(ERW) The Janus Equal Risk Weighted Large Cap ETF Portfolio Liquidates

OKLAHOMA CITY, Feb. 18, 2016  — Effective at the close of business on February 17, 2016, the Janus Equal Risk Weighted Large Cap ETF (NASDAQ: ERW) portfolio was liquidated and will no longer be tracking its Index, the Janus Equal Risk Weighted Large Cap Index. As a result of the liquidation, the NAV now represents a 100% cash position and an intraday portfolio value will no longer be calculated or disseminated. The NAV may be found here.

The Fund will stop trading on the NASDAQ as of the close of business on Wednesday, February 24.

Whether shares are sold or are automatically redeemed, they will generally recognize a capital gain (or loss) equal to the amount received for shares above (or below) an adjusted cost basis in such shares.

For additional information, please call 877-583-5624 or visit https://www.janus.com/advisor/exchange-traded-funds/janus-equal-risk-weighted-large-cap-etf.

(COYN) to Present at the SeeThruEquity & The Brewer Group 2nd Annual

DALLAS, TX / February 18, 2016 / COPsync, Inc. (NASDAQ: COYN), which operates the nation’s only law enforcement in-car information sharing and communication network, today announced that the Company will be presenting at the 2nd Annual Innovations Investor Conference in Miami, FL on Monday, February 22, 2016 at the Ritz-Carlton South Beach, presented by SeeThruEquity and The Brewer Group. Please click here for a list of presenting companies.

Ron Woessner, CEO of COPsync, will give a 30-minute presentation about the company and its solutions, and will schedule one-on-one meetings with current and future investors. “The Company’s COPsync Network helps keep law enforcement officers safer and gives them 21st-century tools to help them catch terrorists, cop killers, smugglers, kidnappers and others that pose a threat. Our COPsync911 companion service connects schools, government buildings, energy centers, hospitals and other potentially at-risk facilities directly to the closest patrol officers, regardless of agency jurisdiction, and provides the first responders up-to-the-second situational information through the on-line portal feature. My presentation at the conference will discuss how these services, both provided via a SaaS business model, offer a unique and potentially lucrative investment opportunity.”

Conference registration: complimentary for qualified investors and equity research analysts.
In order to register as an attendee of the conference, please click HERE.

About SeeThruEquity

Since the company’s founding in 2011, SeeThruEquity (STE) has been committed to its core mission: providing impactful, high-quality research on uncovered and undercovered microcap stocks and hosting investor conferences throughout the year. STE has been able to grow its research universe to over 176 names.

STE conferences are the ultimate event for publicly traded companies with less than $1 billion in market capitalization because it augments the conference experience with the firm’s research which is part of Wall Street consensus and available across industry-leading platforms including Thomson First Call, FactSet, S&P CapitalIQ, Yahoo! Finance and Bloomberg to name a select few. STE has hosted 20 investor conferences which have showcased over 350 companies, attracted over 4500 attendees and have included over 1,700 1-on-1 meetings.

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

About The Brewer Group

The Brewer Group, Inc. (TBG) is an industry agnostic investment and consulting company with assets ranging numerous sectors. TBG’s relationships with key international decision makers spanning government development agencies, financial institutions, multinational corporations, NGOs and numerous leaders in sports and entertainment place TBG in a unique position to grow its portfolio. TBG takes pride in identifying companies whose goal is to make a social impact on the communities in which they serve. For further information, please visit www.thebrewergroup.com.

About COPsync

COPsync, Inc. (COYN) is a technology company that improves communication between and among law enforcement officers and agencies from differing jurisdictions to help them prevent and respond more quickly to crime. The COPsync Network™ connects law enforcement officers and agencies to a common communications system, which gives officers instant access to actionable, mission-critical data and enables them to share information and communicate in real-time with other officers and agencies, even those hundreds and thousands of miles away. The Network’s companion, COPsync911™ threat-alert system, enables schools, courts, hospitals, government buildings, energy, telecommunications and other potentially at-risk facilities to automatically and silently send threat-alerts directly to local law enforcement officers in their patrol cars in the event of a crisis, thereby speeding first responder response times and saving minutes when seconds count. The COPsync Network saves officer and citizen lives, reduces unsolved crimes and assists in apprehending criminals and interdicting criminal behavior — through such features as a nationwide officer safety alert system, GPS/auto vehicle location and distance-based alerts for crimes in progress, such as school crisis situations, child abductions, bank robberies and police pursuits. The COPsync Network also eliminates manual processes and increases officer productivity by enabling officers to write electronic tickets, accident reports, DUI forms, arrest forms and incident and offense reports. The company also sells VidTac®, an in-vehicle, software-driven video system for law enforcement. Visit www.copsync.com and www.copsync911.com for more information.

Contact:

For COPsync:
Ronald A. Woessner
Chief Executive Officer
972-865-6192
invest@copsync.com

Media:
Fred Sommer
Senior Consultant
Investor Relations
Ascendant Partners, LLC.
732-410-9810
fred@ascendantpartnersllc.com

(OUTR) Engaged Capital Sends Letter to Outerwall Board Outlining Immediate Strategy

Engaged Capital, LLC (together with its affiliates, “Engaged Capital”), an investment firm specializing in enhancing the value of small and mid-cap North American equities, and a 14.6% shareholder of Outerwall Inc. (“OUTR” or the “Company”) (NASDAQ:OUTR), announced today that it has delivered a letter and presentation to the Board of Directors (the “Board”) of OUTR. The letter and presentation outline Engaged Capital’s concerns regarding the governance and management of the Company’s assets and recommends a series of actions aimed at creating significant, and lasting, shareholder value.

In the letter, Engaged Capital asserts its belief that OUTR’s underperformance and current depressed valuation is a direct result of the Board’s failed strategies, flawed capital allocation policies, and misaligned governance. Over the last four years, OUTR’s Board has squandered approximately $1.2 billion of shareholder capital, a staggering sum representing approximately 2.5x the Company’s current market value.

In addition, Engaged Capital believes that on at least three occasions in the last year the Board refused to engage with potential acquirers by either insisting the Company was not for sale or simply failing to respond at all to the interested party. If true, these actions represent a dereliction of the Board’s fiduciary duty to shareholders as the pecuniary interests of individual directors and management appear to have been placed above that of the Company’s shareholders. The Board’s interests are clearly misaligned with shareholders as evidenced by the miniscule collective ownership position of OUTR’s independent directors (less than 0.3% of shares outstanding).

Engaged Capital believes there is a path to create immediate and sustainable value for all OUTR shareholders, and that the fix is largely under the Board and management’s control. Due to Chairman Nelson Chan’s refusal to meet with Engaged Capital in a timely fashion, Engaged Capital felt it was necessary to share its views more broadly to encourage swift action by the Board. Specifically, Engaged Capital recommends the Company:

• Cease all growth investments;
• Aggressively manage both Redbox and Coinstar for cash;
• Sell or shut down the ecoATM business;
• Halt the Company’s share repurchase program;
• Use the majority of free cash flow to pay a large annual dividend (ie. a $125 million annual dividend which equates to a 25% yield at current prices) and reduce debt; and
• Immediately retain financial advisors and begin a sales process with the goal of taking OUTR private.

Engaged Capital strongly encourages OUTR’s shareholders to directly contact Mr. Chan, as well as the other directors, and insist the Board of OUTR immediately take the steps outlined in the letter and presentation available at the link below. Engaged Capital will remain vigilant in ensuring the Company enacts these recommendations and will not hesitate to use every method available to shareholders to hold the Board accountable, including nominating new directors at the 2016 annual meeting in June.

The full text of the letter and presentation can be found here:
Letter: http://engagedcapital.com/press/OUTR-BOD-letter.pdf
Presentation: http://engagedcapital.com/press/OUTR-presentation.pdf

About Engaged Capital:

Engaged Capital, LLC (“Engaged Capital”) was established in 2012 by a group of professionals with significant experience in activist investing in North America and was seeded by Grosvenor Capital Management, L.P., one of the oldest and largest global alternative investment managers. Engaged Capital is a limited liability company owned by its principals and formed to create long-term shareholder value by bringing an owner’s perspective to the managements and boards of undervalued public companies. Engaged Capital manages both a long-only and long/short North American equity fund. Engaged Capital’s efforts and resources are dedicated to a single investment style, “Constructive Activism” with a focus on delivering superior, long-term, risk-adjusted returns for investors. Engaged Capital is based in Newport Beach, California.

(NYNY) Announces $290 Million Closing of Rights Offering and Backstop Purchase

Empire Resorts, Inc. (NASDAQ-GM:NYNY) (the “Company”) announced its rights offering (the “Rights Offering”) and standby purchase of shares not sold in the Rights Offering, which generated approximately $290 million in gross proceeds for the Company closed on Wednesday, February 17, 2016. The Company issued a total of 20,138,888 shares of common stock at $14.40 per share. This includes 176,086 shares issued to holders upon exercise of their basic subscription rights and 13,136,817 shares issued to Kien Huat Realty III Limited (“Kien Huat”), our largest stockholder, upon exercise of its basic subscription rights. Kien Huat also acquired the remaining 6,825,985 shares not sold in the Rights Offering pursuant to the terms of a standby purchase agreement. The Company paid Kien Huat a fee of $1,450,000 for its commitment pursuant to the standby purchase agreement and reimbursed Kien Huat for its expenses related to the standby purchase agreement in an amount of $50,000.

The Company anticipates using the net proceeds of the Rights Offering towards the development of Montreign Resort Casino (the “Casino Project”), to redeem the Series E Preferred Stock of the Company, towards the development of the Golf Course and Entertainment Village that, along with the Casino Project, are part of the initial phase of the Adelaar project, and towards the working capital needs of the Company.

Upon consummation of the Rights Offering, a $17.4 million convertible note held by Kien Huat was converted into 1,332,058 shares of common stock of the Company in accordance with the conversion provisions of such note (the “Note Conversion”). After giving effect to the Rights Offering and Note Conversion, Kien Huat owns approximately 88.7% of the outstanding shares of the Company’s common stock.

As a result of Kien Huat’s increased proportionate ownership following the consummation of the Rights Offering and the Note Conversion, at the request of the Company, Kien Huat and the Company entered a letter agreement today, pursuant to which Kien Huat has agreed neither it nor its affiliates (Kien Huat together with its affiliates, the “Kien Huat Parties”) will take certain actions in furtherance of a “going-private” transaction involving the Company unless such transaction is subject to the approval of (x) a majority of the voting stock of the Company held by stockholders other than the Kien Huat Parties and (x) either (A) a majority of disinterested members of the Board of Directors of the Company (the “Board”) or (y) a committee of the Board composed of disinterested members of the Board. In addition, the Company and Kien Huat have agreed to cooperate to ensure that, to the greatest extent possible, the Board includes no fewer than three (3) independent directors. The terms of this letter agreement shall be valid beginning immediately and terminating on the earlier of (i) the three year anniversary of the closing of the Rights Offering and (ii) the one year anniversary of the opening of the Casino Project.

Cautionary Statement Regarding Forward Looking Information

Statements in this press release that are not historical facts are “forward-looking statements” that may involve material risks and uncertainties. The company wishes to caution readers not to place undue reliance on such forward-looking statements, which statements are made pursuant to the Private Securities Litigation Reform Act of 1995, and as such, speak only as of the date made. For a full discussion of risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the company’s registration statement on Form S-3 and the prospectus relating to the rights offering, dated January 4, 2016.

About Empire Resorts

Empire Resorts owns and operates, through its subsidiary Monticello Raceway Management, Inc., the Monticello Casino & Raceway, a harness racing track and casino located in Monticello, New York, and is 90 miles from midtown Manhattan. Further information is available at www.empireresorts.com.

As a result of the award of a gaming facility license from the New York State Gaming Commission, the Company, through its subsidiary Montreign Operating Company, LLC, will begin construction of Montreign Resort Casino – an 18-story casino, hotel and entertainment complex with approximately 102 table games, 2,150 state of the art slot machines and 332 luxury rooms, which includes 12 penthouse suites, 8 garden suites and 7 two-story villas, designed to meet 5-star and 5-diamond standards. For additional information, please visit www.montreign.com.

(ROSG) Receives Approval from New York State on Thyroid Cancer Diagnostic Assay

Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based and other molecular diagnostic testing services, announces conditional approval status for RosettaGX Reveal™, its novel microRNA classifier for the diagnosis of indeterminate thyroid Fine Needle Aspirate (FNA) smears from the New York State Department of Health (NYSDOH) under the Company’s Molecular Oncology permit. RosettaGX Reveal is the only molecular test in the thyroid market that has been validated in a multicenter, international, blinded study using convenient, routinely prepared cytology slides.

