Archive for August, 2016

$HSGX to Present at 18th Annual #Rodman&Renshaw Global Investment Conference

WALTHAM, Mass., Aug. 31, 2016  — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that Adam Gridley, President and Chief Executive Officer of Histogenics, will present at the 18th Annual Rodman & Renshaw Global Investment Conference on Monday, September 12, 2016 at 11:40 AM EDT.  The conference is sponsored by H.C. Wainwright & Co., LLC., and will be held September 11-13, 2016 at the Lotte New York Palace Hotel in New York City.

This presentation will be webcast live and may be accessed by visiting the Investor Relations section of Histogenics’ website at www.histogenics.com.  The webcast will be archived and available on Histogenics’ website for 45 days following the conference.

About Histogenics Corporation

Histogenics is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace.  Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions.  Histogenics’ first investigational product candidate, NeoCart®, is currently in Phase 3 clinical development.  NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells.  Knee cartilage defects represent a significant opportunity in the United States, with an estimated 500,000 or more applicable procedures each year.  NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage, characteristics not exhibited in other current treatment options.  For more information, please visit www.histogenics.com.

Contact:

Investor Relations
Tel: +1 (781) 547-7909
InvestorRelations@histogenics.com
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$VUZI #SmartGlasses Key Component of #DHL Global #AR Program

ROCHESTER, N.Y., Aug. 31, 2016  — Vuzix® Corporation (NASDAQ: VUZI), a leading supplier of Smart Glasses, Augmented Reality (AR) and Virtual Reality (VR) technologies and products for the consumer and enterprise markets, is pleased to announce that the Company’s M100 and next generation M300 Smart Glasses will be key components of DHL’s global AR program. DHL is one of the world’s largest logistics companies.

In 2016, the Ubimax vision picking X-Pick software solution was successfully implemented with Vuzix M100 Smart Glasses to deliver effective solutions to customers internationally, including DHL. DHL’s well documented pilot program drove a 25% increase in efficiency using this solution. DHL has subsequently moved towards broader implementation at additional sites. Vuzix will participate in the global roll-out of DHL’s expanded pilot programs for vision picking, as DHL Supply Chain expands its vision picking program over the next six months across different industries. The initial expansion phase will focus in the United States, Europe and the United Kingdom.

Pickers are equipped with Vuzix Smart Glasses that visually display where each picked item needs to be placed on the trolley. Vision Picking enables hands free order picking at a faster pace, along with reduced error rates. Throughout 2016, the smart glasses will be piloted across various industries such as technology, retail, consumer and automotive industries. The data available from these pilots will further determine the technology’s potential for even broader implementation. The sites are spread across the United States, Mainland Europe and the United Kingdom, with the Ricoh facility in Bergen op Zoom, the Netherlands, where the solution was first tested, being the launch site for this new phase.

AR is a market with exceptional growth potential. The AR and VR market is said to be the next big thing after smartphones, although estimates vary significantly. Goldman Sachs estimates a base case of $80 billion for both virtual and augmented reality by 2025, while M&A advisory firm Digi-Capital predicts a total volume of $150 billion by 2020. The current success of mobile app Pokémon Go reflects the market potential, as are 225 venture capital investments worth $3.5 billion made in AR / VR over the last two years.

DHL Supply Chain will be one of the first companies to widely implement the technology into their operations. The initial 2014 test in the Netherlands showed a significant increase in productivity, reduced error rates and overall rise in employee satisfaction, proving that augmented reality can make an impactful difference in reality. The following video highlights the use of smart glasses in improving efficiency in warehouse applications:  https://www.youtube.com/watch?v=I8vYrAUb0BQ.

“DHL will be expanding into further programs with the M300 following the strong productivity improvements they were able to achieve with the M100. We expect that these efforts, moving to the M300, will see even stronger ROIs and translate into productive implementation,” said Paul Travers, President and Chief Executive Officer at Vuzix.

“The Vision Picking Program is DHL Supply Chain’s first translation of what augmented reality solutions can look like for supply chains. The broad spectrum in which the technology can be applied across various sectors is exciting to us, and the potential of this technology for business is still largely untapped. We believe this program is a game changer in how we run our supply chain operations and deliver added value to our customers,” states Markus Voss, CIO Supply Chain.

About Vuzix Corporation
Vuzix is a leading supplier of Smart-Glasses, Augmented Reality (AR) and Virtual Reality (VR) technologies and products for the consumer and enterprise markets. The Company’s products include personal display and wearable computing devices that offer users a portable high quality viewing experience, provide solutions for mobility, wearable displays and virtual and augmented reality. Vuzix holds 43 patents and 23 additional patents pending and numerous IP licenses in the Video Eyewear field. The Company has won Consumer Electronics Show (or CES) awards for innovation for the years 2005 to 2016 and several wireless technology innovation awards among others. Founded in 1997, Vuzix is a public company (NASDAQ: VUZI) with offices in Rochester, NY, Oxford, UK and Tokyo, Japan.

Forward-Looking Statements Disclaimer
Certain statements contained in this news release are “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. Forward looking statements contained in this release relate to, among other things, the success and impact of the DHL programs with the M100 and M300 smart glasses, and the Company’s leadership in the Video Eyewear, VR and AR display industry. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and MD&A filed with the United States Securities and Exchange Commission and applicable Canadian securities regulators (copies of which may be obtained at www.sedar.com or www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

Investor and Media Relations Contact:
Andrew Haag
Managing Partner
IRTH Communications
vuzi@irthcommunications.com
1-866-976-4784

Vuzix Corporation
25 Hendrix Road, Suite A
West Henrietta, NY 14586 USA
Investor Information – Grant Russell
IR@Vuzix.com
Tel: (585) 359-7562
www.vuzix.com

For further sales, and product information, please visit:

North America:
http://www.vuzix.com/contact/

Europe/UK:
https://www.vuzix.eu/contact/

Asia:
http://www.vuzix.jp/contact.html

Wednesday, August 31st, 2016 Uncategorized Comments Off on $VUZI #SmartGlasses Key Component of #DHL Global #AR Program

$KEQU Raises Quarterly #Dividend 15%

STATESVILLE, N.C., Aug. 31, 2016  — Kewaunee Scientific Corporation (Nasdaq: KEQU) announced today its Board of Directors approved a fifteen percent increase in the quarterly cash dividend to fifteen cents per outstanding share from thirteen cents per outstanding share, payable on September 26, 2016 to stockholders of record at the close of business on September 12, 2016. We are confident the recent improvements in our financial results reflect sustainable operating improvements in our core business. As a result, we are increasing our quarterly dividend by two cents.

About Kewaunee Scientific
Founded in 1906, Kewaunee Scientific Corporation is a recognized global leader in the design, manufacture, and installation of laboratory, healthcare, and technical furniture products. Products include steel, wood, and laminate casework, fume hoods, adaptable modular systems, moveable workstations, stand-alone benches, biological safety cabinets, and epoxy resin worksurfaces and sinks.

The Company’s corporate headquarters is located in Statesville, North Carolina. Direct sales offices are located in the United States, India, Singapore, and China. Three manufacturing facilities are located in Statesville serving the domestic and international markets, and one manufacturing facility is located in Bangalore, India serving the local and Asian markets. The Company’s China headquarters, sales office, and assembly operation are located in Suzhou Industrial Park, China. Kewaunee Scientific’s website is located at http://www.kewaunee.com.

Contact:  Thomas D. Hull III
704/871-3290

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$APPS Appoints #BarrettGarrison as #CFO

Former NetSpend CFO to start September 12

AUSTIN, Texas, Aug. 31, 2016  — Digital Turbine, Inc. (Nasdaq: APPS), the company empowering mobile operators and Original Equipment Manufacturers (“OEMs”) around the globe with end-to-end mobile solutions, today announced the appointment of Barrett Garrison as Chief Financial Officer effective September 12, 2016 replacing Andrew Schleimer. Mr. Schleimer will onboard Mr. Garrison over the next 30 days.

“Digital Turbine is poised for its next phase of growth. Barrett’s complete end-to-end CFO experience of assisting rapidly growing companies, his strong understanding of technology and execution-focus in the areas of strategic planning, risk management, and corporate governance are the skillsets necessary to continue to scale this business and leverage the tremendous global opportunity before us,” stated Bill Stone, Chief Executive Officer of Digital Turbine. “The timing is now right for an orderly transition.  I want to thank Andrew for his many contributions to Digital Turbine over the past two years. He has been a valuable business partner and played an integral part in getting the company to this point in our evolution. I wish him great success in all his future endeavors.”

Garrison brings more than 17 years of accounting and financial experience to the position with a focus on financial reporting, regulatory compliance, internal control and corporate finance activities. He previously served as Vice President and then Chief Financial Officer of NetSpend Corporation, the leading provider of reloadable prepaid debit cards, that was acquired by NYSE-listed TSYS for $1.4 billion in 2013. Before the acquisition, NetSpend went public in 2010 raising $204 million in its IPO. Mr. Garrison played an instrumental operational and financial role scaling the business from $130 million to $440 million in revenue, increasing profitability, taking NetSpend public, and implementing all the public company controls. Subsequent to NetSpend, Mr. Garrison was Chief Financial Officer of Competitor Group, a leading media and event company in the active lifestyle industry company based in San Diego. Mr. Garrison was the Financial Controller of Dell Financial Services, a $2 billion business for Dell Technologies Inc., from 2007 to 2008.

Garrison commented, “Digital Turbine’s unique app delivery software and native app media are gaining momentum in the marketplace, and given my history and experience in emerging technology companies, I am excited to join Digital Turbine at this pivotal stage. I look forward to working with the entire team as we continue on the path of long-term value creation for all of our stakeholders.”

About Digital Turbine
Digital Turbine works at the convergence of media and mobile communications, delivering end-to-end products and solutions for mobile operators, device OEMs, app advertisers and publishers, that enable efficient user acquisition, app management and monetization opportunities. The company’s products include Ignite™, a mobile device management solution with targeted app distribution capabilities, Marketplace™, an application and content store, and Pay™, a content management and mobile payment solution. Digital Turbine Media encompasses a leading independent user acquisition network as well as an advertiser solution for unique and exclusive carrier inventory. Digital Turbine has delivered more than 150 million app installs for hundreds of advertisers. In addition, more than 31 million customers use Digital Turbine’s solutions each month across more than 30 global operators. The company is headquartered in Austin, Texas with global offices in Durham, Berlin, San Francisco, Singapore, Sydney and Tel Aviv. For additional information visit http://www.digitalturbine.com/ or connect with Digital Turbine on Twitter at @DigitalTurbine.

Forward-Looking Statements 
This news release includes “forward-looking statements” within the meaning of the U.S. federal securities laws. Statements in this news release that are not statements of historical fact and that concern future results from operations, financial position, economic conditions, product releases and any other statement that may be construed as a prediction of future performance or events, including financial projections and growth in various products are forward-looking statements that speak only as of the date made and which involve known and unknown risks, uncertainties and other factors which may, should one or more of these risks uncertainties or other factors materialize, cause actual results to differ materially from those expressed or implied by such statements.

