapeutics and Pfizer Inc, where he worked with commercial teams on the design, development, and implementation of patient support programs and payer strategy in the U.S. for rare disease products. Most recently, he served as national sales director for neurology in autoimmune and rare diseases at Mallinckrodt Pharmaceuticals.

ABOUT AKCEA THERAPEUTICS
Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, Inc., is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders. Akcea is advancing a mature pipeline of four novel drugs with the potential to treat multiple diseases, including volanesorsen, AKCEA-APO(a)-L_Rx, AKCEA-ANGPTL3-L_Rx and AKCEA-APOCIII-L_Rx. All four drugs were discovered and are being co-developed by Ionis, a leader in antisense therapeutics, based on Ionis’ proprietary antisense technology. The most advanced drug in its pipeline, volanesorsen, is under regulatory review in the U.S. and EU for the treatment of familial chylomicronemia syndrome, or FCS, and is currently in Phase 3 clinical development for the treatment of familial partial lipodystrophy, or FPL. Akcea is building the infrastructure to commercialize its drugs globally with a focus on lipid specialists as the primary call point. Akcea is located in Cambridge, Massachusetts. Additional information about Akcea is available at www.akceatx.com.

FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding the business of Akcea Therapeutics, Inc. and the therapeutic and commercial potential of volanesorsen and other products in development. Any statement describing Akcea’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in 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. Akcea’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Akcea’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Akcea. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Akcea’s programs are described in additional detail in its final prospectus for its initial public offering and its most recent quarterly report on Form 10-Q, which are on file with the SEC.

In this press release, unless the context requires otherwise, “Akcea,” “Company,” “we,” “our,” and “us” refers to Akcea Therapeutics.

Akcea Therapeutics™ is a trademark of Ionis Pharmaceuticals, Inc. Ionis Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals, Inc.

Media and Investor Contact:
D. Wade Walke, Ph.D.
Vice President, Corporate Communications and Investor Relations
760-603-2741

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

WALTHAM, Mass., Sept. 05, 2017 — EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a clinical-stage specialty pharmaceutical company focused on developing and commercializing products using our two proprietary platform technologies for treating diseases and disorders of the eye, today announced that it will be featured as a presenting company at the 19th Annual Rodman & Renshaw Global Investment Conference, being held on September 10-12, 2017 at The Lotte New York Palace Hotel in New York, NY.

Details for the presentation are as follows:

Date: Tuesday, September 12, 2017
Time: 10:00 – 10:25 AM EDT
Room: Holmes II

Investors attending the conference who would like to schedule a one-on-one meeting with EyeGate’s management may do so by contacting their Rodman & Renshaw representative, or Lee Roth or Janhavi Mohite at The Ruth Group at lroth@theruthgroup.com / jmohite@theruthgroup.com.

About EyeGate:
EyeGate is a clinical-stage specialty pharmaceutical company focused on developing and commercializing products using its two proprietary platform technologies for treating diseases and disorders of the eye. EyeGate’s most advanced platform is based on a cross-linked thiolated carboxymethyl hyaluronic acid (“CMHA-S”), a modified form of the natural polymer hyaluronic acid (“HA”), which is a gel that possesses unique physical and chemical properties such as hydrating and healing when applied to the ocular surface. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries.

EGP-437, EyeGate’s other product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate II Delivery System. For more information, please visit www.EyeGatePharma.com.

Forward-looking Statements
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate’s EGP-437 combination product and those of Jade Therapeutics, Inc., a wholly owned subsidiary of EyeGate, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, plus other risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on February 23, 2017 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Contact:
Lee Roth / Janhavi Mohite
The Ruth Group for EyeGate Pharmaceuticals
646-536-7012 / 7026
lroth@theruthgroup.com / jmohite@theruthgroup.com

$WATT Announces GaN-based High-Power, Near Field WattUp Charging Solution

New WattUp Near Field transmitter offers additional power to charge larger electronic devices including smartphones, tablets and smart speakers

$PULM Receives Award from Cystic Fibrosis Foundation

The Award Supports Advancement of PUR1900 to Phase 1/1B Clinical Trial in 2018

LEXINGTON, Mass., Sept. 5, 2017 — Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that it has received an award from Cystic Fibrosis Foundation Therapeutics (CFFT), the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, to support the development of its lead inhaled anti-fungal product candidate PUR1900 for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with cystic fibrosis and asthma.