The assay is CLIA certified, but New York requires an additional license from the NYSDOH for CLIA-certified tests to be offered to patients in the state. With this conditional approval, RosettaGX Reveal is now available in all 50 states. In making the assay available pending final approval, the NYSDOH requires the Company to provide any additional information that it may request within 60 business days.

“We are very pleased to have approval to market this important cancer diagnostic for the benefit of physicians and patients in the vast New York market,” stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. “It is estimated that nearly 550,000 FNAs are performed on thyroid nodules each year in the U.S. and that approximately 740,000 are performed annually in Europe. Interpretation of FNA samples is not always straightforward, leading to an indeterminate result in up to 30% of the samples. Many patients with indeterminate results undergo surgery as a precaution despite the fact that up to 80% of these cases are benign. This exposes patients to unnecessary surgical risk and costs the healthcare system hundreds of millions of dollars. Through an analysis of our validation study data, we believe we can help prevent up to 75% of unnecessary thyroid surgeries.”

“In addition to this expanded geographic access, recent managed care contracting initiatives have resulted in covered lives for RosettaGX Reveal exceeding 150 million in the U.S. These increases in geographic and health insurance access, along with the potential health economic benefits the RosettaGX Reveal assay can bring by avoiding unnecessary surgeries, should enhance adoption into a market valued at more than $350 million annually in the U.S. alone. This market is one that continues to see accelerating penetration of molecular classifiers such as RosettaGX Reveal, which we expect to continue over the next several years,” added Mr. Berlin.

About Rosetta Genomics

Rosetta develops and commercializes a full range of microRNA-based and other molecular diagnostics. Rosetta’s integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. Through the acquisition of PersonalizeDx, the Company now offers core FISH, IHC and PCR-based testing capabilities and partnerships in Pathology, Oncology and Urology that provide additional content and platforms that complement Rosetta’s microRNA and Next-Gen Sequencing offerings. RosettaGX Reveal™, a Thyroid microRNA Classifier for the diagnosis of indeterminate thyroid FNA smears, as well as the full RosettaGX™ portfolio of cancer testing services are commercially available through the Company’s Philadelphia, PA- and Lake Forest, CA-based CAP-accredited, CLIA-certified labs, respectively. For more information visit www.rosettagx.com.

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta’s future expectations, plans and prospects including, but not limited to statements relating to potential health economic benefits of Rosetta tests, adoption of the Rosetta Genomics tests or penetration of those tests into the marketplace, benefits to physicians and patients, and Rosetta Genomics achieving New York State final approval for any or all of its tests, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those risks more fully discussed in the “Risk Factors” section of Rosetta’s Annual Report on Form 20-F for the year ended December 31, 2014 as filed with the SEC. In addition, any forward-looking statements represent Rosetta’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.

Rosetta Genomics
Ken Berlin, President & CEO
267.298.1159
investors@rosettagenomics.com
or
Rosetta Genomics Investor:
LHA
Anne Marie Fields
(212) 838-3777
afields@lhai.com

(SEMI) Solidifies Polysilicon Supply

ST. PETERS, Mo., Feb. 18, 2016  — SunEdison Semiconductor Limited (NASDAQ:SEMI) (“SunEdison Semiconductor” or the “Company”) today provided additional details of its comprehensive strategy for the procurement of electronic-grade polysilicon, one of the key raw materials used in the production of semiconductor wafers.

Over the past several months, the company has been working on several initiatives to improve contingency planning for polysilicon supply and manage the transition to multiple sources of poly.  These initiatives include:

• Building significant polysilicon inventory from the Pasadena facility;
• Negotiating backup supply agreements for polysilicon from additional suppliers at acceptable prices; and,
• Supporting the early stages of the production ramp at SMP, and starting customer qualifications

“Over the last several months, we have successfully de-risked our polysilicon supply chain,” said Shaker Sadasivam, President & CEO. “These improvements will be sufficient to meet all of our polysilicon requirements.  I want to thank our R&D, Supply Chain and Operations teams who have worked diligently to accomplish this goal.”

Forward Looking Statements

Certain matters discussed in this news release are forward-looking statements which represent the Company’s judgment as of the date of this release.  The Company disclaims, however, any intent or obligation to update these forward-looking statements.

About SunEdison Semiconductor

SunEdison Semiconductor is a global leader in the manufacture and sale of silicon wafers to the semiconductor industry. For over 55 years, SunEdison Semiconductor has been a pioneer in the design and development of silicon wafer technologies. With R&D and manufacturing facilities in the U.S., Europe, and Asia, SunEdison Semiconductor enables the next generation of high performance semiconductor devices. SunEdison Semiconductor’s common stock is listed on the NASDAQ OMX Global Select Market under the symbol “SEMI.”

Investor & Media Contact

Chris Chaney
Director, Investor Relations & Corporate Communications
SunEdison Semiconductor Limited
cchaney@sunedisonsemi.com
+1 636 474 5226

(STAF) Officially Rebrands The JM Group Division in the UK

The JM Group Undergoes Comprehensive Rebranding, Including the Refreshment of Its Corporate Website

Investor Relations Firm:

PCG Advisory Group
Stephanie Prince
Managing Director
646.762.4518
Email contact

Corporate Investor Contact:

Staffing 360 Solutions, Inc.
Darren Minton
Executive Vice President
212.634.6413
Email contact

Financial Contact:

Staffing 360 Solutions, Inc.
Wade Pearson
Senior Vice President of Finance
212.634.6423
Email contact

(RMTI) Enters Into Exclusive License Agreement With Wanbang Biopharma

Rockwell to Receive $39 Million in Upfront and Milestone Payments Plus Ongoing Earnings From Product Sales

WIXOM, Mich., Feb. 16, 2016  — Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that it has signed exclusive licensing and manufacturing supply agreements with Wanbang Biopharmaceutical Co., Ltd. (Wanbang), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA: 600196 and HKG: 02196), for the rights to commercialize Rockwell’s Triferic and Calcitriol for End-Stage-Renal-Disease (ESRD) patients, that also includes new therapeutic indications for Triferic, in the People’s Republic of China. Triferic is Rockwell’s proprietary iron replacement and hemoglobin maintenance drug for treating anemia. Calcitriol is Rockwell’s generic (active vitamin D) injection for treatment of secondary hyperparathyroidism in dialysis patients.

Under the terms of the agreement, Wanbang will become the exclusive distributor for Triferic and Calcitriol in China for an initial commercial term of 10 years, with an extended term of 10 or more years based on achievement of annual minimum purchase requirements. In consideration for the exclusive rights, Rockwell will receive from Wanbang an upfront fee plus regulatory and revenue milestone payments totaling USD$39 million in aggregate. Notably, Rockwell will receive ongoing earnings from product sales of Triferic and Calcitriol, and other additional Triferic therapeutic indications. Rockwell retains manufacturing responsibility of all products. Wanbang is required to achieve annual minimum purchase requirements to retain exclusive commercialization rights. In addition to the hemodialysis indication, Wanbang has the exclusive right to develop and commercialize Triferic for new therapeutic indications for the Chinese market. Wanbang is responsible for all clinical, regulatory and marketing expenses for Triferic and Calcitriol in China as well as development and regulatory costs for new Triferic indications.

“We are thrilled to establish this strategic partnership with Wanbang,” stated Robert L. Chioini, Founder, Chairman and CEO of Rockwell. “China has been a top priority in our global Triferic licensing strategy, and this agreement further validates Triferic’s potential for becoming the world-wide standard of care in iron maintenance therapy for the treatment of anemia. This commercialization arrangement enables Rockwell to enter into and capitalize on what is projected to become the largest dialysis market in the world. There are about 300,000 dialysis patients currently receiving hemodialysis in China and that market is expected to double over the next few years as the Chinese government, in conjunction with the private sector, establishes the infrastructure to serve the nearly 2 million patients who are presently in need of hemodialysis but lack access. We are very pleased with this commercialization arrangement in which our primary economic value will be derived from product sales in this fast-growing Chinese market.” Mr. Chioini further stated, “We are excited to work with Wanbang, a leading company in the Chinese healthcare market and one of the key suppliers of biosimilar ESA product and other drugs in the renal space. Wanbang, and their experienced team, is highly skilled and intensely focused on leveraging their business into the forefront of the rapidly growing domestic dialysis market in China, and we expect them to have great success selling Triferic and Calcitriol.”

Mr. Yifang Wu, Chief Operating Officer of Fosum Pharma, Chairman and CEO of Wanbang, added, “We are very excited to have partnered with Rockwell Medical and to be able to have the opportunity to offer such great drugs to the Chinese hemodialysis market. We believe Triferic is a revolutionary iron replacement product that will greatly improve the lives of Chinese dialysis patients and we intend to work in partnership with Rockwell management to offer it to patients as fast as possible. The opportunity to market Triferic in other therapeutic indications is exciting as well. Wanbang is committed to addressing the needs of patients and healthcare providers with a comprehensive range of therapeutic options across home, in-center and hospital settings. This partnership enhances Wanbang’s product portfolio with the addition of Rockwell’s high-quality drug products.”

Wanbang Biopharmaceuticals is a leading pharmaceutical company in China that specializes in research, production and marketing of medicines for endocrinology, cardiovascular disease and renal diseases. Wanbang is a subsidiary of Fosun Pharma, which is listed on the Shanghai Stock Exchange (SHA: 600196) and the Stock Exchange of Hong Kong Limited (HKG: 02196). Fosun Pharma, one of the major shareholders of Sino Pharma (HKG:1099) who is the largest drug distributor in China, is part of the Fosun Group, the leading non-state owned enterprise group in China, which is listed on the Hong Kong stock exchange (HKG:0656). In addition to its comprehensive therapeutic product portfolio, Wanbang and Fosun Pharma have sound relationships with public healthcare institutions and providers and directly own and operate a network of private hospitals in China.

About Triferic
Triferic is a unique iron replacement product that is delivered to hemodialysis patients via dialysate, replacing the ongoing iron loss that occurs during their dialysis treatment. Triferic is added to the bicarbonate concentrate on-site at the dialysis clinic. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. Triferic delivers sufficient iron to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin). Please visit www.triferic.com.

About Rockwell Medical
Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis.

Rockwell’s Triferic is indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin).

Rockwell’s FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.

Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three U.S. manufacturing/distribution facilities.

Rockwell’s exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information.

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to launch Calcitriol and Triferic following FDA approval. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan”, “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in Rockwell Medical’s SEC filings. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Triferic^® is a registered trademark of Rockwell Medical, Inc.

Michael Rice, Investor Relations; 646-597-6979

(ETRM) Named One of Fast Company’s Top Ten Most Innovative in Biotech

ST. PAUL, Minn., Feb. 16, 2016  — EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Fast Company has recognized EnteroMedics among the Top 10 Most Innovative Companies in Biotech for 2016.

Dan Gladney, President and Chief Executive Officer of EnteroMedics, stated, “Having brought to market the first new medical device approved by the FDA for the treatment of obesity in over 10 years, EnteroMedics’ inclusion on Fast Company‘s list is validation of the work we have accomplished to date and the vision we have for the future. We continue to work to bring this unique and safe alternative for obesity treatment to patients underserved by the therapeutic options currently available to them.”

Most Innovative Companies is one of Fast Company‘s most significant and highly anticipated editorial efforts of the year, honoring leading enterprises and rising newcomers that exemplify the best in nimble business and impactful innovation. The Most Innovative Companies issue (March 2016) is now available online at www.fastcompany.com/MIC as well as in app form via iTunes, and on newsstands beginning February 23, 2016.

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 Maestro® Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics’ Maestro Rechargeable System has received U.S. Food and Drug Administration approval, CE Mark and is listed on the Australian Register of Therapeutic Goods.

Information about the Maestro® Rechargeable System and vBloc® Neurometabolic Therapy

You should not have an implanted Maestro Rechargeable 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 Maestro Rechargeable 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 the Maestro Rechargeable System. For additional prescribing information, please visit www.enteromedics.com.

If you are interested in learning more about vBloc 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 lack of commercial sales experience with our Maestro® Rechargeable 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 comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro 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 13, 2015. 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.

(PSTI) NIAID Initiating Dose Evaluation Studies in PLX-R18

Second Hematologic Indication Being Developed in the U.S. for PLX-R18

HAIFA, Israel, Feb. 16, 2016  — Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapy products, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), will initiate studies in large animals to evaluate dosing for Pluristem’s PLX-R18 as a medical counter measure in the treatment of the hematologic components of Acute Radiation Syndrome (ARS). Once the optimal dose is determined in large animals, a pivotal trial could be conducted and the results used to support a Biologics License Application (BLA) submission of PLX-R18 for this indication under the Animal Rule regulatory pathway. In September 2015, the FDA had confirmed that data from earlier trials conducted by NIAID were sufficient for the future design of studies in Pluristem’s development path for PLX-R18. NIAID is supporting and collaborating on the dosing studies, and Pluristem is supplying PLX-R18.