These factors and risks include:

  • risks associated with Ignite adoption among existing customers (including the impact of possible delays with major carrier and OEM partners in the roll out for mobile phones deploying Ignite)
  • actual mobile device sales and sell-through where Ignite is deployed is out of our control
  • risks associated with the timing of Ignite software pushes to the embedded bases of carrier and OEM partners
  • risks associated with end user take rates of carrier and OEM software pushes which include Ignite
  • new customer adoption and time to revenue with new carrier and OEM partners is subject to delays and factors out of our control
  • risks associated with fluctuations in the number of Ignite slots across US carrier partners
  • required customization and technical integration which may slow down time to revenue notwithstanding the existence of a distribution agreement
  • risk that strong Apple iPhone sales could result in a disproportionately low amount of Android sales
  • the difficulty of extrapolating monthly demand to quarterly demand
  • the challenges, given the Company’s comparatively small size, to expand the combined Company’s global reach, accelerate growth and create a scalable, low-capex business model that drives EBITDA (as well as Adjusted EBITDA)
  • challenges to realize anticipated operational efficiencies, revenue (including projected revenue) and cost synergies and resulting revenue growth, EBITDA (and Adjusted EBITDA) and free cash flow conversion from the Appia merger
  • the impact of currency exchange rate fluctuations on our reported GAAP financial statements, particularly in regard to the Australian dollar
  • ability as a smaller Company to manage international operations
  • varying and often unpredictable levels of orders; the challenges inherent in technology development necessary to maintain the Company’s competitive advantage such as adherence to release schedules and the costs and time required for finalization and gaining market acceptance of new products
  • changes in economic conditions and market demand
  • rapid and complex changes occurring in the mobile marketplace
  • pricing and other activities by competitors
  • pricing risks associated with potential commoditization of the A&P/Appia Core business as competition increases and new technologies, in particular Real Time Bidding, add pricing pressure
  • developing RTB for A&P/Appia Core to the level required to compete in the increasingly important programmatic bidding area will require additional investment that, given the Company’s limited resources, may not be available in the time or on the terms necessary
  • technology management risk as the Company needs to adapt to complex specifications of different carriers and the management of a complex technology platform given the Company’s relatively limited resources, and
  • other risks including those described from time to time in Digital Turbine’s filings on Forms 10-K and 10-Q with the Securities and Exchange Commission (SEC), press releases and other communications. You should not place undue reliance on these forward-looking statements. The Company does not undertake to update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Follow Digital Turbine:

Twitter: https://twitter.com/DigitalTurbine
Facebook: https://www.facebook.com/DigitalTurbineInc
LinkedIn: http://www.linkedin.com/company/digital-turbine

For more information, contact:

Investor relations contact:

Brian Bartholomew
Digital Turbine
ir@digitalturbine.com
(512) 800-0274

Carolyn Capaccio/Sanjay M. Hurry
LHA
(212) 838-3777
digitalturbine@lhai.com

Wednesday, August 31st, 2016 Uncategorized Comments Off on $APPS Appoints #BarrettGarrison as #CFO

$SINO to Develop a #Mobile #App for #ShortHaul #Trucking in #US

Expects to Launch Fully-Functioning App in 2017

ROSLYN, N.Y., Aug. 31, 2016  — Sino-Global Shipping America, Ltd. (NASDAQ: SINO) (“Sino-Global”, the “Company” or “us”), a non-asset based global shipping and freight logistic integrated solution provider, today announced that its Board of Directors has authorized management to move forward with the development of a mobile application that will provide a full-service logistics platform between the US and China to short-haul trucking in the US.

The decision follows an extensive review by the Company’s management team and Board in identifying Sino-Global’s key competitive advantages as an expert in global logistics between the US and China, and then leveraging that experience to both address the needs of its customer base and provide solutions to current issues affecting logistics and supply chain. The Company completed a market analysis and feasibility study related to building a mobile based logistics application for short-haul trucking in US ports to better manage the over 25 million containers, or TEU moving between China and US each year.

Explaining the Market Need

The results of the study revealed that there was a tremendous bottleneck between the huge demands of door to door container logistics service in China and small scale independent fleet owners in US ports. The Company feels that its experience in providing logistics service and solutions, coupled with its long term relationships with major shipping carriers, provide it a competitive advantage to build a mobile-based platform.

Sino-Global is currently evaluating technology and business partners to move forward with the development of the mobile application, which the management hopes to launch in 2017.

Mr. Lei Cao, Chief Executive Officer of Sino-Global, stated, “We were very pleased with the findings of our initial research into a mobile-based logistics strategy. We believe that Sino-Global is in the right position to solve bottleneck issues in this traditional industry with mobile application technology. We connected with major shipping carriers in China and multiple small short-haul trucking fleet operators in US. Universally each one recognized the benefit of an easily accessible and transparent mobile logistic platform which will bring market efficiency to our industry. The Company estimates that this platform would create a considerable savings for major shipping carriers in China in terms of short-haul trucking in US and streamline the process, while also providing independent fleet operators with more opportunities of direct communication with clients and reducing intermediate steps. We will continue to update investors as we develop the application and are incredibly excited about its potential.”

About Sino-Global Shipping America, Ltd.

Sino-Global Shipping America, Ltd., a Virginia corporation, is a non-asset based global shipping and freight logistic integrated solution provider. Sino-Global provides tailored solutions and value added services to its shipping and freight customers to drive effectiveness and control in related links throughout entire logistic chain. Additional information about Sino-Global can be found on the Company’s corporate website at www.sino-global.net. The Company routinely posts important information on its website.

Forward Looking Statements

No statement made in this press release should be interpreted as an offer to purchase any security. Such an offer can only be made in accordance with the Securities Act of 1933, as amended, and applicable state securities laws. Any statements contained in this release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties as identified in Sino-Global’s filings with the Securities and Exchange Commission. Actual results, events or performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as the date hereof. Sino-Global undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Contact Information

The Equity Group Inc.
Adam Prior
Senior Vice-President
(212)-836-9606 / aprior@equityny.com

Wednesday, August 31st, 2016 Uncategorized Comments Off on $SINO to Develop a #Mobile #App for #ShortHaul #Trucking in #US

$MKGI is Helping Define the Future of #Creative #Travel

The travel and tourist industry is one of the largest industries in the world, with a global annual contribution in the trillions of dollars according to Statista (http://nnw.fm/xQ1DT). Solely considering international travel, there are over a billion international tourist arrivals worldwide each year.  People book their accommodation according to price, ratings, previous experiences, and other parameters, and the type of travel varies widely, from high-end to low.

This leads us to the topic of backpacking. Backpacking was often considered a form of hiking or camping holiday. Today, it is one of the trendiest ways to travel among people of all ages. With this rising trend comes the advent of new forms of backpacking such as “flashpacking” and “poshpacking.” These terms are used for the more affluent backpackers who do not necessarily need to travel on a small budget but still choose the freedom attached to this form of travel.

Thanks to the evolution of technology, more and more people are traveling light without having to give up comfort. The world of the digital nomad is here and the travel industry is gearing up to capitalize on these emerging trends. In recent years, companies have increased the technological interaction with their consumers making everything more accessible online.

Aside from the rise of technology, different levels of backpacking have become more accessible thanks to the introduction of cheaper flights, trains, buses, hotels, hostels and dining opportunities. These are marketed online to budget travelers and often include the option to make all-inclusive bookings through one platform. To the new-age flashpacker, it’s becoming a way of life. Travelers today are not isolated. They are followed by a digital world full of tools.

According to The Future of Backpacking by Ferda Van Vaals (http://nnw.fm/zkmS4), some of the new characteristics expected by 2030 include infrastructure expansion, greater tourist mobility, and growing global tourism and destinations. In other words, the world will continue to become more accessible, and more people will value experience rather than just material possessions.

Who makes such expanding ease of travel possible? Today there are thousands of travel agencies, both online and in-shop, in millions of locations. Online travel agencies are making travel more accessible thanks to the options to book flights, accommodation, and other factors through the Internet. However, backpackers today want more. Travel agencies are reigning in and offering all-inclusive booking facilities online, making the booking process, easier, quicker and often cheaper.

Monaker Group, Inc. (OTCQB: MKGI) is a technology travel company on the leading edge of these ever-changing holiday booking trends. The company is made up of multiple divisions and brands offering a real-time booking engine featuring a wider and creative range of lodgings for a variety of backpackers, flashpackers, and holiday makers. In addition to this, the company allows consumers to book from an array of airlines, hotels, cruises, rental cars, tours, and much more.

The company’s flagship brand, NextTrip.com, is the industry’s first and only real-time booking engine that features alternative lodging (vacation home rentals, resort residences and unused timeshare inventory), as well as a full selection of airlines, hotels, cruises, rental cars, tours and concierge services. These features are combined into a single, easy-to-use platform that gives travelers complete real-time control when planning and booking their vacations.

Most NextTrip listings are in desirable locations in the U.S., the EU and the Caribbean with about 20% exclusive listings, and the company anticipates rapid exclusive listing growth because of its competitive edge, proprietary solutions, and interest in strategic partnerships and acquisitions, in addition to new travel trends.

The company recently launched its own Monaker Booking Engine and Premium Service for property owners, opening its offerings up to an even broader variety of consumers.

For more information, visit www.MonakerGroup.com

 

Tuesday, August 30th, 2016 Uncategorized Comments Off on $MKGI is Helping Define the Future of #Creative #Travel

$KMDA Meets Primary Endpoint US Phase 2 Study #Inhaled Alpha-1 #Antitrypsin

Company’s Inhaled AAT Demonstrated Significant Increase in Endothelial Lining Fluid Inhibitory Capacity

Study Results Also Showed that Inhaled AAT is the Most Efficient Way of Delivering Therapeutic Amounts of AAT to the Primary Sites of Potential Lung Injury

Kamada to Utilize Results to Design Pivotal U.S. Study and Support Responses to European Medicines Agency (EMA) Regarding Company’s Marketing Authorization Application (MAA) for Inhaled AAT 

NESS ZIONA, Israel, Aug. 30, 2016  — Kamada Ltd. (Nasdaq:KMDA) (TASE:KMDA.TA), a plasma-derived protein therapeutics company focused on orphan indications, today announced positive top-line results, meeting the primary endpoint of the Company’s U.S. Phase 2 clinical trial of its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). AATD is an orphan disease currently treated by intravenous AAT augmentation therapy.

