(ACTS) Special Committee Appoints Counsel

ZHUHAI, China, May 23, 2016  — Actions Semiconductor Co., Ltd. (ACTS) (“Actions Semiconductor” or the “Company”), one of China’s leading fabless semiconductor companies that provides comprehensive portable multimedia and mobile internet system-on-a-chip (SoC) solutions for portable consumer electronics, today announced that the independent special committee of the Company’s Board of Directors (the “Special Committee”), formed to evaluate the previously announced preliminary non-binding “going-private” proposal received on May 19, 2016, has retained Jones Day as its U.S. counsel and Maples and Calders as its Cayman Islands counsel.

The Special Committee cautions the Company’s shareholders and others considering trading in the Company’s securities that no decision has been made on the response to the proposal. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated. The Special Committee does not undertake any obligation to provide any updates with respect to this or any other transaction, except as required under applicable law.

About Actions Semiconductor

Actions Semiconductor is one of China’s leading fabless semiconductor companies that provides comprehensive portable multimedia and mobile internet system-on-a-chip (SoC) solutions for portable consumer electronics. Actions Semiconductor products include SoCs, firmware, software, solution development kits, as well as detailed specifications of other required components. Actions Semiconductor also provides total product and technology solutions that allow customers to quickly introduce new portable consumer electronics to the mass market in a cost effective way. The Company is headquartered in Zhuhai, China, with offices in Shanghai, Shenzhen, Hong Kong and Taipei. For more information, please visit the Actions Semiconductor website at http://www.actions-semi.com.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995

Statements contained in this release that are not historical facts are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements concerning the preliminary, non-binding going private proposal.  Actions Semiconductor uses words like “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project” and similar expressions to identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are estimates reflecting current assumptions, expectations and projections about future events and involve significant risks, both known and unknown, uncertainties and other factors that may cause Actions Semiconductor’s actual performance, financial condition or results of operations to be materially different from those suggested by the forward-looking statements including, among others, customers’ cancellation or modification of their orders; our failure to accurately forecast demand for our products; the loss of, or a significant reduction in orders from, any of our significant customers; fluctuations in our operating results; our inability to develop and sell new products; defects in or failures of our products; the expense and uncertainty involved in our customer design-win efforts; the financial viability of the distributors of our products; consumer demand; worldwide economic and political conditions; fluctuations in our costs to manufacture our products; our reliance on third parties to manufacture, test, assemble and ship our products; our ability to retain and attract key personnel; our ability to compete with our competitors; and our ability to protect our intellectual property rights and not infringe the intellectual property rights of others. Other factors that may cause our actual results to differ from those set forth in the forward-looking statements contained in this press release and that may affect our prospects in general are described in our filings with the Securities and Exchange Commission, including our most recently filed Forms F-1, 20-F and 6-Ks. Other unknown or unpredictable factors also could have material adverse effects on Actions Semiconductor’s future results, performance or achievements. In light of these risks, uncertainties, assumptions and factors, the forward-looking events discussed in this press release may not occur. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date stated, or if no date is stated, as of the date of this press release. Except as required by law, Actions Semiconductor undertakes no obligation and does not intend to update or revise any forward-looking statement to reflect subsequent events or changed assumptions or circumstances.

(NSPH) & (LMNX) Provide Update on Acquisition Agreement

AUSTIN, Texas and NORTHBROOK, Ill., May 23, 2016  — Luminex Corporation (NASDAQ: LMNX) and Nanosphere, Inc. (NASDAQ: NSPH) announced today that they have entered into an amendment to the definitive agreement under which Luminex will acquire Nanosphere, a leader in the molecular microbiology and molecular diagnostic market.  The purchase price has been increased to $1.70 per share from $1.35 per share in an all cash transaction valued at approximately $77 million. This increase was in response to an unsolicited third party offer for Nanosphere at $1.50 per share.

About Luminex Corporation

Luminex is committed to applying its passion for innovation toward creating breakthrough solutions to improve health and advance science. The company is transforming global healthcare and life-science research through the development, manufacturing and marketing of proprietary instruments and assays utilizing xMAP^® open-architecture multi-analyte platform, MultiCode^® real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies, that deliver cost-effective rapid results to clinicians and researchers. Luminex’s technology is commercially available worldwide and in use in leading clinical laboratories, as well as major pharmaceutical, diagnostic, biotechnology and life-science companies. Luminex is meeting the needs of customers in markets as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical research including genomic and proteomic research, personalized medicine, biodefense research and food safety. For further information on Luminex Corporation and the latest advances in multiplexing using award winning technology, please visit http://www.luminexcorp.com/.

About Nanosphere, Inc.

Nanosphere is enhancing medicine through targeted molecular diagnostics that result in earlier disease detection, optimal patient treatment and improved healthcare economics. The Company’s versatile technology platform, the Verigene^® System, enables clinicians to rapidly detect the most complex, costly and deadly infectious diseases through a low cost and simple-to-use multiplexed diagnostic test. The combination of this innovative technology and Nanosphere’s customer-driven solutions keeps commitment to the patient at the forefront of its business. Nanosphere is based in Northbrook, IL. Additional information is available at http://www.nanosphere.us.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements in this press release, including statements regarding the proposed transaction between Luminex and Nanosphere, Luminex’s and Nanosphere’ financial results and estimates and/or business prospects, the combined company’s plans, objectives, expectations and intentions, leadership in biological testing technologies in the clinical diagnostic and life science industries and the expected size, scope and growth of the combined company’s operations and the markets in which it will operate, expected synergies, as well as the expected timing and benefits of the transaction, may contain words such as “expects,” “may,” “potential,” “upside,” “approximately,” “project,” “would,” “could,” “should,” “will,” “anticipates,” “believes,” “intends,” “estimates,” “targets,” “plans,” “envisions,” “seeks” and other similar language and are considered forward-looking statements or information under applicable securities laws. These statements are based on Luminex’s current expectations, estimates, forecasts and projections about the proposed transaction and the operating environment, economies and markets in which Luminex and Nanosphere operate, are subject to important risks and uncertainties that are difficult to predict and the actual outcome may be materially different. These statements reflect beliefs and assumptions that are based on Luminex’s and Nanosphere’ perception of historical trends, current conditions and expected future developments as well as other factors management believes are appropriate in the circumstances. In making these statements, Luminex and Nanosphere have made assumptions with respect to the ability of Luminex and Nanosphere to achieve expected synergies and the timing of same, the ability of Luminex and Nanosphere to predict and adapt to changing customer requirements, preferences and spending patterns, the ability of Luminex and Nanosphere to protect their intellectual property, future capital expenditures, including the amount and nature thereof, trends and developments in the clinical diagnostic and life science industries, business strategy and outlook, expansion and growth of business and operations, credit risks, anticipated acquisitions, future results for Luminex being similar to historical results, expectations related to future general economic and market conditions and other matters. Luminex’s and Nanosphere’ beliefs and assumptions are inherently subject to significant business, economic, competitive and other uncertainties and contingencies regarding future events and as such, are subject to change. Luminex’s beliefs and assumptions may prove to be inaccurate and consequently Luminex’s actual results could differ materially from the expectations set out herein.

Actual results or events could differ materially from those contemplated in the forward-looking statements as a result of the following:

Contacts
Luminex Investor Contact
Harriss Currie
Sr. Vice President of Finance and CFO
512.219.8020
hcurrie@luminexcorp.com

Matthew Scalo
Sr. Director, Investor Relations
512.219.8020
mscalo@luminexcorp.com

(REXI) Signs Definitive Agreement to Be Acquired by C-III Capital Partners LLC

(XNPT) to be Acquired by Arbor Pharmaceuticals

Arbor Pharmaceuticals, LLC (Arbor) and XenoPort, Inc. (XenoPort) (NASDAQ:XNPT) announced today that they have signed a definitive agreement under which Arbor will acquire XenoPort for $7.03 per share in cash, or a total equity value of approximately $467 million. The purchase price per share represents a 60 percent premium to the closing price of XenoPort shares on May 20, 2016.

“We are pleased to be adding HORIZANT and the XenoPort pipeline to the growing portfolio of Arbor products,” said Ed Schutter, President and Chief Executive Officer of Arbor. “We believe that XenoPort’s lead product HORIZANT offers patients and physicians a valuable treatment option for moderate-to-severe primary restless legs syndrome and postherpetic neuralgia. The XenoPort sales team has done an excellent job of growing HORIZANT, and we look forward to supporting them to continue this significant momentum.”

Vincent J. Angotti, Chief Executive Officer of XenoPort, stated, “This transaction provides immediate and substantial value to our stockholders, and we believe that Arbor is well positioned to provide the proper resources for a more expanded commercialization effort of HORIZANT. We evaluated many potential options to maximize the value for stockholders and believe this transaction represents a great outcome for XenoPort stockholders.”

Under the terms of the agreement, Arbor will commence a tender offer to purchase all of the outstanding shares of XenoPort for $7.03 per share. Following the closing of the tender offer, the agreement provides for the parties to effect, as promptly as practicable, a merger that would result in all shares not tendered in the tender offer being converted into the right to receive $7.03 per share in cash. The transaction, which has been unanimously approved by both the Arbor Board of Directors and the XenoPort Board of Directors, is expected to close in the third quarter of 2016.

Closing of the tender offer and merger is subject to certain customary conditions, including the tender of more than 50 percent of all outstanding shares of XenoPort. The transaction is also subject to review by the U.S. Government under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act, as amended, and other customary closing conditions.

Centerview Partners is serving as exclusive financial advisor to XenoPort, and Weil, Gotshal & Manges LLP is serving as legal advisor to XenoPort. Deutsche Bank has provided sole committed debt financing to Arbor in support of the transaction. Alston & Bird, LLP and Simpson, Thacher & Bartlett LLP acted as legal advisors to Arbor.

About Arbor Pharmaceuticals

Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the cardiovascular, hospital and pediatric markets. The company has over 600 employees including 500 sales professionals promoting its products to physicians, hospitals and pharmacists. Arbor currently markets twenty NDA or ANDA approved products with over 35 more in development.

For more information regarding Arbor Pharmaceuticals or any of its products, visit www.arborpharma.com or send email inquiries to info@arborpharma.com.

About XenoPort

XenoPort, Inc. is a biopharmaceutical company focused on commercializing HORIZANT in the United States. XenoPort has entered into a clinical trial agreement with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) under which the NIAAA has initiated a clinical trial evaluating HORIZANT as a potential treatment for patients with alcohol use disorder. REGNITE^® (gabapentin enacarbil) Extended-Release Tablets is being marketed in Japan by Astellas Pharma Inc. XenoPort has granted exclusive world-wide rights for the development and commercialization of its clinical-stage oral product candidate, arbaclofen placarbil, to Indivior PLC for all indications. It has granted exclusive U.S. rights for the development and commercialization of its clinical-stage oral product candidate, XP23829, to Dr. Reddy’s Laboratories. XenoPort’s other clinical-stage product candidate, XP21279, is a prodrug of levodopa that is a potential treatment for patients with idiopathic Parkinson’s disease.

To learn more about XenoPort, please visit the website at www.XenoPort.com.

HORIZANT, REGNITE and XENOPORT are registered trademarks of XenoPort, Inc.

Important Additional Information

The tender offer for the outstanding shares of XenoPort, referenced in this press release has not yet commenced. This announcement is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of XenoPort, nor is it a substitute for the tender offer materials that Arbor and its acquisition subsidiary will file with the U.S. Securities and Exchange Commission (the “SEC”) upon commencement of the tender offer. At the time the tender offer is commenced, Arbor and its acquisition subsidiary will file tender offer materials on Schedule TO, and XenoPort will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. The tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement will contain important information. Holders of shares of XenoPort are urged to read these documents when they become available because they will contain important information that holders of XenoPort shares should consider before making any decision regarding tendering their shares. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of XenoPort at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Arbor media relations at the phone number or e-mail address below or XenoPort investor relations at the phone number or e-mail address below.