ARS is caused by exposure to very high levels of radiation, such as those that could occur in a nuclear catastrophe. The syndrome can cause severe illness or death. When human trials are not ethical or feasible, as in this indication, the FDA’s Animal Rule regulatory pathway allows for the determination of the efficacy of drugs using animal efficacy studies and human safety data.

“We are very pleased to receive the support and collaboration of the NIH for the development of PLX-R18 as a medical countermeasure in the treatment of ARS, which is the first indication we are targeting in the defense technology space,” stated Pluristem Chairman and CEO Zami Aberman.

Pluristem recently received FDA clearance to initiate a Phase I trial of PLX-R18 to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). This trial is scheduled to begin in the first half of 2016 in the U.S. Additionally, Pluristem has entered into a Memorandum of Understanding (MOU) with Japan’s Fukushima Medical University, Fukushima Global Medical Science Center to develop PLX-R18 for the treatment of ARS and for morbidities following radiotherapy in cancer patients.

Previous NIH/NIAID studies of PLX-R18 in ARS

The NIH has supported and completed two mouse studies of PLX-R18 as a potential treatment of the component of ARS that affects bone marrow function. ARS involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells and platelets, as well as to other systems and organs. Severe damage to bone marrow quickly makes victims vulnerable to life-threatening hemorrhage, infection and anemia. A recently concluded NIH/NIAID study showed that administration of PLX-R18 resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation, and described the treatment’s mechanism of action. The NIH/NIAID’s first study of PLX-R18 showed a substantial, statistically significant improvement in 30-day survival and overall survival of irradiated rodents given PLX-R18 versus a control group.

About PLX-R18

PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure. Pluristem received FDA clearance to initiate a Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation. With its capabilities, PLX-R18 could potentially treat a broad range of hematologic indications, which together constitute a substantial global market.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the expected NIAID study, continued support of the NIH, when we discuss the results of the study and its potential use to apply for marketing authorization PLX-R18, the possibility to use results of the study in question to conduct a pivotal study and facilitating the development of PLX-R18 in other hematologic indications, when we discuss our plan to begin a Phase I trial to treat incomplete hematopoietic recovery following HCT in the first half of 2016, and when we discuss PLX-R18’s potential to treat a broad range of hematologic indications, which together constitute a substantial global market. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

Contact:

Pluristem Therapeutics Inc.
Karine Kleinhaus, MD, MPH
Divisional VP, North America
1-914-512-4109
karinek@pluristem.com

(FLXN) Reports Primary Endpoint Met in Pivotal Phase 3 Trial of Zilretta

• Primary endpoint at week 12 against placebo achieved p value of <0.0001; statistically significant and clinically meaningful pain relief demonstrated at weeks 1 through 16
• Zilretta also achieved statistical significance on WOMAC^® A (pain), WOMAC B (stiffness) and WOMAC C (function) through week 12 against both placebo and immediate-release triamcinolone acetonide
  
• Zilretta patients experienced, on average, a 50 percent reduction in pain from baseline over weeks 1 through 12 
• Zilretta, an investigational non-opioid/non-NSAID, has received Fast-Track designation by FDA; planned NDA submission on track for second half of 2016
  
• Conference call tomorrow, February 17, at 9:00 a.m. ET 

BURLINGTON, Mass., Feb. 16, 2016  —  Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported that the Phase 3 clinical trial for its lead drug candidate Zilretta (also known as FX006) met its primary endpoint at week 12, demonstrating highly significant (p<0.0001), durable and clinically meaningful pain relief against placebo in patients with moderate to severe osteoarthritis (OA) knee pain. In addition, Zilretta achieved statistically significant analgesia against placebo at weeks 1 through 16 and patients treated with Zilretta experienced, on average, a 50 percent reduction in pain from baseline over weeks 1 through 12. In pre-specified analyses, Zilretta achieved statistical significance against placebo in validated OA and quality of life secondary measures through week 12.

In pre-specified secondary measures, compared to immediate-release triamcinolone acetonide (TCA), the most commonly injected intra-articular (IA) corticosteroid, Zilretta achieved statistical significance through 12 weeks on WOMAC A¹ (pain), WOMAC B (stiffness) and WOMAC C (function) and the validated Knee injury and Osteoarthritis Outcome Score (KOOS) quality of life subscale and was numerically superior at weeks 2 through 12 on the daily pain rating scale, although it did not achieve statistical significance in that measure.

The frequency of treatment-related side effects was comparable across all treatment arms in the trial. No drug-related serious adverse events were observed and no patients treated with Zilretta were discontinued from the study due to a treatment-related side effect.

“We are extremely gratified with these Phase 3 data that strongly reinforce Zilretta’s previous clinical efficacy results, which are consistent with substantial and durable pain relief,” said Flexion Therapeutics President and Chief Executive Officer Michael Clayman, M.D. “We believe that Zilretta has the potential to become an important new non-opioid treatment in a therapeutic area that hasn’t seen meaningful innovation in many years. More than 12 million people in the U.S. suffer from the painful and debilitating effects of knee OA and many have not found effective relief with existing therapies. We look forward to working closely with the U.S. Food and Drug Administration (FDA) as we prepare to submit our New Drug Application (NDA) for Zilretta.”

Zilretta was designed using proprietary microsphere technology and is intended to provide localized and long-lasting pain relief over a period of months while minimizing systemic exposure and avoiding serious side effects common to oral therapies prescribed for OA pain. Current oral treatment options for OA knee pain include non-steroidal anti-inflammatory drugs (NSAIDS), COX II inhibitors and opioids. All are labeled with black box warnings for serious, sometimes fatal, side effects. IA medicines, such as immediate-release corticosteroids and hyaluronic acid injected into the joint, are generally well-tolerated but fail to produce pain relief of sufficient magnitude or duration.

“There have been no major advances in the treatment of OA for decades and given the limited efficacy and the safety liabilities of available therapies, patients are in need of a new treatment option,” said Stan Cohen, M.D., Medical Director, Metroplex Clinical Research Center and Clinical Professor of Internal Medicine, UT Southwestern Medical School, Dallas. “These data suggest that Zilretta has the potential to be a significant advance in pain management for patients with OA of the knee.”

About the Phase 3 Trial

The randomized, double-blind Phase 3 placebo-controlled, active-comparator trial enrolled 486 patients at approximately 40 centers worldwide. Patients were randomized to one of three treatment groups (1:1:1) and received either a single IA injection of 40 mg of Zilretta, normal saline (placebo) or 40 mg of immediate-release TCA. Each patient was evaluated for efficacy and safety during seven outpatient visits over 24 weeks after receiving an injection. The primary objective of the study was to assess the magnitude of pain relief of Zilretta at 12 weeks against placebo. The secondary objectives of the study were to assess the magnitude and duration of pain relief and effect of Zilretta against placebo and immediate-release TCA in a variety of additional pre-specified measures.

Flexion plans to present detailed results from the Phase 3 clinical trial at an upcoming scientific meeting.

Conference Call

At 9:00 a.m. ET tomorrow, Flexion’s management will host a conference call to discuss the Phase 3 clinical results and provide a general update on the Zilretta program. The dial-in number for the conference call is (855) 770-0022 for U.S. participants and (908) 982-4677 for international participants, with Conference ID # 51030771. A live webcast of the conference call can also be accessed through the “Investors” tab on the Flexion Therapeutics website at www.flexiontherapeutics.com. A webcast replay will be available online after the call.

About Osteoarthritis of the Knee

OA is a common joint disease that affects 27 million Americans, and the prevalence of the disease is expected to significantly grow as a result of aging, obesity and sports injuries. OA is a type of degenerative arthritis that is caused by the progressive breakdown and eventual loss of cartilage in one or more joints. OA is characterized by pain, swelling, stiffness and decreased mobility of the affected joint. While OA is being diagnosed at increasingly younger ages, prevalence rises after age 45, and the knee is one of the most commonly affected joints. In 2014, more than 12 million Americans were diagnosed with OA of the knee. OA has a significant impact on the daily lives of patients, and it commonly affects large weight-bearing joints like the knees and hip but also occurs in the shoulders, hands, feet and spine. As the disease progresses, it becomes increasingly painful and debilitating, culminating, in many cases, in the need for total joint replacement.

Each year, at least five million OA patients in the U.S. receive immediate-release corticosteroid and hyaluronic acid IA injections for knee pain, but these injections generally provide limited relief, and no alternative injectable therapy has been approved in more than a decade. Opioids are another treatment option, and as many as 40 percent of Medicare patients are prescribed opioids for chronic OA pain.

About Zilretta

Zilretta is being investigated as the first IA sustained-release, non-opioid treatment for patients with moderate to severe OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting corticosteroid — with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude and prolong the duration of pain relief.

To date, over 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with immediate-release TCA and placebo. The data from these trials are consistent with Zilretta providing meaningful and durable pain relief.

About Flexion Therapeutics

Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive IA injections for knee OA annually. The company is also investigating another product candidate, FX007, a locally administered TrkA receptor antagonist for post-operative pain.

Forward-Looking Statements

Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our ongoing development of Zilretta and our other product candidates; our interpretation of the data and results from our Zilretta clinical trials; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; our plans to commercialize Zilretta and its market potential; and the potential therapeutic and other benefits of Zilretta and our other product candidates, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; the fact that results of past clinical trials may not be predictive of subsequent trials; our reliance on third parties to manufacture and conduct clinical trials of Zilretta and our other product candidates, which could delay or limit their future development or regulatory approval; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any of our other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta and our other product candidates; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta or our other product candidates; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

¹ WOMAC (Western Ontario and McMaster Universities Arthritis Index) is a validated, widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.

Investor Contact
David Carey
Lazar Partners LTD
T: 212-867-1768 
dcarey@lazarpartners.com

Media Contact
Mariann Caprino
TogoRun
T: 917.242.1087  
M.Caprino@togorun.com

Corporate Contact
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com

(OPCO) Expects New Product Line to Make Big Splash at Global Pet Expo

OurPet’s New Products Will Be Featured at Booth #2455

(TBRA) Completes Patient Recruitment for ORION Phase 2a Study

SOUTH SAN FRANCISCO, Calif., Feb. 9, 2016  — Tobira Therapeutics, Inc. (NASDAQ: TBRA), a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, announced that it has completed recruitment for the Phase 2a ORION study.

ORION is a randomized, double-blind, placebo-controlled study exploring the metabolic effects of cenicriviroc (CVC) in obese adults (BMI greater than or equal to 30 kg/m²) with prediabetes or diabetes and suspected non-alcoholic fatty liver disease (NAFLD). The primary outcome of ORION will measure changes in insulin sensitivity in peripheral and adipose tissue over a 24-week period and will include an interim analysis at 12 weeks. Tobira plans to announce the top-line 12-week interim analysis in the second quarter of 2016 and submit results for presentation at a scientific conference.

“Completion of enrollment in this mechanistic study marks another milestone for Tobira as we explore the full potential of CVC,” said Laurent Fischer, M.D., chief executive officer of Tobira. “In previous clinical and nonclinical studies, CVC has demonstrated anti-inflammatory and anti-fibrotic activity, impacting two key engines of disease progression in NASH. ORION allows us to explore CVC’s impact on insulin resistance, which plays a determining role in NASH.”

In obese patients, the over-expression of CCR2 and CCR5 receptors and their ligands in fat tissue has been shown to promote both inflammation and insulin resistance. Insulin resistance is associated with the development of NAFLD and is a key driver for disease progression to its more severe form, non-alcoholic steatohepatitis (NASH), as well as other diabetes-related complications.

Details about ORION can be found at www.clinicaltrials.gov using identifier NCT02330549.

About Cenicriviroc (CVC) and Non-alcoholic Steatohepatitis (NASH)
CVC is an oral, once-daily, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways in NASH that cause liver damage and often lead to cirrhosis, liver cancer or liver failure. Tobira believes this novel approach will establish CVC as both a single-agent and as a cornerstone treatment in multi-therapy regimens for NASH, for which there is currently no approved drug.

CVC is currently being evaluated in Tobira’s fully enrolled global Phase 2b CENTAUR study (identifier NCT02217475) and the company expects to announce the study’s primary endpoint in the third quarter of 2016. CENTAUR is comparing CVC to placebo in 289 patients with NASH and liver fibrosis. CVC has been granted Fast Track status in NASH in patients with liver fibrosis, the patient population at highest risk of progression to cirrhosis. The CENTAUR study includes surrogate endpoints identified as suitable for registrational studies in findings of an FDA-AASLD workshop reported in Hepatology. To date, approximately 600 subjects have been dosed in completed studies with CVC, including 115 HIV infected subjects on treatment for up to 48 weeks.