The U.S. Phase 2 clinical trial was a double-blind, placebo-controlled study evaluating the safety and efficacy of AAT by inhalation in 36 AATD patients. Patients were treated with Kamada’s AAT for inhalation (80 mg/day or 160 mg/day) or placebo via the eFlow® device for 12 weeks during the double-blind period. Primary efficacy measures included antigenic AAT levels and Anti-Neutrophil Elastase inhibitory (ANEC) levels in the lung as well as additional anti-proteolitic and anti-inflammatory biomarkers. Following this double-blind period, eligible patients (total of 26) entered an additional 12-week open-label extension study with the active drug (160mg/day) to further assess safety and tolerability.

AATD patients treated with Kamada’s inhaled AAT demonstrated a significant increase in endothelial lining fluid (ELF) AAT antigenic level compared to the placebo group [median increase 4551 nM, p-value<0.0005 (80 mg/day, n=12), and 13454 nM, p-value<0.002 (160mg/day, n=12)]. These results are more than twice the increase of ELF antigenic AAT level (+2600 nM) observed in Kamada’s previously completed intravenous (IV) AAT pivotal study (60mg/kg/week). Antigenic AAT represents the total amount of AAT in the lung, both active and inactive.

In addition, ELF ANEC level also increased significantly [median increase 2766 nM, p-value<0.0005 (80mg/day) and 3557 nM., p-value<0.004 (160 mg/day)]. The increase in ELF ANEC level was also more than twice that demonstrated in Kamada’s previously completed IV AAT pivotal study. The ANEC level represents the active AAT that can counterbalance further damage by neutrophil elastase.

“These measures of AAT concentration at the lung target site are extremely encouraging, demonstrating that the inhaled formulation provides substantially higher levels of antigenic AAT and ANEC than those achieved with the existing standard of care given by IV injection,” said Dr. Naveh Tov, MD PhD, Kamada’s VP Clinical Development and Medical Director for Pulmonary Diseases.

“The results of this study are extremely compelling,” said Professor Mark Brantly, MD, the Primary Investigator in this study who serves as a Vice Chair of Research, Department of Medicine, Chief Division of Pulmonary, Critical Care and Sleep Medicine, Professor of Medicine, Molecular Genetics and Microbiology at the University of Florida College of Medicine and Alpha One Foundation Research Professor. “Based on the results of this study, it is clear that inhaled AAT is the most effective mode of treatment for reaching the primary sites of potential lung injury, and restoring AAT inhibitory capacity. I look forward to the start of a pivotal study in the U.S. to confirm these results.”

Kamada’s inhaled AAT also demonstrated a strong safety profile, adding to the safety data generated in the Company’s previously completed European Phase 2/3 clinical study of Inhaled AAT for the treatment of AATD.  There were no differences seen in safety parameters (treatment emergent adverse events, serious adverse events, etc.) between the placebo and treatment groups (both 80mg and 160mg) during the double-blind and open-label extension periods.  Two patients discontinued the study during the double-blind period, including one in the treated group, which was determined to be unrelated to treatment, and one in the placebo group.

“We strongly believe our inhaled AAT has the potential to change the treatment paradigm for AATD,” said Amir London, Chief Executive Officer of Kamada Ltd.  “We intend to utilize the excellent results from this successful Phase 2 study to design a pivotal U.S. study and to support our responses to the EMA’s 120-day comments in regards to Kamada’s MAA for Inhaled AAT, which was submitted earlier this year.  We also intend to continue our discussions with the U.S. Food and Drug Administration with this additional phase 2 data and the data from our EU phase 2/3 study in order to obtain guidance on the regulatory pathway for Inhaled AAT in the U.S.”

About Kamada
Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial product portfolio and a robust late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived Immune globulins.  AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company’s flagship product is Glassia®, the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets Glassia® in the U.S. through a strategic partnership with Baxalta (formerly Baxter International Inc.’s BioScience business and now part of Shire plc) and in other counties through local distributors.  In addition to Glassia®, Kamada has a product line of seven other pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. Kamada has five late-stage plasma-derived protein products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency that its MAA was submitted to the EMA after completing a pivotal Phase 2/3 clinical trials in Europe. Kamada has also completed its Phase 2 clinical trials in the U.S. for the treatment of AAT deficiency using our proprietary inhaled AAT. In addition, Kamada’s intravenous AAT is in development for other indications such as type-1 diabetes, GvHD and prevention of lung transplant rejection. Kamada also leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 10 pharmaceutical products in Israel that are manufactured by third parties.

Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.  Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecast, commercial results, timing and results of clinical trials and EMA and U.S. FDA submissions and authorizations.  Forward-looking statements are based on Kamada’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions.  Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, unexpected results of clinical trials, delays or denial in the U.S. FDA or the EMA approval process, additional competition in the AATD market or further regulatory delays.  The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

 

CONTACT:
Gil Efron
Chief Financial Officer
ir@kamada.com

Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.com
Tuesday, August 30th, 2016 Uncategorized Comments Off on $KMDA Meets Primary Endpoint US Phase 2 Study #Inhaled Alpha-1 #Antitrypsin

$EVEP Announces Approval of Unitholder Proposals

HOUSTON, Aug. 30, 2016  — EV Energy Partners, L.P. (Nasdaq:EVEP) announced that its unitholders approved the 2016 Long Term Incentive Plan and the ratification of Deloitte & Touche LLP as EVEP’s independent registered public accounting firm for the fiscal year ending December 31, 2016 during a special meeting of the Partnership’s unitholders.

A quorum at the special meeting required the presence, either in person or by proxy, of a majority of all the Partnership’s outstanding units as of the record of date of July 7, 2016.  Approximately 38.7 million or 79% percent of the Partnership’s outstanding units participated in the special meeting.

About EV Energy Partners, L.P.

EV Energy Partners, L.P. is a Houston based master limited partnership engaged in acquiring, producing and developing oil and natural gas properties. More information about EVEP is available on the Internet at www.evenergypartners.com.

(code #: EVEP/G)

EV Energy Partners, L.P., Houston
Nicholas Bobrowski
713-651-1144
http://www.evenergypartners.com
Tuesday, August 30th, 2016 Uncategorized Comments Off on $EVEP Announces Approval of Unitholder Proposals

$NRCIB Recognizes Award Winners, Declares Quarterly Dividend

SAN DIEGO, CA–(August 30, 2016) – National Research Corporation (NRC) (NASDAQ: NRCIA) (NASDAQ: NRCIB) is proud to announce the 2016 Excellence, Dimension, and Improvement Best Practice Award winners. The winners were recognized at awards presentations throughout the 22nd Annual NRC Picker Patient-Centered Care Symposium, August 28-30 in San Diego.

Twenty-nine NRC clients received the Excellence Award. The award recipients were selected based on their achievement status within categories that patients have identified as being most important to the quality of their care. The award is only bestowed upon those organizations that are ranked by patients as being a top performer in one of the following categories: Overall Hospital Rating, Overall Provider Rating, Improvement Planner Champion, Value-Based Purchasing Champion, and Patient-Centered Care Champion. Click here to learn more about the award categories and see the winners.

In addition to the Excellence Awards, the Dimension Awards honor organizations with highest combined percentages of patients rating them positively on one of the the eight individual Dimensions of Patient-Centered Care: Access to Care, Continuity and Transition, Coordination of Care, Emotional Support, Information and Education, Involvement of Family and Friends, Physical Comfort, and Respect for Patient Preferences. The Patient Centered Care Champion represents the organization that had the highest combined rating for all eight dimensions.

Kaiser Permanente Woodland Hills Medical Center, Woodland Hills, CA received the Improvement Best Practice Award. The award is given to an organization that has demonstrated best practices resulting in significant improvements in patient-centered care and healthcare outcomes. NRC defines a best practice in patient-centered care as an innovative use of resources with documented results of significant improvement in cost, quality, patient satisfaction, and safety — all factors that affect the health of an organization and its patients.

The other top two finalists for the Improvement Best Practice Award were Sentara Williamsburg Regional Medical Center (Sentara Healthcare), Williamsburg, VA and Texas Scottish Rite Hospital for Children, Dallas, TX.

“It is always a special pleasure for us to honor the work of so many outstanding organizations making significant efforts to improve the quality of patient-centered care. The Symposium Excellence Awards recognize the work of so many people, all focusing on what matters most to those they serve,” said Helen Hrdy, Senior Vice President of Client Service at NRC.

About Symposium
The NRC Picker Patient-Centered Care Symposium provides an opportunity for healthcare professionals to network and share best practices related to improving the patient experience across the healthcare continuum. The event encompasses leading professional speakers, hands-on breakout sessions, and topical agenda items that cover the latest trends in healthcare.

About National Research Corporation
For 35 years, National Research Corporation (NASDAQ: NRCIA) (NASDAQ: NRCIB) has been at the forefront of patient-centered care. Today, the company’s focus on empowering customer-centric healthcare across the continuum extends patient-centered care to incorporate families, communities, employees, senior housing residents, and other stakeholders.

For more information call 800-388-4264, write to info@nationalresearch.com, or visit www.nationalresearch.com.

Contact:
Kayla Lounsbery
Marketing Director
National Research Corporation
800-388-4264
klounsbery@nationalreesearch.com

LINCOLN, NE–(August 30, 2016) – National Research Corporation (NASDAQ: NRCIA) (NASDAQ: NRCIB) today announced that its Board of Directors has declared a quarterly cash dividend of $0.08 (eight cents) per Class A share and $.48 (forty-eight cents) per Class B share payable Friday, October 14, 2016, to shareholders of record as of the close of business on Friday, September 30, 2016.

For more than 35 years, National Research Corporation has been at the forefront of patient-centered care, helping healthcare providers measure and improve quality and services through analytics that offer a rich understanding of customers’ experiences, preferences, risks and behaviors across the healthcare continuum.

Contact:
Kevin R. Karas
Chief Financial Officer
402-475-2525

Tuesday, August 30th, 2016 Uncategorized Comments Off on $NRCIB Recognizes Award Winners, Declares Quarterly Dividend

$KPTI to Host Conference Call with Update on #MultipleMyeloma Plans

NEWTON, Mass., Aug. 30, 2016  — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced it will provide an overview of top-line results from its Phase 2b STORM study and the planned development path for selinexor (KPT-330) in multiple myeloma (MM) on Tuesday, September 6, 2016, followed by a conference call on Tuesday, September 6, 2016 at 8:30 a.m., Eastern time.  To access the conference call, please dial (855) 437-4406 (US) or (484) 756-4292 (international) at least five minutes prior to the start time and refer to conference ID: 74213103.  Accompanying slides will be available under “Events & Presentations” in the “Investor” section of Karyopharm’s website, http://www.karyopharm.com, where an audio recording of the call will be available approximately two hours after the event.

Karyopharm today confirmed that, as had been reported on clinicaltrials.gov, it intends to expand its Phase 2b STORM study evaluating the activity of selinexor in multiple myeloma (MM) to include approximately 120 additional patients with penta-refractory MM.  Patients with penta-refractory myeloma have previously received two proteasome inhibitors (PIs) (bortezomib (Velcade®) and carfilzomib (Kyprolis®)) and two immunomodulatory agents (IMiDs) (lenalidomide (Revlimid®) and pomalidomide (Pomalyst®)), and their disease is refractory to at least one PI, at least one IMiD and an anti-CD38 monoclonal antibody, such as daratumumab (Darzalex™) or isatuximab, and has progressed following their most recent therapy.  Selinexor, the Company’s lead, novel, oral Selective Inhibitor of Nuclear Export / SINE™ compound, is being developed for the treatment of a variety of malignancies, including MM.

