(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

(CDNA) Revised Share Purchase Agreement

Combination Creates an International Transplantation Diagnostics Company With Expanded Distribution and Growth Potential

BRISBANE, Calif., Feb. 09, 2016  — CareDx, Inc. (NASDAQ:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant patients, today announced a revision to the terms of its public offer to the shareholders of Allenex AB (Stockholm:ALNX, S+).

Under the agreements entered into on December 16, 2015, the three principal Allenex shareholders, collectively owning 78% of the outstanding shares (the “Majority Shareholders”), agreed with CareDx to tender their shares for a combination of cash and CareDx common stock that valued Allenex at approximately $35 million. Under the original terms, $6 million of the cash consideration to the Majority Shareholders would be made contingent on Allenex achieving certain commercial and financial milestones in 2016. Under the revised terms, CareDx and the Majority Shareholders have agreed to defer the payment of these milestones until March 31, 2017, if earned.  In addition, the Majority Shareholders will be issued a total of 150,000 additional shares of CareDx common stock.  This deferred milestone payment only applies to the Majority Shareholders.

CareDx is also revising the cash and common stock alternative offered to the remaining 22% of Allenex shareholders (the “Non-Majority Shareholders”) by increasing the common stock component by the same proportion from 0.01298 to 0.01458 CareDx share per Allenex share. If the offer is accepted in its entirety under the cash and common stock alternative, 1,753,806 shares of common stock will be issued by CareDx, which would represent 12.8% of the outstanding shares of CareDx. The Non-Majority Shareholders have also been offered an all cash alternative which remains unchanged from the original offer.

The public offer is made to all shareholders of Allenex. The Majority Shareholders have already agreed to tender their shares. The offer document is expected to be published in the first quarter of 2016.

The combination of CareDx and Allenex will create an international transplantation diagnostics company with product offerings along the pre-post-transplant continuum. The Olerup SSP line and AlloMap® are foundational diagnostics that are well recognized by the transplant community.  The combined company will have a presence and direct distribution channels in the US and Europe.

A link to the release can be found here:
http://news.cision.com/caredx–inc-/r/caredx-announces-revised-terms-in-its-recommended-offer-to-all-shareholders-in-allenex,c9910367

About CareDx
CareDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant patients. The company has commercialized AlloMap®, a gene expression test that aids clinicians in identifying heart transplant patients with stable graft function who have a low probability of moderate/severe acute cellular rejection.  CareDx is also developing additional products for transplant monitoring using a variety of technologies, including AlloSure™, its next-generation sequencing—based test to detect donor-derived cell-free DNA after transplantation. For more information, please visit: www.CareDx.com.

About Allenex AB
Allenex AB, headquartered in Stockholm, is a life sciences company that develops, manufactures, markets and sells high quality products that increase the chance of successful transplants by facilitating a better match between the donor and the recipient of stem cells and organs. Allenex AB currently markets two key products: Olerup SSP, a set of HLA typing used prior to hematopoietic stem cell/bone marrow transplantation and organ transplantation, and XM-ONE®, the first standardized test used for crossmatching that identifies the presence of non-HLA antibodies strongly associated with rejection episodes and reduced kidney function after transplant.

Forward Looking Statements

This press release contains forward-looking statements including, but not limited to statements regarding the Company’s expectations regarding future potential, development and commercial activities. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward looking statements, including CareDx’s limited operating history and experience with developing new markets and that closing conditions may not be satisfied and the transaction may not be completed, as well as other risks stated in CareDx’s filings with the SEC located at www.sec.gov. CareDx disclaims any obligation to publicly update or revise any forward looking statements to reflect events that occur or circumstances that exist after the date on which they were made.

Media Contact
Molly Martell, CareDx, Inc.
T: +1 415-287-2397                                                  
E:  mmartell@caredx.com

Investor Contact

Leigh J. Salvo, Westwicke Partners, LLC
T: +1 415-513-1281
E:  lsalvo@westwicke.com

(ZIOP) First Patient Enrolled Phase 1 Study in CAR T-Cell Therapy

BOSTON, Feb. 09, 2016  — ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new cancer immunotherapies, today announced that the first patient has been enrolled in a Phase 1 clinical study of its second generation non-viral CD19-specific chimeric antigen receptor (CAR) modified T-cell therapy in patients with advance lymphoid malignancies. The CD19-specific T cells were modified using the Sleeping Beauty system to stably express the CAR in T cells.

The Sleeping Beauty transposon-transposase is a unique non-viral system for introducing genes encoding CARs and T-cell receptors (TCRs) into lymphocytes and is exclusively licensed by Intrexon Corporation (NYSE:XON) through The University of Texas MD Anderson Cancer Center and accessed as part of ZIOPHARM’s collaboration. This non-viral approach may play an important role in immunotherapy and has several potential advantages over viral delivery systems, including:

• Lower cost of generating genetically modified T cells
• Generate T cells with minimal ex vivo processing
• Conduit to targeting solid tumor neo-antigens using TCRs
• Pathway to overcome regulatory hurdles

“The survival benefit seen in early clinical results with our first generation CD19-specific CAR⁺ T cells were highly encouraging, and preclinical results to date suggest that our next generation CAR structure may improve upon these outcomes,” said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. “These studies continue to strengthen our understanding of the application and benefit of the Sleeping Beauty platform, the only efficient non-viral gene transfer system in clinical application. Sleeping Beauty offers the potential to significantly reduce the expense and simplify the implementation of genetically modified T cells, both of which are critical to the personalization and broad application of immunotherapies based on CARs and TCRs.”

In two prior trials the first generation CD19-specific CAR⁺ T cells, patient-derived (autologous) or donor-derived (allogeneic) T cells were administered to recipients with advanced CD19-expressing leukemias and lymphomas after hematopoietic stem-cell transplantation (HSCT). Results demonstrated an apparent doubling of survivals compared to historical controls.

The second-generation Sleeping Beauty CAR⁺ T cells employ a revised CAR construct designed to improve persistence and anti-tumor response over the first generation therapy. Additionally, this investigational treatment is independent of HSCT. This trial is being conducted at MD Anderson.

About ZIOPHARM Oncology, Inc.:

ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression, control and cell technologies to deliver safe, effective and scalable cell- and viral-based therapies for the treatment of cancer. The Company’s synthetic immuno-oncology programs, in collaboration with Intrexon Corporation (NYSE:XON) and the MD Anderson Cancer Center, include chimeric antigen receptor T cell (CAR-T) and other adoptive cell based approaches that use non-viral gene transfer methods for broad scalability. The Company is advancing programs in multiple stages of development together with Intrexon Corporation’s RheoSwitch Therapeutic System® technology, a switch to turn on and off, and more precisely modulate gene expression in order to improve therapeutic index. The Company’s pipeline includes a number of cell-based therapeutics in both clinical and preclinical testing which are focused on hematologic and solid tumor malignancies.

