(RTTR) $10 Million Common Stock Purchase Agreement With Aspire Capital

(HNSN) Completes Sensei Commercial Transaction With Medtronic

(CAPN) Granted Orphan Designation for Nasal CO2

REDWOOD CITY, Calif., Dec. 21, 2015  — Capnia, Inc. (NASDAQ:CAPN), a diversified healthcare company that develops innovative diagnostics, devices and therapeutics addressing unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company’s nasal, non-inhaled carbon dioxide (nasal CO₂) technology for the treatment of trigeminal neuralgia (TN).

“Receiving orphan designation from the FDA is a key step in the advancement of our nasal CO₂ technology, and speaks to the need for new treatment options for the debilitating pain caused by TN, where limited alternatives currently exist,” said Anish Bhatnagar, M.D., Chief Executive Officer of Capnia. “We continue to execute on our strategy of bringing novel therapies based on our nasal CO₂ technology to patients as quickly as possible.”

Capnia’s therapeutic technology uses nasal, non-inhaled carbon dioxide, delivered at a low-flow rate into the nasal cavity to target local trigeminal nerve endings. Multiple clinical trials for the treatment of allergies as well as pain conditions (such as migraine) have been completed using this technology.  The use of nasal CO₂ for the treatment of TN is supported by data demonstrating that CO₂ may inhibit sensory nerve activation, subsequent release of neuropeptides and alleviate trigeminally-mediated pain. Collectively, these data suggest that nasal CO₂ may provide relief of symptoms associated with TN.

In the U.S., under the Orphan Drug Act, the FDA’s Office of Orphan Products Development grants orphan drug status to a drug intended to treat a rare disease or condition, which is generally a disease that affects fewer than 200,000 individuals in the country. The designation provides Capnia’s nasal CO₂ therapeutic with certain benefits, including seven years of U.S. market exclusivity in the specified indication if Capnia complies with certain FDA requirements. Additional incentives for Capnia include tax credits related to qualified clinical trial expenses and a exemption from FDA application fees.

About Trigeminal Neuralgia

Trigeminal neuralgia (TN) is a clinical condition characterized by debilitating pain in regions of the face innervated by one or more divisions of the trigeminal nerve. The pain is typically described as intense, sharp and stabbing, and is often described as one of the most painful conditions known to humans. It may develop without apparent cause or be a result of another diagnosed disorder, including multiple sclerosis and herpes zoster.

About Capnia

Capnia, Inc. is a diversified healthcare company that develops innovative diagnostics, devices and therapeutics addressing unmet medical needs. Capnia’s proprietary therapeutic technology uses nasal, non-inhaled CO₂ and is being evaluated to treat the symptoms of allergies, as well as the trigeminally-mediated pain conditions such as cluster headache, trigeminal neuralgia and migraine. Capnia’s lead commercial product, CoSense, is based on the Sensalyze™ Technology Platform. It is a portable, non-invasive device that rapidly and accurately measures carbon monoxide (CO) in exhaled breath. CoSense has 510(k) clearance for sale in the U.S. and has received CE Mark certification for sale in the European Union. CoSense is used for the monitoring of CO from internal sources (such as hemolysis, a dangerous condition in which red blood cells degrade rapidly), as well as external sources (such as CO poisoning and smoke inhalation). The initial target market is newborns with jaundice that are at risk for hemolysis, comprising approximately three million births in the U.S. and European Union. The Company’s commercial, neonatology-focused product line also includes innovative pulmonary resuscitation solutions, including the NeoPIP™ Infant T-Piece Resuscitator and Universal T-Piece Circuit consumables.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development, renewed focus on our therapeutic business and our ability to advance our nasal CO₂ technology for TN.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in Capnia’s Form 10-Q filed with the Securities and Exchange Commission on November 12, 2015, including under the caption titled “Risk Factors.” Capnia expressly disclaims any intent or obligation to update these forward looking statements, except as required by law.

Investor Relations Contact:
Michelle Carroll/Susie Kim
Argot Partners
(212) 600-1902
michelle@argotpartners.com
susan@argotpartners.com

(ALXA) Interim Results from its Phase 2a Study of AZ-002 in Epilepsy

Interim Analysis Shows That AZ-002 Produces Dose-Related Decreases in Mean Standardized Photosensitivity Range

MOUNTAIN VIEW, Calif., Dec. 21, 2015  — Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced interim results of its Phase 2a study of AZ-002 (Staccato^® alprazolam) in epilepsy patients.  AZ-002 produced a dose-related decrease in mean Standardized Photosensivity Range (SPR), the primary endpoint in the study.  AZ-002 is being developed for the management of epilepsy in patients with acute repetitive seizures (ARS).  ARS occurs in a subset of patients with epilepsy who regularly experience breakthrough seizures, despite treatment with a regular regimen of anti-epileptic drugs.

This study employs the intermittent photic sensitivity (IPS) model in patients with epilepsy who previously exhibited photoparoxysmal responses on their electroencephalogram (EEG).  The IPS model provides a means for assessing the effects of potential therapeutics in epilepsy patients in a controlled laboratory setting by measuring epileptiform changes on the EEG to varying frequencies of flashes of light.  In addition to producing a dose-related decrease in mean SPR, there have been no serious adverse events reported to date and AZ-002 was generally safe and well tolerated in the study patients.

“Our team has been working with some of the key thought leaders in the field of epilepsy to assess the clinical viability of AZ-002 for ARS.  We are encouraged with the preliminary data from the interim analysis of our AZ-002 Phase 2a study,” said Thomas B. King, President and CEO of Alexza.  “We believe that AZ-002, if developed and approved, could offer great benefit to epilepsy patients who experience seizure emergencies like ARS.”

AZ-002 Study Interim Analysis Results and Clinical Trial Design Summary
The interim analysis from this study shows that AZ-002 had dose-related effects on the SPR, no serious adverse effects and was well tolerated in the patients studied.  There were also dose-related changes in two visual-analogue scales for sedation and for alertness, which are established pharmacodynamic markers of benzodiazepine drug activity.  Importantly, in both measures the pharmacodynamic effect was demonstrated at the two-minute time point, which was the first assessment in the study, demonstrating the rapid onset of effect of alprazolam as delivered by the Staccato technology.

The AZ-002 Phase 2a study is an in-clinic, randomized, placebo-controlled, double-blind design, 5-way crossover evaluating patients with epilepsy using the IPS model, with the primary endpoint being reduction in mean SPR.  This exploratory study has enrolled 3 patients to date (of the 6 planned) at three U.S. clinical centers.  The interim analysis was conducted at the midpoint in this study.  The primary aim of this study is to assess the safety and the pharmacodynamic EEG effects of a single dose of AZ-002 at three dose strengths (0.5mg, 1.0mg and 2.0mg) vs. placebo (administered twice during the 6-week protocol for each patient).

Interim IPS Results for AZ-002

• For the placebo dose (administered twice during the study period), the mean SPR was approximately 7 at all time points, from pre-dose baseline to 6 hours post dosing.
• For the 0.5 mg dose, the mean SPR at baseline was 6.3 and the maximal effect occurring at the 1 hour time point) was 3.3, reflecting approximately a 48% decrease in the mean SPR.
• For the 1.0 mg dose, the mean SPR at baseline was 7 and the maximal effect, occurring at the 2 minute time point, was 3, reflecting approximately a 42% decrease in the mean SPR.
• For the 2.0 mg dose, the mean SPR at baseline was 6.7 and the maximal effect, occurring at the 2 min time point, was 2, reflecting approximately a 70% decrease in the mean SPR.
• Duration of effect also appeared to be dose-related. The observed reduction in SPR was approximately 4 hours and 6 hours for the 0.5mg and 1.0mg doses. At the six-hour time point (the last time point measured), the 2.0 mg dose still exhibited IPS activity, with the mean SPR remaining below baseline.

The most frequently reported adverse events in subjects receiving AZ-002 were sedation and/or somnolence.  At the 1.0 mg and 2.0 mg doses, there was a rapid onset of effect observed at 2 minutes post inhalation, which can be attributed to the IV-like pharmacokinetics resulting from Staccato drug delivery.

In previous clinical studies, where more than 100 subjects and patients have been dosed, AZ-002 demonstrated dose-proportionality, exhibited a median T_max (time to peak plasma concentration) of two minutes, and was generally safe and well-tolerated.

The Intermittent Photic Stimulation Model
The Intermittent Photic Stimulation (IPS) model has been used successfully to evaluate potential anti-seizure effects of new agents in early stage development in small groups of patients with photically-induced generalized epileptiform responses on their electroencephalogram (EEG), called photoparoxysmal responses (PPR).  The number of flash frequencies at which PPR can be elicited (delineated by upper and lower thresholds elicited during IPS) can be used as a quantitative measure of photosensitivity and therefore epileptogenic threshold.  When patients with PPR receive single test doses of possible anti-seizure medication, changes in the number of frequencies at which a PPR response is identified on the EEG can be used to screen for antiepileptic effects without triggering actual seizures.  In photosensitivity studies, the patient is exposed to IPS at 14 predetermined unequally separated frequencies in order to detect changes in response around typical upper and lower frequency thresholds. Each flash frequency that elicits a photosensitive response is considered one “step.”  The ranges in Hz between the upper bound and the lower bound for each patient are transformed into a metric, called the standardized photosensitive range (SPR). The maximum SPR is 14, based on the total number of flash frequencies tested.

Acute Repetitive Seizures (ARS)
Epilepsy, a disorder of recurrent seizures, affects approximately 2.5 million Americans, making it the third most common neurological disorder in the United States.  ARS refers to seizures that are serial, clustered or crescendo, and ones that are distinct from the patient’s usual seizure pattern.  Typically there is recovery between the seizures in the cluster¹.

Among the implications of ARS are concerns for patient safety.  Seizure effects generally correlate directly with seizure duration.  Prolonged or recurrent seizure activity persisting for 30 minutes or more may result in serious injury, health impacts or death.  If left untreated, ARS has been reported to evolve into status epilepticus, a life-threatening condition in which the brain is in a state of persistent seizure which has a mortality rate of 3% in children and 26% in adults.²

Benzodiazepines are considered to be medications of first choice for the treatment of ARS.  The most immediate treatment for out-of-hospital care and the only U.S. Food and Drug Administration-approved product for acute repetitive seizures is rectal diazepam gel.  Treatment may produce central nervous system depression.  Oral, buccal, and sublingual benzodiazepines (lorazepam, diazepam), which are not approved for patients with ARS, are sometimes used for treatment, but only if the risk of aspiration is not a concern and it is recognized that the absorption time will be increased.  Nasal benzodiazepine products, available in some countries, are not yet available in the United States.  Intravenous benzodiazepines are rapidly acting, but must be administered by a healthcare professional in a medical facility.

The ability to treat a patient quickly is clinically imperative to avoid the epilepsy becoming status epilepticus or causing other serious complications³.  Alexza believes that a product that can be administered easily in the home setting to effectively treat ARS may result in avoiding a trip to the hospital for treatment or diminish the use of the rectal formulation of diazepam.  AZ-002 could be administered after the first seizure in a cluster, with the aim of preventing further seizures.  The caregiver could provide dosing assistance between seizures.  The product could also be used in a healthcare facility, thus avoiding the use of an IV or a rectal formulation of a benzodiazepine.

While there are not firm incidence and prevalence numbers in the literature, there are estimated to be less than 200,000 people with ARS in the United States, which could make AZ-002 eligible for orphan product status.

More information on this Phase 2a study can be found at www.clinicaltrials.gov.  Alexza owns full development and commercial rights to AZ-002.

About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is focused on the research, development, and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions.  Alexza’s products and development pipeline are based on the Staccato^® system, a hand-held inhaler designed to deliver a pure drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner.  Active pipeline product candidates include AZ-002 (Staccato alprazolam) for the management of epilepsy in patients with acute repetitive seizures and AZ-007 (Staccato zaleplon) for the treatment of patients with middle of the night insomnia.

ADASUVE^® is Alexza’s first commercial product and is currently available in 20 countries, approved for sale by the U.S. Food and Drug Administration, the European Commission and in several Latin American countries.  Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd., is Alexza’s current commercial partner for ADASUVE in the United States, though Alexza has announced its intention to reacquire the United States commercial rights from Teva with an estimated target completion date of January  2016.  Grupo Ferrer Internacional SA is Alexza’s commercial partner for ADASUVE in Europe, Latin America, the Commonwealth of Independent States countries, the Middle East and North Africa countries, Korea, Philippines and Thailand.

ADASUVE^® and Staccato^® are registered trademarks of Alexza Pharmaceuticals, Inc.  For more information about Alexza, the Staccato system technology or the Company’s development programs, please visit www.alexza.com.

This news release contains forward-looking statements that involve significant risks and uncertainties. Any statement describing the Company’s expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs, including the ability of Alexza and Ferrer to effectively and profitably commercialize ADASUVE, Alexza’s ability to secure a new U.S. commercial partner for ADASUVE and the terms of any such partnership, estimated product revenues and royalties associated with the sale of ADASUVE, the adequacy of the Company’s capital to support the Company’s operations, and the Company’s ability to raise additional funds and the potential terms of such potential financings. Additionally, there are risks and uncertainties inherent in the process of negotiating the acquisition of the U.S. rights for ADASUVE from Teva and restructuring the obligations under the outstanding note from Teva. Alexza does not have a defined timeline for this process and is not confirming that the process will result in any specific action or transaction.  The Company’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 Alexza’s business are described in additional detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 and the Company’s other Periodic and Current Reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Reference:
1.  Cereghino, JJ., 2007.  Identification and treatment of acute repetitive seizures in children and adults
2.  Boggs, J., 2004.  Mortality Associated with Status Epilepticus
3.  Dreifuss, Fritz E., 1998.  Comparison of Rectal Diazepam Gel and Placebo for Acute Repetitive Seizures

(CERC) Names Uli Hacksell President and CEO

Cerecor Inc. (NASDAQ: CERC) today announced that Uli Hacksell, Chairman of Cerecor and former CEO of ACADIA, has been named to the additional positions of CEO and President of the company as of January 1, 2016. Dr. Blake Paterson will step down as the company’s CEO and resign from its board, but will continue to work with the company as a scientific advisor.