“This award will help fund the non-clinical safety studies needed for the Phase 1/1B clinical trial that we plan to begin in 2018,” explained Pulmatrix CEO Dr. Robert Clarke. “It underscores the potential for PUR1900 to treat this serious condition, which is currently a major unmet medical need.”

ABPA is caused by the spore-forming mold Aspergillus fumigatus. People breathe in Aspergillus spores all the time. Usually, the spores get stuck in the moist linings of the airways and are expelled in mucus, or are tackled and neutralized by the immune system. But in cystic fibrosis patients or others with compromised lung function or immune systems, the mold can lead to serious infections—and allergic reactions that manifest as ABPA.

Fighting these lung infections and the allergic reactions has been difficult. Oral anti-fungal drugs exist, but getting enough drug through the bloodstream to the lungs requires high doses that cause severe side effects—and still have low efficacy.

Pulmatrix has addressed this problem by combining an anti-fungal drug, itraconazole, with the company’s innovative and proprietary iSPERSE^TM dry powder. The powder is designed to “fly” easily into the lungs when inhaled, delivering the high amounts of the drug directly to the lungs where it is needed.

The inhaled drug delivery approach is expected to reduce the risk of serious side effects and drug-drug interactions, while increasing the levels of the drug in the lung compared to oral dosing. In fact, preclinical trials with PUR1900 show that it achieves much higher concentrations of the drug in the lung, and much lower levels in the blood, compared to giving the drug orally.

The new award from CFFT will help fund on-going non-clinical safety studies of PUR1900. The company plans to follow those studies with a Phase 1/1B clinical study in healthy volunteers and asthmatic patients to compare PUR1900 with oral itraconazole dosing in early 2018.

PUR1900 has already received an Orphan Drug designation and a Qualified Infectious Disease Product (QIDP) designation from the FDA for the treatment of fungal infections in patients with cystic fibrosis. These two designations together provide up to 12 years of market exclusivity for PUR1900 if approved for cystic fibrosis patients.

For more information on cystic fibrosis, go to www.cff.org.

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.

$INSM Announces Proposed Public Offering of Common Stock

BRIDGEWATER, N.J., Sept. 05, 2017 — Insmed Incorporated (Nasdaq:INSM) announced today that it has commenced an underwritten public offering of $250 million of shares of its common stock. All of the shares of common stock in the offering would be sold by Insmed.  In addition, Insmed intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering at the public offering price, less the underwriting discount.  The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Insmed intends to use the net proceeds from this offering to fund ongoing and future clinical development of amikacin liposome inhalation suspension (ALIS) for patients with treatment refractory nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC) and its efforts to obtain potential regulatory approvals and, if approved, commercialize ALIS in its approved indication; invest in increased third-party manufacturing capacity for and commercial inventory production of ALIS in anticipation of possible commercial launch, initially in the United States and subsequently in Japan and other countries; fund further clinical development of INS1007, a novel oral reversible inhibitor of dipeptidyl peptidase 1; and fund working capital, potential debt repayment, capital expenditures, general research and development, and for other general corporate purposes, which may include the acquisition or in-license of additional compounds, product candidates, technology or businesses.

