(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

(EDIT) greement with Cystic Fibrosis Foundation Therapeutics

Editas to Receive up to $5 Million Award to Fund Genome Editing Research

CAMBRIDGE, Mass., May 16, 2016  — Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, today announced a three-year agreement with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation, in which CFFT will pay up to $5 million to Editas Medicine to support the discovery and development of CRISPR/Cas9-based medicines for the treatment of cystic fibrosis (CF). In addition, Editas will access CFFT’s extensive network of CF scientific advisors and clinical researchers.

“We are delighted to work with Cystic Fibrosis Foundation Therapeutics to discover and develop medicines for people with cystic fibrosis,” said Katrine Bosley, President and Chief Executive Officer, Editas Medicine. “While significant medical and scientific progress has been made in recent years, a great deal of work remains. I’m hopeful that our genome editing approach will one day create important new therapies that can address the genetic mutations that cause this disease.”

“We believe that the CRISPR approach to gene editing holds significant promise for repairing the underlying cause of cystic fibrosis,” said Preston W. Campbell III, M.D., President and Chief Executive Officer, CF Foundation. “We’re pleased to work with Editas Medicine and are excited by the possibilities of what can be accomplished on behalf of people with CF.”

The gene that causes CF encodes the cystic fibrosis transmembrane conductance regulator protein (CFTR), which helps maintain the water balance within the lung and in other tissues.  Mutations in this gene lead to problems with the flow of fluids and salt into and out of cells.  This causes a thick buildup of mucus in the lungs, pancreas and other organs. The mucus clogs the airways and traps bacteria, leading to chronic infections and inflammation of the airways. There are more than 1,800 known mutations within the CFTR gene. As part of this agreement, Editas Medicine will explore targeting both common mutations as well as mutations not addressed by conventional approaches.

About Editas Medicine
Editas Medicine is a leading genome editing company dedicated to treating patients with genetically defined diseases by correcting their disease-causing genes. The Company was founded by world leaders in genome editing, and its mission is to translate the promise of genome editing science into a broad class of transformative genomic medicines to benefit the greatest number of patients.

Forward-Looking Statements
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.  The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements.  Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including:  uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of the Company’s product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements.  These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future.  Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Media Contact 
Dan Budwick

Pure Communications, Inc.

(973) 271-6085 
dan@purecommunicationsinc.com

Investor Contact
Jesse Baumgartner
Stern Investor Relations, Inc.
(212) 362-1200
jesse@sternir.com

(EPIX) Reports Financial Results for the Second Quarter Ended March 31, 2016

HOUSTON and VANCOUVER, May 13, 2016  – ESSA Pharma Inc. (“ESSA” or the “Company”) (TSX: EPI, NASDAQ: EPIX) today reported financial results for the second quarter and three months ended March 31, 2016.  Amounts, unless specified otherwise, are expressed in United States dollars and in accordance with International Financial Reporting Standards (“IFRS”).

Second Quarter Highlights and Corporate Update

Financings

The Company completed two private placements during the period in for gross proceeds of approximately $15 million (“January 2016 Financing”) and $5 million (“March 2016 Financing”).  The net proceeds of these financings will be used for general corporate purposes and expenses related to the Phase 1/2 clinical trials.

Information regarding the structure of the financings are provided in the news releases dated January 14, 2016 and March 21, 2016.

Enhanced Management Team and Corporate Appointments

Dr. David R. Parkinson was appointed as the company’s President and Chief Executive Officer on January 7^th, 2016, bringing significant drug development and business experience to the Company.

On closing of the January 2016 Financing, Scott Requadt, Managing Director of Clarus Ventures, LLC, was appointed to the board of directors.

At the Annual General and Special Meeting of Shareholders held on March 10, 2016, the shareholders re-elected board members David R. Parkinson, Richard M. Glickman, Marianne Sadar, Raymond Andersen, Gary Sollis, Franklin M. Berger and Scott Requadt.

Phase 1/2 Clinical Trial

The Company continues to enroll patients in the Phase 1 dose escalation portion of the clinical study of EPI-506 as a treatment for metastatic castration-resistant prostate cancer (“mCRPC”).  The study is being conducted at 5 sites in the United States and Canada.

In the Phase 1/2 clinical trial, ESSA intends to demonstrate the safety, tolerability, maximum tolerated-dose, pharmacokinetics, and efficacy of EPI-506 in prostate cancer patients who have failed abiraterone or enzalutamide or both, the current standard-of-care drugs in mCRPC.