In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, XenoPort files annual, quarterly and special reports and other information with the SEC. You may read and copy any reports or other information filed by Arbor or XenoPort at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Arbor’s and XenoPort’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.

XenoPort Forward-Looking Statements

This press release contains “forward-looking” statements, including, without limitation, all statements about the proposed acquisition of XenoPort by Arbor, the commencement of a tender offer for shares of XenoPort common stock, and benefits from the proposed acquisition, business strategies, market potential, future financial prospects and other matters that are not historical facts. 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 “believe,” “could,” “intend,” “may,” “plans,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon XenoPort’s current expectations. Forward-looking statements involve risks and uncertainties. XenoPort’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the parties’ ability to satisfy the conditions to the consummation of the tender offer and the other conditions set forth in the merger agreement between the parties, the possibility of any termination of the merger agreement between the parties, and the parties’ ability to obtain regulatory approval in a timely manner. These and other risk factors are discussed under the heading “Risk Factors” in XenoPort’s Securities and Exchange Commission filings and reports, including in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the Securities and Exchange Commission on May 5, 2016. XenoPort expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

HORIZANT^® (gabapentin enacarbil) Extended-Release Tablets

INDICATIONS

HORIZANT^® (gabapentin enacarbil) is a prescription medicine used to:

• treat adults with moderate-to-severe primary Restless Legs Syndrome (RLS). HORIZANT is not for people who need to sleep during the daytime and stay awake at night.
• manage pain from damaged nerves (postherpetic neuralgia) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.

IMPORTANT SAFETY INFORMATION

• Do not drive after taking your dose of HORIZANT until you know how it affects you, including the morning after you take it. Do not operate heavy machinery or do other dangerous activities until you know how HORIZANT affects you. HORIZANT can cause sleepiness, dizziness, slow thinking, and can affect your coordination. Ask your healthcare provider when it is okay to do these activities.
• Do not take other medicines that make you sleepy or dizzy while taking HORIZANT without talking to your healthcare provider. Taking HORIZANT with these other medicines may make your sleepiness or dizziness worse.
• HORIZANT may cause suicidal thoughts or actions in a very small number of people (about 1 in 500). Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • thoughts or actions about suicide, self-harm, or dying; attempt to commit suicide
  • new or worsening depression or anxiety; or feeling agitated
  • new or worse restlessness or panic attacks
  • new or worse trouble sleeping (insomnia); or irritability
  • acting aggressive, being angry, or violent; acting on dangerous impulses
  • an extreme increase in activity or talking (mania); other unusual changes in mood or behavior
• Do not stop taking HORIZANT without first talking to your healthcare provider. Suicidal thoughts or actions can be caused by things other than medicines. If you have these thoughts or actions, your healthcare provider may check for other causes.

• HORIZANT may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have a rash with these types of reactions. Call a healthcare provider right away if you have any of the following symptoms: skin rash, hives, fever, swollen glands that do not go away, swelling of your lips or tongue, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, unexpected severe muscle pain, or frequent infections. These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking HORIZANT.
• HORIZANT is not the same medicine as gabapentin (for example, Neurontin^® and Gralise^®). HORIZANT should not be used in their place. Do not take these or other gabapentin products while taking HORIZANT.
• Before taking HORIZANT, tell your healthcare provider if you:
  • have or have had kidney problems or are on hemodialysis
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have or have had seizures
  • have a history of drug abuse
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if HORIZANT will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant while taking HORIZANT. You and your healthcare provider will decide if you should take HORIZANT while you are pregnant
  • are breastfeeding or plan to breastfeed. Your body turns HORIZANT into another drug (gabapentin) that passes into your milk. It is not known if this can harm your baby. You and your healthcare provider should decide if you will take HORIZANT or breastfeed
  • drink alcohol

• Do not drink alcohol while taking HORIZANT because it may increase the risk of side effects.
• Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking HORIZANT with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
• Do not stop taking HORIZANT without talking to your healthcare provider first. If you stop taking HORIZANT suddenly, you may develop side effects.
• The most common side effects of HORIZANT include dizziness, sleepiness, and headache. Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of HORIZANT. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. See Medication Guide.

XNPT2G

Arbor Media Contact
Brian Adams, 404-496-5915
brian.adams@arborpharma.com
or
XenoPort IR and Media Contact
Jackie Cossmon, 408-616-7220
ir@XenoPort.com

(ISCO) Cryoport to Provide Cold Chain Logistics Support

IRVINE, Calif., May 23, 2016  — Cryoport, Inc. (NASDAQ: CYRX) (“Company”), the world’s leading cryogenic logistics company for the life sciences industry, today announced that it will provide global logistics support to International Stem Cell Corporation’s (OTCQB: ISCO) (“ISCO”) for its Phase I clinical trial in Australia for the treatment of moderate to severe Parkinson’s disease. ISCO commenced patient enrollment for the study earlier this month.

Two of Cryoport’s strategically located depots, in southern California and Singapore, will provide logistics support for the clinical study from ISCO’s research facility in California to the study site in Australia. As the premier cryogenic logistics provider, Cryoport’s extensive experience with the movement of high-value biologic material for clinical trials and commercialization programs globally gives ISCO’s team assurance that its shipment will arrive with fully documented chain of custody and chain of condition data.

“This trial will take place across the globe and it is imperative that our cell therapy maintains integrity. We are pleased to have Cryoport handle our global logistics requirements,” said Russell Kern, PhD, Executive Vice President and Chief Scientific Officer of ISCO.

Jerrell Shelton, Chief Executive Officer of Cryoport, commented, “Cryoport is proud to work with ISCO and support its efforts. We are fully confident in our ability to manage the logistics of the therapies as specified – and with certainty. We look forward to furthering our relationship with ISCO as we move forward.”

About Cryoport, Inc.

Cryoport is the premier provider of cryogenic logistics solutions to the life sciences industry through its purpose-built proprietary packaging, information technology and specialized cold chain logistics expertise. Supporting the entire lifecycle of therapies from clinical trials to approval and commercialization, the Company provides leading edge logistics solutions for biologic materials, such as immunotherapies, stem cells, CAR-T cells and reproductive cells for clients worldwide. Cryoport actively supports points-of-care, CRO’s, central laboratories, pharmaceutical companies, contract manufacturers and university researchers. For more information, visit www.cryoport.com.

To download Cryoport’s investor relations app, which offers access to SEC documents, press releases, videos, audiocasts and more, please click to download from your iPhone and iPad or Android mobile device.

Forward Looking Statements
Statements in this news release which are not purely historical, including statements regarding Cryoport, Inc.’s intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. It is important to note that the company’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties associated with the effect of changing economic conditions, trends in the products markets, variations in the company’s cash flow, market acceptance risks, and technical development risks. The company’s business could be affected by a number of other factors, including the risk factors listed from time to time in the company’s SEC reports including, but not limited to, the annual report on Form 10-K for the year ended March 31, 2015. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Cryoport, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

(MDGN) to Present at the UBS Global Healthcare Conference

PHILADELPHIA, PA–(May 20, 2016) – Medgenics, Inc. (NYSE MKT: MDGN) today announced that Michael F. Cola, President and Chief Executive Officer, will present at the annual UBS Global Healthcare Conference in New York, NY on Wednesday May 25, 2016 at 8:00 a.m. EDT at the Grand Hyatt New York.

A live webcast of the presentation can be accessed under “Presentations” in the Investors section of the Company’s website at www.medgenics.com or you may use the link: https://cc.talkpoint.com/ubsx001/052316a_ae/?entity=111_2U887X7

About Medgenics, Inc.

Medgenics is dedicated to unlocking the potential of genomic medicine to identify and treat patients with life-altering conditions. Its efforts, including its internal research and development and ongoing sponsored research and licensing agreements with a well-respected pediatric academic medical center, give Medgenics the ability to focus on the underlying genetic pathway of pediatric diseases with the goal of finding therapeutic solutions for subpopulations of both children and adults living with rare and other difficult-to-treat diseases. Medgenics is also the developer of TARGT™ (Transduced Autologous Restorative Gene Therapy. For more information, visit the Company’s website at www.medgenics.com.

Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company’s financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning, “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.

CONTACT:

Medgenics
Brian Piper
240-899-5554
Email Contact

Westwicke Partners
Chris Brinzey
339-970-2843
Email Contact

(AVXL) FDA Orphan Drug Designation to ANAVEX 2-73

NEW YORK, May 20, 2016  — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reports the U.S. Food and Drug Administration’s (FDA) Office of Orphan Product Development (OOPD) has granted Orphan Drug Designation (ODD) to ANAVEX 2-73 for the treatment of Rett syndrome.

“The Orphan Drug Designation marks the first U.S. movement for ANAVEX 2-73.  Rett syndrome is a devastating disease occurring in early childhood and almost exclusively in girls.  As there is currently no cure and limited treatment, Rett syndrome represents a clear unmet clinical need,” commented Christopher U. Missling, PhD, President and Chief Executive Officer.  “The acknowledgement from the Agency for this orphan designation allows us to formally move forward with the planned human clinical study in this disease indication, thereby potentially expanding the reach for ANAVEX 2-73 in addition to Alzheimer’s disease.”

The FDA’s Office of Orphan Products Development advances the evaluation of drugs that show promise for the safe treatment of rare diseases, defined as those affecting fewer than 200,000 people in the United States.  The designation provides sponsors with development and commercial incentives, including seven years of market exclusivity in the U.S., prioritized consultation by FDA on clinical studies and certain exemptions from or reductions in regulatory fees.

About Rett Syndrome
Rett syndrome is rare non-inherited genetic postnatal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child’s life: their ability to speak, walk, eat, and even breathe easily. The hallmark of Rett syndrome is near constant repetitive hand movements while awake. It is characterized by normal early growth and development (6 to 18 months) followed by a slowing of development, loss of purposeful use of the hands, distinctive hand movements, slowed brain and head growth, problems with walking, seizures, and intellectual disability. There is currently no cure for Rett syndrome and treatment of the disorder is symptomatic. Management of the symptoms is done through a multidisciplinary approach utilizing medication for motor difficulties, breathing irregularities, and control of seizures through anticonvulsant drugs. Rett syndrome is caused by mutations in the MECP2 gene and strikes all racial and ethnic groups and occurs worldwide in approximately 1 in every 10,000-15,000 live female births.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:

Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email:  info@anavex.com

Investors:
866-505-2895
Email: ir@anavex.com

Media:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com

(TGTX) Presentations at the Upcoming 21st European Hematology Assoc. Congress

Presentations demonstrate the safety and efficacy of TGR-1202 in combination with ublituximab as well as in combination with ibrutinib in patients with CLL and NHL

NEW YORK, May 20, 2016  — TG Therapeutics, Inc. (Nasdaq:TGTX), today announced that updated data has been selected for presentation at the upcoming 21^st European Hematology Association (EHA) Annual Congress, to be held from June 9 – 12, 2016 in Copenhagen, Denmark.

Presentations Include:

• Title: Long-term follow-up of the next generation PI3K-delta inhibitor TGR-1202 demonstrates safety and high response rates in CLL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
  • Abstract Number: P207
  • Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
  • Location: Poster Hall H
  • Presenter: Anthony Mato, MD, University of Pennsylvania, Philadelphia, PA
• Title: Long-term follow-up of the next generation PI3Kδ inhibitor TGR-1202 demonstrates safety and high response rates in NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
  • Abstract Number: P315
  • Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
  • Location: Poster Hall H
  • Presenter: Owen A. O’Connor, MD, PhD, Columbia University Medical Center, NY, NY
• Title: Preliminary results of a Phase I/Ib study of ibrutinib in combination with TGR-1202 in patients with relapsed/refractory CLL or MCL
  • Abstract Number: E1053
  • E-poster Presentation
  • Presenter: Matthew S. Davids MD, Dana-Farber Cancer Institute, Boston, MA

A copy of the EHA abstracts were made available yesterday, May 19, 2016 through the EHA meeting website at www.ehaweb.org.   Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

TGTX – G

CONTACT:

Jenna Bosco
Vice President- Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com

(OTIC) Assignment of C Code and Pass-Through Payment Status for OTIPRIO™

SAN DIEGO, May 20, 2016  — Otonomy, Inc. (Nasdaq:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through status and established a new billing code for OTIPRIO™ (ciprofloxacin otic suspension). The code, C9479, will become effective July 1, 2016.

