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(MVIS) Licenses Its PicoP® Display Technology to Fortune Global 100 Partner
MicroVision, Inc. (NASDAQ:MVIS), a leader in innovative ultra-miniature projection display technology, today announced it has signed a multi-year license agreement with its Fortune Global 100 partner for MicroVision PicoP® display technology. The license agreement marks an important milestone in the ongoing relationship between the two companies that began in April 2013.
The license agreement grants the Fortune Global 100 company a non-exclusive license to MicroVision PicoP display technology for use in display modules it manufactures and sells. As part of the agreement, MicroVision expects to receive an $8 million up-front license fee later this month. In addition to the initial up-front license fee, MicroVision will also receive royalties for display modules sold by the Fortune Global 100 company. Further terms of the license agreement are confidential for competitive reasons.
“This is a significant step forward for MicroVision and PicoP display technology. By licensing our technology to a leading global consumer electronics brand we have the potential to significantly expand the reach of our PicoP display technology on a scale commensurate with a company known for technology innovation and its global reach,” said Alexander Tokman, president and CEO of MicroVision. “This milestone is a credit to the hard work of both teams, and we look forward to making this endeavor successful and enduring for both companies.”
The completion of the license agreement is a very significant step in this business relationship. The two companies began joint development on a display module incorporating PicoP display technology in April 2013. The development phase was completed in 2014, and the Fortune Global 100 company contracted with MicroVision for commercialization support services which are ongoing. The license agreement represents a milestone achievement in MicroVision’s execution of its ingredient brand licensing business model. The Fortune Global 100 company will also purchase proprietary components from MicroVision for incorporation in its display modules pursuant to the license agreement.
About MicroVision
MicroVision is the creator of PicoP® display technology, an ultra-miniature laser projection solution for mobile consumer electronics, automotive head-up displays and other applications. MicroVision’s patented display technology helps OEMs break down display boundaries and offer enhanced visibility to mobile experiences. Extensive research has led MicroVision to become an independently recognized leader in the development of intellectual property. MicroVision’s IP portfolio has been recognized by the Patent Board as a top 50 IP portfolio among global industrial companies and has been included in the Ocean Tomo 300 Patent Index. The company is based in Redmond, Wash.
For more information, visit the company’s website at www.microvision.com, on Facebook at www.facebook.com/MicroVisionInc or follow MicroVision on Twitter at @MicroVision.
MicroVision and PicoP are trademarks of MicroVision, Inc. in the United States and other countries. All other trademarks are the properties of their respective owners.
Forward-Looking Statements
Certain statements contained in this release, including those relating to potential benefits of announced agreements and future operating results, potential demand for MicroVision technology and potential applications and features of MicroVision technology, and those containing words such as “potential,” “ongoing,” “expand,” “enduring,” and “expects,” are forward-looking statements that involve a number of risks and uncertainties. Factors that could cause actual results to differ materially from those projected in the company’s forward-looking statements include the following: the risk that our partner may not have significant sales of products and we may not receive significant future royalties under the license agreement; our ability to raise additional capital when needed; products incorporating our PicoP display technology may not achieve market acceptance; our ability to conclude agreements with potential customers; commercial partners may not perform under agreements as anticipated; we may be unsuccessful in identifying parties interested in paying any amounts or amounts we deem desirable for the purchase or license of IP assets; our or our customers’ failure to perform under open purchase orders; our financial and technical resources relative to those of our competitors; our ability to keep up with rapid technological change; government regulation of our technologies; our ability to enforce our intellectual property rights and protect our proprietary technologies; the ability to obtain additional contract awards; the timing of commercial product launches and delays in product development; the ability to achieve key technical milestones in key products; dependence on third parties to develop, manufacture, sell and market our products; potential product liability claims; and other risk factors identified from time to time in the company’s SEC reports, including the company’s Annual Report on Form 10-K filed with the SEC. Except as expressly required by federal securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changes in circumstances or any other reason.
MicroVision, Inc.
Investors:
Dawn Goetter, 425-882-6629
ir@microvision.com
or
Media:
Nicole Cobuzio, 732-212-0823 ext. 102
nicolec@lotus823.com
(CALA) Gains Exclusive, Worldwide License to TransTech Pharma’s Hexokinase II
SOUTH SAN FRANCISCO, Calif., March 5, 2015 — Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, announced today an exclusive global license agreement with TransTech Pharma, a clinical stage pharmaceutical company, granting Calithera exclusive world-wide rights to research, develop and commercialize TransTech’s portfolio of hexokinase II inhibitors. Hexokinase II is the first and rate-limiting enzyme in the pathway that enables cancer cells to convert glucose to energy and building blocks that feed cancer cell growth. Under the terms of the agreement, Calithera will obtain exclusive, worldwide rights to TransTech’s hexokinase II inhibitors for research, development and commercialization. TransTech will receive an upfront payment and will be eligible to receive future development and commercialization milestones as well as royalties on sales of approved products.
“TransTech’s hexokinase II inhibitor program will further expand Calithera’s portfolio of pre-clinical programs and solidify our leadership in the area of tumor metabolism drug research and development as we are now able to target two essential nutrients that cancer cells rely on for growth and survival: glutamine and glucose,” said Susan M. Molineaux, CEO, Calithera Biosciences. “We believe we can apply our expertise to rapidly advance TransTech’s potent small-molecule hexokinase II inhibitors into the clinic to become our third potential first-in-class therapy for cancer patients.”
About Tumor Metabolism and Hexokinase II Inhibitors
The field of tumor metabolism seeks to exploit the unique ways in which cancer cells take up and utilize nutrients in order to grow and proliferate. Cancer cells have altered cellular metabolic pathways to acquire and utilize these nutrients and redirect them to provide the necessary building blocks for growth. When these metabolic pathways are blocked, cancer cells are essentially starved of critical nutrients and stop growing or die, whereas normal cells are largely unaffected.
Most cancer cells have increased uptake of the sugar glucose relative to surrounding normal cells. This phenomenon forms the basis for the widely used tumor imaging procedure known as 18F-2-deoxyglucose (FDG)/PET. Tumors take up more FDG, a radioactive glucose analog, than the surrounding normal tissue and this differential can be visualized with PET imaging. Not only do tumors take up more glucose, but they also utilize the nutrient in a unique way. Tumors convert glucose into lactic acid in a process known as aerobic glycolysis or the “Warburg effect”, a route rarely utilized in normal cells. This unique uptake and processing of glucose by tumors relative to normal tissue creates an opportunity to selectively target tumors by cutting off their ability to use this fuel.
In many cancers, hexokinase II is over expressed and has been linked to more aggressive and invasive tumors. Pre-clinical studies in mice have confirmed that the reduction of hexokinase II activity through genetic deactivation (siRNA knockdown studies) results in a significant reduction of tumor growth. The hexokinase inhibitors in-licensed from TransTech may provide an opportunity to inhibit the unique way cancer cells utilize glucose, and the overall Warburg effect, which could result in new treatments for cancer.
About Calithera Biosciences
Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. Calithera’s lead product candidate, CB-839, an orally bioavailable inhibitor of glutaminase, is currently being evaluated in three Phase 1 clinical trials in solid and hematological cancers. Calithera is headquartered in South San Francisco. For more information about Calithera, please visit www.calithera.com.
About TransTech Pharma
TransTech Pharma, LLC is a privately held, clinical-stage pharmaceutical company focused on the discovery and development of human therapeutics to fill unmet medical needs. The Company’s high-throughput drug discovery platform, Translational Technology®, translates the functional modulation of human proteins into safe and effective medicines. TransTech Pharma, LLC has a pipeline of small-molecule clinical and pre-clinical drug candidates for the treatment of a wide range of human diseases, including central nervous system disorders, diabetes and metabolic disorders, inflammation and oncology. For further company information, visit www.ttpharma.com.
Forward-Looking Statements
This news release contains forward-looking statements by Calithera that involve risks and uncertainties. These statements include those related to Calithera’s ability to rapidly advance TransTech’s potent small-molecule hexokinase II inhibitors into the clinic; that hexokinase II inhibitors may have therapeutic potential in the treatment of cancer; and the potential of tumor metabolism pathways to be transformational in the treatment of cancer. Actual results may differ from Calithera’s expectations and important factors that could cause actual results to differ materially. Calithera’s hexokinase II inhibitor program or other potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price. Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s Quarterly Report on Form 10-Q for the period ended September 30, 2014 and other periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
CONTACT: Jennifer McNealey
Calithera Biosciences, Inc.
ir@Calithera.com
650-870-1071
(NETE) Taps Industry Veteran Eric Kirk as Aptito Executive Vice President
Rapidly Growing Payment Platform Provider Appoints Kirk to Strengthen Leadership and Lead Client Engagement
MIAMI, March 5, 2015 — Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a technology-driven group specializing in mobile payments and value-added transactional services in emerging countries and in the United States, today names Eric Kirk as the executive vice president of Aptito, LLC, an all-in-one digital POS solution. In this role, Kirk will be responsible for enhancing Aptito’s client engagement and operations in addition to leading Aptito’s national sales team.
Kirk joins Aptito from RetailCloud where he served as the vice president of marketing and sales and managed the independent sales organization and reseller channel. Kirk was instrumental in conceptualization and execution of RetailCloud’s POS system and the development of a SaaS model pricing structure that has become an industry standard. Prior to this, Kirk held various executive positions with PayNet Transactions where he managed direct sales of POS solutions, payment processing, and onsite-managed services for sport franchise merchandising operations. In his operations role at PayNet, Kirk directed onsite support staff and inventory management team for major events, including the US Open Tennis tournaments, NFL Superbowl, and NHL and NBA all-star games.
Throughout his career, Kirk has established a track record of technological innovation, business savvy and sound management. Kirk brings this business acumen and industry experience to strengthen and grow the Aptito platform and product offering.
“In recent months Aptito has achieved considerable advances and generated significant interest,” states Net Element Chief Executive Officer Oleg Firer. “Eric’s proven leadership and professional versatility will greatly strengthen Aptito’s next stage of propulsion and success. We’re pleased to welcome such an experienced and visionary professional to the team.”
“Net Element is rapidly solidifying Aptito as a powerful and innovative industry standard by dramatically improving the way restaurants conduct the most vital components of their operations,” states Kirk. “I’m honored to be a part of Aptito’s progression and market penetration. I look forward to being part of this incredible company and its future success.”
About Net Element (NASDAQ: NETE)
Net Element (NASDAQ: NETE) is a global technology-driven group specializing in mobile payments and value-added transactional services. The Company owns and operates a global mobile payments and transaction processing provider, TOT Group. TOT Group companies include Unified Payments; Aptito, a next generation cloud-based point of sale payments platform; and TOT Money, which has a leading position in Russia and has been ranked as the #1 SMS content provider by Beeline, Russia’s second largest telecommunications operator. Together with its subsidiaries, Net Element enables ecommerce and adds value to mobile commerce environments. Its global development centers and high-level business relationships in the United States, Russia and Commonwealth of Independent States strategically position the Company for continued growth. More information is available at www.netelement.com.
About Aptito, LLC
Aptito, LLC (“Aptito”), a subsidiary of Net Element’s TOT Group, Inc., is a new generation, customer-engaged, patent-pending payments platform specializing in mobile Point of Sale (“mPOS”), mobile commerce application, and self-ordering Apple® iPad®-based kiosk. Utilizing its disruptive, cloud-based payments platform, Aptito provides merchants a feature-rich, innovative and socially driven, all-in-one digital software solution for the food-service industry. Aptito’s Restaurant mPOS solution provides restaurants with tools to increase sales, productivity, and customer loyalty. Aptito’s suite of integrated tools enables inventory management, complete payroll, staff scheduling, patron reservations and digital menus. More capable and less costly than a traditional restaurant POS systems, Aptito doesn’t have the steep learning curve associated with typical POS products. Aptito was named a silver winner in the Most Innovative Product of the Year – SMB category in Best in Biz Awards for 2014. More information is available at www.aptito.com.