Summary Results

ESSA recorded a net loss of $11.0 million ($0.41 per Common Share) for the three months ended March 31, 2016, compared to a net loss of $3.5 million ($0.20 per Common Share) for the three months ended March 31, 2015.

Research and Development (“R&D”) expenditures for the three month period were $2.5 million compared to $2.5 million for 2015.  The R&D expenditures for the three months ended March 31, 2015 included recognition of recoveries of $0.2 million from a grant from the Cancer Prevention and Research Institute of Texas (“CPRIT”).

R&D expenditures in the period are primarily related to manufacturing and clinical costs as the Company transitions into the clinical development stage with respect to clinical candidate EPI-506. In the previous quarter ended December 31, 2015, the Company commenced enrolling patients into its Phase 1/2 clinical trial.  The composition of R&D costs has therefore evolved from preclinical and Investigational New Drug (“IND”) application work in the quarter ended March 31, 2015 to include clinical, manufacturing and additional staff salaries in the period ending March 31, 2016.  The Company received approval from the U.S. Food and Drug Administration for its IND application in September 2015 and a ‘no objection letter’ in November 2015 from the Health Protection Branch of Health Canada for its application for Clinical Trial Authorization.

General and administration expenditures for the three months ended March 31, 2016 were $1.9 million compared to $1.3 million for the comparative period. The increase was primarily due to increased activity as a public corporate entity, and additional general and administrative expenditures to support the clinical development of EPI-506.

Liquidity and Outstanding Share Capital

Working capital as at March 31, 2016 was $15.7 million. During the quarter, the Company closed the January 2016 Financing and March 2016 Financing, which management believes provides sufficient funds to execute the Company’s Phase 1 portion of the Phase 1/2 clinical trial, prior to the receipt of the third and final advance of funds from CPRIT in the amount of $5.4 million or the exercise of any warrants associated with the January 2016 Financing. The Phase 1 portion is anticipated to complete in the second half of calendar 2016. Management continues to consider sources of additional financing which would assure continuation of the Company’s operations and research programs.

As of March 31, 2016 and the date of this release, the Company had 29,075,889 Common Shares issued and outstanding, 3,793,519 Common Shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of CAD$2.69 per share, and 7,099,542 Common Shares issuable upon the exercise of outstanding warrants at a weighted-average exercise price of $3.27 per share.

About ESSA Pharma Inc.

ESSA Pharma is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of castration resistant prostate cancer (“CRPC”) in patients whose disease is progressing despite treatment with current therapies. ESSA believes that its product candidate, EPI-506, can significantly expand the interval of time in which patients suffering from CRPC can benefit from hormone-based therapies. EPI-506 acts by disrupting the androgen receptor (“AR”) signaling pathway, which is the primary pathway that drives prostate cancer growth. We have shown that EPI-002, the primary metabolite of EPI-506, prevents AR activation by binding selectively to the N-terminal domain (“NTD”) of the AR. A functional NTD is essential for activation of the AR. Blocking the NTD prevents activation of the AR by all of the three known mechanisms of activation. In pre-clinical studies, blocking the NTD has demonstrated the capability to overcome the known AR-dependent mechanisms of CRPC. ESSA was founded in 2009 and is located in Houston Texas, and Vancouver, British Columbia.

About Prostate Cancer

Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide (Globocan, 2012). Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay of hormonal treatment for over six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone (for example, ADT), disease progression despite castrate levels of testosterone generally represents a transition to the lethal variant of the disease (mCRPC) and most patients ultimately succumb to the illness. The treatment of mCRPC patients has evolved rapidly over the past five years; despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing treatments including abiraterone or enzalutamide, or those that have contraindications to receive those drugs. Over time, patients with mCRPC generally experience continued disease progression, worsening pain, leading to substantial morbidity and limited survival rates. In both in vitro and in vivo studies, ESSA’s novel approach to blocking the androgen pathway has been shown to be effective in blocking tumor growth when current therapies are no longer effective.

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995 and/or Canadian securities laws that may not be based on historical fact, including without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Forward-looking statements in this news release include, but are not limited to, statements regarding the use of the net proceeds of the January 2016 Financing and the March 2016 Financing, the sufficiency of ESSA’s funds to execute the Phase 1 portion of the Phase 1/2 clinical trial, the anticipated timing of the Phase 1 portion and possible future financings by ESSA.

Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause ESSA’s actual results, performance or achievements to be materially different from those expressed or implied thereby. Such statements reflect ESSA’s current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. In making forward-looking statements, ESSA may make various material assumptions, including but not limited to the accuracy of ESSA’s financial projections and the Phase 1 portion of the Phase 1/2 clinical trial proceeding as expected.

Forward-looking information is developed based on assumptions about such risks, uncertainties and other factors including, among others, the factors  discussed in or referred to under the heading “Risk Factors” in ESSA’s Annual Report on Form 20-F for the year ended September 30, 2015 which is available under ESSA’s profile on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Forward-looking statements are made based on management’s beliefs, estimates and opinions on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as may be required by applicable law. Readers are cautioned against attributing undue certainty to forward-looking statements.

(TROV) Clinical Data Revelas KRAS Mutation Detection/Mapping Capabilities

92.9% of metastatic pancreatic cancer patients determined to be KRAS positive using Trovagene’s Precision Cancer Monitoring assay

SAN DIEGO, May 13, 2016  — Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, announced today that clinical study results featuring the Company’s Precision Cancer Monitoring® (PCM) platform were presented at the 2016 AACR Special Pancreatic Cancer Meeting in Orlando, Florida. The poster, entitled Detection and Quantification of ctDNA KRAS Mutations from Patients with Unresectable Pancreatic Cancer, was presented by Fernando Blanco, Ph.D., medical science liaison at Trovagene.

Highlights from the poster include:

• Detection rate of circulating tumor DNA (ctDNA) KRAS in 210-patient study closely matches the published prevalence of KRAS mutations in pancreatic cancer (~90%)
• ctDNA KRAS levels can be used to distinguish between locally advanced and metastatic cancer (p<0.0001), suggesting an improved biomarker for disease differentiation
• Longitudinal monitoring of KRAS can be informative in determining responsiveness to therapy and to predict disease progression months in advance of imaging
• The dataset is the largest prospective study exploring ctDNA KRAS in unresectable pancreatic cancer

“In this data set, we have shown the ability to detect KRAS mutations in pancreatic cancer patients with high sensitivity from a liquid biopsy,” stated Julia Johansen, M.D., University of Copenhagen, Denmark and Lead Investigator. “The quantitative assessment of KRAS mutational load using ctDNA at baseline and over time has potential to become an important biomarker in the treatment of metastatic pancreatic cancer, given a high correlation to disease status and the reliability challenges with CA19-9, a biomarker often used in practice to monitor patients with metastatic cancer for progression.”

“This large prospective study demonstrates the high sensitivity of our KRAS assay, and the ability to determine mutational status without the need for tissue biopsy,” added Erlander. “Metastatic pancreatic cancer is among the most deadly cancer types, and our assay can assist physicians in determining the aggressiveness of a patient’s disease, and provide useful information such that therapy may be tailored accordingly.”

About Pancreatic Cancer and KRAS Mutations

Pancreatic cancer is one of the deadliest human malignancies. According to the American Cancer Association, approximately 53,000 Americans will be diagnosed with pancreatic cancer this year, and roughly 42,000 will die from the disease. While little progress has been made in its treatment over the past several decades, advances in the understanding of the disease’s biology provide new potential opportunities for treatment. An estimated 90% of pancreatic cancers harbor somatic KRAS G12/G13 mutations. Such mutations are hallmarks of late-stage disease, and the presence of circulating tumor DNA (ctDNA) KRAS mutations at diagnosis has prognostic implications. Accurate identification of both the presence of ctDNA KRAS mutations and quantification of the number of ctDNA KRAS mutant copies could be an improved therapeutic response biomarker over CA19-9, which is known to be uninformative in certain patients with pancreatic cancer.

About Trovagene’s Precision Cancer Monitoring platform

Trovagene’s urine and blood-based BRAF, KRAS and EGFR oncogene mutation assays are now available to healthcare providers for detection and or monitoring of tumor dynamics in their patients before, during and after treatment. Physicians interested in utilizing these tests should contact Client Services at 888-391-7992. For more information, please visit www.trovagene.com/our-tests.

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine.  The Company’s technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene’s Precision Cancer Monitoring^® platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.