Forward-Looking Safe-Harbor Statement:

This press release contains certain forward-looking information about ZIOPHARM Oncology, Inc. that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” and “believes.” These statements include, but are not limited to, statements regarding the progress, timing and results of preclinical and clinical trials involving the Company’s drug candidates, and the progress of the Company’s research and development programs. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied by, the forward-looking statements. These risks and uncertainties include, but are not limited to: whether chimeric antigen receptor T cell (CAR T) approaches, Ad-RTS-IL-12, TCR and NK cell-based therapies, or any of our other therapeutic candidates will advance further in the pre-clinical or clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether chimeric antigen receptor T cell (CAR T) approaches, Ad-RTS-IL-12, TCR and NK cell-based therapies, and our other therapeutic products will be successfully marketed if approved; the strength and enforceability of our intellectual property rights; competition from other pharmaceutical and biotechnology companies; and the other risk factors contained in our periodic and interim SEC reports filed from time to time with the Securities and Exchange Commission, including but not limited to, our Annual Report on Form 10-K for the fiscal year ended December 31, 2014, and our Quarterly Reports on Form 10Q for the quarters ended March 31, 2015, June 30, 2015 and September 30, 2015. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Trademarks

RheoSwitch Therapeutic System^® (RTS^®) technology is a registered trademark of Intrexon Corporation.

Contact:
Lori Ann Occhiogrosso
ZIOPHARM Oncology, Inc.
617-259-1987
locchiogrosso@ziopharm.com

David Pitts
Argot Partners
212-600-1902
david@argotpartners.com

(SLI) Announces Receipt of Revised Non-Binding Acquisition Proposal

SL Industries, Inc. (NYSE MKT: SLI) (the “Company”) announced that Handy & Harman Ltd., a publicly traded NASDAQ company, has delivered a revised non-binding proposal to acquire all outstanding shares of common stock of the Company. Under the terms of the revised proposal, Handy & Harman has proposed to pay $35.50 per share in an all cash transaction. Handy & Harman is an affiliate of Steel Partners Holdings L.P., which beneficially owns 25.1% of the Company’s outstanding common stock.

Handy & Harman’s initial proposal, received by the independent directors of the Company’s Board of Directors in June 2015, included a per share price of $43.00 to $45.00. The initial proposal contemplated that Company stockholders other than Steel Partners Holdings would be able to elect to receive cash or Handy & Harman stock (with Steel electing to receive all stock), subject to proration so that the aggregate consideration consisted of 55% cash and 45% Handy & Harman stock.

The Special Committee of the Company’s Board of Directors, which was authorized, among other things, to evaluate the initial Handy & Harman proposal, will review and consider the revised proposal carefully in due course, consistent with its fiduciary duties to act in the best interest of stockholders. The Special Committee’s independent financial adviser is Houlihan Lokey Capital, Inc. and its legal counsel is Gardere Wynne Sewell LLP.

The Company cautions its stockholders and others considering trading in its securities that the Handy & Harman proposal was just received and no decisions have been made by the Special Committee with respect to a response. There can be no assurance that any agreement will be executed or that any transaction will be consummated.

The Company presently does not intend to comment further regarding the revised Handy & Harman proposal or any other potential transaction, unless and until a specific transaction is approved by the Special Committee.

About SL Industries

SL Industries, Inc., designs, manufactures and markets power electronics, motion control, power protection, and power quality electromagnetic equipment that is used in a variety of medical, commercial and military aerospace, solar, computer, datacom, industrial, LED lighting and audio visual systems, and telecom applications. For more information about SL Industries, Inc. and its products, please visit the Company’s web site at www.slindustries.com.

Forward-Looking Statements

This press release contains certain “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, that reflect the Company’s current expectations and projections about its future results, performance, prospects, and opportunities. The Company has tried to identify these forward-looking statements by using words such as “may,” “should,” “expect,” “hope,” “anticipate,” “believe,” “intend,” “plan,” “estimate,” and similar expressions. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause its actual results, performance, prospects, or opportunities in 2016 and beyond to differ materially from those expressed in, or implied by, these forward-looking statements. These factors include, without limitation: the effectiveness of the cost reduction initiatives undertaken by the Company, changes in demand for the Company’s products, product mix, the timing of customer orders and deliveries, the impact of competitive products and pricing, constraints on supplies of critical components, excess or shortage of production capacity, difficulties encountered in the integration of acquired businesses and other risks discussed from time to time in the Company’s Securities and Exchange Commission filings and reports. In addition, such statements could be affected by general industry and market conditions and growth rates, and general domestic and international economic conditions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable and achievable, such statements involve significant risks and uncertainties, and no assurance can be given that the actual results will be consistent with these forward-looking statements. Except as otherwise required by Federal securities laws, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or any other reason.

(NYMX) Announces Prostate Cancer Clinical Trial Results

HASBROUCK HEIGHTS, N.J., Feb. 09, 2016  — Nymox Pharmaceutical Corporation (NASDAQ:NYMX) today announced results from the completion of the Company’s U.S. 40 month (18 month outcomes) localized prostate cancer Phase 2 NX03-0040 clinical trial of fexapotide triflutate (NX-1207). The study successfully met its pre-determined endpoints. Cancer progression clinical outcomes were significantly improved in the fexapotide treated patient groups.

The clinical trial commenced in February 2012 at 28 U.S. investigational clinical trial sites and enrolled 147 patients with low grade localized (T1c) prostate cancer. The study lasted 40 months overall from the first patient randomized to the last patient 18 month endpoints.

Results from the completed 18 month outcome study after a single injection of fexapotide included the following:

• Absence of tumors (Primary Endpoint) controlled for size in baseline area: fexapotide 15 mg superior to control (p=.035); crossover fexapotide 15 mg superior to control (p=.002); crossover fexapotide overall superior to control (p=.014).
• 75.5% reduction in biopsy proven prostate cancer Gleason upgrades (pathological progression) after 18 months in fexapotide 15 mg treated patients compared to control (p=.0055). 71.7% reduction in prostate cancer Gleason upgrades in fexapotide treated patients overall (p=.0045 vs controls).
• 84.8% reduction after 18 months in surgery or radiotherapy instituted for prostate cancer Gleason upgrade (biopsy worsening) in fexapotide treated patients overall compared to control group (p=.014).
• 54.8% reduction after 18 months in surgery or radiotherapy instituted for all causes with or without prostate cancer Gleason upgrade in fexapotide 15 mg treated patients compared to control (p=.026).
• Significant improvement for fexapotide patients compared to controls in 4 out of 4 Secondary Endpoints. Tumor volume reduction in the treated area, combined dosages (p=.04); tumor volume change in prostate overall, fexapotide patients overall (p=.014); median tumor grade outcome in the treated area, all dosages (fexapotide median benign, vs control median Gleason 3+3), and superior median tumor grade in prostate overall, fexapotide 15 mg vs controls.
• Consistent safety results with no significant drug-related adverse events and no significant related sexual adverse events.
• Overall superior results for the fexapotide 15 mg dose compared to the 2.5 mg dose (dose-response).
• Other statistically significant improvement outcomes in fexapotide patients compared to controls, to be presented comprehensively at medical meetings.

“These results demonstrate that a single targeted office injection of fexapotide has led to statistically significant improvement in outcomes with much less surgery or radiotherapy required after 18 months. This means a reduction in patient discomfort, and a reduction in permanent side effects and life changes when the more invasive treatments are required,” said Paul Averback, CEO of Nymox.

Dr. Averback added, “Based on these outcomes, we believe there are exciting potential patient benefits from one or more painless fexapotide office injections for this common and distressing condition.”

The Company will report at a later date concerning its plans for moving the compound forward toward the market for this important medical problem.

