Archive for February, 2014
(SYMX) and Zhangjiagang Chemical Machinery Company Join Forces
ZCM-SES Joint Venture to Deliver Comprehensive Equipment, Engineering and Gasification Technology Solutions for Multibillion-dollar Coal-Chemicals and Energy Industries in China and Key Asian Markets
HOUSTON, Feb. 14, 2014 — Synthesis Energy Systems, Inc. (SES) (Nasdaq:SYMX) today announced that its wholly owned subsidiary, SES Asia Technologies, Ltd., has entered into definitive agreements to form a joint venture: ZCM-SES Sino-U.S. Clean Energy Technologies Limited (“ZCM-SES” or the “JV”), with Zhangjiagang Chemical Machinery Co., Ltd. (“ZCM”) (Shenzhen listing code: 002564). The JV combines SES’ advanced proprietary gasification technology with the market reach of one of China’s leading coal-chemical equipment manufacturers and is expected to provide a uniquely competitive and high growth platform for both SES and ZCM in China and other major Asian markets.
ZCM has agreed to contribute RMB 100 million (approximately US$16.5 million) to the JV to fund its working capital needs for a 65% ownership interest. ZCM will have exclusive manufacturing rights for all ZCM-SES customer projects in China as well as the joint venture’s additional markets of Indonesia, Malaysia, Mongolia, the Philippines, and Vietnam. SES is contributing exclusive usage of its advanced, proprietary gasification technology in these Asian markets for a 35% interest in ZCM-SES. SES’ two operating plants, Yima and Zaozhuang (ZZ), both remain under SES’ ownership unrelated to this joint venture. SES believes its China business can deliver positive operating cash flows from further improving revenues and lower overall expenses once the ZCM-SES JV begins operation combined with results from its ZZ and Yima plants. The ZCM-SES JV is subject to customary Chinese government approvals which are expected to be completed within 60-90 days.
“This is a pivotal point in our company’s history, and key to our global growth strategy, as we build upon the foundation of our two commercially operating plants. ZCM-SES will offer superior competitive advantages in the market by combining our proven technology with ZCM’s manufacturing, marketing and implementation capabilities,” said Robert Rigdon, SES President and CEO. “Partnering with a strong, aggressive and respected Chinese company will greatly enhance our technology’s ability to penetrate the China market. ZCM is a leader in China for good reason, and is one of its largest suppliers to the coal-chemical industry and is expanding as an equipment supplier into global markets. Because of ZCM’s position in the market, and our technology, the formation of this joint venture greatly expands SES’ potential market penetration in China, thereby affording the opportunity for much more value creation for our shareholders than we could achieve on our own. In addition to expanding our market reach, the business model of the JV will extend beyond customary licensing and proprietary equipment sales to include an expanded range of equipment, engineering and services, leading to turnkey installations. This is a well-timed and potentially game-changing approach to the large Chinese market which expands our opportunities for retrofitting existing plants and constructing new facilities. SES also intends to utilize this JV to help bring cost-competitive projects to its global business initiatives, including small-scale power and DRI steel. We cannot overstate our excitement about the business potential and promise this partnership brings.”
“We are very pleased to be launching this joint venture with SES. SES’ leading technology is best suited for China’s development priorities and, when combined with ZCM’s leadership in China’s coal chemical industry, we will create a new business that creates real value for all of the parties,” said ZCM’s Chairman, Mr. Chen Yuzhong.
ZCM is a public company with more than 3,000 employees headquartered in Zhangjiagang City, Jiangsu Province with a market capitalization of approximately RMB 5 billion. ZCM is one of the country’s largest and most respected manufacturers of a wide variety of equipment for the coal-chemical and general chemical industries. Last year sales are estimated at RMB 1.8 billion. ZCM’s extensive customer base, experience, manufacturing and sales capabilities, combined with SES’ superior, cleaner coal gasification technology, give ZCM-SES a significant leadership position from the outset.
The region’s demand for economic, yet cleaner, technology and equipment solutions for its expanding chemicals, power, fertilizers, natural gas, fuels and DRI steel industries is expected to continue to rise, paralleling China’s ascent as a global industrial power. Approximately half of China and the Asian region’s indigenous coal supply is lower quality coal which is critical to economically fueling chemical and energy needs for many years to come. Previous technologies deployed in China are generally unable to process these lower quality coals economically and cleanly whereas SES’ proprietary advanced gasification technology is capable of unlocking the value of these lower cost and abundant low-quality coals and coal wastes by efficiently converting them to syngas to produce high-value end products.
About Synthesis Energy Systems, Inc.
Synthesis Energy Systems (SES) is a Houston-based technology company focused on bringing cleaner high-value energy to developing countries from low-grade coal and biomass natural resources through its proprietary gasification technology. The technology, which is licensed from the Gas Technology Institute, enables greater fuel flexibility and efficient small-scale operations close to fuel sources. Fuel sources include low-rank, low-cost high ash, high moisture coals, which are significantly cheaper than higher grade coals, many coal waste products, and biomass feedstocks. For more information, please visit: www.synthesisenergy.com.
About Zhangjiagang Chemical Machinery Co., Ltd.
Zhangjiagang Chemical Machinery Co., Ltd. is the leading manufacturer of pressure vessels in China and a leading equipment supplier to the coal and chemical sectors. It has served China’s petro-chemical, coal-chemical, refinery, metallurgy, green energy, nuclear and offshore industries for more than four decades. ZCM has more than 3,000 employees across its four manufacturing plants: Linjiang and Chengyang Plants located in Zhangjiagang, Jiangsu Province; Urumchi and Ili Plants located in the Sinkiang Autonomous Area. It also owns and operates port facilities on the Yangtze River, 100km west of Shanghai. ZCM has received certifications from the H.S.E (Health, Safety, & Environment) and ASME (American Society of Mechanical Engineers). Their clients include Shell, GEA, CB&I, Lurgi, Halder Topsoe, KBR, BP, Mitsubishi, SINOPEC, CNPC, and CNOOC. ZCM is a publicly listed company, listed on the Shenzhen Exchange since 2011 (Shenzhen listing code: 002564). For more information, please visit: www.zcmchina.com
Forward-Looking Statements
This press release includes “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. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are: the development stage of the operations of Synthesis Energy Systems; the ability of the ZZ joint venture to effectively operate XE’s methanol plant and produce methanol; the ability of the Yima project to produce earnings and pay dividends; the ability of SES to secure a partner for its China business initiative; the ability of SES to develop its power business unit and marketing arrangement with GE and its other business verticals, steel and renewables; the ability of SES to successfully develop its licensing business; its ability to reduce operating costs; the limited history and viability of its technology; commodity prices and the availability and terms of financing opportunities; its ability to obtain the necessary approvals and permits for future projects; its ability to raise additional capital and its estimate of the sufficiency of existing capital sources; the sufficiency of internal controls and procedures; and its results of operations in foreign countries where it is developing projects, such as India. Although Synthesis Energy Systems believes that in making such forward-looking statements its expectations are based upon reasonable assumptions, such statements may be influenced by factors that could cause actual outcomes and results to be materially different from those projected. Synthesis Energy Systems cannot assure you that the assumptions upon which these statements are based will prove to have been correct.
Contact: |
MDC Group |
Investor Relations: |
David Castaneda |
Arsen Mugurdumov |
414.351.9758 |
IR@synthesisenergy.com |
Media Relations: |
Susan Roush |
747.222.7012 |
PR@synthesisenergy.com |
(INGN) NASDAQ Welcomes Inogen to the NASDAQ Stock Market
NEW YORK, Feb. 14, 2014 — The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ) announced that trading of Inogen, Inc (Nasdaq:INGN), a leading medical technology company that develops, manufactures and markets innovative portable oxygen concentrators used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions, commenced on The NASDAQ Global Select Market on February 14, 2014.
Inogen is a medical technology company that develops, manufactures and markets innovative portable oxygen concentrators used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions.
“Inogen is improving the quality of life for supplemental long-term oxygen therapy users by offering innovative products and services,” said Nelson Griggs, Senior Vice President, NASDAQ OMX Corporate Client Group. “Inogen exemplifies the pioneering nature of a NASDAQ-listed company and we are pleased to have them call NASDAQ home.”
NASDAQ has been the exchange of choice for some of the world’s largest and most revolutionary companies. NASDAQ has been the exchange of choice to 100 percent of health care companies that have listed on the U.S. markets year-to-date in 2014.
Cautionary Note Regarding Forward-Looking Statements
The information contained above is provided for informational and educational purposes only, and nothing contained herein should be construed as investment advice, either on behalf of a particular security or an overall investment strategy. Neither The NASDAQ OMX Group, Inc. nor any of its affiliates makes any recommendation to buy or sell any security or any representation about the financial condition of any company. Statements regarding NASDAQ-listed companies are not guarantees of future performance. Actual results may differ materially from those expressed or implied. Past performance is not indicative of future results. Investors should undertake their own due diligence and carefully evaluate companies before investing. ADVICE FROM A SECURITIES PROFESSIONAL IS STRONGLY ADVISED.
About NASDAQ OMX Group
NASDAQ OMX (Nasdaq:NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents. Through its diverse portfolio of solutions, NASDAQ OMX enables customers to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today’s global capital markets. As the creator of the world’s first electronic stock market, its technology powers more than 70 marketplaces in 50 countries, and 1 in 10 of the world’s securities transactions. NASDAQ OMX is home to more than 3,200 listed companies with a market value of over $8 trillion. To learn more, visit www.nasdaqomx.com.
NDAQG
CONTACT: MEDIA RELATIONS CONTACT: Christine Barna (646) 441-5310 Christine.Barna@nasdaqomx.com
(GOMO) Announces Acquisition of Mobile Ad Network
GUANGZHOU, China, Feb. 12, 2014 — Sungy Mobile Limited (Nasdaq:GOMO) (“Sungy Mobile” or the “Company”), a leading provider of mobile internet products and services globally with a focus on applications and mobile platform development, today announced that it had recently acquired GetJar, Inc. (“GetJar”), a privately held mobile ad network based in California for $5.3 million in cash. The Company may also issue up to an aggregate of 1,443,074 Class A ordinary shares to the seller of GetJar by early 2016 as earnout payments if certain performance targets are achieved. In addition, the Company will grant certain equity incentives to the management and key personnel of GetJar who will be employed by the Company.
“We are pleased to expand our global footprint with our first international acquisition,” stated Mr. Yuqiang Deng, Sungy Mobile’s chief executive officer. “Our acquisition of GetJar provides our platform with state-of-the-art mobile data analytics capabilities that will support our mobile advertising research and development initiatives, and accelerate our product development process. We are happy to bring GetJar underneath the Sungy Mobile umbrella, and look forward to working with the GetJar team to build out our service offerings together.”
About Sungy Mobile Limited
Sungy Mobile Limited (Nasdaq:GOMO) 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. Sungy Mobile also operates 3G.cn, a popular mobile internet portal, and a large mobile reading service, in China. For more information about Sungy Mobile, please visit http://www.sungymobile.com.
Safe Harbor Statements
This press release contains forward-looking statements. These statements 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. These forward-looking statements include, but are not limited to, statements about: Sungy Mobile’s growth strategies; Sungy Mobile’s ability to retain and increase its user base and expand its product and service offerings; Sungy Mobile’s ability to monetize its platform; Sungy Mobile’s future business development, financial condition and results of operations; competition from companies in a number of industries including internet companies that provide mobile internet portal services and operate mobile reading services; expected changes in Sungy Mobile’s revenues and certain cost or expense items; and general economic and business condition globally and in China. Further information regarding these and other risks is included in Sungy Mobile’s filings with the U.S. Securities and Exchange Commission. 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: For further information, please contact Sungy Mobile Limited Laura Huang Email: IR@sungymobile.com http://www.sungymobile.com ICR, LLC Jeremy Peruski Tel: +1-646-417-5388 Email: IR@sungymobile.com
(ZGNX) Establishes External Safe-Use Board
Experts to Provide Independent Oversight and Recommendations
SAN DIEGO, Feb. 12, 2014 — Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today announced the formation of an External Safe-Use Board. The Board will be a key part of the company’s comprehensive approach supporting the appropriate use of ZohydroTM ER (hydrocodone bitartrate) extended-release capsules, the first and only extended-release hydrocodone without acetaminophen for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The areas of expertise of the standing members of the Board are matched to ensure Zogenix will receive timely, independent and thorough feedback and recommendations regarding the use of Zohydro ER after launch in early March. The Board will meet regularly to review a variety of data inputs regarding the medication’s prescribing and use.
“Instituting the External Safe-Use Board is another example of our commitment to responsible commercialization of our products,” said Roger Hawley, chief executive officer of Zogenix. “The important role of this Board serves to report independent assessments, interpretations and recommendations regarding the use of Zohydro ER directly to the Board of Directors of Zogenix and to me. Our intentions are to proactively share this information with the Food & Drug Administration (FDA). This will be the first time that a Schedule II opioid product will have launched with an expert, independent safety review board in place from the first day of product availability.”
Chairperson of the External Safe-Use Board, Jeffrey Gudin, MD, Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center in New Jersey, said, “This type of voluntary initiative on the part of Zogenix, will allow external, highly experienced specialists, to provide valuable insight and advice about the impact of introducing this new pain treatment to the community and, if needed, to recommend specific actions needed to ensure that the risk of abuse, misuse and diversion is minimized. The creation of this Board exemplifies Zogenix’s commitment to the appropriate use of Zohydro ER.”
The members of the External Safe-Use Board consist of widely recognized experts in pain management, risk management, pharmacovigilance, surveillance, addiction, patient care and law enforcement. The Board members will meet quarterly and have responsibility for interpreting and identifying the assessment of the benefit/risk profile of Zohydro ER, effectiveness of the current surveillance tools, current education and prevention programs, and identification of opportunities to enhance signal detection or risk mitigation activities.
Zogenix is committed to promoting the appropriate use of Zohydro ER through a comprehensive suite of voluntary initiatives, which include integrated educational resources for patients, prescribers and pharmacists, surveillance programs to identify misuse, abuse and diversion, commercial activity focused on selected prescribers experienced with managing pain using Schedule II extended-release opioids, education and training requirements for Zogenix territory representatives who will be compensated on achieving educational goals during launch year and provision of safe storage mechanisms for prescription medicines.
In addition, Zogenix is fully engaged in developing an abuse deterrent formulation of Zohydro ER, as announced in November 2013, consistent with the Food & Drug Administration’s (FDA) draft guidance for the industry on the evaluation and labeling of abuse deterrent opioids.
External Safe-Use Board
Jeffrey Gudin, MD – Chairperson; Pain Management Specialist
Dr. Gudin is currently Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center in New Jersey, an affiliate of the Mount Sinai School of Medicine. His clinical and research focus includes the safe use of controlled substances for the treatment of pain, preemptive analgesia, and increasing clinician awareness of pain management and palliative care. He is board certified in Pain Medicine, Anesthesiology, Addiction Medicine and Hospice and Palliative Care.
John J. Burke – Law Enforcement Specialist
Commander Burke has been a law enforcement officer for over 43 years. He is the president of the non-profit organization, National Association of Drug Diversion Investigators, and is the owner and president of Pharmaceutical Diversion Education Inc., a company which provides education and consulting work on a wide variety of prescription drug abuse issues to law enforcement, health professionals, and the pharmaceutical industry.