NASH is an emerging health crisis impacting 3% to 5% of the U.S. population and 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. Additionally, this population is estimated to be three to five times larger than the size of the population with hepatitis C in the U.S.

About Tobira Therapeutics
Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies to treat liver disease, inflammation, fibrosis and HIV. The company’s lead product candidate, cenicriviroc (CVC), is a first-in-class immunomodulator and dual inhibitor of CCR2 and CCR5 being evaluated for the treatment of non-alcoholic steatohepatitis (NASH). Learn more about Tobira at www.tobiratherapeutics.com.

Tobira® is a registered trademark owned by Tobira Therapeutics, Inc.

©2016 Tobira Therapeutics, Inc. All Rights Reserved.

Forward Looking Statements
This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the company’s clinical development of cenicriviroc (CVC), the potential timing and outcomes of clinical studies of CVC undertaken now or in the future; the ability of the company to timely source adequate supply of its development products from third party manufacturers on whom the company depends; the company’s limited cash reserves and its ability to obtain additional capital on acceptable terms, or at all; the company’s ability to successfully progress, partner or complete further development of its programs; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; the company’s ability to protect its intellectual property; competition; changes in the regulatory landscape or the imposition of regulations that affect the company’s products; and other factors listed under “Risk Factors” in the company’s filings with the Securities and Exchange Commission.

Tobira Investor & Media Contact:
Ian Clements, Ph.D.
+1 (650) 351-5013
ir@tobiratherapeutics.com

Canale Communications Media Contact:
Pam Lord
+1 (619) 849-6003
pam@canalecomm.com

(RAVE) Announces New Expansion Deal

Former Applebee’s CEO and family members sign on for 10 more locations

DALLAS, Feb. 12, 2016  — Pie Five Pizza is adding another expansion deal to its growing Circle of Crust. The brand known for fresh, custom, artisan pizzas served in under five minutes today announced plans to add up to 10 new Pie Five locations in Kansas City. Under the new development agreement, franchisee, Dave Goebel, along with sons Kevin and Kerry and daughter Lyssa, plan to strategically fill in trade areas in the Kansas City metro area on both the Kansas and Missouri sides. Additionally, the team is looking north of the city in St. Joseph, MO.

“Our family couldn’t be more pleased with our decision to be part of the Pie Five family — the first two and a half years with Pie Five have significantly exceeded our expectations and initial projections,” said Goebel. “Our guests have responded extremely well to this innovative approach to high quality, customized and fast pizza. We’re excited to extend our reach in the Kansas City, Lawrence, Topeka, Manhattan and St. Joseph areas in order to become even more convenient to pizza lovers.”

Goebel brings 35 years of experience in the retail, food service and hospitality segments and currently serves as president of KC Pie, LLC, a multi-unit franchise partner for Pie Five Pizza Co.  He is the former chief executive officer of casual-dining Applebee’s restaurants. KC Pie, LLC currently owns and operates eight Pie Five Pizza Co. locations with a ninth set to open next later this month.

“Additionally, we’re excited to continue our affiliation with Children’s Mercy Hospital,” said Goebel, who serves on the board at Children’s Mercy Hospital. “We are closing in on our goal of $100,000 in support for the outstanding work this organization does in the states of Kansas and Missouri.”

Throughout the year, KC Pies LLC has given 5% of their totals sales every Monday to Children’s Mercy Hospitals. They have donated over $80,000 to date.

This is the second Pie Five franchisee to add additional locations this year. Last month, franchise owner, Rob Byford, signed a development deal to add 7 new Pie Five location s in the Memphis market. The fast casual pizza leader currently has 400 locations in development.

Pie Five’s unique fast casual model allows patrons to customize a personal handcrafted pizza, choosing from a wide selection of fresh, artisan ingredients — all in under 5 minutes. Pie Five pizzas bake in just 145 seconds in a custom-designed, state-of-the-art oven. There are millions of possible pizza combinations Pie Five customers can create with four crusts (including artisan thin, classic pan, whole grain Neapolitan and gluten-free), seven sauces and 28 fresh toppings. Additionally, guests can add one of Pie Five’s freshly-tossed hand-made salads.

ABOUT PIE FIVE PIZZA CO.
Dallas-based Pie Five Pizza Co. is a subsidiary of RAVE Restaurant Group, Inc. (NASDAQ: RAVE). RAVE owns, franchises and supplies more than 300 Pie Five and Pizza Inn restaurants operating domestically and internationally. Pie Five Pizza Co. is the leading brand in the rapidly growing fast-casual pizza space, offering individual handcrafted pizzas with fresh ingredients made to order in less than five minutes. Named among Fast Casual’s Top “Movers & Shakers” for three consecutive years, 2015 “Best Franchise Deal” by QSR Magazine, 2012 Hot Concepts winner by Nation’s Restaurant News and one of “10 Hot New Restaurant Chains from Established Brands” by Forbes.com, the company currently has 86 locations in 24 states and the District of Columbia. For more information, please visit PieFivePizza.com.

Contact: Marcus Dockter, MWWPR
213-234-1746
mdockter@mww.com

(ABCD) Participates in Providing Credit Facility for Cambium Learning

CHARLOTTE, N.C., Feb. 12, 2016  — Babson Capital Management, a global asset management firm with approximately $223 billion in assets under management, announced today that it led the Term Loan B issuance in a $135 million credit facility to Cambium Learning Inc. Babson also served as co-documentation agent on the transaction, which included revolving credit and term loan facilities.

Founded in 2003 and based in Dallas, Cambium Learning Inc. is an educational solutions and services company providing supplemental digital and print products to teachers and students from pre-K through high school in math, reading, science and other subjects. Cambium Learning Inc. is a wholly owned subsidiary of Cambium Learning Group Inc. (NASDAQ: ABCD), which is majority-owned by Veronis Suhler Stevenson (“VSS”).

“Babson added value through its ability to provide solutions across the capital structure and its flexibility and responsiveness in meeting the needs of both sponsor and borrower,” said David Bainbridge, Managing Director for Veronis Suhler Stevenson. “VSS appreciates Babson’s partnership in the refinancing of Cambium Learning Inc. and we look forward to working with them again soon.”

“Babson is excited to partner with VSS and the lending group on a financing solution for Cambium,” said Ian Fowler, Managing Director and Co-Head of Babson’s North American Private Finance Group. “With significantly lower cost of capital and continuing support from VSS, we believe Cambium is positioned to leverage its strong market position and capitalize on organic and strategic growth opportunities.”

About Veronis Suhler Stevenson

Veronis Suhler Stevenson is a leading private investment firm that invests in the information, tech-enabled business services, healthcare IT, and education industries in North America and Europe. With offices in New York and London, VSS provides capital for buyouts, recapitalizations, growth financings and strategic acquisitions to middle-market companies and management teams with the goal of building companies organically and through a focused add-on acquisition program. Since 1987, VSS has managed seven private investment funds with aggregate initial capital commitments totaling over $3 billion, including four equity funds and three structured capital funds. To date, VSS funds have invested in 74 platform companies, which have together completed over 330 add-on acquisitions. To learn more, visit www.vss.com.

About Babson Capital Management

Babson Capital Management LLC is one of the world’s leading asset management firms, with approximately $223 billion in assets under management as of December 31, 2015. Through proprietary research, analysis and a focus on investment fundamentals, the firm and its global affiliates develop products and strategies that leverage its broad expertise in global fixed income, structured products, middle market finance, commercial real estate, alternatives and equities. A member of the MassMutual Financial Group, Babson maintains a strong global footprint with operations on four continents and clients in 31 countries. Learn more at www.babsoncapital.com

Contact:
Brian Whelan, Babson Capital Management, 704.805.7244, bwhelan@babsoncapital.com
David Coburn, Luquire George Andrews, 704.552.6565, coburn@lgaadv.com

(UUUU) Reports Production Updates

LAKEWOOD, CO, Feb. 12, 2016  – Energy Fuels Inc. (NYSE MKT:UUUU; TSX:EFR) (“Energy Fuels” or the “Company”), one of the largest producers of uranium in the United States, is pleased to announce that the Company has achieved several key licensing, development, and production milestones at its Nichols Ranch in situ recovery (“ISR”) Project in Wyoming.

The Company is pleased to announce that it has completed the construction and licensing of the previously announced elution circuit at the Nichols Ranch ISR Plant as scheduled.  The Company has received final notice from the U.S. Nuclear Regulatory Commission (“NRC”) that uranium recovery operations involving elution, precipitation, filter press, and slurry processes are authorized to commence.  Now that the elution circuit is completed and fully-licensed, Energy Fuels has 100% self-contained ISR processing capabilities.  The new elution circuit is expected to significantly lower the Company’s future costs of production on a per pound basis by avoiding 3^rd party toll processing fees.  The elution circuit also provides the Company with operational flexibility as it executes its development plans and responds to future market conditions.

The Company is also increasing production at the Nichols Ranch Project on a controlled basis.  Through ongoing well-field development and drilling, the Company is confirming – and in certain cases increasing – its level of confidence in the uranium resource estimates contained in the most recent Technical Report and Preliminary Economic Assessment for the Nichols Ranch Uranium Project dated February 28, 2015, prepared in accordance with National Instrument 43-101 (the “Technical Report”).

A 6^th header-house at the Nichols Ranch Project began production in November 2015.  It continues to maintain grades and produce uranium at higher-than-expected rates.  Furthermore, through the successful execution of slant hole drilling, the Company has been able to place significant additional resources under pattern at this 6^th header-house that were previously thought to be inaccessible due to challenging terrain.

The Company is scheduled to place the 7^th and 8^th header-houses on-line at the Nichols Ranch Project in March 2016 and July 2016, respectively.  Drilling and installation of production wells for these two header-houses is proceeding at the current time.  The pattern for the 7^th header-house was originally believed to have lower uranium grades.  However, drilling is now indicating that the high-grade zones identified in earlier patterns of the project are more continuous than originally estimated.  Indeed, the Company has recorded the 3^rd highest intercept ever observed at Nichols Ranch (0.441% U₃O₈ with a thickness of 15.5 feet), in addition to other high-grade intercepts between 0.11% – 0.15% U₃O₈ with thicknesses of 9.0 – 14.5 feet.  Future drilling will confirm whether additional resources can be placed under pattern above the estimates contained in the current Technical Report.  Finally in late 2015, the Company successfully completed the installation of the monitor wells and began baseline and hydrological testing work in the next phase of the Nichols Ranch Project.  Energy Fuels expects to start development and uranium recovery operations in this next phase in the latter part of 2016.

Stephen P. Antony, President and CEO of Energy Fuels stated:  “Nichols Ranch continues to meet – and exceed – the high expectations we had when we acquired the project in June 2015.  Nichols Ranch is proving itself to be a reliable and scalable long-term U.S. uranium production center, which has large areas of high grade uranium resources that can be produced at an attractive cost.  The 6^th header-house at Nichols Ranch is producing very well, and we have similarly high expectations for the 7^th and 8^th header-houses, which are scheduled to come online later this year.  While we expect uranium prices to increase in the coming years, Nichols Ranch has become vitally important for Energy Fuels as we navigate today’s challenging uranium price environment.  I wish to congratulate our permitting and technical teams for achieving these important milestones at Nichols Ranch.  Between our ISR team in Wyoming and our conventional mining teams in Utah and Arizona, I think it is clear that Energy Fuels has the right people and projects in place to solidify our position as a dominant uranium producer in the U.S.”

Stephen P. Antony, P.E., President & CEO of Energy Fuels, is a Qualified Person as defined by National Instrument 43-101 and has reviewed and approved the technical disclosure contained in this news release.

About Energy Fuels:  Energy Fuels is a leading integrated US-based uranium mining company, supplying U₃O₈ to major nuclear utilities.  Energy Fuels operates two of America’s key uranium production centers, the White Mesa Mill in Utah and the Nichols Ranch Processing Facility in Wyoming.  The White Mesa Mill is the only conventional uranium mill operating in the U.S. today and has a licensed capacity of over 8 million pounds of U₃O₈ per year.  The Nichols Ranch Processing Facility, acquired in the Company’s acquisition of Uranerz Energy Corporation, is an in situ recovery (“ISR”) production center with a licensed capacity of 2 million pounds of U₃O₈ per year.  Energy Fuels also has the largest NI 43-101 compliant uranium resource portfolio in the U.S. among producers, and uranium mining projects located in a number of Western U.S. states, including producing mines, mines on standby, and mineral properties in various stages of permitting and development.  The Company’s common shares are listed on the NYSE MKT under the trading symbol “UUUU”, and on the Toronto Stock Exchange under the trading symbol “EFR”.