“We welcome CMS’s decision to grant pass-through status and assign a new C code for OTIPRIO which can be used for billing in the hospital outpatient and ambulatory surgery center (ASC) settings,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Furthermore, the timing of this assignment early in the launch of OTIPRIO will, we believe, be very helpful in our ongoing efforts to facilitate patient access.”

According to a CMS reference article, “C codes are unique temporary pricing codes that were initially established by CMS for the Hospital Outpatient Prospective Payment System (OPPS). The C codes are used on Medicare OPPS claims but may also be recognized on claims from other providers or by other payment systems.” Hospital outpatient departments and ASCs billing for drugs assigned a C code are eligible for payment by Medicare for the pass-through drug in addition to the fee received by the facility for the related procedure. Pass-through payment is typically available for two to three years and Otonomy believes, based on long-standing CMS policy, that pass-through payment for OTIPRIO will be effective through the end of 2018. Coverage and payment by non-Medicare payors including Medicaid and commercial insurers is determined by each payor’s policies and individual provider contracts.

About OTIPRIO

OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. OTIPRIO is administered by a physician as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed. In two Phase 3 trials, a single intraoperative administration of OTIPRIO demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone (p-value <0.001).

Important Safety Information for OTIPRIO

Contraindications: OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.

Warnings and Precautions – Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, institute alternative therapy.

Adverse Reactions: Adverse reactions (incidence at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).

Use in Specific Populations – Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established.

Full prescribing information can be found at www.OTIPRIO.com.

About Otonomy

Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery in pediatric patients, and commercial launch commenced in March 2016. OTO-104 is a steroid in development for the treatment of Ménière’s disease and other severe balance and hearing disorders. Two Phase 3 trials in Ménière’s disease patients are underway, with results expected during the second half of 2017. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. Otonomy’s proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. For additional information please visit www.otonomy.com.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, whether payors will provide reimbursement according to the C code, the timing of any such reimbursement, how long pass-through payments and the C code will remain effective, and the timing of results for the two OTO-104 Phase 3 clinical trials in Ménière’s disease. Otonomy’s expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomy’s limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy’s ability to obtain additional financing; Otonomy’s dependence on the commercial success of OTIPRIO and the regulatory success and advancement of additional product candidates, such as OTO-104 and OTO-311; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy’s ability to adequately demonstrate the safety and efficacy of its product candidates, the preclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy’s ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy’s product candidates; competition in the biopharmaceutical industry; Otonomy’s dependence on third parties to conduct preclinical studies and clinical trials; the impact of coverage and reimbursement decisions by third-party payors on the pricing and market acceptance of OTIPRIO; Otonomy’s dependence on third parties for the manufacture of OTIPRIO and product candidates; Otonomy’s dependence on a small number of suppliers for raw materials; Otonomy’s ability to protect its intellectual property related to OTIPRIO and its product candidates in the United States and throughout the world; expectations regarding potential market size, opportunity and growth; Otonomy’s ability to manage operating expenses; implementation of Otonomy’s business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Otonomy’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 9, 2016, and Otonomy’s future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.

Contacts:

Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior Vice President
619.849.5377
heidi@canalecomm.com

Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

(CLRB) Patent App for Phospholipid-Ether Analogs as Cancer Targeting Drug

Patent Further Supports the Company’s Phospholipid Drug Conjugate (PDC) Platform and Provides Intellectual Property Protection for Chemotherapeutic Drug Conjugates to November 2036

MADISON, Wis., May 20, 2016  — Cellectar Biosciences, Inc. (NASDAQ:CLRB) (the Company), an oncology-focused biotechnology company, today announces that its previously filed non-provisional US and International (PCT) patent applications for Phospholipid-Ether Analogs as Cancer Targeting Drug Vehicles have received their US Patent and Trademark Office (USPTO) identification numbers and have been published by the USPTO, which marks the next step in the application process for approval and issuance of these patents.

As previously stated, these patents will protect both composition of matter and method of use for those phospholipid drug conjugates, or PDCs, developed with Cellectar’s proprietary phospholipid-ether delivery vehicle conjugated with any existing or future cytotoxic agents, including chemotherapeutics such as paclitaxel, for targeted delivery to cancer cells and cancer stem cells.

“When issued, these patents will provide Cellectar and potential partners with intellectual property (IP) protection through approximately November 2036, providing significant runway for product development and commercialization,” said Jim Caruso, president and CEO of Cellectar. “This expanded IP protection supports the value-optimizing potential of our CLR CTX chemotherapeutic program and we look forward to providing ongoing updates as we continue to advance this R&D program.”

The objective of the CLR CTX program is to develop PDC chemotherapeutics through conjugation of the Company’s delivery vehicle and non-targeted anti-cancer agents to improve therapeutic indices and expand potential indications through targeted cancer cell delivery of chemotherapeutic payloads.

About Phospholipid Drug Conjugates (PDCs)

Cellectar’s PDC platform has demonstrated highly selective cancer targeting both preclinically in over 60 in vivo cancer models, and subsequently confirmed clinically in over 10 cancer types. The platform’s payload diversity has been validated using cytotoxic radioisotopes for cancer therapy; PET imaging isotopes for cancer imaging; fluorophores for image-guided surgery, and now the company plans to expand its payload portfolio to chemotherapeutics with further preclinical study of paclitaxel and other non-targeted anti-cancer agents with both in-house and collaborative R&D efforts.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC Delivery Platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase 1 study in patients with relapsed or refractory multiple myeloma. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1602-PTX), a preclinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For additional information please visit www.cellectarbiosciences.com.

This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

INVESTOR AND MEDIA CONTACT:

Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com

(CPXX) Announces VYXEOS™ Granted Breakthrough Therapy Designation

FDA awards designation for treatment of adults with therapy-related AML or AML with myelodysplasia-related changes – – VYXEOS significantly improved overall survival in a Phase 3 clinical trial

EWING, N.J., May 19, 2016  — Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced that the United States Food and Drug Administration (FDA) granted Breakthrough Therapy designation to VYXEOS (also known as CPX-351). VYXEOS is an investigational product in development as a treatment for AML and other blood cancers.

The Breakthrough Therapy designation is primarily based upon the positive results from the pivotal Phase 3 clinical trial in older patients with previously untreated high-risk (secondary) AML.  The designation is for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).  This designation includes the patient populations enrolled in the Phase 3 clinical trial.

The Phase 3 trial met its primary endpoint demonstrating a statistically significant improvement in overall survival.  Data will be presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting on Saturday, June 4^th.

The median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving 7+3, representing a 3.61 month improvement in favor of VYXEOS.  The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3.   The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm.  The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.

Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS.

No substantial difference in Grade 3-5 adverse events was observed between VYXEOS and 7+3. In the intent-to-treat population, Grade 3-5, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events. In the intent-to-treat population, Grade 3-5, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.

“We are very happy the FDA granted Breakthrough Therapy designation for VYXEOS,” said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals.  “The breadth of the designation, which includes all adults with t-AML and AML-MRC, is encouraging as AML patients are in need of advancements in treatment.  We look forward to working with the FDA to bring VYXEOS to patients as quickly as possible.”

FDA awards Breakthrough Therapy designation in order to expedite the development and review of new medicines that are intended to treat serious or life-threatening diseases when the therapy has demonstrated substantial improvement over available therapies on at least one clinically significant endpoint or when there is significant unmet medical need.

Celator plans to submit a New Drug Application (NDA) to the FDA by the end of the third quarter of 2016.

About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is an oncology-focused biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. Celator’s proprietary technology platform, CombiPlex®, enables the rational design and rapid evaluation of optimized combinations of anti-cancer drugs, incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anti-cancer activity. CombiPlex addresses several fundamental shortcomings of conventional combination regimens, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination after administration and ensuring exposure of this ratio to the tumor. Celator’s lead product is VYXEOS™ (also known as CPX-351), a nano-scale liposomal formulation of cytarabine:daunorubicin that has completed a Phase 3 trial for the treatment of acute myeloid leukemia. Celator has also conducted clinical development on CPX-1, a nano-scale liposomal formulation of irinotecan:floxuridine studied in colorectal cancer; and have a preclinical stage product candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation. More recently, the company has advanced its CombiPlex platform and broadened its application to include molecularly targeted therapies. For more information, please visit Celator’s website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.

Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Celator, 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,” 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 the safety, potential efficacy, therapeutic potential, our expectations regarding the timing of our regulatory filings and the timing of regulatory approvals, and commercial potential of VYXEOS, our expectations regarding our research and development programs, expanding our pipeline and advancing our CombiPlex platform, our ability to pursue R&D collaborations with pharmaceutical companies 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, working capital, 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 regulatory process, whether the final results of our clinical studies will be supportive of regulatory approval to market VYXEOS and other matters that could affect the commercial potential of our drug candidates, the uncertainties inherent in the conduct of future clinical studies, enrollment in clinical studies and whether clinical trial results obtained to date will be predictive of future results. Celator 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 Celator in general, see Celator’s Form 10-K for the year ended December 31, 2015 and other filings by Celator with the U.S. Securities and Exchange Commission.

CONTACTS:
Media:

Sam Brown, Inc.
Mike Beyer, 312-961-2502
mikebeyer@sambrown.com

Investors:

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

(ONCE) & (PFE) Announce Data from Initial Subjects in Hemophilia B Trial

Subjects received one-time administration of a highly optimized gene therapy at initial low dose without the need for immunosuppression

Therapeutic Factor IX activity sustained at levels exceeding those considered sufficient to reduce the risk of joint bleeds and need for prophylactic clotting Factor infusions

Expanded dataset on first cohort to be presented June 11 at European Hematology Association meeting

PHILADELPHIA and NEW YORK CITY, May 19, 2016  — Spark Therapeutics (NASDAQ:ONCE) and Pfizer Inc. (NYSE:PFE) announced today that new data will be presented on June 11 at the European Hematology Association’s (EHA) 21^st Congress. These data will show encouraging initial observations for the first subjects dosed in the Phase 1/2 clinical trial of SPK-9001, the lead investigational compound in the SPK-FIX program, which is being studied for the treatment of Hemophilia B. SPK-9001, a novel bio-engineered adeno-associated virus (AAV) capsid expressing a codon-optimized high-activity human Factor IX variant, was developed using Spark’s proprietary technology platform for selecting, designing, manufacturing and formulating highly optimized gene therapies. The conference abstract, including a figure demonstrating Factor IX activity levels (as % of normal) expressed by subject over time, was made available today: http://www.ehaweb.org/congress-and-events/21st-congress/key-information-3/

Data available today demonstrate that the first three subjects enrolled in the study experienced AAV-mediated Factor IX activity levels following one administration of SPK-9001 at the initial dose level (5 x 10¹¹ vg/kg) studied in the trial. Factor IX activity levels in the first two subjects, without prior history of liver disease, rose consistently through the first four weeks post-administration.  At the time of abstract submission, the first subject stabilized at 28% of normal at eighteen weeks, and the second subject at 30% of normal at seven weeks post-administration. Factor IX activity level in the third subject, with a history of liver disease, also rose consistently and was at 16% of normal at three weeks post–administration. Data from a natural history of patients with hemophilia suggest that circulating factor activity levels sustained at a threshold of greater than or equal to 12% of normal generally are considered to be sufficient to reduce the risk of joint bleeds and the need for prophylactic clotting factor infusions.