About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other major diseases. Karyopharm’s SINE™ compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). In addition to single-agent and combination activity against a variety of human cancers, SINE™ compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm, which was founded by Dr. Sharon Shacham, currently has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the therapeutic potential of and potential clinical development plans for Karyopharm’s drug candidates, including the reporting of data from such trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. For example, there can be no guarantee that selinexor (KPT-330) will successfully complete necessary preclinical and clinical development phases or that development of selinexor will continue.  Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Karyopharm’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; Karyopharm’s ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm’s competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm’s ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption “Risk Factors” in Karyopharm’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, which was filed with the Securities and Exchange Commission (SEC) on August 4, 2016, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Velcade® is a registered trademark of Takeda Pharmaceutical Company Limited
Revlimid® and Pomalyst® are registered trademarks of Celgene Corporation
Kyprolis® is a registered trademark of Onyx Pharmaceuticals, Inc.
Darzalex™ is a trademark of Janssen Biotech, Inc.

Contact:
Justin Renz
(617) 658-0574
jrenz@karyopharm.com

Gina Nugent
(617) 460-3579
nugentcomm@aol.com
Tuesday, August 30th, 2016 Uncategorized Comments Off on $KPTI to Host Conference Call with Update on #MultipleMyeloma Plans

$RIGL #Fostamatinib Meets Primary Endpoint in Phase 3 Study in Chronic #ITP

Conference call and webcast today at 8:00 AM Eastern Time

SOUTH SAN FRANCISCO, Calif., Aug. 30, 2016  — Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, met the primary endpoint in the first of two double-blind studies in the FIT Phase 3 clinical program for the treatment of adult chronic/persistent immune thrombocytopenia (ITP).  The study (n=76) showed that 18% of patients receiving fostamatinib achieved a stable platelet response compared to none receiving a placebo control (p=0.0261).  A stable platelet response was defined as achieving greater than 50,000 platelets per uL of blood on at least four of the last six scheduled visits between weeks 14 and 24 of treatment. The results from the second FIT Phase 3 study are expected in October/November 2016.

The most frequent adverse events were gastrointestinal-related, and the safety profile of the product was consistent with prior clinical experience, and no new or unusual safety issues were discovered.

“These data demonstrate the potential benefit of fostamatinib for chronic ITP patients who are in need of new treatment options,” said Raul Rodriguez, president and chief executive officer of Rigel. “We believe that fostamatinib has significant commercial potential given that it has a unique mechanism of action that may work where other products have failed.”

“We are very encouraged by these results,” said Anne-Marie Duliege, M.D., executive vice president and chief medical officer of Rigel. “Consistent with the prior clinical study of fostamatinib in ITP, this FIT Phase 3 study demonstrated that fostamatinib provided a robust and enduring benefit for those patients who responded to the drug candidate.”

Patients who met the primary endpoint of this study typically had an increase in platelet counts to a level above 50,000/uL within the initial weeks of treatment, providing early feedback as to whether it was a viable option for treating their ITP.

In general, the clinical goal of ITP treatment is to raise platelet counts to more than 50,000/uL. Patients who met the primary endpoint in this study had their platelet counts increase from a median of 16,000/uL at baseline to a median of more than 100,000/uL at week 24, a robust response that potentially allows patients to remain above 50,000/uL more consistently.

All of the patients from this study who met the stable platelet response endpoint enrolled in the long-term, Phase 3 extension study and continued to maintain their platelet levels for months past the initial study period of 24 weeks. These data affirm similar results observed in two patients from the Rigel Phase 2 study of fostamatinib in ITP who have been taking fostamatinib for more than seven years and have maintained stable platelet levels over this extended time period.

Fostamatinib’s clinical safety profile includes more than 5,000 patient years of data across multiple autoimmune indications and has a well-defined and manageable safety profile, providing data that it may be suitable for long-term maintenance therapy in chronic ITP.

If these results are reproduced in the second Phase 3 study and are supported by the results of a planned interim analysis of the Phase 3 extension study, the company expects to submit a New Drug Application with the U.S. Food and Drug Administration in the first quarter of 2017.  Further results from the FIT Phase 3 studies and long-term extension will be presented at future medical meetings.

FIT Phase 3 Program
The FIT program consists of two identical multi-center, randomized, double-blind, placebo-controlled studies of approximately 75 adult patients each. The patients have been diagnosed with persistent or chronic ITP, and have blood platelet counts consistently below 30,000/uL of blood. The patients all had experience with at least one other ITP treatment such as steroids, Rituxan, splenectomy and/or TPO mimetics.  Patients were randomized in a 2:1 ratio to receive either fostamatinib or placebo twice a day to be taken for up to six months. Study subjects remained on treatment for up to 24 weeks.  The primary efficacy endpoint of this program is a stable platelet response defined as achieving platelet counts at or above 50,000/uL of blood for at least four of the last six clinic visits of the study.  Patients were subsequently offered to enroll in an open-label, Phase 3, long-term extension study, which is ongoing.

Fostamatinib and ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. There are approximately 50-60 thousand adult patients in the U.S. living with primary chronic ITP.  ITP patients can suffer extraordinary bruising, bleeding and fatigue as a result of low platelet counts.  Further, people suffering with chronic ITP live with increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy.  While these treatment options can be effective in treating ITP symptoms, given the heterogeneity of the disease, each has significant limitations. It can be difficult to predict which approved treatments are going to be effective.

Fostamatinib is an oral investigational drug with a unique mechanism of action designed to inhibit SYK kinase, a key player in the immune process that leads to platelet destruction in ITP.  The U.S. Food and Drug Administration has granted Orphan Drug designation to fostamatinib for the treatment of patients with ITP.  Unlike other therapies that modulate the immune system in different ways or stimulate platelet production, fostamatinib may address the underlying autoimmune basis of ITP by impeding platelet destruction.  Fostamatinib potentially offers a compelling addition to the treatment options available for ITP patients.

Conference Call and Webcast Presentation Today at 8:00AM Eastern Time
Rigel will hold a live conference call and webcast today at 8:00am Eastern Time (5:00am Pacific Time). Participants can access the live conference call by dialing 855-892-1489 (domestic) or 720-634-2939 (international) and using the Conference ID number 72149873.

The conference call and accompanying slide presentation will also be webcast live and can be accessed from Rigel’s website at www.rigel.com.  The webcast will be archived and available for replay after the call via the Rigel website.

About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a clinical-stage biotechnology company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company’s current clinical programs include fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, which is in Phase 3 clinical trials for immune thrombocytopenia (ITP); a Phase 2 clinical trial for autoimmune hemolytic anemia (AIHA); and a Phase 2 clinical trial for IgA nephropathy (IgAN). In addition, Rigel has two oncology product candidates in Phase 1 development with partners BerGenBio AS and Daiichi Sankyo.

This press release contains “forward-looking” statements, including, without limitation, statements related to Rigel’s clinical development plans, including the timing, design and nature of planned clinical trials and the timing and nature of results of those trials, as well as the potential activity of fostamatinib with respect to ITP. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “planned,” “will,” “may,” “expect,” and similar expressions are intended to identify these forward-looking statements.  These forward-looking statements are based on Rigel’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, the availability of resources to develop Rigel’s product candidates, Rigel’s need for additional capital in the future to sufficiently fund Rigel’s operations and research, the uncertain timing of completion of and the success of clinical trials, risks associated with and Rigel’s dependence on Rigel’s corporate partnerships, as well as other risks detailed from time to time in Rigel’s reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-Q for the year ended June 30, 2016. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

Contacts:

Raul Rodriguez
Phone: 650.624.1302
Email: invrel@rigel.com

Jessica Daitch
Chandler Chicco Agency
Phone: 917.816.6712
Email: jessica.daitch@inventivhealth.com

Tuesday, August 30th, 2016 Uncategorized Comments Off on $RIGL #Fostamatinib Meets Primary Endpoint in Phase 3 Study in Chronic #ITP

$NYMX New Phase 3 Long-Term U.S. Results For #Prostate Enlargement Drug #Fexapotide Show

1. Dramatic Decrease in Prostate Cancer and

2. Major Reduction in Need For BPH Prostate Surgery

HASBROUCK HEIGHTS, N.J., Aug. 29, 2016  — Nymox Pharmaceutical Corporation (Nasdaq:NYMX) lead drug fexapotide which has been in development for over a decade and which has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, has been found after 7 years of prospective placebo controlled double blind studies of treatment of 995 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. This is in stark contrast to some conventional BPH treatments in routine clinical use today which on the other hand increase prostate cancer risk, and which have many other well-known undesirable side effects such as retrograde ejaculation which is when men lose the ability to have normal orgasms.

The same clinical program conducted at the same highly regarded treatment centers under rigorous trial scrutiny and performed strictly at arms-length by top teams of clinical investigators across the country, has now also shown that the long-term blinded placebo crossover group study has resulted in an 82-95% reduction in the number of these patients who required surgery after they received crossover fexapotide in the trial, as compared to patients who did not receive fexapotide but instead received crossover conventional approved BPH treatments (p<.0001). The aim of the crossover study was to determine the clinical benefit fexapotide can provide to men who initially were double blind randomized to and received placebo, remained blinded as to their placebo treatment, and who subsequently required additional medical and/or surgical treatment. In this study long-term outcomes were determined in 391 patients who were given double blind placebo injections, which were followed by crossover to other treatments at the patients’ discretion. The numbers of blinded placebo patients who subsequently received surgical treatment during the next 2-3 years for their BPH symptoms were then prospectively analyzed.

For the long-term cancer incidence analysis, the men in the study received fexapotide or placebo for the treatment of their prostate enlargement (BPH) symptoms. All men were thoroughly evaluated at expert urological testing investigational centers to exclude any prostate cancer prior to qualifying for enrollment in the studies. The participants were enrolled at these over 70 top well-known U.S. urological investigational centers, and were followed for up to 7 years (median of 5 years) after treatment. The study analyzed all cases of prostate cancer that were subsequently diagnosed. The expected rate of new prostate cancer in the U.S. general male population in this age group is in the 5-20% range after 7 years. In the BPH population in published large trials of drugs for the prevention of prostate cancer, the incidence of new prostate cancer cases after 4-7 years has been reported in major studies to be 20-25%.  The new data analysis from the Nymox fexapotide study has now shown the statistically significant and very low incidence of 1.3% for prostate cancer in this comparable fexapotide treated BPH population. By comparison, for example in a population of patients with erectile dysfunction treated with PDE5 inhibitor drugs after 4 years the rate of subsequent prostate cancer was 19.5% (and 22.7% in controls) as recently reported in a large U.S. study published in the Journal of Urology (Volume 196; 3, 2016). The quoted study was in a population of middle aged and elderly men without prostate cancer, similar to the Nymox study population.