For more information please contact info@nymox.com or 800-936-9669.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for fexapotide. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox’s regulatory filings, Nymox’s substantial dependence on fexapotide, Nymox’s commercialization plans and efforts and other matters that could affect the availability or commercial potential of fexapotide. Nymox undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2014, and its Quarterly Reports.

Paul Averback
Nymox Pharmaceutical Corporation
800-93NYMOX
www.nymox.com

(BLPH) Positive Data Phase 2 INOpulse Study

Long-Term Extension Data Reinforces Earlier Phase 2 Data and Indicates Sustainability of Benefits for PAH Patients

WARREN, N.J., Feb. 09, 2016  — Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced positive data from the final analysis of the Company’s Phase 2 long-term extension study of INOpulse for the treatment of Pulmonary Arterial Hypertension (PAH) (Part 2 of the Company’s Phase 2 trial). 

The Phase 2 long-term extension study indicated a sustained benefit to PAH patients who received INOpulse 75 mcg/kg ideal body weight per hour (iNO 75) therapy for at least 12 hours per day combined with Long-Term Oxygen Therapy (LTOT). In Part 1 of the Phase 2 study, these patients showed a mean improvement in 6 minute walk distance (6MWD) of 52.4 meters after 16 weeks of therapy.  In Part 2 of the study, after 16 to 32 months of treatment, the patients who remained on iNO 75 for at least 12 hours a day combined with LTOT continued to maintain a mean increase in 6MWD of 55.2 meters.  None of these patients had a decrease in 6MWD.  Patients, including those on LTOT, who were on either iNO 25 mcg/kg ideal body weight per hour (iNO 25) or maintained therapy for less than 12 hours per day had on average a decrease in 6MWD.

A recent study by Farber et al. shows that “worsening of the 6MWD was strongly and significantly associated with a poor prognosis.” (REVEAL Registry, Farber et al., J Heart Lung Transpl., 2015).

These data directly support the design of the planned Phase III trial.

Data from Long-term Extension Analysis
Following 16 weeks of blinded therapy in Part 1 of the trial, in Part 2 of the trial 65 patients were randomized to receive iNO 25 or iNO 75.  The long-term extension analysis was performed after patients had completed between 16 and 32 months of INOpulse treatment, and data from the long-term extension analysis was compared to baseline measurements taken at the beginning of Part 1 of the trial.  All patients in the trial were on at least one approved PAH therapy, and most were on two or three PAH therapies.

The long-term extension analysis showed the following:

• Patients on LTOT in the iNO 75 dose treatment arm who remained on INOpulse therapy for at least 12 hours a day had a mean improvement of 55.2 meters as compared to baseline (n=7).
• Patients on LTOT in the iNO 75 dose treatment arm who remained on INOpulse therapy for less than 12 hours a day showed a mean decrease of 18.0 meters as compared to baseline (n=6).
• Patients in the iNO 25 dose treatment arm, including those on LTOT, had a mean decrease of 43.7 meters from baseline (n=12).

For patients in the long-term extension study, no significant safety issues have been found with no reports of methemoglobin elevation and no adjudicated cases of pulmonary rebound.  Only 2 Serious Adverse Events have been reported as possibly related, with these subjects continuing on iNO therapy.

These findings also confirmed a recently released interim analysis of the Phase II data which was performed at 12 months after entry into the study.  The 12 month analysis also found that LTOT patients who used iNO 75 for at least 12 hours a day had the greatest benefit.

Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, stated, “The long-term analysis is very encouraging for PAH patients, as the data indicates a clinically significant and sustained benefit for patients on Long-Term Oxygen Therapy and the higher iNO 75 dose, when used for at least 12 hours per day.  The analysis supports the hypothesis generated from Part 1 of the Phase 2 study and is well aligned with the design of the Phase 3 program, for which we have agreement with the FDA through a SPA and with the European Medicines Agency through a Scientific Advice Working Party.”

Phase 3 Development Program
The key elements of the planned U.S. and EU Phase 3 development program are:

• The Phase 3 program will consist of two clinical trials totaling 450 patients; one trial with two treatment arms (iNO 75 and placebo) and one with three treatment arms (iNO 75, iNO 50 and placebo).  Each treatment arm will consist of approximately 90 patients.
• All patients in the trials will be on LTOT.
• Each trial will have a run-in period of two weeks to ensure compliance.  Patients who do not stay on the therapy for at least 16 hours a day during this period will be replaced.
• The primary endpoint is improvement in 6MWD compared to placebo after 16 weeks.
• The secondary endpoint is Time to Clinical Worsening (TTCW), with analysis pooled across both trials.  Patients will stay on therapy until the last patient visit measuring 6MWD.  One component of the definition of TTCW is decrease in 6MWD.

The Phase 3 trials will utilize the second-generation INOpulse device, which is considerably smaller and lighter (approximately 2.5 lbs.) than the original INOpulse DS device used in the Phase 2 study (approximately 7.5 lbs.).  In addition to the significant reduction in size and weight, the INOpulse device also has an improved user interface and better breath detection technology, made possible by the Company’s proprietary tri-lumen cannula.

About Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH) is a rare, chronic and currently incurable disease that causes the walls of the arteries of the lungs to tighten and stiffen.  Estimates suggest that there are about 35,000 patients diagnosed with PAH in the United States and Europe.  In PAH patients, the right side of the heart has to work harder to pump blood through narrowed arteries in the lungs, which can decrease blood flow through the body.  Eventually, the extra stress causes the heart to enlarge and become less flexible, further compromising its ability to pump blood out of the heart, through the lungs, and into the rest of the body.  Patients with PAH have symptoms ranging from dizziness and fainting to shortness of breath during exercise. This range of symptoms, combined with the rare nature of the condition, often makes diagnosis difficult, and many PAH patients are not diagnosed until the disease has progressed.  According to Thenappan et al, European Respiratory Journal 2007, even with today’s currently available therapies, the average mortality remains high, at 60% after five years.

About Bellerophon
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary diseases.  The Company is currently developing three product candidates under its INOpulse® program, a proprietary pulsatile nitric oxide delivery device. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company intends to commence Phase 3 clinical trials in 2016. The second is for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), which is in Phase 2 development and the third candidate is for the treatment of pulmonary hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF).  The Company’s plans also call for the completion of further work on the use of INOpulse to treat PH-COPD and PH-IPF during 2016.  For more information, please visit www.bellerophon.com.

Forward-looking Statements
Any statements in this press release about Bellerophon’s future expectations, plans and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Company’s clinical trials and expectations regarding the sufficiency of the Company’s cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, the FDA’s substantial discretion in the approval process, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of the Company’s most recent filings with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent Bellerophon’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Contact
At Bellerophon:                                                               
Amy Edmonds, Vice President                                   
(908) 574-4765

At Rx Communications Group:
Melody Carey
(917) 322-2571

(TRCH) Provides Update on the Orogrande Project

(LSG) & (TAHO) Announce Business Combination

Tahoe Resources Inc.
Ira M. Gostin
Vice President Investor Relations
775-448-5807
investors@tahoeresourcesinc.com

Lake Shore Gold Corp.
Tony Makuch
President & CEO
(416) 703-6298

Lake Shore Gold Corp.
Mark Utting
Vice-President, Investor Relations
(416) 703-6298
www.lsgold.com

(TATT) Reports Joint Venture Announcement

GEDERA, Israel, February 8, 2016  —

TAT Technologies Ltd. (NASDAQ: TATT) (“the Company”), a leading provider of services and products for the commercial and military aerospace and ground defense industries, announced today that it has signed an agreement with Engineering Holding of Moscow, Russia, to establish a new maintenance facility for heat exchangers. The new company, TAT-Engineering LLC, will be based in Novosibirsk’s Tolmachevo airport.