Over the combined 28 weeks of observation reported in the abstract, none of the three subjects received regular infusions of Factor IX concentrates to prevent bleeding events. Only one precautionary infusion has taken place due to a suspected ankle bleed in one subject two days after administration of vector. SPK-9001 has been well-tolerated and no subjects have needed, or received, immunosuppression.

“We are highly encouraged by these initial data, which are supportive of the target profile of a potential gene therapy product capable of eliminating the need for regular infusions to control and prevent bleeding episodes through a one-time, intravenous administration,” said Katherine A. High, MD, co-founder, president and chief scientific officer of Spark. “Our hypothesis had been that delivery of a highly optimized gene therapy at low doses could allow expression of therapeutic levels of FIX while avoiding the need for immunosuppression. The data summarized in the abstract of SPK-9001 appear to support this hypothesis, although we will continue to monitor and investigate the validity of the hypothesis as well as assess long-term efficacy and safety of the product candidate.”

Spark and Pfizer entered into a collaboration in 2014, under which Spark will be responsible for conducting all Phase 1/2 studies for any product candidates that may be developed under the SPK-FIX program, while Pfizer will assume responsibility for pivotal studies, any regulatory activities and potential global commercialization of any products that may result from the collaboration.

“Although these results are early, we believe that the initial SPK-9001 data are promising,” said Greg LaRosa, Chief Scientific Officer, Rare Disease Research Unit, Pfizer. “Pfizer has a longstanding commitment to the hemophilia community and strong history of providing hemophilia products to patients for nearly two decades. We look forward to our continued collaboration with Spark as we work toward our shared goal of bringing to market a novel potential therapy for hemophilia patients around the world.”

Up-to-date results from the trial will be presented at the EHA Congress on June 11 by Dr. Spencer Sullivan, an Assistant Professor of Pediatrics and Medicine at the University of Mississippi Medical Center, one of the trial investigators. The trial is led by Dr. Lindsey George of the Children’s Hospital of Philadelphia.  In addition, the work has been selected by the EHA for press briefing at the Congress scheduled for June 11, 8:30 am CET.

About Hemophilia B and the SPK-FIX Program
Hemophilia B is a rare genetic blood disorder that affects approximately 4,000 males in the U.S. and 26,000 males worldwide. Current treatment requires recurrent intravenous infusions of either plasma-derived or recombinant Factor IX to control and prevent bleeding episodes. Spark’s proprietary technology platform for selecting, designing, manufacturing and formulating highly optimized gene therapies was applied to developing SPK-9001, a novel bio-engineered adeno-associated virus (AAV) capsid expressing a codon-optimized high-activity human Factor IX variant enabling endogenous production of Factor IX, with the potential to be a one-time therapy. The SPK-FIX program leverages a long track record of hemophilia B gene therapy research and clinical development conducted by Spark and its founding scientific team over nearly three decades. SPK-9001 is being developed under a partnership with Pfizer.

About Spark Therapeutics
Spark is a gene therapy leader seeking to transform the lives of patients with debilitating genetic diseases by developing one-time, life-altering treatments. Spark’s validated gene therapy platform is being applied to a range of clinical and preclinical programs addressing serious genetic diseases, including inherited retinal dystrophies, hematologic disorders and neurodegenerative diseases. Spark’s most advanced product candidate, SPK-RPE65 (voretigene neparvovec), which has received both breakthrough therapy and orphan product designation, reported positive top-line results from a pivotal Phase 3 clinical trial for the treatment of rare blinding conditions. Spark builds on two decades of research, development and manufacturing at The Children’s Hospital of Philadelphia, including human trials conducted across diverse therapeutic areas and routes of administration. To learn more, please visit www.sparktx.com.

Spark Cautionary Note on Forward-looking Statements:
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the company’s SPK-FIX program. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that: (i) our lead SPK-FIX product candidate may not produce sufficient data in our Phase 1/2 clinical trial to warrant further development; and (ii) our overall collaboration with Pfizer may not be successful. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in our Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and other filings we make with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Spark undertakes no duty to update this information unless required by law.

Pfizer and Rare Diseases
Rare diseases are among the most serious of all illnesses and impact millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact in addressing unmet medical needs. The Pfizer focus on rare diseases builds on more than two decades of experience, a dedicated research unit focusing on rare diseases, and a global portfolio of more than 20 medicines approved worldwide that treat rare diseases in the areas of hematology, neuroscience, inherited metabolic disorders, pulmonology, and oncology.

Pfizer Inc: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

PFIZER DISCLOSURE NOTICE: The information contained in this release is as of May 19, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about SPK-9001, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with initial data, including the risk that the final results of the Phase I/2 study for SPK-9001 and/or additional clinical trials may be different from (including less favorable than) the initial data results and may not support further clinical development;  whether and when any applications may be filed with regulatory authorities for SPK-9001; whether and when regulatory authorities may approve any such applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of SPK-9001; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Contacts

Investor Relations
Spark Therapeutics, Inc.
Stephen W. Webster
Chief Financial Officer
(855) SPARKTX (1-855-772-7589)

Media
Ten Bridge Communications
Dan Quinn
(781) 475-7974
dan@tenbridgecommunications.com

(AQMS) & Interstate Batteries Form Strategic Partnership

Interstate Invests in Aqua Metals, Has Agreed to Provide Millions of Pounds Of Used Batteries to Recycle at World’s First AquaRefinery

ALAMEDA, Calif., May 19, 2016  — Aqua Metals, Inc. (NASDAQ:AQMS) (Aqua Metals), which is commercializing a non-polluting electrochemical lead recycling technology called AquaRefining™, today announced the signing of definitive agreements with Interstate Batteries. Interstate Batteries is the No. 1 replacement battery brand, the largest independent battery distribution system in North America and the country’s leading battery recycler.

Upon the closing of these agreements, Interstate Batteries has agreed to supply more than a million automotive and other lead-acid batteries as feedstock for Aqua Metals’ AquaRefineries. This partnership will start with Aqua Metals’ first AquaRefinery, which will be located in Nevada’s Tahoe-Reno Industrial Complex (TRIC) and is set to open in July 2016. Interstate Batteries will also make a strategic investment of approximately $10 million into Aqua Metals.

With a nationwide network of more than 200,000 dealers returning battery cores, Interstate Batteries recycled more than 24.9 million automotive batteries in 2015, which is more than it sells. In the automotive industry alone, Interstate Batteries sells more than 17 million automotive batteries annually in addition to powering everything including marine and heavy equipment, golf carts, lawn and garden care equipment, data center cloud infrastructure and security systems.

“Interstate Batteries seeks out innovation, pursues opportunities and invests in the technology we need to succeed not just today, but also tomorrow,” said Scott Miller, president and CEO of Interstate Batteries. “Our focus is on the future of our industry and continued growth. Aqua Metals’ breakthrough technology is a promising new way for recycling lead-acid batteries.”

Aqua Metals’ patent-pending AquaRefining process is an environmentally friendly electrochemical process for recycling lead-acid batteries. AquaRefining is a closed-loop, room temperature, water-based recycling method that is fundamentally non-polluting, yet able to yield nearly 100 percent lead recovery.

“With its forward-thinking environmental goals, broad distribution network and strong brand name, Interstate Batteries is an ideal partner for us as we scale our business,” said Dr. Stephen Clarke, chairman and CEO of Aqua Metals. “As we grow, we are able to create a more sustainable ecosystem for lead as a power source. We look forward to growing our partnership with Interstate Batteries.”

Interstate Batteries’ $10 million strategic investment into Aqua Metals will be in the form of common stock, a fixed-price note that converts into common stock, and two cash warrants to purchase common stock over the next three years.

Concurrent with all of these agreements with Interstate Batteries, Aqua Metals signed definitive agreements with various institutional and individual accredited investors to raise additional gross proceeds of approximately $5.1 million in a private placement of common stock. National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (NASDAQ:NHLD), acted as sole placement agent for the additional $5.1 million investment. The Liquid Venture Partners group at National Securities Corporation was primarily responsible for the sourcing and execution of that portion of the investment.

All of these agreements are expected to close on or before May 23, 2016, subject to customary closing conditions. Additional details of all of the agreements are included in the Aqua Metals’ recently filed Quarterly Report on Form 10-Q.

About Interstate Batteries
Interstate’s starting, lighting, ignition (SLI) batteries have been under millions of car hoods since 1952, each one backed by Outrageously Dependable^® service, quality and value. Interstate PowerCare offers premier products, technical expertise and reliable service for critical and motive power needs, and Interstate All Battery Centers meet the growing demand for portable power in both retail and commercial markets. Today, Interstate sells more than 17 million batteries in North, Central and South America and China – and they recycle more than they sell. With a nationwide network of more than 200,000 dealers returning battery cores, they’ve turned batteries into one of America’s greatest recycling successes. For more information, please visit www.interstatebatteries.com.

About Aqua Metals
Aqua Metals (NASDAQ:AQMS) is reinventing lead recycling with its patent-pending  AquaRefining^TM technology. Unlike smelting, AquaRefining is a room temperature, water-based process that is fundamentally non-polluting. These modular systems are expected to  allow the lead-acid battery industry to simultaneously improve environmental impact and scale production to meet rapidly growing demand. Aqua Metals is based in Alameda, California, and is building its first recycling facility in Nevada’s Tahoe Reno Industrial Complex. To learn more, please visit www.aquametals.com.

Safe Harbor
This press release contains forward-looking statements concerning Aqua Metals, Inc., the lead-acid battery recycling industry, the intended benefits of its agreements with Interstate Batteries, the future of lead-acid battery recycling via traditional smelters, the Company’s development of its commercial lead-acid battery recycling facilities and the quality, efficiency and profitability of Aqua Metals’ proposed lead-acid battery recycling operations. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (1) the fact that Company has not yet commenced revenue producing operations or developed its initial commercial recycling facility, thus subjecting the Company to all of the risks inherent in a pre-revenue start-up; (2) the uncertainties involved in any new commercial relationship and the risk that Aqua Metals will not receive the intended benefits of its agreements with Interstate Batteries; (3) risks related to Aqua Metals’ ability to raise sufficient capital, as and when needed, to develop and operate its recycling facilities; (4) changes in the federal, state and foreign laws regulating the recycling of lead-acid batteries; (5) the Company’s ability to protect its proprietary technology, trade secrets and know-how and (6) those other risks disclosed in the section “Risk Factors” included in the Annual Report on Form 10-K  filed with the SEC on March 28, 2016. Aqua Metals cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake, and specifically disclaims any obligation, to update or revise such statements to reflect new circumstances or unanticipated events as they occur.

Aqua Metals Media Relations:
Antenna
Sharon Golubchik
Director
609-418-0058
aquametals@antennagroup.com

Aqua Metals Investor Relations:
MZ North America
Greg Falesnik
Senior Vice President
Main: 949-385-6449
greg.falesnik@mzgroup.us 
www.mzgroup.us

Interstate Batteries Media Relations:
Jackson Spalding
Patrick Hill
404-724-2506  
phill@jacksonspalding.com 	

John Tucker
917-576-2813
jtucker@jacksonspalding.com

(KOOL) Publication of a Case Report on AMIRST in AMI

Data highlights promising results obtained from the AMIRST pilot study.

RANCHO CORDOVA, Calif., May 19, 2016  — Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced publication of data from a pilot study utilizing the company’s innovative technology for treatment of Acute Myocardial Infarction. The report was published in the “International Journal of the Cardiovascular Academy”, currently online*.

Results from the single-patient study titled, “Autologous bone marrow concentrate enriched in progenitor cells – an adjuvant in the treatment of acute myocardial infarction” were obtained using Cesca’s integrated point-of-care technology, Acute Myocardial Infarction Rapid Stem cell Therapy (AMIRST).