Goldman Sachs & Co. LLC and Leerink Partners LLC are acting as joint book-running managers for the offering. Evercore Group L.L.C. is acting as a passive bookrunner. Stifel, Nicolaus & Company, Incorporated is acting as co-lead.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above has been filed with the Securities and Exchange Commission (SEC) and became automatically effective upon filing.  A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus related to this offering may be obtained, when available, from (1) Goldman Sachs & Co. LLC at Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1-866-471-2526, by facsimile at 212-902-9316 or by email at prospectus-ny@ny.email.gs.com, or (2) Leerink Partners LLC at Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 extension 6132 or by email at syndicate@leerink.com.

This press 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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Insmed

Insmed Incorporated is a global biopharmaceutical company focused on the unmet needs of patients with rare diseases. The Company’s lead product candidate is ALIS for adult patients with treatment refractory NTM lung disease caused by MAC, which is a rare and often chronic infection that is capable of causing irreversible lung damage and can be fatal. The Company is not aware of any approved inhaled therapies specifically indicated for refractory NTM lung disease caused by MAC in North America, Japan or Europe.  Insmed’s earlier-stage clinical pipeline includes INS1007, a novel oral reversible inhibitor of dipeptidyl peptidase 1 with therapeutic potential in non-cystic fibrosis bronchiectasis, and INS1009, an inhaled nanoparticle formulation of a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders, including pulmonary arterial hypertension.

Forward-looking statements

This press release contains forward looking statements. “Forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “intends,” “potential,” “continues,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company’s current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such factors include, among others: risks that the full six-month data from the CONVERT study or subsequent data from the remainder of the study’s treatment and off-treatment phases will not be consistent with the top-line six-month results of the study; uncertainties in the research and development of the Company’s existing product candidates, including due to delays in data readouts, such as the full data from the CONVERT study, patient enrollment and retention or failure of the Company’s preclinical studies or clinical trials to satisfy pre-established endpoints, including secondary endpoints in the CONVERT study and endpoints in the CONVERT extension study; failure to obtain, or delays in obtaining, regulatory approval from the U.S. Food and Drug Administration, Japan’s Ministry of Health, Labour and Welfare, the European Medicines Agency, and other regulatory authorities for the Company’s product candidates or their delivery devices, such as the eFlow Nebulizer System, including due to insufficient clinical data, selection of endpoints that are not satisfactory to regulators, complexity in the review process for combination products or inadequate or delayed data from a human factors study required for U.S. regulatory approval; failure to maintain regulatory approval for the Company’s product candidates, if received, due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from confirmatory clinical studies; safety and efficacy concerns related to the Company’s product candidates; lack of experience in conducting and managing preclinical development activities and clinical trials necessary for regulatory approval, including the regulatory filing and review process; failure to comply with extensive post-approval regulatory requirements or imposition of significant post-approval restrictions on the Company’s product candidates by regulators; uncertainties in the rate and degree of market acceptance of product candidates, if approved; inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of the Company’s product candidates, if approved; inaccuracies in the Company’s estimates of the size of the potential markets for the Company’s product candidates or limitations by regulators on the proposed treatment population for the Company’s product candidates; failure of third parties on which the Company is dependent to conduct the Company’s clinical trials, to manufacture sufficient quantities of the Company’s product candidates for clinical or commercial needs, including the Company’s raw materials suppliers, or to comply with the Company’s agreements or laws and regulations that impact the Company’s business; inaccurate estimates regarding the Company’s future capital requirements, including those necessary to fund the Company’s ongoing clinical development, regulatory and commercialization efforts as well as milestone payments or royalties owed to third parties; failure to develop, or to license for development, additional product candidates, including a failure to attract experienced third-party collaborators; uncertainties in the timing, scope and rate of reimbursement for the Company’s product candidates; changes in laws and regulations applicable to the Company’s business and failure to comply with such laws and regulations; inability to repay the Company’s existing indebtedness or to obtain additional capital when needed; failure to obtain, protect and enforce the Company’s patents and other intellectual property and costs associated with litigation or other proceedings related to such matters; restrictions imposed on the Company by license agreements that are critical for the Company’s product development, including the Company’s license agreements with PARI Pharma GmbH and AstraZeneca AB, and failure to comply with the Company’s obligations under such agreements; competitive developments affecting the Company’s product candidates and potential exclusivity related thereto; the cost and potential reputational damage resulting from litigation to which the Company is a party, including, without limitation, the class action lawsuit pending against the Company; loss of key personnel; lack of experience operating internationally; and risks that the net proceeds from the offering are not spent as currently intended or in ways that enhance the value of your investment in the Company’s common stock.

