Archive for April, 2015
(ISDR) Acquires Cloud-based Disclosure Technology
The Technology Will be Used to Extend its Disclosure Platform as the Company Continues to Increase its Higher Margin, Platform Licensing Product Mix
MORRISVILLE, NC / April 16, 2015 / Issuer Direct Corporation (NYSE MKT: ISDR), a market leader and innovator of disclosure management solutions and cloud-based compliance technologies, today announced it has entered into an asset purchase agreement to acquire a cloud-based, reporting platform technology from Xselus LLC. The acquisition provides Issuer Direct a unique and logical path toward expanding its business and creating the opportunity to introduce higher value-added products and services into both existing and new adjacent markets. The technology will be incorporated into Issuer Direct’s existing Disclosure Management System (DMS), which will enable the Company to offer an issuer a controlled reporting platform.
Brian Balbirnie, CEO of Issuer Direct commented, “This acquisition exemplifies our commitment to becoming an end to end platform for the disclosure and communications marketplace. What makes the Xselus transaction truly unique, is the expertise and thought leadership of the founders, Alex Neblett and John Yapundich, who have joined Issuer Direct in order to assist in growing both our platform and disclosure business. Previous to founding Xselus, Alex and John were founding partners of EDGARfilings and creators of EDGARizer(R), which they sold in 2008 – as such they have a proven understanding of the market and we are delighted to have them on board.”
There are approximately 8,500 + SEC reporting issuers, and more than 75% of them still outsource control of the document to service providers – this is a significant number considering the document properties have not changed in years.
“Given that Issuer Direct is building the ultimate compliance platform, and Xsellus is a key component, Alex and I are thrilled to be joining an amazing team at this juncture in the company’s history,” stated John Yapundich.
“Issuer Direct’s vision to integrate news distribution, full compliance and communications in the flow, is unique in the industry and as such provides Issuer Direct with a clear opportunity to dominate the market for the many smaller issuers,” said Alex Neblett.
Mr. Balbirnie concluded, “As we move our business towards a software-based Platform engagement, we are not only anticipating increased margins from our disclosure business, but management also expects to see significant client growth as the product offer is fully commercialized.”
About Issuer Direct Corporation:
Issuer Direct is a disclosure management and targeted communications company. Our integrated platform provides tools, technologies and services that enable our clients to disclose and disseminate information through our network. With a focus on corporate issuers, the Company alleviates the complexity of maintaining compliance with its integrated portfolio of products and services that enhance companies’ ability to efficiently produce and distribute their financial and business communications both online and in print.
Learn more about Issuer Direct today: http://ir.issuerdirect.com/tearsheet/html/isdr.
Forward-Looking Statements. This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (which Sections were adopted as part of the Private Securities Litigation Reform Act of 1995). Statements preceded by, followed by or that otherwise include the words “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “project,” “prospects,” “outlook,” and similar words or expressions, or future or conditional verbs such as “will,” “should,” “would,” “may,” and “could” are generally forward-looking in nature and not historical facts. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any anticipated results, performance or achievements. The Company disclaims any intention to, and undertakes no obligation to, revise any forward-looking statements, whether as a result of new information, a future event, or otherwise. For additional risks and uncertainties that could impact the Company’s forward-looking statements, please see the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, including but not limited to the discussion under “Risk Factors” therein, which the Company has filed with the SEC and which may be viewed at http://www.sec.gov.
Contact:
Issuer Direct Corporation
Brian R. Balbirnie
919-481-4000
brian.balbirnie@issuerdirect.com
Brett Maas
Hayden IR
(646) 536-7331
brett@haydenir.com
James Carbonara
Hayden IR
(646)-755-7412
james@haydenir.com
(HQCL) Completes 64 MWp Delivery to vogt solar in the UK
Leading developer behind four new solar parks featuring high-quality HSL 60 Poly Modules
SEOUL, South Korea, April 16, 2015 — Hanwha Q CELLS Co. Ltd. (the “Company,” or “Hanwha Q CELLS”) (NASDAQ: HQCL), a top-10 global photovoltaic manufacturer of high-quality, cost-competitive solar modules, today announced that four solar farms with a total of 64 MWp of Hanwha Q CELLS high performance HSL 60 PV modules were completed by vogt solar ltd., a fully-owned subsidiary of ib vogt GmbH, in March 2015. The projects are located in the UK regions of Gloucestershire, Telford and Wrekin, Sussex and Kent.
The solar farms have a total expected annual output of 64.6 GWh — enough to power more than 15,000 British homes. ib vogt GmbH is specialized in the development, financing, turnkey realization, operation and asset management of large scale solar power plants.
“During what has been a very challenging first quarter of 2015 for the UK market, Hanwha SolarOne has once again proven to be a reliable supplier of high quality products and has certainly contributed to our success,” said Carl von Braun, CFO of ib vogt. “Hanwha’s new HSL 60 S modules fit perfectly with our concept of highly optimized solar farms that incorporate state-of-the-art technology and top quality engineering components.”
“As a long-time partner of vogt solar, we are proud to work with this solar farm pioneer once again to complete these impactful solar projects,” said Kyung Min Kim, Managing Director of Hanwha SolarOne GmbH, an EU branch of Hanwha Q CELLS. “With the four solar farms connected to the grid, our durable HSL 60 modules will generate clean, reliable solar energy in the UK for many years to come.”
HSL-60 modules, characterized by excellent performance and extended durability, are backed by a 12 year workmanship warranty and a 25 year linear performance warranty.
About Hanwha Q CELLS
In February 2015 Hanwha Q CELLS Co., Ltd. (NASDAQ:HQCL) emerged as a new global solar power leader from combining two of the world´s most recognized photovoltaic manufacturers, Hanwha SolarOne Co., Ltd. and Hanwha Q CELLS Investment Co., Ltd. The combined company is listed on NASDAQ under the trading symbol of HQCL. It is headquartered in Seoul, South Korea, (Global Executive Headquarters) and Thalheim, Germany (Technology & Innovation Headquarters) and is the world’s largest solar cell manufacturer as well as one of the largest photovoltaic module manufacturers. Due to its diverse international production footprint including facilities in China, Malaysia and South Korea, Hanwha Q CELLS is flexibly positioned to address all global markets, even ones with import tariffs, such as the United States and the European Union. Based on its respected “Engineered in Germany” technology, innovation, and quality, Hanwha Q CELLS offers the full spectrum of photovoltaic products, applications, and solutions, from modules to kits to systems to large scale solar power plants. The combined company is also engaged in downstream development and EPC business. Through its growing global business network spanning Europe, North America, Asia, South America, Africa, and the Middle East the company provides excellent services and long-term partnership to its customers in the utility, commercial, government, and residential markets. Hanwha Q CELLS is a flagship company of Hanwha Group, a FORTUNE® Global 500 firm, and a top-ten business enterprise in South Korea. For more information, visit: http://investors.hanwha-qcells.com/.
About ib vogt
Established in 2002, ib vogt GmbH has been focusing on the development of solar power plants in the UK, Germany, the Southeast Asian and Indian markets since 2009.
ib vogt’s activities cover project development, financing, engineering, procurement, construction, operation and maintenance, as well as ownership and asset management of its portfolio.
As a manufacturer-independent integrated developer, the company focuses on tailor made solar power plant solutions that maximize lifecycle performance.
To date ib vogt has realized plants with a total rated output of > 400 MWp. All projects have been commissioned on time, quality and budget. ib vogt and its affiliated companies are also invested in solar power plants with a total rated output of approximately 100 MWp. ib vogt employs over 80 experts in all areas of the PV power plant value chain. The company operates from offices in Germany, United Kingdom, Eastern Europe, India and South East Asia.
For more information, please visit: www.vogt-solar.com
Safe-Harbor Statement
This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the quotations from management in this press release and the Company’s operations and business outlook, contain forward-looking statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in Hanwha Q CELLS’ filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. Except as required by law, the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
(XXII) Announces Launch of “0.0 mg Nicotine” MAGIC Cigarettes in Spain
22nd Century Group, Inc. (NYSE MKT:XXII) today announced that on April 21, 2015 in Valencia, Spain at the SH Valencia Palace hotel, the Company will hold a press conference announcing the launch of MAGIC cigarettes in approximately 900 state-licensed retail shops across Spain. MAGIC cigarettes will be available to consumers starting April 24, 2015.
22nd Century’s MAGIC cigarettes are made with the Company’s proprietary very low nicotine tobacco and are manufactured for sale in Europe by Orion Tobacco Corporation. Designed to appeal to discriminating consumers and positioned to compete with premium cigarette brands, MAGIC 0 yields only 0.04 mg nicotine per cigarette – 95% less nicotine than conventional cigarette brands. Indeed, MAGIC 0 is the world’s only virtually nicotine-free tobacco cigarette. MAGIC 2 yields 0.2 mg nicotine per cigarette – an 80% reduction in nicotine as compared to conventional brands.
In accordance with European regulations which require cigarette manufacturers to list the nicotine yield directly on each pack of cigarettes and to round the yield to the nearest 1/10 place, MAGIC 0 packs prominently feature the words: “0.0 mg nicotine.” MAGIC 2 packs read “0.2 mg nicotine.” Dr. Michael Moynihan, VP of Research and Development at 22nd Century remarked: “We are very proud of our technology which allows us to grow the world’s lowest nicotine tobacco. This technology is what makes our extraordinary MAGIC 0 cigarettes possible.”
Aldista 2000, the distributor for MAGIC cigarettes across Spain, has taken pre-orders for MAGIC cigarettes at more than 900 stores and expects to place MAGIC in 2,500 retail stores – approximately 18% of the retail cigarette stores in Spain – by the end of this summer.
Mr. Miguel Molina of Trexper who serves 4,500 retail locations in Spain explained, “Since I learned that MAGIC was coming to Spain, I knew I wanted to sell these nicotine-free cigarettes in my stores. I am confident MAGIC 0 cigarettes will be very well received by consumers who want to be free of their addiction to nicotine.”
“Using proprietary, real tobacco grown in the United States – without any artificial extraction or chemical processes – 22nd Century is the only company in the world that can make ‘0.0 mg nicotine’ cigarettes,” explained Henry Sicignano III, President and Chief Executive Officer. “Launching in Spain is an important first step for us… Later this year, we intend to expand distribution of MAGIC cigarettes to other parts of Europe.”
About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century owns or exclusively controls 128 issued patents plus an additional 52 pending patent applications in 96 countries. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.
Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2014, filed on February 5, 2015, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.
Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com
or
Redington, Inc.
Tom Redington, 203-222-7399
(MNOV) FDA Grants Fast Track To MN-001 (tipelukast)
LA JOLLA, Calif., April 16, 2015 — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for MN-001 (tipelukast) for the treatment of patients with nonalcoholic steatohepatitis (NASH) with fibrosis. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening diseases and demonstrate the potential to address unmet medical needs for such diseases. An important feature of the FDA’s Fast Track program is that it emphasizes frequent communication between the FDA and the sponsor throughout the entire drug development and review process to improve the efficiency of product development. Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval.
In January 2015, MediciNova announced an open Investigational New Drug (IND) application for MN-001 in NASH. Importantly, due to safety data from previous clinical studies of MN-001, FDA has agreed that MediciNova may proceed with a Phase 2 study as the first clinical study of MN-001 in NASH.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are very pleased that MN-001 has received Fast Track designation and believe this validates its potential to address unmet medical needs in this life-threatening disease. We look forward to providing further updates as our development progresses.”
About Fast Track Designation
According to the FDA, in order to be granted Fast Track designation, a drug must (1) be intended for the treatment of a serious or life-threatening disease or condition; and (2) demonstrate the potential to address unmet medical needs for the disease or condition.
A drug that receives Fast Track designation may be eligible for:
- More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
- Accelerated Approval, i.e., approval based on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality;
- Priority Review, with an FDA goal for completing review within six months of submission; and
- Rolling Review, which means that a sponsor can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
About NASH (nonalcoholic steatohepatitis)
Nonalcoholic steatohepatitis (NASH) is a condition in which there is fat in the liver along with inflammation and damage to liver cells. NASH is a common liver disease that resembles alcoholic liver disease but occurs in people who drink little or no alcohol. According to the U.S. National Digestive Diseases Information Clearinghouse (NDDIC), NASH prevalence in the U.S. is 2-5%, and an additional 10-20% of Americans have “fatty liver.” The underlying cause of NASH is unclear, but it most often occurs in persons who are middle-aged and overweight or obese. Many patients with NASH have elevated serum lipids, diabetes or pre-diabetes. Progression of NASH can lead to liver cirrhosis. Liver transplantation is the only treatment for advanced cirrhosis with liver failure. At this time, there is no treatment for NASH.
About MN-001
MN-001 (tipelukast) is a novel, orally bioavailable small molecule compound thought to exert its effects through several mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development and MN-001’s inhibitory effect on 5-LO and the 5-LO/LT pathway is considered to be a novel approach to treat fibrosis. MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. In addition, histopathological data shows that MN-001 reduces fibrosis in multiple animal models.
Previously, MediciNova evaluated MN-001 for its potential clinical efficacy in asthma and had positive Phase 2 results. MN-001 has been exposed to more than 600 subjects and is considered generally safe and well-tolerated.
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a commercial focus on the U.S. market. MediciNova’s current strategy is to focus on MN-166 (ibudilast) for neurological disorders such as progressive MS, ALS and substance dependence (e.g. methamphetamine dependence, opioid dependence) and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). MediciNova’s pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbations of asthma and MN-029 (denibulin) for solid tumor cancers. MediciNova is engaged in strategic partnering and other potential funding discussions to support further development of its programs. For more information on MediciNova, Inc., please visit www.medicinova.com.
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-221, MN-001, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “will,” “would,” “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-221, MN-001, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova’s operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2014 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.
CONTACT: INVESTOR CONTACT: Geoff O'Brien Vice President MediciNova, Inc. info@medicinova.com
(GOGO) Business Aviation Selected by NetJets
Program will deliver one of the most advanced and comprehensive in-flight connectivity and entertainment experiences in the private aviation industry
BROOMFIELD, Colo., April 15, 2015 — Gogo Inc. (NASDAQ: GOGO), a leading provider of in-flight connectivity and entertainment solutions to the global aero market, announces that its subsidiary, Gogo Business Aviation LLC, has been selected by NetJets, a Berkshire Hathaway company and the worldwide leader in private aviation, for a new program that will bring a minimum of 650 Gogo in-flight entertainment and connectivity (IFEC) systems to the NetJets fleet.
The program will provide NetJets customers with a full suite of IFEC capabilities including voice and texting (via passengers’ own smartphones and mobile numbers), Internet, e-mail, on-demand movies, TV episodes, news, moving maps, flight progress information, destination weather and more.
No other fractional provider is believed to offer such an advanced and complete in-flight connectivity and entertainment experience to its customers. Adam Johnson, NetJets’ SVP of Global Sales, Marketing and Owner Services said, “We continue to incorporate the latest in market trends to our fleet offerings through partnerships like we have developed with Gogo. Collectively, these help to create the customer experience that is so unique to NetJets.”
John Wade, Gogo Business Aviation’s executive vice president and general manager, said, “We’re pleased to continue our long-standing relationship with NetJets while helping deliver a new level of in-flight experience to its owners. Connectivity and entertainment services are significant competitive differentiators in today’s fractional market. Behind safety, we continue to hear those services cited as most critical by passengers.”
Today’s announcement marks a number of historic aviation milestones:
- Business aviation’s largest fleet selection of In-Flight Entertainment (IFE)
- Business aviation’s first fleet selection of Gogo Vision
- First deployment of automatic IFE content updates in fractional market
- First selection of Gogo Text & Talk in the fractional market
- Business aviation’s largest fleet selection of Gogo Text & Talk to date
- First selection of UCS 5000 smart router/media server in fractional market
The program will deploy a host of individual products, services and on-board hardware from Gogo Business Aviation, including:
- Gogo Biz – in-flight Internet and voice service
- Gogo Text & Talk – service that enables calling and texting in flight with passengers’ own smartphones and mobile numbers.
- Gogo Vision – in-flight entertainment and information service
- Includes on-demand movies, TV episodes, news, moving maps, flight progress information and destination weather.
- Operationally, Gogo Vision will be updated automatically via Gogo Cloud, the company’s exclusive, nationwide content delivery network. Gogo Cloud is now available at select Signature Flight Support locations in the U.S.
- UCS 5000 – in-cabin smart router and media server
Installations aboard the first aircraft in the program have already been completed at Duncan Aviation facilities in Lincoln, NE, and Battle Creek, MI.