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 words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’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 need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that our Precision Cancer Monitoring^® platform will be utilized by oncologists or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement.  Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2015 and its other periodic reports filed with the Securities and Exchange Commission.

Trovagene Contacts

(FNJN) to Host Shareholder Update Conference Call on May 16th at 1:30 PM PST

Management to Participate at Upcoming Investor Conferences

(NVDA) Announces Upcoming Events for Financial Community

(GSAT) Statement Regarding Commission Circulation of an Order in IB Docket No. 13-213

COVINGTON, La., May 13, 2016  — The Office of the Chairman of the Federal Communications Commission has informed Globalstar, Inc. (NYSE MKT:GSAT) that an Order in Docket No. 13-213 has been circulated and is now pending action by the full Commission.

L. Barbee Ponder, Globalstar’s General Counsel & Vice President Regulatory Affairs, commented, “The Commission’s staff has spent a tremendous amount of time and effort on this lengthy proceeding. We look forward to the Commission adopting a final order authorizing Globalstar’s TLPS.”  

Additional information regarding the proceeding will be provided in the near future.

About Globalstar, Inc.
Globalstar is a leading provider of mobile satellite voice and data services, leveraging the world’s newest mobile satellite communications network. Customers around the world in industries like government, emergency management, marine, logging, oil & gas and outdoor recreation rely on Globalstar to conduct business smarter and faster, maintain peace of mind and access emergency personnel.  Globalstar data solutions are ideal for various asset and personal tracking, data monitoring and SCADA applications.  The Company’s products include mobile and fixed satellite telephones, the innovative Sat-Fi satellite hotspot, Simplex and Duplex satellite data modems, tracking devices and flexible service packages.  For more information, visit www.globalstar.com.

Note that all SPOT products described in this press release are the products of SPOT LLC, which is not affiliated in any manner with Spot Image of Toulouse, France or Spot Image Corporation of Chantilly, Virginia. For more information, visit www.globalstar.com.

Investor Contact Information:
Email: investorrelations@globalstar.com
Phone: (985) 335-1538

Media Contact Information:
Email: allison.hoffman@globalstar.com

(EXPI) Reports Record Revenue and Growth for First Quarter

Revenue and Agent Count Both Up Over 100%

(KTOV) Receives Pre-NDA Response From FDA for KIT-302, Supporting NDA Submission

Kitov expects to submit New Drug Application to FDA at the end of 2016 for KIT-302 – a fixed dose combination that simultaneously treats osteoarthritis pain and hypertension

TEL-AVIV, Israel, May 12, 2015  — Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, today announced it has received, from the U.S. Food and  Drug Administration (FDA), meeting minutes from its recent pre-New Drug Application meeting for KIT-302 . Based on the details of the FDA’s response, Kitov is on track to submit the NDA for marketing approval of KIT-302 by the end of 2016.

The meeting, which took place on April 11, 2016, had been requested by Kitov to seek FDA concurrence that the NDA content will meet the agency’s requirements for NDA submission.

The FDA confirmed that an Advisory Committee Review should not be required for the NDA review, and that the FDA may accept 6 months data of long term stability at the time of submission. Furthermore, based on  the minutes, the Company will include additional information as part of the planned NDA submission, such as market data and a medical literature review on the use of amlodipine and celecoxib in animals. The  FDA requested that the statistical calculation for the primary efficacy endpoint be performed using an alternate mathematical technique. This calculation was subsequently performed by Kitov and also demonstrates that KIT-302 met its primary efficacy endpoint.

“These minutes bring us closer to submitting an NDA to the FDA for KIT-302 via the 505(b)(2) path at the end 2016, as currently planned. This paves the way for potential regulatory approval in 2017,” stated Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer.

A combination drug, KIT-302, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain.  KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension.

Pain medications for osteoarthritis account for billions of dollars in annual sales globally. Most pain medications for osteoarthritis, including celecoxib, are non-steroidal anti-inflammatory drugs (NSAIDs) which have the side effect of elevating blood pressure, and increasing the risk of heart attacks, strokes and death. Of the 27 million Americans who live with osteoarthritis, 13.5 million also suffer from hypertension, which also increases the risk of heart attack, stroke, and death.