Debra Gordon, RN, DNP, FAAN – Patient Advocate
Dr. Gordon is a Teaching Associate with the Department of Anesthesiology & Pain Medicine at the University of Washington (UW), Seattle. She works in conjunction with the inpatient and outpatient Pain Relief Services, clinics and hospital staff to collaborate on improving systems of care and designing outcome evaluations that benefit patients and populations across the continuum of care. She has also been involved in a number of national and international projects focused on improving the quality and safety of pain management.
Herbert Neuman, MD, MBA – Pharmacovigilance Expert
Dr. Neuman, President of R3xperts LLC, has Dr. Neuman, President of R3xperts LLC, has designed global drug safety and risk management systems for multiple companies and advises healthcare firms on a broad range of product safety issues. He has experience working with the FDA to understand and mitigate important drug safety and risk management issues.
Scott Novak, PhD – Surveillance Expert
Dr. Novak, Senior Developmental Epidemiologist at RTI International, holds research interests in the causes, correlates, and consequences of substance use, including the behavioral and psychiatric sequelae. He currently directs the program of research on prescription drug abuse within RTI’s behavioral health epidemiology program. He is also active in studies investigating the epidemiology of new synthetic/designer drugs of abuse in the United States and internationally.
Steven Passik, PhD – Addiction Specialist
Dr. Passik is the Director of Clinical Addiction Research and Education at Millennium Laboratories and is a Professor of Psychiatry and Anesthesiology at Vanderbilt University Medical Center in Nashville, Tennessee. He has served on the editorial board of several peer-reviewed pain management journals, and was the president of the Indiana Cancer and AIDS Pain Initiative and the editor in chief of the National Cancer Institute’s PDQ Supportive Care Editorial Board.
Joseph Pergolizzi, Jr., MD – Risk Management Expert
Dr. Pergolizzi is a senior partner in the Naples Anesthesia and Physician Associates Group and Chairman of the Board of the Association of Chronic Pain Patients. He has served as a member of various medical and scientific societies and acted on a number of institutional committees including the Medical Errors Committee and Pharmacy and Therapeutics Committee, and is also a participant of the FDA’s Safe Use Initiative Roundtable.
About Zohydro ER
INDICATION
Zohydro™ ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
LIMITATIONS OF USE
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Zohydro ER is not indicated for use as an as‑needed (prn) analgesic.
Please see the Zohydro ER full prescribing information for the complete boxed warning and safety information.
WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME and INTERACTION WITH ALCOHOL
- Zohydro ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions.
- Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow Zohydro ER whole to avoid exposure to a potentially fatal dose of hydrocodone.
- Accidental consumption of Zohydro ER, especially in children, can result in fatal overdose of hydrocodone.
- For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome. Prolonged use during pregnancy can result in life-threatening neonatal opioid withdrawal syndrome.
- Instruct patients not to consume alcohol or any products containing alcohol while taking Zohydro ER because co-ingestion can result in fatal plasma hydrocodone levels.
IMPORTANT SAFETY INFORMATION
Zohydro ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma or hypercarbia; known or suspected paralytic ileus; and hypersensitivity to hydrocodone bitartrate or any other ingredients in Zohydro ER.
Zohydro ER contains hydrocodone, a Schedule II controlled substance. As an opioid, Zohydro ER exposes users to the risks of addiction, abuse, and misuse. As modified-release products, such as Zohydro ER, deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.
Potential serious adverse events caused by opioids include respiratory depression, potential for misuse and abuse, CNS depressant effects, prolonged gastric obstruction, and severe hypotension. The most common adverse reactions associated with Zohydro ER ( ≥ 2%) include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, peripheral edema, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain and tremor.
For more information about Zohydro ER, please visit: www.ZohydroEr.com or the Zohydro ER REMS website at www.ZohydroERREMS.com.
About Zogenix
Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with pain-related conditions and CNS disorders who need innovative treatment alternatives to help them return to normal daily functioning. Zogenix developed and commercialized the first needle-free subcutaneous injection, SUMAVEL® DosePro® (sumatriptan injection), for migraine and cluster headache. Zogenix received FDA approval for Zohydro ER (hydrocodone bitartrate) extended-release capsules, the first extended-release oral formulation of hydrocodone without acetaminophen. The development pipeline for Zogenix includes a once-monthly subcutaneous injection for schizophrenia.
Forward-Looking Statements
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: the ability to ensure that the risk of abuse, misuse and diversion of Zohydro ER is minimized and the potential to develop an abuse deterrent formulation of Zohydro ER. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Zogenix’s business, including, without limitation: Zogenix’s ability to adequately ensure that the risk of abuse, misuse and diversion of Zohydro ER is minimized; risks and uncertainties associated with the development and regulatory approval of an abuse deterrent formulation of Zohydro ER; the timing and success of any subsequent commercial launch of Zohydro ER; Zogenix’s ability to successfully launch and drive market demand for Zohydro ER; Zogenix’s ability to obtain additional financing as needed to support its operations; the scope and validity of patent protection for Zohydro ER and Zogenix’s ability to commercialize Zohydro ER without infringing the patent rights of others; unexpected adverse side effects or inadequate therapeutic efficacy of Zohydro ER that could limit commercialization, or that could result in recalls or product liability claims; competition from other pharmaceutical or biotechnology companies; other difficulties or delays relating to the development, testing, manufacturing and marketing of and obtaining regulatory approval for an abuse deterrent formulation of Zohydro ER; and other risks detailed in Zogenix’s prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
ZohydroTM ER is a trademark and SUMAVEL® and DosePro® are registered trademarks of Zogenix, Inc.
CONTACT: Investors Zack Kubow | The Ruth Group 646.536.7020 | zkubow@theruthgroup.com Media Julie Normart | WCG 415.946.1087 | jnormart@wcgworld.com
(RARE) Data From Single Patient rhGUS Treatment Encouraging
NOVATO, Calif., Feb. 12, 2014 — Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced data presentations from a single patient treated with recombinant human beta-glucuronidase (rhGUS, UX003), an investigational therapy for the treatment of mucopolysaccharidosis 7 (MPS 7, Sly syndrome).
The following abstract is being presented in oral and poster presentations by William Sly, M.D., Chairman Emeritus of the Department of Biochemistry at Saint Louis University, at the 10th Annual World Lysosomal Disease Network Symposium in San Diego. The oral presentation will take place on February 13, 2014.
J.E. Fox M.D., L. Volpe M.D., J. Bullaro, E.D. Kakkis M.D., Ph.D., W.S. Sly, M.D. Recombinant Human Beta-Glucuronidase Enzyme Replacement Therapy for Mucopolysaccharidosis Type 7: Report of the First Patient Treated
Dr. Sly is presenting the case study of a single 12 year old patient with advanced multi-system MPS 7 with respiratory insufficiency currently being treated with rhGUS. Preliminary data showed a reduction in lysosomal storage based on reduced excretion of urinary glycosaminoglycans and a reduction in the size of the enlarged liver and spleen. The patient showed an improvement of pulmonary function and no infusion-associated reactions during the first 14 weeks of treatment. The patient’s caregivers also reported improved stamina and increased time spent in school.
The treatment is sponsored by Dr. Joyce Fox and Steven and Alexandra Cohen Children’s Medical Center of New York under an emergency IND (eIND) granted by the Food and Drug Administration. rhGUS is provided by Ultragenyx to the hospital under this eIND.
About MPS 7
Mucopolysaccharidosis type 7 (MPS 7, Sly syndrome), originally described in 1973 by William Sly, M.D., is a rare genetic, metabolic disorder and is one of 11 different MPS disorders. MPS 7 is caused by the deficiency of beta-glucuronidase, an enzyme required for the breakdown of the glycosaminoglycans (GAGs) dermatan sulfate and heparan sulfate. These complex GAG carbohydrates are a critical component of many tissues. The inability to properly break down GAGs leads to a progressive accumulation in many tissues and results in a multi-system disease.
While its clinical manifestations are similar to MPS 1 and MPS 2, MPS 7 is one of the rarest among the MPS disorders. MPS 7 has a wide spectrum of clinical manifestations and can present as early as at birth. There are no approved therapies for MPS 7 today. The use of enzyme replacement therapy as a potential treatment is based on 20 years of research work in murine models of the disease. Enzyme replacement as a strategy is well established in the MPS field as there are currently three approved enzyme replacement therapies for other MPS disorders: MPS 1 (Aldurazyme®, laronidase), MPS 2 (Elaprase®, idursulfase), and MPS 6 (Naglazyme®, galsulfase).
Ultragenyx initiated a Phase 1/2 study in the UK to evaluate the safety, tolerability, efficacy, and dose of intravenous administration of rhGUS in December 2013.
About Ultragenyx
Ultragenyx is a development-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases, with an initial focus on serious, debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.
For more information on Ultragenyx, please visit the company’s website at www.ultragenyx.com.
CONTACT: Ultragenyx Pharmaceutical Inc. 844-758-7273 For Media, Bee Nguyen For Investors, Robert Anstey
(OVRL) Expands Strategic Relationship With Sphere 3D
Overland Partner Sphere 3D Acquires V3 Systems, Creating New Purpose Built VDI Appliance and Software Defined Storage Solution
SAN DIEGO, CA–(Feb 12, 2014) – Overland Storage (NASDAQ: OVRL), a trusted global provider of unified data management and data protection solutions across the data lifecycle, today announced an expanded relationship with Sphere 3D Corporation (TSX VENTURE: ANY) (OTCQX: SPIHF), a virtualization technology solution provider, as a result of Sphere 3D’s recently announced agreement to acquire the product portfolio of V3 Systems. Once completed, this acquisition by Sphere 3D is expected to enable incompatible devices and applications to run over the cloud. Pursuant to Overland’s existing supply agreement with Sphere 3D, Overland’s NAS platform will be included in the V3 offering, which will be delivered through Overland’s channel partners.
Sphere 3D recently announced a definitive agreement to acquire V3 Systems, Inc., of Salt Lake City, Utah. V3 is the creator of the Desktop Cloud Orchestrator™ virtualization software, which is designed to allow administrators to manage local, cloud hosted and hybrid virtual desktop deployments, as well as a series of purpose-built, compact, efficient and easy-to-manage servers, known as V3 Appliances. As an Embedded OEM VMware partner, V3 has revolutionized the speed, ease of deployment and even the size of the data center required for virtual desktop infrastructure (VDI).
According to International Data Corporation (IDC), “The rapidly changing virtualization landscape continues to have a significant impact on storage systems. In 2010, 41.8% of external storage systems’ capacity was attached to virtualized environments. IDC expects 2014 to be the crossover year in which more storage capacity will be shipped to virtualized environments than to non-virtualized environments — a good chunk of this capacity will be for desktop virtualization infrastructures.” IDC forecasts that by 2016, storage attached to virtualized x86 workloads will be 71.1% of external storage systems capacity.
“We expect the combination of the joint technologies of Sphere 3D and V3, along with the Overland NAS platform, to create a unique value proposition that satisfies pain points in today’s growing market. This new level of flexibility creates an opportunity to deliver new business value to our customers, including faster time to deployment, reduced complexity, increased performance, as well as cost efficiencies that go right to the bottom line,” said Eric Kelly, President and CEO of Overland.
V3, Sphere 3D, and Overland have been working closely together for several months and Overland began shipping the V3 Systems products in December 2013. In addition, pursuant to the existing agreements between Overland and Sphere 3D, the parties intend to deliver and provide support for both Sphere 3D’s existing and newly acquired V3 product suites through Overland’s extensive global network of channel partners and service providers. Peter Tassiopoulos, CEO of Sphere3D, said, “I couldn’t be more excited with the blended solution we have created with Overland and V3. Overland’s massive global reach will enable us to create the market penetration velocity needed to deliver our solution through a proven and trusted partner.”
Sphere 3D’s purchase of the V3 product portfolio is subject to various closing conditions, including the completion of due diligence, financing conditions, receipt of approval of the Toronto Stock Exchange and various other conditions customary of a transaction of its nature. Sphere 3D has notified Overland that the closing is expected to occur on or about February 28, 2014.
Safe Harbor Statement
Except for the factual statements made herein, the information contained in this news release consists of forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Such forward-looking statements are not guarantees of performance and our actual results could differ materially from those contained in such statements. Factors that could cause or contribute to such differences include, but are not limited to: risks related to the ability of Sphere3D to raise capital and to close the contemplated transaction with V3, our ability to maintain our relationship with Sphere3D; our ability to maintain and increase sales volumes of our products; our ability to continue to aggressively control costs and operating expenses; our ability to achieve the intended cost savings and maintain quality with our manufacturing partner; our ability to generate cash from operations; the ability of our suppliers to provide an adequate supply of components for our products at prices consistent with historical prices; our ability to raise outside capital and to repay our debt as it comes due; our ability to introduce new competitive products and the degree of market acceptance of such new products; the timing and market acceptance of new products introduced by our competitors; our ability to maintain strong relationships with branded channel partners; our ability to maintain the listing of our common stock on the NASDAQ Capital Market; customers’, suppliers’ and creditors’ perceptions of our continued viability; rescheduling or cancellation of customer orders; loss of a major customer; our ability to enforce our intellectual property rights and protect our intellectual property (including the outcome of our ongoing patent litigation); general competition and price measures in the market place; unexpected shortages of critical components; worldwide information technology spending levels; and general economic conditions. Reference is also made to other factors detailed from time to time in our periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this release and we undertake no obligation to publicly update any forward-looking statements to reflect new information, events or circumstances after the date of this release.
About Overland Storage
Overland Storage is a trusted global provider of unified data management and data protection solutions across the data lifecycle. By providing an integrated range of technologies and services for primary, nearline, offline, and archival data storage, Overland makes it easy and cost effective to manage different tiers of information over time whether distributed data is across the hall or across the globe. Overland SnapScale, SnapServer, SnapSAN, NEO Series and REO Series solutions are available through a select network of value-added resellers and system integrators. For more information, visit www.overlandstorage.com.
Connect with Overland Storage:
Read the Overland blog: http://overlandstorage.com/blog
Follow Overland on Twitter: http://www.twitter.com/OverlandStorage
Visit Overland on Facebook: http://www.facebook.com/OverlandStorage
Overland Storage, SnapScale, SnapSAN, SnapServer, NEO Series, REO Series and the Overland logo are trademarks of Overland Storage, Inc., that may be registered in some jurisdictions. All other trademarks used are owned by their respective owners.
Investor Relations Contact:
Todd Kehrli or Jim Byers
MKR Group Inc.
323-468-2300
ovrl@mkr-group.com
(CTRL) For Winter Games, Control4 Picks Gold, Silver and Bronze Ski Houses
Six days into the 22nd Winter Games, spectators across the globe are mesmerized by an exciting and entertaining two weeks of winter sports and medal ceremonies. In the spirit of the 2014 Winter Games, Control4 (NASDAQ: CTRL) has awarded Gold, Silver and Bronze monikers to three high-tech ski homes that exemplify dedication to slope-side living.