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. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, whether Net Element or its business continues to grow, whether the appointment of Kirk will have a positive impact on the business of Aptito, whether Net Element can secure any additional financing and if such additional financing will be adequate to meet the Company’s objectives. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K and the subsequently filed quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
(AMRN) New In Vitro Study On Atheroprotective Benefit of Omega-3 Fatty Acid EPA & Atorvastatin
Study Shows Unique Antioxidant and Endothelial Benefits of Combination Not Seen With Other Triglyceride Lowering Agents in Combination With Atorvastatin
BEDMINSTER, NJ and DUBLIN, IRELAND–(March 04, 2015) – Amarin Corporation Plc (NASDAQ: AMRN), announced today the presentation of findings from a new in vitro study that the combination of eicosapentaenoic acid (EPA), an omega-3 fatty acid, and the active metabolite of atorvastatin (ATM) provided significantly increased nitric oxide (NO) bioavailability in an additive fashion. The study found that this effect was not observed with other triglyceride lowering agents (fenofibrate, niacin, or gemfibrozil) or the omega-3 fatty acid docosahexaenoic acid (DHA). The research was presented yesterday at a peer-reviewed poster session at the DEUEL Conference on Lipids in Monterey, California.
Endothelial cell dysfunction contributes to increased risk for atherosclerosis and heart disease and is characterized by reduced nitric oxide (NO) levels and increased production of the cytotoxic peroxynitrite anion that can lead to an inflammatory response in blood vessels.(i),(ii) Endothelial cell dysfunction has been observed in patients with diabetes and is associated with other cardiovascular risk factors.(iii),(iv),(v)
“With significant clinical research demonstrating the essential role of endothelial cell dysfunction in the development of atherosclerosis, it is critical that we explore therapeutic options to address the multiple risks in patients with high triglycerides,” said R. Preston Mason, Ph.D., Department of Medicine, Division of Cardiology, at the Harvard Medical School-Brigham and Women’s Hospital in Boston and lead author of the study. “The findings of this in vitro study clearly show the potential for an atheroprotective benefit with the combination of EPA and atorvastatin beyond therapeutic changes in lipid levels alone, and these results should support additional clinical research to better understand the exact mechanism for the observed effect.”
This study demonstrated that oxidative stress induced by oxidized LDL (oxLDL) decreased human umbilical vein endothelial cell (HUVEC) release of NO by 22% as compared to untreated cells. In HUVECs first exposed to oxLDL and then treated with EPA or ATM separately, NO release increased by 45% or 64%, respectively, while the EPA and ATM combination treatment significantly increased NO release by two-fold as compared to the oxLDL plus vehicle control. The NO/peroxynitrite (ONOO−) ratio, an indicator of normal endothelial cell function, significantly increased by approximately three-fold with the EPA and ATM treatment as compared to oxLDL plus vehicle control. An improvement in NO release over ATM alone was not observed with any of the other TG-lowering agents or with DHA in combination with the statin. These data suggest that EPA plus a statin such as atorvastatin may reverse endothelial cell dysfunction resulting from oxidative stress in a manner that is enhanced by their co-administration. More study is needed.
The study was supported by Amarin and led by a researcher from Brigham and Women’s Hospital in collaboration with investigators at Elucida Research in Beverly, MA and Ohio University in Athens, OH.
About Amarin
Amarin Corporation Plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Amarin’s clinical program includes commitment to an ongoing outcomes study. For more information about Amarin visit www.amarincorp.com.
Forward-looking statements
This press release contains forward-looking statements, including statements about the potential efficacy, safety and therapeutic benefits of EPA and atorvastatin and the clinical importance of certain parameters, the impact of such pharmaceutical intervention on such parameters and the potential for atheroprotective benefit. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development and clinical trials, including the risk that in vitro results may not be predictive of results in clinical trials or replicated and that studied lipid parameters may not have clinically meaningful effect. A list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent annual report on Form 10-K. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Availability of other information about Amarin
Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
(i) Harrison DG, Freiman PC, Armstrong ML, et al. Circ Res. 1987; 61:74-80.
(ii) Liao JK. Clin Chem. 1998; 44:1799-1808.
(iii) Grattagliano I, Palmieri VO, Portincasa P, et al. J Nutr Biochem. 2008; 19:491-504.
(iv) Kurioka S, Koshimura K, Murakami Y, et al. Endocr J. 2000; 47:77-81.
(v) Mason RP, Kubant R, Jacob RF, et al. Am J Hypertens. 2009; 22:1160-1166.
Amarin contact information
Mike Farrell
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Graham Morrell
Trout Group
In U.S.: +1 (646) 378-2954
gmorrell@troutgroup.com
(DRAM) Announces Integrated Corporate Strategy to Fuel Growth, Streamline Operations
Dataram Corporation [NASDAQ:DRAM] announced today that the Company has begun executing its plan to consolidate strategies for, and operations of, its four business entities under a unified Dataram umbrella. With the integrated business model, the four entities — Princeton Memory, MicroMemoryBank, MemoryStore.com and 18004memory.com — will leverage Dataram’s corporate brand, support and manufacturing functions, and report directly into the Dataram corporate entity. This effort is expected to further reduce operating costs while aligning the company to focus on revenue growth.
The Company expects this transition will effectively leverage the Dataram brand, formed over the last 48 years, while enabling each business unit to focus on unique growth opportunities and go-to-market capabilities within its respective segment. Dataram also expects this strategy will reduce operational complexity and costs, while still allowing Dataram to establish distinct capital allocation policies and revenue goals. Finally, this integration strategy is designed to facilitate partnerships and development of M&A strategies, while allowing optimum strategic flexibility.
As the Company continues to streamline operations and establish the foundation for global growth, this integration is also designed to maximize shareholder value, while continuing to drive the growth that has recently reignited Dataram under Dave Moylan’s leadership as Chairman and CEO.
“As the technology space continues to change at an accelerating pace, it is clear that our efforts must be refocused through a unified and integrated business strategy. Bringing together our business units under a cohesive corporate strategy leverages our overall corporate strengths, while still affording each business unit the flexibility, speed and focus to capitalize on market opportunities, to drive growth, and enhance shareholder value,” said David A. Moylan, Chairman and CEO. “In the meantime, we expect this decisive step to enable Dataram to maximize its potential and help ensure Dataram has the operational and financial scale to thrive.”
About Dataram Corporation
Dataram is a leading independent manufacturer of memory products and provider of performance solutions that increase the performance and extend the useful life of servers, workstation, desktops and laptops sold by leading manufacturers such as Dell, Cisco, Fujitsu, HP, IBM, Lenovo and Oracle. Dataram’s memory products and solutions are sold worldwide to OEMs, distributors, value-added resellers and end users. Dataram supplies 70 of the Fortune 100 companies, and governmental agencies including the Department of Defense. Additionally, Dataram manufactures and markets a line of Intel Approved memory products for sale to manufacturers and assemblers of embedded and original equipment. Founded in 1967, the Company is a US based manufacturer, with presence in the United States, Europe and Japan. For more information about Dataram, visit www.dataram.com.
All names are trademarks or registered trademarks of their respective owners.
The information provided in this press release may include forward-looking statements relating to future events, such as the development of new products, pricing and availability of raw materials or the future financial performance of the Company. Actual results may differ from such projections and are subject to certain risks including, without limitation, risks arising from: changes in the price of memory chips, changes in the demand for memory systems, increased competition in the memory systems industry, order cancellations, delays in developing and commercializing new products and other factors described in the Company’s most recent Annual Report on Form 10-K, filed with the Securities and Exchange Commission, which can be reviewed at www.sec.gov. The Company has based these forward-looking statements on its current expectations and assumptions about future events. While management considers these expectations and assumptions to be reasonable, they are inherently subject to significant business, economic, competitive, regulatory, and other risks, contingencies, and uncertainties, most of which are difficult to predict and many of which are beyond the Company’s control. The Company does not assume any obligations to update any of these forward-looking statements.
Dataram
Jeffrey Goldenbaum, 609-799-0071
Director, Marketing
info@dataram.com
(CRMD) Provides Multiple Strategic Business Updates
-CorMedix Inc. Engages Evercore as Financial Advisor to Explore Strategic Alternatives to Maximize Shareholder Value- -Elliott Management Provides Backstop Financing Commitment and Granted Right to Appoint Two Incremental Board Members- -CorMedix Notified of Compliance with NYSE Listing Requirements- – Expiration Date Extended for Certain Warrants- -Will report Fourth Quarter 2014 Results and Host Conference Call on March 13 at 9 am EDT
BEDMINSTER, N.J., March 4, 2015 — CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases, today announced several strategic business updates.
CorMedix Engages Evercore as Financial Advisor to Explore Strategic Alternatives
CorMedix announced today that it has retained investment bank Evercore as financial advisor to explore strategic alternatives, in order to accelerate the global development of Neutrolin® Catheter Lock Solution and maximize shareholder value.
“Based on our ongoing belief in the value and clinical potential of Neutrolin® as an important product to address a significant medical need, the CorMedix Board and management has retained Evercore to evaluate and identify strategic alternatives aimed to accelerate the product’s global development and commercialization,” said Randy Milby, CorMedix Chief Executive Officer. “We believe Evercore’s premier reputation, track record, and industry expertise will help us to maximize the value of Neutrolin® more efficiently.”
Neutrolin® is a novel formulation of taurolidine, citrate and heparin 1000 u/ml that provides a combination preventative solution, decreases the triple threat of infection, thrombosis and biofilm to keep catheters operating safely and efficiently by optimizing catheter blood flow while minimizing infections and biofilm formation for oncology, hemodialysis, and intensive care patients. Neutrolin® has CE mark approval for use in the European Union and was recently approved to enter a Phase 3 program in the United States. The U.S. Food and Drug Administration (FDA) has designated Neutrolin®, as a Qualified Infectious Disease Product (QIDP), which provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity under Hatch-Waxman patent exclusivity.
CorMedix Extends Expiration Date for Certain Warrants; Elliott Management Provides Backstop Financing Commitment
CorMedix is extending to April 30, 2015 the expiration date for certain of its warrants for which the resale of the common stock underlying the warrants has not yet been registered. The extension is to allow the company time to register the resale of the underlying shares. These warrants were issued to pre-IPO bridge investors in 2010. In addition, CorMedix announced that Elliott Management has extended to the company a financing commitment to serve as a back stop in the event these warrants are not exercised; CorMedix also agreed it will amend certain warrants held by Elliott and issue 200,000 additional warrants at an exercise price of $7.00. Additionally, CorMedix granted Elliott the right to appoint two incremental board members.
CorMedix Notified of Compliance with NYSE MKT Listing Requirements
On Monday, March 2, 2015, the NYSE MKT notified CorMedix that the company has regained compliance with the NYSE MKT listing requirements since the Company as of February 26, 2015 qualified for the market capitalization exception in Section 1003(a) of the NYSE MKT Company Guide.
Fourth Quarter 2014 Financial Results Conference Call
CorMedix will host its fourth quarter 2014 financial results conference call on March 13, 2015 at 9 am EDT. The conference call may be accessed by dialing 877- 407-8031 for domestic callers and 201-689-8031 for international callers. Please specify to the operator that you would like to join the “CorMedix Fourth Quarter 2014 Financial Results Call”. All participants who dial in will need to give the operator the following information:
– First and Last Name
– Company Name: CorMedix
– Replay Number (Toll Free): 1-877-660-6853 (International): 201-689-8031
– Conference ID #: 13603512
– Teleconference Replay Available Until: Mar 20, 2015 at 11:59 PM
About CorMedix Inc.
CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix’s first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients including neonates, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications. Please see the company’s website at www.cormedix.com for additional information. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, future revenues and projected costs, or ability to identify and enter into strategic transactions, should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: our ability to successfully identify, pursue and realize strategic opportunities; the cost, timing and results of the planned Phase 3 trial for Neutrolin in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix’s product candidates, including marketing of Neutrolin® in countries other than Europe; the risks associated with the launch of Neutrolin® in new markets; CorMedix’s ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix’s ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources; the outcome of clinical trials of CorMedix’s product candidates and whether they demonstrate these candidates’ safety and effectiveness; CorMedix’s dependence on its collaborations and its license relationships; achieving milestones under CorMedix’s collaborations; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; CorMedix’s dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
(CNDO) New Subsidiary, Checkpoint Therapeutics For Immuno-Oncology Antibodies
Checkpoint licenses rights to 3 novel immuno-oncology targeted antibodies, including Anti-PD-L1, Anti-GITR and Anti-CAIX
Dr. Wayne Marasco to chair Checkpoint’s Scientific Advisory Board
Checkpoint and TG Therapeutics execute a collaboration agreement to accelerate the development of Anti-PD-L1 antibody and Anti-GITR antibody in hematological malignancies
NEW YORK, March 4, 2015 — Coronado Biosciences, Inc., (Nasdaq:CNDO) announced today the formation of a new subsidiary company, Checkpoint Therapeutics, Inc., to develop a portfolio of fully human immuno-oncology targeted antibodies generated in the laboratory of Dr. Wayne Marasco, MD, PhD, a Professor in the Department of Cancer Immunology and AIDS at Dana-Farber Cancer Institute (Dana-Farber). Dr. Marasco will chair the Scientific Advisory Board of the Company. Under the terms of the agreement, Checkpoint will pay Dana-Farber an up-front licensing fee in addition to development and sales-based milestone payments and royalties on net sales.
The portfolio of antibodies licensed from Dana-Farber includes antibodies targeting PD-L1, GITR and CAIX. Checkpoint plans to develop these novel immuno-oncology and checkpoint inhibitor antibodies on their own and in combination with each other, as data suggests that combinations of these targets can work synergistically together. Clinical trials are expected to start in the second half of next year.
In connection with the license agreement with Dana-Farber, Checkpoint Therapeutics entered into a collaboration agreement with TG Therapeutics, Inc. (Nasdaq:TGTX) to develop and commercialize the Anti-PD-L1 and Anti-GITR antibody research programs in the field of hematological malignancies. Checkpoint retains the right to develop and commercialize these antibodies in solid tumors. Both programs are currently in pre-clinical development. Under the terms of the agreement, TG Therapeutics will pay Checkpoint an up-front licensing fee as well as make development and sales-based milestone payments and will pay a tiered single digit royalty on net sales.
Dr. Lindsay A. Rosenwald, Chairman and CEO of Coronado Biosciences stated, “We are absolutely delighted to partner with one of the pioneers in this field, Dr. Wayne Marasco.” Dr. Rosenwald continued, “Immuno-oncology is one of the most exciting areas in cancer drug development. Drugs that inhibit key immune checkpoint proteins have the potential to unlock the immune system to kill cancer cells. Results for PD-1 inhibitors in melanoma and lung cancer have been impressive but these are early innings of a long game to optimize the right combination of checkpoint inhibitors and other targeted agents to provide lasting cures to all patients. The early work will pave the way for novel combinations, which is where Checkpoint plans to play a pivotal role. The three antibodies licensed today may work synergistically together as well as with other agents. To accelerate development in one area, hematological malignancies, Checkpoint partnered with TG Therapeutics. With TG’s impressive early results with its drug candidates, expertise and relationships in hematological malignancies, we believe we can accelerate development of these important antibodies in this area.”
About anti-PD-L1 and anti-GITR
Anti-PD-L1 antibodies target programmed cell death ligand 1 (PD-L1). Signals from PD-L1 on tumor cells and in tumor microenvironment help those tumors avoid immune attack and elimination by preventing activation of tumor specific effector T-cells. Anti-PD-L1 antibodies are designed to block that signal permitting effector T-cells to attack the cancer. Anti-GITR antibodies target glucocorticoid-induced tumor necrosis factor receptor related protein (GITR), which is regularly expressed on the surface of regulatory T-cells (Tregs) and is expressed on the surface of effector T-cells after their activation. Modulation of GITR with agonistic antibodies has been shown to amplify the antitumor immune responses in animal models via multiple mechanisms. Anti-GITR antibodies are designed to activate the GITR receptor thereby increasing the proliferation and function of effector T cells. At the same time, ligation of GITR on surface of Tregs could abrogate suppressive function of these cells on tumor specific effector T-cells thus further augmenting T-cell immune response. While targeting PD-1/PD-L1 axes alone has already demonstrated impressive anticancer efficacy and durable responses in humans, its efficacy appears to be limited to certain patients. It is believed the effects of anti-PD-L1 intervention can be enhanced by utilizing a co-stimulatory antibody, like one targeting GITR, that can turn on tumor specific effector T-cells. Combining immunotherapies like anti-PD-L1 that counters the tumor’s immune-evading defense system with an anti-GITR that activates effector T-cells, represents a rational approach to use the body’s own immune system to help fight cancer. Pre-clinical research on the combination of the two approaches has yielded very encouraging results to support synergistic potential of this combination. Anti-CAIX antibodies target carbonic anhydrase IX (CAIX), which is over-expressed on the surface of renal cell carcinoma (RCC) and hypoxic solid tumors making it a promising therapeutic target. RCC is a significant public health issue with over 60,000 new cases and over 13,000 deaths predicted in US last year. As a number of RCC cases have already been shown to be sensitive to anti-tumor immune response generated as a result of PD-1/PD-L pathway inhibition, it makes it reasonable to attempt improving the response rate in this malignancy further by additional targeting of immune responses to this tumor with other immune stimulating agents such as anti-CAIX and anti-GITR antibodies.
About Checkpoint Therapeutics
Checkpoint Therapeutics is an innovative, immuno-oncology company spun out of the laboratory of Dr. Wayne Marasco of Dana-Farber Cancer Institute, a principal teaching affiliate of Harvard Medical School, as a newly formed subsidiary of Coronado Biosciences, Inc. (Nasdaq:CNDO). Checkpoint is developing novel checkpoint inhibitors and other immuno-oncology drug candidates that may be active on their own but are designed to also work synergistically together and with other immuno-oncology agents and targeted drugs. Checkpoint plans to build a portfolio of complimentary drug candidates to treat a wide variety of solid tumors and, through its partnership with TG Therapeutics, hematological cancers. Currently, the company is developing three antibodies targeting anti-PD-L1, anti-GITR and anti-CAIX. Checkpoint Therapeutics is headquartered in New York City.
About Coronado Biosciences
Coronado Biosciences is a biopharmaceutical company dedicated to investing in, acquiring, developing and commercializing novel pharmaceutical products. The Company’s portfolio includes novel immunotherapy agents for the treatment of autoimmune diseases and cancer. As part of its growth strategy, the company plans to leverage its biopharmaceutical business and drug development expertise to acquire rights to, or to finance, innovative pharmaceutical and biotechnology products, technologies and/or companies, using a variety of approaches including licensing, partnerships, joint ventures, direct financing and/or public and private spin-outs. For more information, visit www.coronadobiosciences.com.
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs as may be implemented by us and/or our subsidiaries and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to attract, integrate, and retain key personnel; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
CONTACT: Lucy Lu, MD, Executive Vice President &
Chief Financial Officer
Coronado Biosciences, Inc.
781-652-4525; ir@coronadobio.com
(NVGN) US Studies Confirm Ability of TRXE-009 to Kill Brain Cancer Stem Cells
— Potent killing of highly resistant adult and pediatric brain cancer cells — Opportunity to effect prevention of recurrence of brain cancer
SYDNEY, March 4, 2015 — Australian/US biotechnology company, Novogen Limited (ASX:NRT; NASDAQ:NVGN), today announces that it has confirmed that one of its lead candidate products, TRXE-009, is showing the potential to become an important new therapy in the fight against adult and pediatric brain cancer.
The latest study looked at the ability of TRXE-009 to kill a library of patient-derived cell cultures from subjects with glioblastoma multiform (GBM). The cells were cultured under conditions that promote cancer stem cell growth. These stem-like cancer cells are believed to be responsible for chemotherapy resistance and tumor recurrence.
Killing these highly-resistant GBM cancer stem cells is considered to be a fundamental requirement to successfully treating this highly destructive disease.
All patient derived cancer cells represented in the library responded to TRXE-009 at clinically relevant doses, suggesting a strong therapeutic potential.
The studies were conducted by Drs John Boockvar and Marc Symons at the Feinstein Institute for Medical Research (Feinstein) and with which Novogen is forging a strong collaboration to oversee advancing TRXE-009 into the clinic for adult and pediatric brain cancers.
These findings join with other recently announced pre-clinical studies showing that TRXE-009 is highly cytotoxic of chemo-resistant pediatric brain cancers such as Diffuse Intrinsic Pontine Glioma (DIPG) as well as other pediatric neural and neural crest-derived tumors (i.e. medulloblastoma and neuroblastoma, respectively). Together, these studies suggest that TRXE-009 is a unique drug candidate in preferentially targeting tumors with a common embryonic origin in neural/neural crest cells.
The next step in this drug’s development is to confirm it’s ability to cross the blood-brain barrier, a key filtering mechanism that effectively blocks the majority of chemotherapic drugs from reaching brain tissue.
TRXE-009 was designed to cross the blood-brain barrier and has been formulated as a proprietary drug product known as Trilexium. It is anticipated that Trilexium will have application in the treatment of cancers both with and without brain involvement. Trilexium is due to enter a Phase 1 study in early-2016.
In conjunction with Feinstein, alternative means of delivering TRXE-009 to the brain are under investigation including direct injection into the brain cancer by the process known as convection-enhanced delivery, and the use of lipid brain-targeting particles injected intravenously.
Dr. Graham Kelly, Novogen Group CEO, said, “TRXE-009 has been a drug development success story, thanks to a team led by Andrew Heaton PhD and Eleanor Ager, PhD. The TRXE-009 story started with the discovery of a compound that was highly cytotoxic against GBM brain cells that came from patients who had failed to respond to Temozolomide, the only standard of care chemotherapy for GBM; it then showed itself to be an equally effective killer of GBM cancer stem cells; it also is highly active in vitro against a range of pediatric brain cancer cells that are notoriously resistant o chemotherapy; it has been designed to cross the blood-brain barrier; it shows little toxicity against normal human brain cells (astrocytes) in vitro; in its parenteral delivery form, the Trilexium drug-product is highly active in animal models of xenografted human tumors, including GBM, and is reasonably well tolerated. So far it has ticked every box asked of it.
“The urgent need to find a successful treatment for devastating cancers such as primary and secondary brain cancers in adults and children is what is driving our collaboration with Feinstein to bring TRXE-009 into the clinic,” Kelly added.
About Novogen Limited
Novogen is a public, Australian drug-development company whose shares trade on both the Australian Securities Exchange (‘NRT’) and NASDAQ (‘NVGN’). The Novogen group includes US-based, CanTx Inc, a joint venture company with Yale University.
