$XGTI Regains #Compliance with @Nasdaq #ListingRequirements

SARASOTA, Fla., Jan. 10, 2017  — xG Technology, Inc. (“xG” or the “Company”) (Nasdaq: XGTI, XGTIW), a leader in providing critical wireless communications for use in challenging operating environments, announced today that the Company has regained full compliance with all listing requirements of the Nasdaq Stock Market (“Nasdaq”).

In a letter received from the Listing Qualifications Department of Nasdaq on January 9, 2017, the Company was informed that it has regained compliance with the bid price and rights/warrants rules, as required by the Panel’s decision dated November 21, 2016, and is in compliance with other applicable requirements as set forth in the decision and required for listing on The Nasdaq Capital Market. Accordingly, the Panel has determined to continue the listing of the Company’s securities on The Nasdaq Stock Market and is closing this matter.

About xG Technology, Inc.         

Founded in 2002, xG Technology has developed technologies that enable always-available, always-connected and always-secure voice, broadband data and video communications. The company’s brand portfolio includes xMax and Integrated Microwave Technologies (IMT).

xMax is a patented all-IP, software-defined cognitive radio network that delivers mission-assured wireless connectivity in any RF environment. It provides a solution to the challenges of interoperability, survivability and flexibility in expeditionary and critical communications networks. xMax incorporates advanced optimizing technologies that include spectrum sharing, interference mitigation, multiple-input multiple-output (MIMO) and software defined radio (SDR), making it ideal for wide area, as well as rapid emergency communication deployment in unpredictable environments and during fluid situations. xMax offers solutions for numerous industries worldwide, including military, emergency response and public safety, telemedicine and critical infrastructure.

IMT is a leading provider of mission-critical video solutions, advanced digital microwave systems and engineering, integration, installation and commissioning services serving the Broadcast, Sports & Entertainment and MAG (Military, Aerospace & Government) markets. Since its inception, IMT has focused on building a product portfolio that incorporates a high level of performance, reliability and build quality, extended operating ranges and compact form factors. IMT’s product lines include digital broadcast microwave video systems, compact microwave video equipment for licensed and license-free sports and entertainment applications, and wireless video solutions designed for use by state, local and federal police departments. More information on IMT can be found at www.imt-solutions.com.

Based in Sarasota, Florida, xG has over 100 patents and pending patent applications. xG is a publicly traded company listed on the NASDAQ Capital Market (symbol: XGTI) For more information, please visit www.xgtechnology.com

Cautionary Statement Regarding Forward Looking Statements

Statements contained herein that are not based upon current or historical fact are forward-looking in nature and 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. Such forward-looking statements reflect the Company’s expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties.  These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to xG Technology, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company’s actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.

For More Information:

Daniel Carpini
xG Technology
daniel.carpini@xgtechnology.com
(941) 953-9035

$ONTX Discusses Target Indications and Clinical Development w/ StockNewsNow.com

LOS ANGELES, Jan. 10, 2017  — StockNewsNow.com, The Official MicroCap News Source™, today published an SNNLive Video Interview with Ramesh Kumar, President & CEO of Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with primary focus on Myelodysplastic Syndromes, according to the Company’s website (see here: www.onconova.com). The video interview was recorded on Wednesday, December 7^th, 2016 at the LD Micro “Main Event” 2016 in Bel Air, CA.

Click the following link to watch the SNNLive Video Interview on StockNewsNow.com:

Onconova Therapeutics, Inc. – Phase 3 Clinical-stage Biopharmaceutical Company Discusses Target Indications and Clinical Development

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About Onconova Therapeutics, Inc.

Onconova Therapeutics is a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with primary focus on Myelodysplastic Syndromes. Onconova’s clinical and pre-clinical stage drug development candidates are derived from its extensive chemical library and are designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. The Company’s most advanced product candidate, rigosertib, is a small molecule inhibitor of cellular signaling and acts as a RAS mimetic. These effects of rigosertib appear to be mediated by direct binding of the compound to the RAS-binding domain (RBD) found in many RAS effector proteins, including the Raf and PI3 kinases. Rigosertib is protected by issued patents (earliest expiry in 2026) and has been awarded Orphan Designation for MDS in the United States, Europe and Japan.  In addition to rigosertib, two other candidates are in the clinical stage, and several candidates are in pre-clinical stages.  For more information, please visit http://www.onconova.com.

About IV Rigosertib

The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trial involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 global INSPIRE trial as 2^nd-line treatment for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is suited for patients with advanced disease and provides long duration of exposure and ensures adequate dosing under a controlled setting.

About INSPIRE

The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the  U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial.  INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first nine months of initiation of HMA treatment. This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).

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$BIOC Secures In-Network #ProviderAgreement with #BlueCrossBlueShieldofTexas #BCBSTX

SAN DIEGO, Jan. 10, 2017  — Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of clinically actionable liquid biopsy tests designed to improve the outcomes of cancer patients, announces that it has secured an in-network provider agreement with Blue Cross Blue Shield of Texas (BCBSTX), the largest provider of health benefits in that state.

“Determining the molecular status of a tumor can help physicians individualize treatment for their patients and our highly sensitive Target Selector™ platform can provide this important information from a simple blood sample,” said Biocept’s Senior Vice President and Senior Medical Director Veena Singh, MD. “Our liquid biopsy testing is changing the way physicians evaluate tumor status and monitor both response and resistance to treatment.”

“It is gratifying that health plans are seeing the value of our liquid biopsy approach for profiling and monitoring important cancer biomarkers,” said Michael Nall, President and Chief Executive Officer of Biocept. “Partnering with health insurers is a major focus of our business strategy, as it may increase physician access to this non-invasive technology for their patients and provide timely adjudication of claims for patients. Securing this in-network agreement is an important milestone for Biocept, as Texas is one of our largest markets and BCBSTX is the largest provider in that state. With this agreement, the number of patients with in-network access to our tests has grown to approximately 185 million, with some members having access via multiple plans.”

About Biocept

Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company uses its proprietary liquid biopsy technology to provide physicians with information for treating and monitoring patients diagnosed with cancer. The Company’s patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both circulating tumor cells (CTCs) and in plasma (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient’s disease and therapeutic options. For additional information, please visit www.biocept.com.

Forward-Looking Statements Disclaimer Statement

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the diagnosis and treatment of cancer, our ability to increase physician access to our technology, and our ability to provide timely adjudication of claims, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC’s website located at www.sec.gov.

$EXEL Update on Dispute with $RHHBY Group Member #Genentech

Exelixis, Inc. (Nasdaq:EXEL) announced today that Genentech, Inc. has withdrawn its counterclaim against Exelixis in the ongoing JAMS arbitration concerning alleged breaches of the parties’ collaboration agreement. Genentech had asserted a counterclaim for breach of contract, which sought monetary damages and interest related to cost allocations under the collaboration agreement. When notifying the arbitral panel, and Exelixis, of this unilateral action, Genentech further stated that it is changing the manner in which it allocates promotional expenses of the COTELLIC^® (cobimetinib) plus Zelboraf^® (vemurafenib) combination therapy.

As a result of Genentech’s decision to change its cost allocation approach, Exelixis is relieved of $18.7 million of disputed costs previously charged by Genentech. Exelixis has invoiced Genentech an additional $7.1 million with interest for expenses that Exelixis paid previously.

Genentech’s revised allocation applies retrospectively and prospectively and will substantially reduce Exelixis’ exposure to costs associated with promotion of the COTELLIC + Zelboraf combination in the United States. Exelixis and Genentech have shared promotional costs since commercial activities were initiated in early 2013. As detailed in previous regulatory filings, Exelixis charged its Profit and Loss Statement approximately $38 million for promotional costs through the third quarter of 2016. With the new approach that Genentech has adopted unilaterally, Exelixis’ liability for promotional costs will be reduced to approximately $15 million for the same period.

Other significant issues remain in dispute between the parties. Genentech’s action does not address the claims in Exelixis’ Demand for Arbitration related to Genentech’s clinical development, pricing and promotional costs for COTELLIC in the United States, nor does it fully resolve claims over revenue allocation. And, Genentech has not confirmed how it intends to allocate promotional costs incurred with respect to the collaboration’s promotion of other combination therapies that include cobimetinib for other indications that are in development and may be approved. Exelixis will continue to press its position before the arbitral panel to obtain a just resolution of these claims and the clarity it requires.

About the Dispute

On June 3, 2016, Exelixis filed a Demand for Arbitration before JAMS in San Francisco, California asserting claims against Genentech related to its clinical development, pricing and promotion of COTELLIC, and cost and revenue allocations in connection with COTELLIC’s promotion in the United States. The arbitration demand asserts that Genentech has breached the parties’ contract by, amongst other breaches, failing to meet its diligence and good faith obligations. The demand seeks various forms of declaratory, monetary, and equitable relief, including without limitation that the cost and revenue allocations for COTELLIC be shared equitably consistent with the collaboration agreement’s terms, along with attorneys’ fees and costs of the arbitration. Genentech had asserted a counterclaim for breach of contract, which sought monetary damages and interest related to the cost allocations under the collaboration agreement.

About Exelixis

Exelixis, Inc. (Nasdaq: EXEL) is a biopharmaceutical company committed to the discovery, development and promotion of new medicines with the potential to improve care and outcomes for people with cancer. Since its founding in 1994, three medicines discovered at Exelixis have progressed through clinical development to receive regulatory approval. Currently, Exelixis is focused on advancing cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL and VEGF receptors, which has shown clinical anti-tumor activity in more than 20 forms of cancer and is the subject of a broad clinical development program. Two separate formulations of cabozantinib have received regulatory approval to treat certain forms of kidney and thyroid cancer and are marketed for those purposes as CABOMETYX™ tablets (U.S. and EU) and COMETRIQ^® capsules (U.S. and EU), respectively. Another Exelixis-discovered compound, COTELLIC^® (cobimetinib), a selective inhibitor of MEK, has been approved in major territories including the United States and European Union, and is being evaluated for further potential indications by Roche and Genentech (a member of the Roche Group) under a collaboration with Exelixis. For more information on Exelixis, please visit www.exelixis.com or follow @ExelixisInc on Twitter.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ position that Genentech’s revised allocation approach will substantially reduce Exelixis’ exposure to costs associated with promotion of the COTELLIC + Zelboraf combination in the United States; Exelixis’ plan to continue to press its position before the arbitral panel to obtain a just resolution of the issues remaining in dispute with Genentech; Exelixis’ commitment to the discovery, development and promotion of new medicines with the potential to improve care and outcomes for people with cancer; Exelixis’ focus on advancing cabozantinib; and the continued development of cobimetinib. Words such as “will,” “may,” “committed,” “focused,” “potential,” or other similar expressions identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: that Genentech/Roche may not account for promotional expenses in accordance with Exelixis’ expectations; Exelixis’ dependence on its relationship with Genentech/Roche with respect to cobimetinib and ability to maintain its rights under the collaboration; risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 3, 2016, and in Exelixis’ future filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Exelixis, the Exelixis logo, COMETRIQ and COTELLIC are registered U.S. trademarks, and CABOMETYX is a U.S. trademark.

$RAVE Restaurant Group Names #ScottCrane as #CEO

DALLAS, Jan. 9, 2017  — RAVE Restaurant Group, Inc. (NASDAQ:RAVE) today announced that the Board of Directors has named Scott Crane as Chief Executive Officer, effective today.  Crane succeeds Interim CEO Clinton J. Coleman, who will remain in his role as a member of the Board, where he has served since 2007.

“Scott is dynamic leader with a proven track record of growth with success,” said Mark Schwarz, Chairman of RAVE Restaurant Group, Inc.  “An entrepreneur at an early age, Scott’s restaurant industry focus has led to a succession of managerial roles of progressively greater responsibility and achievement throughout his career, including most recently growing the Smashburger concept from scratch to a thriving, profitable business that led to its highly successful transaction with Jollibee Foods Corporation last year at an enterprise valuation of $335 million.  Scott is an exceptional leader who will contribute greatly to the culture, growth and success at Rave.  I am confident his expertise and keen understanding of the fast casual category will be a true asset to the continuing development of our Company.”

Crane most recently served as President and Chief Executive Officer of the high-growth fast casual dining company Smashburger, where he led its development from a two-unit start up concept in 2007 to a global company with more than 330 corporate and franchise locations operating in 35 states and seven countries with annual sales in excess of $350 million at the time of his departure in 2016.  Previously, Mr. Crane was at Fugate Enterprises, Inc., one of the largest Pizza Hut franchisees in the country, where he was responsible for the operation of 210 Pizza Hut units, in addition to Taco Bell, Wing Street, Sonic and Blockbuster Video locations.

“Under Scott’s leadership, Smashburger has been broadly credited as being the leading fast casual brand in ‘better burger’ segment, receiving numerous business and consumer accolades including Forbes No. 1 Most Promising Company, Inc. 500 list of fastest growing private companies, Technomic’s #1 Social Media Brand and numerous “top” franchisor awards,”  said Clinton Coleman, Board Member and Interim CEO at RAVE Restaurant Group, Inc.  “To support the Company’s continued growth under Scott’s leadership, RAVE recently announced a $3 million capital raise by way of a registered rights offering, which is projected to be completed in February 2017.”

“I am excited to be joining RAVE at this particular time and look forward to leading it into the next phase of success and delivering results for its guests, employees, franchisees and all stakeholders,”  said Crane.  “I look forward to working with the Rave team as we unlock the enormous potential of the Pie Five concept and continue to introduce consumers to the new and growing category of fast casual pizza.  I also have tremendous respect for and am excited to lead Pizza Inn, a brand rich with tradition that has served more than three generations of American families.”

About RAVE Restaurant Group, Inc.

Founded in 1958, Dallas-based RAVE Restaurant Group [NASDAQ: RAVE] owns, operates and franchises more than 300 Pie Five Pizza Co. and Pizza Inn restaurants domestically and internationally. Pie Five Pizza Co. is a leader in the rapidly growing fast-casual pizza space offering made-to-order pizzas ready in under five minutes. Pizza Inn is an international chain featuring freshly made pizzas, along with salads, pastas, and desserts. The Company’s common stock is listed on the Nasdaq Capital Market under the symbol “RAVE”. For more information, please visit www.raverg.com.

Contact:
Jami Zimmerman
RAVE Restaurant Group, Inc.
469-384-5132

$CTIC Announces Progress Of Lead Programs And Strategic Objectives For 2017

SEATTLE, Jan. 9, 2017  — CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced positive progress on its lead programs in addition to key business priorities for 2017.

“Throughout 2016 we maintained our commitment to bringing new therapies to patients with unmet medical needs, and were successful in working with the FDA to remove the full clinical hold on pacritinib and get it back on the development track for the benefit of myelofibrosis patients,” said Richard Love, Interim President and Chief Executive Officer of CTI BioPharma. “The PERSIST-2 clinical trial of pacritinib was highlighted as one of six late-breaking data presentations at the American Society of Hematology conference in December.  We believe this oral presentation was well received by the hematology/oncology community, which recognizes the unmet need for myelofibrosis patients who are  ineligible to receive or are not benefitting from the approved JAK1/JAK2 inhibitor, ruxolitinib. Additionally, the PIX306 confirmatory trial of our commercial product PIXUVRI^(R)(pixantrone) continues to progress toward an announcement of top-line results  later this year.  If positive, this trial could provide the opportunity for full approval and label expansion by EMA, and discussions with the FDA about accelerated PIXUVRI approval in the US for the treatment of patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. We have also made significant effort at reducing our expenses and believe we are well positioned moving into 2017.”