ASSETS FOR EDITORS
- VIDEO: Gogo Text & Talk overview (http://business.gogoair.com/services/gogo-text-and-talk/)
- VIDEO: UCS 5000 smart router and media server overview (http://business.gogoair.com/gogo-business-aviation-ucs-5000-smart-router-and-media-server-hd/)
About Gogo
Gogo is a leading global aero-communications service provider that offers in-flight Internet, entertainment, text messaging, voice and a host of other communications-related services to the commercial and business aviation markets. Gogo has more than 2,000 commercial aircraft equipped with its services on more than 10 major airlines. More than 6,000 business aircraft are also flying with its solutions, including the world’s largest fractional ownership fleets. Gogo also is a factory option at every major business aircraft manufacturer.
Gogo has more than 800 employees and is headquartered in Itasca, IL, with additional facilities in Broomfield, CO, and various locations overseas. Connect with us at www.gogoair.com and http://business.gogoair.com.
About Gogo Business Aviation
Gogo Business Aviation, formerly known as Aircell, is a leading provider of in-flight connectivity equipment, services and support to the business aviation market. Through a full range of capabilities including Internet, voice, entertainment, cockpit data and more, the company increases the productivity, safety, and enjoyment of the business aviation travel experience. An AS9100-certified company, Gogo Business Aviation serves a global customer base and has an authorized dealer/distributor network that spans six continents. The only company to offer all three of business aviation’s most popular network technologies – Gogo Biz®, SwiftBroadband and Iridium – it offers solutions to fulfill any customer need, aircraft type or geography.
A Collier Trophy nominee and the recipient of several dozen awards for innovation, Gogo Business Aviation is widely credited with many of the industry’s most influential historical achievements, beginning with the groundbreaking airborne cellular concept that launched the company in 1991. Connect with us at http://business.gogoair.com and on Twitter at www.twitter.com/gogobizav.
Cautionary Note Regarding Forward-Looking Statements
Certain disclosures in this press release include certain “forward-looking statements” within the meaning of the federal securities laws that are based largely on our current expectations and reflect various estimates and assumptions by the Company. Forward-looking statements are subject to known and unknown risks, tends and uncertainties, many of which may be beyond our control that could cause actual results and achievements to differ materially from those expressed in such forward-looking statements, and are in some instances beyond our control. Such risks, trends and uncertainties include those described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on [February 27, 2015]. The words “may,” “might,” “will,” “could” “should,” “estimate,” “project,” “plan,” “anticipate,” “expect,” “intend,” “outlook,” “seek,” “designed,” “assume,” “implied,” “believe” and similar expressions generally identify forward-looking statements. Readers are cautioned not to place undue reliance on such forward-looking statements, which are being made as of the date of this press release. Any forward-looking information presented herein is made only as of the date of this press release and we undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Media Relations Contact: | Investor Relations Contact: |
Tom Myers | Varvara Alva |
Senior Director, Global Marketing | Vice President, Investor Relations |
Office +1.303.301.3237 | Office +1.630.647.7460 |
tmyers@gogoair.com | ir@gogoair.com |
www.twitter.com/gogobizav |
(NFLX) Teams With Silverback Films and WWF to Create Our Planet
BEVERLY HILLS, Calif., April 15, 2015 — Netflix, the world’s leading Internet TV network, will premiere across all its territories in 2019 in collaboration with Silverback Films and WWF, Our Planet, an astonishing new eight part natural history series made by the creators of the critically and popularly acclaimed series Planet Earth.
The ambitious four year project — the largest of its kind ever attempted — will take viewers into never-before-filmed wilderness areas from the ice caps and deep ocean to deserts and remote forests, introducing them to the most precious species and places that must withstand the impact of humanity so generations to come can enjoy the bounties of the natural world. Using the latest in 4K camera technology, the series and a range of specially produced storytelling for multi-media platforms will bring millions of people into intimate contact with some of the world’s rarest animals and most precious natural habitats.
The series is being produced by Silverback Films, led by Alastair Fothergill and Keith Scholey, who created Planet Earth, Frozen Planet and Blue Planet for the BBC, as well as the Disneynature films Earth, Bears, African Cats and Chimpanzee. WWF, the world’s leading conservation organization with operations in more than 100 countries and over 5 million members, is providing the Silverback team unparalleled access to its projects in protected areas around the world and will collaborate on multi-media storytelling across its web and other platforms.
“Netflix is proud to be the global home for perhaps Silverback’s most ambitious project to date,” said Lisa Nishimura, Vice President, Netflix Original Documentaries. “The Planet projects have enjoyed great success on Netflix and have helped launch new technologies for viewing at home. We think watching Our Planet, fully on demand in 4K will be an unforgettable experience for our members.”
“Our Planet is going to raise the bar for natural history landmarks,” said Alastair Fothergill, Executive Producer Silverback Films. “We will reveal the most amazing sights on Earth and show them in ways they have never been seen before. Partnering with Netflix and WWF gives us the ability to reach and enthuse global audiences with the wonder and importance of the natural world.”
“Our Planet will inspire millions of people around the world by showcasing the planet’s most precious species and most fragile habitats through a visionary series and cutting edge multimedia storytelling,” said Colin Butfield, Executive Producer, WWF. “At this critical time for global conservation we are honored to work with Silverback and Netflix on this completely unique collaboration.”
About Netflix
Netflix (NASDAQ:NFLX) is the world’s leading Internet TV network with over 57 million members in over 50 countries enjoying more than 100 million hours of TV shows and movies a day, including original series. Members can watch as much as they want, anytime, anywhere, on nearly any Internet-connected screen. Members can play, pause and resume watching, all without commercials or commitments.
About Silverback Films
Silverback Films specializes in the production of high quality wildlife films for both television and cinema. Formed in 2012 by Alastair Fothergill and Keith Scholey, the company brings together a world-class team of wildlife filmmakers to create the highest quality natural history films. The company is currently making a landmark series for BBC One, The Hunt and feature films for Disneynature.
About WWF
WWF is one of the world’s largest independent conservation organisations, with more than five million supporters and a global network active in more than one hundred countries. Through our engagement with the public, businesses and government, we focus on safeguarding the natural world, creating solutions to the most serious environmental issues facing our planet, so that people and nature thrive. Find out more about our work, past and present at panda.org
(BIOD) Announces Pricing of Public Offering of Common Stock
DANBURY, CT–(April 15, 2015) – Biodel Inc. (NASDAQ: BIOD) today announced that it has priced a public offering of 32,608,696 shares of its common stock at a price of $0.92 per share. The offering is expected to close on April 20, 2015, subject to customary closing conditions. In addition, Biodel has granted the underwriters a 30-day option to purchase up to 4,891,304 additional shares of common stock to cover over-allotments, if any.
William Blair and Ladenburg Thalmann are acting as joint book-running managers for the offering. Roth Capital Partners is acting as co-manager.
The gross proceeds to Biodel from this offering are expected to be approximately $30,000,000 before deducting underwriting discounts and commissions and other offering expenses payable by Biodel. All of the shares in the offering are being sold by Biodel. Biodel intends to use the net proceeds from the offering for operating costs, capital expenditures and for general corporate purposes, including working capital.
The shares will be issued pursuant to a registration statement on Form S-1, as amended, previously filed with and declared effective by the Securities and Exchange Commission. Biodel also will file with the Securities and Exchange Commission a final prospectus with respect to the offering, which will be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus may also be obtained from the offices of William Blair, by contacting William Blair & Company, L.L.C., 222 West Adams Street, Chicago, IL 60606, Attention: Equity Capital Markets, telephone 312-236-1600.
This announcement shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Biodel, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. Biodel’s product candidates are developed by applying proprietary technologies to existing drugs in order to improve their therapeutic profiles. More information about Biodel is available at www.biodel.com.
Safe-Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent Biodel’s management’s judgment regarding future events. All statements, other than statements of historical facts, including statements regarding Biodel’s strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Biodel’s forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, the progress, timing or success of Biodel’s research and development and clinical programs for Biodel’s product candidates; Biodel’s ability to conduct the development work necessary to finalize the formulation and design of Biodel’s auto-reconstitution glucagon rescue product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the filing of a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for that product candidate; Biodel’s ability to engage a strategic partner in the further development of Biodel’s prandial ultra-rapid-acting insulin formulations, including BIOD-531, which uses regular human insulin, or RHI, as the active pharmaceutical ingredient, and Biodel’s insulin analog-based formulations; the success of Biodel’s formulation development work to improve the stability of Biodel’s newer ultra-rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and injection site toleration characteristics associated with earlier formulations; the results of Biodel’s real-time stability programs for Biodel’s RHI-, insulin analog- and glucagon-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and Biodel’s ability to accurately project long term stability on the basis of accelerated testing; Biodel’s ability to accurately anticipate technical challenges that the company may face in the development of Biodel’s ultra-rapid-acting RHI- and insulin analog-based product candidates or Biodel’s glucagon rescue product candidates; Biodel’s ability to secure approval by the FDA for Biodel’s product candidates under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act; Biodel’s ability to enter into collaboration arrangements for the commercialization of Biodel’s product candidates and the success or failure of any such collaborations into which the company enters, or Biodel’s ability to commercialize its product candidates on its own; Biodel’s ability to enforce Biodel’s patents for Biodel’s product candidates and Biodel’s ability to secure additional patents for Biodel’s product candidates; and other factors identified in our most recent annual report on Form 10-K for the fiscal year ended September 30, 2014. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
BIOD-G
Contact:
Clayton Robertson
(The Trout Group)
+1-646-378-2964
(FOMX) Upsizing and Pricing of Its $60 Million Public Offering
REHOVOT, Israel and BRIDGEWATER, N.J., April 15, 2015 — Foamix Pharmaceuticals Ltd. (Nasdaq:FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing its proprietary topical foams to address unmet needs in dermatology, today announced the pricing of an upsized public offering of 6,451,612 ordinary shares at a price to the public of $9.30 per share. All of the shares are being offered by the company. In addition, Foamix has granted the underwriters a 30-day option to purchase up to 967,741 additional ordinary shares. The offering is expected to close on Monday, April 20, 2015, subject to customary closing conditions.
Barclays Capital Inc., Cowen and Company, LLC and Guggenheim Securities, LLC are acting as book-running managers for the offering. Oppenheimer & Co. Inc. is acting as co-manager. The offering of these securities will be made only by means of a written prospectus. A copy of the prospectus related to the offering, when available, may be obtained from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1 (888) 603-5847, or by emailing: Barclaysprospectus@broadridge.com; Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 631-274-2806, fax: 631-254-7140; or Guggenheim Securities, LLC, 330 Madison Avenue, 8th Floor, New York, NY 10017, Attention: Equity Syndicate Department, telephone: (212) 518-9349 or by emailing: GSEquityProspectusDelivery@guggenheimpartners.com.
A registration statement relating to these securities was declared effective by the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Foamix Pharmaceuticals Ltd.
Foamix is a clinical-stage specialty pharmaceutical company focused on developing and commercializing its proprietary minocycline foam for the treatment of acne and other skin conditions. Foamix’s lead product candidate, FMX101 for moderate-to-severe acne, is a novel topical foam formulation of the antibiotic minocycline. Foamix also has early-stage stable foam formulations of various drugs for the treatment of common dermatological indications.
CONTACT: Dov Tamarkin, CEO Foamix Pharmaceuticals Ltd. dov.tamarkin@foamixpharma.co.il +972-8-9316233 U.S. Investor Relations Michael Rice LifeSci Advisors, LLC 646-597-6979
(SWHC) Updates Financial Expectations
– Increasing Guidance for Fourth Quarter and Full 2015 Fiscal Year Net Sales and Earnings Per Share
SPRINGFIELD, Mass., April 15, 2015 — Smith & Wesson Holding Corporation (NASDAQ Global Select: SWHC), a leader in firearm manufacturing and design, today announced that it is updating expectations for its fourth quarter and full 2015 fiscal year, which will end April 30, 2015. The company indicated that orders throughout its fiscal fourth quarter have been stronger than originally anticipated and it is therefore increasing its guidance.
Financial Outlook
For the fourth quarter of fiscal 2015, the company expects net sales of between $175.0 million and $179.0 million and GAAP earnings per diluted share from continuing operations of between $0.34 and $0.36. On a non-GAAP basis, the company expects earnings per diluted share to be between $0.39 and $0.41. (See below “Reconciliation of Expected GAAP Earnings per Share from Continuing Operations to Expected Non-GAAP Earnings per Share from Continuing Operations” table.)
For full 2015 fiscal year, the company expects net sales of between $546.0 million and $550.0 million and GAAP earnings per diluted share from continuing operations of between $0.84 and $0.86. On a non-GAAP basis, the company expects earnings per diluted share to be between $0.96 and $0.98. (See below “Reconciliation of Expected GAAP Earnings per Share from Continuing Operations to Expected Non-GAAP Earnings per Share from Continuing Operations” table.)
Reconciliation of U.S. GAAP to Non-GAAP Financial Measures
In this press release, certain non-GAAP financial measures, including non-GAAP earnings per share from continuing operations, are presented. From time-to-time, the company considers and uses these supplemental measures of operating performance in order to provide the reader with an improved understanding of underlying performance trends. The company believes it is useful for itself and the reader to review, as applicable, both GAAP measures that include: (i) fair value inventory step-up and backlog expense, (ii) amortization of acquired intangible assets, (iii) acquisition-related costs, and (iv) the tax effect of non-GAAP adjustments, which are primarily related to the acquisition of Battenfeld Technologies, Inc., and the non-GAAP measures that exclude such information. The company presents these non-GAAP measures because it considers them an important supplemental measure of its performance. The company’s definition of these adjusted financial measures may differ from similarly named measures used by others. The company believes these measures facilitate operating performance comparisons from period to period by eliminating potential differences caused by the existence and timing of certain expense items that would not otherwise be apparent on a GAAP basis. These non-GAAP measures have limitations as an analytical tool and should not be considered in isolation or as a substitute for the company’s GAAP measures. The principal limitations of these measures are that they do not reflect the company’s actual expenses and may thus have the effect of inflating its financial measures on a GAAP basis.
About Smith & Wesson
Smith & Wesson Holding Corporation (NASDAQ Global Select: SWHC) is a U.S.-based leader in firearm manufacturing and design, delivering a broad portfolio of quality firearms, related products, and training to the global military, law enforcement, and consumer markets. The company’s firearm division brands include Smith & Wesson®, M&P®, and Thompson/Center Arms™. As an industry leading manufacturer of shooting, reloading, gunsmithing, and gun cleaning supplies, the company’s accessories division produces innovative, top quality products under Battenfeld Technologies, Inc., including Caldwell® Shooting Supplies, Wheeler® Engineering, Tipton® Gun Cleaning Supplies, Frankford Arsenal® Reloading Tools, Lockdown® Vault Accessories, and Hooyman™ Premium Tree Saws. Smith & Wesson facilities are located in Massachusetts, Maine, Connecticut, and Missouri. For more information on Smith & Wesson, call (800) 331-0852 or log on to www.smith-wesson.com.
Safe Harbor Statement
Certain statements contained in this press release may be deemed to be forward-looking statements under federal securities laws, and we intend that such forward-looking statements be subject to the safe-harbor created thereby. Such forward-looking statements include statements regarding orders having been stronger than originally anticipated; and our expectations for net sales, GAAP earnings per diluted share from continuing operations, and non-GAAP earnings per diluted share from continuing operations for the fourth quarter of fiscal 2015 and for fiscal 2015. We caution that these statements are qualified by important factors that could cause actual results to differ materially from those reflected by such forward-looking statements. Such factors include the demand for our products; the costs and ultimate conclusion of certain legal matters; the state of the U.S. economy in general and the firearm industry in particular; general economic conditions and consumer spending patterns; the potential for increased regulation of firearms and firearm-related products; speculation surrounding fears of terrorism and crime; our growth opportunities; our anticipated growth; our ability to increase demand for our products in various markets, including consumer, law enforcement, and military channels, domestically and internationally; the position of our hunting products in the consumer discretionary marketplace and distribution channel; our penetration rates in new and existing markets; our strategies; our ability to introduce new products; the success of new products; our ability to expand our markets; our ability to integrate acquired businesses in a successful manner; the success of our partnership with General Dynamics Ordnance and Tactical Systems; the general growth of our firearm accessories business; difficulties in the integration of Battenfeld Technologies, Inc. with our company; the potential for cancellation of orders from our backlog; and other risks detailed from time to time in our reports filed with the SEC, including our Annual Report on Form 10-K for the fiscal year ended April 30, 2014.