Novogen has two main drug technology platforms: super-benzopyrans (SBPs) and anti-tropomyosins (ATMs). SBP compounds have been designed to kill the full heterogeneity of cells within a tumor, including the cancer stem cells. The molecular target is a trans-membrane electron-transfer pump mechanism oncogene that is common to all cancer cells. Cells die by respiratory distress and mitochondrial disintegration.
The ATM compounds target the micro-filament component of the cancer cell’s cytoskeleton and have been designed to combine with anti-microtubular drugs (taxanes, vinca alakaloids) to produce comprehensive and fatal destruction of the cancer cell cytoskeleton.
The Company pipeline comprises three SBP drug candidates (TRXE-002, TRXE-009, TRXE-0025) and one ATM drug candidate (‘Anisina’).
About TRXE-009
TRXE-009 is an SBP compound generated by the Company’s VAL-ID (Versatile Approach to Library-based Iterative Design) drug discovery process, with structure-activity relationship driving design based on activity against brain cancer stem cells and the known required chemical criteria to facilitate passage across the blood-brain barrier.
About Trilexium
Trilexium is the name give to a proprietary parenteral formulation of TRXE-009 selected for its ability to maximize systemic drug delivery and effectiveness in pre-clinical rodent models of human cancer.
Further information is available on our website www.novogen.com.
About the Feinstein Institute of Medical Research
Feinstein is the research entity of the North Shore-LIJ Health System, New York, one of the largest healthcare providers in the US and the largest integrated health system in the State of New York.
John Boockvar MD holds the following appointments:
- Director, Brain Tumor and Pituitary/Neuroendocrine Center
- Department of Neurosurgery
- The New York Head and Neck Institute
- Lenox Hill Hospital/Manhattan Eye, Ear and Throat Hospital
- Investigator, Laboratory for Brain Tumor Biology and Therapy
- Center for Neuroscience and Oncology
- Director, Brain Tumor Biotech Center
- Feinstein Institute for Medical Research
- Professor of Neurosurgery and Otolaryngology/Head and Neck Surgery
- Department of Neurosurgery
- Hofstra-North Shore LIJ School of Medicine
Marc Symons PhD holds the following appointments:
- Investigator, The Feinstein Institute for Medical Research
- Co-Director, Brain Tumor Biotech Center, The Feinstein Institute for Medical Research
- Director, Light Microscopy Facility, The Feinstein Institute for Medical
- Professor, Department of Molecular Medicine and Department of Neurosurgery, Hofstra North Shore-LIJ School of Medicine
For more information please contact:
| Corporate ContactDr. Graham Kelly
Executive Chairman & CEO Novogen Group +61 (0) 2 9472 4100 |
Media EnquiriesCristyn Humphreys
Chief Operating Officer Novogen Group +61 (0) 2 9472 4111 |
Forward Looking Statement
This press release contains “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as “expects,” “appear,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “should,” “would,” “may,” “target,” “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to any statements relating to the Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s drug development program, including, but not limited to, TRXE-009, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to TRXE-009, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to, TRXE-009, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, including, but not limited to, the intellectual property relating to [DRUG], and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on management’s current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.
(ENG) Signs 5-Year Extension Agreement With Xcel Energy
HOUSTON, March 4, 2015 — ENGlobal (Nasdaq:ENG), a leading provider of energy-related engineering and automation services, announced today the award of a new five-year Professional Services Agreement with Xcel Energy in Denver. ENGlobal’s ongoing scope of work is expected to consist of engineering, design, construction management and procurement support for Xcel Energy’s natural gas pipeline and facility projects in all of its operating regions.
To date, ENGlobal and Xcel Energy have successfully teamed on work that includes the 60 – mile West Main segment pipeline replacement and the 34 – mile Cherokee CACJ (Clean Air – Clean Jobs Act) pipeline. These representative major capital assignments are in addition to smaller capital and maintenance jobs having been performed on Xcel Energy’s local gas transmission and distribution network. ENGlobal expects to primarily utilize its Broomfield, Colorado office in support of this work, which includes a growing staff of project execution professionals dedicated to the midstream and downstream energy sectors.
“Xcel Energy and ENGlobal have a proven history of successful collaboration – having worked well together to efficiently manage and execute a substantial capital program,” said William A. Coskey, P.E., Chairman and Chief Executive Officer of ENGlobal. “We would like to thank Xcel Energy for their continued confidence in our capabilities.”
About Xcel Energy
Xcel Energy is a major U.S. electric and natural gas company, with annual revenues of $10.9 billion. Based in Minneapolis, Minn., Xcel Energy has regulated operations in eight Midwestern and Western states including, Colorado, Michigan, Minnesota, New Mexico, North Dakota, South Dakota, Texas and Wisconsin. Xcel Energy provides a comprehensive portfolio of energy-related products and services to approximately 3.5 million electricity customers and 1.9 million natural gas customers through four operating companies.
About ENGlobal
ENGlobal (Nasdaq:ENG) is a provider of engineering and related project services primarily to the energy sector throughout the United States and internationally. ENGlobal operates through two business segments: Automation and Engineering. ENGlobal’s Automation segment provides services related to the design, fabrication and implementation of advanced automation, control, instrumentation and process analytical systems. The Engineering segment provides consulting services for the development, management and execution of projects requiring professional engineering, construction management, and related support services. Within the Engineering segment, ENGlobal’s Government Services group provides engineering, design, installation and operation and maintenance of various government, public sector and international facilities, and specializes in the turnkey installation and maintenance of automation and instrumentation systems for the U.S. Defense industry worldwide. Further information about the Company and its businesses is available at www.ENGlobal.com.
Safe Harbor for Forward-Looking Statements
The statements above regarding the Company’s expectations regarding its operations and certain other matters discussed in this press release may constitute forward-looking statements within the meaning of the federal securities laws and are subject to risks and uncertainties. For a discussion of additional risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see ENGlobal’s filings with the Securities and Exchange Commission, including the Company’s most recent reports on Form 10-K and 10-Q, and other SEC filings.
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CONTACT: Mark A. Hess
(281) 878-1040
ir@ENGlobal.com
(FLKS) Medtronic, Leading Neurostimulation Company, Invests
Flex Pharma, Inc. (NASDAQ: FLKS), a biotechnology company that is developing innovative and proprietary treatments for nocturnal leg cramps and spasms associated with severe neuromuscular conditions, today announced that Medtronic invested in the Flex Pharma initial public offering on January 29, 2015.
“As a market leader in neurostimulation to ameliorate a wide range of human disease, Medtronic is focused on backing potentially breakthrough new therapies in this arena,” said Stephen Oesterle, M.D., Medtronic Senior Vice President Medicine & Technology. “Flex Pharma has opened a potentially important, novel means of therapeutic neurostimulation, via topically acting ion channel agonists.”
“Flex Pharma’s strategy of stimulating particular nerves by TRP channel activation may feed into some of the same pathways as electrical neurostimulation,” noted National Academy of Science member and Flex Pharma Scientific Co-Founder, Bruce Bean, Ph.D. “So we think there may be interesting overlaps and synergies for treating various disorders by combining TRP channel activation with Medtronic’s approved neurostimulation therapies.”
“We intend to explore whether activators of Transient Receptor Potential (TRP) channels may be beneficial in patients suffering from muscle spasms caused by a variety of neurological diseases,” commented Nobel Laureate and Flex Pharma Scientific Co-Founder, Rod MacKinnon, M.D. “This small molecule modality, alone or in combination, may represent a potential new approach to neurostimulation.”
About Flex Pharma
Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for nocturnal leg cramps and spasms associated with severe neuromuscular conditions. In three randomized, blinded, placebo-controlled, cross-over studies, Flex Pharma’s proprietary treatment has shown a statistically significant reduction in the intensity of muscle cramps in healthy normal volunteers.
Flex Pharma was founded by National Academy of Science members Rod MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D., recognized leaders in the fields of ion channels and neurobiology, along with Chairman and Chief Executive Officer Christoph Westphal, M.D., Ph.D.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success and timing of ongoing and anticipated clinical studies for our current product candidates; our expectations regarding the effectiveness and safety of our product candidates; our expectations for future studies in various diseases; and our beliefs regarding potential synergies in TRP channel activation and neurostimulation therapies. Various factors may cause differences between our expectations and actual results as discussed in greater detail under the heading “Risk Factors” in the registration statement on Form S-1 (commission file number 333-201276), which was declared effective by the Securities and Exchange Commission (SEC) on January 28, 2015. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
VP, Investor Relations & Corporate Communications
irdept@flex-pharma.com
(DATE) Announces Receipt of “Going Private” Proposal and Departure of Director
BEIJING, March 3, 2015 — Jiayuan.com International Ltd. (“Jiayuan” or the “Company”) (NASDAQ: DATE), operator of the largest online dating platform in China, today announced that its Board of Directors (the “Board”) has received a preliminary non-binding proposal letter, dated March 3, 2015 (the “Proposal Letter”), from Vast Profit Holdings Limited (“Vast Profit”) that proposes a “going-private” transaction involving the acquisition of all of the outstanding ordinary shares of the Company not already owned by Vast Profit at a price per share of US$3.58, or US$5.37 per American depositary share of the Company, in cash (the “Transaction”). Every two American depositary shares of the Company represent three ordinary shares. Vast Profit completed its acquisition of 8,003,763 ordinary shares of the Company from Aprilsky Ltd. (“Aprilsky”) on March 2, 2015. Aprilsky is an indirect, wholly-owned subsidiary of the trustee of the Pangu Trust, an irrevocable trust established under the laws of the British Virgin Islands. Ms. Haiyan Gong is the settlor of the Pangu Trust and Ms. Gong and her family members are the beneficiaries. In addition, according to the Proposal Letter, Vast Profit expects to complete the acquisition of an additional 1,805,126 ordinary shares of the Company by March 15, 2015. A copy of the Proposal Letter is attached hereto as Exhibit A.
The Board is in the process of forming a special committee of independent directors to consider the Transaction.
The Company cautions its shareholders and others considering trading in its securities that the Board has just received the non-binding proposal from Vast Profit and no decisions have been made with respect to the Company’s response to the proposal. 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 the Transaction or any other transaction, except as required under applicable law.
In addition, the Company today announced that Ms. Gong resigned from her position as a director of the Company, effective immediately, and will no longer hold the position of Co-Chairman of the Board. Ms. Gong will continue to serve as a consultant to the Company.
Exhibit A: http://photos.prnasia.com/prnk/20150303/0861501438
About Jiayuan
Jiayuan.com International Ltd. (“Jiayuan”) (NASDAQ: DATE) operates the largest online dating platform in China. Jiayuan is committed to providing a trusted, effective, and user-focused online dating platform that addresses the dating and marriage needs of China’s rapidly growing urban singles population. As a pioneer in China’s online dating market, Jiayuan ranks first in terms of number of unique visitors, average time spent per user and average page views per user among all online dating websites in China in 2014, according to iResearch. Jiayuan recorded an average of 6.2 million monthly active user accounts in the third quarter of 2014. Every two of Jiayuan’s American depositary shares represent three ordinary shares.
For more information, please visit http://ir.jiayuan.com.
Forward-Looking Statements
This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of 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,” “confident” and similar statements. Jiayuan may also make written or verbal forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission, in its annual report to shareholders, in press releases and other written materials and in verbal statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: our growth strategies; our future business development, including development of new products and services; our ability to attract and retain users; competition in the Chinese online dating markets; changes in our revenues and certain cost or expense items as a percentage of our revenues; the outcome of any litigation or arbitration; the expected growth of the number of Internet and broadband users in China; Chinese governmental policies relating to the Internet and online dating websites and general economic conditions in China and elsewhere. Further information regarding these and other risks is included in our documents filed with the U.S. Securities and Exchange Commission. Jiayuan does not undertake any obligation to update any forward-looking statement, except as required under applicable law. All information provided in this press release is as of the date of the press release, and Jiayuan undertakes no duty to update such information, except as required under applicable law.