Recent Progress Update

Pacritinib

In January 2017, CTI BioPharma announced the U.S. Food and Drug Administration (FDA) removed the full clinical hold on studies being conducted under the Investigational New Drug (IND) application for pacritinib.

In December 2016, data from the randomized Phase 3 PERSIST-2 clinical trial comparing pacritinib with physician-specified best available therapy (BAT), including ruxolitinib, for treatment of patients with myelofibrosis whose baseline platelet counts are less than 100,000 per microliter was one of six late-breaking oral presentations at the American Society of Hematology Annual Meeting. Patients in the trial were randomized to receive 200 mg pacritinib twice daily (BID), 400 mg pacritinib once daily (QD), or BAT. In those patients who had a chance to reach Week 24 (the primary analysis time point) at the time the clinical hold was imposed, the trial showed a statistically significant response rate in spleen volume reduction (SVR) in patients treated with pacritinib compared to BAT irrespective of prior treatment with ruxolitinib. The co-primary endpoint of reduction of Total Symptom Score (TSS) was not achieved but trended toward improvement in TSS. Although secondary objectives could not be evaluated formally due to the study not achieving one of the primary objectives, when the two pacritinib dosing arms were evaluated separately versus BAT, pacritinib BID showed a higher percent of SVR and TSS responses compared to BAT; whereas, pacritinib given QD showed only a higher percent SVR responses compared to BAT. There was no significant difference in overall survival (OS) across treatment arms, censored at the time of clinical hold. The most common treatment-emergent adverse events (AEs), occurring in 20 percent or more of patients treated with pacritinib within 24 weeks, of any grade, were gastrointestinal (generally manageable diarrhea, nausea and vomiting) and hematologic (anemia and thrombocytopenia) and were generally less frequent for BID versus QD administration.  The most common serious treatment-emergent AEs (incidence of ≥5 percent reported in any treatment arm irrespective of grade) were anemia, thrombocytopenia, pneumonia and acute renal failure none of which exceeded 8 percent individually in any arm. The presentation was also selected to be part of the “2017 Highlights of ASH” program designed to review significant scientific updates presented at ASH with hematologists/oncologists at five locations across the U.S.

PIXUVRI^®

In January 2017, CTI BioPharma received a €7.5 million milestone payment from its partner Servier following achievement of  a milestone associated with patient enrollment in the Phase 3 PIX306 clinical trial of PIXUVRI. The trial is a post-authorization trial as part of the conditional marketing authorization of PIXUVRI in the European Union (E.U.) The PIX306 is comparing PIXUVRI and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell non-Hodgkin lymphoma (NHL). The trial continues to enroll patients.

2017 Key Objectives

Advance Marketing Authorization Application in E.U. and define regulatory pathway in U.S. for pacritinib. CTI BioPharma continues to have dialogue with the European Medicines Authority (EMA) on the Marketing Authorization Application (MAA) for pacritinib that had been previously filed by its former partner, Baxalta.  At the time of the filing only data from the first Phase 3 clinical trial of pacritinib, PERSIST-1, was available. With the availability of  results from the PERSIST-2 clinical trial and the recent completion of the PERSIST-2 clinical study report, CTI BioPharma believes that the best strategy currently to achieve marketing authorization is to utilize the combined clinical evidence from both Phase 3 trials.  Accordingly, CTI BioPharma is evaluating whether to update the current application with the additional data from PERSIST-2 or to resubmit the MAA. Under either plan, CTI BioPharma would expect to pursue marketing authorization for the treatment of patients with myelofibrosis who are ineligible to receive, intolerant of or have insufficient response to the approved JAK1/JAK2 inhibitor, ruxolitinib.

CTI BioPharma also intends to discuss with the FDA the future development of pacritinib.

Initiate PAC203 trial. CTI BioPharma expects to initiate the PAC203 trial in the second quarter of 2017. The trial plans to enroll up to approximately 105 patients with primary myelofibrosis who have failed prior ruxolitinib therapy to evaluate the safety and the dose response relationship for efficacy (spleen volume reduction at 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID.

Secure ex-U.S. partner for pacritinib. CTI BioPharma intends to secure a partnership for the development and commercialization of pacritinib in certain territories outside the U.S.

Release top-line results of PIX306. CTI BioPharma expects to complete enrollment in the ongoing PIX306 trial of PIXUVRI and release top-line results by the end of 2017.

Financial

CTI BioPharma’s preliminary, unaudited estimates of its cash and cash equivalents balance as of December 31, 2016 is approximately $44.0 million. In January 2017, we received a €7.5 million milestone payment from Servier. CTI BioPharma expects that its cash burn (a non-GAAP financial measure), excluding cash inflows from future business development activities and proceeds from capital markets financing activities, would be approximately $65-75 million for 2017. The Company expects to meet its cash requirements for 2017 with existing cash and by partnering one or more product assets during the course of the year.

About Pacritinib

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia, or AML, myelodysplastic syndrome, or MDS, chronic myelomonocytic leukemia, or CMML, and chronic lymphocytic leukemia, or CLL, due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.

In August 2014, pacritinib was granted Fast Track designation by the FDA for the treatment of intermediate and high risk myelofibrosis including, but not limited to, patients with disease-related thrombocytopenia (low platelet counts); patients experiencing treatment-emergent thrombocytopenia on other JAK2 inhibitor therapy; or patients who are intolerant of, or whose symptoms are not well controlled (sub-optimally managed) on other JAK2 therapy.

Pacritinib was evaluated in two Phase 3 clinical trials, known as the PERSIST program, for patients with myelofibrosis, with one trial in a broad set of patients without limitations on platelet counts, the PERSIST-1 trial; and the other in patients with low platelet counts, the PERSIST-2 trial. The PERSIST-1 trial met its primary endpoint of spleen volume reduction (35 percent or greater from baseline to Week 24 by MRI/CT scan). The PERSIST-2 trial met one of its co-primary endpoints, that of spleen volume reduction. The co-primary endpoint of reduction of Total Symptom Score (TSS) was not achieved but trended toward improvement in TSS.

Clinical studies under the investigational new drug (IND) for pacritinib were subject to a full clinical hold issued by the FDA in February 2016. In January 2017, the FDA removed the full clinical hold and stated that clinical trials may be resumed.

About PIXUVRI® (pixantrone)

PIXUVRI is a novel aza-anthracenedione with unique structural and physiochemical properties. In May 2012, the European Commission granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory B-cell aggressive NHL. The benefit of PIXUVRI treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.pixuvri.eu. PIXUVRI does not have marketing approval in the United States.

In September 2014, CTI BioPharma entered into an exclusive license and collaboration agreement, with Servier with respect to the development and commercialization of PIXUVRI. Under the agreement, CTI BioPharma retains full commercialization rights to PIXUVRI in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, the United Kingdom and the U.S. while Servier has exclusive rights to commercialize PIXUVRI in all other countries.

About CTI BioPharma

CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a commercial presence in Europe with respect to PIXUVRI^® and a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington, with offices in London and Milan under the name CTI Life Sciences Limited. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI BioPharma’s securities. Such statements include, but are not limited to, expectations with respect to our ability to be able to interpret clinical trial data and results despite not satisfying the pre-specified minimum evaluable patient goal, expectations with respect to the potential therapeutic utility of pacritinib, including pacritinib’s potential to achieve treatment goals across patients with myelofibrosis, regardless of baseline characteristics, and statements regarding CTI BioPharma’s expectations with respect to the development of CTI BioPharma, its financial position and its product and product candidate portfolio, including strategies and plans for achieving marketing authorization and other approvals, partnerships, and the initiation or completion of clinical strials. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. In particular, meaningful interpretation of PERSIST-2 may not be possible because the pre-specified minimum evaluable patient goal was not met. The statements are based on assumptions about many important factors and information currently available to us to the extent we have thus far had an opportunity to fully and carefully evaluate such information in light of all surrounding facts, circumstances, recommendations and analyses. Risks that contribute to the uncertain nature of the forward-looking statements include, among others: risks associated with the biopharmaceutical industry in general and with CTI BioPharma and its product and product candidate portfolio in particular, risks associated with the pace or geography of enrollment of its clinical trials, risks associated with the commencement or outcome of preclinical and clinical studies, that trial results observed to date may differ from future results or that different conclusions or considerations may qualify such results once existing data has been more fully evaluated, that CTI BioPharma may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities or will not be in a position to submit regulatory submissions as or when projected, risks related to the actions of regulatory bodies and other governmental authorities, risks related to changes in laws and regulations, product quality, product efficacy, study protocol, data integrity or patient safety issues, risks related to the costs of developing, producing and selling PIXUVRI, pacritinib and CTI BioPharma’s other product candidates, and other risks, including, without limitation, competitive factors, technological developments,  and that CTI BioPharma may not achieve previously announced goals and objectives as or when projected as well as other risks listed or described from time to time in CTI BioPharma’s most recent filings with the SEC on Forms 10-K, 10-Q and 8-K.  Except as required by law, CTI BioPharma does not intend to update any of the statements in this press release upon further developments.PIXUVRI is a registered trademark of CTI BioPharma Corp.

CTI BioPharma Contacts:

Ed Bell
+1 206-272-4345
ebell@ctibiopharma.com

$WOOF to #Acquire #VCA

All-cash transaction valued at approximately $9.1 billion VCA shareholders to receive $93 per share of VCA common stock VCA to be a separate business unit within Mars Petcare

MCLEAN, Va. and LOS ANGELES, Jan. 9, 2017  — Mars, Incorporated and VCA Inc. (NASDAQ:WOOF) today announced that they have entered an agreement under which Mars will acquire all of the outstanding shares of VCA for $93 per share, or a total value of approximately $9.1 billion including $1.4 billion in outstanding debt.  The transaction price represents a premium of approximately 41 percent over VCA’s 30-day volume weighted average price on January 6, 2017, and a premium of approximately 31 percent over VCA’s closing price on January 6, 2017.  The agreement has been unanimously approved by the boards of directors of both companies.

VCA joins Mars Petcare, one of the world’s leading pet care providers. Pet care has been an important part of Mars for over 80 years. The transaction reaffirms Mars’ commitment to the pet care industry and the veterinary profession, and once completed will help drive Mars Petcare’s purpose to create A Better World for Pets.  Mars Petcare’s portfolio of Veterinary Services businesses includes BANFIELD® Pet Hospital, BLUEPEARL® and PET PARTNERS™.  Together with VCA, these businesses will provide an unprecedented level of access to high quality veterinary care for pets, from wellness and prevention to primary, emergency and specialty care. Mars Petcare is already an industry leader in pet nutrition with global brands that include ROYAL CANIN®, PEDIGREE® and WHISKAS®.  Mars has a growing business in pet DNA testing through the WISDOM PANEL®, and in 2015 also acquired pet technology provider WHISTLE.

“We are thrilled to welcome VCA to the Mars family and to our portfolio of brands and businesses around the world,” said Mars Chief Executive Officer Grant F. Reid.  “VCA is a leader across pet health care and the opportunity we see together—for pets, pet owners, veterinarians and other pet care providers —is tremendous.  We have great respect for VCA, with whom we share many common values and a strong commitment to pet care.  Together, we will be able to provide even greater value, better service and higher quality care to pets and pet owners.”

Since its founding in 1986, VCA has grown from one facility in Los Angeles to nearly 800 animal hospitals with 60 diagnostic laboratories throughout the United States and Canada.  Through organic growth and a series of acquisitions, VCA has become one of the largest and most diverse pet healthcare companies, operating across four divisions including veterinary services, laboratory diagnostics, imaging equipment and medical technology, and pet care services.

“Joining the Mars family of brands provides significant value to our stockholders while also preserving the Company’s values and a culture focused on investing in our people and facilities to promote excellence in pet care and long-term growth,” said VCA Chief Executive Officer Bob Antin.  “Mars has a long-standing commitment to pet health, wellness and nutrition.  We will work together every day to continue to provide the quality care and excellent service VCA is known for to our clients and their pet families.”

“We have always been impressed by VCA and the excellent services it offers to pets across diverse business segments,” said Mars Global Petcare President Poul Weihrauch.  “VCA’s industry-leading partnerships with veterinarians and pet care providers together with its expertise in veterinary services, diagnostics and technology will position Mars to deliver accessible, quality care and continue to create a better world for pets.  VCA’s philosophy of partnering with the veterinary profession and educational institutions is aligned with our core values and culture.  We look forward to together providing the best care possible for pets.”

As one of the world’s leading pet care providers, Mars Petcare is committed to attracting, developing and retaining the best veterinarians and pet care professionals in the world, supporting them in their efforts to provide cutting edge delivery of healthcare to pets and to advancing the profession.

VCA to be a distinct and separate business unit within Mars Petcare

Upon completion of the transaction, VCA will operate as a distinct and separate business unit within Mars Petcare, alongside its other Veterinary Services businesses, BANFIELD® Pet Hospital, BLUEPEARL® and PET PARTNERS™, and will continue to be led by Bob Antin, Chief Executive Officer, President, Chairman and a founder of VCA.  The company will remain headquartered in Los Angeles, California and will remain focused on its business model and strategic objectives.

Closing Conditions

The transaction is subject to certain customary closing conditions, including, among other things, VCA shareholder approval and customary regulatory approvals.  Mars has committed financing for the purchase of VCA.  We expect the transaction to close in Q3 2017.

Advisors

Morgan Stanley & Co. LLC and BDT & Co. are Mars’ financial advisors, and Skadden, Arps, Slate, Meagher & Flom is providing legal advice on the acquisition, with Simpson Thacher & Bartlett providing legal advice for the debt financing and McDermott Will & Emery assisting on antitrust matters.  J.P. Morgan is providing financing to Mars for the transaction.

Barclays is acting as exclusive financial advisor to VCA, and Akin Gump Strauss Hauer & Feld LLP and Potter Anderson Corroon LLP are serving as legal advisors. 

About Mars, Incorporated

Based in McLean, Virginia, Mars has net sales of more than $35 billion, six business segments including Petcare, Chocolate, Wrigley, Food, Drinks, Symbioscience, and more than 80,000 Associates worldwide that are putting its Principles into action to make a difference for people and the planet through its performance. Mars brands include: Petcare – PEDIGREE®, ROYAL CANIN®, WHISKAS®, BANFIELD® Pet Hospital, CESAR®, SHEBA®, DREAMIES® and NUTRO®; Chocolate – M&M’S®, SNICKERS®, DOVE®, GALAXY®, MARS®, MILKY WAY® and TWIX®; Wrigley – DOUBLEMINT®, EXTRA®, ORBIT® and 5™ chewing gums, SKITTLES® and STARBURST® candies, and ALTOIDS® AND LIFESAVERS® mints. Food – UNCLE BEN’S®, DOLMIO®, EBLY®, MASTERFOODS®, SEEDS OF CHANGE® and ROYCO®; Drinks – ALTERRA COFFEE ROASTERS™, THE BRIGHT TEA COMPANY™, KLIX® and FLAVIA®; Symbioscience – COCOAVIA® and WISDOM PANEL®.