SMITH & WESSON HOLDING CORPORATION AND SUBSIDIARIES | ||||||||
RECONCILIATION OF EXPECTED GAAP EARNINGS PER SHARE FROM CONTINUING OPERATIONS TO EXPECTED NON-GAAP EARNINGS PER SHARE FROM CONTINUING OPERATIONS (Unaudited) |
||||||||
Range for the Three Months Ended April 30, 2015 | Range for the Year Ended April 30, 2015 | |||||||
GAAP income from continuing operations per share – diluted | $ 0.34 | $ 0.36 | $ 0.84 | $ 0.86 | ||||
Fair value inventory step-up and backlog expense | 0.04 | 0.04 | 0.08 | 0.08 | ||||
Amortization of acquired intangible assets | 0.04 | 0.04 | 0.07 | 0.07 | ||||
Acquisition-related costs | — | — | 0.04 | 0.04 | ||||
Tax effect of non-GAAP adjustments | (0.03) | (0.03) | (0.07) | (0.07) | ||||
Non-GAAP income from continuing operations per share – diluted | $ 0.39 | $ 0.41 | $ 0.96 | $ 0.98 |
Contact: Liz Sharp, VP Investor Relations
Smith & Wesson Holding Corp.
(413) 747-6284
lsharp@smith-wesson.com
(CLSN) Positive Interim Data from its Phase 2 DIGNITY Study in Breast Cancer
ThermoDox® Continues to Demonstrate Impressive Local Response Rate in Highly Refractory Patients Company to Initiate Euro-DIGNITY Trial This Quarter European Early Access Program Set to Launch This Month
LAWRENCEVILLE, N.J., April 15, 2015 — Celsion Corporation (NASDAQ: CLSN) announced today positive interim data from its ongoing open-label Phase 2 DIGNITY Trial of ThermoDox® in recurrent chest wall (RCW) breast cancer. The trial is designed to enroll up to 20 patients at several U.S. clinical sites and is evaluating ThermoDox in combination with mild hyperthermia. Of the 16 patients enrolled and treated, 12 were eligible for evaluation of efficacy. Based on data available to date, 67% of patients experienced a clinical benefit of their highly refractory disease with a local response rate of 58% observed in the 12 evaluable patients, notably 5 complete responses (CR), 2 partial responses (PR) and 1 patient with stable disease (SD). The Company remains on track to complete enrollment in the study in the third quarter of 2015.
“The objective tumor response data including 5 complete responses emerging from the Phase 2 DIGNITY study are extremely impressive, particularly since the patients in the trial presented with highly resistant chest wall tumors that had progressed on multiple therapies, including chemotherapy, radiation and hormone therapy,” noted Dr. Nicholas Borys, Celsion’s Senior Vice President and Chief Medical Officer. “Together with the data from earlier Phase 1 studies, these interim results highlight the significant potential of ThermoDox® plus hyperthermia to stabilize disease in this difficult-to-treat patient population, and we look forward to bringing this trial to completion later this year.”
These data are consistent with the previously reported Phase 1 data for ThermoDox® plus hyperthermia in RCW breast cancer, including combined clinical data from the Company’s Phase 1 DIGNITY Study and a Duke University sponsored Phase 1 trial of ThermoDox®. The two similarly designed studies enrolled patients with highly resistant tumors found on the chest wall and who had progressed on previous therapies. There were 29 patients treated in the two trials, representing 11 patients in the DIGNITY study and 18 patients in the Duke study. Of the 29 patients treated, 23 were eligible for evaluation of efficacy. A local response rate of over 60% was reported in 14 of the 23 evaluable patients, with 5 complete responses and 9 partial responses.
“We are leveraging the remarkable data from our ThermoDox® program in RCW breast cancer to accelerate the development and commercialization of ThermoDox® in this indication in Europe,” stated Michael H. Tardugno, Celsion’s chairman, president and CEO. “The strength of the DIGNITY data is driving investigator interest in Europe and forming the basis for our Euro-DIGNITY trial, which is set to begin later this quarter. In addition, we are committed to providing patients who are suffering from this aggressive form of breast cancer with access to ThermoDox®, and continue to work closely with myTomorrows to launch an Early Access Program in Europe for ThermoDox® in RCW breast cancer.”
The Euro-DIGNITY trial will evaluate ThermoDox® plus hyperthermia in RCW breast cancer patients and is designed to support a registration filing in Europe. This study will be conducted in five countries with the support of key European investigators and with assistance from MedLogics Corporation, an Italian-based hyperthermia device company. In addition, Celsion has a license and distribution agreement with myTomorrows to implement an Early Access Program (EAP) for ThermoDox® in all countries of the European Union territory plus Switzerland for the treatment of patients with RCW breast cancer. The Company expects to have ThermoDox® available for sales at commercial prices to physicians who are treating patients with limited therapeutic options in the second quarter of 2015. The EAP provides physicians with access to products in later stage development demonstrating evidence of clinical benefit, with an acceptable safety profile and a quality manufacturing process in place.
About Celsion Corporation
Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company’s lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer. The pipeline also includes EGEN-001, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. Celsion has three platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies, including TheraPlas™, TheraSilence™ and RAST ™. For more information on Celsion, visit our website: http://www.celsion.com.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; HEAT Study data is subject to further verification and review by the HEAT Study Data Management Committee; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses or the possible failure to make such acquisitions or licenses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion’s periodic reports and prospectuses filed with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
(GALE) Completes Over-Enrollment of NeuVax(TM) (nelipepimut-S) Phase 3 Clinical Trial
PRESENT Clinical Trial Milestone Achieved With 758 Patients Enrolled
PORTLAND, Ore., April 14, 2015 — Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced the completion of enrollment in the NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. NeuVax™ is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting.
As anticipated, Galena over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat (ITT) population. The protocol for the PRESENT trial, being conducted under an FDA approved Special Protocol Assessment (SPA), called for 700 patients; and, the Company expects this higher number of ITT patients will increase the confidence in both the timing and quality of the statistics and the final outcome of the trial. The primary endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of treatment, or a total of 141 events (recurrence or death) occur, whichever comes later.
“Completion of enrollment in our Phase 3 PRESENT trial is a landmark event for Galena and for breast cancer patients worldwide,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “As we look forward to reaching our interim analysis by the end of this year or in Q1, 2016, it is important to note the significant medical need that Galena aims to address with NeuVax. Despite advances in the diagnosis and treatment of breast cancer, approximately 25% of node positive patients have a recurrence within three years after achieving no evidence of disease. NeuVax is designed to prevent these often fatal recurrences, and we anticipate that data from the PRESENT study, as well as our ongoing combination studies of NeuVax in breast cancer, will demonstrate this capability.”
“The women in the PRESENT trial are part of the approximately fifty percent of breast cancer patients who have tumors that are HER2 1+ or 2+, and currently have no available treatment options to maintain their disease-free status after their standard of care therapy. Based on our early work with NeuVax, we believe this agent can have a meaningful impact for these women. I am grateful to the hundreds of women who participated in this study and for all of the sites and investigators who devoted their time to help us accomplish this milestone,” added Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center and the Principal Investigator of the PRESENT trial.
PRESENT is a randomized, double blind, placebo controlled, international, Phase 3 trial and is the most advanced study in Galena’s pipeline. The trial is being run in 13 countries at more than 140 sites. The PRESENT trial targets the approximately 50%-60% of women with breast cancer who have low to intermediate (immunohistochemistry [IHC] 1+/2+ or fluorescence in situ hybridization [FISH] < 2.0) HER2 expression and achieved no evidence of disease following current standard of care treatment (surgery, chemotherapy, and radiation therapy). Patients enrolled must be lymph node positive, haplotype (HLA) A2 or A3 positive, and have Stage IIa-IIIa breast cancer. Once patients completed their current standard of care treatment, they are administered an injection once a month for six months (Primary Vaccine Series), then receive five booster injections once every six months for a total of eleven injections over a three year period. Currently there are no other treatment options for these patients to maintain their disease-free status.
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. NeuVax has been shown to bind to HLA-A2 and A3, as well as HLA-A24 and A26 molecules. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading leading to a broader, more robust anti-tumor immune response.
NeuVax is currently in an international, Phase 3 study called PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) being conducted under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). Additional information on the PRESENT trial can be found at www.neuvax.com (clinicaltrials.gov identifier: NCT01479244). Galena has two additional breast cancer studies ongoing with NeuVax in combination with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in node positive and high risk node negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in neoadjuvantly treated node positive and negative HER2 IHC 3+ patients not achieving a pathological complete response (pCR) or adjuvantly treated node positive HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698).
About HER2 1+/2+ Breast Cancer
According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena’s development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company’s commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena’s clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information, visit www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of Abstral® and development of Galena’s product candidates, including patient enrollment in our clinical trials, as well as statements about our expectations, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2014 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.
Abstral and NeuVax are trademarks of Galena Biopharma, Inc. All other trademarks are the property of their respective owners.
CONTACT: Remy Bernarda SVP, Investor Relations & Corporate Communications (503) 405-8258 rbernarda@galenabiopharma.com
(VCYT) & (GE) Announce Research Collaboration
SOUTH SAN FRANCISCO, Calif., April 14, 2015 — Veracyte, Inc. (NASDAQ: VCYT), a molecular diagnostic company pioneering the field of molecular cytology, and GE today announced a research collaboration to develop new solutions that can improve disease diagnosis. Financial and other terms were not disclosed.
“We are delighted to work with GE, a world leader in medical imaging, to explore the concept of deriving innovative diagnostic approaches from a combination of digital imaging and genomic technologies – with a goal of improving patient care and reducing healthcare costs,” said Bonnie H. Anderson, Veracyte’s president and chief executive officer. “This research opportunity is uniquely enabled by our vast database of clinical, imaging and genomic data, which we have assembled through the rigorous prospective, multicenter clinical trials used to develop and validate our genomic tests.”
Veracyte will collaborate with GE Ventures, GE Healthcare, and the GE Global Research Center to explore the feasibility of combining Veracyte’s genomic technology with GE Healthcare’s digital imaging technology. Through the agreement, Veracyte and GE aim to identify features from raw imaging data that, when combined with genomic information, have the potential to elucidate useful, new information to further address unmet clinical needs.
GE Ventures’ director of healthcare ventures, Ruchita Sinha, added, “We’re excited to expand upon our partnership with Veracyte’s industry leading team, and believe this research collaboration will help to further shape the new age of patient care and improve upon disease diagnosis.” Ms. Sinha noted that GE Ventures is an investor in Veracyte.
About Veracyte
Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, focusing on genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s first commercial solution, the Afirma® Thyroid FNA Analysis, centers on the proprietary Afirma Gene Expression Classifier (GEC) to resolve ambiguity in diagnosis and is becoming a new standard of care in thyroid nodule assessment. Since launching its Afirma solution in 2011, Veracyte estimates it has helped approximately 15,000 patients with thyroid nodules avoid unnecessary surgery, reducing healthcare costs by millions of dollars. The Afirma test is recommended in leading practice guidelines and is covered for 145 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte intends to expand its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. The company expects to launch the Percepta™ Bronchial Genomic Classifier, a test to resolve preoperative ambiguity in lung nodules that are suspicious for cancer, by mid-2015. Veracyte is also developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.
About GE Ventures
GE Ventures is committed to identifying, scaling and accelerating ideas that will make the world work better. Focused on the areas of software, advanced manufacturing, energy and healthcare, GE Ventures helps entrepreneurs and start-ups succeed by providing access to GE’s technical expertise, capital and opportunities for commercialization through GE’s global network of business, customers and partners. GE Ventures offers an unparalleled level of resources through its Global Research Center, including: 35,000 engineers; 5,000 research scientists; 8,000 software professionals; as well as 40,000 sales, marketing and development resources in over 100 countries. For more information, please visit http://geventures.com/.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information, please visit www.gehealthcare.com.
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. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our beliefs regarding the drivers of adoption of Afirma, our expectations with respect to our planned entry into the pulmonology market, the potential benefits of the research collaboration with GE, and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and any future products we may develop or sell; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our test; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop new, innovative diagnostic solutions that address unmet clinical needs through strategic alliances; our ability to develop and commercialize new products and the timing of commercialization; our ability to successfully introduce and achieve adoption of our Percepta Bronchial Genomic Classifier; our ability to achieve sales penetration in complex commercial accounts; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to expand into international markets; our ability to obtain capital when needed; and other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Annual Report on Form 10-K for the year ended December 31, 2014. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.
Veracyte, Afirma, Percepta, the Veracyte logo and the Afirma logo are trademarks or registered trademarks of Veracyte, Inc. This press release also contains trademarks and trade names that are the property of their respective owners.
Media:
Tracy Morris
650-380-4413
tracy.morris@veracyte.com
Investors:
Pam Lord
Canale Communications
619-849-6003
pam@canalecomm.com
(CLNE) to Open Four New Natural Gas Fueling Stations
Clean Energy Fuels Corp. (NASDAQ: CLNE) today announced fueling has begun at two new compressed natural gas (CNG) fueling station in Southern California as well as two new truck-friendly CNG stations in Lake Havasu City, Ariz., and Kansas City, Kan. The company also received industry recognition for its new NGV Easy Bay® from Heavy Duty Trucking Magazine as well as the top transit engineering honor at the Canadian Deputy Minister’s Consulting Engineers Awards. Additional agreements representative of Clean Energy’s growing portfolio of natural gas fueling customers were also announced.
Trucking
Seaboard Transport Expands CNG Fueling at Two New Truck-friendly Stations
- Seaboard contracted to increase its CNG fueling by an anticipated 240,000 DGEs annually for its expanded fleet of 58 heavy duty natural gas trucks.
- Clean Energy will open heavy duty truck-friendly stations in Lake Havasu City, Ariz., and Kansas City, Kan. The fleet currently fuels throughout Clean Energy’s network of stations in Calif., Ariz., N.M., Colo., Texas, Ill., Ind., Ohio and Va.
Potelco Signs LNG Fueling Agreement
- Clean Energy to fuel approximately 75 heavy duty liquefied natural gas (LNG) trucks for Washington-based Potelco, Inc.
- The fleet provides electrical and gas line construction and maintenance services for many customers throughout the Northwest and is forecasted to consume approximately 360,000 DGEs of LNG annually.
Team Campbell Logistics Expands CNG Fleet
- Ten additional heavy duty CNG trucks are scheduled to be deployed and fuel at Clean Energy’s Fontana, Calif., station. These additional trucks are forecasted to consume approximately 10,000 DGEs of CNG annually.
Transit
DART Expands CNG Fleet with 63 Additional Buses
- The additional vehicles are forecasted to consume approximately 630,000 DGEs of CNG annually and will fuel at DART’s four natural gas stations built, operated and maintained by Clean Energy.
SuperShuttle of Austin Signs Multi-year Fueling Agreement
- Longtime Clean Energy customer SuperShuttle of Austin has extended its fueling relationship for its fleet of 20 CNG vans fueling at Clean Energy’s Austin public-access station, where it is forecasted to consume approximately 240,000 GGEs of CNG annually.
Torrance, Calif., Public Works Begins Fueling Fleet at Private Station
- Fueling commenced at Torrance’s private natural gas station which was designed, built, and is being operated and maintained by Clean Energy.
- The station is fueling approximately 35 refuse trucks and 29 transit buses with an estimated 390,000 DGEs of CNG annually. The Torrance natural gas transit fleet is expected to expand with an additional 26 transit buses in the second quarter of 2015.
Refuse
Burrtec Contracts with Clean Energy for Third CNG Station
- Clean Energy to design, build, operate and maintain a CNG station in Santa Clarita, Calif., for longtime customer Burrtec.
- The station will fuel approximately 22 CNG refuse trucks which are forecasted to consume approximately 200,000 DGEs of CNG annually.
Accolades
Clean Energy’s IMW Subsidiary Receives Top Award for Transit Engineering at 11th Annual Deputy Minister’s Consulting Engineers Awards
- IMW Industries, Ltd., a wholly-owned subsidiary of Clean Energy, was recognized for its work on Victoria, BC-based BC Transit’s Compressed Natural Gas Bus Fuel Station in Nanaimo, BC.
- This first-of-its-kind CNG station for BC Transit was designed and built by Clean Energy and IMW; it began fueling in the spring of 2014.“Our government is actively promoting natural gas as an efficient and clean transportation fuel, and transit as an environmentally friendly and viable mode of transportation. This new infrastructure supports both these priorities, and I congratulate Clean Energy Fuels for receiving this well-deserved award,” said Todd Stone, Minister of Transportation and Infrastructure, British Columbia.