Gold Medal: One Happo, Hakuba, Japan
Nestled near the Nagano ski slopes, this world-class smart home is defined by its James Bond-like style, smarts, and intelligent sustainability. Guests of the chalet are treated to the ultimate convenience and luxury. In the morning, automated blinds gently open, followed by streaming music of the guest’s choice before a 3D plasma TV descends from the ceiling while kicking on the morning news. Strategically placed iPad® mobile devices also allow visitors to custom-tailor their experience by dimming lights and controlling underfloor radiant heating. A Control4-controlled HVAC system, more than 30 controllable blinds and automated lighting solutions, adjust automatically, or can be customized by the homeowners to optimize interior conditions according to the season. The roof, driveway, and ground heating systems are managed through automatic snow sensors, while the eight-person hot tub is automated to fill, heat, and clean itself. (Images Here)
Silver Medal: Truckee Ski House, Northstar, California
Guests at this smart ski home can utilize one of the seven Control4-enabled cameras, conveniently pointed at the ski slopes, to remotely check ski conditions before gearing up for the day ahead. Featuring eighteen zones of hydronic heating and six zones of forced air heating/cooling, plus remote-start gas fireplaces and automated shading, the home’s custom Control4® system keeps guests warm and comfortable all winter. The homeowners frequently take advantage of the Control4 4Sight® remote access feature, which allows them to monitor and control the above systems from anywhere in the world. After a day on the slopes, the owners can press a single button named “Party Mode” to kick off a playlist in each of 16 audio zones through the home’s Tannoy speakers. Other one-touch functions include control over the home’s Marantz electronics, as well as the operation of a motorized lift, which reveals a Panasonic Professional Plasma TV. (Images Here)
Bronze Medal: New York Ski Chalet, Ellicottville, NY
This three-story ski chalet has all of the Control4 automated home essentials, including controllable security with Kwikset locks and closed circuit cameras, lighting, thermostat, and HVAC systems for maximum energy efficiency. Sensors can detect and notify the owner via email when temperatures inside or outside of the home dip dangerously low – whether for guests’ benefits or to protect the home’s systems. What would a high-tech ski chalet be without three separate, automated outdoor heating mats for melting snow, radiant floor heat, heated bathroom tiles, and even heated toilet-seats? The chalet’s owner can program “disposable codes” that make it easy for renters to access the house without exchanging keys. These homeowners also make good use of the Control4 4Sight remote access service, as they manage temperatures, review the cameras, and monitor the home before arrival. (Images Here)
Whether it’s a luxurious ski chalet equipped with all the entertainment luxuries or a warm, safe home to relax in after a long day on the slopes, Control4 offers automation technology that assures homeowners have a medal-worthy winter getaway.
To learn more about Control4 automation solutions, please visit: www.control4.com
About Control4
Control4 (CTRL) is a leading provider of automation systems for homes and businesses, offering personalized control of lighting, music, video, temperature, security, communications and similar functionalities into a unified home automation solution that enhances the daily lives of its customers. Control4 unlocks the potential of connected devices, making entertainment systems easier to use, homes more comfortable and energy efficient, and families more secure. More than 75% of Control4’s consumers have integrated two or more functionalities with Control4’s solution, which is available through more than 2,800 custom integrators, retail outlets, and distributors in over 80 countries. By delivering insightfully simple control solutions that enhance the lives of individuals and families, Control4 is the automation platform of choice for consumers, major consumer electronics companies, hotels, and businesses around the world.
(TQNT) Drives LTE Advances with a Growing Line of Unique, High-Performance Filters
TriQuint Semiconductor, Inc. (NASDAQ: TQNT), a leading RF solutions supplier and technology innovator, today announced several new premium filters for next-generation smartphones and other mobile devices. The high-performance filters utilize the company’s advanced acoustic wave filtering technologies to address some of the industry’s toughest LTE interference problems.
The number of cellular and Wi-Fi bands packed inside compact high-end smartphones is skyrocketing to support 2G/3G/4G voice and data services, as well as global roaming. Advanced filter technology is required to mitigate the resulting interference issues. A global spectrum crunch adds to the growing interference problems as governments around the world squeeze new 4G bands with higher performance requirements next to existing bands, often with minimal band guards.
“TriQuint’s expanding line of advanced filters solves challenging LTE interference issues for mobile device manufacturers and can provide higher data rates over longer distances for end-users,” said Sean Riley, Vice President of Mobile Products. “Our specialty quadplexer also enables carrier aggregation techniques for operators eager to boost spectrum efficiency within their overburdened networks. These filters leverage our proprietary acoustic wave technologies to accelerate the next generation of wireless communications.”
TriQuint’s specialty filters are capturing numerous design wins in high-volume 4G smartphones from multiple manufacturers, as well as coveted sockets on reference designs from leading chipset suppliers. The new filters reflect the TriQuint hallmark: providing industry-leading performance in the world’s smallest form factors. They include the industry’s first diplexer for LTE Bands 38 and 40, which is more than 30% smaller than discrete solutions. TriQuint also unveiled the first carrier aggregation module for Bands 2/25 and 4, an integrated quadplexer that is half the size of discrete architectures. The company’s new Band 7 LTE duplexer and its Band 41 LTE receive filter both achieve exceptionally low insertion loss to help maximize the incoming signal strength, resulting in higher data throughput over longer operating distances.
Product Details
Part # | Description | Bands | Size (mm) | Features | ||||||||||||
885043 | LTE Tx/Rx Diplexer | B38 & B40 | 1.7 x 1.3 | 2-in-1 Filter for Full Band 40 Coverage with Low Loss; BAW filter technology | ||||||||||||
TQQ2504 | LTE SE / SE Duplexer | B25 & B4 | 3.6 x 2.0 | B2 /25 / 4 Quadplexer; BAW & SAW filter technology | ||||||||||||
TQQ0041 | LTE Rx Filter | B41 | 2.0 x 2.0 | Low IL and High Wi-Fi Attenuation; BAW filter technology | ||||||||||||
TQM976027 | LTE SE / SE Duplexer | B7 | 2.0 x 1.6 | Excellent Insertion Loss; BAW filter technology | ||||||||||||
To learn more about TriQuint’s advanced filtering solutions, meet our technology experts at Mobile World Congress in Barcelona Feb. 24-27, or visit http://www.triquint.com/applications/mobile-devices/advanced-filters. To locate TriQuint’s distributors, resellers or field sales representatives, see www.triquint.com/sales.
FORWARD LOOKING STATEMENTS
This TriQuint Semiconductor, Inc. (NASDAQ: TQNT) press release contains forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that forward-looking statements involve risks and uncertainties. The cautionary statements made in this press release should be read as being applicable to all related statements wherever they appear. Statements containing such words as ‘leading’, ‘high performance’, ‘best-in-class’ or similar terms are considered to contain uncertainty and are forward-looking statements. A number of factors affect TriQuint’s operating results and could cause its actual future results to differ materially from any results indicated in this press release or in any other forward-looking statements made by, or on behalf of, TriQuint including, but not limited to: those associated with the unpredictability and volatility of customer acceptance of and demand for our products and technologies, the ability of our production facilities and those of our vendors to meet demand, the ability of our production facilities and those of our vendors to produce products with yields sufficient to maintain profitability, as well as the other “Risk Factors” set forth in TriQuint’s most recent 10-Q report filed with the Securities and Exchange Commission. This and other reports can be found on the SEC web site, www.sec.gov. A reader of this release should understand that these and other risks could cause actual results to differ materially from expectations expressed / implied in forward-looking statements.
FACTS ABOUT TRIQUINT
Founded in 1985, TriQuint Semiconductor (NASDAQ: TQNT) is a leading global provider of innovative RF solutions and foundry services for the world’s top communications, defense and aerospace companies. People and organizations around the world need real-time, all-the-time connections; TriQuint products help reduce the cost and increase the performance of connected mobile devices and the networks that deliver critical voice, data and video communications. With the industry’s broadest technology portfolio, recognized R&D leadership, and expertise in high-volume manufacturing, TriQuint creates standard and custom products using gallium arsenide (GaAs), gallium nitride (GaN), surface acoustic wave (SAW) and bulk acoustic wave (BAW) technologies. The company has ISO9001-certified manufacturing facilities in the U.S., production in Costa Rica, and design centers in North America and Germany. For more information, visit www.triquint.com.
(IRBT) Honored for Strong Patent Portfolio
iRobot Corp. (NASDAQ: IRBT), a client of Fish & Richardson, was recently recognized by the Patent Board™ for having one of the top patent portfolios overall within the competitive electronics and instruments industry. iRobot ranked #5 overall on the list, putting the company ahead of many other major electronics and instruments companies. iRobot’s patent portfolio ranked #2 in the category of “Science Strength” and #3 in the category of “Industry Impact” among the list of 50 industry leaders.
The company’s #2 “Science Strength” ranking, which measures the degree to which a company’s portfolio is linked to core science, was four times stronger than the nearest company on the list. iRobot’s #3 ranking for “Industry Impact,” measures the impact of a company’s patents on technology developed by the rest of the industry.
“We are pleased to be working with iRobot to help them strategically develop their patent portfolio,” said James Babineau, a principal at Fish & Richardson. “Building a strong patent portfolio is a collaborative process, and we work closely with their talented in-house legal team and key technology and business leaders to continually evaluate and refine their portfolio. Because iRobot is such a technology-rich company, we are able to help them develop patent positions that keep pace with their continually evolving market and competitive posture.”
“Working with Fish & Richardson, iRobot has been strategic and aggressive in filing U.S. and international patent applications,” said Glen Weinstein, executive vice president and general counsel at iRobot. “The significant investments iRobot has made to protect its intellectual property will help the company sustain a long-term competitive advantage as the leading developer of robotic technology-based solutions.”
To date, iRobot has been awarded 238 U.S. patents, bringing its total worldwide patents to more than 400.
The “Patent Scorecard™,” which publishes in The Wall Street Journal, tracks the U.S. patent portfolios of more than 2,500 of the world’s top technology firms and ranks the strength of those patent portfolios by specific industries. In January 2014, the Patent Scorecard™ ranked electronics and instruments companies on patent quality, technological strength and breadth of impact. The metrics reflect varying aspects of innovation, speed, strength, and relevancy.
To view the January 2014 WSJ Patent Scorecard, click here: http://bit.ly/1kwPbRS.
Fish & Richardson is a global patent, intellectual property (IP) litigation, and commercial litigation law firm with more than 400 attorneys and technology specialists across the U.S. and Europe. Fish has been named the #1 patent litigation firm in the U.S. for 10 consecutive years. Fish has been winning cases worth billions in controversy – often by making new law – for the most innovative clients and influential industry leaders since 1878. For more information, visit www.fr.com.
(HNSN) Medical Announces FDA Clearance of the Magellan™ 6Fr Robotic Catheter
New Smaller Diameter Catheter Extends Clinical Benefits of Intravascular Robotics to Broader Set of Patients, Physicians and Procedures FDA Clearance Triggers the Mandatory Exercise of Approximately $14 Million of Series A Warrants
MOUNTAIN VIEW, CA–(Feb 11, 2014) – Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its smaller diameter Magellan™ 6Fr Robotic Catheter for peripheral vascular interventions.
The Magellan 6Fr Robotic Catheter is the latest addition to the growing family of catheters available for use with the Magellan Robotic System, and features several important advances. Specifically, the Magellan 6Fr Robotic Catheter features novel dual-bend technology, enabling independent robotic control of two separate bend sites on a single catheter, compared to the current Magellan 9Fr Robotic Catheter which is designed as a telescoping device with two, independently controlled robotic catheters. The 6Fr catheter’s new design provides for precise robotic navigation and control in a single, smaller diameter 6Fr outer diameter catheter, and enables use of the Magellan Robotic System in smaller vessels in the peripheral vasculature and by physicians who may prefer a smaller diameter vessel insertion site.
“This is a major development for Hansen Medical and intravascular robotics,” said Barry Katzen M.D., founder and Medical Director of Baptist Cardiac & Vascular Institute (Baptist Hospital of Miami). “With this lower profile robotic catheter, we can now increase the number and types of procedures we perform with the Magellan Robotic System. The new catheter expands the clinical applications to many interventional vascular therapies involving smaller vessels, including cancer treatment, women’s health, and lower limb treatment.”
“The Magellan 6Fr Robotic Catheter will enable our physician customers to apply the benefits of robotic precision, control and procedural predictability to the treatment of many more vascular patients, which is one of the fastest growing service lines in hospitals today,” said Peter J. Mariani, Chief Financial Officer of Hansen Medical. “This new catheter demonstrates our commitment to expanding the potential clinical applications of Magellan, providing further support to the compelling return on investment potential associated with a multi-disciplinary Intravascular Robotics program.” Mr. Mariani continued, “In addition to enabling a smaller diameter, the Magellan 6Fr Robotic Catheter also features a simplified clinical workflow and was designed for improved manufacturability. I want to congratulate the talented engineering and product development teams at Hansen Medical for this important milestone in our continued development of intravascular robotics technology.”
The Company’s Magellan Robotic Catheters work with the Magellan Robotic System and are designed to allow improved procedural predictability, control and catheter stability as a physician navigates a patient’s peripheral vasculature, and then provide a conduit for manual placement of therapeutic devices for the treatment of vascular disease. The Magellan Robotic System also allows the physician to navigate through the vasculature while seated comfortably at a remote workstation, away from the radiation field, potentially reducing physician radiation exposure and fatigue. Approximately two million peripheral vascular procedures are performed annually in the U.S. and Europe, the majority of which are now potentially addressable with the Magellan Robotic System.
The Company will begin a limited release of the Magellan 6Fr Robotic Catheter, collecting clinical and procedure data over a broad set of cases over the next several months, and anticipates a more wide-scale release later in 2014.
Mandatory Exercise of Series A Warrants
Additionally, the FDA clearance of the Magellan 6Fr Robotic Catheter triggers the mandatory exercise of $14 million of Series A Warrants that were issued as part of the private placement of stock and warrants that was announced on July 31, 2013. The Company issued approximately 11 million Series A warrants with a per share exercise price of $1.23 as part of the private placement transaction. The holders of these Series A warrants are required to exercise the warrants, upon 15 days’ notice of the FDA clearance of the 6Fr catheter, and the Company expects to provide notice to holders today. The Company also issued 11 million Series B Warrants with an exercise price of $1.50, and 11 million Series C warrants with an exercise price of $2.00 as part of the private placement transaction. These warrants expire in August of 2015 and are not subject to mandatory exercise.
About the Magellan™ Robotic System
Hansen Medical’s Magellan Robotic System is intended to be used to facilitate navigation in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic System is designed to deliver improved predictability, control and catheter stability to endovascular procedures. Since its commercial introduction in the U.S. and Europe, the Magellan Robotic System has demonstrated its clinical versatility in many cases in a broad variety of peripheral vascular procedure types in centers across the U.S. and Europe. The Magellan Robotic System offers several important features including:
- Provides improved predictability, control and catheter stability as a physician navigates a patient’s peripheral vasculature and then provides a conduit for manual treatment of vascular disease with standard therapeutic devices.
- Is designed to enable more predictable procedure times and increased case throughput potentially allowing hospitals to improve utilization within their vascular business line
- Employs an open architecture designed to allow for the subsequent use of many therapeutic devices on the market today
- Is designed to potentially reduce physician radiation exposure and fatigue by allowing the physician to navigate procedures while seated comfortably at a remote workstation away from the radiation field and without wearing heavy lead as required in conventional endovascular procedures.
- The Magellan 9Fr Robotic Catheter for independent, robotic control of the distal tip of two telescoping catheters (an outer Guide and an inner Leader catheter), as well as robotic manipulation of standard guidewires.