“I am looking forward to the next phase of my career and will continue to serve as a scientific advisor to the Cerecor going forward” said Paterson. “I am excited about the next phase of Cerecor’s growth as it continues to develop CNS drug candidates.”

Dr. Hacksell joined Cerecor Inc. in May 2015 as its Chairman, seeing the company through its initial public offering. Prior to Cerecor, Dr. Hacksell served as Chief Executive Officer of ACADIA from September 2000 to March 2015 and was a member of its Board of Directors. Dr. Hacksell joined ACADIA when it was private and led it to becoming a multibillion dollar public biotech company. Dr. Hacksell had initially joined ACADIA as Executive Vice President of Drug Discovery. From August 1991 to February 1999, Dr. Hacksell held various senior executive positions at Astra, a major pharmaceutical company, including Vice President of Drug Discovery and Technology as well as President of Astra Draco, one of Astra’s largest research and development subsidiaries, where he directed an organization of more than 1,100 employees. From August 1991 to May 1994, he served as Vice President of CNS Preclinical R&D at Astra Arcus, another subsidiary. Earlier in his career, Dr. Hacksell held the positions of Professor of Organic Chemistry and Department Chairman at Uppsala University in Sweden and also served as Chairman and Vice Chairman of the European Federation of Medicinal Chemistry. He currently serves on the board of directors of Uppsala University, InDex Pharmaceuticals, and Glionova Therapeutics.

“I am very pleased to be serving Cerecor.” said Dr. Hacksell. “There is a lot to be excited about at Cerecor, it has a portfolio of CNS products, each with its own unique mechanisms and significant market potential. Cerecor has clear development plans, strong leadership, and very talented employees. I am committed to our shareholders to help Cerecor become a leader in developing CNS drugs.”

“We are thankful for Blake’s significant contributions during his tenure as Chief Executive Officer. Under Blake’s leadership, Cerecor made significant progress towards strategic imperatives, including enhancing our portfolio of compounds and positioning the company for long-term development success. We wish Blake the best in the next phase of his career,” said Isaac Blech, Vice Chairman. “As we move forward, we are fortunate to have a leader of Uli Hacksell’s experience to lead our development and executive team at Cerecor.”

About Cerecor

Cerecor Inc. is a Baltimore-based biopharmaceutical company with the goal of becoming a leader in the development of innovative drugs that make a difference in the lives of patients with neurological and psychiatric diseases. www.cerecor.com

Forward-Looking Statements

This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Cerecor’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Cerecor’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of Cerecor’s management but are subject to significant risks and uncertainties, including those detailed in Cerecor’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the timing for the separation of Cerecor’s publicly traded units into their component securities as described herein) may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecor’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For more information about the Company and its products, please visit: www.cerecor.com or contact Mariam E. Morris, Chief Financial Officer, at (443) 304-8002.

Media:
MacDougall Biomedical Communications
Doug MacDougall or Joe Rayne, 781-235-3060
jrayne@macbiocom.com

(NTWK) Contract to Implement NFS Ascent Valued at More Than $100 Million

Agreement Calls for Implementation of Company’s Next-Generation Finance and Leasing Software Solution across 12 Markets in Asia and South Africa

Conference Call Scheduled for Today at 9:00 a.m. EST

CALABASAS, Calif., Dec. 21, 2015  — NetSol Technologies, Inc. (Nasdaq:NTWK), a global business services and enterprise application solutions provider, today announced the signing of a contract currently valued at more than $100 million, which includes license, maintenance, services and expected customization, with a long-standing customer to implement NFS Ascent^TM.

The agreement calls for upgrading to NetSol’s NFS Ascent platform, the company’s advanced solution for the auto and equipment finance and leasing industry, from the company’s NFS^TM platform in Australia, China, Hong Kong, India, Japan, New Zealand, Singapore, South Korea, Taiwan, Thailand and Malaysia. The contract also includes implementation of NFS Ascent in South Africa, a new market for NetSol.  The implementation phase spans a five-year period, with maintenance and support over ten years.

“This is a transformative agreement for NetSol, representing the largest contract in the company’s history, and a strong endorsement for NFS Ascent from a nearly two-decade-long partnership with our client,” said Najeeb Ghauri, CEO of NetSol. “The agreement also reflects their trust in NetSol and our talented technology professionals. The significant investments we made in our infrastructure and staffing are paying off and building leverage into our business.”

The implementation encompasses the full end-to-end finance and leasing lifecycle, covering NFS Ascent’s Loan Origination System (LOS), Contract Management System (CMS), Wholesale Financing System (WFS) and its Dealer/Auditor Access System (DAAS). It also includes NFS Mobility^TM mAccount, which gives customers visibility into their auto financing contract. Once complete, the system will provide a single regional platform that improves business visibility and assists with strategic planning.

“With the signing of this agreement, NFS Ascent has established itself as the premium auto and asset finance platform in the market,” said Naeem Ghauri, head of global sales for NetSol. “This is a watershed event for NetSol given the expected value of the contract and geographical footprint of the implementation in 12 markets. In addition, we believe NFS Ascent is well-positioned to leverage this success to sign additional multi-market deals in the future.”

The name of NetSol’s client is not being released per client request.

Special Conference Call

A live webcast will be available online within the investor relations section of NetSol’s website at http://www.netsoltech.com. A replay of the webcast will be available one hour following conclusion of the live call, and will be archived for one year.

To sign up to receive news alerts and regulatory filing notifications, please visit http://ir.netsoltech.com/email-alerts.

About NFS Ascent™

NFS Ascent™ offers a technologically advanced solution for the auto and equipment finance and leasing industry. NFS Ascent’s architecture and user interfaces were designed based on the Company’s collective experience with global Fortune 500 companies over the past 40 years. The platform’s framework allows auto captive and asset finance companies to rapidly transform legacy driven technology into a state-of-the-art IT and business process environment. At the core of the NFS Ascent platform is a lease accounting and contract processing engine, which allows for an array of interest calculation methods, as well as robust accounting of multi-billion dollar lease portfolios in compliance with various regulatory standards. NFS Ascent, with its distributed and clustered deployment across parallel application and high volume data servers, enables finance companies to process voluminous data in a hyper speed environment. More information about NFS Ascent can be found by visiting: http://ascent.netsoltech.com

About NetSol Technologies

NetSol Technologies, Inc. (Nasdaq:NTWK) is a worldwide provider of IT and enterprise software solutions primarily serving the global leasing and financing industry. The Company’s suite of applications are backed by 40 years of domain expertise and supported by a committed team of more than 1500 professionals placed in eight strategically located support and delivery centers throughout the world.

Forward-Looking Statements

This press release may contain forward-looking statements relating to the development and implementation of the Company’s products and services, completion of contracts, projected revenues, future operation results and product and services outlook, including statements regarding the Company that are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words “expects,” “anticipates,” variations of such words, and similar expressions, identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, but their absence does not mean that the statement is not forward-looking. These statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Factors that could affect the Company’s actual results include the progress and costs of the development of products and services and the timing of the market acceptance. The subject Companies expressly disclaim any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based.

Investor Contacts:

PondelWilkinson
Matt Sheldon | investors@netsoltech.com
(310) 279-5975

Media Contacts:

PondelWilkinson
George Medici | gmedici@pondel.com
(310) 279-5968

(BBRY) 43 Percent YOY Organic Growth in Software License Revenue

Total software and services revenue grows 183 percent year over year

Investor Contact:
BlackBerry Investor Relations
+1-519-888-7465
investor_relations@blackberry.com

Media Contact:
BlackBerry Media Relations
(519) 597-7273
mediarelations@BlackBerry.com

(WPRT) & AVL Sign Agreement to Deliver Next-Generation HPDI Technology

~ AVL’s Global Engineering Capability to Support Rapid Adoption of Advanced Natural Gas Engine Technology ~

VANCOUVER, Dec. 18, 2015  – Westport Innovations Inc. (TSX:WPT / Nasdaq:WPRT), engineering the world’s most advanced natural gas engines and vehicles, and AVL List GmbH., the world’s leading independent company for development, simulation and testing technology of powertrains for global original equipment manufacturers (OEMs), announced today that they have entered into an agreement to deliver next-generation High Pressure Direct Injection (HPDI) gas technology.

This agreement enables Westport and AVL to leverage Westport’s proprietary HPDI 2.0 natural gas technology, along with AVL’s engine and powertrain development capabilities, proprietary techniques and global market reach, for timely delivery of solutions to OEMs. This gives the two companies a formidable advantage in natural gas engine and vehicle development as the industry moves towards offering next-generation natural gas vehicles.

“As concern about transportation greenhouse gas emissions continues to grow, one of the simplest and cost-effective approaches for OEMs is to offer HPDI 2.0 natural gas versions of their commercial vehicles,” said David Demers, Westport’s CEO. “HPDI 2.0 is compatible with the world’s most advanced diesel engines and offers a fast path to market for high-performance trucks and off-road vehicles. It does not compromise performance yet delivers greenhouse gas benefits along with lower-cost fuel. When renewable natural gas (RNG) such as landfill gas is used, HPDI 2.0 can reduce the production of greenhouse gas emissions by more than 80% compared to equivalent diesel trucks.”

“One of the biggest challenges faced by the commercial vehicle industry today is finding affordable ways to reduce greenhouse gas emissions, including CO2, while further lowering conventional emissions,” said Helmut List, CEO of AVL. “AVL’s powertrain engineering experience and testing solutions, combined with this exciting new HPDI 2.0 technology, will create great opportunities for our customers.”

AVL has been delivering advanced powertrain solutions to global OEMs for decades and will work with Westport to market and provide the HPDI 2.0 solutions to customers for rapid adoption. AVL’s global network of more than 7,470 employees and numerous technical centres will be available to support parallel engine development programs to ensure OEMs can take advantage of this cutting-edge technology.

AVL and Westport will collaborate through shared technology and engineering processes, and the companies will establish a Strategic Governance Group to provide long-term relationship oversight. Meanwhile, OEM customers will continue to source HPDI 2.0 components and technology directly from Westport. For competitive reasons, further terms and conditions of the agreement have not been disclosed.

Westport HPDI 2.0 is the only natural gas technology capable of delivering performance and fuel economy equivalent to that of current high performance diesel-fuelled engines. This combination of high performance and high efficiency is critical for heavy-duty engines in demanding commercial applications. HPDI 2.0 is fully compatible with natural gas from renewable sources, which is increasingly available in the transportation marketplace.

About Westport

Westport engineers the world’s most advanced natural gas engines and vehicles. More than that, we are fundamentally changing the way the world travels the roads, rails and seas. We work with original equipment manufacturers (OEMs) worldwide from design through to production, creating products to meet the growing demand for vehicle technology that will reduce both emissions and fuel costs.  To learn more about our business, visit westport.com, subscribe to our RSS feed, or follow us on Twitter @WestportDotCom.

About AVL

AVL is the world’s largest independent company for the development, simulation and testing technology of powertrains (hybrid, combustion engines, transmission, electric drive, batteries and software) for passenger cars, trucks and large engines. As of 2014 AVL had more than 7,470 employees worldwide and annual sales of EUR 1.15 billion.  To learn more about AVL, go to www.avl.com.

This press release contains forward-looking statements, including statements regarding the qualities and performance of HPDI 2.0, the timing and delivery of the referenced components and commercial production, production capacity and the timing thereof, the ease of and methods of manufacturing, service, integration and support for HPDI 2.0 trucks, the establishment of the referenced strategic governance group and functioning of the collaborative relationship with AVL, the demand for our products, the future success of our business and technology strategies, investment in new product and technology development and otherwise, intentions of partners and potential customers, the performance and competitiveness of Westport’s products and expansion of product coverage, future market opportunities and timing of future agreements as well as Westport management’s response to any of the aforementioned factors. These statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties and are based on both the views of management and assumptions that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activities, performance or achievements expressed in or implied by these forward looking statements. These risks and uncertainties include risks and assumptions related to our industry and products, the general economy, governmental policies and regulation, technology innovations, the availability and price of natural gas, global government stimulus packages, the acceptance of and shift to natural gas vehicles, the relaxation or waiver of fuel emission standards, the inability of fleets to access capital or government funding to purchase natural gas vehicles, the development of competing technologies, our ability to adequately develop and deploy our technology, the actions and determinations of our joint venture and development partners, as well as other risk factors and assumptions that may affect our actual results, performance or achievements or financial position discussed in our most recent Annual Information Form and other filings with securities regulators. Readers should not place undue reliance on any such forward-looking statements, which speak only as of the date they were made. We disclaim any obligation to publicly update or revise such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in these forward looking statements except as required by National Instrument 51-102. The contents of any website, RSS feed or twitter account referenced in this press release are not incorporated by reference herein.

SOURCE Westport Innovations Inc.

Inquiries: Darren Seed, Vice President, Capital Markets & Communications, Westport, T: +1 604-718-2046, invest@westport.com; Media Inquiries: Holly Black, Director, Communications, Westport, T: +1 604-718-2011, media@westport.com; Michael Ksela, AVL Company Spokesman, T: +43 664 132 81 78, Michael.ksela@scoopandspoon.comCopyright CNW Group 2015

(CENX) Reaches Power Agreement for Mt. Holly Smelter

Arrangement to Allow Mt. Holly to Operate at Half Capacity as SC Legislature Seeks Long-Term Solution

(NYNY) Announces Consideration of Gaming Facility Licen

Empire Resorts, Inc. (NASDAQ-GM: NYNY) (“Empire”) and its wholly owned subsidiary Montreign Operating Company, LLC (“Montreign” and together with Empire and its other subsidiaries, the “Company”) today announced that the consideration of gaming facility licenses by the New York State Gaming Commission (the “Commission”) is on the agenda for the Commission’s meeting to be held at 2:00 p.m. on December 21st, 2015 in New York, New York. The Commission’s official media advisory includes notice that its agenda includes, “Consideration of Gaming Facilities Licensing” for the three applicants selected by the New York State Facility Location Board, including Montreign.