About Kitov Pharmaceuticals

Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical company focused on late-stage drug development. Leveraging deep regulatory and clinical-trial expertise, Kitov’s veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov’s pipeline currently features two combination drugs intended to treat osteoarthritis pain and hypertension simultaneously, including one that achieved the primary efficacy endpoint for its Phase III clinical trial. Lowering development risk and cost through rapid and efficient regulatory approval of novel late-stage therapeutics, Kitov delivers rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives. For more information, the content of which is not part of this press release, visit www.kitovpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements involve certain risks and uncertainties, including, among others, the risk that drug development involves a lengthy and expensive process with uncertain outcome; the Company’s ability to successfully develop and commercialize its pharmaceutical product; the length, progress and results of any clinical trials; the introduction of competing products; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals to commercialize the Company’s products; the lack of sufficient funding to finance the clinical trials; the difficulty of predicting actions of the USA FDA; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; or changes in the global pharmaceutical industry. . Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Kitov Pharmaceuticals Holdings Ltd.’s Registration Statement on Form F-1 filed with the SEC, which is available on the SEC’s website, www.sec.gov.

Contact:
Simcha Rock
Chief Financial Officer
+972-2-6254124
Simcha@kitovpharma.com

Bob Yedid
Managing Director
LifeSci Advisors, LLC
646-597-6989
bob@LifeSciAdvisors.com

(HCKT) Announces $5 Million Increase To Share Repurchase Program Authorization

The Hackett Group, Inc. (NASDAQ: HCKT), a global intellectual property-based strategic consultancy and leading enterprise benchmarking and best practices implementation firm, today announced that its Board of Directors increased the authorization under its share repurchase program by an additional $5 million. As of Tuesday, May 10, 2016, the company had approximately $3.1 million available under the Company’s share repurchase program.

Under the share repurchase plan, The Hackett Group may buy back shares of its outstanding common stock either on the open market or through privately negotiated transactions subject to market conditions and trading restrictions. This share repurchase program does not obligate the company to repurchase any shares and may be modified, suspended, or terminated by the company at any time.

About The Hackett Group

The Hackett Group (NASDAQ: HCKT) is an intellectual property-based strategic consultancy and leading enterprise benchmarking and best practices implementation firm to global companies. Services include business transformation, enterprise performance management, working capital management, and global business services. The Hackett Group also provides dedicated expertise in business strategy, operations, finance, human capital management, strategic sourcing, procurement, and information technology, including its award-winning Oracle EPM and SAP practices.

The Hackett Group has completed more than 11,000 benchmarking studies with major corporations and government agencies, including 93% of the Dow Jones Industrials, 86% of the Fortune 100, 87% of the DAX 30 and 52% of the FTSE 100. These studies drive its Best Practice Intelligence Center™ which includes the firm’s benchmarking metrics, best practices repository, and best practice configuration guides and process flows, which enable The Hackett Group’s clients and partners to achieve world-class performance.

More information on The Hackett Group is available at: www.thehackettgroup.com, info@thehackettgroup.com, or by calling (770) 225-3600.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and involve known and unknown risks, uncertainties and other factors that may cause The Hackett Group’s actual results, performance or achievements to be materially different from the results, performance or achievements expressed or implied by the forward-looking statements. Factors that impact such forward-looking statements include, among others, the ability of our products, services, or offerings mentioned in this release to deliver the desired effect, our ability to effectively integrate acquisitions into our operations, our ability to retain existing business, our ability to attract additional business, our ability to effectively market and sell our product offerings and other services, the timing of projects and the potential for contract cancellations by our customers, changes in expectations regarding the business consulting and information technology industries, our ability to attract and retain skilled employees, possible changes in collections of accounts receivable due to the bankruptcy or financial difficulties of our customers, risks of competition, price and margin trends, foreign currency fluctuations, changes in general economic conditions and interest rates, our ability to obtain debt financing through additional borrowings under an amendment to our existing credit facility as well as other risks detailed in our Company’s Annual Report on Form 10-K for the most recent fiscal year filed with the Securities and Exchange Commission. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

The Hackett Group, Inc.
Robert A. Ramirez, CFO, 305-375-8005
rramirez@thehackettgroup.com

(MARA) Erich Spangenberg Joins Marathon Patent Group Management Team

Renowned IP Industry Veteran Will Focus on European and Asian Opportunities

(MGT) Acquires Ownership Interest in Technology Incubator Round House

Provides MGT with Valuable Pipeline, Including Equity in RecMed

HARRISON, N.Y., May 12, 2016  — MGT Capital Investments, Inc. (NYSE MKT: MGT) announced today that it has acquired a Membership Interest in The Round House LLC, an Alabama-based technology incubator, offering co-working space, accelerator services and angel investment.  Located a few miles from Auburn University, Round House was founded by Kyle Sandler, a successful serial entrepreneur with eight years of experience at Google and three major successful technology exits. With an experienced executive team, Round House has attracted top entrepreneurs from Google, E-Nable, Rockstar Games, American Express, and many more companies.  Round House offers start-ups a creative and collaborative environment along with two-way Gigabit internet access, 3-D printers and a full-time “community engineer.”