- The Magellan 6Fr Robotic Catheter allows for independent robotic control of two separate bend sites on a single catheter, as well as robotic manipulation of standard guidewires. This smaller catheter design may be preferred by certain physicians who prefer a smaller diameter vessel incision site, or in procedures in smaller vessels, including peripheral vascular embolization.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is a global leader in intravascular robotics, developing products and technology designed to enable the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company’s Magellan™ Robotic System, Magellan™ 9Fr Robotic Catheter, Magellan™ 6Fr Robotic Catheter, and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone both CE marking and 510(k) clearance and are commercially available in the European Union, and the U.S. In the European Union, the Company’s Sensei® X Robotic Catheter System and Artisan® and Artisan Extend® Control Catheters are cleared for use during electrophysiology (EP) procedures, such as guiding catheters in the treatment of atrial fibrillation (AF), and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the U.S., the Company’s Sensei X Robotic Catheter System and Artisan and Artisan Extend Control Catheters are cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in EP procedures. In the U.S., the Sensei X Robotic Catheter System is not approved for use in guiding ablation procedures; this use remains experimental. The U.S. product labeling therefore provides that the safety and effectiveness of the Sensei X Robotic Catheter System and Artisan and Artisan Extend Control Catheter for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including AF, have not been established. Additional information can be found at www.hansenmedical.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “plan,” “expects,” “potential,” “believes,” “goal,” “estimate,” “anticipates,” and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such statements include statements about the potential benefits, market size, timing and results of commercializing our Magellan 6Fr Robotic Catheter. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: engineering, regulatory, manufacturing, sales and customer service challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the effect of credit, financial and economic conditions on capital spending by our potential customers; the uncertain timelines for the sales cycle for newly introduced products; the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to manage expenses and cash flow, and obtain additional financing; and other risks more fully described in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 filed with the SEC on November 8, 2013 and the risks discussed in our other reports filed with the SEC. Given these uncertainties, you should not place undue reliance on the forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart Design), Sensei and Lynx are registered trademarks, and Magellan and NorthStar are trademarks of Hansen Medical, Inc. in the United States and other countries.
Investor Contacts:
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
650.404.5800
Westwicke Partners, LLC.
Mark Klausner
443.213.0501
Email Contact
Mike Piccinino, CFA
443.213.0509
Email Contact
(PED) Kazakhstan Government Approval of the Production License
DANVILLE, CA–(February 11, 2014) – Pacific Energy Development (NYSE MKT: PED), an energy company engaged in the acquisition and development of strategic high-value energy projects in the U.S. and Asia, today announced that it has been informed by Aral Petroleum Capital Limited Partnership (“Aral”) that in December 2013 the Central Development Committee of the Republic of Kazakhstan approved the development plan proposed by Aral for the development of its 2,199 acre contract area located in the East Zhagabulak Block oilfield, thereby officially moving the oilfield into the development stage under Aral’s existing production license issued by the Republic of Kazakhstan. Under Kazakh law, a government-approved development plan is necessary to commence formal oil production under a production license. With receipt of this approval, Aral now formally enters into the production stage, which expires in 2034.
Following the previously announced completion of two target zones in wells #306 and #315, the asset has recently been producing approximately 1,522 barrels of oil equivalent per day (517 BOE/D to our 34% net interest) at approximately 50% choke from these two wells. Production was recently voluntarily halted by Aral pending receipt of a required gas-flaring permit or finalization of a gas off-take agreement for the sale of gas produced from the asset, following which Aral plans to commence commercial production within the coming months.
The Company is currently in contract to acquire an indirect 34% interest in Aral, which holds a production license covering 2,199 acres located in the North Block of Kazakhstan’s Pre-Caspian Basin, which acreage is covered by an exploration license issued by the Republic of Kazakhstan that covers 380,000 acres and is 100% held by Aral. The Company’s acquisition of this interest is subject to the satisfaction of certain customary closing conditions, including the requisite approvals from the Republic of Kazakhstan
Commenting on these recent developments, President and CEO Frank Ingriselli noted, “The recent production increases are very exciting and Aral’s receipt of the Government of Kazakhstan approval to move into production is a major achievement. These are two important milestones in the development of this field that will allow formal commercial production to soon commence. We likewise look forward to receiving the further necessary Government of Kazakhstan approvals to close our acquisition of this interest as soon as possible, and to participating in the further development of this exciting asset.”
About Pacific Energy Development (PEDEVCO Corp.)
PEDEVCO Corp, d/b/a Pacific Energy Development (NYSE MKT: PED), is a publicly-traded energy company engaged in the acquisition and development of strategic, high growth energy projects, including shale oil and gas assets, in the United States and Asia. The Company’s principal assets include its Niobrara asset located in the DJ Basin in Colorado, its Mississippian asset located in Comanche, Harper, Barber and Kiowa Counties, Kansas, its Eagle Ford asset in McMullen County, Texas, and its North Sugar Valley asset located in Matagorda County, Texas. The Company has also previously announced its entry into agreements to acquire (i) a controlling interest in a 380,000 acre producing asset located in the Pre-Caspian Basin, one of the largest producing basins in Kazakhstan, and (ii) an additional approximately 28,241 net acres and wells producing approximately 400 net barrels of oil equivalent per day in Weld and Morgan Counties, Colorado. Pacific Energy Development is headquartered in Danville, California, with offices in Houston, Texas and Beijing, China.
Forward-Looking Statements
All statements in this press 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 contained herein 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 Company’s control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company’s public filings with the SEC.
Contacts
Pacific Energy Development
Bonnie Tang
1-855-733-3826 ext 21 (Media)
PR@pacificenergydevelopment.com
Investor Relations:
Liviakis Financial Communications, Inc.
John Liviakis
+1-415-389-4670
john@liviakis.com
Stonegate, Inc.
Casey Stegman
214-987-4121
casey@stonegateinc.com
(MNK) to Acquire (CADX) for $14.00 Per Share, in Cash
Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceuticals company, and Cadence Pharmaceuticals, Inc. (NASDAQ: CADX) today announced that they have entered into a definitive agreement under which a subsidiary of Mallinckrodt plc will commence a tender offer to acquire all outstanding shares of Cadence Pharmaceuticals, Inc. for $14.00 per share in cash or approximately $1.3 billion on a fully diluted basis, which represents a 32% premium to the trailing 30-trading-day volume weighted average price (VWAP) of $10.62 per share for Cadence Pharmaceuticals, Inc.
Subject to customary terms and conditions, the parties expect the transaction to close in mid- to late-March. Mallinckrodt expects the acquisition will be immediately accretive to its fiscal year 2014 adjusted diluted earnings per share, and significantly accretive to its fiscal year 2015 adjusted diluted earnings per share.
Cadence Pharmaceuticals is a biopharmaceutical company focused on commercializing products principally for use in the hospital setting. The company’s product OFIRMEV® (acetaminophen injection) is a proprietary intravenous formulation of acetaminophen for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics and the reduction of fever. Since its introduction, OFIRMEV has experienced strong growth, and in a press release issued January 13, 2014, Cadence reported that it expects net revenues of $110.5 million for OFIRMEV in calendar year 2013 compared to 2012 reported OFIRMEV net product revenues of $50.1 million. OFIRMEV is currently on formulary in more than 2,350 U.S. hospitals and has been used to treat an estimated 6 to 7 million patients since its launch in January 2011 A New Drug Submission for the product has been approved by Health Canada.
This transaction accelerates growth in Mallinckrodt’s Specialty Pharmaceuticals segment in key ways. First, the company adds another powerful growth product, OFIRMEV, to the segment’s robust portfolio of core controlled substance generics and its growing roster of brands like EXALGO®, Gablofen®, PENNSAID® 2% and, if approved, XARTEMIS™ XR and longer term, MNK-155. Additionally with the strong presence Cadence has established in the adjacent hospital market, the acquisition adds another potential growth dimension for the segment, providing Mallinckrodt an opportunity to expand the company’s reach and penetration in this important channel.
“The acquisition of Cadence Pharmaceuticals is consistent with our goal of becoming a leading global specialty pharmaceuticals company,” said Mark Trudeau, Chief Executive Officer and President of Mallinckrodt. “OFIRMEV’s growth is driven by an expanding base of physicians who are prescribing the product for an increasing number of surgical patients, and we believe the product will be an outstanding addition to the brands component of Mallinckrodt’s Specialty Pharmaceutical segment. We have been impressed with the strong relationships that Cadence’s commercial organizations have established with customers in the hospital channel and are excited by the opportunity to build on these relationships to expand our platform in this area. We believe Mallinckrodt is well-positioned to further accelerate the trajectory of OFIRMEV and realize the full value of this product in the marketplace.”
“We are very proud of what our employees have accomplished, and in particular the very strong growth we have achieved with OFIRMEV,” said Ted Schroeder, President and Chief Executive Officer of Cadence Pharmaceuticals. “The relationships we’ve established with our customers and the benefits the drug has provided to millions of patients across the U.S. have contributed to the strong year-on-year growth we’ve seen for the product since launch. We believe Mallinckrodt is a natural fit to provide the resources and expertise that can expand patient access for OFIRMEV. Additionally, this transaction will provide Cadence shareholders with a strong return on their investment.”
Additional Terms of the Transaction
The Boards of Directors of both companies have unanimously approved the transaction. Under the terms of the agreement, a subsidiary of Mallinckrodt plc will commence a tender offer to purchase all of the outstanding shares of Cadence Pharmaceuticals, Inc. common stock for $14.00 per share in cash. The completion of the tender offer is subject to customary terms and conditions, including Cadence Pharmaceuticals’ stockholders tendering a majority of Cadence Pharmaceuticals’ outstanding shares and the expiration or termination of the waiting period under the Hart Scott Rodino Antitrust Improvements Act. Following the successful completion of the tender offer, the agreement provides that Cadence Pharmaceuticals, Inc. will merge with a subsidiary of Mallinckrodt and become a wholly-owned subsidiary of Mallinckrodt, and all remaining outstanding shares of Cadence Pharmaceuticals, Inc. will receive the same consideration paid to other stockholders in the tender offer.
The tender offer is expected to be completed in mid- to late-March 2014, subject to the satisfaction or waiver of the offer conditions. In connection with the tender offer, certain funds affiliated with Domain Associates, Cam L. Garner, James C. Blair, William R. LaRue and certain other entities have entered into a tender and support agreement with Mallinckrodt plc pursuant to which they have agreed to tender an aggregate of approximately 13% of Cadence Pharmaceutical’s outstanding shares in the offer. Following the completion of the transaction, Cadence Pharmaceuticals, Inc. shares will be delisted from NASDAQ.
Financing
Mallinckrodt plc has entered into debt financing commitments with affiliates of Deutsche Bank Securities Inc. that, together with cash on hand, are expected to provide the funds necessary to consummate the acquisition. Mallinckrodt expects that the financing for the transaction will be a senior secured term loan facility.
Advisors
Mallinckrodt’s financial advisor for the transaction is Deutsche Bank Securities Inc., and its legal advisors are Wachtell, Lipton, Rosen & Katz in the U.S. and Arthur Cox in Ireland.
Cadence Pharmaceuticals’ financial advisors for the transaction are Lazard and Centerview Partners and its legal advisor is Latham & Watkins LLP.
CONFERENCE CALL AND WEBCAST
Mallinckrodt will hold a conference call for investors on Tuesday, February 11, 2014, beginning at 8:30am/U.S. Eastern Standard Time. This call can be accessed in three ways:
At the Mallinckrodt website: http://mallinckrodt.com/investor_relations.aspx
By telephone: For both “listen-only” participants and those who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 866-515-2915. For participants outside the U.S., the dial-in number is 617-399-5129. The access code for all callers is 21258039.
Through an audio replay: A replay of the call will be available beginning at 12:30pm/ U.S. Eastern Standard Time on February 11, 2014, and ending at 11:59pm/U.S. Eastern Standard Time on February 18, 2014. The dial-in number for U.S. participants is 888-286-8010. For participants outside the U.S., the replay dial-in number is 617- 801-6888. The replay access code for all callers is 60095354.
Cadence® and OFIRMEV® are registered trademarks of Cadence Pharmaceuticals, Inc.
PENNSAID is a registered trademark of Nuvo Research Inc.
ABOUT OFIRMEV® (ACETAMINOPHEN) INJECTION
OFIRMEV (acetaminophen) injection (1000 mg / 100 mL, 10 mg / mL; for intravenous use only), Cadence Pharmaceutical’s proprietary intravenous formulation of acetaminophen, is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics and the reduction of fever. The FDA approval of OFIRMEV was based on data from clinical trials in approximately 1,020 adult and 355 pediatric patients. These trials included two studies evaluating the safety and effectiveness of OFIRMEV in the treatment of pain, and one study evaluating OFIRMEV in the treatment of fever. The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients less than two years of age.
Important Safety Information
RISK OF MEDICATION ERRORS AND HEPATOTOXICITY
Take care when prescribing, preparing, and administering OFIRMEV injection to avoid dosing errors which could result in accidental overdose and death.
OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.
OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur, or at the first appearance of skin rash. Do not use in patients with acetaminophen allergy.
The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. The antipyretic effects of OFIRMEV may mask fever in patients treated with postsurgical pain. OFIRMEV is approved for use in patients ≥ 2 years of age. Do not exceed the recommended maximum daily dose of OFIRMEV. OFIRMEV should be administered only as a 15-minute infusion.
For more information, please see the full OFIRMEV Prescribing Information, including the complete boxed warning, which is available at www.OFIRMEV.com or www.cadencepharm.com.
ABOUT MALLINCKRODT PLC
Mallinckrodt is a global specialty pharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. The company’s Specialty Pharmaceuticals segment includes branded and specialty generic drugs and active pharmaceutical ingredients, and the Global Medical Imaging segment includes contrast media and nuclear imaging agents. Mallinckrodt has approximately 5,500 employees worldwide and a commercial presence in roughly 70 countries. The company’s fiscal 2013 revenue totaled $2.2 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
ABOUT CADENCE PHARMACEUTICALS, INC.
Cadence Pharmaceuticals is a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting. The current version of Cadence Pharmaceuticals’ corporate overview may be viewed on the Investors page of www.cadencepharm.com under “Events & Presentations” by selecting “Corporate Overview.”
ADDITIONAL INFORMATION AND WHERE TO FIND IT
The tender offer for the outstanding shares of Cadence Pharmaceuticals, Inc. (“Cadence Pharmaceuticals”) referenced in this document has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares, nor is it a substitute for the tender offer materials that Mallinckrodt plc (“Mallinckrodt”) and its subsidiary will file with the Securities and Exchange Commission (“SEC”). At the time the tender offer is commenced, Mallinckrodt and its subsidiary will file tender offer materials on Schedule TO, and thereafter Cadence Pharmaceuticals will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION. HOLDERS OF SHARES OF CADENCE PHARMACEUTICALS COMMON STOCK ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF SHARES OF CADENCE PHARMACEUTICALS COMMON STOCK SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of Cadence Pharmaceuticals common stock at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s website at www.sec.gov. Additional copies of the tender offer materials may be obtained for free by contacting Mallinckrodt plc at 675 James S. McDonnell Blvd, Hazelwood, MO 63042, Attention: John Moten, Vice President Investor Relations, (314) 654-6650. In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Cadence Pharmaceuticals and Mallinckrodt file annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by Cadence Pharmaceuticals or Mallinckrodt at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Cadence Pharmaceuticals’ and Mallinckrodt’s filings with the SEC are also available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov.