“These results are astonishingly good. Other drug treatments and controls tested in similar studies have been associated with a prostate cancer incidence 10 times higher than the results reported by Nymox for fexapotide. This is truly good news. The data strongly indicate that in addition to benefit for BPH symptoms, fexapotide will also help to prevent cancer in these patients,” said Dr. Ronald Tutrone, one of the Principal Investigators in the Nymox Fexapotide Prostate Cancer and BPH studies. Dr. Tutrone is Chief of the Division of Urology, Greater Baltimore Medical Center; Medical Director of Chesapeake Urology Research Associates and Chairman of the William E. Kalhert Endowment for Urological Research.

“These exciting results from this long-term prospective analysis confirm what I and other researchers have consistently seen in the clinic —  that it is obvious that fexapotide greatly helps patients in terms of symptomatic benefit for their BPH;  and with these results, the clinical benefit also results in much less need for surgical intervention over the long-term. I believe these clinical results, combined with previously reported incidence and progression of prostate cancer in this patient population are truly important.  Furthermore, the extreme safety of this new drug and the lack of sexual side effects are remarkably helpful for patients,” said Dr. Mo Bidair, Medical Director of San Diego Clinical Trials in San Diego, CA and an Investigator who has participated for many years in the Fexapotide Clinical Trials.

Clinical trial results from Nymox’s Phase 2 clinical program for fexapotide previously have been promptly and frequently reported at large national and international urology meetings, after the completion of the studies. There were peer review publications and over 12 well attended presentations to the AUA and EAU as soon as the Phase 2 data was available. The Company now greatly looks forward to publication of the results and to the upcoming presentations of completed Phase 3 data at national and international medical conferences at the appropriate time.

Dr. Paul Averback, CEO of Nymox said, “The new results now add a third dimension to fexapotide utility: clinical prostate cancer prevention. The drug has now demonstrated statistically significant prospective long-term outcome data showing dramatic reduction in the incidence of newly diagnosed prostate cancer after minimal BPH treatment with fexapotide. Nymox announced in Q3 last year that it will seek regulatory approvals for fexapotide for BPH based on the long-term BPH safety and efficacy data announced Q3 last year. We believe that the exciting new prostate cancer prevention results will add significantly to the evidence in fexapotide’s favor towards our goal of widespread major benefit for middle-aged and elderly men.”

Dr. Averback added, “These prospective study results in blinded placebo crossover patients clearly demonstrate that fexapotide reduces the long-term need for surgery by up to 82-95% compared to approved conventional BPH treatments. We are extremely grateful to the thousands of people who have been part of these clinical trials. The Company also thankfully acknowledges our shareholders for their long-term commitment that supports these studies.”

Nymox has completed and fully financed the execution of seven Phase 3 U.S. BPH (prostate enlargement) clinical protocols, including 2 prospective randomized multicenter single injection double blind clinical trials; 2 U.S. repeat injection clinical trials; and 3 U.S. blinded long-term clinical trial extension studies. In addition, a number of Phase 3 safety and clinical pharmacology studies and analyses have been completed. The Company expects to file for approvals in the next 1-2 quarters.  The Company also expects to report further analyses and results when available in the near future.

Fexapotide is a safe and painless single injection treatment given in the urologist’s office. The drug is in Phase 3 for BPH and Phase 2 for prostate cancer. It has been tested in over 1700 drug and placebo treatment administrations in the U.S.  As a treatment for low grade localized BPH, fexapotide shows long-term efficacy without the safety risk and side effect concerns or added cancer risk associated with currently approved BPH treatments. As a treatment for prostate cancer fexapotide was found to lead to highly statistically significant reduction in disease progression in a large 147 patient multi-year Phase 2 study of U.S. men with low grade cancer.

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

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for fexapotide. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox’s regulatory filings, Nymox’s substantial dependence on fexapotide, Nymox’s commercialization plans and efforts and other matters that could affect the availability or commercial potential of fexapotide. Nymox undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2015, and its Quarterly Reports.

 

Contact:
Paul Averback
Nymox Pharmaceutical Corporation
800-93NYMOX
www.nymox.com
Monday, August 29th, 2016 Uncategorized Comments Off on $NYMX New Phase 3 Long-Term U.S. Results For #Prostate Enlargement Drug #Fexapotide Show

$PRSC & #FrazierHealthcarePartners Announce #StrategicPartnership

Frazier Healthcare Partners to acquire a majority interest in Matrix Medical Network; Providence Service Corporation will maintain a significant interest and have representatives on Matrix’s Board of Director

Transaction values Matrix at $537.5 million

Providence to receive gross cash proceeds of approximately $418 million before transaction costs, taxes, and customary post-closing adjustments

STAMFORD, Conn., Aug. 29, 2016  — The Providence Service Corporation (“Providence”) (Nasdaq:PRSC) today announced it has signed a definitive subscription agreement with an affiliate of Frazier Healthcare Partners (“Frazier”), a leading private equity firm based in Seattle, pursuant to which Frazier will own a 60% equity interest in Matrix Medical Network (“Matrix”), which values Matrix at approximately $537.5 million.  Following closing of the transaction, Providence will retain a 40% equity interest in Matrix and have representatives on Matrix’s Board of Directors.

“This partnership will allow us to accelerate our growth strategy into a diversified healthcare services company by leveraging our proven operational platform as the foundation,” said Walt Cooper, CEO of Matrix.  “We look forward to partnering with one of the preeminent healthcare investors by utilizing their strategic relationships and broad expertise to bring care to more markets and more populations.”

“We are excited to partner with Providence to help Matrix expand its core offerings into adjacent markets and provide innovative additional services to its customers’ members,” said Ben Magnano, General Partner at Frazier.  “This partnership is another successful example of Frazier’s operating partner model whereby we work with experienced executives to identify and invest in growth areas within healthcare.  Brett Moraski, who is a long-tenured managed care executive and Frazier Operating Partner, helped create the opportunity for investment into Matrix in partnership with Providence.  We look forward to working with the Matrix team and Brett to continue driving the future growth of the business.”

According to James Lindstrom, CEO of Providence, “After recently completing its two millionth in-home health assessment visit, we are creating this partnership with Frazier to accelerate Matrix’s growth opportunities.  Partnering with Frazier is an example of how Providence seeks to work with leaders in industry domains, particularly where those partners with deep industry insight, when combined with our long-term investment perspective, can provide advantages for our clients, colleagues and shareholders.  For Providence, the transaction represents a validation of the investment to date and the liquidity provides further opportunity for disciplined capital deployment.”

Strategic Partnership Overview

The strategic partnership with Frazier is expected to generate substantial strategic and operational benefits, such as:

  • Positioning Matrix to accelerate growth in its chronic care management and assessment offerings;
  • Providing Matrix with access to Frazier’s network and domain expertise in payor services, which can provide additional acquisition and investment opportunities for both Providence and Frazier; and
  • Allowing Providence to benefit from Matrix’s enhanced earnings growth profile through its ongoing equity ownership.

The transaction, which has been approved by the Providence Board of Directors, values Matrix at $537.5 million.  Providence will receive gross cash proceeds from Matrix of approximately $418 million before transaction fees, taxes, and customary post-closing adjustments while also retaining a 40% equity interest in Matrix.  The cash proceeds to Providence are comprised of a new term loan fully underwritten by SunTrust Robinson Humphrey and Frazier’s subscription for a 60% equity interest.  Further details can be found in the 8-K to be filed on or about August 31, 2016.

Matrix Background

Acquired by Providence in October 2014 for approximately $393 million, Matrix has strengthened its strategic value through a variety of initiatives under the Matrix and Providence leadership teams.  In an effort to build a foundation for future growth, Matrix has since launched an in-home chronic care management program and expanded its in-home assessments offerings into adjacent markets.  In 2015, Matrix generated $217.4 million of revenue and operating income of $22.1 million, which included $29.5 million of depreciation and amortization.

Additional Transaction Considerations

Providence intends to use a portion of the cash proceeds to repay in full its term loan and swingline credit facilities.  Upon the closing of the transaction, Providence expects to have approximately $194 million of undrawn capacity on its swingline credit facilities.  Based upon Providence’s anticipated outstanding debt immediately after closing of the transaction, Providence expects its annual interest expense to decrease to approximately $0.5 million per year and to be comprised primarily of undrawn revolving commitment fees.

Providence expects to recognize a pre-tax gain as a result of the transaction in the range of $125 million to $150 million in the fourth quarter of 2016.  Upon closing, Providence expects to report its 40% equity interest in Matrix as an equity investment.

Subject to additional management evaluation of market and business conditions, share price and other factors and evaluation and approval by Providence’s Board of Directors, the remaining net proceeds from the transaction may be used by Providence for acquisitions, investments in the long-term development of the Company’s other businesses and the return of capital to stockholders through a share buyback program, among other uses.

The transaction is subject to satisfaction of customary closing conditions and is expected to close in the fourth quarter of 2016.

TripleTree served as financial advisor to Providence.  Debevoise & Plimpton LLP served as Providence’s primary legal counsel.  Goodwin & Proctor LLP served as Frazier’s primary legal counsel.

About Providence

The Providence Service Corporation is a holding company whose subsidiaries provide critical healthcare and workforce development services, comprised of non-emergency transportation services, workforce development services, legal offender rehabilitation services, health assessment services, and care management services in the United States and abroad.  For more information, please visit www.prscholdings.com.

About Frazier Healthcare Partners

Founded in 1991, Frazier Healthcare Partners is a leading provider of growth capital to healthcare companies. The firm has over $2.9 billion in committed capital under management and has made investments in over 170 healthcare companies with investment types ranging from company creation and venture capital to growth buyouts and leveraged recapitalizations. Frazier’s experienced team takes an active approach to helping build portfolio companies, leveraging the team’s deep domain expertise and expansive network of healthcare executives, advisors and industry thought leaders. The firm’s Growth Buyout team invests in profitable companies focusing on healthcare services, pharmaceutical services, medical products, and related sectors. The firm’s Life Sciences team invests in therapeutics and related areas that are addressing unmet medical needs through innovation. Frazier has offices in Seattle, Washington and Menlo Park, California, and invests broadly across the United States, Canada, and Europe. Additional information about Frazier is available through its website, www.frazierhealthcare.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “demonstrate,” “expect,” “estimate,” “forecast,” “anticipate,” “should” and “likely” and similar expressions identify forward-looking statements. In addition, statements that are not historical should also be considered forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. Such forward-looking statements are based on current expectations and assumptions of Providence’s management that involve a number of known and unknown risks, uncertainties and other factors which may cause actual events to be materially different from those expressed or implied by such forward-looking statements. These factors include, but are not limited to, the timing of the closing of, and risks associated with the ability to consummate, the transaction between Providence and Frazier, the ability of Matrix to realize the anticipated benefits of the partnership between Providence and Frazier, the potential impact of the announcement of the transaction or consummation of the transaction on relationships, including with employees, customers and competitors and other risks detailed in Providence’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and subsequent filings.  Providence is under no obligation to (and expressly disclaims any such obligation to) update any of the information in this press release if any forward-looking statement later turns out to be inaccurate whether as a result of new information, future events or otherwise.