Among the companies in which Round House has equity ownership is RecMed First Aid, founded by a local teenager, Taylor Rosenthal. This past Monday, Taylor became the youngest person to exhibit at TechCrunch Disrupt in New York. He has been featured on numerous national media outlets in the past several days, and Taylor has stated that RecMed is being courted by some large retail and healthcare companies.

Several companies within the Round House portfolio are cybersecurity related, offering MGT an early look into potentially disruptive technologies in file sharing, chat and other applications.

About MGT Capital Investments, Inc.

MGT and its subsidiaries are principally engaged in the business of acquiring, developing and monetizing intellectual property assets. MGT’s portfolio currently includes social casino and gaming platforms, and ownership stakes in DraftDay.com, a top daily fantasy sports wagering platform and DraftDay Fantasy Sports, Inc. operator of an online entertainment marketing and rewards platform.

MGT also recently announced the acquisition of certain technology and assets from D-Vasive Inc., a provider of leading edge anti-spy software.  In conjunction with the acquisition, The Company also announced the proposed appointment of John McAfee as Executive Chairman and Chief Executive Officer.  Further, MGT Capital also intends to change its corporate name to John McAfee Global Technologies, Inc. Closing of the acquisition is contingent on customary conditions including approval by MGT’s stockholders.

Forward–looking Statements

This press release contains forward–looking statements. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions are intended to identify “forward–looking statements.” MGT’s financial and operational results reflected above should not be construed by any means as representative of the current or future value of its common stock. All information set forth in this news release, except historical and factual information, represents forward–looking statements. This includes all statements about the Company’s plans, beliefs, estimates and expectations. These statements are based on current estimates and projections, which involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward–looking statements. These risks and uncertainties include issues related to: rapidly changing technology and evolving standards in the industries in which the Company and its subsidiaries operate; the ability to obtain sufficient funding to continue operations, maintain adequate cash flow, profitably exploit new business, license and sign new agreements; the unpredictable nature of consumer preferences; and other factors set forth in the Company’s most recently filed annual report and registration statement. Readers are cautioned not to place undue reliance on these forward–looking statements, which reflect management’s analysis only as of the date hereof. The Company undertakes no obligation to publicly revise these forward–looking statements to reflect events or circumstances that arise after the date hereof. Readers should carefully review the risks and uncertainties described in other documents that the Company files from time to time with the U.S. Securities and Exchange Commission.

(HTGM) Research Collaboration Agreement with Bristol-Myers Squibb

TUCSON, Ariz., May 12, 2016  — HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments and reagents for molecular profiling applications, today announced a research collaboration agreement with Bristol-Myers Squibb (NYSE:BMY) to evaluate the potential for immuno-oncology molecular profiling in multiple tumor types. The collaboration between HTG and Bristol-Myers Squibb will utilize the next generation sequencing (NGS)-based HTG EdgeSeq system as a tool for use in support of Bristol-Myers Squibb’s translational research activities.

“We believe this collaboration will provide many benefits to Bristol-Myers Squibb’s immuno-oncology development programs and further add to HTG’s industry leadership in the development of NGS-based molecular diagnostic assays toward the goal of precision medicine. This collaboration is the result of a long-standing Bristol-Myers Squibb/HTG relationship and we are excited to continue as a partner with Bristol-Myers Squibb’s translational research team,” said John Lubniewski, HTG’s Chief Business Officer.

Under the terms of the agreement, HTG will provide Bristol-Myers Squibb access to its NGS-based HTG EdgeSeq system and the companies will collaborate to develop tools for use for molecular profiling research for immuno-oncology.

“Immuno-oncology is a very important business segment for us and this agreement and the expansion of our relationship with BMS is a validation of our HTG EdgeSeq technology and value proposition,” stated TJ Johnson, President and CEO of HTG Molecular Diagnostics. “We firmly believe in the potential of immuno therapies in treating cancer patients and we are honored to be chosen as a profiling partner for Bristol-Myers Squibb, a recognized leader in this space.”