Mr. Itsik Maaravi, TAT Technologies Ltd. President and CEO said, “We are proud of this joint venture with Engineering Holding. It enables us to expand our capabilities and offer local support for our customers in the CIS region. This would be an additional activity for our company in Eastern Europe and Russia, a market where we already deliver our Heat Management solutions. The combination of our vast experience in heat exchangers maintenance with the strength and reputation of the largest aircraft maintenance station in Russia will enable us to provide a timely and competitive service for our customers in the region.”

About TAT Technologies LTD

TAT Technologies Ltd. is a leading provider of services and products to the commercial and military aerospace and ground defense industries. TAT operates under four segments:  (i) Original Equipment Manufacturing or “OEM” of Heat Management Solutions (ii) Heat Transfer Services and Products (iii) Maintenance, Repair and Overhaul or “MRO” services of Aviation Components; and (iv) overhaul and coating of jet engine components.

TAT’s activities in the area of OEM Heat Management Solutions are focused on the design, development, manufacture, and sale of the following: (i) a broad range of heat transfer components includings heat exchangers, pre-coolers and oil/fuel hydraulic coolers used in mechanical and electronic systems on-board commercial, military and business aircraft; (ii) environmental control and cooling systems on board aircraft and for ground applications; and (iii) a variety of other electronic and mechanical aircraft accessories and systems such as pumps, valves, power systems and turbines.

TAT’s activities in the area of Heat Transfer Services and Products include the maintenance, repair and overhaul of heat transfer equipment and to a lesser extent, the manufacture of certain heat transfer product parts. TAT’s Limco subsidiary operates an FAA certified repair station, which provides heat transfer MRO services and products for airlines, air cargo carriers, maintenance service centers and the military.

TAT’s activities in the area of MRO services for Aviation Components include the maintenance, repair and overhaul of APUs, Landing Gears and other aircraft components. TAT’s Piedmont subsidiary operates an FAA certified repair station, which provides aircraft component MRO services for airlines, air cargo carriers, maintenance service centers and the military.

TAT’s activities in the area of jet engine overhaul includes the overhaul and coating of jet engine components, including turbine vanes and blades, fan blades, variable inlet guide vanes, afterburner flaps and other components.

Safe Harbor for Forward-Looking Statements

This press release contains forward-looking statements which include, without limitation, statements regarding possible or assumed future operation results. These statements are hereby identified as “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that could cause our results to differ materially from management’s current expectations. Actual results and performance can also be influenced by other risks that we face in running our operations including, but are not limited to, general business conditions in the airline industry, changes in demand for our services and products, the timing and amount or cancellation of orders, the price and continuity of supply of component parts used in our operations, the change of control that will occur on the sale by the receiver of the Company’s shares held by our previously controlling stockholders, and other risks detailed from time to time in the company’s filings with the Securities Exchange Commission, including, its annual report on form 20-F and its periodic reports on form 6-K. These documents contain and identify other important factors that could cause actual results to differ materially from those contained in our projections or forward-looking statements. Stockholders and other readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. We undertake no obligation to update publicly or revise any forward-looking statement.

For more information of TAT Technologies, please visit our web-site:  http://www.tat-technologies.com

Guy Nathanzon – CFO
TAT Technologies Ltd.
Tel: +972-8-862-8500
GuyN@tat-technologies.com

(GOLD) Bucks Industry Trend to Deliver Record Production for 2015

(NVCR) Phase 3 Pivotal Glioblastoma Trial Results Selected For Major Cancer Report

Novocure’s (NASDAQ: NVCR) phase 3 pivotal clinical trial results of Tumor Treating Fields (TTFields) in combination with temozolomide in newly diagnosed glioblastoma (GBM) have been selected for inclusion in the American Society of Clinical Oncology’s Clinical Cancer Advances 2016: Annual Report on Progress Against Cancer. The report, which was published first online on Feb. 4 in the Journal of Clinical Oncology, reviews the recent top advances and emerging trends in clinical cancer research that are leading to improved cancer treatments for patients.

“Clinical Cancer Advances 2016 represents and acknowledges the collective wisdom that has made progress against cancer possible,” ASCO President Julie M. Vose wrote in the report. “I hope these achievements will inspire all of us to do our part to further accelerate the pace of research and discovery to help millions of people who are living with cancer and the millions more who will face a cancer diagnosis in their lifetime.”

Novocure’s phase 3 pivotal trial compared TTFields therapy in combination with temozolomide to temozolomide alone in 695 patients with newly diagnosed GBM. The trial met its endpoints at the interim analysis. The trial’s results demonstrated superior progression-free and overall survivals in patients receiving TTFields therapy in combination with temozolomide compared to temozolomide alone (median progression-free survival of 7.2 months compared to 4.0 months, hazard ratio=0.62, p=0.001; median overall survival of 20.5 months compared to 15.6 months, hazard ratio=0.66, p=0.004).

In October 2015, the U.S. Food and Drug Administration approved Optune – a portable, non-invasive device that delivers TTFields – in combination with temozolomide for the treatment of adult patients with newly diagnosed glioblastoma. TTFields are the first FDA-approved therapy in more than a decade to demonstrate statistically significant extension of overall survival in newly diagnosed GBM, with a two-year survival of 48 percent versus 32 percent compared to temozolomide alone.

“We are honored that our research has been selected as a top advancement in cancer care by ASCO, a leading organization in oncology research and education,” said Novocure CEO Asaf Danziger. “Such advancements are critical to improving treatment and extending the lives of cancer patients. We are proud to receive this designation and believe it will help raise awareness of the benefits of TTFields therapy within the broader oncology community.”

About Novocure

Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s U.S. operations are based in Portsmouth, New Hampshire, and New York City. Additionally, the company has offices in Germany, Switzerland, and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Quarterly Report on Form 10-Q filed on Oct. 27, 2015, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

Media and Investor Contact:
Novocure
Ashley Cordova, 212-767-7558
acordova@novocure.com

(SIEN) Announces Return of All Products to U.S. Market

SANTA BARBARA, Calif., Feb. 08, 2016  — Sientra, Inc. (NASDAQ:SIEN) (“Sientra” or the “Company”), a medical aesthetics company, today announced all of its medical devices, including all Sientra breast implant products, will return to the U.S. market beginning March 1, 2016.

Sientra is taking this action subsequent to the completion of extensive independent, third-party testing and analyses of its products in the U.S.  Under worst-case testing conditions, the products exhibit a high safety margin compared to numerous U.S. and international standards for medical device and materials safety.  The conclusive results of our testing indicate no anticipated significant safety concerns with the use of Sientra products, including our breast implants, consistent with their approval status since 2012.