For more information, please visit mars.com. Follow us: facebook.com/mars, twitter.com/marsglobal, youtube.com/mars, linkedin.com/company/mars

About VCA Inc.

VCA is a leading provider of pet health care services in the country delivered through nearly 800 small animal veterinary hospitals in the US and Canada, a preeminent nationwide clinical laboratory system that services all 50 states and Canada (Antech Diagnostics), the leading animal diagnostic imaging company in the market (Sound), and Camp Bow Wow (CBW), the nation’s Premier Doggy Day and Overnight Camp® franchise.

Forward Looking Statements

This document contains forward-looking statements within the meaning of the securities laws with respect to the proposed transaction between the Company, Mars and certain subsidiaries of Mars.  We have included herein statements that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We generally identify forward-looking statements in this document using words like “believe,” “intend,” “expect,” “estimate,” “may,” “plan,” “should,” “could,” “forecast,” “looking ahead,” “possible,” “will,” “project,” “contemplate,” “anticipate,” “predict,” “potential,” “continue,” or similar expressions. You may find some of these statements below and elsewhere in this document. These forward-looking statements are not historical facts and are inherently uncertain and outside of our control. Any or all of our forward-looking statements in this document may turn out to be incorrect. They can be affected by inaccurate assumptions we might make, or by known or unknown risks and uncertainties.  Many factors mentioned in our discussion in this document will be important in determining future results. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially.   Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) the risk that the proposed transaction may not be completed in a timely manner or at all, which may adversely affect the Company’s business and the price of the common stock of the Company; (ii) the failure to satisfy or obtain waivers of the conditions to the consummation of the proposed transaction, including the adoption of the merger agreement by the stockholders of the Company and the receipt of certain governmental and regulatory approvals; (iii) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (iv) the effect of the announcement or pendency of the proposed transaction on the Company’s business relationships, operating results and business generally; (v) risks that the proposed transaction disrupts current plans and operations of the Company, including the risk of adverse reactions or changes to business relationships with customers, suppliers and other business partners of the Company; (vi) potential difficulties in the hiring or retention of employees of the Company as a result of the proposed transaction; (vii) risks related to diverting management’s attention from the Company’s ongoing business operations; (viii) potential litigation relating to the merger agreement or the proposed transaction; (ix) unexpected costs, charges or expenses resulting from the proposed transaction, (x) competitive responses to the proposed transaction; and (xi) legislative, regulatory and economic developments.

The foregoing list of factors is not exclusive.  Additional risks and uncertainties that could affect the Company’s financial and operating results are included under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission (the “SEC”) on February 26, 2016, and the Company’s more recent reports filed with the SEC.  The Company can give no assurance that the conditions to the proposed transaction will be satisfied, or that it will close within the anticipated time period.  Investors and security holders are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which statements were made.  Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Additional Information and Where to Find It

This document is being made in respect of the proposed transaction between the Company, Mars and certain subsidiaries of Mars. In connection with the proposed transaction, the Company will file relevant materials with the SEC, including a preliminary proxy statement on Schedule 14A.  Following the filing of the definitive proxy statement with the SEC, the Company will mail the definitive proxy statement and a proxy card to each stockholder entitled to vote at the special meeting relating to the proposed transaction.  The Company also plans to file with the SEC other documents regarding the proposed transaction. INVESTORS AND SECURITY HOLDERS OF THE COMPANY ARE URGED TO CAREFULLY READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) IN THEIR ENTIRETY AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE PROPOSED TRANSACTION THAT THE COMPANY WILL FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY AND THE PROPOSED TRANSACTION.  When completed, a definitive proxy statement and form of proxy will be mailed to the stockholders of the Company. The definitive proxy statement, the preliminary proxy statement and other relevant materials in connection with the proposed transaction (when they become available), and any other documents filed by the Company with the SEC, may be obtained free of charge at the SEC’s website (http://www.sec.gov) or through the investor relations section of the Company’s website (http://investor.vca.com).

Participants in Solicitation

This document does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities.  The Company and its directors, executive officers and certain employees may be deemed to be participants in the solicitations of proxies from the Company’s stockholders with respect to the meeting of stockholders that will be held to consider the proposed transaction.  Information about the persons who may, under the SEC rules, be considered to be participants in the solicitation of stockholders of the Company in connection with the proposed transaction, is set forth in the proxy statement for the Company’s 2016 Annual Meeting of Stockholders filed with the SEC on March 4, 2016.  Stockholders may obtain additional information regarding the direct and indirect interests of any such persons who may, under the SEC rules, be considered to be participants in the solicitation of stockholders of the Company in connection with the proposed transaction, including the interests of the Company’s directors and executive officers in the proposed transaction, which may be different than those of the stockholders of the Company generally, by reading the proxy statement and other relevant documents regarding the proposed transaction when they become available, which the Company will file with the SEC.  Copies of these documents (when they become available) may be obtained free of charge as described in the preceding paragraph.

$ARIA to be #Acquired by #TakedaPharmaceutical

Takeda Pharmaceutical Company Limited (TSE:4502) (“Takeda”) and ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) (“ARIAD”) today announced that they have entered into a definitive agreement under which Takeda will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, or an enterprise value of approximately $5.2 billion. The transaction has been approved unanimously by the boards of directors of both companies, and is expected to close by the end of February 2017, subject to required regulatory approvals and other customary closing conditions. Sarissa Capital, the holder of 6.6% of ARIAD’s common shares, as well as each of the members of ARIAD’s Board of Directors have agreed to tender their shares to Takeda pursuant to the offer.

“The acquisition of ARIAD is a unique opportunity that will enable us to positively impact the lives of more patients worldwide, advance our strategic priorities and generate attractive returns for our shareholders,” said Christophe Weber, president and chief executive officer of Takeda. “This is a very exciting time for Takeda as we will broaden our hematology portfolio and transform our global solid tumor franchise through the addition of two innovative targeted therapies. Opportunities to acquire such high-quality, complementary targeted therapies do not come often, and we are very excited about the potential for this transaction to benefit patients, our shareholders and other stakeholders.”

Paris Panayiotopoulos, president and chief executive officer of ARIAD, said, “We are very pleased to combine with Takeda, which will allow us to not only accelerate our mission to discover, develop and deliver precision therapies to patients with rare cancers, but also deliver immediate and meaningful value to our shareholders through a substantial cash premium. This exciting transaction is a testament to the hard work and dedication of ARIAD’s talented team of employees. We have tremendous respect for Takeda, and I believe our shared commitment to innovation and research-driven cultures will provide for a smooth transition.”

“This transaction is a great outcome for shareholders of ARIAD and Takeda. Both ARIAD and Takeda are passionate about helping cancer patients, and I believe the talent and resources of Takeda coupled with ARIAD’s pipeline and people will accelerate the development of cancer treatments. I would like to extend my deepest gratitude to the management team and everyone at ARIAD for their unrelenting dedication,” said Alexander J. Denner, Ph.D., Chairman of the Board of ARIAD.

Highly strategic deal which transforms global oncology portfolio and pipeline by expanding into solid tumors and reinforcing existing strength in hematology

The acquisition of ARIAD brings two innovative targeted therapies that will expand and enhance Takeda’s existing oncology portfolio. Brigatinib, an investigational drug product, has the potential to add a differentiated, global therapy in a genetically-defined subpopulation of non-small cell lung cancer (NSCLC). The addition of Iclusig will broaden Takeda’s strong hematology franchise to include chronic myeloid leukemia (CML) and a subset of acute lymphoblastic leukemia (ALL). Together, these two innovative targeted therapies will position Takeda for sustainable long-term growth in oncology.

Takeda’s track record of successful oncology product launches [ADCETRIS^® (Brentuximab Vedotin), NINLARO^TM (ixazomib) and VELCADE^® (bortezomib)] means it has the experience and expertise required to deliver the successful launch of brigatinib and to ensure that it achieves global reach and share of voice thereafter.

Accretive to Takeda’s Underlying Core Earnings by FY2018 and generates immediate and long-term revenue growth

The transaction is a compelling opportunity for Takeda shareholders. It will provide immediate revenue, bring considerable long-term revenue potential and deliver synergy savings.

ARIAD provided calendar year 2016 revenue guidance for Iclusig of $170-180 million, and Takeda expects significant long-term revenue potential from the two lead assets.

Takeda projects the acquisition of ARIAD to be accretive to Underlying Core Earnings by FY2018 and broadly neutral in FY2017. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the brigatinib launch.

Attractive value drivers include two very innovative medicines, Iclusig and brigatinib, an exciting early stage pipeline and cost synergies

Iclusig, a commercialized therapy with continued strong sales growth potential, delivers immediate value. Brigatinib, an investigational drug product with peak annual sales potential of over $1 billion, will generate significant long-term value for Takeda. U.S. approval is expected in the first half of 2017 with global filing thereafter. Beyond Iclusig and brigatinib, ARIAD’s commitment and expertise in targeted kinase inhibition linked to strong translational science generated further pipeline opportunities which provide additional long-term upside potential.

Takeda will leverage ARIAD’s R&D capabilities and platform, and largely absorb its R&D costs within Takeda’s existing R&D budget. G&A cost synergies will be fully captured by FY2018.

Takeda retains financial flexibility with no impact on dividend policy

The transaction will be funded by up to $4.0 billion of new debt and the remainder from existing cash. FY2017 Net Debt/EBITDA is estimated at approximately 2.6x, which is expected to remain investment grade. The transaction has no impact on Takeda’s dividend policy.

Transaction terms

The acquisition is structured as an all cash tender offer by a subsidiary of Takeda for all of the outstanding shares of ARIAD common stock, followed by a merger in which remaining shares of ARIAD would be converted into the right to receive the same $24.00 cash per share price paid in the tender offer and ARIAD will become an indirect wholly owned subsidiary of Takeda.

The transaction is subject to the tender of a majority of the outstanding shares of ARIAD common stock as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close by the end of February 2017.

Takeda Pharmaceuticals U.S.A, a wholly owned subsidiary of Takeda, has established Kiku Merger Co., Inc. to effect the transaction.

Overview of ARIAD

^* As reported in the 13F filings. Percentage of shares is calculated by dividing the number of shareholdings (as of the end of September 2016) by the number of total shares outstanding of the target company.

Change in ownership before and after acquisition

Schedule

^* Fulfillment of the terms and conditions of the U.S. Antitrust Law and the satisfaction of certain other customary conditions are required to complete the acquisition.

Outlook

FY2016

At this stage we expect minimal impact on Underlying Revenue and Underlying Core Earnings. We do expect to incur transition and integration expenses, however, these expenses are not material to the current year result. We will incorporate the financial impact in our FY2016 consolidated earnings forecast and announce at the third quarter earnings conference in February 2017.

FY2017 and beyond

It is expected that the acquisition of ARIAD will be accretive to Takeda’s Underlying Core Earnings by FY2018 and broadly neutral in FY2017. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the brigatinib launch. Takeda’s financial guidance, including EPS, for FY2017 will be announced when Takeda reports earnings for FY2016 in May 2017.

Conference Call Webcast Information

Takeda will host a media/investors conference call at 7:30 p.m. EST January 9, 2017 (9:30 a.m. JST January 10, 2017) to discuss the transaction.

You can listen to the conference call at the following link:

http://www.Takeda.com/investor-information/results/

A replay of the conference call will be available within 24 hours.

In light of this announcement, ARIAD will not be presenting today at the 35^th Annual J.P. Morgan Healthcare Conference.

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. Additional information about Takeda is available through its corporate website, www.Takeda.com.

About Iclusig^® (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel, Canada and Japan.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

• Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
• Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.

Limitations of use:

Limitations of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.

IMPORTANT SAFETY INFORMATION

Based on the Phase 2 48 mo. follow-up analysis (N=449), except where noted

IMPORTANT U.S. SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: ARTERIAL OCCLUSION, VENOUS THROMBOEMBOLISM, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning.

• Arterial occlusion has occurred in at least 35% of Iclusig^® (ponatinib)-treated patients including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Interrupt or stop Iclusig immediately for arterial occlusion. A benefit-risk consideration should guide a decision to restart Iclusig.
• Venous Thromboembolism has occurred in 6% of Iclusig-treated patients. Monitor for evidence of thromboembolism. Consider dose modification or discontinuation of Iclusig in patients who develop serious venous thromboembolism.
• Heart Failure, including fatalities occurred in 9% of Iclusig treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.
• Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

Warnings and Precautions

Arterial Occlusions: Arterial occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease have occurred in at least 35% of Iclusig-treated patients from the phase 1 and phase 2 trials. In the phase 2 trial, 33% (150/449) of Iclusig-treated patients experienced a cardiac vascular (21%), peripheral vascular (12%), or cerebrovascular (9%) arterial occlusive event; some patients experienced more than 1 type of event. Fatal and life-threatening events have occurred within 2 weeks of starting treatment, with doses as low as 15 mg per day. Iclusig can also cause recurrent or multi-site vascular occlusion. Patients have required revascularization procedures. The median time to onset of the first cardiac vascular, cerebrovascular, and peripheral vascular arterial occlusive events was 193, 526, and 478 days, respectively. Patients with and without cardiovascular risk factors, some age 50 years or younger, experienced these events. The most common risk factors observed with these events were hypertension, hyperlipidemia, and history of cardiac disease. Arterial occlusive events were more frequent with increasing age and in patients with a history of ischemia, hypertension, diabetes, or hyperlipidemia. In patients suspected of developing arterial occlusive events, interrupt or stop Iclusig.

Venous Thromboembolism: Venous thromboembolic events occurred in 6% (25/449) of Iclusig-treated patients with an incidence rate of 5% (13/270 CP-CML), 4% (3/85 AP-CML), 10% (6/62 BP-CML) and 9% (3/32 Ph+ ALL). Events included: deep venous thrombosis, pulmonary embolism, superficial thrombophlebitis, and retinal vein thrombosis with vision loss. Consider dose modification or discontinuation of Iclusig in patients who develop serious venous thromboembolism.

Heart Failure: Fatal or serious heart failure or left ventricular dysfunction occurred in 6% of Iclusig-treated patients (29/449). Nine percent of patients (39/449) experienced any grade of heart failure or left ventricular dysfunction. The most frequently reported heart failure events were congestive cardiac failure and decreased ejection fraction (14 patients each; 3%). Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig. Consider discontinuation if serious heart failure develops.

Hepatotoxicity: Iclusig can cause hepatotoxicity, including liver failure and death. Fulminant hepatic failure leading to death occurred in a patient within one week of starting Iclusig. Two additional fatal cases of acute liver failure also occurred. The fatal cases occurred in patients with BP-CML or Ph+ ALL. Severe hepatotoxicity occurred in all disease cohorts, with 11% (50/449) experiencing grade 3 or 4 hepatotoxicity. The most common forms of hepatotoxicity were elevations of AST or ALT (54% all grades, 8% grade 3 or 4, 5% not reversed at last follow-up), bilirubin, and alkaline phosphatase. Hepatotoxic events were observed in 29% of patients. The median time to onset of hepatotoxicity event was 3 months. Monitor liver function tests at baseline, then at least monthly or as clinically indicated. Interrupt, reduce or discontinue Iclusig as clinically indicated.