About HTG:

Headquartered in Tucson, Arizona, HTG’s mission is to empower precision medicine at the local level. In 2013 the company commercialized its HTG Edge instrument platform and a portfolio of RNA assays that leverage HTG’s proprietary nuclease protection chemistry. HTG’s product offerings have since expanded to include its HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.

Safe Harbor Statement:

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected benefits of our agreement with BMS, the role that immuno-oncology molecular profiling will have in clinical settings, including precision medicine, the potential of immunotherapy treatments, and our business and the capabilities of our technology. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, risks associated with the process of developing and commercializing immuno-oncology applications and biomarker panels. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including without limitation our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact: 

Westwicke Partners
Jamar Ismail
Phone: 415-513-1282
Email: jamar.ismail@westwicke.com

TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: 520-547-2827 x130
Email: tjjohnson@htgmolecular.com

(CNCK) Partners With ATLETO to Promote a Tailored Sports Experience for a Healthier Life

(EFOI) Names Human Resources Veteran Gail Thakarar Chief People Officer

NEW YORK, May 11, 2016  — Energy Focus, Inc. (NASDAQ:EFOI), a leader in LED lighting technologies, announced today that Gail Thakarar joined the company as its Chief People Officer. To advance the company’s business strategies and growth goals, in this role, Ms. Thakarar is responsible for leading, developing and expanding the company’s human resources infrastructure, which includes talent acquisition, leadership development, employee engagement, culture enrichment, organizational design and compensation and benefits.

Ms. Thakarar has a strong track record of building and leading complex and global human resources operations for large as well as high-growth entrepreneurial corporations. Her past successes include growing and improving human capital management functions for companies across various industries, resulting in significantly enhanced shareholder value. Ms. Thakarar gained her extensive global experience as a top human resources executive for several Fortune 500 companies, notably General Electric, Glaxo Smith Kline, The Mony Group (acquired by AXA Financial), Countrywide Financial Corporation and Occidental Petroleum. Most recently, she was the Chief Human Resources Officer with AMC Health, a leading provider of virtual care solutions for at-risk populations. She holds an undergraduate degree in Accounting from The University of Bombay, India, and an MBA in Human Resources from the University of Pennsylvania’s Wharton School.

“We are absolutely proud and pleased to have Gail as part of our leadership team as we look to dramatically strengthen our people capacities and capabilities to facilitate and accelerate our expansion in the U.S. and internationally,” said James Tu, Chairman, President & Chief Executive Officer of Energy Focus, Inc. “Energy Focus believes deeply in attracting, growing and retaining the best talent to enable the company to become the most trusted LED lighting brand in our dedicated markets. Gail brings to us not only a trove of experience and expertise in global talent acquisition and development, but also proven wisdom to build sustainable, scalable and transformational human resources operations from massive conglomerates to technology startups. We very much look forward to her positive and powerful contributions to lay the critical cultural and people foundation for the next phase of our growth.”

“I’m truly thrilled to have joined Energy Focus as a member of its dynamic leadership team,” stated Ms. Thakarar. “I look forward to supporting and contributing to the company’s vision to build an impactful organization by creating triple-bottom-line benefits that encompass people, planet and profit for its stakeholders as well as its customers.”

About Energy Focus, Inc.:
Energy Focus, Inc. is a leading provider of energy efficient LED lighting products and a developer of energy efficient lighting technology. Our LED lighting products provide energy savings, aesthetics, safety and maintenance cost benefits over conventional lighting. Our long-standing relationship with the U.S. Government continues to enable us to provide energy efficient LED lighting products to the U.S. Navy and the Military Sealift Command fleets. Customers include national, state and local U.S. government agencies as well as Fortune 500 companies and many other commercial and industrial clients. World headquarters are located in Solon, Ohio with additional offices in Washington, D.C., New York City and Taiwan. For more information, see our web site at www.energyfocusinc.com.

Investor Contacts:
Energy Focus, Inc.
Marcia J. Miller, Chief Financial Officer
(440) 715-1300
ir@energyfocusinc.com

Darrow Associates, Inc.
Peter Seltzberg, Managing Director
(516) 419-9915
pseltzberg@darrowir.com