Investor Relations Contact
Chris Brigleb – VP of Finance
(203) 816-6589
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$OSUR #OMNIgene Kit Proposed as Standardized Test

Human Longevity Inc. Study on OMNIgene®Ÿ GUT Recently Published in Scientific Reports

BETHLEHEM, Pa., Aug. 29, 2016  — OraSure Technologies, Inc. (NASDAQ:OSUR) announced today that a study conducted by Human Longevity, Inc. (HLI) and published in the Journal Scientific Reports (Nature Publishing Group) on August 25, 2016 proposes the use of the OMNIgene•GUT microbiome sample collection and stabilization device sold by OraSure’s wholly-owned subsidiary, DNA Genotek Inc., in global microbiome studies.  The published report can be found online at http://www.nature.com/articles/srep31731.

Research into the human microbiome is emerging as highly informative to our overall understanding of health and disease risk.  The article discusses the need for standardization of sample collection and stabilization to ensure accurate downstream results in microbiome studies and compares OMNIgene•GUT to existing accepted methods including use of both fresh and frozen samples.

The HLI authors state: “Stabilization of biological samples is crucial for accurate analysis of microbiome data, and for comparison across studies.” They then conclude: “This stabilization and collection device (OMNIgene•GUT) allows for ambient temperature storage, automation, and ease of shipping/transfer of samples. The device permitted the same data reproducibility as with frozen samples, and yielded higher recovery of nucleic acids. Collection and stabilization of stool microbiome samples with the DNA Genotek collection device, combined with our extraction and WGS (whole genome sequencing), provides a robust, reproducible workflow that enables standardized global collection, storage, and analysis of stool for microbiome studies.”

“DNA Genotek is pleased to provide a broad spectrum of kits for nucleic acid collection and stabilization from multiple sample types to enable HLI’s extensive research into genomics and metagenomics,” said Brian Smith, Senior Vice President and General Manager, at DNA Genotek Inc. “We are also proud to offer HLI end-to-end logistics support through our custom kitting and fulfillment services. HLI is a thought leader in the field and we are honored that they have provided such positive feedback, supporting the use of our product in support of discoveries impacting global health and wellness.”

OMNIgene•GUT is an all in one system for the easy self-collection and stabilization of microbial DNA from feces/stool for gut microbiome profiling. The device allows for ambient temperature storage and transportation and provides a liquid sample to enable high throughput automation in a laboratory, offering reduced costs and increased consistency and standardization.

OMNIgene•GUT OMR-200 is available for sale in the USA, and is intended for research use only, not for use in diagnostic procedures. This product has not been approved or cleared by the U.S. Food and Drug Administration.  OMNIgene•GUT OM-200 is available for sale outside the U.S. and is CE marked for in vitro diagnostic use.

About DNA Genotek

DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), focuses on providing high-quality biological sample collection products and end-to-end services for human genomics, microbiome and infectious disease applications. The Company’s Oragene•Dx and ORAcollect•Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries. For more information about DNA Genotek, visit www.dnagenotek.com.

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and distribution of point of care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick® platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure’s portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians’ offices, commercial and industrial entities and consumers. The Company’s products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. For more information on OraSure Technologies, please visit www.orasure.com.

Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com

Ron Ticho
SVP, Corporate Communications
484-353-1575
media@orasure.com
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$SYRS Publish on First Selective #CDK12 #CDK13 #Inhibitor in #Cancer

Novel Small Molecule Approach to Targeting Transcriptional Kinases Validates CDK12 and CDK13 Biology in Cancer

Syros Holds Exclusive Rights to Research, Develop and Commercialize This and Related Selective Small Molecule Inhibitors

Research Findings Published in Nature Chemical Biology

Syros Pharmaceuticals (NASDAQ: SYRS) announced today that research from its scientific founders validates CDK12 and CDK13, members of the transcriptional cyclin-dependent kinase family that play a critical role in regulating gene expression, as promising new drug targets for a range of aggressive and difficult-to-treat cancers. These findings were possible as a result of the discovery of a highly selective CDK12 and CDK13 inhibitor by Syros’ scientific founders and underscore the potential of Syros’ pioneering approach for understanding and drugging transcriptional targets to advance a new wave of medicines that control the expression of disease-driving genes.

The research from Nathanael Gray’s lab at Dana-Farber Cancer Institute and Richard Young’s lab at the Whitehead Institute for Biomedical Research, which was published online today in the peer-reviewed scientific journal Nature Chemical Biology (Zhang T., et al., “Covalent targeting of remote cysteine residues to develop CDK12 and CDK13 inhibitors”), shows that inhibiting CDK12 and CDK13 with a small molecule selectively decreases the expression of DNA damage response genes and super-enhancer associated transcription factors implicated in cancer, including acute leukemia and breast and ovarian cancers. The results suggest that a selective CDK12 and CDK13 inhibitor could be effective as a monotherapy in certain cancers and as a combination therapy in other cancers by increasing their susceptibility to targeted therapies involved in DNA damage repair such as PARP1 inhibitors.

Transcriptional kinases have been historically difficult to drug selectively, and the absence of selective CDK12 and CDK13 inhibitors has hindered the ability to study the consequences of inhibiting them in healthy and cancerous cells. Using a novel chemistry approach, Syros’ scientific founders designed the first selective CDK12 and CDK13 inhibitors. This novel class of inhibitors achieves its selectivity in part by covalently, or irreversibly, binding to a cysteine residue near the kinase domain that is unique to some transcriptional kinases. This approach was first used to create SY-1365, Syros’ first-in-class selective CDK7 inhibitor, which is on track to begin a Phase 1/2 trial in the first half of 2017.

Syros holds all research, development and commercial rights to the research compound described in the paper, as well as related compounds, through both ownership of the intellectual property and a license from Dana-Farber. Syros is leveraging its unique expertise in drugging transcriptional kinases to create selective CDK12 and CDK13 inhibitors suitable for clinical development.

“A key focus of our proprietary gene control platform is understanding and drugging transcriptional targets, including transcriptional kinases. By modulating these targets with small molecules, we aim to control the expression of the critical set of genes driving the disease with a single drug,” said Eric Olson, Ph.D., Syros’ Chief Scientific Officer. “These findings provide further evidence of the therapeutic potential of selectively inhibiting transcriptional kinases as a promising approach for treating a range of aggressive cancers. Building on the work of our founders, as well as our success in creating SY-1365, we believe we are uniquely positioned to create selective inhibitors of CDK12 and CDK13 that can achieve a therapeutic benefit without the toxicities associated with less selective CDK inhibitors.”

Selectivity has proven critical in targeting the CDK family. While pan-CDK inhibitors have shown anti-tumor activity, their clinical utility has been limited due to their toxic effect on blood cells. By contrast, Syros’ selective CDK7 inhibitor SY-1365 has been shown to induce tumor regression and prolong survival in preclinical models of acute leukemia, while having minimal effect on blood cells counts, demonstrating a more favorable profile than a non-selective CDK inhibitor.

About Syros Pharmaceuticals

Syros Pharmaceuticals is pioneering the understanding of the non-coding region of the genome to advance a new wave of medicines that control expression of disease-driving genes. Syros has built a proprietary platform to systematically and efficiently analyze this unexploited region of DNA in human disease tissue to identify and drug novel targets linked to genomically defined patient populations. Because gene expression is fundamental to the function of all cells, the Company’s gene control platform has broad potential to achieve profound and durable benefit across a range of diseases. Syros is focused on cancer and immune-mediated diseases and is advancing a growing pipeline, including its lead drug candidates SY-1425, a selective RARα agonist for genomically defined subsets of patients identified by its platform, for a range of cancers including acute myeloid leukemia and myelodysplastic syndrome, and SY-1365, a selective CDK7 inhibitor for a range of blood cancers and solid tumors. Led by a team with deep experience in drug discovery, development and commercialization, Syros is located in Cambridge, Mass.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements by the Company regarding: progress in its clinical development of SY-1365; its drug development strategies; its plans to develop CDK inhibitors and the potential safety and efficacy profile of such inhibitors; and the potential benefits of the Company’s gene control platform. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: Syros’ ability to: advance the development of its programs, including SY-1425 and SY-1365, under the timelines it projects in current and future clinical trials; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; obtain and maintain necessary regulatory approvals; identify, enter into and maintain collaboration agreements with third-parties; manage competition; manage expenses; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies; risks described under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, which is on file with the Securities and Exchange Commission; and risks described in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.

Media Contact:
Syros Pharmaceuticals
Naomi Aoki, 617-283-4298
naoki@syros.com
or
Investor Contact:
Stern Investor Relations, Inc.
Jesse Baumgartner, 212-362-1200
Jesse@sternir.com

Monday, August 29th, 2016 Uncategorized Comments Off on $SYRS Publish on First Selective #CDK12 #CDK13 #Inhibitor in #Cancer

$MCUR & #LeapTherapeutics Announce Definitive #Merger Agreement

Combined company to advance Leap’s two first-in-class immuno-oncology monoclonal antibodies targeting aggressive cancers

CAMBRIDGE, Massachusetts and PETACH TIKVA, Israel, August 29, 2016 —

Leap Therapeutics, Inc., a clinical stage immuno-oncology company, and Macrocure Ltd. (NASDAQ: MCUR) today announced the signing of a definitive merger agreement. Under the terms of the agreement, Macrocure will become a wholly owned subsidiary of Leap, and Leap will become a public company. In connection with the transaction, Leap will apply to have the shares of the combined entity listed for trading on NASDAQ upon completion of the merger.

Under the terms of the agreement, Macrocure shareholders will exchange their Macrocure shares for newly issued shares of Leap common stock.  In addition, existing Leap investors, including entities affiliated with HealthCare Ventures, have committed to invest an additional $10 million at the closing of the transaction.  On a pro forma basis, after giving effect to the merger and the investment, Macrocure equity holders are expected collectively to own approximately 31.8%, and Leap equity holders are expected collectively to own approximately 68.2%, of the combined company, subject to certain possible adjustments based on Macrocure’s net cash level at closing. Existing Leap shareholders will receive the right to a royalty, under certain circumstances, based on future net sales. The combined company is expected to have a minimum of $30 million of cash at closing to finance future operations.