Hypertension: Treatment-emergent elevation of systolic or diastolic blood pressure (BP) occurred in 68% (306/449) of Iclusig-treated patients. Fifty-three patients (12%) experienced treatment-emergent symptomatic hypertension as a serious adverse reaction, including hypertensive crisis. Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath. In patients with baseline systolic BP<140 mm Hg and baseline diastolic BP<90 mm Hg, 80% (229/285) experienced treatment-emergent hypertension; 44% (124/285) developed Stage 1 hypertension, 37% developed Stage 2 hypertension. In 132 patients with Stage 1 hypertension at baseline, 67% (88/132) developed Stage 2 hypertension. Monitor and manage blood pressure elevations during Iclusig use and treat hypertension to normalize blood pressure. Interrupt, dose reduce, or stop Iclusig if hypertension is not medically controlled. In the event of significant worsening, labile or treatment-resistant hypertension, interrupt treatment and consider evaluating for renal artery stenosis.

Pancreatitis: Pancreatitis occurred in 7% (31/449, 6% serious or grade 3/4) of Iclusig-treated patients. The incidence of treatment-emergent lipase elevation was 42% (16% grade 3 or greater). Pancreatitis resulted in discontinuation or treatment interruption in 6% of patients (26/449). The median time to onset of pancreatitis was 14 days. Twenty-three of the 31 cases of pancreatitis resolved within 2 weeks with dose interruption or reduction. Check serum lipase every 2 weeks for the first 2 months and then monthly thereafter or as clinically indicated. Consider additional serum lipase monitoring in patients with a history of pancreatitis or alcohol abuse. Dose interruption or reduction may be required. In cases where lipase elevations are accompanied by abdominal symptoms, interrupt treatment with Iclusig and evaluate patients for pancreatitis. Do not consider restarting Iclusig until patients have complete resolution of symptoms and lipase levels are less than 1.5 x ULN.

Increased Toxicity in Newly Diagnosed Chronic Phase CML: In a prospective randomized clinical trial in the first-line treatment of newly diagnosed patients with chronic phase (CP) CML, single agent Iclusig 45 mg once-daily increased the risk of serious adverse reactions 2-fold compared to single agent imatinib 400 mg once-daily. The median exposure to treatment was less than 6 months. The trial was halted for safety in October 2013. Arterial and venous thrombosis and occlusions occurred at least twice as frequently in the Iclusig arm compared to the imatinib arm. Compared to imatinib-treated patients, Iclusig-treated patients exhibited a greater incidence of myelosuppression, pancreatitis, hepatotoxicity, cardiac failure, hypertension, and skin and subcutaneous tissue disorders. Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

Neuropathy: Peripheral and cranial neuropathy have occurred in Iclusig-treated patients. Overall, 20% (90/449) of Iclusig-treated patients experienced a peripheral neuropathy event of any grade (2%, grade 3/4). The most common peripheral neuropathies reported were paresthesia (5%, 23/449), neuropathy peripheral (4%, 19/449), hypoesthesia (3%, 15/449), dysgeusia (2%, 10/449), muscular weakness (2% 10/449) and hyperesthesia (1%, 5/449). Cranial neuropathy developed in 2% (10/449) of Iclusig-treated patients (<1%, 3/449 – grade 3/4). Of the patients who developed neuropathy, 26% (23/90) developed neuropathy during the first month of treatment. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain or weakness. Consider interrupting Iclusig and evaluate if neuropathy is suspected.

Ocular Toxicity: Serious ocular toxicities leading to blindness or blurred vision have occurred in Iclusig-treated patients. Retinal toxicities including macular edema, retinal vein occlusion, and retinal hemorrhage occurred in 2% of Iclusig-treated patients. Conjunctival irritation, corneal erosion or abrasion, dry eye, conjunctivitis, conjunctival hemorrhage, hyperaemia and edema or eye pain occurred in 14% of patients. Visual blurring occurred in 6% of patients. Other ocular toxicities include cataracts, periorbital edema, blepharitis, glaucoma, eyelid edema, ocular hyperaemia, iritis, iridocyclitis, and ulcerative keratitis. Conduct comprehensive eye exams at baseline and periodically during treatment.

Hemorrhage: Serious hemorrhage events including fatalities, occurred in 6% (28/449) of patients treated with Iclusig. Hemorrhage occurred in 28% (124/449) of patients. The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML, and Ph+ ALL. Gastrointestinal hemorrhage and subdural hematoma were the most commonly reported serious bleeding events occurring in 1% (4/449) each. Most hemorrhagic events, but not all, occurred in patients with grade 4 thrombocytopenia. Interrupt Iclusig for serious or severe hemorrhage and evaluate.

Fluid Retention: Fluid retention events judged as serious occurred in 4% (18/449) of patients treated with Iclusig. One instance of brain edema was fatal. For fluid retention events occurring in >2% of the patients (treatment-emergent), serious cases included: pleural effusion (7/449, 2%), pericardial effusion (4/449, 1%), and edema peripheral (2/449, <1%).

In total, fluid retention occurred in 31% of the patients. The most common fluid retention events were peripheral edema (17%), pleural effusion (8%), pericardial effusion (4%) and peripheral swelling (3%).

Monitor patients for fluid retention and manage patients as clinically indicated. Interrupt, reduce, or discontinue Iclusig as clinically indicated.

Cardiac arrhythmias: Arrhythmias occurred in 19% (86/449) of Iclusig-treated patients, of which 7% (33/449) were grade 3 or greater. Arrhythmia of ventricular origin was reported in 3% (3/86) of all arrhythmias, with one case being grade 3 or greater. Symptomatic bradyarrhythmias that led to pacemaker implantation occurred in 1% (3/449) of Iclusig-treated patients.

Atrial fibrillation was the most common arrhythmia and occurred in 7% (31/449) of patients, approximately half of which were grade 3 or 4. Other grade 3 or 4 arrhythmia events included syncope (9 patients; 2.0%), tachycardia and bradycardia (2 patients each 0.4%), and electrocardiogram QT prolonged, atrial flutter, supraventricular tachycardia, ventricular tachycardia, atrial tachycardia, atrioventricular block complete, cardio-respiratory arrest, loss of consciousness, and sinus node dysfunction (1 patient each 0.2%). For 27 patients, the event led to hospitalization.

In patients with signs and symptoms suggestive of slow heart rate (fainting, dizziness) or rapid heart rate (chest pain, palpitations or dizziness), interrupt Iclusig and evaluate.

Myelosuppression: Myelosuppression was reported as an adverse reaction in 59% (266/449) of Iclusig-treated patients and grade 3/4 myelosuppression occurred in 50% (226/449) of patients. The incidence of these events was greater in patients with AP-CML, BP-CML, and Ph+ ALL than in patients with CP-CML.

Severe myelosuppression (Grade 3 or 4) was observed early in treatment, with a median onset time of 1 month (range <1-40 months). Obtain complete blood counts every 2 weeks for the first 3 months and then monthly or as clinically indicated, and adjust the dose as recommended.

Tumor Lysis Syndrome: Two patients (<1%, one with AP-CML and one with BP-CML) treated with Iclusig developed serious tumor lysis syndrome. Hyperuricemia occurred in 7% (31/449) of patients. Due to the potential for tumor lysis syndrome in patients with advanced disease, ensure adequate hydration and treat high uric acid levels prior to initiating therapy with Iclusig.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Postmarketing cases of reversible posterior leukoencephalopathy syndrome (RPLS—also known as Posterior Reversible Encephalopathy Syndrome (PRES)) have been reported in Iclusig-treated patients. RPLS is a neurological disorder that can present with signs and symptoms such as seizure, headache, decreased alertness, altered mental functioning, vision loss, and other visual and neurological disturbances. Hypertension is often present and diagnosis is made with supportive findings on magnetic resonance imaging (MRI) of the brain. If RPLS is diagnosed, interrupt Iclusig treatment and resume treatment only once the event is resolved and if the benefit of continued treatment outweighs the risk of RPLS.

Compromised Wound Healing and Gastrointestinal Perforation: Since Iclusig may compromise wound healing, interrupt Iclusig for at least 1 week prior to major surgery. Serious gastrointestinal perforation (fistula) occurred in one patient 38 days post-cholecystectomy.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings from animal studies, Iclusig can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at exposures lower than human exposures at the recommended human dose. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Iclusig and for 3 weeks after the last dose.

Most Common Adverse Reactions: Overall, the most common non-hematologic adverse reactions (≥20%) were abdominal pain, rash, constipation, headache, dry skin, fatigue, hypertension, pyrexia, arthralgia, nausea, diarrhea, lipase increased, vomiting, myalgia and pain in extremity. Hematologic adverse reactions included thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia.

Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning.

Iclusig is a registered trademark of ARIAD Pharmaceuticals, Inc.

Additional Information

The tender offer described in this press release has not yet commenced. This press release is provided for informational purposes only and does not constitute an offer to purchase or the solicitation of an offer to sell any securities. At the time the tender offer is commenced, Takeda and its wholly owned subsidiary, Kiku Merger Co., Inc., intend to file with the Securities and Exchange Commission (the “SEC”) a Tender Offer Statement on Schedule TO containing an offer to purchase, a form of letter of transmittal and other documents relating to the tender offer, and ARIAD intends to file with the SEC a Solicitation/Recommendation Statement on Schedule 14D 9 with respect to the tender offer. Takeda, Kiku Merger Co., Inc. and ARIAD intend to mail these documents to the ARIAD stockholders. Investors and shareholders should read those filings carefully when they become available as they will contain important information about the tender offer. Those documents may be obtained without charge at the SEC’s website at www.sec.gov. The offer to purchase and related materials may also be obtained (when available) for free by contacting the information agent for the tender offer.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking information related to Takeda, ARIAD and the proposed acquisition of ARIAD by Takeda that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements in this document include, among other things, statements about the potential benefits of the proposed acquisition, anticipated earnings accretion and growth rates, Takeda’s and ARIAD’s plans, objectives, expectations and intentions, the financial condition, results of operations and business of Takeda and ARIAD, ARIAD’s products, ARIAD’s pipeline assets, and the anticipated timing of closing of the acquisition. Risks and uncertainties include, among other things, risks related to the satisfaction of the conditions to closing the acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including uncertainties as to how many of ARIAD’s stockholders will tender their shares in the tender offer and the possibility that the acquisition does not close; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Takeda’s common stock and on Takeda’s operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition; other business effects, including the effects of industry, market, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; future business combinations or disposals; the uncertainties inherent in research and development, including the ability to sustain and increase the rate of growth in revenues for ARIAD’s products despite increasing competitive, reimbursement and economic challenges; whether and when any drug applications may be filed in any jurisdictions for any indications or any additional indications for ARIAD’s products or for ARIAD’s pipeline assets; whether and when the FDA or any other applicable regulatory authorities may approve any such applications, which will depend on its assessment of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by the FDA or other regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of ARIAD’s products and ARIAD’s pipeline assets; and competitive developments.

Many of these factors are beyond Takeda’s control. Unless otherwise required by applicable law, Takeda disclaims any intention or obligation to update forward-looking statements contained in this document as the result of new information or future events or developments.

$NWMH Ends Year on High Note, Announces Final #Acquisition of 2016

HERNANDO, FL / January 9, 2017 / National Waste Management Holdings, Inc. (OTC PINK: NWMH) (“National Waste”), a growing and emerging vertically integrated solid waste management company, today announces that it has acquired Northeast Data Destruction and Recycling, LLC, located in Kingston, New York.

The transaction, which closed December 31, 2016, expands National Waste Management’s base operations in Upstate New York, where the Company is responding to customer demand for cardboard recycling and document destruction, hard drive destruction, and other data destruction.

“Acquiring Northeast Data Destruction and Recycling extends our reach to Kingston, New York, allowing us to offer roll-off services as we plan future expansion of this location. We are currently searching for a good building – either to buy or move into – that will best suit our needs and the needs of our new client base in the area,” says Louis “Tiny” Paveglio, CEO of National Waste Management. “The acquisition enables our sales team to offer the additional services in both locations, and at the same time enables us to trim overhead costs.”

National Waste Management’s acquisition strategy calls for at least one acquisition per quarter, subsequently diversifying revenue streams. The acquisition of Northeast Data Destruction and Recycling demonstrates management’s commitment to this aggressive business model.

“We are proud to announce our final acquisition of 2016, an achievement on par with our goal to become vertically integrated via strategic acquisition,” says National Waste Management CFO Dali Kranzthor. “We have more acquisitions in the pipeline and look forward to another year of building value for National Waste and its shareholders.”

About National Waste Management Holdings Inc.

National Waste Management Holdings Inc. is a growing and emerging vertically integrated solid waste management company with a concentration on C&D collection, hauling and recycling. National Waste services Florida’s west coast and upstate New York and is a distinguished leader in solid waste services. More information may be found at the Company’s website: http://www.nationalwastemgmt.com.

This release contains certain statements that are, or may be deemed to be, forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934, and are made in reliance upon the protections provided by such Acts for forward-looking statements. We have identified forward-looking statements by using words such as “expect,” “believe,” and “should.” Although we believe our expectations are reasonable, our operations involve a number of risks and uncertainties that are beyond our control, and these statements may turn out not to be true. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company’s Form SEC filings.

Communications Contact:

NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com

$ARDM to Present at 9th Annual #BiotechShowcaseConference on January 9

Aradigm Corporation (Nasdaq:ARDM) (the “Company”) today announced that President and Chief Executive Officer, Igor Gonda, Ph.D., will present an overview of the Company at the 9^th Annual Biotech Showcase Conference on Monday, January 9, 2017, at 5:00 p.m. Pacific time. The event will be held at the Hilton San Francisco Union Square, San Francisco, California.

Interested parties can access a live audio webcast and slide presentation at www.aradigm.com. An archived presentation and the presentation slides will be available on the Company’s Web site for 30 days.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm is completing Phase 3 development of Pulmaquin® (an investigational proprietary formulation of ciprofloxacin for inhalation) for the treatment of non-cystic fibrosis bronchiectasis. Aradigm’s inhaled ciprofloxacin formulations including Pulmaquin are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax. In addition, Aradigm has a pipeline composed of programs to prevent diseases in tobacco smokers through smoking cessation and a diagnostic program to detect aspirations of gastrointestinal fluid into the respiratory tract. More information about Aradigm can be found at www.aradigm.com.

Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.

$BIOS Announces Amendment to Credit Agreement and New #SeniorLoanFacility

DENVER, Jan. 06, 2017  — BioScrip, Inc. (NASDAQ:BIOS) (“BioScrip” or the “Company”), a leading national provider of infusion and home care management solutions, today announced that it has entered into an agreement to amend its existing Credit Agreement (the “Amendment”), dated July 31, 2013, among BioScrip, the guarantors, SunTrust Bank as administrative agent, and a syndicate of lenders. Additionally, BioScrip and the guarantors under the existing Credit Agreement announced a new $25 million senior loan facility.