The patient was able to return to normal life two weeks after the AMIRST procedure, and the main findings of the study showed a significant improvement in the Left Ventricular Ejection Fraction (LVEF) from 35% at patient’s initial assessment to 60.3% at 24 months post-AMIRST intervention. LVEF is a key indicator of cardiac function, and reduced LVEF levels are considered risk factors for cardiovascular morbidity and mortality. In the publication, the authors note that, “This degree of improvement is considered atypical for a patient having suffered an ST elevated myocardial infarction (STEMI) with an ejection fraction below 40% post reperfusion (stenting).” No major adverse events were observed during the procedure and throughout the 24 month follow-up period. Additionally, data from the study demonstrated that Cesca’s AMIRST integrated technology provided all the components necessary for collection, processing and intracoronary delivery of concentrated stem cells from a patient’s own bone marrow directly into the target artery of the heart. The Company’s patented cell processing technology and proprietary protocol was developed to optimize the quality and quantity of the cells being administered to patients.

Dr. Venkatesh Ponemone, the Study Director and Executive Director of TotipotentRX, a subsidiary of Cesca Therapeutics Inc., commented, “The current standard of care treatment for cardiac regenerative medicine can benefit from improved technology. Cesca’s point-of-care technology overcomes some of the present challenges while also offering a clinical alternative for AMI patients and their physicians. The results from this case encourage our efforts to continue the AMIRST Phase II trial.”

“Cardiovascular morbidity and mortality are a significant economic burden on society, and it is encouraging to see Cesca’s innovative approach with the AMIRST protocol,” added Dr. Vinay Sanghi, MD, Principal Investigator and Associate Director, Interventional Cardiology, Fortis Hospital, Shalimarbagh, India.

*The full report is available online here: http://www.sciencedirect.com/science/article/pii/S2405818116300095

About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics.  These include:

• The SurgWerks™ System (in development) – a proprietary system comprised of the SurgWerks Processing Platform, including devices and analytics, and indication-specific SurgWerks Procedure  Kits  for use in regenerative stem cell therapy at the point-of-care for  vascular and orthopedic diseases.
• The CellWerks™ System (in development) – a proprietary cell processing system with associated analytics for intra-laboratory preparation of adult stem cells from bone marrow or blood.
• The AutoXpress® System (AXP^®) – a proprietary automated device and companion sterile disposable for concentrating hematopoietic stem cells from cord blood.
• The MarrowXpress™ System (MXP™) – a derivative product of the AXP and its accompanying sterile disposable for the isolation and concentration of hematopoietic stem cells from bone marrow.
• The BioArchive® System – an automated cryogenic device used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.
• Manual bag sets for use in the processing and cryogenic storage of cord blood.

Forward-Looking Statements and Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
This press release includes statements of future expectations and other forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.  These statements are based on management’s current views and assumptions, speak only as of the date hereof and are subject to change.  Forward-looking statements can often be identified by words such as “may,” “could,” “potential,” “continue,” and similar expressions and include, but are not limited to, statements regarding research and product commercialization.  These forward-looking statements are not guarantees of future results and are subject to known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially and adversely from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by these forward-looking statements is set forth under the caption “Risk Factors” in our Annual Report on Form 10-K, in our Quarterly Reports on Form 10-Q, and in other reports filed with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.  We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.

Company Contact: Cesca Therapeutics Inc. 
ir@cescatherapeutics.com

Investor Contact: The Ruth Group 
Lee Roth / Tram Bui 
646-536-7012 / 7035 
lroth@theruthgroup.com / tbui@theruthgroup.com

(OGES) Bolsters Management Team Ahead of NASDAQ Uplisting

(MGNX) Enters Collaboration and License Agreement with Janssen

• MacroGenics licenses MGD015 to Janssen
• $75 Million upfront license fee paid to MacroGenics
• MacroGenics may elect to fund a portion of late-stage development costs in exchange for a U.S. and Canada profit share
• MacroGenics may elect to co-promote in the United States

Rockville, Maryland, May 18, 2016  —  MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as various autoimmune disorders and infectious diseases, today announced a global collaboration and license agreement for MGD015, a preclinical bispecific molecule, with Janssen Biotech, Inc. This product candidate incorporates MacroGenics’ proprietary Dual-Affinity Re-Targeting, or DART®, platform to simultaneously target CD3 and an undisclosed tumor target for the potential treatment of various hematological malignancies and solid tumors.

Under the terms of the agreement and subject to the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act, MacroGenics will receive a $75 million upfront license fee. Janssen will complete IND-enabling activities and be fully responsible for future clinical development of MGD015. Assuming successful development and commercialization, MacroGenics could receive up to an additional $665 million in clinical, regulatory and commercialization milestone payments.  MacroGenics may elect to fund a portion of late-stage clinical development in exchange for a profit share in the U.S. and Canada. If commercialized, MacroGenics would be eligible to receive double-digit royalties on any global net sales and has the option to co-promote MGD015 with Janssen in the U.S.

“MGD015 is a promising product candidate that employs MacroGenics’ proprietary DART platform to enable a potent redirected T-cell killing mechanism with ‘off-the-shelf’ convenience. This approach is already being evaluated in five other clinical-stage DART programs,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Janssen represents the ideal partner for MGD015, given its track record of successfully developing and commercializing transformative oncology therapies. This collaboration builds on an existing Janssen relationship around MGD011, a DART molecule targeting CD19 and CD3, which is now being evaluated in the clinic.”

About MGD015

MGD015 is designed to redirect T cells, via their CD3 component, to eliminate cells which overexpress an undisclosed antigen in various hematological malignancies and solid tumors. MacroGenics has demonstrated that MGD015 is able to kill these targeted cells both in vitro and in vivo, with high response rates in several mouse tumor xenograft models. In addition, this product candidate and the Company’s other DART molecules that redirect T cells against cancer targets are manufactured using a conventional antibody platform without the complexity of having to genetically modify T cells from individual patients as required by approaches such as chimeric antigen receptor (CAR) T-cells. 

About MacroGenics, Inc.

MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases. The company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics, the MacroGenics logo, and DART are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements 

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company’s product candidates and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

###

Contacts:
Jim Karrels, Senior Vice President, CFO
MacroGenics, Inc.
1-301-251-5172, info@macrogenics.com

Karen Sharma, Senior Vice President
MacDougall Biomedical Communications
1-781-235-3060, ksharma@macbiocom.com

(RPRX) Reports Positive Clinical Data for Oral Proellex®

• Primary endpoint of induction of amenorrhea met for the pooled oral doses compared to placebo, p=0.0004
• Proellex^®-treated subjects reported a median 100% (mean 95%) reduction in diary reports of menstrual bleeding product usage (PBAC)
• Statistically significant reduction in fibroid size from baseline achieved for the combined active arms compared to increase in fibroid volume in placebo arm, p=0.0007

THE WOODLANDS, Texas, May 18, 2016  — Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported that oral administration of Proellex® at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids.

Normal blood loss in a menstrual cycle is approximately 35 mL. Woman experiencing blood loss of >80 mL are considered to suffer from menorrhagia or excessive menstrual bleeding. In this Phase 2b study, 12, 17 and 14 women with confirmed uterine fibroids were enrolled in the 6mg, 12mg and Placebo arms, respectively. One subject dosed at 6mg and one Placebo-treated subject were discontinued as they did not meet entry criteria, and thus were not eligible for efficacy analysis.  At baseline, the mean amount of blood lost for one menstrual cycle was 177 mL, 251 mL and 260 mL for each arm, respectively. The blood loss ranged from a low of 82 mL to a high of 769 mL.  Blood loss was determined by collecting all sanitary products used from an individual and then an alkaline hematin assay was performed to estimate the actual amount of blood collected in the pads.

When a sufficient concentration of Proellex® is achieved in circulation, amenorrhea (cessation of menses) is achieved. At the end of the first course of treatment (18 weeks LOCF), 79% of Proellex®-treated subjects became amenorrheic with no evidence of a dose effect. Two (17%) subjects treated with Placebo had amenorrhea at the end of course 1. The p-value for this comparison is 0.0004. Treatment effect was rapid with 78% of Proellex®-treated subjects became amenorrheic in the first 6 weeks of treatment.   Bleeding diaries consistently report a statistically significant difference in the number of days of bleeding and bleeding intensity between those treated with Proellex® and Placebo.

Bleeding was also evaluated by PBAC (Pictorial Blood Assessment Chart).  Subjects tallied sanitary product usage and stain size as guided by the chart.  Proellex^®-treated subjects reported a median 100% reduction (mean 95% reduction) in PBAC scores while Placebo-treated subjects reported a median 62% reduction, further supporting the treatment effect associated with bleeding (p=0.0001).

Along with changes in menstrual patterns, fibroids measured by MRI were reduced in volume in the Proellex^®-treated arms by 28% while the Placebo group showed continued increase in size, 3%, p= 0.0007.

The drug was generally well tolerated. Women in the drug arms continued to exhibit levels of estradiol consistent with bone preservation.

After the first 18 week treatment period, the women were withdrawn from drug to allow for menses. The women in the study are currently being treated with the second course of treatment for another 18 weeks. The study treatment assignment remains blinded to the subjects, physicians and those managing the study and data. The results of the second course of treatment should be reported within the next 5 months.

The Company believes Proellex^® suggests a significant advantage over GnRH agonists and antagonists in the treatment of uterine fibroids. Once both the vaginal and oral studies complete both 18 week courses of treatment the Company plans to request an end of Phase 2 meeting with the FDA to jointly discuss plans for Phase 3.

About Repros Therapeutics Inc.^®

Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.

Forward-Looking Statements

Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should” or similar expressions. These statements are based on assumptions that the Company has made in light of the Company’s experience in the industry, as well as the Company’s perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to ongoing and future clinical studies and the timing and results thereof, the Company’s plans to communicate with the FDA, possible submission of one or more NDAs and the commercial potential of Proellex®, risks relating to the Company’s ability to protect its intellectual property rights and such other risks as are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:    
Investor Relations:
Thomas Hoffmann
The Trout Group
(646) 378-2931
thoffmann@troutgroup.com

(ANDE) Rejects Unsolicited Proposal from HC2

MAUMEE, Ohio, May 18, 2016  — The Andersons, Inc. (Nasdaq: ANDE) today announced that its Board of Directors has rejected two non-binding, highly conditional, unsolicited proposals from HC2 Holdings, Inc. (NYSE MKT: HCHC) to acquire all outstanding shares of The Andersons.  The Andersons’ announcement is in response to HC2’s public disclosure of its offer on Tuesday.

On January 29, 2016, The Andersons received a private, unsolicited proposal from HC2 to acquire the Company for $35 per share in cash. A subsequent proposal was submitted on March 22, 2016 for $37 per share in cash. The Andersons’ Board of Directors, after careful review in consultation with its independent financial and legal advisors, unanimously determined that both of HC2’s proposals undervalue The Andersons and are not in the best interests of the Company or its shareholders and other stakeholders.

“We believe HC2’s proposals ignore our value and prospects as a standalone entity and represent an opportunistic attempt to acquire the Company at a low point in the industry cycle.  Following a thorough review, and in consultation with our independent financial and legal advisors, our Board determined that the offers are not credible, significantly understate the Company’s true value and are not in the best interests of our shareholders,” said Chairman Mike Anderson. “Our Board and management team remain confident in our ability to execute on our standalone plan and believe we are well positioned to continue to create significant long-term value for shareholders.”

The Company also noted that HC2’s letter dated May 17, 2016 contained numerous inaccuracies and misleading statements. Among others, HC2’s claim that The Andersons did not substantively respond to its $37 per share offer is patently false.

Deutsche Bank is acting as financial advisor and Kirkland & Ellis is acting as legal advisor to The Andersons.

About The Andersons, Inc.