NGV Easy Bay® Named One of Heavy Duty Trucking’s Top 20 Products of 2015
- Clean Energy’s lowest-cost, code-compliant vapor barrier system for the maintenance and storage of natural gas vehicles earned the fourth spot on Heavy Duty Trucking’s list of Top 20 Products of 2015.
- Each product was evaluated based on, “…its level of innovation, whether it addresses significant industry issues or concerns, and its potential to improve a trucking operation’s bottom line.”
IMW’s CleanCNG Compressor Receives INPRO Award for Innovation
- An international panel of industry experts awarded the prestigious INPRO Award to Clean Energy subsidiary IMW for its CleanCNG product during the 2015 International Gas Show which took place in Warsaw, Poland.
- CleanCNG was recognized for, “astonishing innovation,” for CNG fueling applications.
Natural gas fuel costs up to $1.00 less per gallon than gasoline or diesel, depending on local market conditions. The use of natural gas fuel not only reduces operating costs for vehicles, but also reduces greenhouse gas emissions up to 30% in light -duty vehicles and 23% in medium to heavy duty vehicles. In addition, nearly all natural gas consumed in North America is produced domestically.
About Clean Energy
Clean Energy Fuels Corp. (Nasdaq: CLNE) is the leading provider of natural gas fuel for transportation in North America. We build and operate compressed natural gas (CNG) and liquefied natural gas (LNG) fueling stations; manufacture CNG and LNG equipment and technologies for ourselves and other companies; develop renewable natural gas (RNG) production facilities; and deliver more CNG, LNG and Redeem RNG fuel than any other company in the U.S. For more information, visit www.cleanenergyfuels.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks, uncertainties and assumptions, including without limitation statements about the number of vehicles expected to be deployed and the amount of natural gas fuel expected to be consumed by Seaboard Transport, Potelco, Team Campbell Logistics, DART, SuperShuttle, Torrance Public Works and Burrtec, respectively, and the benefits of natural gas relative to gasoline and diesel. 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, without limitation, the price of natural gas relative to gasoline and diesel, the cost and operating experience associated with natural gas vehicles, and permitting and other factors affecting construction. The forward-looking statements made herein speak only as of the date of this press release and, unless otherwise required by law, the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Additionally, the reports and other documents the Company files with the SEC (available at www.sec.gov) contain risk factors, which may cause actual results to differ materially from the forward-looking statements contained in this news release.
Clean Energy Media Contact:
Patric Rayburn
949-437-1411
patric.rayburn@cleanenergyfuels.com
or
Clean Energy Investor Contact:
Tony Kritzer
949-437-1403
tkritzer@cleanenergyfuels.com
(BCLI) to Present Positive NurOwn® Phase 2a Clinical Data
HACKENSACK, N.J. and PETACH TIKVAH, Israel, April 14, 2015 — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that results from its phase 2a study of NurOwn® in amyotrophic lateral sclerosis (ALS) and additional analyses will be presented at the American Academy of Neurology annual meeting, taking place in Washington D.C. from April 18 to 25, 2015.
BrainStorm’s CEO Tony Fiorino, MD, PhD, commented “We are thrilled to have the opportunity to share our results at this prestigious venue, and we look forward to discussing these findings with the medical community.”
NurOwn® is an autologous cell therapy in which bone marrow-derived mesenchymal stem cells are expanded and then, under proprietary conditions, induced to secrete several neurotrophic factors known to promote neuronal survival. BrainStorm has completed two clinical trials of these neurotrophic factor-secreting mesenchymal stem cells in Israel, and is currently enrolling a randomized, double-blind, placebo-controlled phase 2 study at three centers in the United States.
The presentation details are as follows:
Poster: P2.059 “Autologous Transplantation of Mesenchymal Stem Cells Secreting Neurotrophic Factors (Nurown™) in ALS: Results of a Phase 2 Clinical Trial”
Session Date/Time: Session P2, Tuesday April 21, 2015, 7:30am to 12:00pm (EDT)
Location: Walter E. Washington Convention Center, Washington, DC
About BrainStorm Cell Therapeutics, Inc.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. For more information, visit the company’s website at www.brainstorm-cell.com.
Safe Harbor Statement
Statements in this announcement other than historical data and information constitute “forward-looking statements” and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.’s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as “may,” “should,” “would,” “could,” “will,” “expect,” “likely,” “believe,” “plan,” “estimate,” “predict,” “potential,” and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm’s limited operating history, history of losses; minimal working capital, dependence on its license to Ramot’s technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm’s annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm’s forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management’s beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
(HCHC) Definitive Agreement for the Acquisition of (AFG) Long-Term Care Insurance Businesses
Significant milestone for establishing HC2’s insurance platform Acquisition includes $1.2 billion insurance investment portfolio Former NY State Insurance Superintendent, Jim Corcoran, to head insurance unit
HERNDON, VA–(Apr 14, 2015) – HC2 Holdings, Inc. (NYSE MKT: HCHC)
HC2 Holdings, Inc. (“HC2”) (NYSE MKT: HCHC) is pleased to announce that it has signed a definitive agreement for the acquisition of long-term care and life insurance businesses, United Teacher Associates Insurance Company (“United Teacher”) and Continental General Insurance Company (“Continental General”), pursuant to an agreement with American Financial Group, Inc. (NYSE: AFG) (NASDAQ: AFG) (the “Seller”) for an initial payment of $7 million in cash and HC2 securities. The purchase price is subject to adjustment based on certain items, including operating results through the closing date.
“This transaction marks a significant milestone for establishing our insurance platform, while also supporting the continued growth of HC2,” said Philip Falcone, Chairman, President and Chief Executive Officer of HC2. “Given my prior role and experience investing in the insurance space, I believe this transaction specifically — and the sector more broadly — could be a big value driver for HC2. We are thrilled to partner with Jim Corcoran as the new Executive Chairman of our insurance unit, Continental Insurance Group Ltd., as Jim has significant experience in the insurance industry on both the corporate and regulatory side as the former Superintendent of the New York Insurance Department. Together with Jim, and the management team we’re bringing over from AFG, we see an opportunity to build an attractive portfolio of insurance businesses creating significant shareholder value.”
The purchase price will be paid in a mix of cash, issuance of 11.000% Senior Secured Notes due 2019 and new shares of common stock of HC2 (subject to adjustment as set forth in the Stock Purchase Agreement). As of December 31, 2014, United Teacher’s and Continental General’s statutory capital was approximately $77.6 million with nearly $1.2 billion of total combined investment assets under management.
This acquisition represents HC2’s ongoing vision to acquire operating businesses across a diversified range of industries and to branch out into new verticals. The acquisition is subject to customary closing conditions, including receipt of regulatory approvals by the Texas and Ohio insurance departments. HC2 expects the transaction will close during the third fiscal quarter.
Macquarie Capital is acting as financial advisor and Debevoise & Plimpton LLP is acting as legal advisor to HC2 in the transaction.
Please refer to HC2’s Current Report on Form 8-K to be filed with the Securities and Exchange Commission for a more complete description of the terms and conditions of the Stock Purchase Agreement.
Cautionary Statement Regarding Forward-Looking Statements
This release contains, and certain oral statements made by our representatives from time to time, may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements are based on current expectations, and are not strictly historical statements. In some cases, you can identify forward-looking statements by terminology such as “if,” “may,” “should,” “believe,” “anticipate,” “future,” “forward,” “potential,” “estimate,” “opportunity,” “goal,” “objective,” “growth,” “outcome,” “could,” “expect,” “intend,” “plan,” “strategy,” “provide,” “commitment,” “result,” “seek,” “pursue,” “ongoing,” “include” or in the negative of such terms or comparable terminology. These forward-looking statements inherently involve certain risks and uncertainties and are not guarantees of performance or results, or of the creation of shareholder value, although they are based on our current plans or assessments which we believe to be reasonable as of the date hereof. Factors or risks that could cause our actual results to differ materially from the results are more fully described in our most recent annual report, quarterly reports or other filings with the Securities and Exchange Commission, which are available through our website at http://www.hc2.com/. Such factors and risks that relate to the proposed transaction include the risk that we may not obtain regulatory approval of the transactions contemplated by the definitive agreement on the proposed terms and schedule; the risk that the parties may not be able to satisfy the conditions to closing of the transactions contemplated by the definitive agreement; the risk that the transactions contemplated by the definitive agreement may not be completed in the time frame expected by the parties or at all; and our failure, if the transactions contemplated by the definitive agreement are completed, to achieve the expected benefits of such transactions. Other unknown or unpredictable factors could also affect our business, financial condition and results. Although we believe that the expectations reflected in the forward-looking statements are reasonable, there can be no assurance that any of the estimated or projected results will be realized. You should not place undue reliance on these forward-looking statements, which apply only as of the date hereof. Subsequent events and developments may cause our views to change. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.
About HC2
HC2 Holdings, Inc. is a publicly traded (NYSE MKT: HCHC), diversified holding company, which seeks to acquire and grow attractive businesses that generate sustainable free cash flow. HC2 has a diverse array of operating subsidiaries, each with its own dedicated management team, across a broad set of industries, including, but not limited to, telecom/infrastructure, large-scale U.S. construction, energy, subsea services and life sciences. HC2 seeks opportunities that generate attractive returns and significant cash flow in order to maximize value for all stakeholders. Currently, HC2’s largest operating subsidiaries are Schuff, a leading structural steel fabricator in the United States, and Global Marine, a leading global offshore engineering company focused on subsea cable installation and maintenance. Founded in 1994, HC2 is headquartered in Herndon, Virginia.
About American Financial Group, Inc.
American Financial Group is an insurance holding company, based in Cincinnati, Ohio with assets of over $45 billion. Through the operations of Great American Insurance Group, AFG is engaged primarily in property and casualty insurance, focusing on specialized commercial products for businesses, and in the sale of fixed and fixed-indexed annuities in the retail, financial institutions and education markets. Great American Insurance Group’s roots go back to 1872 with the founding of its flagship company, Great American Insurance Company.
For information on HC2 Holdings, Inc., please contact:
Ashleigh Douglas
ir@HC2.com
212-339-5875
(SZYM) & Flotek Industries Announce Strategic Agreements
Flotek Industries, Inc. (NYSE:FTK) (“Flotek”) and Solazyme, Inc. (NASDAQ:SZYM) (“Solazyme”) today announced the companies and certain subsidiaries have entered into agreements to globally commercialize Flocapso™, an innovative, advanced drilling fluid additive. In addition, Flotek will market Solazyme’s Encapso™ lubricant – the first commercially available, biodegradable encapsulated lubricant for drilling fluids – in certain Middle Eastern markets.
Under the Joint Product Development and Marketing Agreement (the “Joint Agreement”), Flotek and Solazyme will commercialize and market Flocapso, a proprietary formulation combining Flotek’s patented Complex nano-Fluid® chemistries with Solazyme’s proprietary Encapso technology to create an environmentally-conscious, highly effective drilling fluid additive focused on better lubricity and greater stabilization for drilling programs worldwide. Laboratory and commercial testing indicate that the Flocapso additive will allow the use of water-based fluids in wells that previously required more expensive and invasive oil-based products, providing an environmentally superior, more efficient solution to drilling challenges around the globe.
“Our partnership with Solazyme is another important step in Flotek’s quest to identify and partner with innovative and efficacious technologies that advance oilfield chemistry for the benefit of our clients,” said John Chisholm, Chairman, President and Chief Executive Officer of Flotek. “Solazyme’s development of Encapso and its rapid recognition as a break-through lubricant in drilling applications is testament to Solazyme’s world-class research team. We are delighted to have an opportunity to work with the Solazyme team as we continue our focus on developing the best chemistry solutions for the oilfield.”
“We are excited to add Flotek as a strategic partner as we continue to focus on broadening the market and customer base for Encapso,” said Solazyme Chief Executive Officer Jonathan Wolfson. “As a leading, global technology company with a focus on oilfield chemistry, Flotek brings new opportunities to expand sales of Encapso in the Middle East, as well as to commercialize and jointly market Flocapso, a unique and high performance product that provides a large global sales opportunity to satisfy an unmet need through the combination of superior technologies. The new Flocapso drilling solution is designed to provide significant advantages in lubricity and stabilization and a much cleaner environmental footprint.”
Under the Joint Agreement, Flotek and Solazyme will continue the development of the Flocapso chemistries and work cooperatively to market Flocapso worldwide. The companies are currently in an active validation project with a large national oil company in the Middle East and are pursuing commercial applications in both domestic and international markets.
Winner of the Presidential Green Chemistry Challenge Award, Solazyme launched Encapso in early 2014. With its unique, targeted lubricant delivery system, Encapso has shown to increase the rate of penetration, decrease drag and reduce both rotational torque and friction in a variety of vertical and horizontal drilling applications. This can lead to lower drilling costs, reduced non-productive time, and accelerated operations. Developed from Solazyme’s proprietary technology platform, Encapso is non-toxic and biodegradable.
Flotek’s Complex nano-Fluid, or CnF®, chemistries are a series of proprietary, patented chemistries designed to enhance performance in oil and natural gas wells, including increased productivity through improved production rates and higher ultimate recoverability. The proprietary combination of citrus-based solvents and surfactants which are combined to create a nano-molecular chemistry provide unique benefits in the drilling process.
“Last year we acquired certain intellectual property related to the use of CnF in drilling fluid applications from Tony Rea, a drilling fluid technology pioneer, which led to discussions and chemical trials with Solazyme,” said Chisholm. “As a result of Tony’s work showing the efficacy of using CnF to improve drilling results and the combination of Solazyme’s Encapso, we developed Flocapso, a drilling fluid additive that we believe will provide significant improvements to drilling efficiency and effectiveness around the globe.”
In addition, the companies have entered into a Strategic Alliance Agreement (the “Agreement”) whereby Solazyme has granted Flotek exclusive distribution rights to sell and market Encapso as a drilling fluid lubricant in certain territories in the Middle East. In exchange, Flotek has agreed to certain minimum purchases of Encapso from Solazyme in the initial year of the Agreement.
“We are excited about the opportunity to work closely with Solazyme to promote the use of the Encapso lubricant in the Middle East and beyond,” added Chisholm. “Our work with the Solazyme team and Encapso gives us great confidence that this game-changing technology has broad applications in many markets, especially those in which we have established relationships. Combined with our jointly developed Flocapso product, we believe this Agreement creates a meaningful advantage for Flotek as we continue to develop Middle Eastern markets.”
“Flotek’s expertise, infrastructure and established and emerging relationships in the Middle East make them an outstanding partner for Solazyme and Encapso,” added Wolfson. “Combined with our relationships and product support team, we believe the Flotek partnership provides an excellent opportunity to accelerate market adoption of Encapso, both through certain of Flotek’s distribution and sales channels in the Middle East, and through sales of the combined Flocapso drilling fluid additive worldwide.”
About Flotek Industries, Inc.
Flotek is a global developer and distributor of a portfolio of innovative oilfield technologies, including specialty chemicals and down-hole drilling and production equipment. It serves major and independent companies in the domestic and international oilfield service industry. Flotek Industries, Inc. is a publicly traded company headquartered in Houston, Texas, and its common shares are traded on the New York Stock Exchange under the ticker symbol “FTK.”
For additional information, please visit Flotek’s website at www.flotekind.com.
About Solazyme, Inc.
Solazyme, Inc. develops and sells high-performance oils and ingredients that are better for people and better for the planet. Starting with microalgae, the world’s original oil producer, Solazyme creates innovative, sustainable, high-performance products. These include renewable oils and ingredients that serve as the foundation for healthier foods; high-performance industrial products; unique home and personal care solutions; and more sustainable fuels. Headquartered in South San Francisco, Solazyme’s mission is to solve some of the world’s biggest problems with one of the world’s smallest and earliest life forms: microalgae.
For additional information, please visit Solazyme’s website at www.solazyme.com.
Forward-Looking Statements – Flotek Industries, Inc.
Certain statements set forth in this Press Release constitute forward-looking statements (within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934) regarding Flotek Industries, Inc.’s business, financial condition, results of operations and prospects. Words such as expects, anticipates, intends, plans, believes, seeks, estimates and similar expressions or variations of such words are intended to identify forward-looking statements, but are not the exclusive means of identifying forward-looking statements in this Press Release.