“The combination with Macrocure positions our organization as a leading immuno-oncology company with sufficient capital to advance our pipeline of first-in-class monoclonal antibodies through significant value-creating events,” commented Christopher K. Mirabelli, PhD, CEO of Leap.  “Importantly, we anticipate achieving substantial clinical milestones over the course of 2016 and 2017.  We plan to present data and initiate randomized studies for DKN-01, our lead development candidate, which has demonstrated clinical activity in esophageal cancer and cholangiocarcinoma when combined with chemotherapy; and we expect to report data from a repeat-dose study of TRX518, a novel GITR agonist monoclonal antibody which is believed to enhance an immune anti-tumor response.”

“After careful review of many alternatives, the executive team and Board of Directors of Macrocure believe this transaction provides great potential for our shareholders,” said Nissim Mashiach, President and Chief Executive Officer of Macrocure Ltd.  “Leap Therapeutics has a maturing pipeline of novel drug candidates focused on key immuno-oncology targets that are designed to provide new and valuable treatment options for patients suffering from aggressive cancers. Furthermore, Leap’s experienced management team has a track record relating to public and private companies and drug development success.”

The executive team of Leap Therapeutics will remain in their positions in the combined entity that will be based out of Leap Therapeutics’ current corporate office in Cambridge, Massachusetts.  The combined entity’s leadership team will consist of Christopher K. Mirabelli, PhD, who will serve as Chief Executive Officer and Chairman of the Board of Directors, Augustine Lawlor as Chief Operating Officer, and Douglas E. Onsi as Chief Financial Officer.  At the closing, two Macrocure designated individuals, including Nissim Mashiach, will join Leap’s Board of Directors.

The Board of Directors of both companies have unanimously approved the proposed merger.  Macrocure’s shareholders who hold approximately 51% of Macrocure’s voting shares, have entered into agreements in support of the proposed transaction.  While these agreements assure the approval of the merger, all Macrocure shareholders will be asked to vote on the merger at a meeting of shareholders.  Additionally, entities affiliated with HealthCare Ventures and Eli Lilly, which own all of Leap’s outstanding voting shares, have entered into agreements in support of the proposed transaction. The transaction is expected to close near year-end, subject to shareholder approval and other customary closing conditions which are set forth in the merger agreement.

Raymond James is serving as exclusive financial advisor to Macrocure Ltd.

Leap expects to file a registration statement on Form S-4 with the U.S. Securities and Exchange Commission to register the shares of common stock to be issued in the merger.  The registration statement will contain more detailed information about the transaction, as well as information about the respective companies. In addition, Macrocure expects to file a current report on Form 6-K shortly regarding the transaction. Macrocure also will be mailing a proxy statement to its shareholders, which will be filed on a current report on Form 6-K and attached as an appendix to Leap’s Form S-4 registration statement.

About DKN-01

DKN-01 is a humanized monoclonal IgG4 monoclonal antibody with neutralizing activity against the Dickkopf-1 protein. DKN-01 is currently being studied in clinical trials in esophageal cancer and cholangiocarcinoma. DKN-01 demonstrated clinical activity as a single agent in patients with non-small cell lung cancer in a Phase 1 dose escalation study that was presented at the American Society for Clinical Oncology (ASCO) 2014 Annual Meeting and in combination with paclitaxel in patients with esophageal cancer in a study that was presented at the European Society for Medical Oncology (ESMO) World GI Congress in 2016.  Additional data from the study of DKN-01 plus the combination of gemcitabine and cisplatin in patients with cholangiocarcinoma will be presented at the ESMO Annual Meeting in October 2016.

About TRX518

TRX518 is a humanized aglycosyl IgG1 monoclonal antibody with agonist activity targeting GITR. TRX518 has been shown to bind and activate GITR through bivalent binding to the receptor. TRX518 was engineered to remove Fc-receptor interactions to prevent complement-mediated cytolysis and antibody-mediated depletion of leukocytes expressing GITR. TRX518 surrogate antibodies have been effective in preclinical animal models, prolonging survival or enhancing immune responses when combined with chemotherapeutics and checkpoint inhibitors.  Initial clinical data on TRX518 was presented at the ASCO 2016 Annual Meeting.

About Leap Therapeutics

Leap Therapeutics is an immuno-oncology company with two clinical stage programs. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in esophageal cancer and cholangiocarcinoma. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response. TRX518 is in clinical trials in patients with advanced solid tumors.  For more information about Leap Therapeutics, please visit http://www.leaptx.com .

About Macrocure Ltd.

Macrocure Ltd. is a clinical-stage biotechnology company that was focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds. For more information, please visit www.macrocure.com.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements that are not historical facts, such as statements regarding assumptions and results related to financial results, forecasts, clinical trials, and regulatory authorizations.  Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements.  Forward-looking statements are based on Macrocure’s and/or Leap’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the expected timing and likelihood of completion of the proposed merger, the occurrence of any event, change, or other circumstance that could result in the termination of the merger agreement or the anticipated financing, receipt and timing of any required governmental or regulatory approvals relating to the registration and listing of Leap’s common stock or otherwise relating to the merger, the anticipated amount needed to finance the combined company’s future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and Macrocure and Leap undertake no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Additional Information and Where to Find It

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval with respect to the proposed Merger or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

In connection with the proposed merger, Leap intends to file with the U.S. Securities and Exchange Commission (SEC) a registration statement on Form S-4 containing a prospectus and other relevant documents relating to the proposed merger and combined company.  Macrocure intends to file a current report on Form 6-K containing its proxy statement and other documents relating to the proposed merger.  This communication is not a substitution for the registration statement, final prospectus, proxy statement, or any other documents that Leap and Macrocure may file with the SEC or send to shareholders in connection with the proposed transaction.  INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, THE PROSPECTUS, THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED, OR TO BE FILED, WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT LEAP, MACROCURE, AND THE PROPOSED MERGER. Investors and security holders will be able to obtain free copies of the registration statement, the prospectus, the proxy statement, and any other documents filed by Leap and Macrocure with the SEC (when available) at the SEC’s website at www.sec.gov. Copies of documents filed by Leap may be obtained for free by contacting Leap Investor Relations by mail at Leap Therapeutics, Inc., 47 Thorndike Street, Suite B1-1, Cambridge, MA 02141, Attention: Investor Relations or by telephone at (617)-714-0360.  Copies of documents filed by Macrocure may be obtained for free by contacting Macrocure Investor Relations by mail at Macrocure Ltd., 25 Hasivim Street, Kiryat Matalon, Petach Tikva 4959383, Israel, Attention: Investor Relations, by telephone at +(972)-54-565-6011, or by going to Macrocure’s Investor Relations page at http://investor.macrocure.com/. The contents of Macrocure’s website are not deemed to be incorporated by reference into the registration statement, the prospectus, or the proxy statement.

 

Leap Therapeutics Contact
Douglas E. Onsi, Chief Financial Officer
donsi@leaptx.com
+1-617-714-0360

Macrocure Ltd. Contact
Shai Lankry, Chief Financial Officer
Shai@macrocure.com
+972-54-565-6011

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$HEB to Present Data on the Activity of #Ampligen Against #Cancer

PHILADELPHIA, Aug. 29, 2016  — Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the “Company” or “Hemispherx”), announced that it will present at CHI’s 4th Annual Immuno-Oncology Summit, August 29 through September 2, 2016 in Boston, MA.  Dr. Christopher Nicodemus of Hemispherx’ Scientific Advisory Board will present the presentation entitled “RINTATOLIMOD: Enhancement of immune responses with a well-tolerated selective TLR3 agonist. The potential for I-O combination.

Dr. David Strayer, Hemispherx’ Chief Scientific Officer, stated, “The next major advance in immuno-oncology will be the use of combinations of drugs that favor the immune system to respond to checkpoint inhibition and improve upon the unprecedented results being recorded with this class of therapy.  We believe that Ampligen as a selective stimulator of innate and adaptive immune responses and modulator of the tumor micro-environment may play an important part in this emerging chapter in immuno-oncology.”

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutics rintatolimod (tradenames Ampligen® or Rintamod®) and Alferon® LDO. Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both rintatolimod and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved for sale in the U.S. and Argentina. The Company’s Alferon N approval in Argentina includes the use of Alferon N Injection (under the pending brand name “Naturaferon”) for use in any patients who fail or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.

Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “intends,” “plans,” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, below, as well as the risks described in Hemispherx’s filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof.

Disclosure Notice
The information in this press release includes certain “forward-looking” statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome in the United States. The final results of these and other ongoing activities could vary materially from Hemispherx’s expectations and could adversely affect the chances for approval of the Ampligen® NDA in the United States and other countries. The clinical studies referenced herein have been previously reviewed by the FDA and are not, in and of themselves, a sufficient basis for approval in the United States. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of the Ampligen® NDA in the United States and other countries.

Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties including, but not limited to, general industry conditions and competition; general economic factors; the Company’s ability to adequately fund its projects; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of the Company’s patents and other protections for products; and the exposure to litigation, including patent litigation, and/or regulatory actions; and numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. The final results of these efforts and/or any other activities could vary materially from Hemispherx’s expectations. Approval of Ampligen® for CFS in the Argentine Republic does not in any way suggest that the Ampligen® NDA in the United States will obtain commercial approval. Also, it is noted that ANMAT approval is only an initial, but important, step in the overall successful commercialization. Namely, additional steps required for commercialization in Argentina will require, among others, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch including possible requirements for approval of final manufacturing, etc., and there are no assurances as to whether or when such multiple subsequent steps will be successfully performed to result in an overall successful commercialization and product launch.

Company/Investor Contact:				     		
Charles Jones								
CJones & Associates Public Relations						
888-557-6480
cjones@cjonespr.com
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$REED Receives Acceptance of Plan to Regain #NYSE #Compliance

LOS ANGELES, Aug. 26, 2016  — Reed’s, Inc. (NYSE MKT:REED), the leading maker of craft sodas nationwide, today announced that it has been notified by the New York Stock Exchange (“NYSE”) that it reviewed the Company’s July 20, 2016 plan and determined to accept the plan and grant a plan period through December 22, 2017.

The Company previously announced on June 28, 2016, that it received a notice from the NYSE that the company’s common stock was not in compliance with the NYSE’s continued listing standard and did not satisfy the listing requirements in Sections 1003(a)(i), 1003(a)(ii) and 1003(a)(iii) of the NYSE MKT Company Guidance since it reported a stockholders’ deficit of $(581,000) as of March 31, 2016 and net losses in its five most recent fiscal years ended December 31, 2015.

ABOUT REEDS
Reed’s, Inc. makes the top-selling sodas in the natural and specialty foods industry and are sold in over 15,000 natural and mainstream supermarkets nationwide. Reed’s products are sold through an additional estimated 40,000 accounts that include specialty gourmet, natural food stores, retail stores, convenience stores and restaurants nationwide and in select international markets. Reed’s has sold over 500 million bottles since inception in June 1989 and is considered the leader of the fast growing craft soda category. Its seven award-winning non-alcoholic Ginger Brews are unique in the beverage industry, being brewed, not manufactured and using fresh ginger, spices and fruits in a brewing process that predates commercial soft drinks. The Company owns the top-selling root beer line in natural foods, the Virgil’s Root Beer product line, and a top-selling cola line in natural foods, the China Cola product line. In 2012, the Company launched its Reed’s Culture Club Kombucha line of organic live beverages. Other product lines include Reed’s Ginger Candies and Reed’s Ginger Ice Creams.