FORWARD-LOOKING STATEMENTS
Statements in this document that are not strictly historical, including statements regarding the proposed acquisition, the expected timetable for completing the transaction, future financial and operating results, benefits and synergies of the transaction, future opportunities for the combined businesses and any other statements regarding events or developments that we believe or anticipate will or may occur in the future, may be “forward-looking” statements within the meaning of the federal securities laws, and involve a number of risks and uncertainties. There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: general economic conditions and conditions affecting the industries in which Mallinckrodt and Cadence Pharmaceuticals operate; the commercial success of OFIRMEV; Mallinckrodt’s and Cadence Pharmaceuticals’ ability to protect intellectual property rights; the uncertainty of approval under the Hart Scott Rodino Antitrust Improvements Act; the parties’ ability to satisfy the tender offer and merger agreement conditions and consummate the tender offer and the merger on the anticipated timeline or at all; the availability of financing, including the financing contemplated by the debt commitment letter, on anticipated terms or at all; Mallinckrodt’s ability to successfully integrate Cadence Pharmaceuticals’ operations and employees with Mallinckrodt’s existing business; the ability to realize anticipated growth, synergies and cost savings; Cadence Pharmaceuticals’ performance and maintenance of important business relationships; Mallinckrodt’s ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; Mallinckrodt’s ability to obtain and/or timely transport molybdenum-99 to our technetium-99m generator production facilities; customer concentration; cost-containment efforts of customers, purchasing groups, third-party payors and governmental organizations; Mallinckrodt’s ability to successfully develop or commercialize new products; competition; Mallinckrodt’s ability to integrate acquisitions of technology, products and businesses generally; product liability losses and other litigation liability; the reimbursement practices of a small number of large public or private issuers; complex reporting and payment obligation under healthcare rebate programs; changes in laws and regulations; conducting business internationally; foreign exchange rates; material health, safety and environmental liabilities; litigation and violations; information technology infrastructure; and restructuring activities. Additional information regarding the factors that may cause actual results to differ materially from these forward-looking statements is available in Mallinckrodt’s SEC filings, including its Annual Report on Form 10-K for the fiscal year ended September 27, 2013 and Quarterly Report on Form 10-Q for the quarterly period ended December 27, 2013, as well as Cadence Pharmaceuticals’ SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2012 and Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2013, June 30, 2013 and September 30, 2013. The forward-looking statements made herein speak only as of the date hereof and none of Mallinckrodt, Cadence Pharmaceuticals or any of their respective affiliates assumes any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
(ATNM) Presenting at the 16th Annual BIO CEO & Investor Conference Today at 1:30 pm ET
Management Looks Forward to Communicating Its Exciting Prospects and Meeting with Conference Attendees
Actinium Pharmaceuticals, Inc. (OTCQB:ATNM.OB) (“Actinium” or “the Company”), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, is presenting today at 1:30 pm ET at the 16th Annual BIO CEO & Investor Conference. Dr. Kaushik J. Dave, President and CEO, will present a corporate update.
Presentation Information:
Date: | Tuesday, February 11, 2014 | |||
Time: | 1:30 pm ET | |||
Location: | The Waldorf-Astoria Hotel: Conrad Room, New York, NY | |||
Webcast: | http://www.veracast.com/webcasts/bio/ceoinvestor2014/68234189.cfm | |||
A live webcast of the presentation will be available via the “Investor Relations” page of the Actinium website, www.actiniumpharmaceuticals.com. A replay of the webcast will also be archived on Actinium’s website for 90 days following the presentation.
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (ATNM.OB) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy is based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company is conducting a single, pivotal, multicenter Phase 3 clinical study of Iomab™-B in refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55 with a primary endpoint of durable complete remission. The company’s second program, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial. For more information, please visit www.actiniumpharmaceuticals.com.
For more information:
Visit our web site www.actiniumpharmaceuticals.com
Forward-Looking Statement for Actinium Pharmaceuticals, Inc.
This news release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
(DWCH) Announces Proposed Public Offering of Common Stock
CHELMSFORD, Massachusetts, Feb. 10, 2014 — Datawatch Corporation (NASDAQ-CM: DWCH), a leading global provider of visual data discovery solutions, announced today that it plans to offer and sell, subject to market and other conditions, 1,500,000 shares of its common stock in an underwritten public offering. Datawatch also will grant the underwriters a 30-day option to purchase up to an additional 225,000 shares to cover over-allotments, if any. Datawatch intends to use the net proceeds from the offering for product development, commercialization of its products, working capital and other general corporate purposes, including repayment of outstanding indebtedness.
Canaccord Genuity Inc. and William Blair & Company, L.L.C. are acting as joint book-running managers for the offering. Cowen and Company, LLC and Craig-Hallum Capital Group LLC are acting as co-managers for the offering.
The public offering of common stock will be made only by means of a prospectus and prospectus supplement pursuant to Datawatch’s effective shelf registration statement filed with the Securities and Exchange Commission (“SEC”). Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained from the offices of Canaccord Genuity Inc., Attn: Syndicate Department, 99 High Street, Floor 12, Boston, MA 02110, by telephone at +1-617-371-3900; or from William Blair & Company, L.L.C., 222 W. Adams Street, Chicago, IL 60606, by telephone at (800) 621-0687. Alternatively, you may also obtain these documents by visiting EDGAR on the SEC website at www.sec.gov.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities, in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.
ABOUT DATAWATCH CORPORATION
Datawatch Corporation (NASDAQ-CM: DWCH) provides visual data discovery software that enables more informed decisions through next generation analytics applications. Datawatch software empowers individuals, business units and entire enterprises to access and visualize a multitude of data varieties, regardless of source and format, and to generate real-time strategic and operational insights from their Big Data. Datawatch is headquartered in Chelmsford, Massachusetts with offices in New York, London, Munich, Stockholm, Singapore, Sydney and Manila, and with partners and customers in more than 100 countries worldwide.
Forward-Looking Information
This release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Datawatch’s expectations regarding the completion of the public offering. These statements are based on management’s current expectations and accordingly are subject to uncertainty and changes in circumstances. Actual results and the timing of events may vary materially from those expressed or implied by such forward-looking statements due to various important factors, including, without limitation, risks and uncertainties related to Datawatch’s business and the satisfaction of the conditions of the closing of the public offering. More detailed information about those factors is set forth in Datawatch’s filings with the Securities and Exchange Commission, including Datawatch’s annual report on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K. Datawatch is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
Investor Contact:
Datawatch Investor Relations
investor@datawatch.com
Phone: +1-978-441-2200 ext. 8323
Media Contact:
Sarah Bernardi
Datawatch Corporation
Sarah_Bernardi@datawatch.com
Phone: +1-978-441-2200 ext. 8387
Twitter: @datawatch
(RVLT) Lighting Technologies Provides Business Update
Revolution Lighting Technologies, Inc. (NASDAQ:RVLT) (“Revolution Lighting”), a leader in advanced LED lighting technology, today provided a business update prior to announcing financial results for the fourth quarter and full year 2013 on March 13, 2014.
“2013 was a solid year for Revolution Lighting Technologies as we continued to build and transform our company into a leading LED lighting enterprise,” noted Robert V. LaPenta, Chairman and Chief Executive Officer. “During 2013, we broadened our product portfolio with the acquisitions of Relume and CMG, expanded our distribution network, and strengthened our engineering and management teams, positioning our company for the rapid growth of the LED industry that we believe lies ahead.”
Revolution Lighting’s fourth quarter 2013 revenues are expected to approximate $7 million with pro forma revenue growth of over 100% and an increase of approximately 600% when comparing actual fourth quarter revenue to the prior year’s fourth quarter. The Company had expected revenues in the range of $10 million for the fourth quarter, but a large international order has been delayed.
The Company’s business pipeline is stronger than ever with Revolution Lighting being selected for several strategic projects in recent months, including the following:
- Downselected on LED lighting retrofit projects for several large nationwide franchise operators with over 6,000 outlets commencing in 2014 with a potential of over $100 million
- Designated the preferred provider of LED products for New Jersey and select New York State public school systems with the potential of over $30 million
- Selected to participate in a large multi-use project in a major U.S. city, including hotels, apartments and retail outlets with a potential of $20 million
During the quarter, the Company completed and initiated a number of key projects, including:
- Completed LED retrofit projects for the Empire Casino in Yonkers, New York and the MGM Casino in Detroit, Michigan
- Completed the project with U.S. Navy’s Military Sealift Command to supply Lewis and Clark dry cargo/ammunition ships with 17,000 Seesmart two and four foot LED tube lamp; the Company expects follow-on orders throughout 2014
- Commenced retrofit of the Connecticut Convention Center, located in Hartford, Connecticut; this 540,000 square foot building is the largest energy reduction project in the state
Revolution Lighting will start 2014 with a robust pipeline of close to $200 million in actionable opportunities over the next 12 to 18 months. For 2014 the Company expects revenue to be in the $50 million range with organic revenue growth of over 50% and gross margins of 35% or greater.
“With our robust opportunity pipeline, our broad portfolio of proven quality LED products, and the rapid growth of LED acceptance around the world, we are extremely excited about the future and we are enthusiastically looking forward to 2014 and beyond,” concluded Mr. LaPenta.
About Revolution Lighting Technologies Inc.
Revolution Lighting Technologies, Inc. is a leader in the design, manufacture, marketing, and sale of light emitting diode (LED) lighting solutions focusing on the industrial, commercial and government markets in the United States, Canada, and internationally. Through advanced technology and aggressive new product development, Revolution Lighting has created an innovative, multi-brand, lighting company that offers a comprehensive advanced product platform. The company goes to market through its Seesmart brand, which designs, engineers and manufactures an extensive line of high-quality interior and exterior LED lamps and fixtures; Lighting Integration Technologies Inc., which sells and installs Seesmart products; Lumificient, which supplies LED illumination for the signage industry; Relume Technologies, a leading manufacturer of outdoor LED products; and Sentinel, a revolutionary patented and licensed monitoring and smart grid control system for outdoor lighting applications. Revolution Lighting Technologies markets and distributes its product through a network of independent sales representatives and distributors, as well as through energy savings companies and national accounts. Revolution Lighting Technologies trades on the NASDAQ under the ticker RVLT. For additional information, please visit: www.rvlti.com.
Cautionary Statement for Forward-Looking Statements
Certain of the above statements contained in this press release are forward-looking statements that involve a number of risks and uncertainties, including the anticipated benefits of the Relume acquisition and statements relating to the anticipated future growth and profitability of our business. Such forward-looking statements are within the meaning of that term in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Reference is made to Revolution Lighting’s filings under the Securities Exchange Act for additional factors that could cause actual results to differ materially, including our history of losses, the potential for future dilution to our existing common stockholders, our status as a controlled company, the risk that demand for our LED products fails to emerge as anticipated, competition from larger companies, and risks relating to third party suppliers and manufacturers, as well as the other Risk Factors described in Item 1A of our Form 10-K for the fiscal year ended December 31, 2012. Revolution Lighting Technologies, Inc. undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Readers 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 indicated in the forward-looking statements as a result of various factors. Readers are cautioned not to place undue reliance on these forward-looking statements.
Pro Forma Revenue
Pro Forma Revenue assumes that the company’s 2012 and 2013 acquisitions had occurred on October 1, 2012.
(DAVE) Names Ed Rensi Interim CEO
MINNEAPOLIS, Feb. 10, 2014 — Famous Dave’s (Nasdaq:DAVE) today announced that Ed Rensi, Director, has been appointed as the Company’s Interim Chief Executive Officer, effective immediately. He succeeds John Gilbert, who resigned.
Rensi commented, “I have been a customer and a fan of Famous Dave’s for 20 years and I am delighted to lead Famous Dave’s for the foreseeable future! Dave Anderson has been a professional friend of mine for a long time. Dave and his barbecue are iconic and I look forward to working with him and the Famous Dave’s team on this great brand to unleash all of its potential.”
Ed Rensi has spent the majority of his career at McDonald’s U.S.A., rising to President from 1984-1991 and then President & CEO through 1997. Rensi founded Tom & Eddies restaurant chain. Mr. Rensi also started and owned Team Rensi Motorsports, which competed in the NASCAR Nationwide Series. He currently serves on the Board of Directors of Snap-On Incorporated. He has served on the board of Great Wolf Resorts, Inc., International Speedway Corporation and Freedom Group, Inc. Mr. Rensi earned a Bachelor of Science degree from The Ohio State University.
“On behalf of the board, I appreciate that Mr. Rensi has stepped in to bring his years of effective restaurant management and franchisor expertise to serve as interim CEO during this important transition period for Famous Dave’s of America,” said Dean Riesen, Chairman of the Company’s board of directors.
Riesen also said that the company’s plan to release Fourth Quarter and 2013 results would proceed on schedule after market close on February 12, 2014. In anticipation of that release, he noted the following (unaudited) financial highlights for the year:
- Revenue of $155.4 million increased approximately $444,000, reflecting an increase in restaurant sales, partially offset by a decline in franchise royalty revenue and fees.
- Comparable sales for Company-owned restaurants open 24 months or more were a positive 0.2% compared to a decrease of 1.8% in 2012.
- Fourth quarter comparable sales for Company-owned restaurants open 24 months or more decreased 2.6%, compared to a decrease of 6.0% for the comparable quarter in the prior year.
- Restaurant-level cash flow margins increased 250 basis points, reflecting year-over-year improvement in all operating line items.
- Income from operations for fiscal 2013 was approximately $7.7 million and increased 25% over fiscal 2012.
- During fiscal 2013, the Company used approximately $6.9 million to repurchase approximately 379,000 shares at an average price of $18.22, excluding commissions, and has approximately 252,000 shares remaining on its current authorization.
The company will host a conference call on February 13, 2014 at 10:00 a.m., Central Time, to discuss its financial results.
About Famous Dave’s
Famous Dave’s of America, Inc. develops, owns, operates and franchises barbeque restaurants. As of today, the company owns 54 locations and franchises 142 additional units in 34 states, the Commonwealth of Puerto Rico, and 1 Canadian province. Its menu features award-winning barbequed and grilled meats, an ample selection of salads, side items and sandwiches, and unique made-from-scratch desserts.
CONTACT: Diana G. Purcel - Chief Financial Officer 952-294-1300
(PLUG) Receives Multi-Site GenKey Order
Multi-Site Deal With Major North American Retailer Includes Fuel Cells, Hydrogen and Services
LATHAM, N.Y., Feb. 10, 2014 — Plug Power Inc. (Nasdaq:PLUG), a leader in providing clean, reliable energy solutions, today announced it has received a significant GenKey contract from a leading retailer to roll out its turnkey hydrogen fuel cell system solutions at six North America distribution centers over approximately a two year period. The first site is expected to be operational in the second quarter of 2014.
With this deal, Plug Power solidifies its position as the premier global proton exchange membrane (PEM) fuel cell system solution provider. This landmark contract is a result of demonstrated performance and customer trust gained through proven Plug Power expertise and know-how. The contract is a notable event in the history of the mobile fuel cell industry and demonstrates that this technology has become mainstream.
The multi-site GenKey deal includes over 1,500 GenDrive PEM fuel cell power units coupled with multi-year contracts for GenFuel hydrogen, GenFuel fueling infrastructure, and GenCare service. GenKey makes the transition to hydrogen fuel cell power seamless for customers, as Plug Power delivers a complete range of turnkey services to simplify the conversion process.