The Andersons, Inc. is a diversified company rooted in agriculture. Founded in Maumee, Ohio, in 1947, the company conducts business across North America in the grain, ethanol, and plant nutrient sectors, railcar leasing, turf and cob products, and consumer retailing. For more information, visit The Andersons online at www.andersonsinc.com.

(MZOR) Signs Strategic Commercial and Investment Agreements With Medtronic

Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a leading developer of innovative bone mounted surgical robotic guidance systems, today entered into two strategic agreements with Medtronic plc (NYSE: MDT). One agreement is a two-stage, multi-faceted, commercial agreement for co-promotion, co-development and, upon meeting certain milestones, potential global distribution of certain Mazor products. The second agreement is for an equity investment by Medtronic in Mazor.

Commercial Agreement

The commercial agreement has an initial U.S.-based co-promotion phase. If both organizations achieve their respective milestones by the end of 2017, then the companies will enter the second phase of the agreement, in which Medtronic will assume exclusive global sales and distribution rights for Mazor’s future spine products. The second phase includes annual quotas with a cumulative potential of hundreds of next-generation systems over a four-year period. The commercial agreement is for Mazor’s future systems and applications, and Medtronic has placed a commitment to purchase 15 of these future systems during 2016. The agreement also stipulates Mazor will be Medtronic’s sole strategic partner for development and commercialization of robotic-based spine systems and applications. The two companies have already begun co-development activities of synergistic products and applications for spine, and will begin working closely together to meet designated sales targets through a defined methodology for cooperation.

“The structure of the commercial agreement features some very important points for our customers as well as our shareholders,” said Ori Hadomi, Mazor Robotics’ Chief Executive Officer. “New developments, such as synergistic implants, could generate new revenue streams for Mazor, beyond the anticipated growth in our current revenue streams from capital equipment, service agreements and disposables. The synergy between the organizations’ teams will potentially yield operational efficiency benefits for Mazor,” Mr. Hadomi added.

Equity Investment

The investment agreement provides for a three-step equity investment in Mazor. In the first tranche, Medtronic will purchase from Mazor newly issued securities representing four percent of Mazor’s issued and outstanding share capital on a fully diluted basis, at a price per share equal to the trailing 20-day volume weighted average price of the shares, or a total of $11.9 million. In the second tranche, Medtronic will purchase newly issued securities representing six percent of Mazor’s issued and outstanding securities, subject to the achievement by Mazor of certain operational milestones, bringing Medtronic to a total holding of ten percent of Mazor’s issued and outstanding securities on a fully diluted basis. The share price will be determined by the average price per share during the 20 trading days following the occurrence of such milestones.

In a potential third tranche, Mazor will have the right to consummate the issuance to Medtronic of securities representing up to five percent of Mazor’s outstanding ordinary shares on a fully diluted basis. Consummation of this tranche is subject to consummation of the second tranche as well as the commencement of the Global Distribution Agreement, and, provided certain other conditions are met, will be solely at Mazor’s discretion, at a per-share price equal to the trailing 20-day volume weighted average price prior to Mazor’s exercise of the option. Medtronic, at its sole discretion, may cap each of the second and third tranches at $20 million each.

Mazor remains an independent company, which will continue to innovate in spine as well as in other markets, and will continue to sell and fully support the RenaissanceSystem through its own sales team and distribution partners. Throughout the agreement, current and jointly developed Mazor systems will continue to maintain universal implant compatibility, allowing complete hospital and surgeon freedom in surgical tool, implant and procedure selection.

Conference Call Dial-In Information

The Company will host a conference call to discuss today’s announcement today at 10:00am ET (5:00 PM IST). Investors within the United States interested in participating are invited to call 877-269-7756. Participants in Israel can use the toll free dial-in number 809-406-247. All other international participants can use the dial-in number 201-689-7817. A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 877-660-6853 and reference the Replay Access Code: 13637743. All international callers can dial 201-612-7415, using the same Replay Access Code. To access the webcast, please use the following address http://public.viavid.com/index.php?id=119691 or visit www.mazorrobotics.com and select ‘Investor Relations.’

About Mazor Robotics

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic-based technology and products aimed at redefining the gold standard of quality care. Mazor Robotics Renaissance^® Guidance System enables surgeons to conduct spine and brain procedures in a more accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the agreements with Medtronic, the impact such agreements shall have on Mazor’s revenues, growth and timeline for profitability, the development of new products, the use of the equity investment proceeds, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 2, 2016 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

U.S. Contacts: EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
Doug Sherk, 646-445-4800
dsherk@evcgroup.com
or
Media
David Schemelia, 646-201-5431
dave@evcgroup.com

(MKGI) MissionIR Exclusive Audio Interview With Monaker Group, Inc. Chief Executive Officer

(CRDC) Positive Results of Long-Term Evaluation of Company’s C-Port® System

Study Demonstrates a Statistically Significant Reduction in Long-Term Graft Occlusion Rates

BALTIMORE, May 17, 2016  — Positive results of a clinical study of the C-Port^® Distal Anastomosis System from Cardica, Inc. (Nasdaq:CRDC) were presented today at the Annual Meeting of the American Association for Thoracic Surgery (AATS) by Husam Balkhy, M.D., associate professor of Surgery and director of Robotic and Minimally Invasive Cardiac Surgery at The University of Chicago’s Medicine & Biological Sciences Division.

The MAGIC (Multicenter Assessment of Grafts in Coronaries) Study, a long-term post-market evaluation of the C-Port device, examined acute-to-mid-term and long-term vein graft occlusion rates for coronary revascularization using the C-Port compared to hand-sewn anastomoses. Patients receiving at least one C-Port anastomosis during coronary artery bypass grafting (CABG) surgery were enrolled at eight sites in the United States.

Results of the study indicated that the C-Port device is safe and effective when used to create the distal anastomosis in CABG surgery, with equivalent patency rates to hand-sewn grafts at 12 months. “When compared to hand-sewn anastomoses in a comparable population in a recent large prospective trial, the C-Port device demonstrated a statistically significant reduction in long-term graft occlusion rates,” Dr. Balkhy said.

Dr. Balkhy has performed an extraordinary number of robotic beating-heart, totally endoscopic coronary artery bypass, sometimes known at TECAB, procedures completed with Cardica’s C-Port Flex-A^® – almost 500 since 2008. During these procedures, Dr. Balkhy has completed over 800 endoscopic anastomoses on the beating heart with the C-Port Flex-A device.  “About 65 percent of my cases have been multi-vessel procedures, and this would not be possible on the beating heart if it were not for the Flex-A device,” he said. “C-Port is a breakthrough approach to performing coronary bypass surgery.”

Of the 117 patients enrolled in the MAGIC study (intent to treat population: ITT), 78 patients with 104 C-Port vein grafts completed the study to patency assessment via CT scanning (per protocol population: PP). Clinical follow-up and index graft patency were performed at least 12 months following surgery. The primary efficacy endpoint was graft patency compared to a performance goal established using the peer-reviewed results from the PREVENT IV trial, which studied the efficacy and safety of the E2F transcription factor decoy edifoligide. The primary safety endpoint was MACE (death, myocardial infarction or target vessel revascularization) rate at mid-term and long-term (12 months).

The ITT group had an overall mortality at 12 months of 0.8% (1/117) and a MACE rate of 4.3% (5/117). Only two of these MACE events occurred in patients who were included in the PP population, and both patients had patent grafts. The C-Port vein graft occlusion rate was 16.3% (PP population), compared to 26.6% in the PREVENT IV trial. The C-Port arterial graft occlusion rate was equivalent to the PREVENT IV trial. There were no significant differences in the occlusion rate between the C-Port vein grafts, 16.3%, and the hand-sewn vein grafts, 14.9%, within the MAGIC study.

“The results of The Magic Study confirm the innovative success of C-Port, even in very small coronary arteries,” said Julian Nikolchev, president and CEO of Cardica. “We applaud Dr. Balkhy’s dedication to innovation for the benefit of his patients and are thrilled that C-Port has played an important role in hundreds of his totally endoscopic coronary artery bypass procedures.”

About the C-Port^® Distal Anastomosis Systems (C-Port systems)
The C-Port systems – the C-Port xA system and the Flex-A^® system – can be used on- or off-pump and create compliant anastomoses that expand and contract with blood flow. With miniature stainless steel staples to secure the bypass graft to the coronary artery, C-Port reduces time required for anastomosis, which can be completed in two minutes. The C-Port systems work on coronary arteries as small as 1.25 millimeters in internal diameter and work with grafts of various diameters and wall thicknesses less than 1.4 millimeters. The Flex-A system allows surgeons to position the device to create a secure connection even in the most difficult to reach areas of the heart.

About Cardica
Cardica designs and manufactures proprietary stapling and automated anastomotic devices for cardiac and laparoscopic surgical procedures. Cardica’s technology portfolio is intended to minimize operating time and enable minimally-invasive and robot-assisted surgeries. Cardica manufactures and markets its automated anastomosis systems, the C-Port^® Distal Anastomosis Systems and PAS-Port^® Proximal Anastomosis System for coronary artery bypass graft (CABG) surgery, and has shipped over 56,500 units throughout the world. In addition, Cardica’s MicroCutter XCHANGE^® 30, the world’s smallest-profile articulating stapler, is manufactured and cleared for use in the U.S. for transection and resection in multiple open or minimally invasive urologic, thoracic and pediatric surgical procedures, as well as application for transection, resection and/or creation of anastomoses in the small and large intestine and the transection of the appendix.

Forward-Looking Statements
The statements in this press release regarding Cardica’s beliefs as to the confirmation of the innovative success of C-Port Flex-A in very small coronary arteries are “forward-looking statements.” There are a number of important factors that could cause such results to differ materially from those indicated by these forward-looking statements, including: that the C-Port Flex-A may be unsuccessful if used in very small coronary arteries as well as the risks detailed from time to time in Cardica’s reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended December 31, 2015, under the caption “Risk Factors,” filed on February 10, 2016. Cardica expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. You are encouraged to read Cardica’s reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.

Contact:

Investors:
Bob Newell
Vice President, Finance and Chief Financial Officer
(650) 331-7133
investors@cardica.com

Media:
Jessica Volchok
(310) 849-7985
jessica@nicoleosmer.com

(GNCA) to Present at the 2016 UBS Global Healthcare Conference

CAMBRIDGE, Mass., May 17, 2016  — Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced that management will present a company overview at the upcoming 2016 UBS Global Healthcare Conference on Tuesday, May 24, 2016 at 9:00 a.m. ET in New York, NY.

A live webcast of the presentation can be accessed by visiting the “Events and Presentations” tab of the investor relations section of the Genocea website at http://ir.genocea.com. A replay of the webcast will be archived for 30 days following the presentation.

About Genocea Biosciences, Inc.
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immunity. Using ATLAS, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus (development suspended), and earlier-stage programs in chlamydia, genital herpes, malaria, Epstein-Barr virus infections and related cancers, and cancer immunotherapy. For more information, please visit the company’s website at www.genocea.com.

For media: 	
Liz Bryan 	
Spectrum Science Communications, Inc.	
O: 202-955-6222	
lbryan@spectrumscience.com 	

For investors: 
Jonathan Poole
Genocea Biosciences, Inc.
O: 617-876-8191 
jonathan.poole@genocea.com

(RESN) Signs Second Licensing Agreement

Resonant Inc. (NASDAQ: RESN), a designer of filters for radio frequency, or RF, front-ends that specializes in delivering designs for difficult bands and complex requirements, today announced it signed another licensing agreement with an existing customer. This license agreement relates to the development engagement that was outlined in the memorandum of understanding signed with this customer in March 2016.

The license agreement encompasses three Surface Acoustic Wave (SAW) duplexer designs for high volume Bands. Design acceptance milestone payments and royalty terms have been agreed upon, but will not be disclosed due to the confidential nature of such agreements.