Although forward-looking statements in this Press Release reflect the good faith judgment of management, such statements can only be based on facts and factors currently known to management. Consequently, forward-looking statements are inherently subject to risks and uncertainties, and actual results and outcomes may differ materially from the results and outcomes discussed in the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, but are not limited to, demand for oil and natural gas drilling services in the areas and markets in which the Company operates, competition, obsolescence of products and services, the Company’s ability to obtain financing to support its operations, environmental and other casualty risks, and the impact of government regulation.
Further information about the risks and uncertainties that may impact the Company are set forth in the Company’s most recent filings on Form 10-K (including without limitation in the “Risk Factors” Section), and in the Company’s other SEC filings and publicly available documents. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Press Release. The Company undertakes no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this Press Release.
Forward-Looking Statements – Solazyme, Inc.
This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 about Solazyme, including statements that involve risks and uncertainties concerning: its commercialization plans; meeting commercialization and technology targets; successful product trials and market acceptance of its products; and Solazyme’s ability to maintain its relationships with its partners. When used in this press release, the words “will”, “can”, “expects”, “intends” and other similar expressions and any other statements that are not historical facts are intended to identify those assertions as forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any such statement may be influenced by a variety of factors, many of which are beyond the control of Solazyme, that could cause actual outcomes and results to be materially different from those projected, described, expressed or implied in this press release due to a number of risks and uncertainties. Potential risks and uncertainties include, among others: Solazyme’s limited operating history; its limited history in commercializing products; implementation risk in deploying new technologies; its limited experience in constructing, ramping up, optimizing and operating commercial manufacturing facilities; its ability to sell its products at a profit; delays related to construction, start-up, ramp-up and optimization of production facilities; its ability to manage costs, including operational costs at production facilities; its ability to enter into and maintain strategic collaborations; successful product trials by its customers and market acceptance of its products by end-users; its ability to obtain requisite regulatory approvals; and its access, on favorable terms, to any required financing. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on the results of operations or financial condition of Solazyme.
In addition, please refer to the documents that Solazyme, Inc. files with the Securities and Exchange Commission, including its Annual Report on Form 10-K and it’s Quarterly Reports on Form 10-Q, as updated from time to time, for a discussion of these and other risks. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this press release. Solazyme is not under any duty to update any of the information in this press release.
For Solazyme, Inc.
Genet Garamendi, 650-780-4777
VP Communications
Press@solazyme.com
or
For Flotek Industries, Inc.
Investor Relations
713-849-9911
IR@flotekind.com
(GOMO) Receipt of a Preliminary Non-Binding “Going-Private” Proposal at $4.90 per ADS
GUANGZHOU, China, April 13, 2015 — provider of mobile internet products and services globally with a focus on applications and mobile platform development, today announced that its board of directors has received a preliminary non-binding proposal letter, dated April 13, 2015, from Mr. Yuqiang Deng, chairman and chief executive officer of Sungy Mobile, and Mr. Zhi Zhu, co-chief operating officer of the Company. According to the proposal letter, Mr. Deng and Mr. Zhu are interested in acquiring all of the Company’s outstanding ordinary shares that are not currently beneficially owned by them, including ordinary shares represented by the Company’s American depositary shares or “ADSs” (each representing six Class A ordinary shares of the Company), at a price of $4.90 in cash per ADS (or approximately $0.82 in cash per ordinary share).
Mr. Yuqiang Deng and Mr. Zhi Zhu’s proposal letter states that they intend to finance the proposed transaction with debt capital. Furthermore, the proposal letter specifies that Mr. Yuqiang Deng and Mr. Zhi Zhu’s proposal constitutes on a preliminary indication of their interest, and is subject to negotiation and execution of definitive agreements relating to the proposed transaction. There can be no assurance that any definitive offer will be made by Mr. Yuqiang Deng, Mr. Zhi Zhu or any other person, that any definitive agreement will be executed relating to the proposed transaction, or that the proposed transaction or any other transaction will be approved or consummated.
About Sungy Mobile Limited
Sungy Mobile Limited is a leading provider of mobile internet products and services globally with a focus on applications and mobile platform development. Sungy Mobile’s platform product, GO Launcher EX, manages apps, widgets and functions on Android smartphones and serves as users’ first entry point to their phones; it is the mobile access point from which many Android users are able to find new and innovative ways to customize their experience, download apps and interact with their mobile devices every day.
Safe Harbor Statements
This press release contains forward-looking statements. These statements, including management quotes and business outlook, constitute forward-looking statements under the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements. Sungy Mobile does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.
CONTACT: Investor Relations Contact ICR, Inc. Chenjiazi Zhong Tel: +1-646-417-5388 Email: IR@gomo.com
(BLFS) Announces Preliminary Q1 2015 Revenue of $1.5 Million
30% Year Over Year Proprietary Product Revenue Growth; Customer Cell Therapy Pre-Clinical Projects and Clinical Trials With Products Embedded Now Estimated at 185
BOTHELL, Wash., April 13, 2015 — BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues (“BioLife” or the “Company”), today announced preliminary revenue of $1.5 million for the first quarter of 2015 comprised entirely of core proprietary product revenue, representing 30% growth over the same period of 2014.
Proprietary revenue growth was driven by a 92% year over year increase from customers in the regenerative medicine segment. Several new regenerative medicine customers commenced product evaluations in the quarter and others started using CryoStor and HypoThermosol to preserve cell-based therapeutics in clinical trials focused on various cancers including leukemia, melanoma, renal cancer, liver cancer, as well as limb ischemia and dermal defects.
Mike Rice, CEO, remarked on BioLife’s first quarter of 2015 by stating; “Our team is focused on operational execution, acquiring new customers and launching biologistex. We are very encouraged by our progress and optimistic about continued growth in 2015.”
Management estimates that the Company’s proprietary biopreservation media products are being used to preserve living human cells in at least 185 pre-clinical projects and clinical trials in the regenerative medicine market segment. Within the cellular immunotherapy segment of the regenerative medicine market, BioLife’s products are embedded in the manufacturing, storage, and delivery processes of at least 75 clinical trials of chimeric antigen receptor T cells (CAR-T), T cell receptor (TCR), dendritic cell (DC), tumor infiltrating lymphocytes (TIL), and other T cell-based cellular therapeutics targeting solid tumors, hematologic malignancies, and other diseases and disorders.
Other developments during the quarter included:
- Continued progress on the development and pre-launch activities of the biologistex service for cold chain management of biologic payloads.
- Expansion of intellectual property protection with the granting of new Australian patent number 2009228056 titled, “Materials and Methods for Hypothermic Collection of Whole Blood”.
- Dr. Aby J. Mathew, PhD, Chief Technology Officer, was appointed to the founding board of directors of the newly formed Cord Blood Association.
- Kevin O’Donnell, Vice President, Cold Chain Standards, Practices, and Compliance was named 2014 Distinguished Editor/Author of the Year by the Parenteral Drug Association, for his published book “Cold Chain Chronicles”.
Mr. Rice commented further, “We believe that the significant regulatory, economic, and clinical risks our regenerative customers face in developing and commercializing cellular therapeutics will drive continued interest in our biopreservation media products and biologistex service. This market is open for the disruptive technologies that we offer. We believe it is likely that regulatory and payer pressure will continue to influence customers to move away from traditional, non-optimized biopreservation and biologistics methods to engineered, connected solutions that address real unmet needs and provide actionable data on the manufacture and delivery of cell-based therapies that will benefit patients throughout the world.”
About BioLife Solutions
BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company’s proprietary HypoThermosol® and CryoStor® biopreservation media products are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife’s proprietary products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. This enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.
This press release contains forward-looking statements, including, but not limited to, statements concerning the company’s anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, projected financial results, new products, and third party projections regarding the future market for regenerative medicine and cold chain packaging and instrumentation services. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding market adoption of products; uncertainty regarding third party market projections; market volatility; competition; litigation; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
Media & Investor Relations
Daphne Taylor
Senior Vice President, Chief Financial Officer
(425) 402-1400
dtaylor@biolifesolutions.com
(ABIO) Receives FDA Fast Track Designation for Gencaro™ Atrial Fibrillation
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of GencaroTM for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population (heart failure patients with reduced left ventricular ejection fraction, HFREF). Gencaro is the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator.
Dr. Michael Bristow, CEO, ARCA biopharma (Photo: Business Wire)
According to the FDA’s Fast Track Guidance document, Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Gencaro is currently being evaluated as a potential treatment for atrial fibrillation in a genetically-defined heart failure (HFREF) population in GENETIC-AF, a Phase 2B/3 adaptive design clinical trial. ARCA anticipates that enrollment of approximately 200 patients in the Phase 2B portion of the trial will be completed by the end of 2016.
“We view Fast Track designation for the Gencaro development program as an important acknowledgement of the need for advancements in the treatment of atrial fibrillation in heart failure patients,” said Michael R. Bristow, President and Chief Executive Officer of ARCA. “Atrial fibrillation afflicts over 2.7 million people in the United States with 250,000 to 500,000 new cases diagnosed each year. We believe we have a significant opportunity to improve the treatment options for heart failure patients living with atrial fibrillation.”
Fast Track drug development designation was included in the FDA Modernization Act of 1997 (FDAMA) as a formal process to enhance interactions with the FDA during drug development. A drug development program with Fast Track designation is eligible for consideration for some or all of the following programs for expediting development and review: scheduled meetings to seek FDA input into development plans, priority review of the New Drug Application (NDA), the option of submitting portions of an NDA for review prior to submission of the complete application and potential accelerated approval.
Atrial Fibrillation (AF)
Atrial fibrillation, the most common sustained cardiac arrhythmia, is considered an epidemic cardiovascular disease and a major public health burden. The estimated number of individuals with AF globally in 2010 was 33.5 million. According to the 2015 American Heart Association report on Heart Disease and Stroke Statistics, the estimated number of individuals with AF in the U.S. in 2010 ranged from 2.7 million to 6.1 million people. Hospitalization rates for AF increased by 23% among US adults from 2000 to 2010 and hospitalizations account for the majority of the economic cost burden associated with AF.
AF is a disorder in which the normally regular and coordinated contraction pattern of the heart’s two small upper chambers (the atria) becomes irregular and uncoordinated. The irregular contraction pattern associated with AF causes blood to pool in the atria, predisposing the formation of clots potentially resulting in stroke. AF increases the risk of mortality and morbidity due to stroke, congestive heart failure and impaired quality of life. The approved therapies for the treatment or prevention AF have certain disadvantages in patients with heart failure and/or reduced left ventricular ejection fraction (HFREF) patients. These include toxic or cardiovascular adverse effects, and most of the approved drugs for AF are contra indicated or have warnings in their prescribing information for such patients. The Company believes there is an unmet medical need for new AF treatments that have fewer side effects than currently available therapies and are more effective, particularly in HFREF patients.
About Pharmacogenomics
Pharmacogenomics is the study of genetic polymorphisms that underlie individual differences in responses to therapeutics drugs. Pharmacogenomics includes identifying candidate genes and polymorphisms, correlating these polymorphisms with possible therapies, predicting drug response and clinical outcomes, reducing adverse events and selection, and selecting dosing of therapeutic drugs on the basis of genotype. One goal of pharmacogenomics is to customize drugs for defined sub-populations of patients.
A DNA sub-study of patients from the BEST Phase 3 heart failure mortality trial of Gencaro indicated that the combinations of beta-1 389 and alpha-2C polymorphisms in individual patients in the trial appeared to influence the response to Gencaro.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. For more information please visit www.arcabiopharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding, potential timing for patient enrollment in the GENETIC-AF trial, potential timeline for GENETIC-AF trial activities, the sufficiency of the Company’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation prevention treatment. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2014, and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.
Investor & Media Contact:
ARCA biopharma, Inc.
Derek Cole, 720-940-2163
derek.cole@arcabiopharma.com
(REPH) Completes Acquisition of IV/IM Meloxicam and cGMP Manufacturing Facility
– Transformative Acquisition Diversifies Recro Pharma’s Development Risk with Second, Complementary Acute Pain Product
– Phase III-Ready, Long-Acting Injectable Meloxicam Has Demonstrated Robust Efficacy, Good Tolerability in Multiple Phase II Trials
– Transaction Includes Cash Flow Positive Manufacturing, Royalty and Formulation Business
MALVERN, Pa., April 13, 2015 — Recro Pharma, Inc. (Nasdaq:REPH) today announced the completion of its previously announced acquisition of assets from Alkermes plc and its affiliates including worldwide rights to IV/IM meloxicam, a proprietary, Phase III-ready, long-acting COX-2 NSAID for moderate to severe acute pain, and a contract manufacturing facility, royalty and formulation business.
“Completion of this transaction is a significant corporate milestone for Recro Pharma as it provides a second, complementary, Phase III-ready acute pain product to our portfolio, and adds infrastructure and cash flow which may help fund the development of our pipeline in the future,” said Gerri Henwood, Recro Pharma’s CEO. “With upcoming top-line data readout of our Post Op Day 1 Phase II trial of Dex-IN mid-year 2015, we are excited for the potential of having two drug candidates in Phase III for the treatment of acute pain by the end of this year.”
Under the terms of the agreement, Recro Pharma paid Alkermes $50 million up-front and obtained the rights to IV/IM meloxicam and ownership of a cGMP manufacturing facility and related business located in Gainesville, GA. In 2014, this facility generated over $70 million in unaudited revenues. Alkermes is eligible to receive up to an additional $120 million in milestone payments upon the achievement of certain regulatory and net sales milestones and royalties, related to IV/IM meloxicam. At closing, Recro Pharma issued Alkermes a seven-year warrant to purchase an aggregate of 350,000 shares of Recro Pharma common stock. The $50 million up-front payment was funded via a five-year senior secured term loan with an affiliate of OrbiMed (“OrbiMed”). In conjunction with the term loan, Recro Pharma issued OrbiMed a seven-year warrant to purchase an aggregate of 294,928 shares of Recro Pharma common stock.
About Recro Pharma, Inc.
Recro Pharma is a revenue generating specialty pharmaceutical company developing multiple non-opioid therapeutics for the treatment of acute post operative pain. Recro Pharma is currently developing IV/IM meloxicam, a proprietary, Phase III-ready, long-acting COX-2 NSAID, and Dex-IN, a proprietary intranasal formulation of dexmedetomidine in Phase II, for the treatment of acute pain. As Recro Pharma’s product candidates are not in the opioid class of drugs, the Company believes its candidates would avoid many of the side effects associated with commonly prescribed opioid therapeutics, such as addiction, constipation and respiratory distress while maintaining analgesic effect.
As a result of this acquisition, Recro Pharma also owns and operates an 87,000 square foot, DEA-licensed facility that manufactures 5 commercial products and receives royalties associated with the sales of these products.
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Recro Pharma’s expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to Recro Pharma or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Recro Pharma as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause actual events to differ materially from those expressed in the forward-looking statements set forth in this press release including, without limitation: the success of Recro’s products and of the newly acquired products; the parties’ ability to satisfy the purchase agreement conditions (including required regulatory approvals); Recro’s ability to realize anticipated growth, synergies and costs savings from the acquisition; changes in laws and regulations; Recro’s ability to successfully integrate the acquired operations, technology and products and to realize anticipated growth, synergies and cost savings; Recro’s ability to successfully develop, obtain regulatory approvals or commercialize new products and Recro’s ability to protect intellectual property rights. In addition, the forward-looking statements in this press release should be considered together with the risks and uncertainties that may affect Recro Pharma’s business and future results included in Recro Pharma’s filings with the Securities and Exchange Commission at www.sec.gov. Recro pharma assumes no obligation to update any such forward looking statements.
CONTACT: Recro Pharma, Inc. Charles T. Garner Chief Financial Officer (484) 395-2425 Media and Investors: Argot Partners Susan Kim (212) 600-1902 susan@argotpartners.com
(SYRX) Lilien Systems Named to 2015 List of CRN Tech Elite
Big data software solutions and infrastructure provider Sysorex (NASDAQ: SYRX) today announced that its Lilien Systems subsidiary, has once again been named to The Channel Company’s CRN® Tech Elite 250. This annual list recognizes an elite group of IT solution providers that have invested in the training and education needed to earn the most advanced technical certifications from leading vendors. This is the third time that Lilien Systems has been named to the Tech Elite list.
“We are pleased to once again be recognized for our dedication to education and training. Our Professional Services Group has years of experience working with leading technologies in all types of environments,” said Lilien Systems’ President Bret Osborn. “Collectively, our knowledgeable staff holds over 200 technical certifications for products and solutions that span the data center and beyond,” he added.
In compiling the list, The Channel Company’s research group and CRN editors collaborated to assess the most customer-beneficial technical certifications in the IT channel. These technical certifications—from vendors including Cisco, Citrix, Dell, EMC, HP, IBM, NetApp, Microsoft, VMware and Symantec, among others—have enabled solution providers to deliver an outstanding level of premium products, services and support to their North American customers.