“GenKey accelerates the transition to GenDrive fuel cells and enables rapid fleet conversion. This allows customers to swiftly realize the advantages of increased productivity and improved environmental benefits,” said Andy Marsh, CEO of Plug Power. “This turnkey deal represents a significant milestone for Plug Power. We’ve, without a doubt, clearly demonstrated our leadership position as the premier provider of industrial fuel cell solutions. In the coming year, we plan to grow not only in the material handling industry, but also expand into other fleet vehicle applications such as transport refrigeration units, ground support equipment and range extenders.”
Plug Power has over 4,500 GenDrive units deployed with leading North American material handling operators, such as Walmart, Procter & Gamble, Kroger, BMW and Mercedes Benz. GenDrive is an attractive power solution that improves customer productivity while reducing operational costs. GenDrive replaces multiple lead acid batteries, eliminates time-consuming battery changes and operates at 100% output power for a full shift without the effects of battery degradation. Furthermore, GenDrive fuel cells offer environmental benefits to customers, supporting sustainable operations through greenhouse gas emission reductions when compared to charging batteries from the grid.
Further information on this deal will follow in future press releases.
About Plug Power Inc.
The architects of modern fuel cell technology, Plug Power is revolutionizing the industry with cost-effective power solutions that increase productivity, lower operating costs and reduce carbon footprints. Long-standing relationships with industry leaders, including Walmart, Sysco, Procter & Gamble, and Mercedes Benz, forged the path for Plug Power’s innovative GenKey hydrogen and fuel cell system solutions. With more than 4,500 GenDrive units deployed to material handling customers, accumulating over 16 million hours of runtime, Plug Power manufactures tomorrow’s incumbent power solutions today. Additional information about Plug Power is available at www.plugpower.com.
Safe Harbor Statement
This communication contains statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding our expectations regarding the timing and rollout of the new GenKey contract, the performance of our GenKey offering and the expansion into new markets. These forward-looking statements contain projections of our future results of operations or of our financial position or state other forward-looking information. We believe that it is important to communicate our future expectations to our investors. However, there may be events in the future that we are not able to accurately predict or control and that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements. Investors are cautioned not to unduly rely on forward-looking statements because they involve risks and uncertainties, and actual results may differ materially from those discussed as a result of various factors, including, but not limited to: the risk that we continue to incur losses and might never achieve or maintain profitability, the risk that we may need to raise additional capital to fund our operations and such capital may not be available to us; the risk that we may not have enough cash to fund our operations to profitability and if we are unable to secure additional capital, we may need to reduce and/or cease our operations; the risk that a “going concern” opinion from our auditors, KPMG LLP, could impair our ability to finance its operations through the sale of equity, incurring debt, or other financing alternatives; our lack of extensive experience in manufacturing and marketing products may impact our ability to manufacture and market products on a profitable and large-scale commercial basis; the risk that unit orders will not ship, be installed and/or converted to revenue; the risk that pending orders may not convert to purchase orders; the risk that we fail to comply with NASDAQ’s listing standards which may result in our common stock being delisted from the NASDAQ stock market, which may severely limit our ability to raise additional capital; the cost and timing of developing, marketing and selling our products and our ability to raise the necessary capital to fund such costs; the ability to achieve the forecasted gross margin on the sale of our products; the risk that our actual net cash used for operating expenses exceeds our projected net cash for operating expenses; the cost and availability of fuel and fueling infrastructures for our products; market acceptance of our GenDrive systems; our ability to establish and maintain relationships with third parties with respect to product development, manufacturing, distribution and servicing and the supply of key product components; the cost and availability of components and parts for our products; our ability to develop commercially viable products; our ability to reduce product and manufacturing costs; our ability to successfully expand our product lines; our ability to improve system reliability for our GenDrive systems; competitive factors, such as price competition and competition from other traditional and alternative energy companies; our ability to protect our intellectual property; the cost of complying with current and future federal, state and international governmental regulations; and other risks and uncertainties discussed under “Item IA—Risk Factors” in Plug Power’s annual report on Form 10-K for the fiscal year ended December 31, 2012, filed with the Securities and Exchange Commission (“SEC”) on April 1, 2013 and as amended on April 30, 2013 and the reports Plug Power filed from time to time with the SEC. These forward-looking statements speak only as of the date on which the statements were made and are not guarantees of future performance. Except as may be required by applicable law, we do not undertake or intend to update any forward-looking statements after the date of this communication.
CONTACT: Media Contact Teal Vivacqua 518.738.0239 media@plugpower.com
(AMAP) Announces Receipt of “Going Private” Proposal
BEIJING, Feb. 10, 2014 — AutoNavi Holdings Limited (Nasdaq:AMAP) (“AutoNavi” or the “Company”), a leading provider of digital map content and navigation and location-based solutions in China, today announced that its Board of Directors has received a non-binding proposal letter, dated February 10, 2014, from Alibaba Group Holding Limited (“Alibaba”), that proposes a “going-private” transaction (the “Transaction”) to acquire all of the American depositary shares and ordinary shares of AutoNavi not already beneficially owned by Alibaba for US$21 in cash per American depositary share, each representing four ordinary shares.
Alibaba beneficially owns preferred and ordinary shares of the Company representing approximately 28% of the Company’s total issued and outstanding shares.
According to the proposal letter, Alibaba intends to fund 100% of the cash consideration payable in the Transaction with its cash on hand and the Transaction will not be subject to any financing condition. A copy of the proposal letter is attached hereto as Exhibit A.
A copy of the proposal letter accompanying this release is available at http://media.globenewswire.com/cache/12938/file/24553.pdf
AutoNavi’s Board of Directors intends to promptly form a committee of independent directors (the “Independent Committee”) to consider the Transaction. The Independent Committee will be authorized to retain advisors, including an independent financial advisor and legal counsel, to assist it in its work. The Board of Directors cautions the Company’s shareholders and others considering trading in its securities that the Board just received the non-binding proposal letter from Alibaba and no decisions have been made with respect to the Company’s response to the Transaction. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to this or any other transaction, except as required under applicable law.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements made under the “safe harbor” provisions of Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. The Company 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 report 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 the Company’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. Further information regarding these and other risks is included in the Company’s annual report on Form 20-F as well as in its other filings with the Securities and Exchange Commission. All information provided in this press release is current as of the date of the press release, and the Company undertakes no duty to update such information, except as required under applicable law.
This release is not an offer of securities for sale in the United States. Securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of securities to be made in the United States will be made by means of a prospectus that may be obtained from the issuer or selling security holder and that will contain detailed information about the company and management, as well as financial statements.
About AutoNavi Holdings Limited
AutoNavi Holdings Limited (Nasdaq:AMAP) is a leading provider of digital map content and navigation and location-based solutions in China. At the core of its business is a comprehensive nationwide digital map database that covers approximately 3.6 million kilometers of roadway and over 20 million points of interest across China. Through its digital map database and proprietary technology platform, AutoNavi provides comprehensive, integrated navigation and location-based solutions optimized for the China market, including mobile location-based solutions and Internet location-based solutions, automotive navigation solutions, and public sector and enterprise applications. For more information on AutoNavi, please visit http://www.autonavi.com.
CONTACT: For further information, please contact: In China: Investor Relations AutoNavi Holdings Limited Tel: +86-10-8410-7883 E-mail: ir@autonavi.com Derek Mitchell Ogilvy Financial, Beijing Tel: +86-10-8520-3073 E-mail: amap@ogilvy.com In the U.S.: Justin Knapp Ogilvy Financial, New York Tel: +1-616-551-9714 E-mail: amap@ogilvy.com
(DARA) Breast Cancer CAPTURE Registry Abstract Accepted for Poster Presentation
CAPTURE: Compliance and Preference for Tamoxifen Registry Findings Provide Important New Insights Concerning Tamoxifen Adherence Based Upon Stated Patient Experience and Preference
RALEIGH, NC–(February 10, 2014) – DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care specialty pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatments, announced that the Company’s abstract entitled “CAPTURE (Compliance and Preference for Tamoxifen Registry) patient survey reveals potential strategies to improve long-term adherence to TAM based on choice: results of a large internet-based survey” has been accepted for poster presentation at the upcoming National Comprehensive Cancer Network® (NCCN®) 19th Annual Conference: Advancing the Standard of Cancer Care™ — March 13 – 15, 2014 in Hollywood, FL.
The abstract has been selected for poster presentation during General Poster Session One on March 13, 2014. The lead author, Stefan Glück MD, PhD, FRCPC, Sylvester Distinguished Professor, Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center in the University of Miami’s Miller School of Medicine and within the University of Miami Health System (UHealth) and a member of the CAPTURE Scientific Steering Committee, will present the poster.
Additionally, DARA’s abstract is expected to be published in an upcoming issue of JNCCN – Journal of the National Comprehensive Cancer Network, a peer-reviewed indexed medical journal that reaches more than 22,000 oncologists and other cancer care professionals across the United States. NCCN, a not-for-profit alliance of 23 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.
“We are very pleased to have our CAPTURE abstract accepted by this prominent, oncology-focused organization,” commented David J. Drutz M.D., DARA’s CEO and Chief Medical Officer. “Our goal for initiating CAPTURE was to generate important, patient-centric information regarding demographics and medication compliance of breast cancer patients taking tamoxifen tablets, including their expressed potential preference for a liquid formulation. We look forward to reporting the data from this study and believe the key findings will raise awareness of opportunities to help improve long-term compliance with this life-saving therapy.”
CAPTURE was initiated in 2013, subsequent to DARA’s commercialization of Soltamox® (tamoxifen citrate) oral solution, the only FDA-approved liquid formulation of tamoxifen citrate in the United States. A total of 626 women from 17 nationwide oncology practices who had been prescribed and were taking tamoxifen therapy for breast cancer completed the CAPTURE survey, providing investigators with valuable insight into adherence to prescribed tamoxifen tablets based on patient preference for a liquid formulation of tamoxifen or patient prevalence of swallowing difficulties.
Tamoxifen is indicated for the treatment of metastatic breast cancer, adjuvant treatment of breast cancer, the reduction of risk of invasive breast cancer in women with ductal carcinoma in situ, and to reduce breast cancer incidence in high risk women. Currently, more than 1.7 million prescriptions of tamoxifen are written annually in the United States. Between 31 and 61 percent of patients fail to complete their prescribed course of treatment, thereby diminishing its benefits in reducing the risk of breast cancer and breast cancer recurrence.
The NCCN Annual Conference: Advancing the Standard of Cancer Care™ attracts more than 1,500 registrants from across the United States and the globe including oncologists (in both community and academic settings), oncology fellows, nurses, pharmacists, and other health care professionals involved in the care of patients with cancer. Respected opinion leaders present the latest cancer therapies and provide updates on selected NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), the data upon which the NCCN Guidelines® are based, and quality initiatives in oncology. Topics change annually but focus on the major cancers and supportive care areas. The NCCN Annual Conference also includes case study discussion forums with experts from NCCN Member Institutions and roundtable discussions featuring the foremost professionals from the academic, patient advocacy, government, payer, industry, and business realms of cancer care.
Tamoxifen Important Safety Information
Tamoxifen citrate is contraindicated in women who require concomitant coumarin-type anticoagulant therapy, in women with a history of deep vein thrombosis or pulmonary embolus, and in women with known hypersensitivity to the drug or any of its ingredients.
Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism.
The most common adverse reactions to tamoxifen treatment are (incidence greater than or equal to 20%) hot flashes, fluid retention, vaginal discharge, vaginal bleeding, vasodilatation, nausea, irregular menses, weight loss, and musculoskeletal events.
Tamoxifen carries the following Black Box Warning:
WARNING – For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for tamoxifen vs. 0.0 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for tamoxifen versus 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.
*Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma in Prescribing Information. **See Table 3 under CLINICAL PHARMACOLOGY, Clinical Studies in Prescribing Information.
The full Prescribing Information for Soltamox is available at www.soltamox.com/prescribing-information.
About DARA BioSciences, Inc.
DARA BioSciences Inc. of Raleigh, North Carolina, is an oncology supportive care pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatments.
DARA holds exclusive U.S. marketing rights to both Soltamox® and Gelclair® . Soltamox® (tamoxifen citrate) oral solution, the only liquid form of tamoxifen, used for the treatment and prevention of breast cancer. Soltamox® offers a choice to patients who prefer or need a liquid form of tamoxifen. Gelclair® is an alcohol-free bioadherent oral rinse gel for rapid and effective relief of pain associated with oral mucositis caused by chemotherapy and radiation treatment. Gelclair® should not be used by patients with a known or suspected hypersensitivity to the product or any of its ingredients. DARA licensed the U.S. rights to Soltamox® from UK-based Rosemont Pharmaceuticals, Ltd., and Gelclair® from the Helsinn Group in Switzerland. Under an agreement with Innocutis, DARA also markets Bionect® (hyaluronic acid sodium salt, 0.2%) a topical treatment for skin irritation and burns associated with radiation therapy, in U.S. oncology/radiology markets. Bionect® should not be used by patients with known hypersensitivity to any of its ingredients. For further information on Gelclair® and Bionect® and the Full Prescribing Information please visit www.Gelclair.com and www.Bionect.com.
DARA is focused on expanding its portfolio of oncology supportive care products in the United States, via in-licensing and/or partnering of complementary late-stage and approved products. In addition, the company wishes to identify a strategic partner for the clinical development of KRN5500, currently in Phase 2 for the treatment of chronic, treatment refractory, chemotherapy-induced peripheral neuropathy (CCIPN). The FDA has designated KRN5500 as a Fast Track Drug, and DARA is seeking orphan status for the treatment of CCIPN.
In early 2014, DARA kicked off its new partnership with Alamo Pharma Services, a subsidiary of Mission Pharmacal, in deploying a dedicated 20-person national sales team in the U.S. oncology market. In addition to promoting DARA’s products Soltamox® (tamoxifen citrate), Gelclair® and Bionect®, this specialized oncology supportive care sales team also will provide clinicians with access to three Mission Pharmacal products: Ferralet® 90 (for anemia), BINOSTO® (alendronate sodium effervescent tablet indicated for the treatment of osteoporosis in post-menopausal women), and Aquoral® (for chemotherapy/radiation therapy-induced dry mouth).
Important Safety Information and full Prescribing Information for Mission Pharmacal’s products may be found at: www.Ferralet.com, www.Binosto.com, and www.Aquoral.com.
For more information please visit our web site at www.darabio.com.