For investor and media inquiries, please contact:
China
Shirley Zhang
Jiayuan.com International Ltd.
+86 (10) 6442-2321
ir@jiayuan.com
Mr. Christian Arnell
Christensen Investor Relations
Mr. Christian Arnell
+86-10-5900-1548
carnell@christensenir.com
US
Ms. Linda Bergkamp
+1-480-614-3004
Email: lbergkamp@Christensenir.com
(STAA) Caren Mason Appointed President & CEO
Accomplished Leader Brings Broad Expertise and Proven Track Record of Building Successful Healthcare Companies Elected to STAAR’s Board of Directors in June 2014; Serves as Chair of Recently Formed Quality & Regulatory Committee
MONROVIA, Calif., March 3, 2015 — STAAR Surgical Company (NASDAQ: STAA) a leading developer, manufacturer and marketer of implantable lenses and delivery systems for the eye, has named Caren Mason President and Chief Executive Officer effective immediately. Ms. Mason, who was elected to STAAR’s Board of Directors in June 2014, and was appointed by the Board to chair the Quality and Regulatory Committee in September 2014, replaces Barry G. Caldwell who retired as of March 1, 2015.
Ms. Mason joins STAAR after most recently serving as CEO of, and then advisor to, Verinta Health, a leading provider of non-invasive prenatal genetic testing services combining ultra-high-throughput next-generation sequencing with proprietary applications. Ms. Mason led the company from clinical trial and clinical laboratory build status to the development of a complete corporate entity. Illumina acquired Verinata in a transaction valued at several hundred million dollars in February 2013. Previously, she served as President & CEO of publicly traded Quidel Corporation between 2004 and 2009 where she successfully engineered an operational turnaround and delivered significant top line growth, profitability and shareholder value. During her tenure, Quidel was recognized as one of Forbes’ Best 200 Small Companies in 2007 and 2008.
Prior to joining Quidel, Ms. Mason served as President & CEO for MiraMedica, a private, computer-aided detection mammography systems company, securing its strategic sale to Kodak Health Imaging. She also served as CEO of eMed Technologies, General Manager of the Women’s Healthcare business and as a General Manager in various capacities for the Services business of GE Healthcare; held senior executive operating leadership positions with Bayer AG/AGFA and began her career in healthcare with American Hospital Supply/Baxter Healthcare.
“After completing with our outside consultant an extensive and exhaustive search for the next leader of our Company, we determined the ideal candidate was already a member of our team, and we are delighted that Caren has agreed to become our President and CEO,” said Mark Logan, Chairman of the Board of Directors. “Throughout her career, Caren has demonstrated many of the key attributes the Search Committee of the Board sought including a substantial track record of success at building profitable, global, scientifically driven medical technology businesses. In addition, in her previous leadership positions, Caren has developed customer-centric cultures that drove commercial success while maintaining a strong focus on quality systems, regulatory affairs and compliance. The Board has been impressed with her leadership and command of the issues since we asked her to lead the recently formed Quality & Regulatory Committee and we firmly believe she is the right person to lead STAAR towards its full potential.”
“During the past nine months, I’ve had the opportunity to begin my education on the opportunities and challenges STAAR faces,” added Ms. Mason. “STAAR is in a unique and very promising position within the vision care industry. The Company’s proprietary implantable collamer lens provides an outstanding solution to the millions of patients worldwide suffering from myopia and myopia with astigmatism. And, despite more than 500,000 patients with ICL implants, the global market opportunity for our ICL technology remains in its formative stages. I am committed to ensuring that the work underway to remediate and rebuild STAAR’s overall quality system is a strategic imperative and top priority for the company. I look forward to working with the team to capitalize on our opportunities and successfully meet our challenges so that we can build returns for all of the Company’s stakeholders.”
In addition to being a Director of STAAR, Ms. Mason is a Director of HealthTell, an early stage Life Sciences company. She also currently serves on the Executive Committee for the UCSD Moores Cancer Center Board of Visitors and is Chair of the UCSD Moores Cancer Center Advisory and Innovation Council. Ms. Mason holds a Bachelor of Arts degree from Indiana University.
About STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for over 25 years, designs, develops, manufactures and markets implantable lenses for the eye and delivery systems therefor. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or “ICL.” A lens used to replace the natural lens after cataract surgery is called an intraocular lens or “IOL.” More than 500,000 Visian ICLs have been implanted to date. To learn more about the ICL go to: www.visianinfo.com. STAAR has approximately 300 employees and markets lenses in over 60 countries. Headquartered in Monrovia, CA, the company operates manufacturing facilities in Aliso Viejo, CA and Monrovia, CA. For more information, please visit the Company’s website at www.staar.com.
Safe Harbor
All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: any revenue, sales, or any other financial items; the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; statements regarding new or improved products; the size of market opportunities;, and any statements of assumptions underlying any of the foregoing. Important additional factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the Company’s Annual Report on Form 10-K for the year ended January 3, 2014, under the caption “Risk Factors,” and also in the Company’s Quarterly Report on Form 10-Q for the quarter ended July 4, 2014, under the caption “Risk Factors,” both of which are on file with the Securities and Exchange Commission and available in the “Investor Information” section of the company’s website under the heading “SEC Filings.”
These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the following: our limited capital resources and limited access to financing; the negative effect of unstable global economic conditions on sales of products, especially products such as the ICL used in non-reimbursed elective procedures; the challenge of managing our foreign subsidiaries; backlog or supply delays; the risk of unfavorable changes in currency exchange rate; the discretion of regulatory agencies to approve or reject new or improved products, or to require additional actions before approval (including but not limited to FDA requirements regarding the TICL and/or actions related to the FDA Warning Letter and Form 483s), or to take enforcement action; unexpected costs or delays that could reduce or eliminate the expected benefits of our consolidation plans; the risk that research and development efforts will not be successful or may be delayed in delivering for launch; the purchasing patterns of our distributors carrying inventory in the market; the willingness of surgeons and patients to adopt a new or improved product and procedure; patterns of Visian ICL use that have typically limited our penetration of the refractive procedure market, negative media coverage in different regions regarding refractive procedures, and a general decline in the demand for refractive surgery particularly in the U.S. and the Asia Pacific region, which STAAR believes has resulted from both concerns about the safety and effectiveness of laser procedures and current economic conditions. The Visian Toric ICL and the Visian ICL with CentraFLOW are not yet approved for sale in the United States.
| CONTACT: | Investors | Media |
| EVC Group | EVC Group | |
| Brian Moore, 310-579-6199 | Rob Swadosh, 212-850-6021 | |
| Doug Sherk, 415-652-9100 |
(UQM) Initial Purchase Order for Its New Fuel Cell Compressor From (BLDP)
UQM Technologies Inc. (NYSE MKT: UQM) today announced it has received its first fuel cell compressor module purchase order from Ballard Power Systems (NASDAQ MKT: BLDP), a global leader in PEM (proton exchange membrane) fuel cell technology. These compressor modules are an integral component of hydrogen powered fuel cell vehicles.
The UQM R410 fuel cell compressor system is designed for medium duty automotive and commercial bus applications for up to 150kW fuel cell stacks. The purchase order calls for shipments of product to Ballard over the next four months and will generate revenue in excess of $600K. UQM also expects follow on orders from Ballard.
“We are excited to be working directly with Ballard on their fuel cell bus programs,” said Eric R. Ridenour, President and Chief Executive Officer of UQM Technologies, Inc. “Our expansion directly into the fuel cell compressor business is already paying off for UQM and we believe that the advantages our system offers will allow further growth with Ballard and additional customers.”
Paul Cass, Ballard’s Chief Operations Officer added, “We were very pleased to have UQM as our new supplier of these key components for our fuel cell bus programs. UQM is well known in the industry for their high quality and technologically advanced electric motors and controllers and we look forward to working with the UQM team on a variety of fuel cell products.”
About UQM
UQM Technologies is a developer and manufacturer of power-dense, high-efficiency electric motors, generators and power electronic controllers for the commercial truck, bus, automotive, marine, military and industrial markets. A major emphasis for UQM is developing propulsion systems for electric, hybrid electric, plug-in hybrid electric and fuel cell electric vehicles. UQM is TS 16949 and ISO 14001 certified and located in Longmont, Colorado. For more information, please visit www.uqm.com.
About Ballard Power Systems
Ballard Power Systems (NASDAQ: BLDP; TSX: BLD) provides clean energy products that reduce customer costs and risks, and helps customers solve difficult technical and business challenges in their fuel cell programs. To learn more about Ballard, please visit www.ballard.com.
This Release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act. These statements appear in a number of places in this Release and include statements regarding our plans, beliefs or current expectations; including those plans, beliefs and expectations of our management with respect to, among other things, gaining required certifications, new product developments, future orders to be received from our customers, sales of products from inventory, future financial results, liquidity, and the continued growth of the electric-powered vehicle industry. Important Risk Factors that could cause actual results to differ from those contained in the forward-looking statements are contained in our Form 10-K and Form 10-Q’s, which are available through our website at www.uqm.com or at www.sec.gov.
StreetSmart Investor Relations
Annie Leschin, 415-775-1788
or
UQM Technologies, Inc.
David I. Rosenthal, 303-682-4900
(ALLB) of PA & (WSFS) Enter Into Definitive Agreement and Plan of Merger
WILMINGTON, Del., March 3, 2015 — WSFS Financial Corporation (Nasdaq:WSFS) and Alliance Bancorp, Inc. of Pennsylvania (Nasdaq:ALLB) jointly announced today the signing of a definitive agreement and plan of merger whereby WSFS Financial Corporation will acquire Alliance Bancorp, Inc. of Pennsylvania. Upon the closing of the transaction, Alliance Bank, the wholly owned bank subsidiary of Alliance Bancorp, Inc. of Pennsylvania will merge into WSFS Financial Corporation’s wholly owned bank subsidiary, WSFS Bank. Headquartered in Broomall, Pennsylvania, Alliance Bank opened in 1938 as an independent, locally-managed institution dedicated to providing the highest quality community banking services predominantly to Delaware County and neighboring Chester County residents. Alliance Bank reported approximately $421 million in assets, $310 million in loans and $345 million in deposits as of December 31, 2014 and serves its customers from eight branch locations. Following the merger, WSFS will have 17 locations in southeastern Pennsylvania, including 11 in Delaware County.
WSFS President and Chief Executive Officer, Mark A. Turner said, “We are pleased to announce our partnership with Alliance Bank, our fourth acquisition in recent years and our largest to date. Alliance’s eight locations and over three-quarters of a century heritage in southeastern Pennsylvania are a great complement to our branch network and add important relationships to our banking franchise. We believe we have aligned ourselves with a terrific partner in Alliance Bank, as they also share an extraordinary commitment to Customers, Communities and Associates. Southeastern Pennsylvania is a highly desirable and complementary market expansion opportunity for our franchise and we look forward to further expanding our presence in the market.”
The transaction is valued at approximately $92.0 million. Under the terms of the agreement, which has been approved by the boards of directors of both companies, shareholders of Alliance Bancorp, Inc. of Pennsylvania will be entitled to elect to receive either 0.28955 shares of WSFS common stock or $22.00 in cash for each common share of Alliance Bancorp, Inc. of Pennsylvania, subject to an overall allocation of exchanged shares into 70% common stock and 30% cash. The closing is anticipated to occur during the fourth quarter of 2015, subject to approval by Alliance Bancorp, Inc. of Pennsylvania shareholders, regulatory approvals and other customary closing conditions.