“We believe we are gaining momentum with another licensing agreement that demonstrates our customer’s intentions to commercialize the filters we are designing for them,” said Terry Lingren, CEO and Co-Founder of Resonant Inc. “This customer has excellent process capability, is an up-and-coming competitor in this market with a customer base that is complementary to that of our other customer. We believe our designs will help make our customer even more competitive and accelerate their growth. We, in turn, are optimistic about receiving additional opportunities to undertake future development projects with this customer,” concluded Lingren.

About Resonant® Inc.

Resonant is creating innovative filter designs for the RF front-end, or RFFE, for the mobile device industry. The RFFE is the circuitry in a mobile device responsible for the radio frequency signal processing and is located between the device’s antenna and its digital baseband. Filters are a critical component of the RFFE that selects the desired radio frequency signals and rejects unwanted signals and noise.

About Resonant’s ISN® Technology

Resonant can create designs for hard bands and complex requirements that we believe have the potential to be manufactured for half the cost and developed in half the time of traditional approaches. Resonant’s large suite of proprietary mathematical methods, software design tools and network synthesis techniques enable it to explore a much bigger set of possible solutions and quickly derive the better ones. These improved filters still use existing manufacturing methods (i.e. SAW) and can perform as well as those using higher cost methods (i.e. BAW). While most of the industry designs surface acoustic wave filters using a coupling-of-modes model, Resonant uses circuit models and physical models. Circuit models are computationally much faster, and physical models are highly accurate models based entirely on fundamental material properties and dimensions. Resonant’s design methods deliver excellent predictability, enabling achievement of the desired product performance in roughly half as many turns through the fab. In addition, because Resonant’s models are fundamental, integration with its foundry and fab customers is eased because its models speak the “fab language” of basic material properties and dimensions.

Safe Harbor for Forward-Looking Statements

This press release contains forward-looking statements, which include the following subjects, among others: the belief that our designs will make our customer more competitive, and that we may be selected for future development projects with our customer. Forward-looking statements are made as of the date of this document and are inherently subject to risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, including, without limitation, the following: our limited operating history; our ability to complete designs that meet customer specifications; the ability of our customers (or their manufacturers) to fabricate our designs in commercial quantities; the ability of our designs to significantly lower costs compared to other designs and solutions; the risk that the intense competition and rapid technological change in our industry renders our designs less useful or obsolete; our ability to find, recruit and retain the highly skilled personnel required for our design process in sufficient numbers to support our growth; our ability to manage growth; and general market, economic and business conditions. Additional factors that could cause actual results to differ materially from those anticipated by our forward-looking statements are under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our most recent Annual Report (Form 10-K) or Quarterly Report (Form 10-Q) filed with the Securities and Exchange Commission. Forward-looking statements are made as of the date of this release, and we expressly disclaim any obligation or undertaking to update forward-looking statements.

Resonant Inc.
Ina McGuinness, 805-308-9803
IR@resonant.com
or
MZ North America
Matt Hayden, 1-949-259-4986
Matt.hayden@MZGroup.us

(CHRS) Provides Update on ‘135 IPR

Patent Trial and Appeal Board Institutes

REDWOOD CITY, Calif., May 17, 2016  — Coherus BioSciences, Inc. (Nasdaq:CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced that it has received a favorable decision from the Patent Trial and Appeal Board (“PTAB”) of the US Patent and Trademark office instituting Coherus’ petition for Inter Partes Review (“IPR”) of AbbVie’s U.S. Patent 8,889,135 (“the ‘135 Patent”) directed to a dosing regimen in which 40 mg of Humira is administered subcutaneously every 13 to 15 days to treat rheumatoid arthritis.

“We welcome this PTAB decision, and are confident that this will lead to a final decision nullifying the ‘135 Patent, ” said Denny Lanfear, President and Chief Executive Officer of Coherus. “We view this successful IPR institution, along with the US Patent Office’s recent decisions to award patents to Coherus for various embodiments of its adalimumab formulation technology, as clear validation of Coherus’ leadership in biosimilar intellectual property and the effectiveness of our platform. We will continue to aggressively press forward with the development and commercialization of our Humira biosimilar consistent with our corporate strategy.”

About Coherus BioSciences, Inc.

Coherus is a leading pure-play global biosimilar platform company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products, including CHS-5217 (bevacizumab biosimilar) and CHS-3351 (ranibizumab biosimilar). For additional information, please visit www.coherus.com.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Coherus’ plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies, product pipeline, clinical studies, product development, release of data and the potential benefits of its products under development are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including Coherus’ expectations regarding its ability to advance its intellectual strategy for CHS-1420 including a final decision nullifying the ‘135 Patent, to complete CHS-1420 development and to initiate CHS-1420 commercialization. Such forward-looking statements 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 clinical drug development process, including the regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or commercial potential of our biosimilar drug candidates, as well as possible patent litigation. Coherus 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 Coherus’ business in general, see Coherus’ Annual Report on Form 10-Q for the quarter ended March 31, 2016, filed with the Securities and Exchange Commission on May 9, 2016 and its future periodic reports to be filed with the Securities and Exchange Commission.

Enbrel® and Neulasta® are registered trademarks of Amgen Inc.
HUMIRA® is a registered trademark of AbbVie Inc.
Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

CONTACT:

Patrick O’Brien
Coherus BioSciences, Inc.
pobrien@coherus.com
+1 (650) 649-3527

Keith Vendola, M.D.
Coherus BioSciences, Inc.
kvendola@coherus.com
+1 (650) 437-6239

(CYTX) European Scleroderma Trial Investigating Cytori Cell Therapy to Be Presented in Japan

Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that on May 18, 2016, an update regarding the French SCLERADEC I and II clinical trials investigating the use of Cytori Cell Therapy in the treatment of scleroderma-related hand dysfunction will be delivered at the 104^th Annual Meeting of the Japan Society of Aesthetic Surgery in Tokyo, Japan.

Professor Guy Magalon, the SCLERADEC-I principal investigator, is scheduled to present, “New Strategy and Possibility for Using ADRCs for Treating Scleroderma,” in the International Invited Lecture session on May 18^th at the ANA Intercontinental Tokyo in Room A from 10:45 to 11:45 am.

Scleroderma has been designated as an intractable disease in Japan, estimated to affect 27,800 people.^† A study from Japan in 1991 shows that a high number of these patients have hand symptoms. Specifically, 98% exhibit Sclerodactyly (thickening and tightness of the skin in fingers, often leading to ulceration of the fingers) and 95% exhibit Raynaud’s Phenomenon.^‡ Pre-clinical and clinical studies suggest that adipose-derived regenerative cells, or ADRCs, may promote angiogenesis, modulate inflammation and reduce/remodel fibrosis. In addition, Dr. Magalon reported that the open-label SCLERADEC I trial showed a sustained benefit over a two-year period using ADRC therapy prepared by Cytori’s Celution® System. Dr. Magalon will detail those findings in Japan at this presentation.

“Hand involvement is common in scleroderma and few effective medical options exist,” said John Harris, Vice President and General Manager, Cell Therapy. “We are very grateful that Dr. Magalon is here in Japan highlighting the results of this seminal work. The timing coincides nicely with our development and partnering plans here in Japan that have the goal of bringing Cytori’s novel ECCS-50 therapy for hand scleroderma to the market.”

Cytori’s U.S. FDA approved Phase III STAR trial is currently enrolling and thus far, is 75% of the way toward complete enrollment. The trial is scheduled to complete enrollment by mid-June, which is ahead of original schedule. The STAR trial follows the French SCLERADEC-I pilot trial, led by Drs. Magalon and Granel, which was performed at the Assistance Publique Hôpitaux de Marseille. One year post-treatment results were published in the August 2015 edition of the journal Rheumatology. Data recently presented at the Systemic Sclerosis World Congress indicated that a single administration of ECCS-50 therapy could be performed safely and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud’s Phenomena through 2 years following treatment.

^† Japan Ministry of Health, Labor and Welfare

^‡ Tamaki T, Mori S, Takehara K. “Epidemiologic study of patients with systemic sclerosis in Tokyo.” Arch Dermatol Res 1991;283(6):366 –71.

About Cytori

Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information visit www.cytori.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including statements regarding clinical trial enrollment and clinical trial results, and partnering and product introduction plans are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. These risks and uncertainties are described under the heading “Risk Factors” in Cytori’s Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

(ISCO) Announces Operating Results for the Three-Months Ended March 31, 2016

(SGYP) to Present New Plecanatide Data at Digestive Disease Week 2016

Synergy Pharmaceuticals Inc. (NASDAQ: SGYP) today announced that the company will present data on plecanatide, the first uroguanylin analog being evaluated for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), at Digestive Disease Week 2016 in San Diego, May 21-24.

These presentations (five posters and one oral presentation) will include additional results from the two plecanatide phase 3 CIC clinical trials.

The following will be presented at the San Diego Convention Center:

Poster Presentations

All posters will be presented in Hall C from 9:30am to 4:00pm (PT) with author presentation at the poster from 12:00pm to 2:00pm (PT).

Saturday, May 21

A Phase III Study of the Efficacy and Safety of Plecanatide in the Treatment of Chronic Idiopathic Constipation (CIC) (Study-00)

Presenter: Philip B. Miner, Jr., MD, President and Medical Director, Oklahoma Foundation for Digestive Research

Effect of Plecanatide on Patient Assessments in Chronic Idiopathic Constipation (CIC): Results from Two Phase III Studies

Presenter: Maria Nualart, MD, School of Clinical Research USA, LLC

Effect of Plecanatide on Stool Consistency in the Treatment of Chronic Idiopathic Constipation (CIC): Results from Two Phase III Studies

Presenter: Richard Krause, MD, Clinsearch LLC

Sunday, May 22

Efficacy and Safety of Plecanatide in the Treatment of Chronic Idiopathic Constipation (CIC): Results from a Multicenter Phase III Study (Study-03)

Presenter: Philip B. Miner, Jr., MD, President and Medical Director, Oklahoma Foundation for Digestive Research

Monday, May 23

Structural and Dynamic Features Capturing Plecanatide Activity Across Multiple pH Values

Presenter: Andrea Brancale, PhD, Senior Lecturer, Cardiff School of Pharmacy and Pharmaceutical Sciences

Oral Presentation

Tuesday, May 24

The oral presentation will be held in Room 31BC from 10:36am to 10:48am (PT).

Plecanatide, like uroguanylin, activates guanylate cyclase-C signaling in a pH-dependent manner in T84 cells, murine intestinal epithelial cells and tissues

Presenter: Kunwar Shailubhai, PhD, MBA, Chief Scientific Officer, Synergy Pharmaceuticals

About Chronic Idiopathic Constipation (CIC)

CIC affects 14 percent of the population in North America, disproportionately impacting women and older adults. People with CIC have persistent symptoms of difficult and infrequent bowel movements. CIC can severely impact people’s daily lives, increasing stress levels and anxiety.

About Plecanatide

Plecanatide is currently being evaluated for use as a once-daily tablet for two functional gastrointestinal (GI) disorders, CIC and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a peptide made up of 16 amino acids. It is structurally similar to uroguanylin with the exception of a single amino acid change. Plecanatide is the first investigational drug designed to replicate the function of uroguanylin, a naturally occurring human GI peptide, by working locally in the upper GI tract to stimulate digestive fluid movement and support regular bowel function. In 2015, Synergy announced positive phase 3 data with plecanatide in two pivotal CIC clinical trials and on January 29, 2016, the company filed its first new drug application (NDA) for plecanatide in CIC. If approved, Synergy plans to launch plecanatide with the CIC indication in the first quarter of 2017. Synergy presently has two ongoing phase 3 clinical trials with plecanatide in IBS-C and intends to file a second NDA in IBS-C by the end of this year.