Safe Harbor Statement
All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties. These statements are based on the current expectations, estimates, forecasts and projections regarding management’s beliefs and assumptions. In some cases, you can identify forward looking statements by terminology such as “may,” “will,” “should,” “hope,” “expects,” “intends,” “plans,” “anticipates,” “contemplates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “continue,” and other similar terminology or the negatives of those terms. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption “Risk Factors” in DARA’s most recent Annual Report on Form 10-K, filed with the SEC on February 4, 2014, and DARA’s other filings with the SEC from time to time. Those factors include risks and uncertainties relating to DARA’s current cash position and its need to raise additional capital in order to be able to continue to fund its operations; the stockholder dilution that may result from future capital raising efforts and the exercise or conversion, as applicable, of DARA’s outstanding options, warrants and convertible preferred stock; full-ratchet anti-dilution protection afforded investors in prior financing transactions that may restrict or prohibit DARA’s ability to raise capital on terms favorable to the Company and its current stockholders; the potential delisting of DARA’s common stock from the NASDAQ Capital Market; DARA’s limited operating history which may make it difficult to evaluate DARA’s business and future viability; DARA’s ability to timely commercialize and generate revenues or profits from Soltamox, Gelclair, Bionect or other products given that DARA only recently hired its initial sales force and DARA’s lack of history as a revenue-generating company; DARA’s ability to achieve the desired results from the agreements with Mission and Alamo; FDA and other regulatory risks relating to DARA’s ability to market Soltamox, Gelclair, Bionect or other products in the United States or elsewhere; DARA’s ability to in-license and/or partner products; the current regulatory environment in which DARA sells its products; the market acceptance of those products; dependence on partners and third-party manufacturers; successful performance under collaborative and other commercial agreements; DARA’s ability to retain its managerial personnel and to attract additional personnel; potential product liability risks that could exceed DARA’s liability coverage; potential risks related to healthcare fraud and abuse laws; competition; the strength of DARA’s intellectual property, the intellectual property of others and any asserted claims of infringement, and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission (“SEC”). Copies of DARA’s filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA’s expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.
Media Contact:
David Connolly
LaVoie Group
617-374-8800 ext. 104
dconnolly@lavoiegroup.com
Investor Contact:
Jenene Thomas
DARA BioSciences
908-938-1475
jthomas@darabio.com
(CHCI) Reports 2013 Preliminary Highlights
Improved Market Conditions and Robust Sales Contribute to Positive Results and Prospects for Continued Growth
Comstock Holding Companies, Inc., (NASDAQ:CHCI), announced preliminary highlights for its homebuilding operation, including that new orders, unit deliveries, revenue, and backlog increased substantially during 2013.
Preliminary performance highlights for 2013 include:
- Homebuilding revenue increased 364% to approximately $53.8 million from $11.6 million in 2012;
- New orders increased 147% to 126 units, compared to 51 units in 2012;
- Unit deliveries increased 138% to 107, compared to 45 unit deliveries in 2012;
- Backlog at year-end 2013 of 28 units valued at $12.3 million, compared to nine units valued at $5.4 million at year-end 2012;
- Community count increased to ten at year-end 2013 from five at year-end 2012;
- Comstock’s pipeline of controlled land inventory expanded to approximately 637 lots at year-end 2013 from 354 lots at year-end 2012.
“Improving market conditions in the Washington, DC region and a relatively stable and healthy employment picture helped us put Comstock back on a growth path in 2013,” said Chairman and CEO Christopher Clemente. “We’re especially proud of the nearly fourfold increase in homebuilding revenue that we generated. We believe the limited supply of housing, affordability provided by attractive mortgage rates and improving consumer confidence should contribute to Comstock’s prospects for additional growth and enhanced results in 2014. We look forward to reporting our final financial results for the fourth quarter and full year 2013 in March 2014.”
Comstock continues to expand homebuilding operations in its core market of Washington, DC, focusing on highly desirable locations throughout the metropolitan region (Virginia, Maryland, and Washington, DC) where it is able to deliver a wide variety of reasonably priced housing products.
COMSTOCK COMMUNITIES NOW OPEN
- City Homes at the Hampshires (Washington DC) — single-family homes priced from $699,900
- Townes at the Hampshires (Washington DC) — townhomes priced from $479,900
- Villas at East Gate (Chantilly, VA, Fairfax County) — townhome-style flats priced from the high $300s
- Townes at Falls Grove (Manassas, VA, Prince William County) — townhome style condominiums priced from $279,900
- Townes at Shady Grove (Rockville, MD, Montgomery County) — townhomes, adjacent to the Metro, priced from the high $500s
- Townes at Maxwell Square (Frederick, MD, Frederick County) — townhomes in historic downtown Frederick priced from the mid $300s
COMSTOCK COMMUNITIES COMING SOON
- Momentum at Shady Grove (Rockville, MD, Montgomery County) — mid-rise condominiums, adjacent to the Metro, priced from the mid $200s
- Townes at Hallcrest (Sterling, VA, Loudoun County) — townhomes priced from the $400s
- Executive Homes at Falls Grove (Manassas, VA, Prince William County) — single-family homes priced from the high $400s
- Executive Homes at Leland Estates, (Fredericksburg, VA, Stafford County) — single-family homes priced from the upper $300s.
The financial results referenced herein are subject to completion of Comstock’s financial and accounting closing and review procedures.
About Comstock Holding Companies, Inc.
Comstock is a homebuilding and multi-faceted real estate development and services company that builds a wide range of housing products under its Comstock Homes brand through its wholly owned subsidiary, Comstock Homes of Washington, LC. Our track record of developing numerous successful new home communities and more than 5,500 homes, together with our substantial experience in building a diverse range of products including apartments, single-family homes, townhouses, mid-rise condominiums, high-rise condominiums and mixed-use (residential and commercial) developments, has positioned Comstock as a leading residential developer and homebuilder in the Washington, D.C. metropolitan area. Comstock Holding Companies, Inc. is a publicly traded company, trading on NASDAQ under the symbol CHCI. For more information about Comstock or its new home communities, please visit www.comstockhomes.com.
Cautionary Statement Regarding Forward-Looking Statements
This release contains “forward-looking” statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements include, but are not limited to, any statement regarding any of Comstock’s preliminary fourth-quarter and full-year 2013 financial results or performance as well as anticipated performance in 2014. Forward-looking statements involve known and unknown risks and uncertainties that may cause actual future results to differ materially from those projected or contemplated in the forward-looking statements including the finalization of financial and operating results for the fourth quarter of 2013 and the audit of full-year 2013 results by our independent registered public accounting firm, incurring substantial indebtedness with respect to projects, the diversion of management’s attention and other negative consequences. Additional information concerning these and other important risks and uncertainties can be found under the heading “Risk Factors” in the Company’s most recent Form 10-K, as filed with the Securities and Exchange Commission. Comstock specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
(DRNA) to Present at 2014 Leerink Global Healthcare Conference on February 13th
Dicerna Pharmaceuticals, Inc. (NASDAQ: DRNA), a leader in the development of RNAi-based therapeutics, today announced that Douglas M. Fambrough, PhD, the Company’s President and CEO, is scheduled to present at the 2014 Leerink Global Healthcare Conference on Thursday, February 13, 2014 at 1:00 PM ET in New York, NY.
About Dicerna Pharmaceuticals, Inc.
Dicerna is a biopharmaceutical company focused on the discovery and development of innovative treatments for rare inherited diseases involving the liver and for cancers that are genetically defined. Dicerna is using its proprietary RNA interference (RNAi) technology platform to build a broad pipeline in these therapeutic areas and intends to discover, develop and commercialize novel therapeutics either on its own or in collaboration with pharmaceutical partners.
(OUTR) to Repurchase $350 Million of Common Stock through Modified Dutch Auction Tender Offer
BELLEVUE, Wash., Feb. 7, 2014 — Outerwall Inc. (Nasdaq: OUTR), today announced that it intends to purchase $350 million of the company’s common stock through a modified “Dutch auction” tender offer that commenced today. If the tender offer is fully subscribed and completed, Outerwall will have repurchased $555 million of its common stock since February 2013.
“Today’s announcement demonstrates our commitment to driving value creation for our stockholders,” said J. Scott Di Valerio, chief executive officer of Outerwall. “In addition to providing a return of capital to stockholders, this buyback reflects our confidence in the company. We remain enthusiastic about the future of Outerwall, as we continue driving profitable growth through our core Redbox and Coinstar businesses, and scaling our ecoATM business.”
Under the terms of the tender offer, Outerwall’s stockholders will have the opportunity to tender some or all of their shares at a price per share of not less than $66.82 and not greater than $76.32. Based on the number of shares tendered and the prices specified by the tendering stockholders, Outerwall will determine the lowest per share price within the range that will enable it to purchase $350 million in shares, or such lower amount depending on the number of shares that are properly tendered and not properly withdrawn. All shares accepted in the tender offer will be purchased at the same price, regardless of whether a stockholder tendered such shares at a lower price within the range. At the minimum price of $66.82 per share, Outerwall would repurchase a maximum of 5,237,952 shares, or approximately 20.6%, of Outerwall’s outstanding common stock as of February 3, 2014.
The tender offer will expire at 12:00 midnight, New York City time, at the end of the day on March 7, 2014, unless extended or withdrawn. Tenders of shares must be made prior to the expiration of the tender offer and may be withdrawn at any time prior to that time.
The company intends to finance the share repurchase from available domestic cash and borrowings under its existing senior secured credit facility.
Stockholders who have questions may call Morgan Stanley & Co. LLC, the dealer manager for the tender offer, at (855) 483-0952. The information agent for the tender offer is Innisfree M&A Incorporated and the depositary is Computershare Trust Company, N.A. The offer to purchase, the related letter of transmittal, and the other tender offer materials will be mailed to Outerwall stockholders shortly after commencement of the tender offer. Stockholders who have questions or would like additional copies of the tender offer documents, may call the information agent at (888) 750-5834. Banks and brokers may call collect (212) 750-5833.
Outerwall’s directors and executive officers have advised Outerwall that they do not intend to tender any of their shares in the tender offer.
Neither Outerwall nor any of its board of directors, executive officers, the dealer manager, the information agent or the depositary is making any recommendation to stockholders as to whether to tender or refrain from tendering their shares in the proposed tender offer or as to the price or prices at which stockholders may choose to tender their shares, and has not authorized any person to do so. Stockholders must decide how many shares they will tender, if any, and the price or prices within the stated range at which they will tender their shares. In doing so, stockholder should carefully evaluate all of the information in the offer to purchase, the related letter of transmittal, and the other tender offer materials, when available, before making any decision with respect to the tender offer, and should consult their own financial, legal and tax advisors and brokers.
OUTERWALL STOCKHOLDERS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING THE SCHEDULE TO, OFFER TO PURCHASE, LETTER OF TRANSMITTAL AND RELATED TENDER OFFER DOCUMENTS) DATED FEBRUARY 7, 2014 THAT OUTERWALL WILL BE DISTRIBUTING TO ITS STOCKHOLDERS AND FILING WITH THE SEC, AND ANY OTHER DOCUMENTS OUTERWALL FILES WITH THE SEC, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION CONCERNING THE TERMS OF THE TENDER OFFER.
Holders of common stock will be able to obtain these documents as they become available free of charge at the “SEC Filings” tab at ir.outerwall.com, the SEC’s website at www.sec.gov, or at the SEC’s public reference room located at 100 F Street, N.E., Washington, DC 20549. Please call the SEC at 1-800-SEC-0330 for further information about the public reference room. In addition, holders of common stock will also be able to request additional copies of the Schedule TO, the offer to purchase, related letter of transmittal and other filed tender offer documents free of charge by contacting Innisfree M&A Incorporated, the information agent for the tender offer, by telephone at (888) 750-5834 (toll-free), or in writing to 501 Madison Avenue, 20th floor, New York, New York 10022.
About Outerwall Inc.
Outerwall Inc. (Nasdaq: OUTR) has more than 20 years of experience creating some of the most profitable spaces for their retail partners. The company mission is to create a better everyday by delivering breakthrough kiosk experiences that delight consumers and generate revenue for retailers. As the company that brought consumers Redbox® entertainment, Coinstar® money services, and ecoATM® electronics recycling kiosks, Outerwall is leading the next generation of automated retail and paving the way for inventive, scalable businesses. Outerwall™ kiosks are in neighborhood grocery stores, drug stores, mass merchants, malls, and other retail locations in the United States, Canada, Puerto Rico, the United Kingdom, and Ireland. Learn more at www.outerwall.com.
Tender Offer Statement
This press release is for informational purposes only and is neither an offer to buy nor the solicitation of an offer to sell any shares of Outerwall’s common stock. The tender offer is being made only pursuant to the Offer to Purchase, the Letter of Transmittal and related materials dated February 7, 2014 that Outerwall will be distributing to its stockholders and filing with the SEC. Stockholders should read carefully the Offer to Purchase, the Letter of Transmittal and related materials because they contain important information, including the various terms and conditions of the tender offer. Stockholders are urged to carefully read these materials prior to making any decision with respect to the tender offer. Stockholders may obtain free copies of the Offer to Purchase, the Letter of Transmittal and other related materials when filed with the SEC at the SEC’s website at www.sec.gov or at the “SEC Filings” tab at ir.outerwall.com. In addition, stockholders may also obtain copies of these documents, when available, free of charge, by contacting Innisfree M&A Incorporated, the Information Agent for the tender offer, by telephone at (888) 750-5834, or in writing to 501 Madison Avenue, 20th floor, New York, New York 10022.
Forward-Looking Statements
Certain statements in this release are “forward-looking statements”. The words “will,” “expect,” “intend,” and variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The forward-looking statements in this release include statements regarding the timing of expiration and closing of the tender offer, the amount, and the pricing of the tender offer and other terms and conditions of the tender offer. Forward-looking statements are not guarantees of future actions or events, which may vary materially from those expressed or implied in such statements. Differences may result from actions taken by Outerwall or its management, as well as from risks and uncertainties beyond Outerwall’s control, including relating to third parties such as stockholders. Such actions, risks, and uncertainties include, but are not limited to, stockholders’ willingness to tender Outerwall’s common stock, fluctuations in Outerwall’s stock price and trading volume, other uncertainties relating to the tender offer (including those described in the tender offer materials), changes to Outerwall’s financing arrangements, Outerwall’s financial results and condition, changes in financial markets and regulatory and economic conditions, and changes in Outerwall’s strategic and financial objectives, as well as other business- and corporate-related events, including those relating to Outerwall’s industries. The foregoing list of actions, risks and uncertainties is illustrative but by no means exhaustive. For more information on factors that may affect Outerwall, please review “Risk Factors” and other disclosures described in Outerwall’s most recent Annual Report on Form 10-K, as well as other public filings with the SEC. These forward-looking statements reflect Outerwall’s expectations as of the date of this release. Outerwall undertakes no obligation to update the information provided herein.
(ATVI) TeSPA and Blizzard Unveil the Membership Milestone Program
TeSPA and Blizzard Entertainment have announced a partnership that will bring unprecedented support to college gaming groups throughout North America. For the first time, college gaming groups will be able to unlock funding and other tangible benefits as their communities grow through the Membership Milestone program.
As part of the partnership, Blizzard will back student groups in the TeSPA network by guaranteeing event funding, unique in-game rewards, and unrivaled promotion opportunities to active TeSPA chapters. This backing will help chapters strengthen their communities by providing vital resources needed to host local gaming competitions and viewing events.
“TeSPA has been a positive force in the eSports community built from the ground up by a small group of dedicated fans,” said Mike Morhaime, CEO and co-founder of Blizzard Entertainment. “By partnering with TeSPA we hope to give back to the players in a very new way to add fuel to an already thriving collegiate scene.”
The Membership Milestone program outlines structured benefits to student groups and provides critical materials needed to scale, including free access production equipment for events, a leadership and technical instruction manual, and customized banners for campus advertisement. The new program aims to establish the foundation of a vibrant eSports ecosystem that is supported from both the grassroots and professional level.
“Our goal is to empower passionate students to bring their eSports dreams to life,” said TeSPA co-founder Adam Rosen. “By doing this, we hope to cultivate thriving eSports communities while fostering the next generation of entrepreneurial business leaders in the gaming industry.” TeSPA aims to establish campus chapters across all of North America, and is specifically targeting 75 of the most influential campuses to seed student gaming programs in 2014.