WSFS expects to incur pre-tax merger and integration costs of approximately $9.3 million and to achieve cost savings of approximately 40% of Alliance Bancorp, Inc. of Pennsylvania’s non-interest expenses. The acquisition is expected to be accretive to WSFS earnings per share in the first year of combined operations, excluding one-time costs. The transaction has an anticipated IRR of 17%. WSFS expects initial tangible book value dilution of less than 2% from the transaction which is estimated to be earned back in under 5 years.
Dennis D. Cirucci, President and Chief Executive Officer of Alliance Bancorp, Inc. of Pennsylvania said, “I am proud of the organization and relationships our team has built over the last 77 years. We are pleased to partner with WSFS, the largest and oldest bank and trust company headquartered in the Delaware Valley. Their significant presence in Delaware and southeastern Pennsylvania as well as their expanded wealth and commercial product offerings will benefit our community, customers and employees. Our team is delighted to be joining WSFS and we look forward to working together and building additional value for our combined shareholders.”
Boenning & Scattergood, Inc. acted as financial advisor to WSFS Financial Corporation and its legal counsel was Covington & Burling LLP. Keefe, Bruyette & Woods, Inc. acted as financial advisor to Alliance Bancorp, Inc. of Pennsylvania and its legal counsel was Silver Freedman Taff & Tiernan LLP. The agreement has been approved by both of the Boards of Directors of WSFS Financial Corporation and Alliance Bancorp, Inc. of Pennsylvania.
Additional materials are also available on the Investor Relations page of the Company’s website at wsfsbank.com.
About WSFS Financial Corporation
WSFS Financial Corporation is a multi-billion dollar financial services company. Its primary subsidiary, WSFS Bank, is the largest and oldest bank and trust company headquartered in the Delaware Valley with $4.9 billion in assets on its balance sheet and $9.4 billion in fiduciary assets, including over $1 billion in assets under management. WSFS operates from 56* offices located in Delaware (45), Pennsylvania (9*), Virginia (1) and Nevada (1) and provides comprehensive financial services including commercial banking, retail banking and trust and wealth management. Other subsidiaries or divisions include Christiana Trust, WSFS Investment Group, Inc., Cypress Capital Management, LLC, Cash Connect®, Array Financial and Arrow Land Transfer. Serving the Delaware Valley since 1832, WSFS is the seventh oldest bank in the United States continuously operating under the same name. For more information, please visit wsfsbank.com.
*Devon, PA branch scheduled to open later this month.
About Alliance Bancorp, Inc. of Pennsylvania
Alliance Bancorp, Inc. of Pennsylvania is the holding company for Alliance Bank, a Pennsylvania chartered, FDIC-insured savings bank headquartered in Broomall, Pennsylvania. Alliance Bank operates eight full-service branch offices located in Delaware and Chester Counties, Pennsylvania.
Forward-Looking Statement Disclaimer
This press release contains estimates, predictions, opinions, projections and other “forward-looking statements” as that phrase is defined in the Private Securities Litigation Reform Act of 1995. Such statements include, without limitation, references to WSFS’ and Alliance’s predictions or expectations of future business or financial performance as well as their respective goals and objectives for future operations, financial and business trends, business prospects, and management’s outlook or expectations for earnings, revenues, expenses, capital levels, liquidity levels, asset quality or other future financial or business performance, strategies or expectations. Forward-looking statements are typically identified by words such as “believe,” “expect,” “anticipate,” “intend,” “target,” “estimate,” “continue,” “positions,” “prospects” or “potential,” by future conditional verbs such as “will,” “would,” “should,” “could” or “may”, or by variations of such words or by similar expressions. Such forward-looking statements are based on various assumptions (some of which may be beyond the Company’s control) and are subject to risks and uncertainties (which change over time) and other factors which could cause actual results to differ materially from those currently anticipated.
In addition to factors previously disclosed in WSFS’ and Alliance’s reports filed with the U.S. Securities and Exchange Commission (the “SEC”) and those identified elsewhere in this document, the following factors among others, could cause actual results to differ materially from forward-looking statements or historical performance: ability to obtain regulatory approvals and meet other closing conditions to the merger, including approval by Alliance shareholders on the expected terms and schedule; delay in closing the merger; difficulties and delays in integrating the Alliance business or fully realizing cost savings and other benefits; business disruption following the merger; changes in asset quality and credit risk; the inability to sustain revenue and earnings growth; changes in interest rates and capital markets; inflation; customer acceptance of WSFS products and services; customer borrowing, repayment, investment and deposit practices; customer disintermediation; the introduction, withdrawal, success and timing of business initiatives; competitive conditions; the inability to realize cost savings or revenues or to implement integration plans and other consequences associated with mergers, acquisitions and divestitures; economic conditions; and the impact, extent and timing of technological changes, capital management activities, and other actions of the Federal Reserve Board and legislative and regulatory actions and reforms.
Annualized, pro forma, projected and estimated numbers are used for illustrative purpose only, are not forecasts and may not reflect actual results.
Important Additional Information and Where to Find It
In connection with the proposed merger, WSFS will file with the SEC a Registration Statement on Form S-4 that will include a proxy statement of Alliance and a prospectus of WSFS, as well as other relevant documents concerning the proposed transaction. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. SHAREHOLDERS OF ALLIANCE ARE URGED TO READ THE REGISTRATION STATEMENT AND THE PROXY STATEMENT/PROSPECTUS REGARDING THE MERGER WHEN IT BECOMES AVAILABLE AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.
A free copy of the Proxy Statement/Prospectus, as well as other filings containing information about WSFS and Alliance, may be obtained at the SEC’s Internet site (http://www.sec.gov), when they are filed. You will also be able to obtain these documents, when they are filed, free of charge, from WSFS at www.wsfsbank.com under the heading “About WSFS” and then under the heading “Investor Relations” and then under “SEC Filings” or from Alliance by accessing Alliance’s website at www.allianceanytime.com under the heading “Stockholder Information” and then under “Corporate and Market Information”. Copies of the Proxy Statement/Prospectus can also be obtained, when it becomes available, free of charge, by directing a request to WSFS Financial Corporation, WSFS Bank Center, 500 Delaware Avenue, Wilmington, Delaware 19801, Attention: Corporate Secretary, Telephone: (302) 792-6000 or to Alliance Bancorp, Inc. of Pennsylvania, 541 Lawrence Road, Broomall, Pennsylvania 19008, Attention: Corporate Secretary, Telephone: (610) 353-2900.
Alliance and certain of its directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Alliance in connection with the proposed merger. Information about the directors and executive officers of Alliance and their ownership of Alliance common stock is set forth in the proxy statement for Alliance’s 2014 annual meeting of shareholders, as filed with the SEC on Schedule 14A on March 19, 2014. Additional information regarding the interests of those participants and other persons who may be deemed participants in the transaction may be obtained by reading the Proxy Statement/Prospectus regarding the proposed merger when it becomes available. Free copies of this document may be obtained as described in the preceding paragraph.
CONTACT: WSFS Investor Relations Contact: Stephen Fowle
(302) 571-6833 or sfowle@wsfsbank.com
WSFS Media Contact: Cortney Klein
(302) 571-5253 or cklein@wsfsbank.com
Alliance Investor Relations Contact: Peter Meier
(610) 359-6903 or pmeier@alliancebk.com
Alliance Contact: Dennis Cirucci
(610) 359-6978 or dcirucci@alliancebk.com
(MBLX) & Honeywell Partner to Develop Marine Biodegradable Ingredients
New Asensa® ingredients will help Honeywell meet increasing demand for biobased, marine biodegradable ingredients in exfoliants and other personal care products
CAMBRIDGE, Mass., March 3, 2015 — Metabolix, Inc. (Nasdaq:MBLX), an advanced biomaterials company, announced today that it has entered into a global, exclusive commercial and technology alliance with Honeywell to offer new marine biodegradable biopolymers for use in cosmetics and personal care products.
Through the alliance, Metabolix’s Mirel® polyhydroxyalkanoate (PHA) biopolymers will be developed as part of Honeywell’s Asensa® line of personal care additives to help address pending legislation in the U.S. focused on replacing synthetic, non-biodegradable microbeads, as well as global demand for biobased and biodegradable alternatives. This technology is intended to meet increasing regulatory and other requirements around the world for personal care microbeads that biodegrade in marine and fresh water environments. Using applicable ASTM test methods, the marine biodegradability of Mirel PHA biopolymers has been shown to be similar to that of cellulose and paper, and is faster than other commercially available biodegradable polymers.
“Honeywell’s alliance with Metabolix will help us meet increasing consumer demand for environmentally friendly personal care ingredients,” said Heidi Lebel, global business manager for Honeywell’s personal care business. “We look forward to offering new Honeywell Asensa solutions based on Mirel PHA biopolymers that will deliver great exfoliation performance that is gentle on both the skin and the planet.”
“With Honeywell’s material science expertise and market channels, and Metabolix’s history of innovation in sustainable biopolymers, we hope to see a range of new Asensa ingredients introduced to the market through this alliance,” said Max Senechal, vice president, strategy and commercial development for Metabolix. “We are excited to work with Honeywell to bring the benefits of Mirel PHA biopolymers that have been shown to be biodegradable in soil, marine and fresh water environments to the personal care market.”
About Asensa Cosmetics and Personal Care Ingredients
Honeywell offers a comprehensive line of natural and synthetic personal care additives proven to meet diverse formulation needs. Honeywell Asensa products are used in a variety of end-use applications ranging from lipsticks to moisturizers to pressed powders.
Asensa® is a registered trademark of Honeywell. For more information about Honeywell’s Asensa line of personal care ingredients, visit www.asensa.com.
About Metabolix
Metabolix, Inc. is an innovation-driven specialty materials company focused on delivering high-performance biopolymer solutions to customers in the plastics industry. Metabolix’s Mirel® biopolymer resins, which are derived from renewable resources, are a family of biobased performance additives based on PHA (polyhydroxyalkanoates). Metabolix’s proprietary biotechnology platform enables the creation of specialty biopolymers for use in a broad range of applications such as construction and packaging materials, as well as industrial, consumer and personal care products.
For more information, please visit www.metabolix.com. (MBLX-G)
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical, including, without limitation, statements regarding expected results of the alliance with Honeywell, market demand expectations, and commercialization plans for the Company’s PHA biopolymer products, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including the risks and uncertainties detailed in Metabolix’s filings with the Securities and Exchange Commission, including its 10-K for the year ended December 31, 2013 filed on March 28, 2014.
CONTACT: Metabolix Inquiries:
Lynne H. Brum
(617) 682-4693
LBrum@metabolix.com
Caitlin Hunt
MSL Group
(781) 684-0770
metabolix@mslgroup.com
(VICR) Showcase New Power Products, Design Tool Capabilities at APEC 2015
New Product Announcements, PowerBench(TM) Design Tool Demonstrations, and Technical Presentation On Tap for Premier Power Electronics Conference; Attendees Can Visit Vicor at Booth #929
ANDOVER, MA–(Mar 2, 2015) – Vicor Corporation (NASDAQ: VICR) today announced its participation at the Applied Power Electronics Conference (APEC 2015), March 15 -19, in Charlotte, North Carolina, at the Charlotte Convention Center. At the event, Vicor will unveil and exhibit the newest additions to its portfolio of high-performance power components and will demonstrate the latest enhancements to its PowerBench™ power system design tool suite.