The Commission is responsible for the award of Gaming Facility Licenses upon confirmation of the applicants’ suitability and their respective ability to complete the gaming facility.

About Empire Resorts

Empire Resorts, Inc. owns and operates, through its subsidiary Monticello Raceway Management, Inc., the Monticello Casino and Raceway, a harness racing track and casino in Monticello, N.Y., and is 90 miles from midtown Manhattan. For additional information, please visit www.empireresorts.com.

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

Empire Resorts
Charles Degliomini, 845-807-0001
Executive Vice President
cdegliomini@empireresorts.com

(RLOC) Strategic Actions to Improve Adjusted EBITDA, Liquidity

Raises Fourth Quarter Adjusted EBITDA Outlook and Provides Initial Outlook for 2016

WOODLAND HILLS, Calif., Dec. 18, 2015  — ReachLocal, Inc. (Nasdaq:RLOC), a leader in powering online marketing for local businesses, today raised its outlook for fourth quarter 2015 Adjusted EBITDA and announced a series of strategic actions to improve Adjusted EBITDA and its liquidity position in order to provide a foundation for future growth.  The Company:

• Entered into a new financing agreement with affiliates of VantagePoint Capital Partners and amended its existing agreement with Hercules Technology Growth Capital to provide additional liquidity.
• Estimates that operating expenses for 2015 will be approximately 25% lower than 2014 levels, and that additional already-implemented and planned efficiency programs will further reduce operating expenses in 2016 by at least 15% over 2015 levels.
• Revised terms with its key publishers to improve its ability to earn performance bonuses following up on winning top honors with Google’s Innovator Award for its ReachEdge™ solution and winning Google’s Quality Score Champion Award for North America and LATAM.
• Exited direct sales in the UK market in line with its goal of eliminating unprofitable revenues.

“We have taken a number of proactive, strategic steps to reduce costs and improve our cash position and are pleased to raise our Adjusted EBITDA outlook for the fourth quarter and provide an initial view of our Adjusted EBITDA for next year,” said Sharon Rowlands, ReachLocal’s Chief Executive Officer.  “One of our goals for 2015 was to progressively improve Adjusted EBITDA throughout the year, and today’s upward revision is evidence that we are moving in the right direction.  Our revised outlook is driven primarily by more aggressive expense management and business optimization initiatives and incremental upside expected from recently revised publisher rebate agreements.”

Financing Agreements

ReachLocal has entered into a $10 million financing arrangement with affiliates of its largest shareholder, VantagePoint Capital Partners, for the immediate issuance of $5 million of Convertible Secured Subordinated Notes and the possibility of an additional $5 million of notes to be issued upon mutual agreement.  The notes bear interest at a rate of 4 percent, mature in April 2018 and may be converted into ReachLocal common stock at a conversion price of $5 per share at the holder’s option.

“VantagePoint Capital Partners is pleased to provide this facility. Based on our analysis, the $5 million we are providing today, together with the company’s other resources, provides sufficient liquidity to fully support the company’s 2016 operating plan,” said VantagePoint CEO Alan Salzman.  “We have confidence that the ReachLocal management team has implemented the right strategic, cost-cutting, and operational steps so that the company can focus on enhancing Adjusted EBITDA and increasing shareholder value during 2016.”

In addition, Hercules Technology Growth Capital has agreed to reduce the amount of restricted cash required by the Hercules term loan from $17.5 million to $15.0 million.  The amended loan agreement with Hercules also provides that the restricted cash will be reduced to $12.5 million as soon as May 2016 if ReachLocal achieves certain profitability targets as provided in the Hercules term loan.

ReachLocal anticipates ending 2015 with cash, cash equivalents and restricted cash of at least $30 million, including $15 million of restricted cash under the Hercules loan agreement.

Operating Expenses

As discussed on its quarterly earnings calls, throughout 2015 ReachLocal has implemented a number of actions designed to lower operating expenses and promote operating efficiencies. ReachLocal now estimates that these programs will result in an expected 25% decrease in 2015 operating expenses compared to 2014.  Additional cost-focused activities already implemented should result in a further reduction of at least 15% in 2016 operating expenses below 2015 levels.

Publisher Agreements and Awards

ReachLocal has also agreed to revised terms with key publishers to give it the ability to optimize media costs through improved performance bonuses.

As previously announced, ReachLocal won Google’s Innovator Award for its ReachEdge™ Solution awarded to the Premier SMB Partner delivering outstanding technology innovations in their digital advertising solutions.  The Company also won Google’s Quality Score Champion Award for North America and LATAM.  This prestigious award recognizes the Premier SMB Partner with the highest average AdWords Quality Score during the judging period, indicating the superior quality of ReachSearch technology and ReachLocal’s service platform.

Exit from Direct Sales in the U.K. Market

ReachLocal has decided to exit from direct sales in the U.K. market, consistent with its previously stated strategy of focusing only on markets with the potential for positive, sustainable economics and contribution margin.  For the nine months ended September 30, 2015, ReachLocal reported revenues of $20.2 million and an Adjusted EBITDA loss of $1.8 million attributable to operations in the UK.  The impact of the transaction to exit the UK will have an immaterial impact on Adjusted EBITDA in the fourth quarter.  A reconciliation table showing historical pro forma performance of excluding the UK for 2014 and the first three quarters of 2015 will be posted on ReachLocal’s investor relations site.

Business Outlook

The actions detailed above enable ReachLocal to:

• Raise its Adjusted EBITDA guidance for the fourth quarter of 2015 to the range of $2.4 million to $3.0 million, up from the prior range of $0.8 million to $1.4 million. The Company’s prior revenue outlook of $88 million to $92 million for the fourth quarter of 2015 is unchanged.
• ReachLocal anticipates ending 2015 with cash, cash equivalents and restricted cash of at least $30 million, including $15 million of restricted cash under the Hercules loan agreement.
• Provide an initial outlook for Adjusted EBITDA of $15 to $17 million for the full year 2016.

“Taken together, these strategic actions improve our financial position and substantially increase our liquidity as we work to return ReachLocal to growth. We are comfortable that we have the liquidity to achieve our plans and have strong confidence in getting to cash flow positive in the second half of 2016.  Our confidence in our business, leading edge technology and superior service is supported by our three recent awards from Google – Quality Score Champion in North America and Latin America and the Innovator Award for Canada. ReachLocal has made great strides in improving client experience and expanding our software solutions during 2015 and we expect to continue these trends in 2016,” concluded Rowlands.

About ReachLocal, Inc.

ReachLocal, Inc. (RLOC) helps local businesses grow and operate their business better with leading technology and expert service for our clients’ lead generation and conversion. ReachLocal is headquartered in Woodland Hills, Calif. and operates in four regions: Asia-Pacific, Europe, Latin America and North America.

For more information please visit ReachLocal at www.reachlocal.com, follow us at www.reachlocal.com/social or email info@reachlocal.com.

Use of Non-GAAP Measures

ReachLocal management evaluates and makes operating decisions using various financial and operational metrics. In addition to the Company’s GAAP results, management also considers non-GAAP measures including Adjusted EBITDA. Management believes that these non-GAAP measures provide useful information about the Company’s core operating results and thus are appropriate to enhance the overall understanding of the Company’s past financial performance and its prospects for the future. Adjusted EBITDA is defined as net income (loss) from continuing operations before interest, income taxes, depreciation and amortization expenses, excluding, when applicable, stock-based compensation, the effects of accounting for business combinations (including any impairment of acquired intangibles and goodwill), restructuring charges, and other non-operating income or expense. Non-GAAP measures, while having utility, also have limitations as an analytical tool, and should not be considered in isolation or as a substitute for analysis of the Company’s results as reported under GAAP. Some of these limitations are:

• Adjusted EBITDA does not reflect the Company’s cash expenditures for capital equipment or other contractual commitments;
• Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and Adjusted EBITDA does not reflect capital expenditure requirements for such replacements;
• Adjusted EBITDA does not reflect changes in, or cash requirements for, the Company’s working capital needs;
• Adjusted EBITDA does not consider the potentially dilutive impact of issuing equity-based compensation to the Company’s management and other employees;
• Adjusted EBITDA does not reflect the potentially significant interest expense or the cash requirements necessary to service interest or principal payments on indebtedness that the Company may incur in the future;
• Adjusted EBITDA does not reflect income and expense items that relate to the Company’s financing and investing activities, any of which could significantly affect the Company’s results of operations or be a significant use of cash;
• Adjusted EBITDA does not reflect costs or expenses associated with accounting for business combinations;
• Adjusted EBITDA does not reflect certain tax payments that may represent a reduction in cash available to the Company.

Other companies, including companies in the same industry, calculate Adjusted EBITDA measures differently, which reduces their usefulness as a comparative measure.

Adjusted EBITDA is not intended to replace operating income (loss), net income (loss) and other measures of financial performance reported in accordance with GAAP. Rather, Adjusted EBITDA is a measure of operating performance that may be considered in addition to those measures. Because of these limitations, Adjusted EBITDA should not be considered as a measure of discretionary cash available to the Company to invest in the growth of the business.

Caution Concerning Forward-Looking Statements

Statements in this press release regarding the Company’s outlook for future periods and the quotes from management constitute “forward-looking” statements within the meaning of the Securities Exchange Act of 1934. These statements reflect the Company’s current views about future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievement to materially differ from those expressed or implied by the forward-looking statements. Actual events or results could differ materially from those expressed or implied by these forward-looking statements as a result of various factors, including: (i) the Company’s ability to increase productivity of its sales operations; (ii) the Company’s ability to obtain the cost savings contemplated by its cost reduction initiatives and maintain sufficient liquidity; (iii) the Company’s ability to purchase media and receive rebates from Google, Yahoo! and Microsoft under commercially reasonable terms; (iv) the Company’s ability to recruit, train and retain its salespeople; (v) the Company’s ability to attract and retain customers and compete with a wide range of competitors on both price and product offerings; (vi) the Company’s ability to satisfy the covenants under its various financing arrangements, some which have required amendments in the past; (vii) the Company’s ability to manage its international operations; (viii) the Company’s ability to successfully develop and offer new products and services in the highly competitive online advertising industry; (ix) the impact of worldwide economic conditions, including the resulting effect on advertising budgets; and (x) the Company’s ability to comply with government regulation affecting our business, including regulations or policies governing consumer privacy. More information about these factors and other potential factors that could affect the Company’s business and financial results is contained in its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. The Company does not intend, and undertakes no duty, to update this information to reflect future events or circumstances.

Investor Relations:
Alex Wellins
The Blueshirt Group
(415) 217-5861
alex@blueshirtgroup.com

Media Contact:
Amber Seikaly 
Vice President Corporate Communications
(214) 294-0242
amber.seikaly@reachlocal.com

(FSNN) Announces Technology Certification With Panasonic

NEW YORK, NY–(December 17, 2015) – Fusion (NASDAQ: FSNN), a leading provider of cloud services, announced today that its award-winning cloud communications solution has been certified compliant with the interoperability requirements of Panasonic System Communications Company of North America, an industry-leading provider of business communications solutions.

The successful certification allows Panasonic customers to confidently enjoy the service benefits and cost advantages of Fusion’s advanced cloud-based SIP Trunking solution without having to replace existing equipment or infrastructure.

“Our relationship with Fusion is an important part of our ongoing efforts to provide our customers with an increasing number of technology options. We are pleased to work with Fusion to increase the value of our customers’ investments by ensuring that they can take full advantage of the many service benefits of the Fusion cloud services platform,” said Gary Moeller, product manager, Panasonic System Communications Company of North America. “Panasonic and Fusion share a commitment to delivering high quality, fully interoperable and cost-effective communications solutions for all our business customers’ needs,” Moeller continued.

Russell P. Markman, President of Business Services at Fusion, commented, “Fusion is pleased to have successfully met Panasonic’s rigorous certification requirements. Our relationship benefits both our partner community and our customers and supports our mutual efforts to provide Panasonic partners with the most advanced, secure and reliable SIP Trunking service in the industry today.”

About Fusion

Fusion is a leading provider of integrated cloud solutions to small, medium and large businesses. Fusion’s advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including cloud communications, cloud connectivity, and cloud computing. Fusion’s innovative, yet proven cloud solutions lower our customers’ cost of ownership, and deliver new levels of security, flexibility, scalability, and speed of deployment. For more information, please visit www.fusionconnect.com.

About Panasonic Solutions for Business

Panasonic delivers game-changing technology solutions that deliver a customized experience to drive better outcomes — for our customers and our customers’ customers. Panasonic engineers reliable products and solutions that help to create, capture and deliver data of all types, where, when and how it is needed. The complete suite of Panasonic professional solutions for government and commercial enterprises of all sizes addresses unified business communications, mobile computing, security and surveillance, retail point-of-sale, office productivity, visual communications (projectors, displays, digital signage) and HD video production. Panasonic solutions for business are delivered by Panasonic System Communications Company of North America, Division of Panasonic Corporation of North America, the principal North American subsidiary of Panasonic Corporation. For more information, visit https://business.panasonic.com/.

Fusion Contact

Brian Coyne
212-201-2404
Email contact

Darrow Associates Contacts for Fusion

Jordan Darrow
(631) 367-1866
Email contact

Bernie Kilkelly
(516) 236-7007
Email contact

(MNRK) To Be Acquired by (TOWN)

SUFFOLK, Va., Dec. 17, 2015  — Hampton Roads based TowneBank (NASDAQ:TOWN) and Monarch Financial Holdings, Inc., the parent company of Monarch Bank (NASDAQ:MNRK), today announced the signing of a definitive merger agreement pursuant to which TowneBank will acquire Monarch creating a $7.3 billion hometown bank serving Hampton Roads, Richmond and Northeastern North Carolina.  On a proforma basis, the combined companies will rank No. 1 in deposit market share with 20.64% of the Hampton Roads market and will be the only community bank in the top 50 largest MSAs in the United States with a No. 1 market share ranking.