“The solution providers selected for our annual Tech Elite 250 have demonstrated a commitment to excellence and gained industry credibility by investing in the IT certifications necessary to deliver exceptional service to their customers and stay competitive,” said Robert Faletra, CEO, The Channel Company. “These featured solution providers have enhanced and strengthened their partnerships by earning some of the most difficult certifications from some of the most prominent names in IT. We congratulate these organizations and look forward to their continued success.”
Coverage of the Tech Elite 250 will be featured in the April issue of CRN, and online at http://assets.cdnma.com/8247/assets/2015_SP_Lists/2015%20TE250%20PDF.pdf.
About The Channel Company
The Channel Company, with established brands including CRN®, XChange® Events, IPED® and SharedVue®, is the channel community’s trusted authority for growth and innovation. For more than three decades, we have leveraged our proven and leading-edge platforms to deliver prescriptive sales and marketing solutions for the technology channel. The Channel Company provides Communication, Recruitment, Engagement, Enablement, Demand Generation and Intelligence services to drive technology partnerships. Learn more at www.thechannelcompany.com.
About Sysorex
Through focused, custom technology solutions, Sysorex (NASDAQ:SYRX) provides cyber security, data analytics, cloud solutions, Mobile/BYOD solutions and strategic outsourcing to government and commercial clients in major industries around the world. From identifying security risks to helping clients realize value from their big data strategies, Sysorex has the experience, technology, partners, and agility to be your trusted IT partner. Visit www.sysorex.com, follow @SysorexGlobal and Like us on Facebook.
Safe Harbor Statement
All statements in this release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of the control of the registrant and its subsidiaries, which could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not limited to, the fluctuation of global economic conditions, the performance of management and employees, our ability to obtain financing, competition, general economic conditions and other factors that are detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements.
The Channel Company:
The Channel Company
Marc Courchesne, 508-416-1110
mcourchesne@thechannelcompany.com
or
Sysorex:
A. Sage Osterfeld, 760-707-0459
sage.osterfeld@sysorex.com
or
Sysorex Investor Relations:
CorProminence LLC
Scott Arnold, 516-222-2560
scotta@corprominence.com
(BLDR) to Acquire ProBuild
Creates Diversified National Pro Dealer with Approximately $6 Billion in Sales
Significantly Enhances Portfolio of Product Offerings, Services and Capabilities Across Broader Operating Footprint
Expects to Generate $100 Million to $120 Million in Annual Cost Savings
Significantly and Immediately Accretive to Earnings with Strong Long-Term Growth Potential
Positions Combined Company to Capitalize on Continued Recovery in Housing Market
DALLAS and DENVER, April 13, 2015 — Builders FirstSource, Inc. (Nasdaq:BLDR), a leading supplier and manufacturer of structural and related building products for residential new construction in the United States, today announced that it has entered into a definitive purchase agreement to acquire ProBuild Holdings LLC (“ProBuild”), one of the nation’s largest professional building materials suppliers, in an all-cash transaction valued at approximately $1.63 billion. The transaction, which was approved by the Builders FirstSource Board of Directors, is subject to customary closing conditions and regulatory approvals and is expected to close in the second half of 2015.
ProBuild was created in 2006 by Devonshire Investors, the private equity firm affiliated with FMR LLC, the parent company of Fidelity Investments. With approximately $4.5 billion in revenue in 2014, ProBuild is one of the largest distributors of building materials to professional builders, contractors and project-oriented consumers in the United States. ProBuild operates lumberyards, component facilities, millwork shops, gypsum yards and retail stores across 40 states. Together, Builders FirstSource and ProBuild will have an enhanced portfolio of products with increased breadth and depth within its categories, including lumber, windows, doors, millwork, hardware, roof and floor trusses, engineered wood products, gypsum, roofing, metal and concrete products, cabinets and countertops. In addition, the combined company will better serve its customer base through its broader scale and operating footprint, enabling it to deliver products and services more effectively and efficiently.
Floyd Sherman, Chief Executive Officer of Builders FirstSource, said, “We are very pleased to announce this compelling combination with ProBuild to create a more diversified company with enhanced scale and an improved geographic footprint that will drive significant value for our customers and stockholders. As the U.S. housing market continues its recovery, we believe now is the ideal time to position Builders FirstSource for its next phase of growth and value creation. Together we will establish a broader, more efficient platform of manufacturing and distribution capabilities, supported by high-quality service from the best talent in the industry. In addition, each of our companies has complementary strengths, and we plan to learn from each other by implementing best practices across the combined company. Builders FirstSource and ProBuild have two of the best sales forces in the industry and share a commitment to enhancing the deep, long-standing customer relationships that each company has cultivated. We look forward to working with the ProBuild team to plan for a seamless integration that will enable us to create exciting new opportunities.”
Paul S. Levy, Chairman of the Board of Builders FirstSource and Founder of JLL Partners, said, “Since JLL Partners founded Builders FirstSource in 1998 and took the company public in 2005, we have been intently focused on creating a leading platform that professionalizes the building products industry through a best practices approach to conducting business. We are accomplishing our objective by providing a variety of products and services as well as personalized attention to our customers at the local level, and the combination announced today will significantly advance these efforts across a broader operating footprint. We are confident that the substantial additional resources that ProBuild brings to Builders FirstSource will help drive significant value creation over the long-term.”
David A. Barr, Managing Director, Co-Head of Industrial and Business Services, Warburg Pincus, commented, “When we first partnered with Builders FirstSource, we saw significant opportunities for the company to pursue acquisitions in the highly fragmented building products distribution industry. Builders FirstSource has established itself as a leader in its field, and this combination with ProBuild will enable the Company to continue to capitalize on favorable market trends in the housing market.”
Strategic and Financial Benefits of Transaction
- Greater Diversification and Scale: The combination creates a diversified national pro dealer with 2014 combined revenues of approximately $6.1 billion. The transaction represents an important opportunity to grow in four critical customer segments, including Production Builders, Custom Builders, Multi-Family/Commercial and Repair & Remodel. The enhanced diversification of products and services will enable the combined company to capitalize on the continued recovery in the housing market, while also better protecting the Company from cyclicality through broader sales exposure.
- Improved Geographic Footprint: Upon completion of the transaction, the combined company will be better positioned to meet the needs of all customers in the highly fragmented professional building materials segment. The combined company will have a presence in 40 states and 24 of the top 25 metropolitan statistical areas (based on 2014 Single Family Home Building Permits per U.S. Census data).
- Expanded Sales of Higher Margin Products: Builders FirstSource brings to ProBuild significant sales expertise in value-added products, which combined with ProBuild’s attractive customer mix, should result in enhanced sales growth of higher margin products.
- Substantial Cost-Savings: The combination of Builders FirstSource and ProBuild is expected to generate a range of approximately $100 million to $120 million in annual run-rate cost-savings synergies in the first two years following close. Actions to begin capturing a majority of these savings are expected to be implemented within the first 12 months following close through network optimization, procurement, and general and administrative costs. One-time costs of $90 million to $100 million are expected to be incurred to achieve these synergies during the first two years.
- Favorable Timing, Growth Potential and Financial Impact: The U.S. single-family housing market is at near record levels of affordability and demonstrating a solid recovery. At today’s level of approximately 1.0 million total housing starts per year, total housing starts still need to increase approximately 50% to reach the historic median and double to reach prior peak levels. The combined company expects to capitalize on its expanded financial profile through the recovery. Both companies have steadily improved adjusted EBITDA and margins through recognizing efficiencies over the past four years. Additionally, the transaction is expected to enhance adjusted EBITDA and margins through the realization of substantial cost synergies and a more diversified portfolio. The transaction is also expected to be immediately accretive to Builders FirstSource’s earnings.
- Strong Cash Flow Generation Supports Expected Delevering: On a December 31, 2014 pro forma basis, the combined company had pro forma net debt of $2.1 billion, including lease finance obligations, which implies a multiple of 5.6x net debt / adjusted EBITDA, after giving effect to $110 million of annual run-rate cost-savings synergies, the midpoint of the expected range. The combined company is expected to generate significant cash flow that will allow it to delever following the close of the transaction. This delevering will be driven primarily through cost savings realization, earnings expansion, and strong free cash flow generation from operations, further enhanced by the recovering housing sector and the utilization of tax assets.
Leadership
Upon closing of the transaction, Floyd Sherman will serve as Chief Executive Officer of the combined company, and Chad Crow will serve as Chief Financial Officer. Robert Marchbank, Chief Executive Officer of ProBuild, will continue as part of the ProBuild leadership team to support integration planning and ensure a smooth transition. Over the coming months, additional announcements will be made regarding the combined company’s senior leadership team, which will be composed of leaders from both companies.
Financing
The all-cash transaction is valued at approximately $1.63 billion. Builders FirstSource has obtained fully committed financing comprising a rollover of Builders FirstSource’s $350 million existing Senior Secured Notes, new debt issuance in the form of $295 million drawn under a new $800 million ABL facility, and a new $550 million Term Loan B. Builders FirstSource also expects to issue $750 million in new Senior Unsecured Notes and $100 million of new equity through a public offering of shares of Builders FirstSource common stock prior to the consummation of the transaction.
Approvals
The transaction is expected to close in the second half of 2015 and is subject to, among other things, the expiration or termination of the applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, as well as other customary closing conditions.
Advisors
Citi and Deutsche Bank are serving as financial advisors to Builders FirstSource and Skadden, Arps, Slate, Meagher & Flom LLP and Kirkland & Ellis LLP are serving as its legal advisors. Credit Suisse is serving as financial advisor to ProBuild and Goodwin Procter LLC is serving as its legal advisor.
Conference Call and Presentation
Builders FirstSource will host a conference call to discuss the transaction today, April 13, 2015, at 8:00 a.m. Central Time (7:00 a.m. Mountain Time and 9:00 a.m. Eastern Time) and provide accompanying slides, which can be accessed on the company’s website at www.bldr.com under the “Investors” section. To participate in the teleconference, please dial into the call a few minutes before the start time: 888-256-1007 (U.S. and Canada) and 913-312-1489 (international). A live webcast will also be available on the Builders FirstSource website.
A replay of the call will be available at 1:00 p.m. CT through April 18. To access the replay, please dial 888-203-1112 (U.S. and Canada) and 719-457-0820 (international) and refer to pass code 8907768. The archived webcast will be available on the company’s website for approximately 90 days.
About Builders FirstSource
Headquartered in Dallas, Texas, Builders FirstSource is a leading supplier and manufacturer of structural and related building products for residential new construction. The company operates 56 distribution centers and 56 manufacturing facilities in nine states, principally in the southern and eastern United States. Manufacturing facilities include plants that manufacture roof and floor trusses, wall panels, stairs, aluminum and vinyl windows, custom millwork and pre-hung doors. Builders FirstSource also distributes windows, interior and exterior doors, dimensional lumber and lumber sheet goods, millwork and other building products. For more information about Builders FirstSource, visit the company’s website at www.bldr.com.
About ProBuild Holdings, Inc.
Headquartered in Denver, Colorado, ProBuild is one of the nation’s largest diversified suppliers of lumber and building materials to professional builders and contractors. ProBuild currently operates approximately 400 lumber and building product distribution, manufacturing and assembly centers serving 40 U.S. states. ProBuild sells a broad selection of building materials including lumber and plywood, engineered wood, gypsum wallboard and other drywall products, millwork, trusses, roofing, siding products, tools, insulation materials, and metal and hardware specialties. The Company’s manufacturing activities include trusses, wall panels, millwork, and pre-hung door and window fabrication. ProBuild’s construction services include the installation of framing, millwork, insulation and other products. To learn more about ProBuild, visit its website at www.probuild.com.
Forward Looking Information
Statements in this news release that are not purely historical facts or that necessarily depend upon future events, including statements about expected market share gains, forecasted financial performance or other statements about anticipations, beliefs, expectations, hopes, intentions or strategies for the future, may be forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Readers are cautioned not to place undue reliance on forward-looking statements. All forward-looking statements are based upon information available to Builders FirstSource, Inc. on the date this release was submitted. Builders FirstSource, Inc. undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Any forward-looking statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the Company’s growth strategies, including gaining market share, or the Company’s revenues and operating results being highly dependent on, among other things, the homebuilding industry, lumber prices and the economy. Builders FirstSource, Inc. may not succeed in addressing these and other risks. Further information regarding factors that could affect our financial and other results can be found in the risk factors section of Builders FirstSource, Inc.’s most recent annual report on Form 10-K filed with the Securities and Exchange Commission. Consequently, all forward-looking statements in this release are qualified by the factors, risks and uncertainties contained therein.
In addition, there are significant risks and uncertainties relating to Builders FirstSource Inc.’s proposed acquisition and ownership of ProBuild, including: (a) the failure to receive, on a timely basis or otherwise, the required approvals from government and regulatory authorities in connection with the transaction, and the terms of those approvals; (b) the representations, warranties and indemnifications by the sellers of ProBuild are limited in the securities purchase agreement, and the Builders FirstSource Inc.’s diligence into the business has been limited and, as a result, the assumptions on which its estimates of future results of the business have been based may prove to be incorrect in a number of material ways, which could result in an inability to realize the expected benefits of the acquisition or exposure to material liabilities; (c) using debt to finance, in part, the acquisition will substantially increase Builders FirstSource Inc.’s indebtedness; (d) Builders FirstSource Inc.’s obligation to close the acquisition is not conditioned on the completion of its debt or equity financing, and, under certain circumstances, if Builders FirstSource Inc. fails to satisfy its obligation to consummate the acquisition or fails to obtain certain regulatory approvals, Builders FirstSource Inc. may be required to pay a termination fee that could have an adverse effect on Builders FirstSource Inc.’s ability to fund its operations and meet its obligations under its outstanding debt instruments; (e) the inability of Builders FirstSource Inc. to successfully integrate ProBuild’s operations and realize anticipated benefits of the acquisition; and (f) the ability to attract and retain key personnel and to maintain relationships with customers, suppliers or other business partners, including those of ProBuild. These factors are not necessarily all of the important factors that could cause actual results to differ materially from those expressed in any of the forward-looking statements contained herein. Other unknown or unpredictable factors could also have material adverse effects on Builders FirstSource Inc.’s future results.
This news release does not constitute an offer to sell or the solicitation of an offer to buy any securities of Builders FirstSource Inc. or any other issuer, nor shall there be any sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
Additional Information and Where to Find It
This communication may be deemed solicitation material in respect to the approval of the possible acquisition of shares of common stock of Builders FirstSource by JLL Partners Fund V. L.P and Warburg Pincus Private Equity IX L.P, pursuant to the terms of an Equity Commitment Letter entered into among such persons and the Company. In connection with the foregoing issuance of Builders FirstSource common stock, the Company expects to file a proxy statement on Schedule 14A with the Securities and Exchange Commission (the “SEC”) as required by the rules of the NASDAQ Stock Market. INVESTORS AND SECURITY HOLDERS OF BUILDERS FIRSTSOURCE ARE URGED TO READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) THAT BUILDERS FIRSTSOURCE WILL FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT SUCH ISSUANCE. The preliminary proxy statement and the definitive proxy statement, in each case as applicable (when they become available), and any other documents filed by Builders FirstSource with the SEC, may be obtained free of charge on the SEC’s website at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC at Builders FirstSource’s website, investors.bldr.com, or by contacting our Investor Relations department in writing at 2001 Bryan Street, Suite 1600, Dallas, TX 75201.
Builders FirstSource and its directors and executive officers may be deemed to be participants in the solicitation of proxies from Builders FirstSource’s stockholders with respect to the possible issuance of Builders FirstSource’s common stock. The identity of Builders FirstSource’s directors and executive officers and their ownership of the Company’s common stock is set forth in Builders FirstSource’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014, which was filed with the SEC on March 3, 2015 and its proxy statement for its 2014 Annual Meeting of Stockholders, which was filed with the SEC on April 11, 2014. Information regarding the identity of the potential participants, and their direct or indirect interests in the solicitation, by security holdings or otherwise, will be set forth in the proxy statement to be filed with the SEC in connection with the possible issuance of Builders FirstSource common stock pursuant to the terms of the equity commitment letter.