For additional information about the risks and uncertainties that may affect the Company’s business, please see the factors discussed in Item 1A, “Risk Factors,” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016.

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the Securities and Exchange Commission, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Investor Contact:
Blaine Davis
Vice President, Head of Investor Relations
Insmed Incorporated
(908) 947-2841
blaine.davis@insmed.com

$CIIX WallStreet Research™ Issues Updated Corporate Profile on ChineseInvestors.com

NEW YORK, September 5, 2017

WallStreet Research™ (WSR), a top-ranked independent research firm with a history spanning over three decades, today announced that the firm has updated Corporate Profile coverage on ChineseInvestors.com Inc. (OTCQB: CIIX).  WallStreet Research™ is ranked Number One on the Google, Yahoo, and Bing search engines in both small and microcap research with a global following.  An updated analyst Corporate Profile Report, together with additional information about WallStreet Research™, is available at the http://www.WallStreetResearch.org website. The WSR Corporate Profile highlights the Company’s recent accomplishments and growth plans for 2017 and beyond.

Founded in 1999, ChineseInvestors.com, Inc. (“CIIX” or “the Company”) headquartered in San Gabriel, California, with offices in New York and Shanghai China, is a premier financial information website for Chinese speaking investors. http://www.Chinesefn.com, provides web-based, timely market information about United States publicly traded stocks and foreign currencies with free quotes, charts, market news, and links to investment research. The Company recently announced it is planning to launch the first Chinese Daily Video News Broadcast from the NYSE floor covering cryptocurrencies and Bitcoin currency.  CEO, Mr. Warren Wang, an expert in the cryptocurrency market, will be able to add his commentary to the daily broadcasts on the Company’s website at http://www.ChineseFN.com .   The Company earlier announced it is launching cryptocurrency education and trading subscription services on its ChineseFN.com website platform to subscribers.

The Company currently tracks United States stock market quotes and provides access to sample investment portfolios for educational purposes, as well as real-time trading demonstrations. Through its relationship with Phoenix Television, the Company produces and broadcasts a weekly television show covering the financial markets entitled “Wall Street Weekly.” In addition, CIIX offers a wide range of investor relations services to publicly-traded companies in the United States and China. CIIX went public in 2011 and has profited from earning and holding shares in publically traded companies through its consulting and advisory services over the past few years.

In recognition of the unprecedented opportunities in the non-industrial hemp industry, CIIX has expanded its business to capitalize on the growing demand for non-industrial hemp based products including healing oils, food products, and other health and beauty products.  CIIX has opened its retail store “Chinese Wellness Center” in the predominantly Chinese community of San Gabriel, California.  In addition, CIIX announced its release of its first CBD oil product line, “OptHemp™”, a premium, private label oil, made from full-spectrum, Colorado grown, GMO-Free, non-industrial hemp, manufactured using a CO2 Extraction process. As part of its expansion, the Company also has established a wholly owned foreign enterprise, “XiBiDi Biotechnology Co. Ltd,” also known as CBD Biotechnology Co. Ltd., which operates its site ChineseCBDoil.com. In May 2017, CBD Biotechnology appointed Summer (XiangYang) Yun as CEO.  Yun’s initial focus will be the launch o “CBD Magic Hemp Series” cosmetics line, which is expected to launch this quarter with 3-5 CBD-based core skin care products.  Yun is a marketing and branding executive with over 25 years of experience. CBD Biotechnology Co., Ltd. plans to use multiple sales channels to implement its sales plan.