The amended Credit Agreement, together with the new senior loan facility, as approved by BioScrip’s lenders, includes the following benefits:

• $25 million new senior loan facility from existing lenders, providing $19 million in incremental liquidity and a $6 million reduction in existing revolver balances
• Revised covenants, under which the Company anticipates full compliance
• Revised commitment reduction schedule, which the Company believes it can comfortably manage

About BioScrip

BioScrip, Inc. is a leading national provider of infusion and home care management solutions. BioScrip partners with physicians, hospital systems, skilled nursing facilities, healthcare payors, and pharmaceutical manufacturers to provide patients access to post-acute care services. BioScrip operates with a commitment to bring customer-focused pharmacy and related healthcare infusion therapy services into the home or alternate-site setting. By collaborating with the full spectrum of healthcare professionals and the patient, BioScrip provides cost-effective care that is driven by clinical excellence, customer service, and values that promote positive outcomes and an enhanced quality of life for those it serves.

Forward-Looking Statements – Safe Harbor

This press release includes statements that may constitute “forward-looking statements,” that involve substantial risks and uncertainties. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the fact that they do not relate strictly to historical or current facts. In some cases, forward-looking statements can be identified by words such as “may,” “should,” “could,” “anticipate,” “estimate,” “expect,” “project,” “outlook,” “aim,” “intend,” “plan,” “believe,” “predict,” “potential,” “continue” or comparable terms. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Important factors that could cause or contribute to such differences include but are not limited to risks associated with: the Company’s ability to integrate the acquisition of Home Solutions, the Company’s ability to grow its core Infusion revenues, the Company’s ability to continue to experience positive results from its financial improvement plan to reduce operating costs; the Company’s ability to comply with the covenants in its debt agreements; the success of the Company’s initiatives to mitigate the impact of the Cures Act on its business; reductions in federal, state and commercial reimbursement for the Company’s products and services; increased government regulation related to the health care and insurance industries; as well as the risks described in the Company’s periodic filings with the Securities and Exchange Commission. The Company does not undertake any duty to update these forward-looking statements after the date hereof, even though the Company’s situation may change in the future. All of the forward-looking statements herein are qualified by these cautionary statements.

For Further Information:

Investor Contacts

Jeffrey M. Kreger
Chief Financial Officer
(720) 697-5200
jeffrey.kreger@bioscrip.com

David Clair
ICR, Inc.
(646) 277-1266
david.clair@icrinc.com

$PTX Appoints #KenPina as #GeneralCounsel and #CCO

MORRISTOWN, N.J., Jan. 06, 2017  — Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX), a specialty pharmaceutical company with a focus on pain and CNS conditions, today announced the appointment of Ken Piña as Senior Vice President, General Counsel and Chief Compliance Officer.  Mr. Piña will report directly to John Sedor, Chairman and Chief Executive Officer, and will serve as the Company’s senior in-house counsel, overseeing the legal and compliance area, and establishing legal and compliance strategies.

“Ken brings to Pernix extensive legal and life sciences experience with a notable record of achievement in developing and leading global legal and business initiatives for pharmaceutical companies,” said John Sedor, chairman and chief executive officer. “As our general counsel and chief compliance officer, Ken will be responsible for developing and managing our company’s legal and compliance strategies and related functional areas.  He will also fill a vital role as a key member of Pernix’s Executive Leadership Team. We are delighted to welcome Ken to our company.”

Most recently, Mr. Piña was a Founder and the Managing Principal of Core Risks Ltd. (CRL), which was acquired by Jardine Lloyd Thompson.  His practice focused on corporate compliance and ethics programming, enterprise risk and crisis-management program development and litigation support on behalf of a diverse client base.  Prior to joining CRL, Mr. Piña served Senior Vice President, Chief Legal Officer and Secretary for Henkel Corporation, a consumer products and specialty chemical company.  Before joining Henkel, he worked at Rhone-Poulenc Rorer Pharmaceuticals Inc., where he held positions of increasing responsibility, including Vice President, General Counsel and Secretary.

“Pernix has a talented team and an impressive product portfolio which represent a compelling opportunity for all of the Company’s stakeholders,” Mr. Piña said.  “I look forward to supporting Pernix’s continuing efforts to enhance its operations and bring important pain management and CNS products to patients and physicians.”

Mr. Piña received his Juris Doctorate from the Dickinson School of Law, Pennsylvania State University, earned his B.S. degree from the Rutgers University College of Pharmacy.  He has served as an adjunct professor of food and drug law at Temple University and as a lecturer in law at the Villanova School of Law.  He is also co-editor of the industry text, An Introduction to Food and Drug Law and Regulation (FDLI).

About Pernix Therapeutics
Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and pain management, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its integrated Pernix sales force and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc.  To learn more about Pernix Therapeutics, visit www.pernixtx.com.

CONTACT
Investor Relations
Matthew P. Duffy, 212-915-0685
LifeSci Advisors, LLC
matthew@lifesciadvisors.com

$NETE #UnifiedPayments Launches Payment Acceptance for #ReservHotel

Unified Payments enables payment acceptance services for leading travel distribution and booking provider

$HALO Announces #Phase2 Advanced #Pancreatic #Cancer Meets Key Endpoints

-Study shows statistically significant improvement in progression-free survival (PFS) in all evaluable patients and in patients with high levels of hyaluronan (HA), a potential new biomarker- -Stage 2 of HALO 202 shows 91 percent improvement in median progression-free survival of HA-High patients in PEGPH20 arm, 8.6 months compared to 4.5 months in the control arm- -Stage 2 Primary endpoint of reduction in Thromboembolic Events achieved- -Company to host conference call at 8:00 a.m. ET to discuss the results-

SAN DIEGO, Jan. 5, 2017  — Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported topline results from the combined analysis of Stages 1 and 2 and Stage 2 alone of its HALO 202 study, a Phase 2 randomized, multi-center clinical trial of lead investigational drug PEGPH20 in combination with ABRAXANE^® (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer patients.

Among the findings, the overall study population showed a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving ABRAXANE and gemcitabine alone. Stage 2 of the study, which completed enrollment in February 2016, showed a 91 percent improvement in median PFS for HA-High patients in the PEGPH20 arm, 8.6 months compared to 4.5 months in the control arm, and achieved its primary endpoint to evaluate and demonstrate a reduction in the rate of thromboembolic events in the PEGPH20 arm.

“These findings confirm our confidence in the development of PEGPH20 in this difficult to treat cancer,” said Dr. Helen Torley, president and CEO. “We are pleased by the overall consistency of both the efficacy and safety data which are supportive of our ongoing Phase 3 clinical trial, HALO 301, currently underway at more than 160 sites worldwide.”

Dr. Sunil R. Hingorani, the principal investigator leading this trial, and a pancreas cancer expert at Fred Hutchinson Cancer Research Center and professor at University of Washington School of Medicine, said: “The Study 202 data confirm for the first time in a randomized Phase 2 trial using the current standard of care that a biopsy-based biomarker for hyaluronan content can potentially identify patients who will have a meaningfully greater response when PEGPH20 is added to their treatment. The analysis suggests statistically significant and clinically important progress in this very difficult to treat cancer. The median PFS is a notable increase over the current standard of care and supports ongoing exploration in the current Phase 3 study.”

Pancreas cancer is the third-leading cause of cancer related death in the United States, and more than 65,000 people in the U.S. and top five European countries are diagnosed annually with advanced cases of the disease.

Webcast and Conference Call
Halozyme will host a webcast and conference call to discuss the results, today, Jan. 5 at 8:00 a.m. ET/5:00 a.m. PT. Presenting on the call will be Dr. Torley and Dr. Athena Countouriotis, chief medical officer. Two leading pancreas cancer experts will also participate: Dr. Hingorani, and Dr. Eileen M. O’Reilly, associate director of the David M. Rubenstein Center for Pancreatic Cancer Research, attending physician, member at Memorial Sloan Kettering Cancer Center and Professor of Medicine at Weill Cornell Medical College.

The call will be webcast live through the “Investors” section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit http://www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may also be accessed by calling 877-410-5657 (domestic callers) 334-323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 24712688.

About HALO 301 and HALO 202
HALO 301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The trial will be conducted at approximately 200 sites with two primary endpoints, progression free survival and overall survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE^® (nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone. Secondary endpoints also include objective response rate and overall survival. More information may be found at clinicaltrials.gov (search HALO 301 or trial identifier NCT02715804) or www.HALO301.com.

HALO 202 (Halo 109-202) is a phase 2 multi-center, randomized clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. A second primary endpoint assesses the thromboembolic event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival.

About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreas cancer.

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

Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the possible activity, benefits and attributes of PEGPH20, the possible method of action of PEGPH20, its potential application to improve cancer therapies and statements concerning future actions relating to the development of PEGPH20) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company’s most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission.

Contacts:
Jim Mazzola
858-704-8122
ir@halozyme.com

Chris Burton
858-704-8352
ir@halozyme.com

$GNVC Signs #OptionAgreement for #GeneEditing, #CellTargeting from @WUSTLmed

Provides Exclusive Access to Gene Editing and Pulmonary Endothelial Targeting Technologies Complements and Expands Applications for the AdenoVerse™ Gene-Delivery Platform

GAITHERSBURG, Md., Jan. 5, 2017  — GenVec, Inc. (NASDAQ: GNVC), a clinical-stage gene delivery company, announced today that it has entered into an exclusive option agreement with Washington University in St. Louis to license intellectual property and technology related to gene editing and pulmonary endothelial cell targeting. If the option is exercised, the license will allow broad utilization of technology developed by David T. Curiel, M.D., Ph.D., professor of radiation oncology and Jeffrey Arbeit, M.D., professor of surgery at Washington University School of Medicine. GenVec plans to initially focus on research utilizing the technology to develop treatments for hemophilia.

“This agreement provides GenVec with the foundation to establish a proprietary and differentiated program using an individual’s pulmonary endothelium as a site for protein production,” said Douglas Swirsky, president and CEO of GenVec. “Proprietary vectors from our AdenoVerse platform are well suited for the delivery of gene editing payloads and could be useful in emerging therapeutic approaches to the long-term correction of genetic disorders such as those that cause blood factor deficiencies.”

“We are excited to have the opportunity to expand our collaboration with Washington University,” said Douglas E. Brough, Ph.D, chief scientific officer of GenVec. “Combining gene editing and pulmonary endothelial cell targeting approaches with GenVec’s AdenoVerse technology offers a unique and compelling platform to provide patients with proteins that they are deficient in to potentially address hemophilia and numerous other unmet medical needs.”

About Washington University School of Medicine in St. Louis

Washington University School of Medicine’s 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient-care institutions in the nation, currently ranked sixth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.

About GenVec

GenVec is a clinical-stage gene delivery company focused on developing a pipeline of cutting-edge therapeutics and vaccines using its proprietary AdenoVerse platform. The company is a pioneer in the design, testing and manufacture of adenoviral-based product candidates that can deliver on the promise of gene-based medicine. GenVec’s lead product candidate, CGF166, is licensed to Novartis and is currently in a Phase 1/2 clinical study for the treatment of hearing loss and balance disorders. In addition to its internal and partnered pipeline, the company is also focused on opportunities to license its proprietary technology platform, including vectors and production cell lines, for the development and manufacture of therapeutics and vaccines to the biopharmaceutical industry. Additional information about GenVec is available at www.genvec.com and in the company’s various filings with the Securities and Exchange Commission.

Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including with respect to expansion of the reach of GenVec’s technology platform, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act.  GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time.  Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of GenVec’s proposed product candidates (such as marketing, regulatory, patent, product liability, supply, competition and other risks); dependence on the efforts of third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations.  Further information on the factors and risks that could affect GenVec’s business, financial conditions and results of operations are contained in GenVec’s filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. The forward-looking statements speak only as of the date of this presentation, and GenVec assumes no duty to update forward-looking statements.

Contact:
Rena Cohen
(240) 632-5501
ir@genvec.com

$QTNT #Positive #MosaiQ #Results Performance Evaluation Study for #BloodGrouping

• Root-cause investigation completed and corrective actions implemented
• Performance evaluation study for antigen typing achieves targeted endpoints
• Completion of European field trials expected in the first half of 2017

JERSEY, Channel Islands, Jan. 05, 2017 — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today reported positive results from its MosaiQ™ performance evaluation study for antigen typing.  The Company continues to expect European field trials for MosaiQ™, for blood grouping and the initial disease screening panel, to be completed during the first half of 2017.

“We believe the positive results from the performance evaluation study demonstrate the power and potential of MosaiQ™.  Prior to commencing the study, we successfully completed the root-cause investigation previously announced and implemented all necessary corrective actions,” said Paul Cowan, Chairman and Chief Executive Officer of Quotient.  “Results from the performance evaluation study demonstrate our confidence in being able to transfer existing blood grouping tests to the MosaiQ™ platform and that the MosaiQ™ instrument is robust.”

MosaiQ™, Quotient’s next-generation automation platform for blood grouping and donor disease screening, is a transformative and highly disruptive testing platform designed to address the $3.4 billion global transfusion diagnostics market.  Utilizing a single instrument platform, MosaiQ™ is designed to undertake a comprehensive characterization of donor and patient blood (i.e. blood grouping) and all mandated serological and molecular disease screening tests for donor blood.  Adoption of  MosaiQ™ by donor- and patient-testing laboratories is expected to deliver substantial efficiencies and material cost savings, while also improving patient outcomes.

Antigen Typing Performance Evaluation Study – Results

Microarrays incorporating assays to identify ABO, Rhesus and Kell blood-group antigens were used in the performance evaluation study.  Below is a summary of the results.

Microarrays used in the study were manufactured at the Company’s Eysins, Switzerland facility (printing, wet process and final assembly), with microarrays from multiple production lots being used.  Samples were acquired from donor-collection agencies and processed using MosaiQ™ instruments incorporating final hardware and the latest version of the instrument software.  Results using MosaiQ™ were compared with results generated by the donor-collection laboratories providing the samples – using predicate technologies (i.e., the Beckman Coulter PK7300 or manual testing).

Performance evaluation studies for antibody screening/identification and the initial disease screening panel (to screen for CMV and Syphilis) are underway.

MosaiQ™ – Serological Disease Screening Panel

Activities with the Company’s development partner for the full serological disease screening panel have achieved their targeted milestones, prior to final internal development studies and optimization using microarrays manufactured at the Eysins, Switzerland facility and MosaiQ™ instruments.

About MosaiQ™

MosaiQ™ has been designed to offer a breadth of diagnostic tests unmatched by existing commercially available transfusion diagnostic instrument platforms, spanning blood grouping, serological disease screening for donor testing and nucleic acid testing (or molecular disease screening) for donor testing.

Once approved, MosaiQ™ will be the first fully automated solution for blood grouping, providing for the comprehensive characterization of donor and patient blood, with turnaround times significantly quicker than existing methods. Widespread adoption of MosaiQ™ is expected to improve patient outcomes through better and easier matching of donor and patient blood, given cost-effective extended antigen typing offered by MosaiQ™. Improved patient outcomes from the use of MosaiQ™ include the potential for reduced incidence of adverse events associated with transfusion, including alloimmunization where patients develop antibodies to foreign antigens introduced through transfused blood.