“Our Towne family is humbled and excited to join hands with our long-time friends at Monarch,” said G. Robert Aston, Jr., Chairman and CEO of TowneBank.  “Since the founding of our two banks in 1998, our companies have been built around the values of “serving others and enriching lives” while striving to build a great community asset that will help our communities grow and prosper.”

“We have known and respected the senior leadership team and employees at Towne Bank for many years and have been impressed by the way they have grown their company into one of the largest and most successful financial institutions in Virginia”, stated Brad E. Schwartz, CEO of Monarch.  “This combination of the top two performing community banks in the market gives us a dynamic foundation to serve our commercial, mortgage and consumer customers with even greater convenience, expanded product and service offerings, and additional lending capacity.  This merger is a great outcome for our company’s shareholders and positions us well for sustainable success over the long term.”

Based on financials reported on September 30, 2015 the combined companies would have total assets of $7.3 billion, deposits of $5.8 billion and loans of $5.4 billion.  Under the terms of the agreement, common shareholders of Monarch will receive 0.8830 shares of TowneBank common stock for each share of Monarch.  This implies a deal value per share of $18.57 or approximately $220.6 million based on TowneBank’s closing stock price of $21.03 on Wednesday, December 16, 2015.

Using a 20-day moving average of TowneBank’s closing stock price implies a deal value per share of $19.25 or $229 million on an average share price of $21.81.  The share price and total deal value will be determined utilizing the conversion ratio of 0.8830 shares of Monarch common stock for each share of Towne Bank common stock at the merger closing date, expected to be in the second quarter of 2016 subject to shareholder and regulatory approvals.

In consideration of the merger, extensive due diligence was performed over a multi-week period.  Under the proposed terms, the transaction is expected to be accretive to TowneBank’s earnings in 2016 and thereafter.  Further it is anticipated that the transaction will be immediately accretive to TowneBank’s capital ratios, which already exceed well-capitalized regulatory standards.

Brad E. Schwartz will join Aston on the Towne Corporate Management Group as Senior Executive Vice President and Chief Operating Officer along with TowneBank President and Chief Banking Officer, J. Morgan Davis; William B. Littreal, Senior Executive Vice President and Chief Strategy Officer; and Clyde E. McFarland, Senior Executive Vice President and Chief Financial Officer.

Neal Crawford, Monarch Bank President, will join Towne as President and Chief Executive Officer of Towne Financial Services Group.  William T. Morrison, Chief Executive Officer of Monarch Mortgage will become Chairman and Chief Executive Officer of TowneBank Mortgage and Realty Group succeeding Jacqueline B. Amato, currently TowneBank Mortgage CEO, who is planning to retire at the end of the 2016 calendar year.

Monarch Chairman, Jeffrey F. Benson, will join the TowneBank Corporate Board along with Monarch Directors, Elizabeth T. Patterson, Dwight E. Schaubach and Robert M. Oman.  Schwartz, Crawford and Morrison will also join the board.

Monarch Directors, Virginia Sancilio Cross, Taylor B. Grissom, Lawton H. Baker and Joe P. Covington will be elected to the Towne Financial Services Group Board of Directors.

An investor presentation outlining the transaction is provided on the TowneBank website at www.townebank.com under “Investor Relations”.

Sandler O’Neill + Partners, LP acted as financial advisor to TowneBank and LeClairRyan, A Professional Corporation acted as its legal advisor in the transaction.  Raymond James acted as financial advisor to Monarch and Williams Mullen acted as its legal advisor.

About TowneBank
As one of the top community banks in Virginia and North Carolina, TowneBank operates 37 banking offices serving Chesapeake, Chesterfield County, Glen Allen, Hampton, James City County, Mechanicsville, Newport News, Norfolk, Portsmouth, Richmond, Suffolk, Virginia Beach, Williamsburg, and York County in Virginia, along with Moyock, Grandy, Camden County, Southern Shores, Corolla and Nags Head in North Carolina. Towne also offers a full range of financial services through its controlled divisions and subsidiaries that include Towne Investment Group, Towne Insurance Agency, TFA Benefits, TowneBank Mortgage, TowneBank Commercial Mortgage, Berkshire Hathaway HomeServices Towne Realty, Towne 1031 Exchange, LLC, and Beach Properties of Hilton Head. Local decision-making is a hallmark of its hometown banking strategy that is delivered through the leadership of each group’s President and Board of Directors.  With total assets of $6.17 billion as of September 30, 2015, TowneBank is one of the largest banks headquartered in Virginia.

About Monarch
Monarch Financial Holdings, Inc. is the one-bank holding company for Monarch Bank.  Monarch Bank is a community bank with ten banking offices in Chesapeake, Virginia Beach, Norfolk, and Williamsburg, Virginia.  Monarch Bank also has loan production offices in Newport News and Richmond, Virginia.  OBX Bank, a division of Monarch Bank, operates offices in Kitty Hawk and Nags Head, North Carolina.  Monarch Mortgage and our affiliated mortgage companies have over thirty offices with locations in Virginia, North Carolina, Maryland, and South Carolina.  Our subsidiaries/ divisions include Monarch Bank, OBX Bank, Monarch Mortgage (secondary mortgage origination), OBX Bank Mortgage (secondary mortgage origination), Coastal Home Mortgage, LLC (secondary mortgage origination), Fitzgerald Financial, LLC (secondary mortgage origination), Advance Mortgage, LLC (secondary mortgage origination), Monarch Bank Private Wealth (investment, trust, planning and private banking), Monarch Investments (investment and insurance solutions), Real Estate Security Agency, LLC (title agency) and Monarch Capital, LLC (commercial mortgage brokerage).  The shares of common stock of Monarch Financial Holdings, Inc. are publicly traded on the Nasdaq Capital Market under the symbol “MNRK.”

Additional Information and Where to Find It
In connection with the proposed merger, TowneBank will file with the Federal Deposit Insurance Corporation (the “FDIC”) a preliminary proxy statement/prospectus and Monarch will file with the Securities and Exchange Commission (the “SEC”) a preliminary proxy statement.  TowneBank and Monarch will each deliver a definitive joint proxy statement/prospectus to their respective stockholders seeking approval of the merger and related matters.  In addition, each of TowneBank and Monarch may file other relevant documents concerning the proposed merger with the FDIC and SEC.

Investors and stockholders of both companies are urged to read the definitive joint proxy statement/prospectus when it becomes available and any other relevant documents to be filed with the FDIC and SEC in connection with the proposed merger because they will contain important information about TowneBank, Monarch and the proposed transaction.  Investors and stockholders may obtain free copies of certain of these documents through the website maintained by the SEC at http://www.sec.gov.  Free copies of the definitive joint proxy statement/prospectus, when available, also may be obtained by directing a request by telephone or mail to TowneBank, 6001 Harbour View Boulevard,  Suffolk, Virginia 23425, Attention: Investor Relations (telephone: (757) 638-6794), or Monarch Financial Holdings, Inc., 1435 Crossways Boulevard, Suite 301, Chesapeake, Virginia 23320, Attention: Investor Relations (telephone: (757) 389-5112), or by accessing TowneBank’s website at https://townebank.com under “Investor Relations” or Monarch’s website at https://www.monarchbank.com under “Investor Relations.”  The information on TowneBank’s and Monarch’s websites is not, and shall not be deemed to be, a part of this release or incorporated into other filings either company makes with the FDIC or SEC.

TowneBank and Monarch, and their respective directors and executive officers, may be deemed to be participants in the solicitation of proxies from the stockholders of TowneBank and/or Monarch in connection with the merger. Information about the directors and executive officers of TowneBank is set forth in the proxy statement for TowneBank’s 2015 annual meeting of stockholders filed with the FDIC on April 17, 2015.  Information about the directors and executive officers of Monarch is set forth in the proxy statement for Monarch’s 2015 annual meeting of stockholders filed with the SEC on April 2, 2015.  Additional information regarding the interests of these participants and other persons who may be deemed participants in the merger may be obtained by reading the definitive joint proxy statement/prospectus regarding the merger when it becomes available.

Forward-Looking Statements
Statements made in this release, other than those concerning historical financial information, may be considered forward-looking statements, which speak only as of the date of this release and are based on current expectations and involve a number of assumptions. These include statements as to the anticipated benefits of the merger, including future financial and operating results, cost savings and enhanced revenues that may be realized from the merger as well as other statements of expectations regarding the merger and any other statements regarding future results or expectations. Each of TowneBank and Monarch intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and is including this statement for purposes of these safe harbor provisions. The companies’ respective abilities to predict results, or the actual effect of future plans or strategies, is inherently uncertain. Factors which could have a material effect on the operations and future prospects of each of TowneBank and Monarch, and the resulting company, include but are not limited to: the businesses of TowneBank and Monarch may not be integrated successfully or such integration may be more difficult, time-consuming or costly than expected; expected revenue synergies and cost savings from the merger may not be fully realized or realized within the expected timeframe; revenues following the merger may be lower than expected; customer and employee relationships and business operations may be disrupted by the merger; the ability to obtain required regulatory and stockholder approvals, and the ability to complete the merger on the expected timeframe may be more difficult, time-consuming or costly than expected; changes in interest rates, general economic and business conditions; legislative/regulatory changes; the monetary and fiscal policies of the U.S. government, including policies of the U.S. Treasury and the Board of Governors of the Federal Reserve; the quality and composition of the loan and securities portfolios; demand for loan products; deposit flows; competition; demand for financial services in the companies’ respective market areas; the companies’ respective implementation of new technologies and their ability to develop and maintain secure and reliable electronic systems; changes in the securities markets; and changes in accounting principles, policies and guidelines, and other risk factors detailed from time to time in filings made by TowneBank with the FDIC or Monarch with the SEC. TowneBank and Monarch undertake no obligation to update or clarify these forward-looking statements, whether as a result of new information, future events or otherwise. ###

For more information contact:
G. Robert Aston, Jr., TowneBank Chairman and CEO, (757) 638-6780
Brad E. Schwartz, Monarch Financial Holdings, Inc., CEO, (757) 389-5111

(AMSC) Announces $210M Strategic Agreements With Inox Wind Limited

• Multi-year supply contract for the company’s 2MW ECS
• Agreement to collaborate on the development of a 3MW wind turbine design
• AMSC preferred supplier for 2MW ECS and Inox to produce 2MW ECS in India

DEVENS, Mass., Dec. 17, 2015  — AMSC (NASDAQ:AMSC), a global solutions provider serving wind and power grid industry leaders, today announced several agreements with Inox Wind Limited (Inox) that strengthen the collaboration between the two companies. The company announced it has entered into a long-term supply contract (Supply Contract) with Inox.  Under the Supply Contract, AMSC will provide Inox with electrical control systems (ECS) for Inox’s entire 2MW product line.   Full deliveries under the Supply Contract are expected to begin during the first quarter of fiscal 2016.   Under a separate agreement, Inox will be allowed to internally manufacture a limited portion of the ECS requirements for its 2MW product line as a second source based on AMSC’s technology.  The aggregate value of these agreements is approximately $210 million over the next three to four years, when the specified deliveries under this contract are expected to be completed.  Once the specified deliveries under the Supply Contract are completed, further revenues are expected for at least an additional three year period during which AMSC will provide Inox with the majority of its 2MW ECS requirements under a preferred supplier arrangement.

The relationship continues in developing new wind turbine products focused on the Indian market.  AMSC and Inox entered into a heads of agreement to collaborate on the development of a 3MW wind turbine to extend to Inox’s product line.  AMSC would develop a 3MW wind turbine design under a license agreement to be negotiated with Inox.

“With the rapid growth of our business, we felt it was important to deepen our partnership with AMSC, while at the same time enhance our internal manufacturing capabilities,” said Devansh Jain, director of Inox Wind Limited. “We value the relationship with AMSC, which has allowed us to offer our customers wind turbines with superior technology and performance.  We are on track with our wind turbine manufacturing expansion and continue to strengthen our position in the Indian market.”

AMSC’s ECS are an integrated, high-performance suite of power electronics systems that include the wind turbine power converter cabinet, internal power supply and various controls. Together, these systems serve as the “brains” of the wind turbine and enable reliable, high-performance operation by controlling power flows, regulating voltage, monitoring system performance, controlling the pitch of the wind turbine blades and the yaw of the turbines to maximize efficiency.

“These agreements represent an important milestone for AMSC and solidify our belief that Inox is a trusted and valued long-term partner,” said Daniel P. McGahn, President and CEO, AMSC. “We anticipate that our expanded relationship with Inox will provide a solid foundation for our business which we can build around and enable Inox to become the largest wind turbine manufacturer in India.”

The Indian government has targeted to grow its installed wind power generating capacity from more than 22GW in 2014 to more than 100GW by 2022.

To learn more about AMSC’s product offerings for the wind industry, please visit: http://www.amsc.com/windtec/index.html.

Conference Call

In conjunction with this announcement, AMSC management will participate in a conference call with investors beginning at 9:00 am Eastern Time on Monday, December 21, 2015. On this call, management will discuss the business and financial impact of the strategic agreements with Inox discussed in this press release.

Those who wish to listen to the live or archived conference call webcast should visit the “Investors” section of the company’s website at http://www.amsc.com/investors. The live call also can be accessed by dialing 719-325-2448 and using conference ID 692497.