Cautionary Note Regarding Forward-Looking Statements:  Certain information contained in this news release, including any information relating to the Company being one of the largest producers of uranium, the ability of Nichols Ranch to continue to meet or exceed expectations, the ability of the Company to reduce its cost of production and respond to market conditions, the ability of the Company to produce resources placed under pattern, the ability of the Company to increase resource estimates through future drilling, the Company’s position as a dominant uranium producer in the U.S., and any other statements regarding Energy Fuels’ future expectations, beliefs, goals or prospects constitute forward-looking information within the meaning of applicable securities legislation (collectively, “forward-looking statements”).  All statements in this news release that are not statements of historical fact (including statements containing the words “expects”, “does not expect”, “plans”, “anticipates”, “does not anticipate”, “believes”, “intends”, “estimates”, “projects”, “potential”, “scheduled”, “forecast”, “budget” and similar expressions) should be considered forward-looking statements.  All such forward-looking statements are subject to important risk factors and uncertainties, many of which are beyond Energy Fuels’ ability to control or predict.  A number of important factors could cause actual results or events to differ materially from those indicated or implied by such forward-looking statements, including without limitation factors relating to:  the Company being one of the largest producers of uranium, the ability of Nichols Ranch to continue to meet or exceed expectations, the ability of the Company to reduce its cost of production and respond to market conditions, the ability of the Company to produce resources placed under pattern, the ability of the Company to increase resource estimates through future drilling, the Company’s position as a dominant uranium producer in the U.S., and other risk factors as described in Energy Fuels’ most recent annual information forms and annual and quarterly financial reports.  Energy Fuels assumes no obligation to update the information in this communication, except as otherwise required by law.  Additional information identifying risks and uncertainties is contained in Energy Fuels’ filings with the various securities commissions which are available online at www.sec.gov and www.sedar.com.  Forward-looking statements are provided for the purpose of providing information about the current expectations, beliefs and plans of the management of Energy Fuels relating to the future.  Readers are cautioned that such statements may not be appropriate for other purposes.  Readers are also cautioned not to place undue reliance on these forward-looking statements, that speak only as of the date hereof.

(HEES) Reports Quarterly Cash Dividend

H&E Equipment Services, Inc. (NASDAQ: HEES) today announced that its Board of Directors declared a regular quarterly cash dividend to be paid to its stockholders. The Company announced a quarterly cash dividend of $0.275 per share of common stock to be paid on March 9, 2016 for stockholders of record as of the close of business on February 23, 2016.

About H&E Equipment Services, Inc.

The Company is one of the largest integrated equipment services companies in the United States with 77 full-service facilities throughout the West Coast, Intermountain, Southwest, Gulf Coast, Mid-Atlantic and Southeast regions. The Company is focused on heavy construction and industrial equipment and rents, sells and provides parts and services support for four core categories of specialized equipment: (1) hi-lift or aerial platform equipment; (2) cranes; (3) earthmoving equipment; and (4) industrial lift trucks. By providing equipment rental, sales, on-site parts, repair and maintenance functions under one roof, the Company is a one-stop provider for its customers’ varied equipment needs. This full service approach provides the Company with multiple points of customer contact, enabling it to maintain a high quality rental fleet, as well as an effective distribution channel for fleet disposal and provides cross-selling opportunities among its new and used equipment sales, rental, parts sales and services operations.

Forward-Looking Statements

Certain statements in this press release are “forward-looking statements” within the meaning of the federal securities laws. Statements that are not historical facts, including statements about our beliefs and expectations are forward-looking statements. Statements containing the words “may,” “could,” “would,” “should,” “believe,” “expect,” “anticipate,” “plan,” “estimate,” “target,” “project,” “intend” and similar expressions constitute forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which could cause actual results to differ materially from those contained in any forward-looking statement. Such factors include, but are not limited to, the following: (1) general economic conditions and construction and industrial activity in the markets where we operate in North America; (2) the pace of economic recovery in areas affecting our business (although we have experienced an upturn in our business activities from the most recent economic downturn and related decreases in construction and industrial activities, there is no certainty that this trend will continue; if the pace of the recovery slows or construction and industrial activities decline, our revenues and operating results may be severely affected); (3) the impact of conditions of the global credit markets and their effect on construction spending activity and the economy in general; (4) relationships with equipment suppliers; (5) increased maintenance and repair costs as we age our fleet and decreases in our equipment’s residual value; (6) our indebtedness; (7) risks associated with the expansion of our business; (8) our possible inability to effectively integrate any businesses we acquire; (9) competitive pressures; (10) compliance with laws and regulations, including those relating to environmental matters and corporate governance matters; and (11) other factors discussed in our public filings, including the risk factors included in the Company’s most recent Annual Report on Form 10-K. Investors, potential investors and other readers are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements after the date of this release.

(GTIM) Bad Daddy’s Burger Bar Brings Bold Flavors to Village at the Peaks in Longmont

Good Times Restaurants Inc. (Nasdaq: GTIM) is announcing that Bad Daddy’s Burger Bar, a chef-driven, full-service restaurant that uses a mix of artisanal ingredients and made-from-scratch sauces and dressings to create the most delicious, flavorful and downright baddest burgers around, is opening a new location in Longmont. The restaurant, which is set to open its doors on February 15, 2016, will be located in the Village at the Peaks shopping center at 1232 South Hover Road.

With six other established restaurants in Colorado, the new burger bar will be the first location north of the Denver metro area and will provide guests in Longmont a dining experience unlike any other within the popular shopping community. The Village at the Peaks location will feature fan-favorite menu items including its popular gourmet burgers, such as the Bacon Cheeseburger on Steroids and the Bad Ass Burger, as well as chopped salads, specialty sides and appetizers. Additionally, the restaurant offers a full gluten-free menu and regional chef specials that incorporate Colorado flavors and ingredients.

“We’ve opened three locations over the past five months in the Greater Denver area and we’re thrilled to open up another Bad Daddy’s location in Village at the Peaks. Our loyal fans have been the best part of this experience, and we can’t wait to bring our chef-driven menu to Longmont,” said Boyd Hoback, CEO of Bad Daddy’s Burger Bar. “In addition to our regularly featured favorites, throughout February we’ll be honoring the success of the Broncos with the `Omaha! Omaha! Burger,’ that comes complete with pulled pork, pepper jack cheese, onion straws and our housemade apple-bacon barbeque sauce. If our guests are feeling up to the challenge, it pairs well with the Cherry Chocolate milkshake or one of our rotating microbrewed craft beers that are featured each month.”

Along with the restaurant’s core menu items, guests can expect to see new burgers, sides, salads and shake specials created by executive chef Tim Kast each month. The restaurant will continue to place its focus on simple, high-quality ingredients executed at a high level, but Bad Daddy’s Burger Bar doesn’t just stop at burgers. The restaurant’s delicious starters, like their famous Fried Pickles and Back Yard Chicken Nachos, are huge guest favorites, along with the menu of handspun milkshakes. For the health-conscious crowd, the gourmet burger bar offers Giant Chopped Salads tossed to order with fresh ingredients and homemade dressings, as well as a Create Your Own salad option. The Longmont location will also offer craft beers from Longmont’s Left Hand Brewing Company, Lafayette’s Liquid Mechanics Brewery, and Boulder’s Avery Brewing Company.

The Village at the Peaks opening is one of three additional Colorado sites expected to open through early summer 2016.

About Good Times Restaurants Inc.

Good Times Restaurants Inc. (GTIM) operates Good Times Burgers & Frozen Custard, a regional chain of quick–service restaurants located primarily in Colorado, in its wholly owned subsidiary, Good Times Drive Thru Inc. Good Times provides a menu of high-quality all-natural hamburgers, 100% all-natural chicken tenderloins, fresh frozen custard, natural-cut fries, fresh lemonades and other unique offerings. Good Times currently operates and franchises 37 restaurants. For more information about Good Times, please visit www.goodtimesburgers.com. Connect with Good Times on Facebook, Twitter and Instagram. GTIM also owns and operates Bad Daddy’s Burger Bar restaurants. Bad Daddy’s Burger Bar is a full-service, upscale, “small box” restaurant concept featuring a chef-driven menu of gourmet signature burgers, chopped salads, appetizers and sandwiches with a full bar and a focus on a selection of craft microbrew beers in a high-energy atmosphere that appeals to a broad consumer base. GTIM currently owns, operates, franchises and licenses 17 restaurants. For more information about Bad Daddy’s, please visit www.baddaddysburgerbar.com. Connect with Bad Daddy’s on Facebook, Twitter and Instagram.

(WIN) Appoints Jeannie H. Diefenderfer, Larry Laque to Board of Directors

LITTLE ROCK, Ark., Feb. 11, 2016  — Windstream Holdings, Inc. (NASDAQ:WIN) announced today the appointments of Jeannie H. Diefenderfer and Larry Laque to the company’s board of directors. The appointments are effective immediately.

Diefenderfer and Laque qualify as independent board members under Nasdaq-listing requirements. Diefenderfer will serve on the board’s governance committee, and Laque will serve on the audit committee.

“I am very pleased to welcome Jeannie and Larry to the board. Both have deep experience in communications and technology. Their expertise and insight will be beneficial to Windstream and our shareholders,” said Tony Thomas, president and chief executive officer of Windstream.

Jeannie Diefenderfer, 54, is founder and chief executive officer of courageNpurpose, LLC. She has nearly 30 years of technical and operational leadership experience with Verizon Communications. She served as senior vice president of customer care and operations for Verizon Business from 2010 to 2012. She also held senior leadership positions in global network engineering, planning and procurement at Verizon.

Diefenderfer is an independent director on the boards of MRV Communications, Inc. (NASDAQ:MRVC) and Westell Technologies, Inc. (NASDAQ:WSTL), an advisory board member of Vasona Networks, Inc. and a member of the Accenture Network Advisory Council. She also is a trustee of Tufts University.

She holds a bachelor of science in chemical engineering from Tufts University, and an MBA from Babson College.

Larry Laque, 57, serves as executive vice president of global real estate and facilities for Discovery Communications, Inc. With more than 30 years of experience in technical planning and operations, Laque is currently responsible for developing and implementing workplace strategy, including technical facility infrastructure across 82 offices in more than 35 countries for the global media company.

Laque previously served as executive vice president and co-chief information officer and co-head of enterprise operational services for Discovery, where he oversaw global IT infrastructure for the company.

Prior to joining Discovery, Laque served in various leadership positions in network planning, operations and customer service at MCI Communications Corporation.

Laque also serves on the board of Shepherd’s Table, a Silver Spring-based nonprofit organization that provides basic services to homeless and in-need individuals in the greater Washington, D.C. area.

Laque holds a bachelor of arts in business administration from North Carolina State University and an MBA from The George Washington University.

The company also announced that Judy K. Jones and William A. ‘Bill’ Montgomery will not stand for re-election in May and depart the board when their current terms expire. Jones and Montgomery have served as directors of Windstream since its formation in 2006.

“Judy and Bill have provided exceptional guidance while steering the company through tremendous change in our industry. They have been valuable contributors to Windstream’s success, and we appreciate their decade of service on our board,” said Jeffrey T. Hinson, chairman of the board of Windstream, on behalf of the board.

About Windstream

Windstream Holdings, Inc. (NASDAQ:WIN), a FORTUNE 500 company, is a leading provider of advanced network communications and technology solutions for consumers, small businesses, enterprise organizations and carrier partners across the U.S. Windstream offers bundled services, including broadband, security solutions, voice and digital TV to consumers. The company also provides data, cloud solutions, unified communications and managed services to business and enterprise clients. The company supplies core transport solutions on a local and long-haul fiber-optic network spanning approximately 125,000 miles. Additional information is available at windstream.com. Please visit our newsroom at news.windstream.com or follow us on Twitter at @WindstreamNews.

Media Contact:
David Avery, 501-748-5876
david.avery@windstream.com

Investor Contact:
Mary Michaels, 501-748-7578
mary.michaels@windstream.com

(COLL) Announces Favorable Judgment by the District Court of Massachusetts

CANTON, Mass., Feb. 11, 2016  — Collegium Pharmaceutical, Inc. (Nasdaq:COLL) announced that the District Court of Massachusetts issued an order for final judgment in favor of Collegium and against plaintiffs Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P., and Rhodes Technologies. The judgment relates to Purdue’s three Orange Book-listed patents asserted against Collegium that were the cause of the 30 month stay imposed on our New Drug Application for Xtampza™ ER.