MosaiQ™ will also offer the opportunity for substantial cost savings and a range of operational efficiencies for donor and patient testing laboratories, including:

• elimination of the need for expensive, routine manual testing typically undertaken by highly skilled technicians;
• simplification of required consumables and testing processes;
• consolidation of multiple instrument platforms in donor testing laboratories;
• significant reduction in sample volume requirements;
• significant reduction in waste, including the number and volume of patient/donor samples required, consumables and reagent waste; and
• more streamlined processes for matching donor units to patients.

Quotient expects to develop additional applications for MosaiQ™, starting with nucleic acid testing for donor molecular disease screening, upon completion of assay development for the blood grouping and serological disease screening applications.

About Quotient Limited

Quotient is a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and serological disease screening, Quotient is developing its proprietary MosaiQ^TM technology platform to address the $3.4 billion global transfusion diagnostics market. The Company’s operations are based in Switzerland, Scotland and the US.

Forward-Looking Statements

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

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

CONTACT: Paul Cowan, Chairman & Chief Executive Officer – CEO@quotientbd.com; +1 267 756 0842

$ETRM #vBloc #Neurometabolic #Therapy Now at #MedStarHealth, #RoperStFrancis

ST. PAUL, Minn., Jan. 5, 2017 — EnteroMedics Inc. (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the Company’s vBloc^® Neurometabolic Therapy has now been implanted at two additional vBloc Institutes – MedStar Health in Maryland and Roper St. Francis in South Carolina. In order to qualify as a vBloc Institute, a medical center or hospital system must have integrated the Company’s vBloc Therapy and its vBloc^® Achieve support program into its practice. MedStar Health and Roper St. Francis are the twelfth and thirteenth vBloc Institute programs to have integrated vBloc Therapy and the vBloc^® Achieve care delivery program into their practice to fight obesity. vBloc Institutes have previously been established at the following medical centers/hospital systems: VA North Texas Health Care System: Dallas VA Medical Center, NIX Medical (San Antonio), Hartford Hospital, Hackensack University Medical Center, South Florida Surgery and Bariatric Institute, University of Texas Medical Branch (UTMB), Smart Dimensions Weight Loss, Christiana Institute of Advanced Surgery (CHRIAS), Beltline Surgery Center, Winthrop University Hospital and Sky Ridge Medical Center.

vBloc Therapy works to control sensations of hunger using a pacemaker-like device that is implanted under the skin during a safe, minimally-invasive procedure that does not alter or remove any patient anatomy. This device can be adjusted to optimize patients’ therapy needs.  Patients feel the sensation of fullness, empowering them to eat less, control their appetite, make healthier choices and lose weight without the major lifestyle implications of traditional weight loss surgeries.

vBloc Achieve is a comprehensive, personalized weight loss support program to help vBloc patients reach and maintain health goals. While vBloc Therapy addresses hunger signals and cravings, vBloc Achieve provides emotional support and helps patients make positive lifestyle changes, including health, balanced eating and regular exercise that are essential to long-term weight-loss success.

vBloc Therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese, with a BMI of 40 to 45 kg/m², or a BMI of 35 to 39.9 kg/m² with a related health condition such as Type 2 diabetes, high blood pressure, high cholesterol levels or obstructive sleep apnea who have had a poor response to trying to lose weight under supervision in the last 5 years.

About MedStar Health

MedStar Health is a not-for-profit health system dedicated to caring for people in Maryland and the Washington, D.C., region, while advancing the practice of medicine through education, innovation and research. MedStar’s 30,000 associates, 6,000 affiliated physicians, 10 hospitals, ambulatory care and urgent care centers, and the MedStar Health Research Institute are recognized regionally and nationally for excellence in medical care. As the medical education and clinical partner of Georgetown University, MedStar trains more than 1,100 medical residents annually. MedStar Health’s patient-first philosophy combines care, compassion and clinical excellence with an emphasis on customer service. For more information, visit MedStarHealth.org.

About Roper St. Francis

Roper St. Francis is Charleston, South Carolina’s only private, not-for-profit hospital system with a specific focus on community outreach. The healthcare system has three hospitals strategically located across the region: Roper Hospital on the Charleston peninsula, Bon Secours St. Francis Hospital in West Ashley and Roper St. Francis Mount Pleasant Hospital in Mount Pleasant. Roper St. Francis is among Charleston’s largest employers with more than 5,800 employees. The healthcare system has a robust, active medical staff of nearly 800 doctors representing every medical specialty and provides services in more than 125 locations in seven counties.

About EnteroMedics Inc.

EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc^® Neurometabolic Therapy, delivered by a pacemaker-like device called the vBloc^® System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics’ vBloc^® System has received U.S. Food and Drug Administration approval and CE Mark.

Information about the vBloc^® System and vBloc^® Neurometabolic Therapy

You should not have an implanted vBloc^® System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat. The most common related adverse events that were experienced during clinical study of the vBloc System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.

Talk with your doctor about the full risks and benefits of vBloc Therapy and vBloc System. For additional prescribing information, please visit www.enteromedics.com.

If you are interested in learning more about vBloc Neurometabolic Therapy, please visit www.vbloc.com or call 1-800-MY-VBLOC.

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our limited commercial sales experience with our vBloc^® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our ability to regain and then maintain compliance with the Nasdaq continued listing requirements; our ability to commercialize our vBloc^® System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our vBloc^® System; physician adoption of our vBloc^® System and vBloc^® Neurometabolic Therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in the annual report on Form 10-K filed March 28, 2016. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

$EXPI Announces Appointment of Independent Director

$MKGI Appoints #SimonOrange to #BoardOfDirectors, Ramping Towards @NASDAQ Listing

Appointment Advances Monaker’s Plans for NASDAQ Listing

$CEMP to Present at $JPM #Healthcare #Conference

CHAPEL HILL, N.C., Jan. 04, 2017 — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced it will be participating in the 35th Annual J.P. Morgan Healthcare Conference. Management is scheduled to present at 3:30 p.m. PT (6:30 p.m. ET) on Wednesday, January 11, 2017 in San Francisco.

A live audio webcast and archive of the presentations will be available on the company website at http://investor.cempra.com/events.cfm. Listeners are encouraged to visit the site prior to the scheduled presentation to register, download and install any necessary audio software.

About Cempra, Inc.

Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases. Cempra’s two lead product candidates are currently in advanced clinical development. Solithromycin has been successfully evaluated in two Phase 3 clinical trials for community-acquired bacterial pneumonia (CABP). Cempra is currently seeking approval for both intravenous and oral capsule formulations from the FDA and the EMA. Solithromycin is licensed to strategic commercial partner Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Solithromycin is also in a Phase 3 clinical trial for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia. Cempra is contracted with BARDA for the development of solithromycin for pediatric use and has commenced enrollment in a global Phase 2/3 trial to evaluate the safety and efficacy of solithromycin versus standard of care antibiotics in children and adolescents from two months to 17 years of age. Fusidic acid is Cempra’s second product candidate, which has completed enrollment of an initial Phase 3 trial comparing fusidic acid to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI). Cempra also has an ongoing exploratory study of fusidic acid for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra has also synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit www.cempra.com.

Company Contact:
John Bluth
Cempra, Inc.
+1 984 209 4534
jbluth@cempra.com

Investor Contact:
Robert Uhl
Westwicke Partners, LLC
+1 858 356 5932
robert.uhl@westwicke.com

Media Contact:  
Melyssa Weible
Elixir Health PR
+1 201 723 5805
mweible@elixirhealthpr.com

$EFOI #LED lights Verified with “Less Than 1%” Flicker by #UL

First in the U.S. lighting industry with UL-verified flicker performance

SOLON, Ohio, Jan. 04, 2017  — Energy Focus, Inc. (NASDAQ:EFOI), a leader in LED lighting technologies, today announced its new 500D series tubular LED lighting products are the first in the U.S. verified as “Low Optical Flicker, Less Than 1%” by UL, a leading global safety science company for products including electrical devices and components. The designation confirms Energy Focus’ industry-leading status as an innovator of LED lighting technology and commitment to developing flicker-free lighting.

Optical flicker is any fluctuations in brightness over time.  Flicker of sufficiently low frequency can be visually perceived as blinking or flashing.  Higher frequency flicker is invisible to the human eye but puts stress on the human brain as it processes visuals, and is a known cause of headache and eyestrain.   People who have visual hypersensitivity, especially those on the autism spectrum, are susceptible to adverse reactions to fluctuations in light. People with photosensitive epilepsy may experience seizures from flickering light. While LEDs are capable of flicker-free lighting, flicker is often present as a result of low-quality drivers having output current ripple.  By engineering our driver to remove current ripple, Energy Focus products ensures practically flicker-free operation that avoids potential flicker-induced health risks.

UL Verification is an objective, science-based assessment that confirms the accuracy of marketing claims.  The flicker marketing claim Verification service was created in response to new requirements in California Title 24, a new standard designed to reduce commercial and residential energy consumption, for reduced-flicker lighting, as well as address market demand for third-party verified flicker results. This test measures all types of flicker, including frequencies of flicker higher than what the eye can “see” as flashing or blinking, but also the higher frequency, invisible flicker.

“Concern over the effects of optical flicker from lighting on occupants, particularly LED products, has been a frequent topic in the lighting industry,” said Austin Gelder, Technical Advisor for UL’s Lighting division. “The UL Verified Program for Optical Flicker was developed to analyze the optical waveform generated by the product in multiple frequency ranges against the IEEE 1789 recommended practice, and recognizes products that have placed significant effort into their design to minimize the flicker. These requirements are stringent, and the Energy Focus 500D series had less than 1/10^th of the maximum flicker allowed by the program.  It is great to see a lighting manufacturer addressing occupant comfort by prioritizing low flicker in their product design.”

IEEE, or Institute of Electrical and Electronic Engineers, is the world’s largest technical professional organization with a core purpose to foster technological innovations for the benefit of humanity. IEEE Recommended Practice #1789 sets a threshold for “no human impact” of 5% flicker at 120Hz. A new California law requires that flicker be less than 30% when measured at full brightness, and, for lamps that dim, at 20% brightness. UL’s results show less than 0.50% flicker on Energy Focus’ new 500D products.

To learn more about Energy Focus, please call 1-800-327-7877 or visit www.energyfocus.com.

About Energy Focus 
Energy Focus is an industry-leading innovator of energy-efficient LED lighting technology. As the creator of the only UL-verified low-flicker LED products on the market, Energy Focus products provide extensive energy savings, aesthetics, safety and health benefits over conventional and fluorescent lighting.

As a longstanding partner with the US Government providing energy efficient LED lighting products to the U.S. Navy and the Military Sealift Command fleets, Energy Focus products go through rigorous testing in the most adverse conditions possible and still have a zero percent failure rate. In the commercial sphere, customers include national, state and local U.S. government agencies as well as Fortune 500 companies across education, healthcare, retail and manufacturing. Energy Focus is headquartered in Solon, Ohio, with additional sales offices in Washington, D.C., New York and Taiwan.

Media Contact:
Michael Miller
Content Strategist
Energy Focus, Inc.
msmiller@energyfocusinc.com
(440) 715-1300 Office
(734) 945-6359 Cell

Investor Contact:
Peter Seltzberg
Darrow Associates, Inc.
pseltzberg@darrowir.com
(516) 419-9915

$INVE #Hirsch #FICAM Solution 2016 Winner #HomelandSecurity Awards

FREMONT, Calif., Jan. 04, 2017 (GLOBE NEWSWIRE) — Identiv, Inc.  (NASDAQ:INVE) today announced that its award-winning Hirsch government Federal Identity, Credential, and Access Management (FICAM) solution, developed to implement a simple, affordable FICAM-compliant solution simply with optimal performance, has been selected by Government Security News (GSN) as a winner in two categories of its Homeland Security Awards Program. Identiv was selected as the winner in the “Vendors of IT Security Products and Solutions” category as “Best Physical Logical Privileged Access Management Solution” and finalist as “Best User and Entity Behavior Analytics (UEBA) Solution”. Identiv was also selected as the winner in the “Vendors of Physical Security Products and Solutions” category as “Best Access Control Hardware”.

Now in its eighth year, the GSN Awards are recognized as the gold standard of accomplishments and the “best of the best” in IT and cybersecurity, physical security products and services, and the most notable government agency programs, initiatives, and innovations. GSN covers a broad range of homeland security topics including IT and cybersecurity, airport/seaport security, maritime security, law enforcement, video surveillance, law enforcement at federal state, local, and municipal, satellite communications, immigration and border security, critical infrastructure protection, and more.

“There were no inferior security products or services that I evaluated,” said Chuck Brooks, Lead Homeland Security Awards Judge. “They were all stellar. The approaches and methods sometimes differed among the entries, and that is largely because they were highly focused on their specific client needs. As to the government entries, these submissions exemplify the best in public/private cooperation. Government is moving rapidly into the digital era and integrating technologies, processes and accordingly new mandates of their government agencies and programs.”

“We are very pleased to name Hirsch by Identiv’s U.S. government FICAM solution as a winner in multiple categories of the GSN Homeland Security Awards,” said Adrian Courtenay, GSN CEO. “This year, the awards were more difficult than ever to judge because of the incredibly fast pace of change in the categories involved. Identiv was up against impressive competition.”

“Long known as the premier provider of access control and security management systems for government agencies and facilities, our Hirsch government team has applied their expertise built over the years to our Velocity-based FICAM-compliant solution,” said Steve Humphreys, Identiv CEO. “Any of the thousands of doors or portals our systems control in the government space can be easily upgraded to FICAM compliance without the cost and hassle of a forklift replacement, as we leverage virtually all of the existing Hirsch system infrastructure. Those sites needing to replace non-compliant systems will also find our solution extremely cost-effective and quick to deploy, as we don’t rely on third-party certificate processing hardware like so many others. Being recognized by GSN only further reinforces the need for a complete, secure, cost-effective solution for FICAM compliance.”

Identiv’s end-to-end FICAM solution has been developed to address an industry-wide problem of how to implement FICAM simply and with optimal performance. Until now, FICAM solutions from other vendors have been expensive, increasingly difficult to set up, and slow to provide authentication and access at the door. Identiv’s conceptual approach to FICAM and the Federal Information Processing Standard (FIPS) 201 Topology Categories addresses current PACS Infrastructure, Validation System, and Personal Identity Verification (PIV) Reader and is faster and less expensive than the competition. Learn more about Identiv’s solution by visiting identiv.com/ficam, requesting a meeting with an expert, or watching a video demo.

More information about Government Security News, the Homeland Security Awards Programs, and finalists and award winners of 2016 can be found at gsnmagazine.com.

About Identiv
Identiv, Inc. is the leading global player in physical security and secure identification. Identiv’s products, software, systems, and services address the markets for physical and logical access control and a wide range of RFID-enabled applications. Customers in the government, enterprise, consumer, education, healthcare, and transportation sectors rely on Identiv’s access and identification solutions. Identiv’s mission is to secure the connected physical world: from perimeter to desktop access, and from the world of physical things to the Internet of Everything. Identiv is a publicly traded company and its common stock is listed on the NASDAQ Capital Market in the U.S. under the symbol “INVE”. For more information, visit identiv.com.