APEC 2015 attendees will learn more about Vicor’s latest innovations in power, targeted at a wide range of applications requiring the highest levels of power density and efficiency. Designed to help customers architect high-performance power systems with unrivaled flexibility, these new products expand the depth and breadth of Vicor’s solution portfolio and span the complete power chain from power source to point of load.
Attendees can also participate in hands-on demonstrations of Vicor’s online PowerBench™ design tool suite. PowerBench tools enable designers to employ a web-based power component design methodology that eliminates design complexity, reduces development costs, and accelerates time to market. At APEC 2015, Vicor will demo the latest enhancements to its PowerBench Whiteboard, an easy-to-use design tool that equips users to architect end-to-end power chain block diagrams and dynamically analyze system attributes including efficiency and power loss.
With the most recent enhancements to the Whiteboard design tool, users will be able to preview the mechanical layout of their power chains and assess the real-world size and dimensions of the components they’ve selected. Providing a top-down view of the complete component power chain, this capability enables users to better optimize their designs for maximum power density and space savings.
Also at APEC 2015, Vicor application engineer Ankur Patel will present a paper describing the use of Vicor’s proprietary Sine Amplitude Converter (SAC) switching technology in the design of an isolated step-up DC-DC converter. SAC switching enables an elegant method of resolving the challenges of designing DC-DC converters to provide isolated, regulated and step-up voltage transformation, providing a +6% increase in efficiency and more than four times the power density of alternative solutions. This presentation will be delivered in conjunction with the System Integration technical session scheduled for Thursday, March 19, 8:30am to 11:20am local time, in Room 2.
APEC 2015 attendees can visit Vicor at Booth #929.
About APEC
APEC focuses on the practical and applied aspects of the power electronics business, and is considered to be the leading conference for practicing power electronics professionals. The APEC program addresses a broad range of topics in the use, design, manufacture and marketing of power electronics equipment. The conference includes professional development courses taught by world-class experts and presentations of peer-reviewed technical papers covering a wide range to topics of interest in power electronics. www.apec-conf.org
Follow Vicor on Social Media
Twitter: @VicorPower
Vicor Corporation on LinkedIn
Vicor PowerBlog
About Vicor Corporation
Headquartered in Andover, Massachusetts, Vicor Corporation designs, manufactures and markets innovative, high-performance modular power components, from bricks to semiconductor-centric solutions, to enable customers to efficiently convert and manage power from the power source to the point of load. www.vicorpower.com
Vicor and PowerBench are trademarks of Vicor Corporation.
Contact:
Colin Boroski
Rainier Communications
508-475-0025 x 142
Email Contact
(ATHX) & Chugai License Agreement & Collab MultiStem(R) Cell Therapy, Ischemic Stroke
CLEVELAND and TOKYO, March 2, 2015 — Athersys, Inc. (Nasdaq:ATHX) and Chugai Pharmaceutical Co., Ltd. (Tokyo Stock Exchange: 4519) have announced a partnership and license agreement to exclusively develop and commercialize MultiStem® cell therapy for ischemic stroke in Japan. Ischemic stroke represents a priority disease area in Japan, given the high healthcare burden of the condition and the expected increase in incidence associated with Japan’s aging population.
Athersys’ proprietary cell therapy product, MultiStem, is currently being evaluated in a Phase 2 clinical study for ischemic stroke in the United States and Europe, and Athersys has begun preparations for clinical development in Japan, including engagement with the Japanese Health Authority. Chugai is a leading research-based pharmaceutical company with strengths in biotechnology products, and brings to the collaboration substantial expertise and experience in late-stage development and commercialization in Japan.
“We are delighted to have concluded a license agreement with Athersys for the development and marketing of MultiStem, a very innovative cell therapy under clinical development,” said President and Chief Operation Officer at Chugai, Tatsuro Kosaka. “By combining Chugai’s strong expertise in biological pharmaceuticals, we hope to bring MultiStem to the Japanese healthcare system as a new treatment modality during the critical phase of ischemic stroke.”
“We are excited to be working with Chugai in this important area and look forward to combining our respective capabilities and expertise to successfully develop and commercialize MultiStem for the treatment of ischemic stroke in Japan,” said Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer at Athersys. “We believe that Chugai represents an outstanding partner with strong capabilities in all facets of the development, commercialization and marketing of novel medicines in the Japanese healthcare market. Chugai has been a leader in the development and introduction of innovative biologics and has successfully established one of the top sales forces in the prescription drug field in Japan, which we believe represents a key competitive advantage that can help both companies maximize value. Athersys and Chugai are committed to working together to establish a leadership position in the regenerative medicine cell therapy area in Japan.”
As part of the collaboration, Chugai will be responsible for the development and commercialization of MultiStem for ischemic stroke in Japan, and Athersys will have responsibility for product supply. Under the financial terms of the agreement, Athersys will receive an up-front cash payment of $10 million from Chugai and would receive additional payments as the program is further advanced. Athersys is eligible to receive milestone payments from Chugai of up to $45 million upon the successful achievement of certain development and regulatory milestones, and sales milestones of up to 17.5 billion Yen (approximately $150 million based on the current exchange rate). Athersys would also receive from Chugai tiered, double-digit royalties on any net sales, as well as payments for product supplied to Chugai.
In Athersys’ ongoing Phase 2 clinical study, it is evaluating the administration of MultiStem cell therapy to patients who have suffered an ischemic stroke. Based on preclinical research to date, administration of MultiStem has shown significant benefits through several mechanisms, including reduction of inflammation and immune system modulation in the ischemic area, and the protection and rescue of damaged or injured cells, including neuronal tissue. Athersys is treating patients one to two days after the stroke has occurred, in contrast to thrombolytic tPA treatment, which is limited to the first three to four hours following the stroke. Preclinical studies have demonstrated that administration of a single dose of MultiStem therapy, even one week after a stroke, provides significant and durable improvements relative to controls. Enrollment in Athersys’ double-blind, placebo-controlled trial is complete, and interim safety and initial efficacy results following the ninety-day patient data are expected to be announced in April 2015, following analysis and receipt of the unblinded clinical data.
About Ischemic Stroke
Stroke represents an area where the clinical need is particularly significant, since it represents a leading cause of death and significantly lowers Quality of Life for stroke patients. Currently, there are more than 15 million people that suffer a stroke globally and more than two million stroke victims per year in the United States, Europe and Japan, combined. Ischemic strokes, which represent the most common form of stroke, are caused by a blockage of blood flow in the brain that cuts off the supply of oxygen and nutrients and can result in tissue loss and neurological damage, as well as long-term or permanent disability. Unfortunately, current therapeutic options for ischemic stroke victims are limited, since the only available therapy, a clot dissolving agent, or “thrombolytic,” must be administered within several hours of the occurrence of the stroke. As a consequence of this limited time window, only a small percentage of stroke victims are treated with the currently available therapy-most simply receive supportive or “palliative” care. The long-term costs of stroke are substantial, with many patients requiring extended hospitalization, extended physical therapy or rehabilitation (for those patients that are capable of entering such programs), and many require long-term institutional or family care.
About MultiStem
MultiStem cell therapy is a patented regenerative medicine product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem therapy’s potential for multidimensional therapeutic impact distinguishes it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. The product represents a unique “off-the-shelf” stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon its efficacy profile, its novel mechanisms of action, and a favorable and consistent safety profile demonstrated in both preclinical and clinical settings, MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need. Athersys has forged strategic partnerships and a broad network of collaborations to develop MultiStem cell therapy for a variety of indications, with an initial focus in the neurological, cardiovascular and inflammatory and immune disorder areas.
About Athersys, Inc.
Athersys is an international biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product, initially for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas, and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions to further develop its platform and products. More information is available at www.athersys.com.
About Chugai Pharmaceutical Co., Ltd.
Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area. In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals, and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe. The consolidated revenue in 2014 of Chugai totaled 461.1 billion yen and the operating income was 77.3 billion yen (IFRS Core basis).
Additional information is available on the internet at http://www.chugai-pharm.co.jp/english.
Athersys Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “suggest,” “will,” or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, such as the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of acute respiratory distress syndrome and other disease indications. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: the success of our collaboration with Chugai, including our ability to reach milestones and receive milestone payments, and whether any products are successfully developed and sold so that we earn royalty payments; our ability to raise additional capital; final results from our MultiStem clinical trials; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials; changes in external market factors; changes in our industry’s overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our collaborators’ ability to continue to fulfill their obligations under the terms of our collaboration agreements; the success of our efforts to enter into new strategic partnerships and advance our programs; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Athersys, Inc.
William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
Fax: (216) 432-2461
bjlehmann@athersys.com
Chugai Pharmaceutical Co., Ltd.
Corporate Communications Dept.
Media Relations Group
Tel: 81-(0)3-3273-0881
Fax: 81-(0)3-3281-6607
pr@chugai-pharm.co.jp
(BIOC) Dr. David Rimm Joins Biocept, Inc. as a Scientific Advisor
Yale-Affiliated Pathology and Personalized Medicine Leader to Focus on Assays for Immuno-Oncology Therapies
SAN DIEGO, March 2, 2015 — Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of cell-free circulating tumor DNA and circulating tumor cells (CTCs), today announced that David Rimm, M.D., Ph.D., Professor of Pathology and Professor of Medicine in Medical Oncology at Yale University School of Medicine, will join the Company as a scientific advisor.
Dr. Rimm is a noted physician and researcher in the area of clinically-actionable oncology biomarkers. In his advisory role at Biocept, Dr. Rimm plans to focus on the development of CTC-based biomarker tests targeted on Programmed Death Ligand or PD-L1, an important marker in the emerging area of immuno-oncology therapies.
Some researchers believe that upregulation of PD-L1 allows cancers to evade the host immune system. This research has encouraged development of PD-L1 inhibitor cancer therapies, some that are currently FDA-approved, and many others that are in clinical trials.
“We are very excited to have a physician and personalized medicine expert as accomplished as Dr. Rimm collaborate with our team to help drive our company’s scientific strategy,” said Michael Nall, President and CEO of Biocept. “We believe Dr. Rimm’s experience in translational medicine and cancer biomarkers will help advance Biocept’s goal of increasing test offerings tailored to existing and emerging cancer therapies based on a patient’s genetic signature, with the goal of improving treatment outcomes.”
Dr. Rimm also plans to contribute his expertise to help Biocept expand its menu of blood-based biomarkers.
“The ability to qualify patients for targeted therapy in the absence of biopsy tissue, through a simple blood test, is a provocative concept,” Dr. Rimm said. “This is especially true for PD-L1 axis immuno-oncology therapeutics where tumors are very heterogeneous in their expression of PD-L1, meaning, multiple tissue biopsies of the same tumor may not return the same pathological result. The ability to track and monitor patients around this biomarker could be critical for future patient management.”
About Biocept, Inc.
Biocept, Inc., headquartered in San Diego, Calif., is a commercial-stage oncology diagnostics company focused on providing information on patients’ tumors to physicians using its proprietary technology platform to help improve individual patient treatment. Biocept has developed proprietary technology platforms for capture and analysis of circulating tumor DNA, both in circulating tumor cells (CTCs) and in plasma (cell free tumor DNA). A standard blood sample is utilized to provide physicians with important prognostic and predictive information to enhance individual treatment of their patients with cancer. Biocept currently offers its OncoCEE-GATM, OncoCEE-BRTM and OncoCEE-LUNGTM test, respectively for gastric, breast and lung cancer and plans to introduce additional CLIA validated tests for lung, colorectal, prostate and other solid tumors based on its proprietary technology platforms over the coming months.
About David Rimm, M.D., Ph.D.