CONTACT: Builders FirstSource Investors Chad Crow Chief Financial Officer Builders FirstSource, Inc. (214) 880-3585 Media Steve Frankel / Nick Lamplough / Adam Pollack Joele Frank, Wilkinson Brimmer Katcher (212) 355-4449 Devonshire Investors Michael Aalto 617-563-9462
(DXCM) Introduces Apps That Enable Continuous Glucose Monitoring On Apple Watch
Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that its Dexcom G4® PLATINUM Continuous Glucose Monitor System with Share™ will support the Apple Watch™ when it ships to customers on April 24. As the industry’s first mobile-connected system, Dexcom CGM and its mobile apps, Share™2 and Follow, are already approved by the FDA and allow both users and “followers” to view glucose data directly on their iPhone. The Apple Watch apps from Dexcom will now enable users to monitor glucose on the Apple Watch so that people with diabetes can discreetly view their own information while parents and caregivers can conveniently view a child or loved one’s glucose data, giving them peace of mind and reassurance when they are apart.
Dexcom CGM provides patients the opportunity to track their glucose levels and trends right on their wrist with the Apple Watch™. Additionally, patients or “Sharers” can invite up to five people to view their glucose information and send an alert when the sharer’s glucose levels are outside the norm.
“Dexcom is committed to providing our patients with access to the most current technology to better manage their diabetes,” stated Kevin Sayer, Chief Executive Office of Dexcom. “We are excited that the Dexcom CGM glucose data is now available on the Apple Watch™, allowing greater convenience for those who want this important information in an easy-to-use and discreet form. We share Apple’s commitment to making technology more accessible, relevant and personal.”
Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years1. The traditional standard-of-care for glucose (blood sugar) monitoring has been a finger stick meter. CGM augments the use of glucose meters for the management of diabetes. Meters are still required to calibrate CGMs and for guidance in making therapy and meal decisions. CGM is important because, in addition to providing the glucose level, it provides the direction and rate of glucose change with the push of a button and alerts users when glucose is too low or too high.
Diabetes affects 29.1 million Americans and is the 7th leading cause of death in the United States.2 With diabetes, the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. It is estimated that approximately 86 million Americans over the age of 20 years old are at risk for developing diabetes, largely due to obesity, physical inactivity and poor diet.2 People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.3,4
Currently, customers can download the Dexcom Share2 and Follow apps to their iPhone for free from the App Store. As of April 24, these Apple Watch apps will also be available for free download from the Apple Watch App Store.
About Dexcom, Inc.
Dexcom, Inc., headquartered in San Diego, California, develops and markets continuous glucose monitoring systems for use by diabetes patients, as well as blood glucose monitoring systems used by healthcare providers in hospital critical care settings. For more information on the Dexcom CGM, visit www.dexcom.com.
References
1. Clarke SF and Foster JR. A history of blood glucose meters and their role in self-monitoring of diabetes mellitus.
Br J Biomed Sci. 2012;(3)2:83-93.
2. 2014 National Diabetes Statistics Report. Centers for Disease Control and Prevention. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf Accessed March 31, 2015.
3. Hyperglycemia (High blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hyperglycemia.html. Updated August 5, 2013. Accessed December 3, 2013.
4. Hypoglycemia (Low blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html. Updated July 16, 2013. Accessed December 3, 2013.
CONSUMER:
Caren Begun, 201-396-8551
or
INVESTOR:
Steven Pacelli, 858-200-0200
To view multimedia assets
http://www.dexcom.com/media.
(ADMS) Orphan Drug Designation for ADS-510 In PD-Related Levodopa-Induced Dyskinesia
EMERYVILLE, Calif., April 10, 2015 — Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that the Food and Drug Administration (FDA) has granted orphan drug status to ADS-5102 for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease. Adamas currently has multiple Phase 3 studies underway evaluating ADS-5102 for this indication, which currently has no FDA-approved treatment options.
“People with Parkinson’s disease contend with the disability associated with levodopa-induced dyskinesia multiple times a day as the disease progresses and their motor symptoms fluctuate,” said Gregory T. Went, Ph.D., Chairman and CEO of Adamas Pharmaceuticals. “Adamas is committed to bringing new treatments to patients suffering with movement disorders related to neurological disorders. With positive data from our Phase 2/3 study, a pivotal Phase 3 program well underway, and 10 issued US patents, we are pleased with our ongoing momentum.”
About Orphan Drugs
The Orphan Drug Act enables the FDA to grant special status to a product that treats a rare disease or condition upon request of a sponsor. For a drug to qualify for orphan drug designation, the condition must meet certain criteria, including affecting fewer than 200,000 people in the US. Once granted, orphan designation qualifies the sponsor for various incentives including: potential tax credits, a reduction in certain regulatory fees, and the potential for seven years of market exclusivity for the drug when it achieves FDA marketing approval.
About ADS-5102
Adamas’ most advanced wholly owned product candidate is ADS-5102 (amantadine HCl), a high dose, extended-release version of amantadine that is administered once daily at bedtime. Adamas is initially developing ADS-5102 for the treatment of levodopa-induced dyskinesia, or LID, in patients with Parkinson’s disease. LID is a complication that frequently occurs in patients after long-term treatment with levodopa, the most widely used drug for Parkinson’s disease. There are no approved drugs for the treatment of LID in the United States or Europe.
Parkinson’s Disease and Levodopa-induced Dyskinesia (LID)
Parkinson’s disease is a chronic, progressive motor disorder that causes a variety of symptoms, such as tremors, rigidity, slowed movements and postural instability. The most commonly prescribed treatments for Parkinson’s disease are levodopa-based therapies. In the body, levodopa is converted to dopamine to replace the dopamine loss caused by the disease. Patients initially receive relief from symptoms of Parkinson’s disease for much of the day. This period of relief is known as “ON” time. As the effects of levodopa wear off, the symptoms of Parkinson’s disease return. This is known as “OFF” time.
As Parkinson’s disease progresses, most patients require increasing doses of levodopa to achieve equivalent therapeutic benefit. Patients may also experience symptoms of their disease upon waking, prior to the first dose of levodopa taking effect. Over time many patients will suffer from LID, a condition characterized by involuntary movements without purpose. LID can become severely disabling, rendering patients unable to perform routine daily tasks. As Parkinson’s disease advances, the symptoms of LID worsen in frequency and severity. Eventually the total time that a patient spends either “OFF” or “ON” with LID can become a majority of his or her day.
About Adamas Pharmaceuticals
Adamas Pharmaceuticals, Inc. is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system. The company achieves this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone or in fixed-dose combination products. Adamas is currently developing its lead wholly-owned product candidate, ADS-5102, for a complication associated with the treatment of Parkinson’s disease known as levodopa-induced dyskinesia, or LID, and is evaluating other potential indications. The company’s portfolio also includes two approved products with Forest Laboratories Holdings Limited (a subsidiary of Actavis plc), Namzaric™ and Namenda XR®. Forest is responsible for marketing both products in the United States under an exclusive license from Adamas. For more information, please visit www.adamaspharma.com.
Namenda XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA.
Namzaric™ is a trademark of Actavis, Inc. or its affiliates.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including, but not limited to, statements regarding bringing new treatments to patients suffering movement disorders. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “committed” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to research and development activities of ADS-5102 and other current and future products, challenges associated with clinical trials including delays in enrollment, the failure to demonstrate the safety and efficacy of ADS-5102 or other product candidates, as well as risks relating to Adamas’ business in general, see Adamas’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 3, 2015. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release.
CONTACT: Julie Wood Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc. Phone: 510-450-3528
(UBIC) Establishes a New Medical Subsidiary
TOKYO, April 10, 2015 — UBIC, Inc. (Nasdaq:UBIC) (TSE:2158) (“UBIC” or the “Company”), a leading provider of international litigation support and big-data analysis services, announced today that its board of directors resolved at a meeting held on April 10, 2015, to establish a new subsidiary, UBIC Medical, Inc. (“UBIC Medical”).
In the field of healthcare, utilizing the vast volume of data stored in electronic medical-record systems is a challenge. Experts are beginning to recognize that information reflecting the personal opinions of patients, as well as the professional opinions of doctors and other medical staff, are often included in electronic medical records. This information may have important implications for treatment, but up until now the data has gone largely unused.
Since its founding, UBIC has provided support in more than 1,300 international litigation cases and corporate fraud investigations. Through the experience of handling those cases, UBIC has developed and improved a proprietary artificial intelligence (AI) engine that incorporates the tacit knowledge of experts in relevant fields. Over the years, UBIC has gained a reputation for its data analysis techniques that identify sentences and contexts regarded as relevant by experts from among masses of textual data. To provide advanced expert support in the field of healthcare, UBIC has concluded that it is necessary to develop a service system that combines AI technology and healthcare expertise, so it has decided to establish UBIC Medical.
UBIC Medical will support medical institutions and private companies in their efforts to improve the quality and efficiency of medical activities through the analysis of large volumes of data by a specialized healthcare data team. UBIC Medical will formally commence operating on April 16, 2015. The Company will initially invest JPY10 million in the subsidiary and it will hold a 100% equity stake.
UBIC Medical will strive to realize a healthy, safe and secure society by providing solutions such as supporting the analysis of clinical information and improvement of the in-hospital environment so as to help to provide better healthcare services.
About UBIC, Inc.
UBIC, Inc. (Nasdaq:UBIC) (TSE:2158) supports the analysis of big data based on behavior informatics by utilizing its proprietary AI-based software program, “VIRTUAL DATA SCIENTIST” or VDS. Developed by UBIC based on knowledge acquired through its litigation support services, the VDS program incorporates experts’ tacit knowledge, including their experiences and intuitions, and utilizes that knowledge for big data analysis. UBIC continues to expand its business operations by applying VDS to new fields such as healthcare and marketing.
UBIC was founded in 2003 as a provider of e-discovery and international litigation support services. These services include the preservation, investigation and analysis of evidence materials contained in electronic data, and computer forensic investigation. UBIC provides e-discovery and litigation support by making full use of its data analysis platform, “Lit i View®”, and its Predictive Coding technology adapted to Asian languages.
For more information about UBIC, contact usinfo@ubicna.com or visit http://www.ubicna.com.
Safe Harbor Statement
This announcement contains forward-looking statements. These forward-looking statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the amount of data that UBIC expects to manage this year and the potential uses for UBIC’s new service in intellectual property-related litigation, contain forward-looking statements. UBIC may also make written or oral forward-looking statements in its reports filed with, or furnished to, the U.S. Securities and Exchange Commission, in its annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about UBIC’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: UBIC’s goals and strategies; UBIC’s expansion plans; the expected growth of the data center services market; expectations regarding demand for, and market acceptance of, UBIC’s services; UBIC’s expectations regarding keeping and strengthening its relationships with customers; UBIC’s plans to invest in research and development to enhance its solution and service offerings; and general economic and business conditions in the regions where UBIC provides solutions and services. Further information regarding these and other risks is included in UBIC’s reports filed with, or furnished to the Securities and Exchange Commission. UBIC does not undertake any obligation to update any forward-looking statement, except as required under applicable law. All information provided in this press release and in the attachments is as of the date of this press release, and UBIC undertakes no duty to update such information, except as required under applicable law.
CONTACT: UBIC Global PR UBIC North America, Inc. Tel: (212) 924-8242 global_pr@ubic.co.jp
(PCYG) Announces $7.1 Million Registered Direct Offering of Common Stock
SALT LAKE CITY, April 10, 2015 — Park City Group (Nasdaq:PCYG), a cloud-based software company that uses big data management to help retailers and their suppliers sell more, stock less and see everything, today announced that the Company has entered into subscription agreements with notable institutional investors to purchase 570,000 shares of its common stock in a registered direct offering at a price of $12.50 per share. The registered direct offering is expected to close on or about April 15, 2015, subject to the satisfaction of customary closing conditions. Brean Capital, LLC acted as the sole placement agent in connection with the registered direct offering.
Park City Group expects to receive total net proceeds from the registered direct offering of approximately $6,668,750 after deducting placement agent fees and other offering expenses. Proceeds from the registered direct offering will be used for general corporate working capital purposes.
The registered direct offering is being made pursuant to a prospectus included as part of a shelf registration statement filed with the Securities and Exchange Commission (SEC) that was declared effective on April 6, 2015. A prospectus supplement related to the registered direct offering will be filed with the SEC. Copies of the prospectus supplement together with the accompanying prospectus can be obtained at the SEC’s website at http://www.sec.gov, or from Brean Capital, LLC. This announcement is neither an offer to sell nor a solicitation of an offer to buy any shares of common stock of Park City Group. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
About Park City Group
Park City Group (Nasdaq:PCYG) is a Software-as-a-Service (“SaaS”) provider that brings unique visibility to the consumer goods supply chain, delivering actionable information that ensures product is on the shelf when the consumer expects it to be. Park City Group’s services enable customers to “Sell More, Stock Less, and See Everything”. More information is available at www.parkcitygroup.com
Forward-Looking Statement
Any statements contained in this document that are not historical facts are forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “if”, “should” and “will” and similar expressions as they relate to Park City Group, Inc. (“Park City Group”) are intended to identify such forward-looking statements. Park City Group may from time to time update these publicly announced projections, but it is not obligated to do so. Any projections of future results of operations should not be construed in any manner as a guarantee that such results will in fact occur. These projections are subject to change and could differ materially from final reported results. For a discussion of such risks and uncertainties, see “Risk Factors” in Park City’s annual report on Form 10-K, its quarterly report on Form 10-Q, and its other reports filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the dates on which they are made.
CONTACT: Investor Relations Contact: Three Part Advisors, LLC Jeff Elliott 972-423-7070 Dave Mossberg 817-310-0051
(ESSX) Evaluating Strategic Alternatives for Essex Crane Rental Corp.
– Retains RBC Capital Markets, LLC – New Board Candidates To Be Nominated
Essex Rental Corp. (Nasdaq:ESSX) (“Essex” or the “Company”) today announced that it has retained RBC Capital Markets, LLC, a premier advisor in the heavy-lift rental equipment segment, to evaluate strategic alternatives for Essex Crane Rental Corp., one of the Company’s two operating subsidiaries. The Company’s Board of Directors authorized the initiative and the hiring of RBC Capital Markets in January of this year in order to assess alternatives for creating shareholder value. The Company will provide periodic updates on the initiative as warranted.
The Company also announced that two of its long-standing directors, John Nestor and Dan Blumenthal, will not stand for reelection at the upcoming 2015 annual meeting of stockholders, and that the Nominating Committee of the Board is undertaking a search to identify possible candidates for inclusion on management’s slate of director nominees for election at the 2015 annual meeting.
“We thank John and Dan for their years of service and commitment to our Board of Directors, and for their valuable contributions and insights,” commented Laurence Levy, Chairman of Essex’s Board.
Mr. Levy continued, “The turnover of seats on the Board furthers our commitment to responsible corporate governance, and will bring fresh perspectives and highly credentialed and relevant expertise to the Board for the benefit of our stockholders. We are confident that our search for director candidates will yield highly qualified professionals with strong credentials in the equipment rental sector or other relevant areas of expertise; and as a result of this reconstitution, the Board will be optimally positioned to continue our progress to date in both addressing the challenges faced by the Company and pursuing the opportunities available to it.”
Additional information with respect to management’s proposed slate of director nominees for election at the 2015 annual meeting of stockholders will be contained in the Company’s proxy statement to be filed with the Securities and Exchange Commission on or before April 30, 2015.
About Essex Rental Corp.
Essex, through its subsidiaries, is one of North America’s largest providers of rental and distribution for mobile cranes (including lattice-boom crawler cranes, truck cranes and rough terrain cranes), self-erecting cranes, stationary tower cranes, elevators and hoists, and other lifting equipment used in a wide array of construction projects. In addition, the Company provides product support including installation, maintenance, repair, and parts and services for equipment provided and other equipment used by its construction industry customers. With a large fleet, consisting primarily of cranes, as well as other construction equipment and unparalleled customer service and support, Essex supplies a wide variety of innovative lifting solutions for construction projects related to power generation, petro-chemical, refineries, water treatment and purification, bridges, highways, hospitals, shipbuilding, offshore oil fabrication and industrial plants, and commercial and residential construction.