“We are excited to have resolved this litigation of the patents that was delaying the potential final approval of Xtampza. The termination of the 30 month stay is a significant milestone for the Company,” said Michael Heffernan, CEO of Collegium. “We intend to move forward with our request for the U.S. Food and Drug Administration to convert our Tentative Approval to a Final Approval.”

“This judgment provides additional clarity on the timing for the potential commercial launch of Xtampza. Our commercial leadership team has developed our commercialization strategy over the last 12 months,” said Barry Duke, Chief Commercial Officer of Collegium.  “Over the next few months, we will complete the hiring and training of our sales organization, as we prepare for a late second quarter launch.”

About Collegium Pharmaceutical, Inc.

Collegium is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its patent-protected DETERx technology platform for the treatment of chronic pain and other diseases. The DETERx oral drug delivery technology is designed to provide extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options.

About Xtampza™ ER

Collegium’s lead product candidate, Xtampza ER, is an abuse-deterrent, extended-release, oral formulation of oxycodone, in development for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Collegium developed Xtampza using its proprietary DETERx technology platform to address common methods of abuse, including chewing, crushing and/or dissolving, and then taking it orally or snorting or injecting.

The United States Food and Drug Administration (FDA) has granted tentative approval to the Company’s New Drug Application (NDA) for Xtampza ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. With a tentative approval, the FDA has determined that Xtampza ER meets required quality, safety and efficacy standards for approval but it is subject to an automatic stay of up to 30 months as a result of patent litigation filed by Purdue Pharma, L.P.

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 we will obtain final approval for Xtampza ER or any of our other product candidates from the FDA or foreign regulatory authorities; even if Xtampza ER obtains final approval, we may not be able to obtain the label claims that we are 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: our ability to commercialize our product candidates; the existence of any patent infringement or similar litigation relating to any of our products or product candidates, and costs and delays associated with such litigation; the size and growth potential of the markets for our product candidates, and our ability to service those markets; our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of our product candidates; the success, cost and timing of our product development activities, studies and clinical trials; the success of competing products that are or become available; and our expectations regarding our ability to obtain and adequately maintain sufficient intellectual property protection for our product candidates. These and other risks are described under the heading “Risk Factors” in the registration statement on Form S-1 (commission file number 333-208641), which was declared effective by the Securities and Exchange Commission (“SEC”) on January 7, 2016, and those risks described from time to time in other reports which we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact: 
Douglas Carlson
Vice President, Corporate Development
dcarlson@collegiumpharma.com

(CRNT) to Showcase its 5G Wireless Backhaul Technologies

Ceragon’s microwave and millimeterwave backhaul technologies will enable communication service providers to prepare for next generation 5G networks

LITTLE FALLS, New Jersey, February 11, 2016  —

Ceragon Networks Ltd. (NASDAQ: CRNT), the #1 wireless backhaul specialist, today announced that it will showcase its 5G wireless backhaul technologies at Mobile World Congress 2016, in Barcelona, Spain. Commercial offering of 5G services in developed markets is expected to begin by 2020 and is expected to bring exponential growth in network capacity as well as the number and types of connected devices. 5G technology is also anticipated to enable a wide variety of new services, including IoT and M2M, changing the way networks are designed and built. A key requirement to meet 5G service demands is a flexible wireless backhaul infrastructure which meets more stringent performance, reliability, and operational efficiency targets. Ceragon Networks is developing robust technologies to meet the need for 100 times higher capacity at cell sites, at least five times denser cell-site grids, with large scale street-level deployments, network virtualization and optimization, as well as support for mission critical applications.

Powered by Ceragon’s multicore technologies which achieve faster time to market with higher performance at affordable costs by using in-house designed system on chips, which are integrated into Ceragon’s wireless backhaul solutions, Ceragon’s solutions are being optimized for 5G capacity, latency, service and network availability targets.

“Ceragon’s strategic investment in vertically integrated solutions, developing advanced microwave and millimeterwave systems on chips and integrating those into complete products, will allow communication service providers to meet their business objectives as their networks evolve to deliver 5G services,” said Ira Palti, president and CEO of Ceragon. “Supporting our customers today in their 4G deployments and their evolution from 3G to 4G, Ceragon is committed to delivering solutions that enable its customers to achieve the highest value both in operational efficiency and customer experience, while ensuring peace of mind by offering a highly reliable network able to evolve over time.”

Ceragon’s wireless backhaul technologies will enable communication service providers to:

1. Deliver up to 10Gbps backhaul to cell sites using ultra-wide microwave frequency channels with LoS 4×4 MIMO technology at 6 – 42GHz, and millimeterwave compact radios – overcoming spectrum shortages and reducing site acquisition and related costs.
2. Deploy cellular base stations and small cells exactly where needed, in any deployment scenario, by eliminating backhaul constraints caused by lack of spectrum and inability to reuse the microwave spectrum channels. Ceragon’s Advanced Frequency Reuse technology allows for reusing frequency channels twice as often as otherwise possible, ensuring the location of the cellular site is not compromised, that the cost of backhaul is as low as possible, and that the quality of service for customers is not compromised.
3. Overcome microwave spectrum congestion by using multiband carrier aggregation of microwave and millimeterwave spectrum with Ceragon’s unique Multicarrier Adaptive Bandwidth Control technology. This technology meets capacity requirements, intelligently balancing traffic over microwave and millimeterwave channels and achieving service availability and reliability targets, while avoiding expensive trenching of fiber where it is not needed.
4. Enable fast deployment of highly dense cellular base stations and small cell grids by use of Ceragon’s multicore MIMO technology for Non Line of Sight use cases at 6 – 42GHz. Developed by Ceragon, this unique multicore MIMO technology will allow high performance, predictable capacity in NLoS conditions, while simplifying service rollout, eliminating alternative backhaul costs and accelerate revenue generation.
5. Adopt cost reduced network architecture with Cloud RAN by use of ultra-high capacity wireless backhaul (fronthaul) delivering 2.5Gbps to 10Gbps digital signaling between cloud baseband units and remote radio heads.
6. Ensure optimal use of network resources using Software Defined networks (SDN) technologies with open interfaces for simple and quick network integration, overcoming barriers of the current wireless networks eco system. Ceragon’s SDN wireless backhaul technologies optimize resources by performing dynamic spectrum allocation, intelligent power consumption management, and dynamic service reroute to increase operational efficiency, maintain high network reliability and enhance customers’ quality of experience.
7. Enable simplified evolution from 4G to 5G networks using IP-20 Platform technologies and capabilities, allowing maximum use of the Ceragon 4G wireless backhaul investments made today.

About Ceragon Networks Ltd.

Ceragon Networks Ltd. (NASDAQ: CRNT) is the world’s #1 wireless backhaul specialist. We help operators and other service providers worldwide increase operational efficiency and enhance end customers’ quality of experience with innovative wireless backhaul solutions. Our customers include wireless service providers, public safety organizations, government agencies and utility companies, which use our solutions to deliver 4G, mission-critical multimedia services and other applications at high reliability and speed. Ceragon’s unique multicore technology provides a highly reliable, high-capacity 4G wireless backhaul with minimal use of spectrum, power and other resources. It enables increased productivity, as well as simple and quick network modernization. We deliver a range of professional services that ensure efficient network rollout and optimization to achieve the highest value for our customers. Our solutions are deployed by more than 460 service providers, as well as hundreds of private network owners, in more than 130 countries.

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Ceragon Networks® and FibeAir® are registered trademarks of Ceragon Networks Ltd. in the United States and other countries. CERAGON ® is a trademark of Ceragon Networks Ltd., registered in various countries. Other names mentioned are owned by their respective holders.

Safe Harbor

This press release contains statements concerning Ceragon’s future prospects that are “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include: projections of capital expenditures and liquidity, competitive pressures, revenues, growth prospects, product development, financial resources, restructuring costs, cost savings and other financial matters. You can identify these and other forward-looking statements by the use of words such as “may,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “expects,” “intends,” “potential” or the negative of such terms, or other comparable terminology. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including risks associated with the risk that Ceragon will not achieve the benefits it expects from its expense reduction and profit enhancement programs; the risk that Ceragon‘s expectations regarding future revenues and profitability will not materialize; the risk that Ceragon will not continue to comply with the financial or other covenants in its agreements with its lenders; risks associated with doing business in Latin America, including currency export controls and recent economic concerns; risks relating to the concentration of our business in the Asia Pacific region and in developing nations; the risk of significant expenses in connection with potential contingent tax liability associated with Nera’s prior operations or facilities; and other risks and uncertainties detailed from time to time in Ceragon’s Annual Report on Form 20-F and Ceragon’s other filings with the Securities and Exchange Commission, and represent our views only as of the date they are made and should not be relied upon as representing our views as of any subsequent date. We do not assume any obligation to update any forward-looking statements.

Media Contact:
Matthew Krieger
GK Public Relations
Tel: +914-768-4219

matthew@gkpr.com

Company Contact:
Tanya Solomon
Ceragon Networks
Tel: +972-3-543-1163

tanyas@ceragon.com

Investor Contact:
Claudia Gatlin
Tel. +1-(212)-830-9080

claudiag@ceragon.com

(APDNW) to Create Strategic Advisory Board

Appoints Initial Three Members

(QUIK) Enhances Gesture Detection Algorithm in SenseMe Library

(NEWS) Expands Share Repurchase Program

Existing repurchase plan amended to authorize repurchase of $30 million of its common stock

Boston, Massachusetts, Feb. 11, 2016 (GLOBE NEWSWIRE) — The Board of Directors of NewStar Financial Inc. (Nasdaq: NEWS) has authorized an increase to NewStar’s existing stock repurchase program, which was originally authorized by the board in October 2015.

The existing plan authorized the repurchase of up to $5.0 million of NewStar’s common stock from time to time in open market or privately negotiated transactions, of which approximately $4.9 million remains available for repurchase.  The plan was increased to approve the repurchase of up to an aggregate of up to $30.0 million of NewStar’s common stock (inclusive of the amount remaining under the existing plan).

The timing and amount of any shares purchased under the repurchase plan will be determined by the NewStar’s management based on its evaluation of market conditions and other factors. The repurchase plan, as amended, will expire on December 31, 2016 unless extended by the Board and may be suspended or discontinued at any time without notice.

About NewStar Financial, Inc.:

NewStar Financial, Inc. (Nasdaq: NEWS) is an internally-managed commercial finance company with specialized direct lending platforms that provide flexible debt financing options to companies and private equity firms in the middle market with proceeds typically used to fund acquisitions, working capital, growth strategies, and recapitalizations, as well as, equipment purchases.  The company originates credit investments directly through teams of experienced, senior bankers and marketing officers organized around key industry and market segments.  It also offers investment opportunities for qualified institutions to invest in managed credit funds that co-invest in middle market loans that it originates.  NewStar is headquartered in Boston MA and has regional offices in Atlanta GA, Chicago IL, Dallas TX, Darien CT, New York, NY, Portland OR, and San Francisco CA.

Forward-Looking Statements:

This press release contains forward-looking statements, including statements regarding the company’s intention to repurchase shares of its common stock from time to time under the stock repurchase program.  There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements.  These forward-looking statements involve a number of risks and uncertainties that include, but are not limited to, the market price of the company’s stock prevailing from time to time, the company’s cash flows from operations, corporate developments and general economic conditions.  Additional information about the factors that may affect NewStar’s operations is set forth in Item 1A, “Risk Factors” in its Annual Report on form 10‑K for the year ended December 31, 2014, as amended, and as supplemented by any Risk Factors contained in its Quarterly Reports on Form 10‑Q.

Contact:
NewStar Financial, Inc.
Robert K. Brown 
617.848.2558
rbrown@newstarfin.com

(EDGE) New Data From the Phase 1/2 NEWTON Study

BERKELEY HEIGHTS, N.J., Feb. 10, 2016  — Edge Therapeutics, Inc. (Nasdaq:EDGE), a clinical-stage biotechnology company developing novel hospital-based therapies in the management of acute, life-threatening conditions, today announced that the full dataset from its North American Phase 1/2 NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study of EG-1962 has been accepted for an oral presentation at the International Stroke Conference 2016 (ISC), to be held February 17-19 at the Los Angeles Convention Center in Los Angeles, Calif. EG-1962, Edge’s lead product candidate, is in development to treat patients who have suffered an aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm.