About Synergy Pharmaceuticals

Synergy is a biopharmaceutical company focused on the development and commercialization of novel GI therapies. The company has pioneered discovery, research and development efforts around uroguanylin analogs for the treatment of functional GI disorders and inflammatory bowel disease. Synergy’s proprietary GI platform is based on uroguanylin and includes two lead product candidates – plecanatide and dolcanatide. For more information, please visit www.synergypharma.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward- looking words such as “anticipate,” “planned,” “believe,” “forecast,” “estimated,” “expected,” and “intend,” among others. These forward-looking statements are based on Synergy’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Synergy’s Form 10-K for the year ended December 31, 2015 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Synergy Pharmaceuticals Inc.
Gem Hopkins, 212-584-7610
Vice President, Investor Relations and Corporate Communications
ghopkins@synergypharma.com

(FOMX) Names Dr. Stanley Hirsch as Chairman, Dr. Dalia Megiddo as Board Member

REHOVOT, Israel and BRIDGEWATER, N.J., May 16, 2016  — Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced the appointment of Stanley Hirsch, D. Phil., as Chairman, and Dalia Megiddo M.D. as a member of its Board of Directors.

Dr. Stanley Hirsch has 27 years of experience in executive positions in the healthcare and biotech industries. Dr. Hirsch received his D. Phil. from Oxford University in cell biology and immunology. He has extensive executive and board level experience in private and publicly listed companies on US and UK exchanges, as well as experience in raising capital and leading mergers and acquisitions. He has set up and managed companies and subsidiaries in Israel, Brazil, UK, China and the USA.

Dr. Hirsch replaces Mr. Meir Eini, a co-founder of Foamix Pharmaceuticals, who is retiring from the Board but will continue as the Company’s Chief Innovation Officer and member of the Company’s Executive Management Committee, as well as maintaining responsibility for Investor Relations in Israel.

Dr. Hirsch has served as a member of Foamix’s Board since February 2005, where he had executive responsibility for European Business Development until December 2006. In this role, he was instrumental, inter alia, in executing the Company’s collaboration with Bayer Healthcare AG, which resulted in the development and commercialization of Finacea^® Foam.

Currently, he is the CEO and a director of FuturaGene Ltd., an agricultural biotechnology company which has been the first and only company in the world to receive regulatory approval for the commercial deployment of yield enhanced, gene modified trees for the plantation forestry industry. Dr. Hirsch was CEO of FuturaGene during its four-year tenure on the AIM market of the London Stock Exchange, and managed its acquisition by Suzano Pulp and Paper of Brazil in an all-cash transaction.

Dr. Hirsch has also served as general manager of a drug development company, a pharmaceutical marketing company and two diagnostics development companies, and was responsible for business development for a privately held group of healthcare companies. Dr. Hirsch currently serves as a director of Biological Industries Ltd., a developer and manufacturer of bioprocess products. He formerly served as a director of SolGel and at additional private healthcare companies, as well as an advisor to venture capital funds.

Dr. Dalia Megiddo is an experienced healthcare and investment professional in the pharmaceutical and healthcare sectors. She has co-founded a number of pharma companies, including Alcobra Ltd., Bioblast-Pharma Ltd. and Chiasma Ltd. She currently serves as Managing Partner of Expedio Ventures, and previously ran other life science investment funds, including Jerusalem Global Ventures and 7-Health.

Dr. Megiddo serves as a director of Bioblast-Pharma Ltd. She formerly served as a director of Alcobra Ltd., AngioScore Inc., Chiasma (Israel) Ltd., Chiasma Inc., Given Imaging Ltd. and Elron Electronic Industries Ltd.

Dr. Megiddo holds an M.D. in Medicine from Hebrew University, Jerusalem, and is a licensed specialist in family medicine. She also holds an M.B.A. degree from the Kellogg Recanati International School of Business (Tel Aviv University and North Western University).

About Foamix Pharmaceuticals

Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy.

The Company’s clinical stage product candidates include FMX101, a novel minocycline foam for the treatment of moderate-to-severe acne, now in Phase 3 clinical studies, FMX102 for the treatment of impetigo, FMX103 for the treatment of rosacea, and FDX104, a doxycycline foam for the management of acne-like rash induced by EGFRI anticancer drugs.

In addition, Foamix has development and license agreements relating to its technology with various pharmaceutical companies including Bayer HealthCare, Merz, Allergan and Prestium.

For more information, please visit www.foamixpharma.com.

Forward Looking Statements

This press release may include forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.  Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions, expectations, forecasts, beliefs or intentions related to financial results, commercial results, timing and results of clinical trials and U.S. FDA and other regulatory agencies authorizations.  Forward-looking statements are based on our current knowledge and our present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions.  Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, unexpected delays, excess costs or unfavorable results of clinical trials, delays or denial in the U.S. FDA approval process, additional competition in the acne market, denial of reimbursement by third party payors or inability to raise additional capital.  We discuss many of these risks in greater detail under the heading “Risk Factors” in our most recent Annual Report on Form 20-F (File No. 161477078) filed on March 7, 2016, and elsewhere in that Annual Report. Any forward-looking statements that may be made herein speak only as of the date of this release and Foamix undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Contact:			
Dorit Hayon			
Foamix Pharmaceuticals Ltd
+972-8-9316233		
IR@foamixpharma.com	

U.S. Investor Relations
Michael Rice
LifeSci Advisors, LLC
646-597-6979
mrice@lifesciadvisors.com

(GALT) Positive Interim Results from Phase 2a Trial with GR-MD-02

A significant clearing of psoriasis in first four patients prompts the extension of treatment for an additional 12 weeks

Conference call to be held tomorrow at 9:00 a.m. Eastern time

NORCROSS, Ga., May 16, 2016  — Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, announces positive interim results from an exploratory, open-label, Phase 2a clinical trial with GR-MD-02 in patients with moderate-to-severe plaque psoriasis. All four patients who received 12 weeks of therapy (six doses of GR-MD-02) had significant improvement in their plaque psoriasis. Given the improvement noted, Galectin has extended the treatment duration to 24 weeks.

This Phase 2a open-label trial is being conducted in 10 patients with moderate-to-severe plaque psoriasis who have ≥ 10% of their skin surface area affected and a PASI (Psoriasis Area and Severity Index) of ≥ 12 points. The enrolled patients are being treated with 8 mg/kg of GR-MD-02 every other week for a total of seven infusions, with the seventh infusion being administered on the same day the 12-week PASI is scored. The primary efficacy assessment in this study is improvement in PASI, as described in detail in a recent CEO Perspective.

“Each of the four patients who received six doses of GR-MD-02 over 12 weeks of therapy reported improvement in their symptoms related to psoriasis,” said Simon A. Richie, M.D., Staff Dermatologist, Chief of Phototherapy and Tele-Dermatology at San Antonio Military Health System and Principal Investigator of the trial. “Moreover, all four patients had significant improvement in PASI measurements. It is uncommon for patients with moderate-to-severe plaque psoriasis to spontaneously improve without treatment. The drug infusions were well tolerated by patients, and the two adverse events that were noted, one infiltration of the intravenous catheter and one headache during infusion, were mild and transient.”

Interim results are shown in the table below.

“These interim results on four patients in this exploratory clinical trial demonstrate a potentially important clinical effect of GR-MD-02 in clearing moderate-to-severe plaque psoriasis,” said Peter G. Traber, M.D., Galectin’s president, chief executive officer and chief medical officer. “While these patients were not evaluated for fatty liver disease, these findings may have implications for activity in our main therapeutic program targeting NASH, a disease where there is a high incidence of psoriasis and increased galectin-3 in the skin. We are excited to extend this trial to better determine the full potential of GR-MD-02 as a treatment for moderate-to-severe psoriasis.”

The link, if any, between non-alcoholic steatohepatitis (NASH) and psoriasis is not completely understood.  However, patients with psoriasis have more than a two-fold higher incidence of NASH, the severity of which tends to correlate with the severity of liver fibrosis and galectin-3 is increased in psoriatic skin. The genesis of this Phase 2a psoriasis treatment study was a 17 month remission in a NASH patient with severe psoriasis who participated in the Company’s Phase 1 study cohort of 4 mg/kg of GR-MD-02 for the treatment of NASH (see CEO Perspective).

“This Phase 2a clinical trial will be extended so that all patients, including the four who have already completed treatment, will receive a total of 13 drug infusions,” added Dr. Richie. “The one patient among the initial four with the least objective response in PASI was on a systemic retinoid therapy (acitretin) which was stopped one month before entering this study. Stopping this drug can lead to a long-term rebound effect, which may have contributed to the lower treatment response. Doubling the duration of therapy, and continued enrollment to the full 10 patients, will help us to evaluate the full therapeutic potential of GR-MD-02 in psoriasis.”

The announced results are interim in that the originally scheduled 12 weeks of data has been obtained from only four of the ten patients who will participate in the trial.  It is further interim in that the positive information obtained to this point has led to the trial being extended for all 10 study subjects in the trial.

Conference Call and Webcast

Galectin Therapeutics management will host a conference call at 9:00 a.m. Eastern time on May 17, 2016 to discuss this press release.

To access the conference call, U.S.-based listeners should dial 866-634-2258 and international listeners should dial 330-863-3454. All listeners should provide the following passcode: 10667177.  Individuals interested in listening to the live conference call via the Internet may do so by logging on to the Company’s website at www.galectintherapeutics.com.

Following the conclusion of the conference call, a replay will be available through May 23, 2016 and can be accessed by dialing (855) 859-2056 from within the U.S. or (404) 537-3406 from outside the U.S.  All listeners should provide passcode 10667177. The webcast will be available on the Company’s website at www.galectintherapeutics.com for 90 days.

About Psoriasis
Psoriasis, which manifests most often as plaque psoriasis, is a chronic, relapsing, inflammatory skin disorder. Although plaque psoriasis is rarely life threatening, it often is intractable to treatment. According to the International Federation of Psoriasis Associations, about 3% of the world’s population has some form of psoriasis. In the U.S. there are about 150,000 new cases every year, and psoriasis affects about 2% of the U. S. population, according to the Cleveland Clinic.

About GR-MD-02
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.

About Galectin Therapeutics
Galectin Therapeutics is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company’s unique understanding of galectin proteins, which are key mediators of biologic function. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. The Company is pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for GR-MD-02 will lead to the first therapy for the treatment of fatty liver disease with cirrhosis and/or an additional therapy for the treatment of moderate to severe psoriasis and that positive results in treating psoriasis may have implications for the treatment of NASH.  Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that interim results in only four patients may not be indicative of the results when all 10 patients are treated in the Phase 2a trial, and even if the Phase 2a open label trial when completed reports positive results, those results may not be repeated in larger blinded trials that are required for licensing.  Further, Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of GR-MD-02 or any of its other drugs in development. The Company’s current clinical trial, when completed, and any future clinical studies may not produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies.  Plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies. Regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials.  Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.

Contacts:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com

LHA
Kim Golodetz
(212) 838-3777
kgolodetz@lhai.com

(ORMP) to Present at Oppenheimer Annual Israeli Conference

JERUSALEM, May 16, 2016  —

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the Company will participate in the upcoming Oppenheimer Annual Israeli Conference, taking place on May 22, 2016 in Tel Aviv. Nadav Kidron, CEO of Oramed, will present a corporate overview at the conference.

Presentation Details:

Oppenheimer 17th Annual Israeli Conference

Date:            May 22, 2016
Presenter:       Nadav Kidron, Chief Executive Officer
Time:            1:45 pm Israel Time
Location:        David Intercontinental Hotel, Tel Aviv, Israel

About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (POD^TM) technology is based on over 30 years of research by top scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).

For more information, the content of which is not part of this press release, please visit http://www.oramed.com

Forward-looking statements:  This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements when we discuss our clinical trials and revolutionizing the treatment of diabetes with our products. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’s reports filed from time to time with the Securities and Exchange Commission.
Company Contact
Oramed Pharmaceuticals
Estee Yaari
Office: +972-2-566-0001 ext. 2
US: +1-718-831-2512 ext. 2
Email: estee@oramed.com