About Inox Wind Limited

Inox Wind Limited is part of the Inox Group of Companies. Inox Group is a $2 billion+, professionally managed business group, with interests in diverse businesses including Industrial Gases, Refrigerants,
Engineering Plastics, Chemicals, Carbon Credits, Cryogenic Engineering, Renewable Energy and Entertainment. Inox Wind Limited has firm orders for more than 1,200 MW of wind turbines as of September 30, 2015. The INOX Group employs close to 9,000 people at more than 150 business units across the country and has a distribution network that is spread across more than 50 countries around the globe. Each INOX Group company is characterized by three distinct characteristics – early identification of a winning business idea, building it to a size of dominant market leadership in that segment, and attaining a profit leadership position through cutting-edge efficiency in operations. The Inox Group of Companies, besides Inox Wind Limited, includes Inox Air Products Limited, Gujarat Fluorochemicals Limited, Inox India Limited, Inox Renewables Limited, Inox Leisure Limited and Fame India limited. More information is available at www.inoxwind.com.

About AMSC (NASDAQ:AMSC)

AMSC generates the ideas, technologies and solutions that meet the world’s demand for smarter, cleaner … better energy. Through its Windtec™ Solutions, AMSC provides wind turbine electronic controls and systems, designs and engineering services that reduce the cost of wind energy. Through its Gridtec™ Solutions, AMSC provides the engineering planning services and advanced grid systems that optimize network reliability, efficiency and performance. The company’s solutions are now powering gigawatts of renewable energy globally and enhancing the performance and reliability of power networks in more than a dozen countries. Founded in 1987, AMSC is headquartered near Boston, Massachusetts with operations in Asia, Australia, Europe and North America. For more information, please visit www.amsc.com.

AMSC, Windtec, Gridtec, and Smarter, Cleaner … Better Energy are trademarks or registered trademarks of American Superconductor Corporation. All other brand names, product names, trademarks or service marks belong to their respective holders.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Any statements in this release about expectations regarding the value of the agreements with Inox; timing of the commencement of deliveries under the Supply Contract; timing of when deliveries under the Supply Contract are expected to be completed; the availability of further revenues after the completion of deliveries under the Supply Contract; Inox being a trusted and valued long-term partner; effects of our relationship with Inox on our business; Inox becoming the largest wind turbine manufacturer in India; the growth of India’s wind installations; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements represent management’s current expectations and are inherently uncertain. There are a number of important factors that could materially impact the value of our common stock or cause actual results to differ materially from those indicated by such forward-looking statements. Such factors include: We have a history of operating losses, which may continue in the future. Our operating results may fluctuate significantly from quarter to quarter and may fall below expectations in any particular fiscal quarter; we have a history of negative operating cash flows, and we may require additional financing in the future, which may not be available to us; Our Term Loans include certain covenants and other events of default. Should we not comply with these covenants or incur an event of default, we may be required to repay our obligation in cash, which could have an adverse effect on our liquidity; We may be required to issue performance bonds or provide letters of credit, which restricts our ability to access any cash used as collateral for the bonds or letters of credit; Changes in exchange rates could adversely affect our results from operations; If we fail to maintain proper and effective internal controls over financial reporting, our ability to produce accurate and timely financial statements could be impaired and may lead investors and other users to lose confidence in our financial data; Our financial condition may have an adverse effect on our customer and supplier relationships; Our success in addressing the wind energy market is dependent on the manufacturers that license our designs; A significant portion of our revenues are derived from a single customer, Our success is dependent upon attracting and retaining qualified personnel and our inability to do so could significantly damage our business and prospects; We may not realize all of the sales expected from our backlog of orders and contracts; Our business and operations would be adversely impacted in the event of a failure or security breach of our information technology infrastructure; We may not be able to ramp up production at our newly leased manufacturing facility in Romania, and, if we are able to do so, we may have manufacturing quality issues, which would negatively affect our revenues and financial position; We rely upon third-party suppliers for the components and subassemblies of many of our Wind and Grid products, making us vulnerable to supply shortages and price fluctuations, which could harm our business; Many of our revenue opportunities are dependent upon subcontractors and other business collaborators; If we fail to implement our business strategy successfully, our financial performance could be harmed; Problems with product quality or product performance may cause us to incur warranty expenses and may damage our market reputation and prevent us from achieving increased sales and market share; New regulations related to conflict-free minerals may force us to incur significant additional expenses; Our contracts with the U.S. government are subject to audit, modification or termination by the U.S. government and include certain other provisions in favor of the government. The continued funding of such contracts remains subject to annual congressional appropriation which, if not approved, could reduce our revenue and lower or eliminate our profit; Many of our customers outside of the United States, particularly in China, are, either directly or indirectly, related to governmental entities, and we could be adversely affected by violations of the United States Foreign Corrupt Practices Act and similar worldwide anti-bribery laws outside the United States; We have limited experience in marketing and selling our superconductor products and system-level solutions, and our failure to effectively market and sell our products and solutions could lower our revenue and cash flow; We may acquire additional complementary businesses or technologies, which may require us to incur substantial costs for which we may never realize the anticipated benefits; Our success depends upon the commercial use of high temperature superconductor (HTS) products, which is currently limited, and a widespread commercial market for our products may not develop; Growth of the wind energy market depends largely on the availability and size of government subsidies and economic incentives; We have operations in and depend on sales in emerging markets, including India and China, and global conditions could negatively affect our operating results or limit our ability to expand our operations outside of these countries. Changes in India’s or China’s  political, social, regulatory and economic environment may affect our financial performance; Our products face intense competition, which could limit our ability to acquire or retain customers; Our international operations are subject to risks that we do not face in the United States, which could have an adverse effect on our operating results; Adverse changes in domestic and global economic conditions could adversely affect our operating results; We may be unable to adequately prevent disclosure of trade secrets and other proprietary information; Our patents may not provide meaningful protection for our technology, which could result in us losing some or all of our market position; There are a number of technological challenges that must be successfully addressed before our superconductor products can gain widespread commercial acceptance, and our inability to address such technological challenges could adversely affect our ability to acquire customers for our products; Third parties have or may acquire patents that cover the materials, processes and technologies we use or may use in the future to manufacture our Amperium products, and our success depends on our ability to license such patents or other proprietary rights; Our technology and products could infringe intellectual property rights of others, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages and disrupt our business; We have filed a demand for arbitration and other lawsuits against our former largest customer, Sinovel, regarding amounts we contend are overdue. We cannot be certain as to the outcome of these proceedings; We have been named as a party in various legal proceedings, and we may be named in additional litigation, all of which will require significant management time and attention, result in significant legal expenses and may result in an unfavorable outcome, which could have a material adverse effect on our business, operating results and financial condition; and Our common stock has experienced, and may continue to experience, significant market price and volume fluctuations, which may prevent our stockholders from selling our common stock at a profit and could lead to costly litigation against us that could divert our management’s attention.

These and the important factors discussed under the caption “Risk Factors” in Part 1. Item 1A of our Form 10-K for the fiscal year ended March 31, 2015, and our other reports filed with the SEC, among others, could cause actual results to differ materially from those indicated by forward-looking statements made herein and presented elsewhere by management from time to time. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

AMSC Contact:
Brion D. Tanous 
Phone: 978-842-3247 
Email: Brion.Tanous @ amsc.com

(MYOS) Announces Strategic Investment by RENS Technology Inc.

(RWLK) VA Issues National Coverage Policy for ReWalk Robotics Exoskeleton Systems

Landmark Policy Will Provide Veterans Across the U.S. with Access to Evaluation, Training and Supply of ReWalk Personal Systems

YOKNEAM ILIT, Israel and MARLBOROUGH, Mass., Dec. 17, 2015  — ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk”), the leading global exoskeleton developer and manufacturer, announced today that the U.S. Department of Veterans Affairs (“VA”) has issued a national policy for the evaluation, training and procurement of ReWalk Personal exoskeleton systems for all qualifying veterans across the United States.  The VA policy, which is exclusive to ReWalk Robotics exoskeleton systems, is the first national coverage policy in the United States for qualifying individuals who have suffered spinal cord injury (“SCI”).

“This historic policy will provide access to our life-changing technology for thousands of veterans across America,” said ReWalk CEO Larry Jasinski.  “We want all U.S. veterans with a spinal cord injury to know that they now have a path to securing their own ReWalk Personal exoskeleton system.  The policy outlines a sound process to educate, train and importantly, to provide individual veterans with a ReWalk Personal device so that they may walk at home and in the community. We expect this landmark national policy will substantially improve the health and quality of life of many veterans in the years ahead,” Jasinski added.

The comprehensive policy put forth by the VA provides veterans with spinal cord injury access to referral and evaluation at all designated ReWalk Training Centers across the country.  Veterans who meet the physical criteria for ReWalk will be referred for training on the use of the device.  Successful candidates will then be eligible to obtain a ReWalk Personal system.

“We are also very pleased that the VA’s fundamental clinical research conclusively demonstrated that there are significant medical benefits associated with enabling an individual with a spinal cord injury to walk again,” Jasinski said. “Based on their data, the VA’s national policy now defines use of an exoskeleton as the standard of care for qualifying veterans with spinal cord injury. We are hopeful the VA policy will pave the way for additional positive national coverage decisions.”

ReWalk is the only FDA cleared exoskeleton system in the U.S., with clearances for both personal use at home and in the community, as well as for the rehabilitation setting.

Some additional details of the new VA national policy:

• Veterans with SCI may be evaluated for use of the device at one of the 24 Veterans Health Administration SCI Centers nationwide, according to detailed protocols.
• All SCI Centers are encouraged to pursue designation as a ReWalk Training Center.
• Once preliminary criteria for ReWalk training are met, the veteran will be referred to a VA SCI Center designated as a VA ReWalk Training Center.
• Training begins on an outpatient basis and proceeds to the home or community settings.
• Successful training by an individual will be followed by consideration of procurement for a personal unit for use at home and in the community.

About ReWalk Personal 6.0
ReWalk Personal 6.0 is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal cord injury to stand upright and walk. The system provides user-initiated mobility through the integration of a wearable brace support, a computer-based control system and motion sensors. The system allows independent, controlled walking while mimicking the natural gait patterns of the legs. The ReWalk device is the most studied exoskeleton in the industry.  Studies have identified a number of health benefits including: improved bladder and bowel function, improved mental health, improved sleep, reduced fatigue, decreased body fat, decreased pain and improved posture and balance.

About ReWalk Robotics Ltd.
ReWalk Robotics Ltd. develops, manufactures and markets wearable robotic exoskeletons for individuals with spinal cord injury. Our mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies. Founded in 2001, ReWalk has headquarters in the US, Israel and Germany. For more information on the ReWalk systems, please visit http://www.rewalk.com.

ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel.

Forward Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. Such forward-looking statements may include projections regarding ReWalk’s future performance and, in some cases, may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “seek” and similar terms or phrases. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of ReWalk’s control. Important factors that could cause ReWalk’s actual results to differ materially from those indicated in the forward-looking statements include, among others: ReWalk’s expectations regarding future growth, including its ability to increase sales in its existing geographic markets and to expand to new markets; ReWalk’s ability to maintain and grow its reputation and the market acceptance of our products; ReWalk’s ability to achieve reimbursement from third-party payors for our products; ReWalk’s expectations as to its clinical research program and clinical results; ReWalk’s ability to improve its products and develop new products;  ReWalk’s ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; ReWalk’s ability to gain and maintain regulatory approvals; ReWalk’s ability to maintain relationships with existing customers and develop relationships with new customers; and other factors discussed under the heading “Risk Factors” in ReWalk’s U.S. Annual Report on Form 20-F for the year ended December 31, 2014 filed with the U.S. Securities and Exchange Commission on February 27, 2015 and other documents subsequently filed with or furnished to the U.S. Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause ReWalk’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for ReWalk to predict all of them. Except as required by law, ReWalk undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

(ETAK) Announces Executive Appointments and New Board Member

NEW YORK, Dec. 17, 2015  — Elephant Talk Communications Corp. (NYSE MKT: ETAK) (“Elephant Talk” or the “Company”), a global provider of Software Defined Network Architecture (ET Software DNA® 2.0) platforms and cyber security solutions, today announced that the Company has made a series of executive and board appointments as part of its plan to restructure its global business under Hal Turner, recently appointed Executive Chairman.

The executive appointments and transitions include:

• Mr. Gary Brandt has been named Chief Restructuring Officer of the Company responsible for leading the transition and reorganization of Elephant Talk’s global operations. In this capacity, Finance, Legal and Human Resources will report to him directly. Mr. Brandt has 35 years’ C-level and executive finance leadership experience in high technology environments serving at several public companies including Arbinet Corporation, Hydrogenics Corporation, SatCon Technology Inc., MCI, and Nortel.
• Dr. Armin Hessler, formerly Co-President of Elephant Talk’s Mobile Platform business, has been appointed as Chief Operating Officer of the Company.
• Mr. Robert Skaff has been elected as a new independent director replacing Mr. Jaime Bustillo. Mr. Skaff is the founder of DiNotte Lighting Hampton which has developed world-class OEM and recreational lighting products since 2005. Mr. Skaff was previously the president of ID Control, a manufacturer of patented mobile video equipment for police vehicles and was a principal and director of Management Information Systems at Johnson and Johnston Associates which was later acquired by a subsidiary of Japan Energy.
• Tim Payne, currently President of ETNA, Elephant Talk’s North American operations has stepped down as the Interim CEO. Mr. Payne remains President of ETNA.

“When I assumed the role of Executive Chairman last month, one of my first priorities was to undertake an extensive top to bottom review of the Company. With today’s appointments, we have begun implementing the first of a number of critical improvements to our organizational structure, adding talent which we expect will improve our business operations, technological developments and our ability to deliver the best services and support to our growing customer base,” said Hal Turner, Executive Chairman of the Board of Elephant Talk Communications Corp. “With Gary Brandt’s appointment to lead the restructuring and the expansion of Armin Hessler’s responsibilities, we are building a foundation of world-class leadership to run our global business operations that will complement Elephant Talk’s world-class technology.  We expect to announce additional executive appointments in the first half of 2016.”