Details of the oral presentation are as follows:

Title: 190 – Safety, Tolerability, Pharmacokinetics and Efficacy of Intraventricular Sustained Release Nimodipine (EG-1962) for Subarachnoid Hemorrhage
Session: A29. SAH and Other Neurocritical Management Oral Abstracts
Location: Room 515 B
Date: Friday, February 19
Time: 7 – 7:12 a.m. PST
Presenter: Daniel Hanggi, M.D., University Medical Center Mannheim, Ruprecht-Karls-University, Heidelberg, Germany

For more information on the ISC, visit: https://my.americanheart.org/professional/Sessions/InternationalStrokeConference/International-Stroke-Conference_UCM_316901_SubHomePage.jsp.

About EG-1962

EG-1962 is a novel polymeric nimodipine microparticle suspended in a diluent of hyaluronic acid that utilizes Edge Therapeutics’ proprietary Precisa^TM development platform designed to improve patient outcomes following an aneurysmal subarachnoid hemorrhage (aSAH). EG-1962 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of patients with aSAH.

About aSAH

An aneurysmal subarachnoid hemorrhage, or aSAH, is a brain hemorrhage after which blood from a ruptured aneurysm enters the subarachnoid space, the area between the middle and deepest protective layers of the brain. Approximately 600,000 individuals worldwide suffer an aSAH annually. In the U.S., approximately 35,000 aSAH patients, with an average age of 52, arrive alive at the hospital each year, and approximately 75 percent of these patients die or suffer permanent brain damage.

About the NEWTON Study

NEWTON was a multicenter, randomized, controlled, open-label Phase 1/2 study evaluating the safety, tolerability and pharmacokinetics of escalating doses of EG-1962 compared to the current standard of care, oral nimodipine, in subjects with an aneurysmal subarachnoid hemorrhage (aSAH). Fifty-four patients were randomized to receive EG-1962 and 18 patients were randomized to receive oral nimodipine. Pooled efficacy results of the NEWTON study showed that 60 percent of patients treated with EG-1962 achieved a favorable outcome (scores of 6-8 as measured by the Extended Glasgow Outcome Score [GOSE]) at 90 days compared to 28 percent of patients in the active control standard of care oral nimodipine arm who achieved a favorable outcome.

About Edge Therapeutics, Inc.

Edge Therapeutics, Inc. is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, life-threatening neurological conditions. EG-1962, Edge’s lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, or aSAH, which is bleeding around the brain due to a ruptured brain aneurysm. EG-1964, Edge’s second product candidate, is being evaluated as a potential prophylactic treatment in the management of chronic subdural hematoma, to prevent recurrent bleeding on the surface of the brain.

For additional information about Edge Therapeutics, please visit www.edgetherapeutics.com.

Investor Contact:

Allison Wey
Edge Therapeutics, Inc.
Tel: 1-800-208-EDGE (3343)
Email: awey@edgetherapeutics.com

Media Contact:

Laura Bagby
6 Degrees 
Tel: 312-448-8098
Email: lbagby@6degreespr.com

(TRMB) Advances its Precision Irrigation Solution Irrigate-IQ

Irrigate-IQ Uniform Corner Allows Farmers to Maximize Yield Through Uniform Water Application

SUNNYVALE, Calif., Feb. 10, 2016  — Trimble (NASDAQ:TRMB) introduced today the Irrigate-IQ™ uniform corner, a unique solution that allows farmers to apply a consistent amount of water on the area covered by a center-pivot corner arm. The solution prevents over- or under-watering through a uniform application, which can reduce crop stress, promote better nutrient absorption due to reduced run off and leaching, and ultimately improve crop quality and yield. In addition, it enables farmers to optimize water use. This can be beneficial for farmers located in areas with limited water resources or with water restrictions.

Irrigate-IQ uniform corner uses advanced algorithms that enable consistent water application regardless of the position of the corner arm. Whether the corner arm is starting to extend, fully extended, or folding back, Irrigate-IQ uniform corner minimizes the risk of overlaps or gaps in application. Because it controls each individual nozzle based on the desired application depth and the position of the corner arm, uniform corner provides the highest level of accuracy to achieve maximum uniformity across the entire area covered by the corner arm. In addition, Irrigate-IQ uniform corner works with multiple brands of corner arm equipment.

“Most farmers invest in a corner arm system in order to extend their irrigable land. However, typical systems do not provide consistent watering,” said Neil Douglas, Irrigate-IQ market manager for Trimble’s Agriculture Division. “This means they are not optimizing their water resources, and potentially damaging their crop and reducing yield by over- or under-watering it. Irrigate-IQ uniform corner allows farmers to extend the capabilities of their current corner arm through consistent water application to achieve the greatest return on their investment.”

Farmers can set the field depth and let the corner arm run, or they can add Irrigate-IQ monitor and control so they can remotely manage their whole pivot. For farmers who choose to add monitor and control, they can use the Connected Farm™ Irrigate app to remotely keep track of pivot status, or to turn their pivot on or off or change its direction.

Irrigate-IQ uniform corner is expected to be available worldwide in the first quarter of 2016. To learn more, visit: www.trimble.com/agriculture/Irrigate-IQ.

About Irrigate-IQ

The Irrigate-IQ precision irrigation solution is flexible and scalable, allowing farmers to begin with basic remote monitoring and control of their pivots via the Internet, and then easily upgrade to optimal flow or variable rate irrigation (VRI) as their needs evolve. The solution can be installed on most pivot makes and models regardless of manufacturer or panel type, such as basic or smart panels. It also includes reports about where water or fertilizer has been applied.

About Trimble’s Agriculture Division

Trimble Agriculture solutions enable customers to maximize efficiency and reduce chemical and fertilizer inputs while also protecting natural resources and the environment. Trimble’s precision agriculture solutions cover all seasons, crops, terrains, and farm sizes, and its brand-agnostic strategy allows farmers to use Trimble products on most vehicles in their fleet—regardless of manufacturer. To enable better decision making, Trimble offers the Connected Farm solution which allows farmers to collect, share, and manage information across their farm in real time. To optimize water use, Trimble provides water solutions for irrigation, drainage, and land leveling. Trimble’s product suite includes vehicle and implement guidance and steering, as well as a portfolio of correction options that are the most versatile of their kind in the industry. Additional solutions include an unmanned aircraft system (UAS) for aerial imaging and mapping; agri-services; application control for seed, liquid, and granular products; a harvest solution; and farm management software.

For more information on Trimble Agriculture, visit:  www.trimble.com/agriculture.

About Trimble

Trimble applies technology to make field and mobile workers in businesses and government significantly more productive. Solutions are focused on applications requiring position or location—including surveying, construction, agriculture, fleet and asset management, public safety and mapping. In addition to utilizing positioning technologies, such as GPS, lasers and optics, Trimble solutions may include software content specific to the needs of the user. Wireless technologies are utilized to deliver the solution to the user and to ensure a tight coupling of the field and the back office. Founded in 1978, Trimble is headquartered in Sunnyvale, Calif.

For more information, visit: www.trimble.com.

(NNVC) Files Quarterly Report for Period Ending 2015-12-31

SHELTON, Conn., Feb. 10, 2016  — NanoViricides, Inc. (NYSE MKT: NNVC) (the “Company”), filed its quarterly report in a timely manner with the Securities and Exchange Commission on Tuesday, February 9th. The submission can be downloaded from the SEC website at http://www.sec.gov/Archives/edgar/data/1379006/000114420416079966/v429785_10q.htm.

NanoViricides reported that it had approximately $28.3 Million (M) of current assets plus restricted cash (cash, cash equivalents, collateral advance, prepaid expenses, and security deposits) as of December 31, 2015, the end of the reporting period. The net cash used in operating activities during this quarter was approximately $1.22M. Shareholder equity stood at approximately $28.38M for the quarter (unaudited figures). The Company does not anticipate any major capital expenditures in the near future.

The Company estimates that the cash in hand is sufficient to enable us to perform initial human clinical trials of at least one of our drug candidates, as well as to advance at least one more drug candidate drug candidate towards initial human clinical trials. The Company’s expenditures during the reported period were on track with this expectation.

NanoViricides, Inc. is one of a few bio-pharma companies that have all the capabilities needed from research and development to marketable drug manufacture in the small quantities needed for human clinical trials. With the completion of and relocation to our new campus at 1 Controls Drive, Shelton, CT, we now possess state of the art nanomedicines characterization facilities that enable us to perform IND-enabling nanomedicine analysis and characterization studies of any of our various drug candidates in house. All of the biological testing and characterization of our drug candidates continues to be performed by external academic or institutional collaborators and contract research organizations (CRO).

With the recent success of our anti-HSV drug development program, the Company has re-prioritized to focus on topical drug development against several indications related to infections by herpes family viruses. These topical drugs are expected to provide a significantly faster path to human clinical stage than injectable drugs.

In the HerpeCide™ program, the Company is currently developing drugs against four different topical indications, namely: (a) skin cream/lotion for the topical treatment of “cold sores” (typically caused by HSV-1); (b) eye drops/gel for the treatment of ocular herpes keratitis (mostly caused by HSV-1, sometimes by HSV-2 primarily in neonates); (c) skin cream/lotion for the treatment of “genital lesions” caused by herpesvirus (typically HSV-2); and (d) skin cream/lotion for the treatment of shingles (caused by HHV-3 also known as VZV i.e the chickenpox virus).

The Company is in the process of establishing additional collaborations towards IND-enabling development of drug candidates for these indications.  Of these, the Company has announced on February 1, 2016, that it has entered into an agreement with the University of Wisconsin for the evaluation of its nanoviricides® drug candidates in models of ocular herpes virus infections. The studies will be performed in the laboratory of Dr. Curtis Brandt, an expert in herpes simplex virus infections and in evaluating anti-viral agents. The Company has previously reported the successes of its nanoviricides drug candidates in pre-clinical studies of dermal herpes virus infections in mouse models. The goal of these studies will be to identify a drug development candidate as a treatment for ocular keratitis in humans caused by herpes simplex virus infections.

Ocular infections with HSV-1 have been reported to be the leading cause of infectious blindness in the developed world. Corneal transplants to replace the damaged cornea cost about $15,000-25,000. The Company believes that the market for an effective ocular herpes keratitis drug could explode to several hundred millions of dollars. The Company believes that it has sufficient production capacity at its current site to supply the US requirement of the drug for treatment of (ocular) herpes keratitis upon drug licensure.

The Company continues to work on its anti-influenza drug candidates in parallel to its HerpeCide program. We are currently developing Injectable FluCide™ for hospitalized patients with severe influenza as our first, broad-spectrum anti-influenza drug candidate. We have demonstrated the very first effective orally available nanomedicine, namely oral FluCideT™ for out-patients with influenza. The development of Oral FluCide is expected to follow behind Injectable FluCide.

Because of our limited resources, we have assigned lower development priorities to other drug candidates in our pipeline such as DengueCide™ (a broad spectrum nanoviricide designed to attack all types of dengue viruses and expected to be effective in the Severe Dengue Disease syndromes including Dengue Hemorrhagic Fever (DHS) and Dengue Shock Syndrome (DSS)) and HIVCide™ (a potential “Functional Cure” for HIV/AIDS).

NanoViricides believes that it would be able to rapidly develop a drug candidate against the recent epidemic Zika virus by leveraging its Dengue drug efforts. Zika belongs to the same class of viruses as dengue viruses, called flaviviruses. Therefore, we believe that our broad-spectrum anti-dengue drug candidates would provide good leads for Zika drug development, should resources for engaging in this activity become available.

The nanoviricides® mechanism of action is believed to mimic a natural host cell receptor using which the virus binds and infects cells; binding of a nanoviricide nanomicelle to the virus is expected to render it non-infectious. A nanoviricide would thus stop the spread of the viral infection to new uninfected cells. This mechanism is different from that of currently available anti-Herpes drugs. The Company therefore believes that it is able to develop broad-spectrum anti-herpes nanoviricide drugs.

“We continue to make steady progress towards our goal of initiating human clinical trials of our first drug candidate in the near future,” said Eugene Seymour, MD, MPH, CEO of the Company, adding, “And we believe we will be able to perform clinical trials of at least one drug candidate with our available cash resources.”

The Company reports that all of its drug development programs are progressing satisfactorily and that it will continue to provide updates as appropriate.

About NanoViricides:
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “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. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities.  Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

(CUI) First Purchase Order GasPT Tech to Europe’s Largest NatGas Trans Company

TUALATIN, Ore., Feb. 10, 2016  — CUI Global, Inc. (NASDAQ:CUI) announced today that its wholly-owned United Kingdom energy subsidiary, Orbital Gas Systems Ltd. (“Orbital”), has successfully been awarded the initial purchase order (“PO”) for its proprietary GasPT® analyzer from Europe’s largest natural gas transmission company.  The order for 400 devices, including 65 high pressure installations, comes after almost four and a half years of intensive durability and accuracy testing; certification by relevant European Union (“EU”) authorities; and a thorough, independent test protocol conducted by The University of Milan on behalf of the transmission company.