For more information about Reed’s, please visit the Company’s website at: http://www.reedsinc.com or call 800-99-REEDS.

Follow Reed’s on Twitter at http://twitter.com/reedsgingerbrew

Reed’s Facebook Fan Page at https://www.facebook.com/ReedsGingerBrew

SAFE HARBOR STATEMENT

Some portions of this press release, particularly those describing Reed’s goals and strategies, contain “forward-looking statements.” These forward-looking statements can generally be identified as such because the context of the statement will include words, such as “expects,” “should,” “believes,” “anticipates” or words of similar import. Similarly, statements that describe future plans, objectives or goals are also forward-looking statements. While Reed’s is working to achieve those goals and strategies, actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. These risks and uncertainties include difficulty in marketing its products and services, maintaining and protecting brand recognition, the need for significant capital, dependence on third party distributors, dependence on third party brewers, increasing costs of fuel and freight, protection of intellectual property, competition and other factors, any of which could have an adverse effect on the business plans of Reed’s, its reputation in the industry or its expected financial return from operations and results of operations. In light of significant risks and uncertainties inherent in forward-looking statements included herein, the inclusion of such statements should not be regarded as a representation by Reed’s that they will achieve such forward-looking statements. For further details and a discussion of these and other risks and uncertainties, please see our most recent reports on Form 10-K and Form 10-Q, as filed with the Securities and Exchange Commission, as they may be amended from time to time. Reed’s undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

 

Reed's, Inc.
Investor Relations
(310) 217-9400 ext. 18
Email: ir@reedsinc.com
www.reedsinc.com
Friday, August 26th, 2016 Uncategorized Comments Off on $REED Receives Acceptance of Plan to Regain #NYSE #Compliance

$GLBL Launches #ConsentSolicitation Related to Senior Notes

BETHESDA, Md., Aug. 26, 2016  — TerraForm Global, Inc. (Nasdaq:GLBL) (the “Company”), a global owner and operator of clean energy power plants, today announced that its subsidiary TerraForm Global Operating, LLC (“TerraForm Global”) has launched the solicitation of consents (the “Consent Solicitation”) from holders of record as of 5:00 p.m., New York City time, on August 25, 2016 (the “Record Date”) of its 9.75% Senior Notes due 2022 (the “Notes”) to obtain waivers (the “Proposed Waiver”) relating to certain reporting covenants under the indenture dated as of August 5, 2015 (as supplemented, the “Indenture”), among TerraForm Global, as issuer, the Guarantors party thereto and U.S. Bank National Association, as trustee, and to effectuate certain amendments to the Indenture (the “Proposed Amendments” and, together with the Proposed Waiver, the “Proposed Waiver and Amendments”).

The Proposed Waiver would waive (i) any and all Defaults or Events of Default (as such terms are defined in the Indenture) existing as of the Waiver Effectiveness Date (as described below and in the Consent Solicitation Statement), and the consequences thereof, with respect to any failure to comply with the Indenture, the Notes or the Note Guarantees (as defined in the Indenture) that may have occurred, directly or indirectly, as a result of, arising from, relating to or in connection with a failure to comply with the covenants set forth in Section 4.03 of the Indenture other than those under Section 4.03(a)(3) thereof relating to current reports on Form 8-K (such covenants, other than those under Section 4.03(a)(3) thereof, being referred to herein as the “Annual and Quarterly Reporting Covenants”) and (ii) compliance with the Annual and Quarterly Reporting Covenants, in each case from the Waiver Effectiveness Date until 5:00 p.m., New York City time, on December 6, 2016 (such time and date, the “Waiver Expiration Date”), if TerraForm Global has not, by the Waiver Effectiveness Date, filed with the Securities and Exchange Commission (the “SEC”) or made publicly available all annual and quarterly reports that would have been required to be so filed or made publicly available pursuant to the Annual and Quarterly Reporting Covenants and cured each Default or Event of Default in connection therewith.

The Consent Solicitation will expire at 5:00 p.m., New York City time, on September 1, 2016, unless extended or earlier terminated by TerraForm Global in its sole discretion (the “Consent Date”).

TerraForm Global’s obligation to accept consents, pay the Consent Fee (as defined below) and effect the Proposed Amendments is conditioned on, among other things, there being validly delivered and unrevoked consents from the Holders of not less than a majority in aggregate principal amount of the Notes and the Proposed Waiver having become effective under the Indenture, simultaneously with payment of such Consent Fee and effectuation of such Proposed Amendments (the “Requisite Consents”). TerraForm Global is offering each Holder that consents (a “Consenting Holder”) to the Proposed Waiver and Amendments a consent fee (the “Consent Fee”) of $5.00 per $1,000 principal amount of the Notes held by such Holder as to which TerraForm Global receives and accepts consents. If the Requisite Consents are received by the Consent Date, TerraForm Global will be deemed to have accepted the consents if, as and when it pays the Consent Fee in respect thereof, at which time the Proposed Waiver and Amendments will become effective. The date and time at which the Proposed Waiver will become effective is referred to as the Waiver Effectiveness Date.

In addition, under the Proposed Waiver, in the event that (x) TerraForm Global, Inc. (the “Company”) publicly announces at any time an M&A Transaction that has been approved by the Board of Directors of the Company and (y) such M&A Transaction includes an offer by TerraForm Global (or one of its affiliates) or a potential acquiror (or one of its affiliates) to each Holder (as defined in the Indenture) of the Notes to repurchase all of that Holder’s Notes at a purchase price in cash at least equal to 101% of the aggregate principal amount of such Notes repurchased, plus accrued and unpaid interest, if any, on such Notes repurchased to the date of repurchase (such an offer, a “Repurchase Offer”), compliance with the Annual and Quarterly Reporting Covenants will be suspended beginning on the date of such public announcement and the Proposed Waiver will continue in full force and effect regardless of the Waiver Expiration Date; provided that such suspension of compliance with the Annual and Quarterly Reporting Covenants shall cease on the date that is six months following the date of such public announcement if such M&A Transaction (or any other M&A Transaction meeting the requirements of the preceding clause (y) relating to a Repurchase Offer) has not been consummated within such six months; provided, further, that if such M&A Transaction (including such other M&A Transaction meeting the requirements of the preceding clause (y) relating to a Repurchase Offer) has been consummated within such six months (it being understood that such M&A Transaction shall have met the requirement of the preceding clause (y) relating to a Repurchase Offer), (x) any and all Defaults or Events of Default existing as of the consummation of such M&A Transaction, and the consequences thereof, with respect to any failure to comply with the Indenture, the Notes or the Note Guarantees that may have occurred, directly or indirectly, as a result of, arising from, relating to or in connection with a failure to comply with the Annual and Quarterly Reporting Covenants will be waived and (y) compliance with the Annual and Quarterly Reporting Covenants will be waived with respect to any fiscal quarter or fiscal year (other than (i) the first full fiscal quarter that begins after the consummation of such M&A Transaction and any subsequent fiscal quarter thereafter and (ii) the first full fiscal year that begins after the consummation of such M&A Transaction and any subsequent fiscal year thereafter) (it being understood that, with respect to each such fiscal period in (i) and (ii) of this clause (y), compliance with the Annual and Quarterly Reporting Covenants shall again apply).

Copies of the Consent Solicitation Statement and the Letter of Consent may be obtained by holders of the Notes from the Tabulation Agent for the Consent Solicitation, Global Bondholder Services Corporation, at (866) 794-2200.

Citigroup Global Markets Inc. is the Solicitation Agent for the Consent Solicitation. Questions regarding the Consent Solicitation may be directed to Citigroup Global Markets Inc., at (800) 558-3745 and (212) 723-6106.

None of TerraForm Global, the Tabulation Agent, the Solicitation Agent, the Trustee or any of their respective affiliates makes any recommendation as to whether holders of the Notes should deliver their consent to the Proposed Waiver pursuant to the Consent Solicitation, and no one has been authorized by any of them to make such a recommendation. Each holder of the Notes must make its own decision as to whether to give its consent.

THIS NEWS RELEASE IS FOR INFORMATIONAL PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION OF CONSENTS IN ANY JURISDICTION.

THE CONSENT SOLICITATION IS BEING MADE ONLY PURSUANT TO THE CONSENT SOLICITATION STATEMENT AND THE LETTER OF CONSENT THAT THE TABULATION AGENT WILL DISTRIBUTE TO HOLDERS OF THE NOTES. HOLDERS OF THE NOTES SHOULD CAREFULLY READ THE CONSENT SOLICITATION STATEMENT AND LETTER OF CONSENT PRIOR TO MAKING ANY DECISION WITH RESPECT TO THE CONSENT SOLICITATION, BECAUSE SUCH DOCUMENTS CONTAIN IMPORTANT INFORMATION, INCLUDING THE VARIOUS TERMS OF, AND CONDITIONS TO, THE CONSENT SOLICITATION.

About TerraForm Global

TerraForm Global is a renewable energy company that is changing how energy is generated, distributed and owned. TerraForm Global creates value for its investors by owning and operating clean energy power plants in high-growth emerging markets. For more information about TerraForm Global, please visit: www.terraformglobal.com.

Contacts:

Investors:

Brett Prior
TerraForm Global
investors@terraform.com

Media:

Meaghan Repko / Joseph Sala / Nicholas Leasure
Joele Frank, Wilkinson Brimmer Katcher
media@terraform.com
(212) 355-4449
Friday, August 26th, 2016 Uncategorized Comments Off on $GLBL Launches #ConsentSolicitation Related to Senior Notes

$BLDP to Present at 2016 #GatewayConference in #SanFrancisco

VANCOUVER, Aug. 26, 2016 – Ballard Power Systems (NASDAQ: BLDP; TSX: BLD) announces that Guy McAree, Director of Investor Relations will present during the 2016 Gateway Conference at The Four Seasons Hotel in San Francisco on Wednesday, September 7th, 2016 at 10:00 a.m.

During his presentation, Mr. McAree will discuss Ballard’s strategic direction and recent progress within the fast-growing fuel cell and clean energy areas. He will also be available on September 7th and 8th at the conference for 1-on-1 meetings with interested investors.

About Ballard Power Systems
Ballard Power Systems (NASDAQ: BLDP; TSX: BLD) provides clean energy products that reduce customer costs and risks, and helps customers solve difficult technical and business challenges in their fuel cell programs. To learn more about Ballard, please visit www.ballard.com.

Friday, August 26th, 2016 Uncategorized Comments Off on $BLDP to Present at 2016 #GatewayConference in #SanFrancisco