The Company filed its most recent 10K report for the year ended May 31, 2017, and reported total revenues of $1.67 million, up from $.95 million in the previous year, a growth rate of 76%.  The growth in revenues consisted of strong revenue growth from subscription sales and from increased investor relations and consulting activities.  The operating loss was $4.9 million vs. $2.9 million, and EPS was ($.86) vs. ($.26) from the prior fiscal year.  The Company had incurred additional costs related to its growth strategy of adding several new lines of business including the ChineseHempOil.com activities, CBD Biotechnology, and others.

The Company in its 10K filing announced it has authorized up to 10 million shares in Series D Convertible Preferred Stock to accredited investors at $1 per share, each share converting into two shares of common, with a 6% annual dividend for two years.  It has thus far completed approximately $2 million of the offering.

Mr. Alan Stone, Managing Director of WallStreet Research™ commented, “CIIX is gearing up for another year of strong growth with its new expanded business activities and improved financial position.”

About WallStreet Research™

WallStreet Research™ (“WSR”) is a prominent research boutique led by Mr. Alan Stone, Managing Director of Alan Stone & Company, LLC (ASC). The firm specializes in the microcap and small cap investment arena, looking for emerging growth companies with strong management, unique or proprietary technology, significant market potential, financial strength, and outstanding long-term earnings growth possibilities. The firm has offices in Los Angeles, CA, Palm Beach, FL, and New York City, NY, and is well known for discovering undervalued companies and bringing them to the attention of the investment community. ASC/WSR also arranges road shows for its publicly traded clients, before the investment community in New York City, California and Florida.

Information on WallStreet Research™ can be found at http://www.WallStreetResearch.org.

About ChineseInvestors.com, Inc. (CIIX)

ChineseInvestors.com, Inc., (CIIX), headquartered in Los Angeles, with offices in New York and Shanghai China, is a company that engages in providing a wide range of products, services, and information for the global Chinese population. Founded in 1999, CIIX 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) support services to various partners; (c) consultative services to smaller private companies considering becoming a public company; (d) advertising and public relation related support services; and (e) other services they may identify having the potential to create value or partnership opportunity with their existing services.  http://www.Chinesefn.com.

The Company offers various products beyond its website information, the Company also offers a wide range of investor relations and is now beginning to change focus of solely being a premier Internet information provider by expanding into retail and online sales of CBD products via http://www.ChineseCBDoil.com and http://www.ChineseHempOil.com .

CIIX maintains its commitment to continue to grow its membership subscriptions and investor relations business thus adding to the potential for continued growth in the near future.

Information on CIIX can be found at http://www.ChineseInvestors.com.

Disclaimer

The information presented herein is not to be construed as an offer to sell, nor a solicitation of an offer to purchase, any securities. This corporate profile is not a research report, but a compilation of information available to the public, which has been furnished by the featured company or gathered from other sources, in each case without independent verification, and no representations are made as to the accuracy or validity thereof. The information may include certain forward-looking statements within the meaning of Section 21E of the Securities Exchange Commission Act of 1934, which may be affected by unforeseen circumstances or certain risks. Any investment in securities contains inherent risks and should only be done after consulting an investment professional. The featured company paid a fee of $3500 in cash to Alan Stone & Company LLC for preparation and distribution of this profile, including other potential fees associated with various consulting and investor relations’ services. For complete disclaimer information, readers are hereby referred to the Disclaimer Page at the http://www.WallStreetResearch.org website.