Some of the statements in this press release and other written and oral statements made from time to time by Essex and its representatives are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, without limitation, statements regarding possible strategic alternatives for Essex Crane Rental Corp. and the possible effects of any reconstitution of the Board of Directors of the Company. These statements also include statements of Essex’s intent and belief or current expectations of Essex and its management team and may be identified by the use of words like “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “will”, “should”, “seek”, the negative of these terms or other comparable terminology. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Important factors that could cause actual results to differ materially from Essex’s expectations include, without limitation, the continued ability of Essex to successfully execute its business plan, the possibility of a change in demand for the products and services that Essex provides, intense competition which may require us to lower prices or offer more favorable terms of sale, our reliance on third party suppliers, our indebtedness which could limit our operational and financial flexibility, global economic factors including interest rates, general economic conditions, geopolitical events and regulatory changes, our dependence on our management team and key personnel, as well as other relevant risks detailed in our Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission and available on our website, www.essexrentalcorp.com. The factors listed here are not exhaustive. Many of these uncertainties and risks are difficult to predict and beyond management’s control. Forward-looking statements are not guarantees of future performance, results or events. Essex assumes no obligation to update or supplement forward-looking information in this press release whether to reflect changed assumptions, the occurrence of unanticipated events or changes in future operating results or financial conditions, or otherwise.
Essex Rental Corp.
Kory Glen, 847-215-6522
Chief Financial Officer
kglen@essexrental.com
or
Patrick Merola, 847-215-6514
Manager of Investor Relations
pmerola@essexrental.com
(HEAR) New PC Gaming Accessories Now Available At Retail
Leading Gaming Headset Company Expands Portfolio with New Line of Professional Grade PC Gaming Accessories Designed for Competitive Gamers, Including Gaming Keyboards, Gaming Mice and Mousepads
SAN DIEGO, April 10, 2015 — Turtle Beach Corporation (NASDAQ: HEAR) announced today that its new lineup of PC gaming accessories, including gaming keyboards, mice and mousepads, is available at select North American retail outlets. Turtle Beach, the 40-year strong staple of the gaming industry best known for its amazing range of console and PC headsets, including the first fully wireless headsets for Xbox One, opens a new chapter with its entrance into the PC gaming accessories market with its first round of gaming keyboards, gaming mice and gaming mousepads, each with their own unique features that cater to an audience ranging from casual players to hardcore professional gamers.
In true Turtle Beach form, the company has created a variety of accessories from which gamers can choose to suit their desires and budgets, and each one is crafted with high-quality, durable construction and features, including Cherry switches* and steel reinforced chassis for the keyboards, Avago sensors and Omron switches for the mice, and an assortment of different textured and sized mousepads.
Below is a brief breakdown of all Turtle Beach’s new PC gaming accessories, and be sure to see full details at www.turtlebeach.com/products/accessories/pc-accessories:
Keyboards:
- IMPACT 700 Premium Mechanical Gaming Keyboard – Cherry MX Brown switches, adjustable illuminated keys, two USB 2.0 ports w/audio pass-through, pink/green audio/mic jacks, six-key rollover with full anti-ghosting, steel-reinforced chassis w/gunmetal keycap plates, extra gaming keycaps plus metal keycap puller, full-sized 104-key layout, PC/MAC compatible, USB plug-and-play compatible. MSRP: $199.95.
- IMPACT 500 Mechanical Gaming Keyboard – Compact 87-key tenkeyless layout, Cherry MX Blue switches, six-key rollover with full anti-ghosting, steel-reinforced chassis w/black rubberized coating, detachable braided USB cable, PC/MAC compatible, USB plug-and-play compatible. MSRP: $129.95.
- IMPACT 100 Gaming Keyboard – Emulated mechanical feel, full-size 104-key layout, steel-reinforced chassis w/enhanced matte PBD keycaps, 30-key rollover with full anti-ghosting, PC/MAC compatible, USB plug-and-play compatible. MSRP: $59.95.
Mice:
- GRIP 500 Premium Laser Gaming Mouse – Ergonomic 7-button scroll-wheel mouse, Avago 9800 laser sensors, Omron switches, independently adjustable DPI settings (up to 8200 DPI), designed for PC gaming w/customization software included, up to 50 macros w/up to 100 commands each, 16.8 million color options for scroll wheel and varied illumination effects, five color coded profiles, non-slip soft-touch coating, 6-foot snag-free soft rubber USB cable. MSRP: $69.95.
- GRIP 300 Optical Gaming Mouse – Affordable 5-button scroll-wheel mouse, Avago 3050 optical sensors, Omron switches, adjustable mouse speed settings from 500, 1000 and 1750 DPI and polling rates from 125, 500 and 1000Hz, red-illuminated scroll-wheel and Turtle Beach logo, non-slip soft-touch coating, PC/MAC compatible, USB plug-and-play compatible, 6-foot braided USB cable. MSRP: $39.95.
Mousepads:
- DRIFT Fast Microfiber Mousepad – High-quality microfiber surface for fast/smooth mouse control, large surface area, 100% natural rubber anti-slip base, anti-fray edges, multiple sizes (Medium 270x220mm, Large 350x250mm, X-Large 450x350mm and Wide 900x300mm). MSRP: $14.95 – $34.95.
- TRACTION Textured Control Surface Mousepad – High-quality textured weave surface for perfect balance of friction and maximum mouse control, large surface area, 100% natural rubber anti-slip base, anti-fray edges, multiple sizes (Medium 270x220mm, Large 350x250mm, X-Large 450x350mm and Wide 900x300mm). MSRP: $14.95 – $34.95.
About Turtle Beach Corporation
Turtle Beach Corporation (www.turtlebeachcorp.com) designs leading-edge audio products for the consumer, commercial and healthcare markets. Under the Turtle Beach brand (www.turtlebeach.com), the Company markets a wide selection of quality gaming headsets catering to a variety of gamers’ needs and budgets, for use with video game consoles, including officially-licensed headsets for the Xbox One and PlayStation®4, as well as for personal computers and mobile/tablet devices. Under the HyperSound brand (www.hypersound.com), the Company markets pioneering directed audio solutions that have applications in digital signage and kiosks, consumer electronics and healthcare. The company’s shares are traded on the NASDAQ Exchange under the symbol: .
*Cherry MX switches on IMPACT 700 Premium Mechanical Gaming Keyboard and IMPACT 500 Mechanical Gaming Keyboards only. Cherry switches not available on IMPACT 100 Gaming Keyboard.
Forward-Looking Statements
This press release includes forward-looking information and statements within the meaning of the federal securities laws. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding assumptions, projections, expectations, targets, intentions or beliefs about future events. Forward looking statements are based on management’s statements containing the words “may”, “could”, “would”, “should”, “believe”, “expect”, “anticipate”, “plan”, “estimate”, “target”, “project”, “intend” and similar expressions constitute forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which could cause actual results to differ materially from those contained in any forward-looking statement. Forward-looking statements are based on management’s current belief, as well as assumptions made by, and information currently available to, management.
While the Company believes that its expectations are based upon reasonable assumptions, there can be no assurances that its goals and strategy will be realized. Numerous factors, including risks and uncertainties, may affect actual results and may cause results to differ materially from those expressed in forward-looking statements made by the Company or on its behalf. Some of these factors include, but are not limited to, the substantial uncertainties inherent in acceptance of existing and future products, the difficulty of commercializing and protecting new technology, the impact of competitive products and pricing, general business and economic conditions, risks associated with the expansion of our business including the implementation of any businesses we acquire, our indebtedness, and other factors discussed in our public filings, including the risk factors included in the Company’s most recent Annual Report on Form 10-K and the Company’s other periodic reports. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the Securities and Exchange Commission, the Company any is under no obligation to publicly update or revise any forward-looking statement after the date of this release whether as a result of new information, future developments or otherwise.
(GVP) Presents on Human Performance Improvement Solution
Global energy industry performance improvement company GSE Systems, Inc. (NYSE MKT: GVP) (“GSE”) today announced that Moaz Bulbul, Middle Eastern Business Development Manager, gave two presentations at Energy Istanbul 2015. In the presentations, Mr. Bulbul addressed human performance improvement and innovations in simulation technology in the energy industry. The event was held March 19-21 at the Istanbul CNR Expo Fair Center in Istanbul, Turkey.
Mr. Bulbul gave a presentation titled, “Human Performance Improvement in the Energy Sector,” on Saturday, March 21. He discussed current training challenges in the energy sector and ways to optimize talent management by using a blended entry-to-expert training approach.
Later that day, Mr. Bulbul gave another presentation titled, “Innovation in Nuclear Simulations.” Mr. Bulbul provided information about recent technical developments in simulation-based engineering and training that are being used to increase safety and performance of both people and plants in the nuclear industry.
To view these presentations online, go to:
http://www.slideshare.net/GSE_systems/human-performance-improvement
http://www.slideshare.net/GSE_systems/innovation-in-nuclear-simulation
About GSE Systems, Inc.
GSE Systems, Inc. provides performance improvement solutions to the energy and process industries. We improve human performance though turnkey training, unique visualization and simulation applications, and our staff of instructors, as well as plant improvement through our engineering expertise and use of technology to improve plant design, commissioning and operations. The Company has more than 300 employees and over four decades of experience as well as more than 1,100 installations and hundreds of customers in over 50 countries spanning the globe. GSE Systems is headquartered in Sykesville (Baltimore), Maryland, with offices in St. Marys, Georgia; Cary, North Carolina; Huntsville, Alabama; Chennai, India; Nyköping, Sweden; Stockton-on-Tees, UK; Glasgow, UK; and Beijing, China. Information about GSE Systems is available at www.gses.com.
Forward-Looking Statements
We make statements in this press release that are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. These statements reflect our current expectations concerning future events and results. We use words such as “expect,” “intend,” “believe,” “may,” “will,” “should,” “could,” “anticipates,” and similar expressions to identify forward-looking statements, but their absence does not mean a statement is not forward-looking. These statements are not guarantees of our future performance and are subject to risks, uncertainties, and other important factors that could cause our actual performance or achievements to be materially different from those we project. For a full discussion of these risks, uncertainties, and factors, we encourage you to read our documents on file with the Securities and Exchange Commission, including those set forth in our periodic reports under the forward-looking statements and risk factors sections. We do not intend to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Media:
Schubert b2b
Scott Clark, 610-269-2100 x225
PR Executive
sclark@schubertb2b.com
(ROSG) to Acquire PersonalizeDx
Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based and other molecular diagnostics, announces it has agreed to acquire CynoGen, Inc. (d/b/a PersonalizeDx) from Prelude Corporation, a Fjord Ventures portfolio company. The acquisition of PersonalizeDx by Rosetta Genomics is expected to close within the next several weeks and is contingent upon the closing of Prelude’s purchase of PersonalizeDx from a third party.
PersonalizeDx is a rapidly growing molecular diagnostics and services company serving community-based pathologists, urologists, oncologists and other reference laboratories across the U.S. Through this transaction Rosetta Genomics will gain proprietary tests in prostate, bladder and lung cancer, strong commercial and laboratory operations capabilities and a state-of-the-art, high-complexity CLIA laboratory in Lake Forest, California.
The purchase price includes $2.0 million in cash, 500,000 ordinary shares of Rosetta Genomics Ltd., some specified assets and certain services to be provided by Rosetta Genomics to Prelude Corporation. In connection with this transaction Rosetta Genomics will gain rights to market Prelude’s novel assay for ductal carcinoma in situ (DCIS).
“The acquisition of PersonalizeDx will have wide-ranging, positive financial, commercial, operational and pipeline impact on Rosetta Genomics, and brings with it exceptional talent to complement the industry-leading team at Rosetta Genomics. The PersonalizeDx business is an excellent strategic and cultural fit, and we look forward to combining their assays and biomarkers with our current and future microRNA-based and other assays. With the expected close of this transaction, we extend a warm welcome to our new colleagues from PersonalizeDx,” said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.
“In joining forces with PersonalizeDx, Rosetta Genomics will gain critically important commercial and revenue scale in the marketplace for oncology diagnostics, along with a strategic focus on delivering high-value content that aids in diagnoses, optimizes treatment decisions, enables targeted therapy selections and facilitates treatment monitoring. A shared commitment to unsurpassed quality and turnaround time and to improving the lives of people with cancer will guide our operations and contribute to our success,” added Mr. Berlin.
According to Olav Bergheim, Managing Director of Fjord Ventures, “Rosetta Genomics, with its commitment to being a leading provider of differentiated and proprietary content in the area of personalized medicine, is a great strategic fit for PersonalizeDx. In addition to world-leading expertise in microRNA-based assay development, Rosetta Genomics brings strong reimbursement capabilities and service lab operational know-how.”
Financials and Financial Guidance
On an annualized pro forma basis, including the operations of the PersonalizeDx business, Rosetta Genomics expects 2015 revenues to be in the range of $10 million to $12 million, and expects 2016 revenues to exceed $18 million. Rosetta Genomics also expects to achieve positive EBITDA and positive cash flow from operations prior to the end of 2017.
Product and Commercial Synergies
Rosetta Genomics currently offers the Rosetta Cancer Origin Test™, the Rosetta Lung Cancer Test™ and the Rosetta Kidney Cancer Test™, and plans to launch its thyroid neoplasia assay in the third quarter of 2015. Rosetta Genomics markets the Rosetta Genomics PGxOne™ test and the EGFR and KRAS sequencing services for Admera Health.
The expected expanded commercial capability from combining these two companies will benefit the launch of Rosetta Genomics’ novel thyroid assay later this year, as well as the launches of new PersonalizeDx products.
There are multiple areas of product synergies between Rosetta Genomics and the PersonalizeDx business, notably in urologic and lung cancers. For example, the recent combination of Rosetta’s Lung Cancer Test with Admera’s genomic markers for targeted therapies will be strengthened by adding the PersonalizeDx Fluorescence in situ Hybridization (FISH) and molecular markers for actionable genomic targets, thereby creating a strong lung cancer diagnostic franchise.
Including the pipeline from PersonalizeDx, Rosetta Genomics is now positioned to launch five novel, proprietary assays within the next 12 months, which will provide a foundation for growth well into the future.
About Rosetta Cancer Testing Services
Rosetta Cancer Tests are a series of microRNA-based diagnostic testing services offered by Rosetta Genomics. The Rosetta Cancer Origin Test™ can accurately identify the primary tumor type in primary and metastatic cancer including cancer of unknown or uncertain primary (CUP). The Rosetta Lung Cancer Test™ accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. The Rosetta Kidney Cancer Test™ accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and oncocytoma. Rosetta’s assays are designed to provide objective diagnostic data; it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the Rosetta Cancer Origin Test™, 65,000 from the Rosetta Kidney Cancer Test™ and 226,000 patients from the Rosetta Lung Cancer Test™. The Company’s assays are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. In addition, Rosetta markets the Rosetta Genomics PGxOne™ test and the EGFR and KRAS sequencing services for Admera Health. For more information, please visit www.rosettagenomics.com. Parties interested in ordering any of these tests should contact Rosetta Genomics at (215) 382-9000 ext. 309.
About Rosetta Genomics
Rosetta develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000, Rosetta’s integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. Rosetta’s cancer testing services are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab.
About Prelude Corporation
Prelude Corporation is developing a prognostic test for ductal carcinoma in situ (DCIS). The company’s proprietary risk algorithms combine results from a panel of biomarkers that reveal a patient’s DCIS biology. Over 60,000 women in the United States are diagnosed with DCIS (stage 0 breast cancer) annually. Prelude’s DCIS test is designed to enable these women and their treating physicians to make personalized treatment decisions based on their own biological profile. This approach may help thousands of women avoid overly aggressive therapies that contribute to the rising cost of healthcare and increasing morbidity.
About Fjord Ventures
Fjord Ventures, founded by life science entrepreneur Olav Bergheim, is an innovative technology accelerator that creates and invests in companies developing disruptive healthcare solutions. Fjord provides portfolio companies with operational management expertise and a highly capital efficient shared infrastructure. Fjord focuses on identifying, developing and commercializing life science innovations. Since its formation in 2005, Fjord Ventures has created more than 10 companies.
Forward-Looking Statement Disclaimer
Various statements in this news release concerning Rosetta’s future expectations, plans and prospects, including without limitation, the expectation for pro forma revenues in 2015 and 2016, and that Rosetta expects to achieve positive EBITDA and positive cash flow from operations in 2017, statements relating to any synergies, including product synergies, or other expectations regarding the acquisition of PersonalizeDx, including that the acquisition will have wide-ranging and positive financial, commercial, operational and pipeline impact, and the timing with respect to commercial launch of assays within the next 12 months as well any information relating to the expected closing of the acquisition, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those risks more fully discussed in the “Risk Factors” section of Rosetta’s Annual Report on Form 20-F for the year ended December 31, 2014 as filed with the SEC. In addition, any forward-looking statements represent Rosetta’s views only as of the date of this news release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.
Company:
Rosetta Genomics
Ken Berlin, 609-419-9003
President & CEO
investors@rosettagenomics.com
or
Investors:
LHA
Anne Marie Fields, 212-838-3777
afields@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
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