About Elephant Talk Communications Corp.:
Elephant Talk Communications Corp. (NYSE MKT: ETAK) is a global provider of mobile proprietary Software Defined Network Architecture (ET Software DNA® 2.0) platforms for the telecommunications industry. The Company empowers Mobile Network Operators (MNOs), Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, reliable industry expertise and high quality customer service without the need for substantial upfront investment. Elephant Talk counts several of the world’s leading MNOs and technology companies amongst its customers and partners, including Vodafone, T-Mobile, Zain, HP and Affirmed Networks. Visit: www.elephanttalk.com.

About ValidSoft UK Ltd.:
ValidSoft, a subsidiary of Elephant Talk Communications Corp., secures transactions using personal authentication and device assurance. We enable our customers to enhance their security while improving their user experience, utilising our multi-factor authentication platform, Voice Biometric engine and Device Trust technology, all of which may be used as ‘stand-alone’ or integrated into multi-vendor solutions. ValidSoft serves multiple clients across the financial services, government and enterprise sectors and is the only company to have been granted four European Privacy Seals, reflecting its commitment to strong data privacy. Visit: www.validsoft.com.

Forward-Looking Statements:
Certain statements contained herein constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to Elephant Talk’s plans and objectives, projections, expectations and intentions (including, without limitation, Elephant Talk’s plans in regard to its ValidSoft subsidiary). These forward-looking statements are based on current expectations, estimates and projections about Elephant Talk’s industry, management’s beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of Elephant Talk may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, Elephant Talk also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from those projected or suggested in Elephant Talk’s filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from Elephant Talk.

Contacts:

Investor Contact:
Alan Sheinwald or Valter Pinto
Capital Markets Group, LLC
(914) 669-0222
valter@capmarketsgroup.com
www.CapMarketsGroup.com

Public Relations:
Michael Glickman
MWGCO, Inc.
917-397-2272
mike@mwgco.net

(BIND) Appoints Jonathan Yingling, Ph.D., as Chief Scientific Officer

BIND Therapeutics, Inc. (NASDAQ:BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS®, today announced the appointment of Jonathan Yingling, Ph.D., as Chief Scientific Officer. In this position, Dr. Yingling will be responsible for leading BIND’s research and development efforts to identify and pursue new product opportunities where the unique attributes of ACCURINs can be leveraged to provide meaningful improvements in patient care.

“We are very pleased to welcome Jonathan to our leadership team, where he will significantly enhance our ability to discover and develop novel ACCURIN therapeutics,” said Andrew Hirsch, president and chief executive officer, BIND Therapeutics. “As we continue expanding the application of our ACCURIN platform to develop potential breakthrough therapies, his scientific expertise in oncology, proven ability to build high quality research groups, and experience advancing promising science from the lab to the clinic make him ideally suited to successfully execute on our long-range strategic vision.”

Dr. Yingling joins BIND from Bristol-Myers Squibb (BMS), where he was vice president, Oncology Discovery and Translational Research. During his tenure at BMS, he was responsible for the oncology research portfolio as well as translational capabilities in oncology and immunoscience, contributing to the discovery and development of potentially transformative medicines in immuno-oncology. He championed several small molecule drug discovery programs including IDO (indoleamine-2,3 dioxygenase), TGF-β and other important intracellular tumor cell targets. He also expanded the biologics portfolio with the addition of FS102, a novel anti-HER2 monoclonal antibody, and several proprietary antibody drug conjugate assets.

“I’m excited to join Andrew and the talented team at BIND to utilize my drug discovery and translational science expertise to develop innovative medicines leveraging the ACCURIN platform,” said Jonathan Yingling, Ph.D., chief scientific officer at BIND. “I am impressed with the leadership team, the capabilities of the organization and the flexibility of the world-class nanomedicine platform to address significant challenges in developing best-in-class medicines. With the strong foundation and scientists at BIND, I look forward to joining the team at this critical juncture as we accelerate our transition into an integrated drug discovery and pre-clinical development organization. I’m committed to focusing our discovery and research capabilities on developing innovative therapeutics addressing significant unmet medical need with meaningful impact on patients’ lives.”

Dr. Yingling began his pharmaceutical career as a senior biologist in oncology at Eli Lilly & Company in 2000. During his 13-year tenure, he served in various positions of increasing responsibility including CSO of Angiogenesis & Tumor Microenvironment Biology, Vice President of Oncology Research and Vice President of Translational Science and Technology. In those roles, he led innovative drug discovery programs focused on the tumor microenvironment, contributed to the expansion of Lilly’s oncology portfolio into targeted therapy and biologics culminating in the acquisition of ImClone in 2008 and integrated tailored therapeutic capabilities across Lilly Research Laboratories. As vice president of Translational Science and Technology, he led target enablement and screening, structural biology, fragment-based drug design and lead optimization biology capabilities across multiple therapeutic areas. Dr. Yingling earned his Ph.D. in Cell and Molecular Biology and Pharmacology at Duke University and was a Howard Hughes Postdoctoral Fellow at Vanderbilt University.

About BIND Therapeutics

BIND Therapeutics is a clinical-stage nanomedicine company developing a pipeline of ACCURINS®, its novel targeted therapeutics designed to increase the concentration and duration of therapeutic payloads at disease sites while reducing exposure to healthy tissue. BIND is leveraging its Medicinal Nanoengineering® platform to develop a pipeline of ACCURINS targeting hematological and solid tumors and has a number of strategic collaborations with biopharmaceutical companies to develop ACCURINS in areas of high unmet need. BIND’s lead drug candidate, BIND-014, is a prostate-specific membrane antigen (PSMA) -targeted ACCURIN that contains docetaxel, a clinically-validated and widely-used cancer chemotherapy drug. BIND is currently enrolling patients in a trial with BIND-014 for non-small cell lung cancer, or NSCLC, with squamous histology. In addition, BIND is enrolling patients in a clinical trial with BIND-014 for advanced cervical, bladder, head and neck and cholangio cancers. BIND is advancing BIND-510, its second PSMA-targeted ACCURIN drug candidate containing vincristine, a potent microtubule inhibitor with dose limiting peripheral neuropathy in its conventional form, through important preclinical studies to position it for an Investigational New Drug (IND) application filing with the U.S. Food and Drug Administration. BIND is also developing ACCURINS designed to inhibit PLK1 and KSP, both of which BIND believes are promising anti-mitotic targets that have been limited in the clinic due to systemic toxicity at or below therapeutic doses.

BIND has announced ongoing collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd., Merck & Co., or Merck (known as Merck Sharp & Dohme outside the United States and Canada) and Macrophage Therapeutics (a subsidiary of Navidea Biopharmaceuticals) to develop ACCURINS based on their proprietary therapeutic payloads and/or targeting ligands. BIND’s collaboration with AstraZeneca has resulted in the Aurora B Kinase inhibitor ACCURIN AZD2811, which became the second ACCURIN candidate to enter clinical development. BIND’s collaboration with Pfizer has resulted in the selection of an ACCURIN candidate that is entering IND-enabling studies.

For more information, please visit the Company’s web site at www.bindtherapeutics.com.

Forward-Looking Statements Disclaimer

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the discovery and development of breakthrough medicines; our expectation that ACCURINs may lead to meaningful improvements in patient care, our ability to expand and develop novel applications for the ACCURIN platform; the ability of Dr. Yingling to successfully execute our strategic vision; our transition into a drug discovery and preclinical development organization; BIND-510, including without limitation the filing of an IND applicable with the U.S. Food and Drug Administration; our collaborations with Pfizer, AstraZeneca, F. Hoffmann-La Roche Ltd., Merck and Macrophage; and upcoming events and presentations.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the fact that the Company has incurred significant losses since its inception and expects to incur losses for the foreseeable future; the Company’s need for additional funding, which may not be available; raising additional capital may cause dilution to its stockholders, restrict its operations or require it to relinquish rights to its technologies or drug candidates; the Company’s limited operating history; the terms of the Company’s credit facility place restrictions on its operating and financial flexibility; failure to use and expand its medicinal nanoengineering platform to build a pipeline of drug candidates and develop marketable drugs; the early stage of the Company’s development efforts with only BIND-014 in clinical development; failure of the Company or its collaborators to successfully develop and commercialize drug candidates; clinical drug development involves a lengthy and expensive process, with an uncertain outcome; delays or difficulties in the enrollment of patients in clinical trials; serious adverse or unacceptable side effects or limited efficacy observed during the development of the Company’s drug candidates; inability to maintain any of the Company’s collaborations, or the failure of these collaborations; the Company’s reliance on third parties to conduct its clinical trials and manufacture its drug candidates; the Company’s inability to obtain required regulatory approvals; any conclusion by the FDA that BIND-014 does not satisfy the requirements for approval under the Section 505(b)(2) regulatory approval pathway; the fact that a fast track or breakthrough therapy designation by the FDA for the Company’s drug candidates may not actually lead to a faster development or regulatory review or approval process; the inability to obtain orphan drug exclusivity for drug candidates; failure to obtain marketing approval in international jurisdictions; any post-marketing restrictions or withdrawals from the market; effects of recently enacted and future legislation; failure to comply with environmental, health and safety laws and regulations; failure to achieve market acceptance by physicians, patients, or third-party payors; failure to establish effective sales, marketing and distribution capabilities or enter into agreements with third parties with such capabilities; effects of substantial competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; failure to retain key executives and attract, retain and motivate qualified personnel; difficulties in managing the Company’s growth; risks associated with operating internationally, including the possibility of sanctions with respect to our operations in Russia; the possibility of system failures or security breaches; failure to obtain and maintain patent protection for or otherwise protect our technology and products; effects of patent or other intellectual property lawsuits; the price of our common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company; and any securities class action litigation. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 2, 2015, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

(ACRS) Appoints Brett Fair as Senior Vice President of Commercial Operations

MALVERN, Pa., Dec. 16, 2015  — Aclaris Therapeutics, Inc. (NASDAQ:ACRS), today announced that it has appointed Brett Fair, an experienced executive within the field of dermatology, as Senior Vice President of Commercial Operations.

Mr. Fair brings more than 18 years of pharmaceutical commercialization and business development experience to Aclaris.  He has substantial experience with global pharmaceutical companies and has successfully launched products, grown product franchises, and transacted deals to build portfolios in the dermatology specialty area.

“Brett’s industry insight, strategic perspective and operational experience will be extremely valuable to the Aclaris team as we continue to progress our lead program into Phase 3 clinical trials and further expand our development pipeline,” said Dr. Neal Walker, President & CEO of Aclaris.  “Brett is an excellent addition to the team as we continue to build Aclaris into a fully integrated specialty dermatology company.”

Mr. Fair joins Aclaris from Aqua Pharmaceuticals where he served as the Vice President of Business Development. Prior to Aqua Pharmaceuticals, Mr. Fair held global commercial and business development roles at GlaxoSmithKline.  Mr. Fair started his career at Allergan where he held positions of increasing responsibility in sales and marketing.

About Aclaris

Aclaris Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company focused on identifying, developing and commercializing innovative and differentiated drugs to address significant unmet needs in dermatology.  Aclaris Therapeutics, Inc. is based in Malvern, Pennsylvania and more information can be found by visiting the company’s website at www.aclaristx.com.

Contact:  
Aclaris Contact
Dr. Neal Walker
President & CEO
484-324-7933
investors@aclaristx.com

Investor Contact
Patricia L. Bank
Westwicke Partners
Managing Director
415-513-1284
patti.bank@westwicke.com 

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

(ARRY) Phase 3 Binimetinib Trial Meets Primary Endpoint

— Binimetinib achieves statistically significant progression free survival compared to chemotherapy — — Regulatory submissions planned for the first half of 2016 —

BOULDER, Colo., Dec. 16, 2015  — Array BioPharma (Nasdaq: ARRY) today reported top-line results from the ongoing Phase 3 clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma, known as the NEMO trial.  The study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine treatment. The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm; hazard ratio (HR) 0.62, [95% CI 0.47-0.80], p < 0.001.

In the trial, binimetinib was generally well-tolerated and the adverse events reported were consistent with previous results in NRAS melanoma patients.

Array plans to submit binimetinib to regulatory authorities for marketing approval in NRAS-mutant melanoma during the first half of 2016.  Results from the NEMO trial including progression free survival, overall survival, objective response rate, safety and prespecified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at a medical meeting in 2016.

“We are excited to announce positive results from the NEMO trial, which suggest binimetinib has the potential to provide an important new treatment option for patients with advanced NRAS melanoma,” said Ron Squarer, Chief Executive Officer, Array BioPharma.  “We look forward to discussing the data with the FDA and other regulatory agencies in the near future.”

“The presence of an NRAS mutation is a poor prognostic indicator for patients with advanced melanoma,” said Keith T. Flaherty, M.D., Associate Professor, Medicine, Harvard Medical School and Director of Developmental Therapeutics, Cancer Center, Massachusetts General Hospital.  “I am encouraged the NEMO trial met its primary endpoint and look forward to sharing the full results soon.  As the first targeted therapy with positive results in NRAS melanoma, binimetinib will be a welcome addition in this high unmet need population, especially for patients whose disease has progressed following treatment with immunotherapy.”

Binimetinib is also being studied in the Phase 3 COLUMBUS trial for patients with BRAF-mutant melanoma and the Phase 3 MILO trial for patients with low grade serous ovarian cancer, as well as in several other earlier stage clinical trials.

About NEMO

The NEMO trial, (NCT01763164), is an international, randomized Phase 3 study in patients with advanced NRAS-mutant melanoma.  402 patients were randomized 2:1 to receive continuous 45 mg BID binimetinib or 1,000 mg/m² dacarbazine dosed every three weeks.  Prior immunotherapy treatment was allowed.  The primary endpoint of the study is progression free survival, and overall survival is a key secondary endpoint.  Patients underwent radiographic assessment of disease status every six weeks, and assessment of progression was determined by blinded central review.  Over 100 sites across North America, Europe, South America, Asia and Australia participated in the study.