Contact / Source:

WallStreet Research™

Alan Stone, +1-310-444-3940
astone@alanstone.com

Barbara Blake, +1-415-419-4239
bjblake1229@att.net

http://www.WallStreetResearch.org
http://www.SouthFloridaInvestmentForum.com
http://www.SouthernCaliforniaInvestmentForum.com
http://www.SmallCapConference.org

ChineseInvestors.com Inc.
227 W. Valley Blvd. Suite 208 A
San Gabriel, CA 91776

Alan Klitenic, Investor Relations
+1(214)636-2548
Email: warrenwang@chinesefn.com
Headquarters: +1(888)789-1670

http://www.Chineseinvestors.com
http://www.Chinesefn.com
http://www.ChineseCBDoil.com
http://www.ChineseHempOil.com

$ACOR Adopts Shareholder Rights Plan

ARDSLEY, N.Y.

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that its Board of Directors has adopted a Shareholder Rights Plan, effective September 1, 2017, and declared a dividend distribution of one preferred share purchase right on each outstanding share of the Company’s Common Stock. The Rights Plan will expire on August 31, 2018.

The Acorda Board and management team are committed to taking actions that are in the best interest of all of our shareholders. The Board is undertaking this action in accordance with its fiduciary duties to act in the best interests of shareholders, as well as its responsibilities to all of its stakeholders, including the many patients with debilitating neurological disorders who are served by the Company’s innovations, commitment and expertise.

The Rights Plan is intended to promote the fair and equal treatment of all Acorda shareholders and ensure that no person or group can gain control of Acorda through open market accumulation or other tactics potentially disadvantaging the interest of all shareholders. The Rights Plan will also position the Acorda Board of Directors to fulfill its fiduciary duties on behalf of all shareholders by ensuring that the Board has sufficient time to make informed judgments about any attempts to take over the Company. The Rights Plan applies equally to all current and future shareholders and is not intended to deter offers that are fair and otherwise in the best interest of the Company’s shareholders.

The Rights Plan, which was adopted by the Board following evaluation and consultation with the Company’s advisors, is similar to plans adopted by numerous publicly traded companies. The Board adopted the Rights Plan in response to the recent accumulations of significant portions of Acorda’s outstanding Common Stock.

Under the Rights Plan, the Rights will become exercisable if a person or group becomes the beneficial owner of 15% or more of the Company’s outstanding Common Stock. In the event that the Rights become exercisable due to the triggering ownership threshold being crossed, each Right will entitle its holder to purchase, at the Right’s exercise price, a number of shares of Common Stock or equivalent securities having a market value at that time of twice the Right’s exercise price. Rights held by the triggering entity will become void and will not be exercisable to purchase shares at the reduced purchase price. The Board of Directors will, in general, be entitled to redeem the Rights at $0.001 per Right at any time before the triggering ownership threshold is crossed.

The Rights Plan may be amended, redeemed or terminated by the Acorda Board of Directors at any time prior to being triggered or its expiration. The Rights Plan exempts any person or group currently owning 15% or more of the Company’s outstanding Common Stock. However, the Rights will be exercisable if a person or group that already owns 15% or more of the Company’s Outstanding Common Stock acquires any additional shares after the time of announcement of the Rights Plan.

Additional details regarding the Rights Plan are in a Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission.

About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders. Acorda has a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson’s disease and multiple sclerosis. Acorda markets three FDA-approved therapies, including AMPYRA^® (dalfampridine) Extended Release Tablets, 10 mg.

Forward-Looking Statement
This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: the ability to realize the benefits anticipated from the Biotie and Civitas transactions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the ability to successfully integrate Biotie’s operations into our operations; we may need to raise additional funds to finance our operations and may not be able to do so on acceptable terms; our ability to successfully market and sell Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the U.S., which will likely be materially adversely affected by the recently announced court decision in our litigation against filers of Abbreviated New Drug Applications to market generic versions of Ampyra in the U.S.; the risk of unfavorable results from future studies of Inbrija (CVT-301, levodopa inhalation powder), tozadenant or from our other research and development programs, or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market Inbrija, tozadenant, or any other products under development; third party payers (including governmental agencies) may not reimburse for the use of Ampyra, Inbrija or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the occurrence of adverse safety events with our products; failure to maintain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaborator Biogen in connection therewith; competition; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.

These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.