Jeffrey Nugent, Chairman and Chief Executive Officer of Sientra, said, “We are extremely pleased to return our products to the U.S. market where we can once again provide choice to board-certified plastic surgeons. Our decision to place the voluntary hold on Sientra products was difficult, but we felt it was the responsible action to take at the time amid the speculation, to ensure that Sientra products remain a safe choice for our customers and their patients. Following the results of independent, third-party testing, we are more confident than ever in the safety of our devices, and specifically our breast implant products, which are further supported by our 9-year clinical study data to be published in April of 2016.  In terms of the confirmation of our manufacturing supply initiatives, we are confident that our resupply process will be in place in sufficient time to assure our customers of uninterrupted supply.”

Sientra has also sent a letter to its surgeons informing them of the Company’s market re-entry plans. A copy of that letter can be found in the Investor Relations section of Sientra’s web site or by clicking here.

About Sientra

Headquartered in Santa Barbara, California, Sientra is a medical aesthetics company committed to making a difference in patients’ lives by enhancing their body image, growing their self-esteem and restoring their confidence. The Company was founded to provide greater choice to board-certified plastic surgeons and patients in need of medical aesthetics products. The Company has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. The Company sells its breast implants and breast tissue expanders exclusively to board-certified and board-admissible plastic surgeons and tailors its customer service offerings to their specific needs. The Company also offers a range of other aesthetic and specialty products.

Forward-looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, relating to, among other things, the future performance of Sientra that are based on management’s current assumptions and expectations of future events and involve risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding: the exact date that Sientra’s products will return to the U.S. market, the interpretation of the results of the third-party independent testing of Sientra’s products, actions that the FDA may take in response to such matters and the timing and availability of sources of supply. Such statements are subject to risks and uncertainties. The Company’s business, strategy, operations or financial performance, and actual results may differ materially from those predicted or implied. All statements other than statements of historical fact are forward-looking statements. The words ”believe,” ”may,” ”might,” ”could,” ”will,” ”aim,” ”estimate,” ”continue,” ”anticipate,” ”intend,” ”expect,” ”plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections and other forward-looking statements.

More information about factors that could cause actual results to differ materially from those contemplated in this press release can be found under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s most recent Quarterly Report on Form 10-Q at http://investors.sientra.com/financial-info/sec-filings/default.aspx or the SEC’s website at www.sec.gov. Undue reliance should not be placed on the forward-looking statements in this release, which are based on information available to the Company on the date hereof, and except to the extent required by law, Sientra assumes no obligation to update such statements.

Contact

Investor Contacts:
The Ruth Group
Nick Laudico / Brandon Vazquez
(646) 536-7030 / 7032
IR@Sientra.com

(AUPH) Preliminary Topline Data From its Open Label Aurion Study in Lupus

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”) announced today that it has completed a preliminary analysis of its AURION (Aurinia early Urinary protein Reduction Predicts Response) study. In the first seven patients that have reached at least eight weeks of therapy in the AURION study, 100% (7/7) have achieved at least a 25% reduction in proteinuria compared to study entry. A 25% reduction in proteinuria has been shown to be predictive of a positive clinical response at 24weeks¹. All of the other pre-specified eight week biomarkers of active lupus nephritis (LN) have also improved and are trending towards normalization. These biomarkers have also been shown to be predictive of a positive clinical response at 24 weeks¹.

In the first eight weeks of a 48 week regimen of multi-target therapy including voclosporin in AURION, an overall mean reduction of proteinuria of 72% compared to pre-treatment levels was observed, and 57% (4/7) of these patients achieved complete remission as defined by a urinary protein creatinine ratio of ≤ 0.5mg/mg. Overall renal function as measured by eGFR in these patients has remained stable.

The AURION study is an open label, single arm, exploratory study assessing the ability of biomarkers at 8 weeks to predict clinical response rates at 24 and 48 weeks in subjects taking voclosporin 23.7mg twice daily in combination with standard of care, mycophenolate mofetil and corticosteroids, in patients with active LN.

“We are encouraged by these results. This is the first time voclosporin has been used in this particular patient population.” said Dr. Neil Solomons, MD, Chief Medical Officer of Aurinia Pharmaceuticals Inc. “It appears that this data supports our hypothesis that utilizing a multi-targeted approach to treating LN with voclosporin can help patients suffering from this disease. We are very excited to see the results from the 265 patient AURA study later this year.”

The Company will continue to review the AURION data and release more information as it becomes available, a webcast has been scheduled for Tuesday February 16^th, 2016 at 4:30pm Eastern Standard Time. Interested parties can join the webcast at the specified time at the following URL: http://public.viavid.com/index.php?id=118297

¹Dall’Era, M., Stone, D., Levesque, V., Cisternas,M., & Wofsy, D. (2011).Arthritis Care and Research, 63(3), 351–357.

About Aurinia

Aurinia is a clinical stage pharmaceutical company focused on the global nephrology market. The fully-enrolled Phase 2b AURA-LV clinical trial is evaluating the efficacy of its lead drug, voclosporin, as a treatment for active LN. LN is an inflammation of the kidneys, that if inadequately treated can lead to end-stage renal disease, making LN a serious and potentially life-threatening condition.

Voclosporin is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with extensive clinical data in over 2,000 patients in other indications. Voclosporin is made by a modification of a single amino acid of the cyclosporine molecule (a CNI approved for use in transplant patients since 1983). This modification results in a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency vs. cyclosporine, an altered metabolic profile, and potential for flat dosing.

About AURA:

The AURA–LV study or “Aurinia Urine Protein Reduction in Active Lupus Nephritis Study” is an adequate and well-controlled clinical trial that enrolled 265 patients and is being conducted in over 20 countries worldwide. This trial will compare the efficacy of voclosporin against placebo in achieving remission in patients with active lupus nephritis. The AURA-LV study is designed to demonstrate that voclosporin can induce a rapid and sustained reduction of proteinuria in the presence of extremely low steroid exposure. It will compare two dosage groups of voclosporin (23.7mg and 39.5mg) compared to placebo, with all patients receiving mycophenolate mofetil (MMF) and oral corticosteroids as background therapy. There will be a primary analysis to determine complete remission at week 24 (confirmed at 26 weeks) and various secondary analyses at week 48 which include biomarkers and markers of non-renal SLE.

About AURION:

The AURION study or “Aurinia Early Urinary Protein Reduction Predicts Response Study” is an open label, exploratory study being conducted in multiple sites in Malaysia to assess the short term predictors of response using voclosporin (23.7mg) in combination with mycophenolate mofetil and oral corticosteroids in patients with active lupus nephritis. This study will examine biomarkers of disease activity at 8 weeks and their ability to predict response at 24 and 48 weeks.

We seek Safe Harbor.

Aurinia Pharmaceuticals Inc.
Mr. Michael Martin, 250-708-4272
Chief Operating Officer
mmartin@auriniapharma.com
or
Renmark Financial Communications Inc.
Barry Mire: bmire@renmarkfinancial.com
Laura Welsh: lwelsh@renmarkfinancial.com
Tel: 416-644-2020 or 514-939-3989

(CLCD) to Ring The Nasdaq Stock Market Closing Bell

ADVISORY, Feb. 05, 2016  —

What:
CoLucid Pharmaceuticals, Inc. (Nasdaq:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches, will visit the Nasdaq MarketSite in Times Square.

In honor of the occasion, Thomas P. Mathers, Chief Executive Officer, will ring the Closing Bell.