About Binimetinib

MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway. Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as non-small cell lung cancer, melanoma, colorectal, ovarian and thyroid cancers. Binimetinib is a small molecule MEK inhibitor which targets key enzymes in this pathway.  Binimetinib is being studied in three active Phase 3 trials in advanced cancer patients, including: NRAS-mutant melanoma (NEMO), low-grade serous ovarian cancer (MILO) and BRAF-mutant melanoma (COLUMBUS).

About NRAS Melanoma

Melanoma is the fifth most common cancer among men and the seventh most common cancer among women in the United States, with almost 74,000 new cases and nearly 10,000 deaths from the disease projected in 2015. NRAS mutations occur in approximately 15% to 20% of patients with melanoma, and is known to be a poor prognostic factor. When melanoma is diagnosed early, it is generally a curable disease. However, when it spreads to other parts of the body, it is the deadliest and most aggressive form of skin cancer. Historically, a person with metastatic melanoma typically has a short life expectancy with NRAS melanoma patients living an average of 8.5 months from diagnosis.

About Array BioPharma

Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. Six registration studies are currently advancing related to three cancer drugs. These programs include binimetinib (MEK162), encorafenib (LGX818) and selumetinib (AstraZeneca). For more information on Array, please go to www.arraybiopharma.com.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the future development plans of binimetinib and the timing of the announcement of further results of clinical trials for binimetinib; expectations that events will occur that will result in greater value for Array; and the potential for the results of current and further clinical trials to support regulatory approval or the marketing success of binimetinib.  These statements involve significant risks and uncertainties, including those discussed in our most recent annual report filed on Form 10-K, in our quarterly reports filed on Form 10-Q, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, the determination by the FDA that results from clinical trials are not sufficient to support registration or marketing approval of binimetinib; our ability to effectively and timely conduct clinical trials in light of increasing costs and difficulties in locating appropriate trial sites and in enrolling patients who meet the criteria for certain clinical trials; risks associated with our dependence on third-party service providers to successfully conduct clinical trials within and outside the United States; our ability to achieve and maintain profitability and maintain sufficient cash resources; and our ability to attract and retain experienced scientists and management. We are providing this information as of December 16, 2015. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.

(ADXS) FDA Lifts Advaxis Clinical Hold

PRINCETON, N.J., Dec. 16, 2015  — Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on all of the company’s Investigational New Drug (IND) applications for its three product candidates: axalimogene filolisbac (formerly ADXS-HPV), ADXS-PSA and ADXS-HER2. Advaxis will therefore resume all clinical trials with axalimogene filolisbac, ADXS-PSA and ADXS-HER2.

“We appreciate the FDA’s review of this matter. We are grateful that our clinical trials will now resume so that we may continue investigating new treatments for unmet medical needs. We thank both the patients and their physicians for their participation in our clinical trials,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.

In October of 2015, Advaxis received notification from the FDA that its IND applications for axalimogene filolisbac were put on clinical hold in response to the company’s submission of a safety report to the FDA. The clinical hold also included the INDs for ADXS-PSA and ADXS-HER2. Following discussions with the FDA and in accordance with their recommendations, the company agreed to implement certain risk mitigation measures, including revised study protocol inclusion / exclusion criteria, post-administration antibiotic treatment and patient surveillance and monitoring measures.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology™.

About ADXS-PSA

ADXS-PSA is an Lm Technology™ immunotherapy under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

About ADXS-HER2

ADXS-HER2 is an Lm Technology™ immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology™, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’s lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development.

For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapies. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

 CONTACTS:

Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102

Media Contact:
JPA Health Communications
Cory Tromblee
cory@jpa.com
617-945-5183

(ACST) Provides Update on CaPre® Development Pathway

• Encouraging response from FDA on CaPre® clinical development
• Seeking formal approval to commence bioavailability bridging study

LAVAL, Quebec, Dec. 16, 2015  — Acasti Pharma Inc. (“Acasti” or the “Corporation”) (NASDAQ:ACST) (TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces that it has received positive feedback from the US Food and Drug Administration (FDA) on the proposed development pathway for CaPre®.

“Recently, we received encouraging comments from the FDA based on our briefing package submission indicating that the 505(b)(2) pathway represents a course for regulatory review and approval, and that Acasti’s plans for the bioavailability bridging study are viewed as sound,” highlighted Pierre Lemieux, PhD, Acasti’s Chief Operating Officer.  “With this endorsement, Acasti will submit an amendment to its current Investigational New Drug (IND) application to commence a bridging study, while continuing to work closely with the FDA to ensure the Corporation is aligned with their views on CaPre® clinical development.”

As previously announced, the 505(b)(2) approval pathway has been used by many other companies to secure approval for a New Drug Application (NDA).  Acasti’s regulatory and clinical experts believe such a strategy is best for CaPre®.  The 505(b)(2) application also enables regulatory submission for a New Chemical Entity (NCE) approval when some part of the data application is derived from studies not conducted by the applicant.  It allows Acasti to further optimize the advancement of CaPre®, including the Phase 3 protocol design, while also benefiting from the substantial clinical and nonclinical data already available with another FDA-approved omega-3 prescription drug.  In addition, it should reduce expenses, accelerate the timing and streamline the overall development program required to support a NDA submission.

Based on the proposed 505(b)(2) regulatory pathway, Acasti is pursuing a pivotal bioavailability bridging study, comparing CaPre® and another FDA-approved omega-3 prescription drug as a means of establishing a scientific bridge between the two.  This will help determine the feasibility of a 505(b)(2) regulatory pathway, while also optimizing the protocol design of a Phase 3 trial.

505(b)(2) Regulatory Pathway
The 505(b)(2) regulatory pathway is defined in The Federal Food Drug and Cosmetics Act as a New Drug Application (NDA) containing investigations of safety and effectiveness that are being relied upon for approval and were not conducted by or for the applicant, and for which the applicant has not obtained a right of reference. These applications differ from the typical NDA (described under Section 505(b)(1) of the Act), in that they allow a sponsor to rely, at least in part, on the FDA’s findings of safety and/or effectiveness for a previously approved drug. 

About Acasti Pharma Inc.

Acasti is an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, in particular abnormalities in blood lipids, also known as dyslipidemia. Because krill feeds on phytoplankton (diatoms and dinoflagellates), it is a major source of phospholipids and polyunsaturated fatty acids (“PUFAs”), mainly eicosapentaenoic acid (“EPA”) and docosahexaenoic acid (“DHA”), which are two types of omega-3 fatty acids well known to be beneficial for human health. CaPre®, currently Acasti’s only prescription drug candidate, is a highly purified omega-3 phospholipid concentrate derived from krill oil and is being developed to help prevent and treat hypertriglyceridemia, which is a condition characterized by abnormally high levels of triglycerides in the bloodstream. ONEMIA®, a medical food and currently Acasti’s only commercialized product, is a purified omega-3 phospholipid concentrate derived from krill oil with lower levels of phospholipids, EPA and DHA content than CaPre®.

Forward Looking Statements
Statements in this press release that are not statements of historical or current fact constitute “forward-looking statements” within the meaning of the U.S. securities laws and Canadian securities laws. Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties,  readers are urged to consider statements labeled with the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “will,” or “plans” to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.

The forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement and the “Cautionary Note Regarding Forward-Looking Information” section contained in Acasti’s latest Annual Information Form, which also forms part of Acasti’s latest annual report on Form 20-F, and which is available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar.shtml and on the investor section of Acasti’s website at acastipharma.com (the “AIF”). All forward-looking statements in this press release are made as of the date of this press release. Acasti does not undertake to update any such forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in Acasti’s public securities filings with the Securities and Exchange Commission and the Canadian securities commissions. Additional information about these assumptions and risks and uncertainties is contained in the AIF under “Risk Factors”.

Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Acasti Contact:
John Ripplinger
Investor Relations
+1.450.687.2262
j.ripplinger@acastipharma.com
acastipharma.com

(GIGM) Result of Extraordinary General Meeting Held on 16 December 2015

TAIPEI, Taiwan, Dec. 16, 2015  — GigaMedia Limited (NASDAQ: GIGM), an online games and computing services provider, announces that at the Extraordinary General Meeting (“EGM”) of the Company held on 16 December 2015, the sole resolution relating to the matter set out in the Notice of EGM dated 24 November 2015 was duly passed.

The following is the poll result in respect of the ordinary resolution passed at the EGM of the Company:

Resolution – To approve to effect a reverse share split of the Company’s Ordinary Shares by a ratio of five to one

Total Outstanding Shares: 55,261,661

Total Shares Voted: 42,960,487

The Company will execute reverse splits of the issued and outstanding shares including but not limited to common shares, shares granted by employee plans, options, restricted stock awards, and units, warrants and convertible or exchange securities, effective at the open of the market on December 16, 2015. Based upon the Reverse Share Split Scheme, proportionate adjustments are generally required to be made to the per share exercise price and the number of shares issuable upon the exercise or conversion of all outstanding options.

About GigaMedia

Headquartered in Taipei, Taiwan, GigaMedia Limited (Singapore registration number: 199905474H) is a diversified provider of online games and cloud computing services. GigaMedia’s online games business is an innovative leader in Asia with growing game development, distribution and operation capabilities, as well as platform services for games; focus is on mobile games and social casino games. The company’s cloud computing business is focused on providing enterprises in Greater China with critical communications services and IT solutions that increase flexibility, efficiency and competitiveness. More information on GigaMedia can be obtained from www.gigamedia.com.

The statements included above and elsewhere in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. GigaMedia cautions readers that forward-looking statements are based on the company’s current expectations and involve a number of risks and uncertainties. Actual results may differ materially from those contained in such forward-looking statements. Information as to certain factors that could cause actual results to vary can be found in GigaMedia’s Annual Report on Form 20-F filed with the United States Securities and Exchange Commission in April 2015.

Contact:

Amanda Chang
Investor Relations Department
Tel: +886-2-2656-8080
amanda.chang@gigamedia.com.tw

(PZG) Files PEA for Its Sleeper Gold Project in Nevada

Paramount Gold Nevada Corp.
Glen Van Treek
President and CEO
866-481-2233

Paramount Gold Nevada Corp.
Chris Theodossiou
Director of Corporate Communications
866-481-2233

(PCRX) Favorable Resolution With FDA Reaffirms Broad Indication for EXPAREL®

— Terms Include Labeling Changes to Reinforce that the Use of EXPAREL is not Limited to Pivotal Trial Surgical Models, and Formal FDA Rescission of 2014 Warning Letter –

— Conference Call Today at 8:30 am EST –

PARSIPPANY, N.J., Dec. 15, 2015  — Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that it has achieved an amicable resolution with the United States in its lawsuit filed on September 8, 2015, Pacira Pharmaceuticals, Inc. et al v. United States Food & Drug Administration et al, 15-cv-07055 (SDNY Sept. 8, 2015)(LAK).  The resolution confirms that EXPAREL (bupivacaine liposome injectable suspension) is, and has been since 2011, broadly indicated for administration into the surgical site to provide postsurgical analgesia.

“We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand—reducing postsurgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate,” stated Dave Stack, chief executive officer and chairman of Pacira. “This is especially important given the burgeoning U.S. opioid epidemic, underscored by the reality that one in 15 patients will go on to long-term use after receiving an opioid in the hospital setting.”

The key features of the resolution are as follows:

• The U.S. Food and Drug Administration (FDA) confirms that EXPAREL has, since its approval on October 28, 2011, been approved for “administration into the surgical site to produce postsurgical analgesia” in a variety of surgeries not limited to those studied in its pivotal trials.
• The FDA approved a labeling supplement which amends the EXPAREL Package Insert (PI) to clarify and reinforce that:
  • The use, efficacy and safety of EXPAREL is not limited to any specific surgery type or site;
  • The proper dosage and administration of EXPAREL is based on various patient and procedure-specific factors, with the two surgical models utilized in the pivotal trials provided as examples for the purpose of providing general guidance;
  • There was a significant treatment effect for EXPAREL compared to placebo over the first 72 hours in the pivotal hemorrhoidectomy study;
    • The description of that duration of effect now includes a  graphical representation of the mean pain intensity scores over time for the EXPAREL and placebo groups for the full 72-hour efficacy period, as well as information about median time to first opioid use and percentage of opioid-free patients in each treatment group
  • EXPAREL may be admixed with bupivacaine—including co-administered in the same syringe—provided certain medication ratios are observed.
• The September 2014 Warning Letter is formally withdrawn via a “Rescission Letter”  from Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research (CDER) to Dave Stack.
  • At the request of Pacira, the Rescission Letter includes FDA guidance related to two key procedures:
    • Infiltration into the transversus abdominis plane (TAP), which is a field block technique covered by the approved indication for EXPAREL
    • Infiltration to produce postsurgical analgesia at the site of oral surgery procedures including tooth extractions, which is also covered by the approved indication for EXPAREL
• The United States acknowledges that the rescission of the Warning Letter and approval of the Labeling Supplement reflect the scope of the indication in the NDA that FDA approved on October 28, 2011.
• Pacira and FDA agree that, in future interactions, they will deal with each other in an open, forthright and fair manner.

Background on the Legal Complaint and Resolution

In September 2014, the FDA Office of Prescription Drug Promotion (OPDP) issued Pacira a Warning Letter related to certain promotional materials.

Pacira took actions to address the immediate FDA concerns and minimize further disruption to its business, but ultimately sought a court order to defend against any retroactive attempt to limit the broad indication for EXPAREL and restrict communications supported by the approved label.

Pacira and the individual physician plaintiffs were represented in this lawsuit by Ropes & Gray LLP.  Pacira is also represented by Latham & Watkins LLP and Lowenstein Sandler LLP.

Today’s Conference Call and Webcast Information

Pacira will host a conference call today, December 15, 2015, at 8:30 a.m. ET to discuss the legal resolution reached with the FDA. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 2303742. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 2303742. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed on the “Investors & Media” section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

About EXPAREL®

EXPAREL (bupivacaine liposome injectable suspension) is currently indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain score with a decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

Important Safety Information

EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.