Media Contact:
press@identiv.com

$EMAN to Demonstrate Their Highest Brightness #OLED Displays at #CES

eMagin Corporation, or the “Company” (NYSE MKT:EMAN), a leader in the development, design and manufacture of Active Matrix OLED microdisplays for high resolution imaging products, today announced that management will be demonstrating their highest brightness, direct patterned micro-displays designed for the virtual reality (VR) and augmented reality (AR) market by appointment to select customers at CES. eMagin is the only company that has designed and manufactured OLED microdisplays which provide the brightness that consumer products companies demand for their next generation VR and AR headsets.

“I am pleased to report we achieved what we set out to do at the beginning of 2016,” commented Andrew Sculley, President and CEO of eMagin. “We are shipping the 2K x 2K display as part of an agreement with a Tier One company that we entered into last year. We previously stated that we expected to sign at least one additional agreement with a Tier One partner in 2016. I am happy to announce that we met this goal and anticipate signing additional agreements in 2017. Our pipeline of interested parties continues to grow, including OEM partners and mass production partners, both of whom are important for commercializing and scaling production of our cutting-edge technology. We have developed and will be demonstrating full color OLED at brightness levels above 4,000 nits that can be mass produced to achieve truly immersive virtual reality.”

To learn more or schedule a demonstration, contact Steve Costello, VP of Business Development at scostello@emagin.com or 617-462-9726.

“Also, during the fourth quarter we launched our two consumer night vision products, the award-winning BlazeSpark smartphone attachment and the BlazeTorch goggles, both of which are being shown at CES. Overall, our efforts in 2016 laid the foundation for a strong 2017 as we further capitalize on our technology development and marketing initiatives,” concluded Mr. Sculley.

About eMagin Corporation

A leader in OLED microdisplay technology, OLED microdisplay manufacturing know-how and mobile display systems, eMagin manufactures high-resolution OLED microdisplays and integrates them with magnifying optics to deliver virtual images comparable to large-screen computer and television displays in portable, low-power, lightweight personal displays. eMagin’s microdisplays provide near-eye imagery in a variety of products from military, industrial, medical and consumer OEMs. More information about eMagin is available at www.emagin.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding eMagin Corporation’s expectations, intentions, strategies and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors, including those described in the Company’s most recent filings with the SEC. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such statements should not be regarded as a representation by the Company, or any other person, that such forward-looking statements will be achieved. The business and operations of the Company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future events or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements

$OIIM Revises Fourth Quarter 2016 Financial Guidance

GEORGE TOWN, Grand Cayman, Jan. 04, 2017  — O2Micro® International Limited (NASDAQ:OIIM), a global leader in the design, development and marketing of high-performance integrated circuits and solutions, today revised its guidance for the fourth quarter of 2016. The company now expects its fourth quarter revenue to be approximately $15.4 million to $15.9 million, an increase of the Company’s previous guidance of $14.7 million to $15.6 million. In addition, gross margin for the fourth quarter is expected to be between 53% and 55%, versus the Company’s previous guidance of 51% to 53%.  The increase in anticipated revenue for the fourth quarter is primarily the result of increased demand for High End TV and Power Tools.  Gross Margins benefitted from continued cost reductions and an improved product mix.

Sterling Du, Chairman and CEO of O2Micro commented, “We are pleased to announce our anticipated fourth quarter improvements in Revenue Guidance and Gross Margins which reflect continued product ramp up in our high growth drivers for the consumer and industrial end markets, including but not limited to the high end sector.  We believe our solutions for these markets will continue to contribute to our top-line growth and lead O₂Micro back to profitability.”

No conference call will be held in conjunction with this financial guidance update. Additional information will be available when the Company reports its fourth quarter results on January 25^th, 2017.

About O₂Micro

Founded in April 1995, O₂Micro develops and markets innovative power management components for the Computer, Consumer, Industrial, Automotive and Communications markets. Products include LED General Lighting, Backlighting, Battery Management, and Power Management.

O₂Micro International maintains offices worldwide. Additional company and product information can be found on the company website at www.o2micro.com.

O₂Micro, the O₂Micro logo, and combinations thereof are registered trademarks of O₂Micro. All other trademarks or registered trademarks are the property of their respective owners.

Statements made in this release that are not historical, including statements regarding O₂Micro’s or management’s intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause actual results to differ materially from those set forth in these statements. Factors that could cause actual results to differ materially include risks and uncertainties such as reduced demand for products of electronic equipment manufacturers which include O₂Micro’s products due to adverse economic conditions in general or specifically affecting O₂Micro’s markets, technical difficulties and delays in the developments process, and errors in the products. You are also referred to the Form F-1 in connection with the company’s initial public offering in August 2000, Form F-3 in connection with the company’s public offering in November 2001, and the annual reports on Form 20-F, which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements. The company assumes no obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.

Contact Information:
Investor Relations, O2Micro
Phone: 408.987.5920, x8888
Email:  ir@o2micro.com

$EVOK Additional #Gimoti #Diabetic #Gastroparesis Data Quite Promising

Nausea and abdominal pain symptoms significantly reduced in patients with higher symptom severity

Investor Contact:
The Ruth Group
Tram Bui
Tel: 646-536-7035
tbui@theruthgroup.com

$TISA #DonDixon Named Chairman of the Board of Directors

Izhak Nakar Steps Down from Position of Active Chairman and Remains Member of Board

TEL AVIV, Israel and PLANO, Texas, Jan. 03, 2017  — Top Image Systems, Ltd. (NASDAQ:TISA), a global innovator of intelligent content processing solutions, today announced that Mr. Don Dixon has assumed the position of Chairman of the Board of Directors for the Company effective January 1, 2017. Izhak Nakar, Company Founder and Active Chairman of the Board, decided to step down from his position as Active Chairman; Mr. Nakar will retain his membership on the Board and continues to hold a stake in the Company.

With Mr. Dixon agreeing to assume the position of Chairman of the Board and the Company now under the active management of an experienced and professional executive management team, including CEO Brendan Reidy appointed in August 2016 and the CTO, CSO, CFO, CMO and regional Presidents, Mr. Nakar has decided to step down from the position of Active Chairman in order to invest more of his time in managing the other companies in his portfolio and to devote more attention to personal pursuits.

Mr. Dixon, Managing Director of Trident Capital, a major shareholder in Top Image Systems, has extensive experience in transforming and growing shareholder value for the companies in his broad portfolio. He brings his expertise, experience and network to each of his portfolio companies and has helped many to become industry leaders, including Qualys, Merchant e-Solutions, Bytemobile, CSG Systems, and eGistics, Inc. which was acquired by TISA in 2014. Over the course of his career, Mr. Dixon has had successful exits from 36 companies, including serving on the Board of Affiliated Computer Systems which was later sold to Xerox.  Don is Co-Chairman of the Advisory Committee of the Princeton University School of Engineering and Applied Sciences and serves on the Advisory Board of the Harvard Kennedy School Center for Public Leadership.

“As a member of the Board of Directors of Top Image Systems, having also served on the Board of Directors of eGistics and having facilitated the acquisition of eGistics by the Company, I am looking forward to providing additional guidance to accelerate the Company’s transformational initiatives, improve its performance and deliver customer and shareholder value,” commented Don Dixon. “I have full faith and confidence in the leadership provided by the Company’s CEO Brendan Reidy and its executive management team to help us achieve the Company’s objectives. Brendan and I have worked together for over 15 years and he has served as CEO of three of our companies, served as an active Board member for other Trident companies and worked with us as a Venture Partner. Most recently, Brendan spearheaded the turnaround of XRS Corp. contributing to a twelve-fold increase in stock price and a highly successful acquisition by Vista Equity Partners.”

Mr. Nakar, who founded the Company and served as its Chairman and CEO and then returned to serve as Active Chairman in 2009, has led the Company in its development of technological innovations and in expanding the Company’s global reach. Upon Mr. Nakar’s return to Top Image Systems in 2009, the Company enjoyed a positive turnaround during which the TISA stock price and market cap increased significantly. He oversaw the Company’s acquisition of eGistics and subsequent strategic investments, investing some $10 million to transform the company by consolidating its product portfolio, moving towards a cloud-based SaaS business model and leveraging the Company’s process automation knowhow to build a suite of capture-driven process automation solutions, starting with enhanced Financial Process Automation (FPA) solutions via on-premise, cloud and mobile delivery models that will serve as a powerful growth engine for the Company in the years ahead.

“Mr. Nakar has made an enormous contribution to the Company as Active Chairman and as a major shareholder to drive revenue growth, profitability and to generate shareholder value for the Company during his tenure. I would like to take this opportunity to extend our deepest appreciation and gratitude for Izhak’s leadership and unwavering commitment to Top Image Systems,” said Don Dixon.

“It has been an honor and a privilege for me to serve as the Company’s Active Chairman,” said Izhak Nakar, Founder and Active Chairman, Top Image Systems. “I have the utmost confidence that the Company is on the right track and that under the leadership of Don Dixon as Chairman, Brendan Reidy as CEO, and with the support of the Board and executive management team, we will further strengthen our market reach and capitalize on our opportunities, increase revenues and profits and meet our commitments to the Company’s shareholders.”

About Top Image Systems

Top Image Systems™ (TIS™) Ltd. is a global innovator of on-premise and cloud-based applications that optimize content-driven business processes such as procure to pay operations, remittance processing, integrated receivables, customer response management and more.  Whether originating from mobile, electronic, paper or other sources, TIS solutions automatically capture, process and deliver content across enterprise applications, transforming information entering an organization into useful and accessible electronic data, delivering it directly and efficiently to the relevant business system or person for action with as little manual handling as possible.  TIS’ solutions are marketed in more than 40 countries through a multi-tier network of distributors, system integrators, value-added resellers and strategic partners. Visit the company’s website at http://www.TopImageSystems.com for more information.

Top Image Systems Caution Concerning Forward-Looking Statements

Certain matters discussed in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results expressed or implied in those forward looking statements. Words such as “will,” “expects,” “anticipates,” “estimates,” and words and terms of similar substance in connection with any discussion of future operating or financial performance identify forward-looking statements. These statements are based on management’s current expectations or beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially including, but not limited to, risks in product development, approval and introduction plans and schedules, rapid technological change, customer acceptance of new products, the impact of competitive products and pricing, the lengthy sales cycle, proprietary rights of TIS and its competitors, risk of operations in Israel, government regulation, litigation, general economic conditions and other risk factors detailed in the Company’s most recent annual report on Form 20-F and other subsequent filings with the United States Securities and Exchange Commission. We are under no obligation to, and expressly disclaim any obligation to, update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

TIS Company Contact:
Shelli Zargary
Director of Corporate Marketing and Investor Relations
shelli.zargary@topimagesystems.com
+972 3 767 9114

TIS Investors Contact:
James Carbonara
Regional Vice President, Hayden IR
james@haydenir.com
+ 1 646 755 7412

$ZYNE Initiation of #FABC Exploratory #Phase2 #Clinical of #ZYN002 #CBD Gel

DEVON, Pa., Jan. 03, 2017 — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that it has initiated the FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) exploratory Phase 2 clinical trial of ZYN002 cannabidiol (CBD) gel in children with Fragile X syndrome. ZYN002 CBD gel is the first and only patent-protected, synthetic CBD that is formulated as a permeation-enhanced gel for transdermal delivery.

Fragile X syndrome (FXS) is an autism spectrum disorder and the most common inherited intellectual disability in males and a significant cause of intellectual disability in females. It is caused by a mutation in the Fragile X Mental Retardation gene located on the X chromosome and leads to dysregulation of the endocannabinoid pathway including the reduction in endogenous cannabinoids (2-AG and anandamide). The disorder negatively affects synaptic function, plasticity and neuronal connections and results in a spectrum of intellectual disabilities, social anxiety and memory problems.  In the US, there are about 71,000 patients suffering with FXS.

“Fragile X syndrome is devastating to patients and their caregivers and we are very hopeful that ZYN002 CBD gel can provide relief for this underserved patient group,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We anticipate having top line results for the FAB-C trial late in the first half of 2017.  With an orphan drug designation granted by the Food and Drug Administration for Fragile X syndrome, we look forward to working with the FDA to bring a treatment to patients as fast as possible.”

The FAB-C Trial is an exploratory clinical trial designed to evaluate the safety and efficacy of ZYN002 CBD gel in approximately 16 patients between the ages of 8-17 years with Fragile X syndrome. Dosing will be initiated at 50 mg of CBD in ZYN002 4.2% gel once daily and may be titrated up to 125 mg two times per day during the six-week titration period. Between weeks six to twelve, patients will receive a maintenance dose of 50 mg, 100 mg or 250 mg daily of CBD in ZYN002 4.2% gel.  The primary outcome measures include changes in anxiety, depression and mood as measured by the ADAMS scale, a validated patient reported outcomes questionnaire. Other measurements that will be observed include the Aberrant Behavior Checklist and visual analog scale (VAS) to assess for hyperactivity/impulsivity.

About ZYN002 CBD Gel
Zynerba’s ZYN002 CBD gel is the first and only synthetic CBD formulated as a patent-protected permeation-enhanced gel and is being studied in adult epilepsy patients with focal seizures, osteoarthritis and Fragile X syndrome.  ZYN002 is a clear, permeation-enhanced gel that is designed to provide consistent, controlled drug delivery transdermally with twice-daily dosing. Transdermal therapeutics are absorbed through the skin directly into the systemic circulation, avoiding first-pass liver metabolism and potentially enabling lower dosage levels of active pharmaceutical ingredients and rapid and reliable absorption with high bioavailability. In addition, transdermal delivery avoids the gastrointestinal tract and potential stomach acid degradation of CBD into THC (associated with psychoactive effects), as demonstrated in a Zynerba-sponsored in vitro study.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage specialty pharmaceutical company focused on developing and commercializing proprietary next-generation synthetic cannabinoid therapeutics formulated for transdermal delivery. Zynerba is developing therapeutic candidates based on proprietary transdermal technologies that, if successfully developed, may allow sustained, consistent and controlled delivery of therapeutic levels of two cannabinoids: cannabidiol (CBD), a non-psychoactive cannabinoid, and tetrahydrocannabinol (THC). Transdermal delivery has the potential to reduce adverse effects associated with oral dosing. ZYN002, the Company’s CBD gel, is the first and only synthetic CBD formulated as a patent-protected permeation-enhanced gel. In June 2016, the company initiated the Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial of ZYN002 CBD gel in refractory epilepsy patients with focal seizures, the most common form of epilepsy in adults. In August 2016, the Phase 2 STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis) clinical trial in patients with knee pain due to OA was initiated. In December 2016, the Company initiated the exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial in children with Fragile X syndrome (FXS). Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical trial for ZYN001 is planned to begin in the first half of 2017. Learn more at www.zynerba.com and follow the Company on Twitter at @ZynerbaPharma.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration (FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; the Company’s ability to commercialize its product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates; and the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10K, quarterly reports on Form 10Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Investor Contacts
Jim Fickenscher, CFO and VP, Corporate Development
Zynerba Pharmaceuticals
484.581.7483
Fickenscherj@zynerba.com

Kimberly Minarovich
Argot Partners 
212.600.1902 
kimberly@argotpartners.com

Media Contact
Eliza Schleifstein 
Argot Partners 
973.361.1546 
eliza@argotpartners.com

$KOPN Enters Into #StrategicRelationship With #Goertek

Kopin Corporation (Nasdaq:KOPN), a leading developer of innovative wearable computing technologies and solutions, today announced it had entered into a strategic relationship with Goertek Inc. (“Goertek”), a leading innovative global technology company headquartered in Weifang China that provides vertically integrated total solutions and services to globally-renowned companies such as Samsung, Sony, Microsoft, Huawei and Xiaomi to name a few.