Where:
Nasdaq MarketSite – 4 Times Square – 43^rd & Broadway – Broadcast Studio

When:
Monday, February 8, 2016 – 3:45 p.m. to 4:00 p.m. ET

CoLucid Pharmaceuticals Media Contact:
Hans Vitzthum
(212) 915-2568
hans@lifesciadvisors.com

Nasdaq MarketSite:
Emily Pan
(646) 441-5120
emily.pan@nasdaq.com

Feed Information:
Fiber Line (Encompass Waterfront): 4463

Gal 3C/06C 95.05 degrees West
18 mhz Lower
DL 3811 Vertical
FEC 3/4
SR 13.235
DR 18.295411
MOD 4:2:0
DVBS QPSK

Social Media:
For multimedia features such as exclusive content, photo postings, status updates and video of bell ceremonies please visit our Facebook page at:
http://www.facebook.com/NASDAQ.

For photos from ceremonies and events visit our Instagram Page:
http://instagram.com/nasdaq

For news tweets, please visit our Twitter page at:
http://twitter.com/nasdaq

For exciting viral content and ceremony photos visit our Tumblr Page:
http://nasdaq.tumblr.com/

Webcast:
A LiveStream of the Nasdaq Closing Bell will be available at:
https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx

Photos:
To obtain a hi-resolution photograph of the Market Close, please go to http://www.nasdaq.com/reference/marketsite_events.stm and click on the market close of your choice.           

About CoLucid Pharmaceuticals, Inc.
CoLucid is developing oral lasmiditan for the acute treatment of migraine headaches in adults and intravenous lasmiditan for the acute treatment of headache pain associated with migraine in adults in the emergency room and other urgent care settings.

About Nasdaq
Nasdaq (Nasdaq:NDAQ) is a leading provider of trading, clearing, exchange technology, listing, information and public company services across six continents. Through its diverse portfolio of solutions, Nasdaq enables customers to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today’s global capital markets. As the creator of the world’s first electronic stock market, its technology powers more than 70 marketplaces in 50 countries, and 1 in 10 of the world’s securities transactions. Nasdaq is home to more than 3,700 listed companies with a market value of approximately $9.6 trillion and nearly 10,000 corporate clients. To learn more, visit: nasdaq.com/ambition or business.nasdaq.com.

(DHRM) Announces Corporate Restructuring Plan

BEIJING, Feb. 5, 2016  — Dehaier Medical Systems Ltd. (Nasdaq: DHRM) (“Dehaier Medical” or the “Company”), which develops, markets and sells medical devices and wearable sleep respiratory products in China and international markets, today announced its corporate and business restructuring plan which aims to concentrate the Company’s resources to develop its mobile health business, including wearable sleep respiratory business and to focus more on its major businesses. As of this announcement, the Company has officially launched the business and corporate restructuring process.

As part of the restructuring, the Board of Directors of the Company directed the Company to set up a wholly owned subsidiary, Connection Wearable Health Technology (Beijing) Co., Ltd. (“CWHT”), in Beijing. The Company is conducting related procedures to establish CWHT and it anticipates the process to be completed by the end of February 2016. After its incorporation, CWHT will conduct wearable sleep respiratory and mobile health related businesses. On the other hand, Beijing Dehaier Medical Technology Co., Ltd. (“BDL”) will focus on remaining profitable medical device sales, collection of existing accounts receivable, selling off remaining inventory, management and maintenance of intellectual property assets and certifications of all subsidiaries of the Company.

The Company expects to continue scaling down and discontinuing, as appropriate, its unprofitable medical device business, including assembly and sales of X-ray machines and anesthesia machines. The Company plans to maintain only a few profitable businesses such as sales of its patented medical air compressors and cardiopulmonary resuscitation (“CPR”) instruments in the future.

On January 14, 2016, the Company completed an acquisition of 0.8% equity interest of BDL from Beijing Dehaier Technology Co., Ltd. (“BTL”). The Company now holds 100% of the equity interest of BDL. This change reflects BTL’s reduced reliance on business with BDL in providing repair and maintenance services.

Mr. Ping Chen, CEO of the Company commented to the restructuring plan, “We believe these changes are crucial to improve our competitiveness over the longer term. By restructuring our Company to reduce our reliance on our less profitable medical devices assembly and distribution businesses, we will be more able to leverage our resources to develop smart health products and services, which we see as the future of our Company. Our long-term goal is to gradually decrease our production business, and focus instead on developing a complete mobile health operation platform as well as a supply chain management platform by utilizing the products produced by third parties. ”

About Dehaier Medical Systems Ltd.

Dehaier Medical is an emerging leader in the development, marketing and sale of medical products, including medical devices and wearable sleep respiratory products in China and international markets. The company develops and assembles its self-branded medical devices and sleep respiratory products from third-party components. The company also distributes products designed and manufactured by other companies, including medical devices from HEYER (Germany) and Timesco (UK). Dehaier Medical’s technology is based on six patents and eleven software copyrights. More information may be found at http://www.dehaier.com.cn.

Forward-looking Statements

This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. These statements are subject to uncertainties and risks including, but not limited to, product and service demand and acceptance, fulfillment of bids and contracts, changes in technology, economic conditions, the impact of competition and pricing, government regulation, and other risks contained in reports filed by the company with the Securities and Exchange Commission. All such forward-looking statements, whether written or oral, and whether made by or on behalf of the company, are expressly qualified by the cautionary statements and any other cautionary statements which may accompany the forward-looking statements. In addition, the company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.

For more information, please contact:

Dehaier Medical Systems Limited
Janice Wang
+86 10-5166-0080 ext. 211
investors@dehaier.com.cn

(CHRS) to Present at Bloomberg Intelligence Healthcare Event on February 12th

REDWOOD CITY, Calif., Feb. 05, 2016  — Coherus BioSciences, Inc. (Nasdaq:CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced that Denny Lanfear, President and Chief Executive Officer, will be a featured speaker at the 4^th Annual Bloomberg Intelligence Healthcare Event.

The discussion will be held on Friday, February 12 starting at 2:00 pm ET in New York City. Information regarding the event is available at www.bloomberglp.com/healthcareevent2016.

About Coherus BioSciences, Inc.

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

INVESTOR AND MEDIA CONTACT:
Keith Vendola, M.D.
Investor Relations
Coherus BioSciences, Inc.
kvendola@coherus.com
+1 (650) 437-6239

(LSG) Comments on Trading Activity

Lake Shore Gold
Tony Makuch
President & CEO
(416) 703-6298

Lake Shore Gold
Mark Utting
Vice-President, Investor Relations
(416) 703-6298
www.lsgold.com

(SPI) Expands Its Electric Vehicle Rental Business in Southern China

SHANGHAI, Feb. 5, 2016  — SPI Energy Co., Ltd. (“SPI Energy” or the “Company”) (Nasdaq: SPI), a global provider of photovoltaic (PV) solutions for business, residential, government and utility customers and investors, today announced that its majority-owned subsidiary, Beijing Yiwei New Energy Technology Development Company (“Yiwei”), has expanded its business into China’s southern province of Hainan. The Internet-based electric vehicle (EV) rental service provider, which has existing operations in Beijing and Shenzhen, is expanding to Hainan, which is expected to see a spike in tourism during the upcoming Chinese New Year holiday.