Please see the full Prescribing Information for more details available at: http://media.corporate ir.net/media_files/IROL/22/220759/The_New_Label_with_Approval_Cover_Letter.pdf

About Pacira

Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s flagship product, EXPAREL® (bupivacaine liposome injectable suspension), indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.

Forward Looking Statements

Any statements in this press release about our future expectations, plans, outlook and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” 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 risks relating to: the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our plans to expand the use of EXPAREL to additional indications and opportunities, including nerve block, oral surgery and chronic pain, as well as pediatrics, and the timing and success of any related clinical trials; the related timing and success of a United States Food and Drug Administration supplemental New Drug Application; the outcome of the U.S. Department of Justice inquiry; our plans to evaluate, develop and pursue additional DepoFoam-based product candidates; clinical studies in support of an existing or potential DepoFoam-based product; our plans to continue to manufacture and provide support services for our commercial partners who have licensed DepoCyt(e); our commercialization and marketing capabilities; our and Patheon UK Limited’s ability to successfully and timely construct dedicated EXPAREL manufacturing suites; and other factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Company Contact:		
Pacira Pharmaceuticals, Inc.	
Jessica Cho, (973) 254-3574	

Media Contact:
Pure Communications, Inc.
Dan Budwick, (973) 271-6085

(CFRXW) Concludes Phase 1 Study of CF-301

No Clinical Adverse Safety Signals

(MTBC) Announces $500,000 Stock Repurchase Program

SOMERSET, N.J., Dec. 15, 2015  — MTBC (Nasdaq:MTBC), a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, today announced that its Board of Directors has approved the repurchase of up to $500,000 of the Company’s common stock. The plan runs for thirty days.

“This program reflects our Board of Directors’ and executive management team’s great confidence in MTBC’s growth prospects, long-term strategy and ability to generate long-term shareholder returns,” said Mahmud Haq, Chairman and Chief Executive Officer. “We are confident in the strength of our business and committed to building shareholder value as is evident through our repurchase program announcement today. Our stock price presents us with an exciting opportunity to purchase MTBC shares at attractive prices and return value to existing shareholders,” he added.

MTBC’s stock repurchase program allows MTBC to repurchase shares in open-market purchases in accordance with all applicable securities laws and regulations, including Rule 10b-18 of the Securities Exchange Act of 1934, as amended. Repurchases will depend upon a variety of factors, such as price, market conditions, volume limitations on purchases and other regulatory requirements, and other corporate considerations, as determined by MTBC’s management team. The repurchase program does not require the purchase of any minimum number of shares and may be modified, suspended or discontinued at any time. The Company will finance the stock repurchases with existing cash balances.

About Medical Transcription Billing, Corp.

Medical Transcription Billing, Corp. is a healthcare information technology company that provides a fully integrated suite of proprietary web-based solutions, together with related business services, to healthcare providers practicing in ambulatory care settings. Our integrated Software-as-a-Service (or SaaS) platform helps our customers increase revenues, streamline workflows and make better business and clinical decisions, while reducing administrative burdens and operating costs. For additional information, please visit our website at www.mtbc.com.

Forward-Looking Statements

This press release contains various forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended. These statements relate to anticipated future events, future results of operations or future financial performance. In some cases, you can identify forward-looking statements by terminology such as “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “goals”, “intend”, “likely”, “may”, “plan”, “potential”, “predict”, “project”, “will” or the negative of these terms or other similar terms and phrases.

Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Forward-looking statements in this press release include, without limitation, statements reflecting management’s expectations for future financial performance and operating expenditures, expected growth, profitability and business outlook, increased sales and marketing expenses, and the expected results from the integration of our acquisitions.

Forward-looking statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. These factors are including, but not limited to the Company’s ability to manage growth; integrate acquisitions; effectively migrate and keep newly acquired customers and other important risks and uncertainties referenced and discussed under the heading titled “Risk Factors” in the Company’s filings with the Securities and Exchange Commission. Although we believe that the expectations reflected in the forward-looking statements contained in this press release are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not assume any obligations to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT: Amritpal Deol,
Vice President and General Counsel
MTBC
adeol@mtbc.com
Telephone: (732) 873-5133 x 141

(KTOV) Pivotal Phase III Trial Successfully Meets Primary Efficacy Endpoint

– Company plans to file for marketing approval in 2016 for its combination drug KIT-302 – Data show KIT-302 is more effective at lowering hypertension than amlodipine besylate alone – KIT-302 would become the first single medication to treat both osteoarthritis pain and hypertension – KIT-302 addresses a multi-billion market

TEL AVIV, Israel, Dec. 15, 2015  — Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, announced today that the Phase III, double-blind, placebo-controlled clinical trial for its leading drug candidate, KIT-302, successfully met the primary efficacy endpoint of the trial protocol as approved by the U.S. Food & Drug Administration (FDA). Data from the trial further revealed that KIT-302 was more efficacious at reducing hypertension than the widely used hypertension drug amlodipine besylate. Kitov plans to file its New Drug Application (NDA) for marketing approval of KIT-302 with the FDA in the second half of 2016. To view a webcast of the press conference discussing these results in Tel Aviv today, please visit: http//bit.ly/1Qi4WfU

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

The trial protocol, approved by the FDA through the Special Protocol Assessment process, was designed to quantify the decrease of hypertension in patients receiving KIT-302. The trial was performed in the U.K. in four groups of twenty-six (26) to forty-nine (49) patients, with a total of 152 patients. Each patient was treated over a total period of two weeks. Group One was treated with KIT-302, comprised of celecoxib and amlodipine besylate. Group Two was treated with amlodipine besylate only, one of the components of KIT-302. Group Three was treated with celecoxib only, the other component of KIT-302. Group Four was treated with a double placebo.  The trial began in June 2014 and was completed in November 2015.

The primary efficacy end-point of the trial was to show that a combination of the two components of KIT-302, as demonstrated in Group One, lowers daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved in patients in Group Two, who were treated with amlodipine besylate only.

The trial results demonstrated that the number of 152 patients treated was found to be adequate to provide statistical validity and therefore, the results are final. These final results show that in patients treated with amlodipine besylate only, there was a mean reduction in daytime systolic blood pressure of 8.8 mm Hg. In patients treated with KIT-302, there was a mean reduction in daytime systolic blood pressure of 10.6 mm Hg.  Therefore, the primary efficacy endpoint of the study has been successfully achieved with a p value of 0.001.

“We are very pleased with the successful and final outcome of our pivotal Phase III trial and we look forward to meeting with the FDA in the near future to finalize plans for our NDA submission.  We believe we will be ready to submit the NDA for KIT-302 in the second half of 2016. Should the NDA meet with the FDA’s approval, we would expect to receive marketing approval in 2017,” stated Kitov CEO Isaac Israel.

“Data revealing that KIT-302 is more efficacious at reducing daytime systolic blood pressure than amlodipine besylate alone was particularly compelling. We are now conducting an in depth analysis of the robust data produced in this trial, and we look forward to sharing other findings that may be of interest to the medical community,” commented  Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer.

“KIT-302 has the potential to address the multi-billion dollar market for the treatment of osteoarthritis pain and hypertension with one drug that reduces patients’ risk of suffering a heart attack or stroke, while also reducing cost for payers. There is currently no single medication on the market that treats both osteoarthritis pain and hypertension and thus, KIT-302 will be the only NSAID indicated both to treat pain and to reduce the risk of heart attack, stroke and death.”

Pain medications for osteoarthritis account for billions of dollars in annual sales globally. Most pain medications for osteoarthritis, including celecoxib which had global sales of $2.7 billion in 2014, are non-steroidal anti-inflammatory drugs (NSAIDs) which have the side effect of elevating blood pressure, and increasing the risk of heart attacks, strokes and death. Of the 27 million Americans who live with osteoarthritis, 13.5 million also suffer from hypertension, which also increases the risk of heart attack, stroke, and death.

About Kitov Pharmaceuticals Holdings Ltd.
Kitov Pharmaceuticals Holdings Ltd. is a biopharmaceutical company focused on the development of therapeutic candidates for the simultaneous treatment of various clinical conditions. In particular, Kitov focuses on developing combinations of existing drugs in advanced stages of development. Kitov’s lead drug, KIT-302, is formulated for the simultaneous treatment of two clinical conditions – pain caused by osteoarthritis (OA) and hypertension (high blood pressure), which can be pre-existing or caused by the treatment for OA. KIT-302 is based on celecoxib, the active ingredient of a known and approved-for-use drug designed primarily to relieve pain caused by OA, and the generic drug amlodipine besylate. Kitov is traded on the Nasdaq Capital Market (KTOV) and the Tel-Aviv Stock Exchange (KTOV).

Forward-Looking Statements
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements involve certain risks and uncertainties, including, among others, risks impacting the ability of the Company to complete any public offering of its securities because of general market conditions or other factors and risks that could cause the Company’s results to differ materially from those expected by Company management. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Kitov Pharmaceuticals Holdings Ltd.’s Registration Statement on Form F-1 filed with the SEC, which is available on the SEC’s website, www.sec.gov.

Contact:

Simcha Rock, CFO
+972-2-6254124
Simcha@kitovpharma.com

(CFRX) Concludes Phase 1 Study of CF-301

No Clinical Adverse Safety Signals

(AKBA) & Mitsubishi Tanabe Pharma Vadadustat Collaboration in Asia

Akebia Therapeutics, Inc. (NASDAQ:AKBA), and Mitsubishi Tanabe Pharma Corporation (TSE:4508) (MTPC) announced today that they have entered into a development and commercialization agreement for vadadustat (formerly AKB-6548), an oral therapy for the treatment of anemia related to chronic kidney disease (CKD), in Japan and certain other countries in Asia.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20151214005335/en/

Under the terms of the agreement, MTPC will make payments totaling $100 million for costs associated with the global Phase 3 program for vadadustat, including $40 million upon signing. In addition, Akebia is eligible to receive up to approximately $250 million in additional milestone payments, based upon achievement of certain development and sales milestones. MTPC will also make tiered royalty payments, from low teens up to twenty percent, on sales of vadadustat in Japan, Taiwan, South Korea, Indonesia, India and other Asian countries.

“Vadadustat offers a new paradigm for the treatment of anemia for CKD patients. This partnership with MTPC validates vadadustat’s therapeutic potential and helps ensure that its potential is realized in Asia,” said John P. Butler, President and CEO of Akebia. “MTPC is one of the largest, most successful pharmaceutical companies in Japan with a substantial presence in these Asian markets. They are committed to the development and commercialization of innovative products, with a strategic focus on products for renal disease and diabetes, making them an ideal partner for Akebia.”

“A safer treatment for managing anemia related to chronic kidney disease remains a significant unmet need globally,” stated Masayuki Mitsuka, President and Representative Director, CEO of Mitsubishi Tanabe Pharma Corporation. “We see great potential in vadadustat to advance the care of chronic kidney disease patients. We look forward to our collaboration with Akebia.”

Conference Call and Webcast

About Vadadustat

Vadadustat is an oral therapy currently in development for the treatment of anemia related to chronic kidney disease (CKD). Vadadustat is designed to stabilize HIF, a transcription factor that regulates the expression of genes involved with red blood cell (RBC) production in response to changes in oxygen levels, by inhibiting the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzyme. Vadadustat exploits the same mechanism of action used by the body to naturally adapt to lower oxygen availability associated with a moderate increase in altitude. The body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin (EPO) production to increase RBC production and, ultimately, improve oxygen delivery.

As a HIF stabilizer with best-in-class potential, vadadustat raises hemoglobin levels predictably and sustainably, with a dosing regimen that allows for a gradual and controlled titration. Vadadustat has been shown to improve iron mobilization, potentially reducing the need for iron supplementation.

About Anemia Related to CKD

Approximately 30 million people in the United States have CKD, with an estimated 1.8 million of these patients suffering from anemia. Anemia results from the body’s inability to coordinate RBC production in response to lower oxygen levels due to the progressive loss of kidney function, which occurs in patients with CKD. Left untreated, anemia significantly accelerates patients’ overall deterioration of health with increased morbidity and mortality. Renal anemia is currently treated with injectable recombinant erythropoiesis-stimulating agents, which are associated with inconsistent hemoglobin responses and well-documented safety risks.

About Akebia Therapeutics

Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through HIF biology. The company has completed Phase 2 development of its lead product candidate, vadadustat, an oral therapy for the treatment of anemia related to CKD in both non-dialysis and dialysis patients, and plans to initiate its Phase 3 program in 2015. http://akebia.com

About Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma Corporation is a research-driven pharmaceutical company based in Osaka, Japan. MTPC is taking on the challenge of drug discovery in the fields of autoimmune disorders, central nervous system diseases, diabetes and kidney diseases, and vaccines. To those ends, MTPC is strengthening its R&D pipeline. MTPC contributes to the healthier lives of people around the world through the creation of pharmaceuticals. http://www.mt-pharma.co.jp/e.

Forward-Looking Statements

This press release includes forward-looking statements. Such forward-looking statements include those about Akebia’s strategy, future plans and prospects, including statements regarding the potential indications, dosing and benefits of vadadustat, the development plan for vadadustat, and the expected payments from MTPC to Akebia. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the funding required to develop vadadustat and operate the company, and the actual expenses associated therewith; the cost of the Phase 3 studies of vadadustat and the availability of financing to cover such costs; the ability of Akebia and MTPC to successfully complete the clinical development of vadadustat; the timing and scope of regulatory and reimbursement approvals in Japan and other countries included in the territory; the timing and content of decisions made by the FDA, PMDA and other regulatory authorities; Akebia’s ability to manufacture and supply vadadustat to MTPC; the ability of MTPC to perform its obligations under the Collaboration Agreement; MTPC’s ability to distribute, promote, market and sell vadadustat in Japan and the other countries included in the territory; the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; and Akebia’s ability to obtain, maintain and enforce patent and other intellectual property protection for vadadustat. Other risks and uncertainties include those identified under the heading “Risk Factors” in Akebia’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, and other filings that Akebia may make with the Securities and Exchange Commission in the future. Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.