Under the terms of the stock sale agreement, Kopin will sell 7,339,000 shares of Kopin’s common stock to Goertek for US $23,851,750 ($3.25 per share). This represents approximately 9.8% of Kopin’s total outstanding shares of common stock. In addition Kopin and Goertek have entered into agreements to jointly develop and commercialize a range of technologies and wearable products. The goal of the partnership is to utilize Goertek’s industry-leading expertise in design and manufacturing to further develop and sell a range of wearable products incorporating Kopin technologies and components.

“Our partnership with Goertek will enable Kopin to leverage their world class capabilities to commercialize our innovative components and further improve our system products,” said Dr. John C.C. Fan, Kopin’s President and CEO. “In addition to our transmissive and reflective LCD products, we have developed our industry-leading Whisper^® Voice Chip and most recently announced our OLED Lightning^TM microdisplay with 2048 x 2048 resolution with unique Pantile™ Optics which we will demonstrate at CES 2017 this week. We will work with Goertek to incorporate our Whisper Voice Chip and Lightning display into the product designs Goertek provides to its customers. We will also work closely with Goertek to develop system products for consumer mobile augmented reality (AR) and virtual reality (VR) markets.”

“We are excited with this strategic relationship with Kopin which has innovative technologies and products,” said Long Jiang, Goertek’s CEO. “Goertek is the world’s leading designer and manufacturer of VR/AR and other wearable products. This partnership with Kopin will enable us to provide our customers and partners with cutting edge technologies and products for better performance and designs in the fast growing wearable market.”

The stock sale is subject to standard closing conditions and is scheduled for completion by January 27, 2017.

About Goertek

Goertek Inc. was established in June 2001, and listed on the Shenzhen Stock Exchange in May, 2008. As a leading innovative high-tech company, Goertek’s main focuses consist of R&D, production and sales of electro-acoustic components, optical components, and smart hardware system products. Goertek provides vertically integrated total solutions and services to globally-renowned consumer electronics companies. Goertek is one of the main high-end VR/AR ODM solutions providers in the world.

Since Goertek’s establishment in 2001, Goertek has high performance with a consistent and rapid growth rate. By the end of 2015 sales revenue had exceeded over 13.7 billion RMB (total assets 19.2 billion RMB). By market share, Goertek is a top ranked company in the miniature microphone. For more information, please visit Goertek’s website at www.goertek.com.

About Kopin

Kopin Corporation is a leading developer and provider of innovative wearable technologies and solutions for integration into head-worn computing and display systems to military, industrial and consumer customers. Kopin’s technology portfolio includes ultra-small displays, optics, speech enhancement technology, system and hands-free control software, low-power ASICs, and ergonomically designed smart headset reference systems. Kopin’s proprietary components and technology are protected by more than 300 global patents and patents pending. For more information, please visit Kopin’s website at www.kopin.com.

Kopin, Whisper, Lightning, Pantile, and Solos are trademarks of Kopin Corporation.

Forward-Looking Statements

Statements in this press release may be considered “forward-looking” statements under the “Safe Harbor” provisions of the Private Securities Litigation Reform Act of 1995. These include, without limitation, statements relating to our statement that under the terms of the stock sale agreement the Company will sell 7,339,000 shares of the Company’s common stock for $23,851,750 ($3.25 per share); the Company and Goertek have entered into agreements to jointly develop and commercialize a range of technologies and wearable products; the goal of the partnership is to utilize Goertek’s industry leading expertise in design and manufacturing to further develop and sell wearable products incorporating the Company’s technologies and components; the Company’s partnership with Goertek will enable the Company to leverage Goertek’s world class capabilities to commercialize the Company’s innovative components and further improve the Company’s system products; the Company will work with Goertek to incorporate its Whisper Voice Chip and Lightning display into the product designs Goertek provides to its customers; the Company will also work closely with Goertek to develop system products for consumer mobile AR and VR markets; and the accelerating growth Goertek sees in the sale of wearable products. These statements involve a number of risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: The sale of the stock to Goertek may not be completed; the Company and Goertek may not develop or commercialize any technology or products; the partnership may not develop and or sell wearable products based on the Company’s technologies and components; Goertek may not incorporate the Company’s components, Whisper Voice chip or Lightning Display in the product designs it provides to its partners and customers; the Company and Goertek may not develop system products for consumer mobile AR and VR markets; the wearable market may not grow fast; it may take longer than the Company estimates to develop products; the Company’s products may not be accepted by the market place; there may be issues that prevent the adoption or further development of the Company’s wearable computing technologies; manufacturing, marketing or other issues may prevent either the adoption or acceptance of products; the Company might be adversely affected by competitive products and pricing; new product initiatives and other research and development efforts may be unsuccessful; the Company could experience the loss of significant customers; costs to produce the Company’s products might increase significantly, or yields could decline; the Company’s customers might be unable to ramp production volumes of their products, manufacturing delays, technical issues, economic conditions or external factors may prevent the Company from achieving its goals; and other risk factors and cautionary statements listed in the Company’s periodic reports and registration statements filed with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the 12 months ended December 26, 2015, and the Company’s subsequent filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to the Company and only as of the date on which they are made. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances occurring after the date of this release.

$XBIO to Present at #BiotechShowcase 2017

Xenetic Biosciences, Inc. (NASDAQ:XBIO) (“Xenetic” or the “Company”), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, today announced that Scott Maguire, Xenetic’s Chief Executive Officer will present at the 9^th Annual Biotech Showcase™ Conference on Monday, January 9 at 3:00 p.m. PT in San Francisco, CA.

During his presentation, Mr. Maguire will provide a corporate update and discuss the Company’s clinical and regulatory progress for its in-house product candidates, as well as those being developed with Xenetic’s partners. Mr. Maguire will also discuss the Company’s up to $100 million license deal with Shire, one of the Company’s largest shareholders, along with the clinical status of the PSA-Recombinant SHP656 or Factor VIII being developed as a long-acting therapeutic for the treatment of hemophilia utilizing Xenetic’s proprietary PolyXen™ platform technology.

A live webcast of the presentation will be available by accessing the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com). A replay of the webcast will be available for 90 days, starting approximately two hours after the presentation ends.

About Xenetic Biosciences

Xenetic Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on discovery, research and development of next-generation biologic drugs and novel oncology therapeutics. Xenetic’s proprietary drug development platforms include PolyXen™, which enables next generation biologic drugs by improving their half-life and other pharmacological properties. Xenetic’s lead investigational product candidates include FDA orphan designated oncology therapeutic sodium cridanimod for the treatment of progesterone receptor negative endometrial cancer, and a polysialylated form of erythropoietin for the treatment of anemia in pre-dialysis patients with chronic kidney disease.

Xenetic is also working together with Shire plc (formerly Baxalta, Baxter Incorporated and Baxter Healthcare) to develop a novel series of polysialylated blood coagulation factors, including a next generation Factor VIII. This collaboration relies on Xenetic’s PolyXen technology to conjugate polysialic acid (“PSA”) to therapeutic blood-clotting factors, with the goal of improving the pharmacokinetic profile and extending the active life of these biologic molecules. Shire is one of the Company’s largest shareholders having invested $10 million in the common stock of the Company during 2014. The agreement is an exclusive research, development and license agreement which grants Shire a worldwide, exclusive, royalty-bearing license to Xenetic’s PSA patented and proprietary technology in combination with Shire’s proprietary molecules designed for the treatment of blood and bleeding disorders. Under the agreement, Xenetic may receive regulatory and sales target payments for total potential milestone receipts of up to $100 million plus royalties on sales.

Xenetic is also developing a broad pipeline of clinical candidates for next generation biologics and novel oncology therapeutics in a number of orphan disease indications. For more information, please visit the company’s website at www.xeneticbio.com and connect on Twitter, LinkedIn, Facebook and Google+.

Forward-Looking Statements

This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including statements regarding expected benefits of NGS cancer panels, the ability to accurately determine the heritable factors increasing the risk of cancer, permitting tailored treatment, screening and prevention of cancer in patients, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Jenene Thomas Communications, LLC.
Jenene Thomas, 908-938-1475
jenene@jenenethomascommunications.com

$CBAY Exclusive #Licensing Agreement w/ #KowaPharmaceuticals America for #Arhalofenate

— Kowa to fully fund development through NDA approval
— CymaBay to receive up to $205M in up-front and milestone payments
— Conference call and webcast today at 4:30 pm ET

NEWARK, Calif., Jan. 03, 2017  — CymaBay Therapeutics, Inc. (Nasdaq:CBAY), a clinical-stage biopharmaceutical company developing therapies to treat specialty and orphan diseases with high unmet medical need, today announced that it has entered into an exclusive license agreement with Kowa Pharmaceuticals America, Inc. for the development and commercialization of arhalofenate in the United States (U.S.).

Under the terms of the agreement, CymaBay will receive up to $15 million in upfront and near-term milestone payments and is eligible to receive up to an additional $190 million in payments based upon the achievement of specific development, regulatory and sales milestones.  CymaBay is also eligible to receive tiered, double digit royalties on future sales of arhalofenate products.  Kowa will be responsible for all development and commercialization costs. CymaBay had earlier reached agreement with the Food and Drug Administration (FDA) on the size and scope of the Phase 3 program which is estimated to cost $100 million. CymaBay retains full development and commercialization rights for the rest of the world.  Locust Walk served as a transaction advisor to CymaBay.

Kowa Pharmaceuticals America, Inc., a US subsidiary of Kowa Company, Ltd., a privately held, multinational company based in Japan, markets cardiometabolic drugs including LIVALO® (pitavastatin) and Lipofen® (fenofibrate capsules, USP) in the U.S. The company focuses its efforts on the successful commercialization of its current and near term portfolio of pharmaceutical products with an established and growing primary care sales force in the U.S.

“We are extremely pleased to enter into this agreement with Kowa to develop and market arhalofenate in the U.S. Kowa has proven development capabilities as well as the resources to carry out a large Phase 3 development program. They also have an established primary care sales force to market arhalofenate products. As arhalofenate is a potential novel therapy for gout, a disease most often treated by primary care physicians, it is a very good fit with Kowa’s established strength in this area,” said Harold Van Wart, Ph.D., President and CEO of CymaBay. “Identifying a partner to complete the Phase 3 development and commercialization of arhalofenate has been a key part of CymaBay’s strategy. It enables us to advance arhalofenate to the market while allowing us to focus our internal resources on the rest of our pipeline which addresses serious and rare disorders.”

Arhalofenate is an oral, once-daily dual-acting drug candidate for the treatment of gout.   In an extensive Phase 2 clinical program in patients with gout, arhalofenate has been shown to decrease serum uric acid while also suppressing gout flares. It is the first compound in a new class of gout therapy that CymaBay refers to as Urate Lowering Anti-Flare Therapy (ULAFT). Arhalofenate is being developed as a combination product with febuxostat. CymaBay has completed end-of-Phase 2 discussions with the FDA and has come to agreement on a Phase 3 program that would provide a very competitive label that can capture the unique dual actions of arhalofenate.

Conference Call and Webcast

CymaBay management will host a conference call and webcast today, January 3, 2017 at 4:30 p.m. ET to discuss this licensing agreement and provide a corporate update on the company’s strategy. To access the live conference call, please dial (877) 407-0784 from the U.S. and Canada, or (201) 689-8560 internationally. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at http://ir.cymabay.com/events. A replay of the webcast will be available on the Company’s website for 14 days following the live event.

About CymaBay

CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company developing therapies to treat specialty and orphan diseases with high unmet medical need. Seladelpar is a potent, selective, orally active PPARδ agonist. CymaBay has recently completed a Phase 2 study of seladelpar in patients with primary biliary cholangitis as well as a pilot Phase 2 study in patients with homozygous familial hypercholesterolemia, establishing proof-of-concept in both indications.  Previously, a Phase 2 study of seladelpar in patients with mixed dyslipidemia established that it has an anti-atherogenic lipid profile.  Arhalofenate is a potential Urate-Lowering Anti-Flare Therapy that has completed five Phase 2 studies in gout patients. Arhalofenate has been found to reduce painful flares in joints while at the same time promoting excretion of uric acid by the kidney. This dual action addresses both the signs and symptoms of gout while managing the underlying pathophysiology of hyperuricemia. Arhalofenate has been licensed to Kowa Pharmaceuticals America, Inc. in the U.S. CymaBay retains full development and commercialization rights for arhalofenate outside the U.S.

About Arhalofenate

Arhalofenate is an oral, once-daily dual-acting drug candidate for the treatment of gout that both lowers serum uric acid (sUA) and suppresses flares. It is the first compound in a new class of gout therapy that CymaBay refers to as Urate Lowering Anti-Flare Therapy (ULAFT).  Arhalofenate increases the excretion of uric acid into urine resulting in a decrease in sUA levels.  This is accomplished by its inhibition of the urate transporter URAT1 in the proximal tubules of the kidney.  Arhalofenate produces its uricosuric effect gradually and appears to have a favorable overall and renal safety profile in studies completed to date in over 1,100 patients. In a Phase 2 study of arhalofenate in combination with the xanthine oxidase inhibitor febuxostat, which works by blocking the production of uric acid, the sUA lowering activity of arhalofenate was complementary and additive to that of febuxostat.  The anti-flare activity of arhalofenate is attributable to its suppression of the urate crystal-induced production of IL-1β in gouty joints.  The goal of the Phase 3 program is to study the combination of arhalofenate and febuxostat to confirm the urate lowering and anti-flare activity.

Current treatment guidelines for gout recommend the use of urate lowering therapies (ULTs) to reverse hyperuricemia in order to remove deposits of pro-inflammatory urate crystals. The minimal goal of this treatment is to reduce sUA levels to below 6 mg/dL.  The goal for patients with a more advanced form of the disease called tophaceous gout is <5 mg/dL. Many patients treated with currently marketed xanthine oxidase inhibitors (allopurinol or febuxostat) alone do not reach these goals.  In previously published studies, arhalofenate in combination with febuxostat has been shown to significantly increase the number of patients achieving their sUA goals. Paradoxically, the initiation of ULT triggers an increased risk of gout flares for the first six months or more. The anti-inflammatory activity of arhalofenate has been shown in clinical studies to suppress flares, making it uniquely suited for the treatment of gout.

Cautionary Statements

The statements in this press release regarding the potential future performance of CymaBay’s product candidates are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of CymaBay’s product candidates, including but not limited to the expected Phase 3 trial of Arhalofenate and the anticipated resulting label, could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay’s product development activities, including clinical trials of seladelpar and arhalofenate; effects observed in trials to date which may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay’s product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide. Additional risks relating to CymaBay are contained in CymaBay’s filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.

For additional information about CymaBay visit www.cymabay.com.

Contacts

Sujal Shah
CymaBay Therapeutics, Inc.
(510) 293-8800
sshah@cymabay.com

or

Hans Vitzthum
LifeSci Advisors, LLC
(212) 915-2568
Hans@LifeSciAdvisors.com