Xiaofeng Peng, Chairman of SPI Energy said, “Every year more Chinese people are choosing to drive cars to explore the country during the Chinese New Year holiday. This year SPI Energy is pleased to offer EV rental solutions for environmentally conscious travelers visiting China’s popular coastal province of Hainan.  With increasing government support and business investment, there are now EV charging facilities across China that are encouraging more people to rent and purchase EVs.”

SPI Energy closed its investment of RMB30 million for a 60% stake in Yiwei in January 2016 and is leveraging its Solarbao.com platform to help Yiwei expand its existing fleet of EVs and EV chargers in China. Users can book the EVs through Yiwei’s website or mobile app.

About SPI Energy Co., Ltd.

SPI Energy Co., Ltd. is a global provider of photovoltaic (PV) solutions for business, residential, government and utility customers and investors. SPI Energy focuses on the downstream PV market including the development, financing, installation, operation and sale of utility-scale and residential solar power projects in China, Japan, Europe and North America. The Company operates an innovative online energy e-commerce and investment platform, www.solarbao.com, which enables individual and institutional investors to purchase innovative PV-based investment and other products; as well as www.solartao.com, a B2B e-commerce platform offering a range of PV products for both upstream and downstream suppliers and customers. The Company has its operating headquarters in Shanghai and maintains global operations in Asia, Europe, North America and Australia.

For additional information visit: www.spisolar.com, www.solarbao.com or www.solartao.com.

Safe Harbor Statement

This release contains certain “forward-looking statements.” These statements are forward-looking in nature and subject to risks and uncertainties that may cause actual results to differ materially. All forward-looking statements included in this release are based upon information available to the Company as of the date of this release, which may change, and the Company undertakes no obligation to update or revise any forward-looking statements, except as may be required under applicable securities law.

Contact:

Amy Liu
US cell: (800) 548 8767

(IMMU) FDA Grants Breakthrough Therapy Designation to Immunomedics

MORRIS PLAINS, N.J., Feb. 05, 2016  — Immunomedics, Inc., (Nasdaq:IMMU) today announced that its lead investigational antibody-drug conjugate, sacituzumab govitecan, or IMMU-132, has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer (TNBC) who have failed at least 2 prior therapies for metastatic disease.

The Breakthrough Therapy Designation was supported by a Phase 2 study in patients with metastatic TNBC who had received a median of 5 prior therapies (range, 2 – 12).

“We believe Breakthrough Therapy Designation for IMMU-132 further validates this potential therapeutic for patients with TNBC, and we are delighted to receive this important recognition,” commented Cynthia L. Sullivan, President and Chief Executive Officer. “We continue to assess partnering opportunities while completing the scale-up manufacturing and regulatory activities for an international, randomized, controlled, registration trial in TNBC, based on the Special Protocol Assessment agreement that was already granted by the FDA,” she added.

Ms. Sullivan further stated: “IMMU-132 is also in Phase 2 trials in patients with advanced, heavily-pretreated, non-small-cell lung cancer, small-cell lung cancer, and urothelial cancers, where encouraging results have been observed. The Trop-2 receptor targeted by this antibody-drug conjugate has increased expression in a large number of solid cancers. To date, we have enrolled about 300 patients with diverse cancer types.”

About Breakthrough Therapy Designation 

Breakthrough Therapy Designation was created as part of the 2012 FDA Safety and Innovation Act (FDASIA) to expedite the development and review of a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. More information on the Breakthrough Therapy Designation can be accessed at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf.

About Triple-Negative Breast Cancer (TNBC)

TNBC is a serious disease, with an annual incidence estimated to be about 40,000 people, 20,000 for metastatic TNBC, in the United States. As the name implies, TNBC does not express estrogen, progesterone or the HER2 receptor, and is, therefore, insensitive to most of the available targeted therapies for breast cancer treatment, including HER2-directed therapy (such as trastuzumab), and endocrine therapies (such as tamoxifen or the aromatase inhibitors). The median overall survival is 6-13 months and the median PFS is usually 3-4 months. There is currently no single standard chemotherapy to treat patients with relapsed/refractory metastatic TNBC. Rapid relapse, with visceral and brain metastases, is very common.

About Sacituzumab Govitecan

Sacituzumab govitecan, or IMMU-132, is a first-in-class ADC developed by the Company by conjugating the moderately-toxic drug, SN-38, site-specifically and at a high ratio of drug to antibody, to a humanized antibody that targets the Trop-2 receptor expressed by many solid cancers. SN-38 is the active metabolite of irinotecan (Camptosar), which is used to treat certain solid cancers as a part of combination therapies, so its pharmacology and properties are well-known. The ADC has received Fast Track designation from the FDA for the treatment of patients with triple-negative breast cancer, small-cell and non-small-cell lung cancers, and has also been designated an orphan drug for the treatment of patients with small-cell lung or pancreatic cancer in the U.S., and for the treatment of patients with pancreatic cancer in the European Union.

About Immunomedics

Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics’ advanced proprietary technologies allow the Company to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these technologies, Immunomedics has built a pipeline of nine clinical-stage product candidates. Immunomedics’ most advanced candidate is ⁹⁰Y-clivatuzumab tetraxetan. This radiolabeled antibody is in an international Phase 3 registration trial in patients with advanced pancreatic cancer. Immunomedics expects patient enrollment to be completed in calendar year 2016. Immunomedics’ portfolio of investigational products also includes antibody-drug conjugates (ADCs) that are designed to deliver a specific payload of a chemotherapeutic directly to the tumor while reducing overall toxic effects that are usually found with conventional administration of these chemotherapeutic agents. Immunomedics’ most advanced ADCs are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively. Immunomedics has a research collaboration with Bayer to study epratuzumab as a thorium-227-labeled antibody. Immunomedics has other ongoing collaborations in oncology with independent cancer study groups. The IntreALL Inter-European study group is conducting a large, randomized Phase 3 trial combining epratuzumab with chemotherapy in children with relapsed acute lymphoblastic leukemia at clinical sites in Australia, Europe, and Israel. Immunomedics also has a number of other product candidates that target solid tumors and hematologic malignancies, as well as other diseases, in various stages of clinical and preclinical development. These include combination therapies involving its antibody-drug conjugates, bispecific antibodies targeting cancers and infectious diseases as T-cell redirecting immunotherapies, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies, created using its patented DOCK-AND-LOCK^® protein conjugation technology. The Company believes that its portfolio of intellectual property, which includes approximately 282 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. For additional information on the Company, please visit its website at www.immunomedics.com. The information on its website does not, however, form a part of this press release.

This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials (including the funding therefor, outcomes, timing or associated costs), out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, new product development (including clinical trials outcome and regulatory requirements/actions), the Company’s dependence on business collaborations in order to further develop our products and finance our operations, the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates, risks associated with the outcome of pending litigation and competitive risks to marketed products, and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.

For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Corporate Secretary 
(973) 605-8200, extension 123
ccheng@immunomedics.com

(IMDZ) to Present at Leerink Partners 5th Annual Global Healthcare Conference

SEATTLE and SOUTH SAN FRANCISCO, Calif., Feb. 04, 2016  — Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today announced that Carlos Paya, M.D., Ph.D., President and Chief Executive Officer, will present at the Leerink Partners 5^th Annual Global Healthcare Conference in New York on Thursday, February 11, 2016 at 3:05 p.m. ET.