The total scope of the project includes the deployment of 3,300 analyzers across the Italian pipeline system.  Orbital, through its Italian Distributor, SOCRATE S.p.A. (“SOCRATE”), is the only Vendor providing analyzers against this first PO.

The roll-out schedule calls for 50 units to be deployed within 30 days; another 250 units to be deployed 50 days thereafter; and the remainder to be deployed no later than October 2016.  Company representatives will be attending the “kick-off” meeting in Milan next week.

“This is a transformational project for the Company,” explained William Clough, CUI Global’s president & CEO.  “While we have previously deployed several hundred of our GasPT devices, this is the first large scale deployment with Europe’s largest natural gas pipeline company and one of the most respected natural gas transmission companies in the World.”

“We believe that the efficiencies, accuracy, minimal maintenance, and low-cost nature of our GasPT Technology will produce dramatic results for this project and will allow our Energy Division to leverage this exciting project into additional opportunities throughout Western Europe and into North America,” Clough continued.

“We are very pleased to partner with CUI Global and Orbital on this project,” stated Nicola Giorgio Sorrentino, CEO of SOCRATE.  “This venture is only made possible by the unique nature of the GasPT analyzer and its ability to cost-effectively and efficiently monitor natural gas quality in the pipeline.  The initial PO is only the beginning of what will be a tremendous opportunity for both Orbital and SOCRATE.”

The substantial testing conducted in Italy included, but was not limited to:

• A 6-month laboratory bench test for both durability and accuracy;
• An additional 12-month field trial in Mesura, which consisted of comparing GasPT measurements with a well-known and much-respected gas chromatograph (“GC”).  Over 12 months the GasPT was fully operational 100% of the time, while the GC was offline for 14% of the time;
• Deployment of six units for a 24 month field trial, during which the devices demonstrated accuracy of Calorific Value (“CV”) and Wobbe measurements typically better than +0.2% error and always much better than +0.5% (as required by both The International Organization of Legal Metrology and American Gas Association); and then,
• A 6-month comprehensive review of the resulting data by an independent third-party (The University of Milan) to confirm both durability and accuracy figures.

Besides the multifaceted and comprehensive testing regimen for this project, Orbital had to obtain all necessary safety certifications before the tests could begin.  In that regard, the GasPT device fully complies with, and is certified by such iconic organizations as: CSA, BASEEFA, OFGEM, PRCI, and IECEx.  The device is fully EMC compliant as well.

While qualifying for the Italian opportunity, Orbital also received full certification from The International Organization of Legal Metrology (“OIML”).  Specifically, the device is fully certified and compliant with OIML R 140 – Measuring Systems for Gaseous Fuel.  NMi (a highly-respected European test house based in The Netherlands) was engaged to perform that certification.

According to its charter, OIML is a “worldwide, intergovernmental organization whose primary aim is to harmonize the regulations and metrological controls applied by the national metrological services, or related organizations, of its Member States,” including Italy.

“This is certainly an inflection point for our Energy Division and continues to demonstrate the value of our natural gas product portfolio – A portfolio of products which allows us to change and improve the way natural gas is monitored, increase our market penetration, and, thereby, increase our shareholder value,” Clough concluded.

The Company will conduct a conference call and webcast to review the details of this release on Thursday, February 11, 2016 at 8:00 AM EST.

• To access the call, please dial the toll free number at (888) 734-0328 and provide the Conference ID: 48788368
• For international callers, please dial (678) 894-3054
• At the conclusion of the call, a replay will be available for 10 days
• To access the replay of the call dial (855) 859-2056 or (404) 537-3406 and provide the same Conference ID: 48788368
• In addition to the toll-free number listed above, participants can also dial (800) 585-8367 to access Encore

A simultaneous webcast will also be available:  http://edge.media-server.com/m/p/4xqs4nw4

About CUI Global, Inc.
Delivering Innovative Technologies for an Interconnected World . . . . .
CUI Global, Inc. is a publicly traded company dedicated to maximizing shareholder value through the acquisition and development of innovative companies, products and technologies. From Orbital Gas Systems’ advanced GasPT2 platform targeting the energy sector, to CUI Inc’s digital power platform serving the networking and telecom space, CUI Global and its subsidiaries have built a diversified portfolio of industry leading technologies that touch many markets. As a publicly traded company, shareholders are able to participate in the opportunities, revenues, and profits generated by the products, technologies, and market channels of CUI Global and its subsidiaries. But most importantly, a commitment to conduct business with a high level of integrity, respect, and philanthropic dedication allows the organization to make a difference in the lives of their customers, employees, investors and global community.

For more information please visit www.cuiglobal.com

About Orbital Gas Systems Ltd.:
Orbital Gas Systems Ltd (“Orbital-UK”) is the largest natural gas systems integrator in the United Kingdom.  For over 30 years, Orbital-UK has developed its portfolio of products, services and resources to offer a diverse range of personalized gas engineering solutions to the gas utilities, power generation, emissions, manufacturing and automotive industries.  Orbital-UK’s internationally recognized expertise in the natural gas industry, including bringing together the patented VE-technology with the ground-breaking GasPTi device, offers natural gas operators and users a comprehensive engineering array for the next generation of energy metering systems.  Orbital-UK is a wholly owned subsidiary of CUI Global, Inc.

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

Important Cautions Regarding Forward Looking Statements
This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements are subject to risks and uncertainties that could cause actual results to vary materially from those projected in the forward-looking statements. The company may experience significant fluctuations in future operating results due to a number of economic, competitive, and other factors, including, among other things, our reliance on third-party manufacturers and suppliers, government agency budgetary and political constraints, new or increased competition, changes in market demand, and the performance or reliability of our products.  These factors and others could cause operating results to vary significantly from those in prior periods, and those projected in forward-looking statements. Additional information with respect to these and other factors, which could materially affect the company and its operations, are included in certain forms the company has filed with the Securities and Exchange Commission.

(EXPE) Earnings Release Available on Company’s IR Site

BELLEVUE, Wash., Feb. 10, 2016  — Expedia, Inc. (NASDAQ: EXPE) posted its fourth quarter and full year 2015 earnings release and an investor presentation in the Investor Relations section of its corporate website at http://ir.expediainc.com. The earnings release and investor presentation are also available on the Securities and Exchange Commission’s website at http://www.sec.gov. As announced previously, the company will host a conference call today to discuss the earnings release at 1:30 PM Pacific Time / 4:30 PM Eastern Time.

In addition to the earnings release, a live webcast of the conference call will be available to the public at http://ir.expediainc.com. A replay of the call is expected to be available for at least three months.

About Expedia, Inc.
Expedia, Inc. (NASDAQ: EXPE) is one of the world’s leading travel companies, with an extensive brand portfolio that includes leading online travel brands, such as:

• Expedia.com®, a leading full service online travel company with localized sites in 33 countries
• Hotels.com®, the lodging specialist that offers Hotels.com® Rewards and Secret Prices through its mobile booking apps and  localized websites in more than 65 countries
• Hotwire®, a leading discount travel site that offers Hot Rate® Hotels, Hot Rate® Cars and Hot Rate® Airfares, as well as vacation packages
• HomeAway®, a global online marketplace for the vacation rental industry, which also includes the VRBO, VacationRentals.com and BedandBreakfast.com brands, among others
• Travelocity®, a pioneer in online travel and a leading online travel brand in the US and Canada
• Orbitz Worldwide, a global travel portfolio including Orbitz, ebookers and CheapTickets brands, and business-to-business offerings including Orbitz Partner Network and Orbitz for Business
• Egencia®, a leading corporate travel management company
• Venere.com™, an online hotel reservation specialist in Europe
• trivago®, a leading online hotel search with sites in 55 countries worldwide
• Wotif Group, a leading portfolio of travel brands including Wotif.com®, Wotif.co.nz, lastminute.com.au®, lastminute.co.nz and travel.com.au®
• Expedia Local Expert®, a provider of online and in-market concierge services, activities, experiences and ground transportation in hundreds of destinations worldwide
• Classic Vacations®, a top luxury travel specialist
• Expedia® CruiseShipCenters®, a provider of exceptional value and expert advice for travelers booking cruises and vacations through its network of over 200 retail travel agency franchises across North America
• CarRentals.com^™, a premier online car rental booking company with localized sites in 13 countries
• Expedia Affiliate Network (EAN), a global B2B business that powers the hotel business of leading airlines, top consumer brands, online travel agencies and thousands of other partners through its API and template solutions
• Expedia® Media Solutions, the advertising sales division of Expedia, Inc. that builds media partnerships and enables brand advertisers to target a highly-qualified audience of travel consumers

For corporate and industry news and views, visit us at www.expediainc.com or follow us on Twitter @expediainc.

Trademarks and logos are the property of their respective owners.  © 2016 Expedia, Inc.  All rights reserved.  CST: 2029030-50

(KMPH) FDA Grants Priority Review to KemPharm for KP201/APAP NDA

If Approved, KP201/APAP Could Become the First Immediate-Release Hydrocodone Combination Product With Abuse-Deterrent Properties

CORALVILLE, Iowa, Feb. 10, 2016  — KemPharm, Inc. (NASDAQ:KMPH) today announced that the New Drug Application (NDA) for KP201/APAP, its investigational drug candidate for the short-term management of acute pain, has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA).  In addition, the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 9, 2016.

KP201/APAP, an immediate release (IR) combination of KemPharm’s prodrug of hydrocodone, KP201 (benzhydrocodone hydrochloride), and acetaminophen (APAP), was developed to potentially deter certain common methods of abuse and may also limit excessive opioid exposure in patients and non-medical users compared to currently available hydrocodone combination products.  Hydrocodone/acetaminophen products (commonly known by the brand names Vicodin®, Norco® and Lortab®) are among the most prescribed and the most widely abused (non-medical use) medications in the United States.^[i],[ii]  Currently there are no abuse-deterrent IR hydrocodone combination products approved by the FDA.

“We believe this milestone brings us one step closer to providing prescribers and patients with a new acute pain treatment option that may deter certain common methods of abuse while providing the same pharmacokinetic and therapeutic effect as currently available immediate-release hydrocodone/APAP medications,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm. “Equally important, we are pleased that the FDA has agreed to a priority review of the NDA with a target PDUFA date of June 9^th, which is sooner than was previously anticipated.  We look forward to working closely with the agency over the coming months as it considers this potential new option for physicians who are treating patients with acute pain.”

In the NDA submission, KemPharm requested the FDA to recommend that KP201/APAP be classified as a Schedule III controlled substance.  This request is based on what KemPharm believes is the reduced potential for abuse and the potential safety features attributable to lower exposure levels to hydrocodone for KP201/APAP as compared to other hydrocodone/APAP products, which are designated as Schedule II.  In addition, based on the results of the human abuse liability program completed for KP201/APAP, as well as feedback from the FDA, KemPharm believes there may be support for Category 1, Category 2 and potentially Category 3 abuse-deterrent language in the KP201/APAP product label, if approved by the FDA.

KemPharm developed KP201/APAP using the Company’s proprietary Ligand-Activated Technology (LAT), which creates a new prodrug by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug.  Once administered, human metabolic processes, such as those in the gastrointestinal tract, separate the ligand from the prodrug and release the parent drug, which can then provide its therapeutic effect.

About KemPharm
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of prodrugs to treat serious medical conditions through its Ligand Activated Therapy (LAT) platform technology.  KemPharm utilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other CNS disorders.

Caution Concerning Forward Looking Statements
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements include statements regarding the expected timing of approval, if at all, of KP201/APAP by the FDA.  These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm’s financial resources and whether they will be sufficient to meet KemPharm’s business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by KemPharm’s intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; and the FDA approval process under the Section 505(b)(2) regulatory pathway, including without limitation any timelines for related approval. KemPharm’s forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm’s business are described in additional detail in KemPharm’s Periodic and Current Reports filed with the Securities and Exchange Commission.  KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

^[i] IMS Institute for Healthcare Informatics, Medicine Use and Spending Shifts: A Review of the Use of Medicines in the US in 2014, April 6, 2015  https://www.imshealth.com/files/web/IMSH%20Institute/Reports/Medicines_Use_and_Spending_Shifts/Medicine-Spending-and-Growth_1995-2014.pdf

^[ii] National Survey on Drug Use and Health 2014, Substance Abuse and Mental Health Services Administration, Table 1.89A  http://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs2014/NSDUH-DetTabs2014.htm#tab1-89a

Investor Contacts:	
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
jrando@tiberend.com
jdrumm@tiberend.com

Media Contact:
Jim Heins
Cooney Waters Unlimited
212-886-2221  
jheins@cooneywatersunlimited.com