Open recruitment for students looking to take advantage of TeSPA’s membership benefits has now begun. Students looking to join TeSPA with an existing group or to create a new group on their campus should apply at tespa.org/apply/.
About TeSPA
The eSports Association (TeSPA) is a network of the top student talent in eSports and gaming. The TeSPA network is composed of Local Chapters which develop eSports communities on their campuses by hosting events such as competitive gaming tournaments and social viewing events. TeSPA aspires to cultivate communities capable of producing professional-caliber eSports experiences at every university and high school in North America. TeSPA’s founders, Adam Rosen, Tyler Rosen, and Chris Kelly, are members of Blizzard Entertainment’s eSports team.
About Blizzard Entertainment, Inc.
Best known for blockbuster hits including World of Warcraft® and the Warcraft®, StarCraft®, and Diablo® franchises, Blizzard Entertainment, Inc. (www.blizzard.com), a division of Activision Blizzard (NASDAQ:ATVI), is a premier developer and publisher of entertainment software renowned for creating some of the industry’s most critically acclaimed games. Blizzard Entertainment’s track record includes sixteen #1-selling games and multiple Game of the Year awards. The company’s online-gaming service, Battle.net®, is one of the largest in the world, with millions of active players.
(CVM) to Present at 16th Annual BIO CEO & Investor Conference
CEL-SCI Corporation (NYSE MKT: CVM) announced that Geert Kersten, Chief Executive Officer, will be presenting at the 16th Annual BIO CEO & Investor Conference on Tuesday, February 11, 2014 at 3:00 p.m. Hosted by the Biotechnology Industry Organization (BIO), the 16th Annual BIO CEO & Investor Conference will take place February 10-11 at the Waldorf Astoria in New York City.
About the BIO CEO & Investor Conference
The 16th Annual BIO CEO & Investor Conference is the largest independent investor conference focused on publicly-traded biotechnology companies. The conference is designed to foster an informative dialogue between institutional investors and senior biotechnology executives about emerging and current investment opportunities. The 2013 CEO & Investor Conference featured 1,380 partnering meetings, 148 company presentations, and 1,400 attendees, over half of which were investors.
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body’s natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial for head and neck cancer. CEL-SCI is also collaborating through a Cooperative Research and Development Agreement (CRADA) with the U.S. Navy on the development of Multikine for the potential treatment of HIV/HPV co-infected men and women with anal warts. CEL-SCI is further investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
(LIVE) User Traffic Surges 153% Month Over Month
LAS VEGAS, NV–(Feb 7, 2014) – LiveDeal Inc. (NASDAQ: LIVE) (“LiveDeal” or the “Company”), a publicly traded company that operates livedeal.com, today announced that its innovative real-time deal platform experienced a 153% increase in visitors during January 2014 compared to December 2013*.
This news comes on the heels of announcing LiveDeal’s entry into the San Francisco restaurant market. Following San Diego and Los Angeles, San Francisco is the third city where restaurants can take advantage of the online geo-location based deal portal that allows restaurants to instantly create, modify, pause and play and publish offers and deals to nearby potential consumers.
Jon Isaac, President and CEO of LiveDeal commented; “We are very happy to see this organic growth of LiveDeal traffic. We expect an even greater increase in user traffic once the LiveDeal iOS and Android apps are released later in the quarter.”
*Source: Google Analytics
What is livedeal.com?
livedeal.com is a unique, real-time “deal engine” that connects merchants with consumers. The Company believes that it has developed a first-of-its-kind web/mobile platform providing restaurants with full control and flexibility to instantly publish customized offers whenever they wish to attract customers. The website includes a number of user and restaurant-friendly features, including:
- an intuitive interface enabling restaurants to create limited-time offers and publish them immediately or on a preset schedule that is fully customizable;
- state-of-the-art scheduling technology giving restaurants the freedom to choose the days, times and duration of the offers, enabling them to create offers that entice consumers to visit their establishment during their slower periods;
- advanced publishing options allowing restaurants to manage traffic by limiting the number of available vouchers to consumers;
- superior geo-location technology allowing multi-location restaurants to segment offers by location, thereby attracting customers to slower locations while eliminating potential over-crowding at busier sites;
- innovative proprietary restaurant indexing methodology; and
- a user-friendly mobile and desktop web interface allowing consumers to easily browse, download and instantly redeem “live” offers found on livedeal.com based on their location.
Restaurants can sign up to use the LiveDeal platform at the Company’s website (www.livedeal.com).
About LiveDeal Inc.
LiveDeal Inc. provides marketing solutions that boost customer awareness and merchant visibility on the Internet. LiveDeal operates a deal engine, which is a service that connects merchants and consumers via an innovative platform that uses geo-location, enabling businesses to communicate real-time and instant offers to nearby consumers. In November 2012, LiveDeal commenced the sale of marketing tools that help local businesses manage their online presence under the Company’s Velocity Local™ brand. LiveDeal continues to actively develop, revise, and evaluate these products and services and its marketing strategies and procedures. For more information, visit www.livedeal.com.
Forward-Looking and Cautionary Statements
This press release contains “forward-looking” statements that are based on present circumstances and on LiveDeal’s predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements, including any statements regarding the plans and objectives of management for future operations or products, the market acceptance or future success of our products, and our future financial performance, are not guarantees of future performance or results and 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. Forward-looking statements are made only as of the date of this release and LiveDeal does not undertake and specifically declines any obligation to update any forward-looking statements. Readers should not place undue reliance on these forward-looking statements.
(NLST) Announces Pricing of 7,548,500 Share Follow-On Offering
IRVINE, CA–(Feb 6, 2014) – Netlist, Inc. (“Netlist” or the “Company”) (NASDAQ: NLST), a leading provider of high performance and hybrid memory solutions for the cloud computing and storage markets, today announced it has priced a registered firm commitment underwritten public offering of 7,548,500 shares of its common stock at a price to public of $1.30 per share. Additionally, the Company has granted the underwriter the option to purchase up to an additional 1,132,275 shares of its common stock to cover over-allotments, if any, at the price to public. The offering is expected to close on or about February 11, 2014, subject to satisfaction of closing conditions.
The total gross proceeds of the offering are expected to be approximately $9.8 million. After deducting the underwriter’s discount and other estimated offering expenses payable by Netlist, the net proceeds are expected to be approximately $8.9 million. These amounts assume no exercise of the underwriter’s over-allotment option. The Company intends to use the net proceeds of the offering for general corporate purposes.
Craig-Hallum Capital Group LLC is acting as sole underwriter of the offering.
A registration statement relating to shares of the common stock of Netlist has been declared effective by the Securities and Exchange Commission on October 18, 2011. This offering is being made by Netlist by means of a written prospectus supplement forming part of the effective registration statement. A copy of the final prospectus for the offering may be obtained from Craig-Hallum Capital Group LLC at 222 South Ninth Street, Suite 350, Minneapolis, MN 55402, phone number (612) 334-6300.
This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these 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 Netlist:
Netlist, Inc. designs and manufactures high-performance, logic-based memory subsystems for server and storage applications for cloud computing. Netlist’s flagship products include HyperCloud®, a patented memory technology that breaks traditional performance barriers, NVvault™ and EXPRESSvault™, the pioneering family of hybrid memory products utilizing both DRAM and NAND Flash that significantly accelerates system performance and provides mission critical fault tolerance, and a broad portfolio of industrial flash and specialty memory subsystems including VLP (very low profile) DIMMs and Planar-X RDIMMs. Netlist has steadily invested in and grown its IP portfolio, which now includes 41 issued patents and more than 29 US and foreign pending patent applications in the areas of high performance memory and hybrid memory technologies.
Netlist develops technology solutions for customer applications in which high-speed, high-capacity, small form factor and efficient heat dissipation are key requirements for system memory. These customers include OEMs that design and build tower, rack-mounted, and blade servers, storage hardware, high-performance computing clusters, engineering workstations and telecommunications equipment. Founded in 2000, Netlist is headquartered in Irvine, CA with manufacturing facilities in Suzhou, People’s Republic of China. Learn more at www.netlist.com.
Company Contact:
Gail M. Sasaki
Chief Financial Officer
(949) 435-0025
Brainerd Communicators, Inc.
Corey Kinger/Mike Smargiassi (investors)
Sharon Oh (media)
NLST@braincomm.com
(212) 986-6667
(RPRX) Meets With FDA to Discuss Data Requirements for Androxal
- NDA submission remains anticipated by year end 2014
- No additional long-term safety assessments currently planned before NDA submission and review
THE WOODLANDS, Texas, Feb. 6, 2014 — Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced the outcome of its previously announced meeting with the FDA regarding the Androxal® Phase 3 data requirements for an NDA in the treatment of secondary hypogonadism. Repros expects to maintain its timeline for submitting an NDA prior to the end of 2014. This submission will include studies ZA-304 and ZA-305 which were initiated in January 2014. Following the meeting, the Company understands that the safety of Androxal will stand on its own merits during NDA review and no additional safety assessments are currently planned prior to NDA submission. The FDA requested additional background information regarding the endpoints that the Company will use to confirm maintenance of fertility by semen assessments in studies ZA-304 and ZA-305. The Company plans to provide this information promptly to the FDA and while doing so to continue enrollment of ZA-304 and ZA-305 without interruption.
Conference Call Details:
Time: Thursday, February 6, 2014 – 9:30 AM Eastern |
Participant Dial-In Number (Domestic): 877-407-8629; International: 201-493-6715 |
It is recommended that participants call in approximately 15 minutes prior to the start time of the conference call.
Replay Call Details:
Conference ID #: 13575904 |
Domestic: 877-660-6853 |
International: 201-612-7415 |
Teleconference replay will be available approximately 60 minutes after the conclusion of the teleconference and will remain available for 7 days.
About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should” or similar expressions. These statements are based on assumptions that the Company has made in light of the Company’s experience in the industry, as well as the Company’s perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to planned clinical studies and the timing and nature of the results thereof, the impact of the studies on the Androxal label, the lack of need for additional long-term safety assessments and the timing of the Company’s expected filing of an NDA for Androxal. Such statements are based on current expectations that involve a number of known and unknown risks, uncertainties and other factors that may cause actual events to be materially different from those expressed or implied by such forward-looking statements, including the ability to have success in the clinical development of the Company’s technologies, the reliability of interim results to predict final study outcomes, the ability to protect the Company’s intellectual property rights and such other risks as are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please visit the Company’s website at http://www.reprosrx.com.
CONTACT: Investor Relations: Thomas Hoffmann The Trout Group (646) 378-2931 thoffmann@troutgroup.com
(SNCR) to Present at the Stifel Technology, Internet & Media Conference
Synchronoss Technologies, Inc. (NASDAQ: SNCR), the mobile innovation leader that provides cloud solutions and software-based activation for connected devices globally, today announced that its Chief Financial Officer, Executive Vice President & Treasurer, Larry Irving; and its Executive Vice President & Chief Corporate Strategy Officer, Biju Nair, will present at the Stifel Technology, Internet & Media Conference at the Fairmont Hotel in San Francisco on Wednesday, February 12, 2014 at 8:35 a.m. Pacific Time.
A live webcast of the presentation, as well as the replay, will be available on the “Investor Relations” page of the company’s Web site: www.synchronoss.com.
About Synchronoss Technologies, Inc.
Synchronoss Technologies, Inc. (NASDAQ:SNCR), is a mobile innovation leader that provides cloud solutions and software-based activation for connected devices across the globe. The company’s proven and scalable technology solutions allow customers to connect, synchronize and activate connected devices and services that empower enterprises and consumers to live in a connected world. For more information visit us at:
(AKAM) to Participate in the Goldman Sachs Technology and Internet Conference
CAMBRIDGE, Mass., Feb. 6, 2014 /PRNewswire/ — Akamai Technologies, Inc. (NASDAQ: AKAM), the leading provider of cloud services for delivering, optimizing and securing online content and business applications, announced today that it will be participating in the Goldman Sachs Technology and Internet Conference in San Francisco, CA. CEO Tom Leighton will present an update on Akamai’s service offerings.
When: | Tuesday, February 11, 2014 2:40 p.m. (PT) / 5:40 p.m. (ET) |
Where: | Palace Hotel 2 New Montgomery Street San Francisco |
What: | Presentation: Fireside chat with Goldman Sachs Analyst Heather Bellini |
A live audio webcast of the presentation and a replay will be available on Akamai’s website at http://www.akamai.com/html/investor/index.html. Please go to the “News & Events” section of the Akamai Investor Relations Web page to access the presentation.
About Akamai
Akamai® is the leading provider of cloud services for delivering, optimizing and securing online content and business applications. At the core of the Company’s solutions is the Akamai Intelligent Platform™ providing extensive reach, coupled with unmatched reliability, security, visibility and expertise. Akamai removes the complexities of connecting the increasingly mobile world, supporting 24/7 consumer demand, and enabling enterprises to securely leverage the cloud. To learn more about how Akamai is accelerating the pace of innovation in a hyperconnected world, please visit www.akamai.com or blogs.akamai.com, and follow @Akamai on Twitter.
Contacts: | ||
Jeff Young Media Relations 617-444-3913 jyoung@akamai.com |
–or– | Tom Barth Investor Relations 617-274-7130tbarth@akamai.com |
(IDRA) Announces Pricing of Public Offering of Common Stock
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) (“Idera” or the “Company”) today announced the pricing of an underwritten public offering of 6,841,250 shares of common stock for a public offering price of $4.00 per share, and pre-funded warrants to purchase up to an aggregate of 2,158,750 shares of common stock at the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant. The gross proceeds to Idera from this offering are expected to be approximately $36 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Idera and excluding the proceeds, if any, from the exercise of the pre-funded warrants. The Company has granted to the underwriters participating in the offering a 30-day option to purchase up to an additional 1,026,188 shares of common stock to cover over-allotments, if any. The offering is expected to close on or about February 10, 2014, subject to customary closing conditions.
Idera anticipates using the net proceeds from the offering to advance the clinical development of its Toll-like Receptor (TLRs) antagonists in its autoimmune disease and genetically defined B-cell lymphoma programs, to advance the development of its gene silencing oligonucleotides (GSOs) in its GSO program and for working capital and other general corporate purposes.
Piper Jaffray & Co. and Cowen and Company, LLC are acting as joint bookrunning managers for the offering.
The securities described above are being offered by the Company pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”) on September 18, 2013. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered has been filed with the SEC and is available on the SEC’s website at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained from Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, via telephone at 800-747-3924 or email at prospectus@pjc.com; or from Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone at (631) 274-2806 or fax at (631) 254-7140.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Idera Pharmaceuticals, Inc.
Idera’s proprietary technology involves creating novel nucleic acid therapeutics designed to inhibit over-activation of TLRs. Idera is developing these therapeutics for the treatment of genetically defined forms of B-cell lymphoma and for autoimmune diseases with orphan indications. In addition to its TLR programs, Idera is developing GSOs that it has created using its proprietary technology, to inhibit the production of disease-associated proteins by targeting RNA.
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. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company’s strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans, and objectives of management, are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. There are a number of important factors that could cause Idera’s actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether results obtained in early research, preclinical studies and clinical trials will be indicative of the results that will be generated in future clinical studies; whether products based on Idera’s technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company’s products receive approval, they will be successfully distributed and marketed; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 and the Current Report on Form 8-K that was filed on February 5, 2014. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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