A live webcast of the presentation will be available online from the investor relations page of the company’s corporate website at http://ir.immunedesign.com/events.cfm.  After the live webcast, an archive of the presentation will be available on the company website for 30 days.

About Immune Design

Immune Design is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body’s immune system to fight disease. The company’s technologies are engineered to activate the immune system’s natural ability to generate and/or expand antigen-specific cytotoxic T cells, while also enhancing other immune effectors, to fight cancer and other chronic diseases.  CMB305 and G100, the two-pronged focus of Immune Design’s ongoing immuno-oncology clinical programs, are the product of its two synergistic discovery platforms, ZVex^TM and GLAAS^TM. Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com.

Media Contact
Julie Rathbun
Rathbun Communications
julie@rathbuncomm.com                   
206-769-9219

Investor Contact
Shari Annes
Annes Associates
sannes@annesassociates.com
650-888-0902

(VBIV) Partners with the Canadian CMV Foundation

CAMBRIDGE, Mass., Feb. 04, 2016  — VBI Vaccines Inc. (Nasdaq:VBIV) (“VBI”) is proud to announce its continued sponsorship support of Le Classique, the Canadian CMV Foundation’s largest annual fundraiser. Now in its fourth year, Le Classique is a 3-on-3 ball hockey tournament being held in Winnipeg, Canada on February 5th and 6th, 2016, in support of cytomegalovirus (“CMV”) awareness.

“We’re thrilled to be supporting Rob Tetrault and the Canadian CMV Foundation’s efforts to promote CMV awareness and prevention strategies,” said Jeff Baxter, VBI’s President and CEO. “VBI maintains strong ties to Canada – our research facilities and the majority of our workforce are located in Ottawa, Ontario. We believe that more can be done to raise the profile of CMV both in Canada and internationally.”

CMV is among the most common congenital infections in Canada, causing a host of prenatal developmental delays. Strategies can be employed by pregnant women and women considering pregnancy to lower their risk of congenital infection. Despite its prevalence, many women of reproductive age are not aware of the risks posed by CMV. A 2012 study published in Preventative Medicine revealed that only 7% of men and 13% of U.S. women surveyed had heard of congenital CMV.

“Until a vaccine can be developed and deployed, awareness is the best current tool we have to prevent future infections,” said Rob Tetrault, founder of the Canadian CMV Foundation. “Women contemplating pregnancy need to be made aware of the condition so they can understand and better manage potential infection risks.”

To make a contribution, or to learn more about Le Classique and the Canadian CMV Foundation, visit: http://leclassique.ca/.

Event Details

• Event: Le Classique
• Date: February 5th and 6th, 2016
• Location: Whittier Park in Winnipeg, Canada
• Event Website: http://leclassique.ca

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company developing novel technologies that seek to expand vaccine protection in large underserved markets. VBI’s eVLP Platform allows for the design of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus. VBI’s lead eVLP asset is a prophylactic cytomegalovirus (“CMV”) vaccine; VBI has initiated work for GMP manufacturing of its CMV candidate for use in formal preclinical and Phase I trials. VBI’s second platform is a thermostable technology that enables the development of vaccines and biologics that can preserve vaccine potency and withstand storage or shipment at fluctuating temperatures. VBI has completed proof of concept thermostability studies on a number of vaccine and biologic targets. VBI is headquartered in Cambridge, MA with research facilities in Ottawa, Canada.

Website Home: http://www.vbivaccines.com/
News and Insights: http://www.vbivaccines.com/wire/
Investors: http://ir.vbivaccines.com/

Company Contact

Perri Maduri, Communications Executive
Phone: (617) 830-3031 x124
Email: ir@vbivaccines.com

Investor Contacts

Robert B. Prag, President
The Del Mar Consulting Group, Inc.
Phone: (858) 794-9500
Email: bprag@delmarconsulting.com

Scott Wilfong, President
Alex Partners, LLC
Phone: (425) 242-0891
Email: scott@alexpartnersllc.com

Forward-Looking Statement Disclosure

This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the efficacy of potential products, the timelines for bringing such products to market, and the availability of funding sources for continued development of such products. Forward-looking statements are based on management’s estimates, assumptions, and projections, and are subject to uncertainties, many of which are beyond the control of VBI. Actual results may differ materially from those anticipated in any forward-looking statement. Factors that may cause such differences include the risks that potential products that appear promising to VBI cannot be shown to be efficacious or safe in subsequent preclinical or clinical trials, VBI will not obtain appropriate or necessary governmental approvals to market these or other potential products, VBI may not be able to obtain anticipated funding for its development projects or other needed funding, and VBI may not be able to secure or enforce adequate legal protection, including patent protection, for its products. All forward-looking statements included in this press release are made only as of the date of this press release, and VBI does not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

More detailed information about VBI and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in VBI’s filings with the Securities and Exchange Commission (the “Commission”). VBI urges investors and security holders to read those documents free of charge at the Commission’s Web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from VBI. Forward-looking statements speak only as to the date they are made, and except for any obligation under the U.S. federal securities laws, VBI undertakes no obligation to publicly update any forward-looking statement as a result of new information, future events or otherwise.

(AST) Receives Orphan Drug Designation for AST-OPC1

FREMONT, Calif., Feb. 4, 2016 — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, today announced receipt of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its product development candidate, AST-OPC1, for the treatment of acute spinal cord injury.

Orphan Drug Designation is granted by the FDA Office of Orphan Products Development to products that treat rare diseases. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States. Orphan Drug Designation may provide the sponsor certain benefits and incentives, including a period of marketing exclusivity for the first marketing application if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees.

About AST-OPC1

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown in animals or in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hind limb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. They also received low level immunosuppression for the next 60 days. Delivery of AST-OPC1 was successful in all five subjects with no serious adverse events associated with the administration of the cells, with AST-OPC1 itself, or the immunosuppressive regimen. No evidence of rejection of AST-OPC1 was observed in detailed immune response monitoring of all patients. In four of the five patients, serial MRI scans indicated that reduced spinal cord cavitation may have occurred. Based on the results of this study, Asterias received approval from FDA to progress testing of AST-OPC1 to patients with complete cervical spinal cord injuries, which represents the first targeted population for registration trials.  This trial, known as the SCiStar trial, will test three escalating doses of AST-OPC1 administered at 14-30 days post-injury in patients with neurologically complete cervical spinal cord injuries.  Asterias has concluded recruitment of the initial safety cohort of the trial, in which three patients were administered a low dose of 2 million AST-OPC1 cells.  The results of this cohort continue to support a robust safety profile for AST-OPC1.  Additionally at 3 months post-injection the first patient in this cohort had demonstrated neurological improvement progressing from a complete ASIA Impairment Scale (AIS) A injury to an incomplete AIS C injury.  Recruitment is currently underway in the second cohort of the study, in which five patients will be administered a dose of 10 million AST-OPC1 cells, the first of two dose cohorts designed to bracket the predicted optimal dose range of AST-OPC1 based on the preclinical studies.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a leading biotechnology company in the emerging field of regenerative medicine. The company’s proprietary, industry leading platforms are based on its pluripotent stem cell and dendritic cell immunotherapy technologies. Asterias is focused on developing therapies to treat conditions in several medical areas where there is high unmet medical need and inadequate available therapies. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) has demonstrated promise in a Phase 2 study in acute myelogenous leukemia. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic approach to dendritic cell vaccines. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.

FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’s filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.