Dr. David Rimm is a Professor in the Department of Pathology at the Yale University School of Medicine. He completed an MD-PhD at Johns Hopkins University Medical School followed by a Pathology Residency at Yale and a Cytopathology Fellowship at the Medical College of Virginia. He is board certified in Anatomic Pathology and Cytopathology. Dr. Rimm is the Director of Yale Pathology Tissue Services and acting director of Molecular Diagnostics. His laboratory group focuses on quantitative pathology related to predicting response to therapy and predicting recurrence or metastasis in breast and lung cancer. He is the author of over 300 peer-reviewed journal papers and eight patents and was co-founder of HistoRx, (a digital pathology company sold to Genoptix in 2012) and Metamark Genetics, a prognostic determinant company.
Forward-Looking Statements Disclaimer Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to Dr. Rimm’s ability to contribute to the advancement of our tests and other product offerings and our impact on diagnostic strategies, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our SEC filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the Securities and Exchange Commission, which can be accessed over the Internet at the SEC’s website located at www.sec.gov.
CONTACT: Investor Contact:
The Ruth Group
David Burke
Tel: 646-536-7009
dburke@theruthgroup.com
(NXPI) New Secure Service Development Platform for Secure Mobile Transactions
Platform Facilitates the Rapid Introduction of Secure NFC Applications
EINDHOVEN, Netherlands, March 2, 2015 — NXP Semiconductors N.V. (Nasdaq:NXPI) today announced the availability of its Secure Service Development Platform (SSDP) developed to facilitate the rapid introduction of applications that utilize NXP’s NFC and embedded Secure Element (eSE) module, PN66T. The SSDP provides a turnkey approach for the loader service on the PN66T enabling a faster time-to-market for secure mobile applications. Secure NFC applications can now be realized quickly and easily, reducing design effort and resources while maintaining quality levels expected in a commercially available mobile or wearable device.
The SSDP is a set of hardware tools and software blocks that enable application developers to quickly start building apps that leverage the eSE in the PN66T. With the platform developers are able to test and validate their secure applications on a commercial phone. As well as providing real-world phone solutions, the development platform also contains example industry use-cases from companies such as Hyatt, 7Eleven and TransportKiosk. The SSDP can be used to create many different applications ranging from secure banking, transit, access control, authentication, automotive, and much more.
“The SSDP supports partners wanting to create new secure applications by removing the technical challenges they face in getting credentials on to the secure element in phones and wearable devices. Now, instead of taking months, new applications can be created and validated in a matter of weeks,” said Jeff Miles, VP Business Development, NXP Semiconductors. “The SSDP will streamline the process for the development community therefore enabling phone and wearable technology manufacturers to bring these new apps to market faster.”
Customer Quotes:
“NXP’s SSDP makes the rock-solid trust of secure elements much easier for Sequent’s Trusted Services products to manage and leverage in security-sensitive applications like payments, transit, access control, and identity. The SSDP complements Sequent’s Open Wallet Platform, Digital Issuance, and Trust Authority products in dramatically reducing the complexity, time-to-market, and cost of enabling trusted services on connected, mobile devices,” said Hans Reisgies, SVP of Market Development of Sequent.
As a leading operator of Secure Mobile Wallet Platforms, TORO unifies through the wallet access to all available security options to offer an mCommerce technical and business one-stop-shop for Banks, Retailers, Transit, ticketing, etc. “NXP’s SSDP offers an access to the high level of security that some service providers need, and at the same time a much simplified user enrolment to new services. As the key focus of our platform is user adoption, we welcome this initiative as it supports our objective to reach all end-users and it improves the on-boarding of service providers to generate a much stronger user adoption,” said Laurent Renard, CEO of TORO.
“MeaWallet is a leader in cloud based mobile solutions and has quickly developed a deep competence and understanding of the Secure Element through our work with the SSDP. Being able to validate our solutions on the development platform means that we can support our customers and partners in the enabling of next generation solutions for access, transit and ticketing, further expanding the use of smartphones instead of plastic cards,” said Lars Sandtorv, CEO of MeaWallet.
“We are integrating our SP TSM with NXP’s SSDP loader service to enable all service providers – like banks and mass transit companies operating on the Cardtek SP TSM platform – to easily deploy NFC-based services on devices with NXP’s new chip set. This new platform will not only simplify the technology adaptation for vendors like us but also will increase the interoperability and compatibility with smart devices like smart phones, tablets and wearable gadgets,” said Ali Salcı, EVP of Cardtek Group.
About NXP Semiconductors
NXP Semiconductors N.V. (Nasdaq:NXPI) creates solutions that enable Secure Connections for a Smarter World. Building on its expertise in High Performance Mixed Signal electronics, NXP is driving innovation in the application areas Connected Car, Security, Portable & Wearable and Internet of Things. NXP has operations in more than 25 countries, and posted revenue of $5.65 billion in 2014. Find out more at nxp.com.
Forward-looking Statements
This document includes forward-looking statements which include statements regarding NXP’s business strategy, financial condition, results of operations and market data, as well as other statements that are not historical facts. By their nature, forward-looking statements are subject to numerous factors, risks and uncertainties that could cause actual outcomes and results to be materially different from those projected. Readers are cautioned not to place undue reliance on these forward-looking statements. Except for any ongoing obligation to disclose material information as required by the United States federal securities laws, NXP does not have any intention or obligation to publicly update or revise any forward-looking statements after NXP distributes this document, whether to reflect any future events or circumstances or otherwise. For a discussion of potential risks and uncertainties, please refer to the risk factors listed in NXP’s SEC filings. Copies of NXP’s SEC filings are available from the SEC website, www.sec.gov.
CONTACT: For further press information, please contact:
NXP Semiconductors
Europe: Martijn van der Linden
+31 6 10914896
martijn.van.der.linden@nxp.com
Greater China / Asia: Esther Chang
+886 2 8170 9990
esther.chang@nxp.com
Americas: Hillary Cain
+1 408 518 5227
hillary.cain@nxp.com
(OHRP) Additional Positive Anatomic Data From the OHR-102 IMPACT Study
Rapid Resolution in SHRM Correlates With Early Improvements in Visual Acuity Observed in Phase II IMPACT Study in Wet AMD
NEW YORK, March 2, 2015 — Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, today announced the presentation of new data from the IMPACT study interim analysis at the 38th Annual Macula Society Meeting which took place February 25-28th, in Scottsdale, Arizona. The new data show an early regression of subretinal hyper-reflective material (SHRM), an anatomic biomarker for the wet form of age-related macular degeneration (wet-AMD), which is consistent with the early gains in visual acuity previously reported from this study. The data were presented by Jason S. Slakter, MD, Chief Medical Officer at Ohr and Clinical Professor of Ophthalmology, NYU School of Medicine.
The IMPACT study is a nine-month Phase II clinical trial evaluating Squalamine Eye Drops (OHR-102) for the treatment of wet-AMD. Previously announced interim data demonstrated that the combination of OHR-102 plus Lucentis® resulted in a meaningful and clinically relevant improvement in visual acuity compared with Lucentis monotherapy. OHR-102 appeared to have a rapid onset of action, with differences between the combination and control arms observed as early as 4 weeks and continuing to increase at week 12. At the end of the study, patients treated with the combination of OHR-102 plus Lucentis were still improving. The dramatic and early vision gains observed are believed to result in part from the regression of SHRM, which is widely considered to be a combination of neovascular tissue, pre-fibrotic material and other sub retinal exudative and inflammatory debris.
The new data presented at the Macula Society Meeting showed that, in a masked analysis of spectral domain optical coherence tomography (OCT) images, the reduction in SHRM occurred early in the study, with differences between the treatment and control groups observed by week 4. The early differences between combination therapy and control groups were observed both in the overall treatment population, as well as in the subset of patients with classic-containing choroidal neovascularization (CNV) lesions, where the difference was even greater.
Also presented were new data showing that treatment with OHR-102 appears to prevent further development of SHRM. In those patients treated with the OHR-102 plus Lucentis combination, none experienced worsening in SHRM over the 9 months of the study. In contrast, among Lucentis monotherapy patients, 15% of the overall group and 23% of the classic-containing CNV lesion group experienced worsening of SHRM by the end of the study.
Dr. Jason S. Slakter, who presented the data, commented, “These new results from IMPACT demonstrate the potency of OHR-102 and help us further understand its underlying mechanism of action and benefit to patients. It is very interesting to see the rapid reduction in SHRM and how it correlates with the increases in visual acuity, providing an explanation for the early clinical improvements we observed in the patients in this study. Moreover, it appears that some patients treated with Lucentis monotherapy had a higher risk of further anatomical deterioration, supporting our belief that OHR-102 is having a disease modifying effect on exudative AMD and patients will benefit from continued treatment with OHR-102 combination therapy.”
About Ohr Pharmaceutical, Inc.
Ohr Pharmaceutical, Inc. is an ophthalmology research and development company whose lead product, Squalamine, is being studied as an eye drop formulation (OHR-102) in several company-sponsored and investigator sponsored Phase II clinical trials for various back-of-the-eye diseases. These diseases include the wet form of age-related macular degeneration, retinal vein occlusion, diabetic macular edema, and proliferative diabetic retinopathy. In addition, Ohr has a sustained release micro fabricated micro-particle ocular drug delivery platform with several preclinical drug product candidates in development for glaucoma, steroid-induced glaucoma, ocular allergies, and protein drug delivery. The company also has a research agreement with Alcon on a sustained release program. Additional information on the company may be found at www.ohrpharmaceutical.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and Ohr Pharmaceutical undertakes no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the future success of our scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory and competitive developments, the financial resources available to us, and general economic conditions. Shareholders and prospective investors are cautioned that no assurance of the efficacy of pharmaceutical products can be claimed or assured until final testing; and no assurance or warranty can be made that the FDA will approve final testing or marketing of any pharmaceutical product. Ohr’s most recent Annual Report and subsequent Quarterly Report discuss some of the important risk factors that may affect our business, results of operations and financial condition. We disclaim any intent to revise or update publicly any forward-looking statements for any reason.
Lucentis is a registered trademark of Genentech, Inc.
CONTACT: Ohr Pharmaceutical Inc.
Investor Relations
888-388-2327
ir@ohrpharmaceutical.com
LifeSci Advisors, LLC
Michael Wood
646-597-6983
mwood@lifesciadvisors.com
(ONCY) FDA Orphan Drug Designation for Cancer of the Fallopian Tube
CALGARY, March 2, 2015 – Oncolytics Biotech® Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY), a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN®, for the treatment of cancer of the fallopian tube. The designation was granted on the basis of the Company’s December 2014 application for an Orphan Drug Designation encompassing ovarian, fallopian tube and primary peritoneal cancers which are generally treated as one indication. On February 11, 2015, the Company announced that it had received Orphan Drug Designation for ovarian cancer.
“The FDA’s recognition of ovarian and fallopian tube cancers as distinctly separate indications paves the way for a more targeted approach to the treatment of gynecological cancers,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We are pleased to have secured our third Orphan Drug Designation in the United States and look forward to continuing our development and commercialization program for REOLYSIN®.”
Oncolytics has supported two sponsored clinical studies assessing REOLYSIN® in the treatment of cancers of the fallopian tube. The first was a Phase 1/2 clinical trial (OSU-07022) for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous and intraperitoneal administration of REOLYSIN® that provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells. The second is an ongoing randomized Phase II trial (GOG186H) of weekly paclitaxel versus weekly paclitaxel with REOLYSIN® in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. The second trial completed enrollment in September 2014.
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval. For more information, please visit: http://www.fda.gov/forindustry/DevelopingProductsforrareDiseasesConditions/default.htm.
About Fallopian Tube Cancer
The incidence rate of fallopian tube cancers is estimated to be 0.37 per 100,000 women. Approximately 15,750 patients are affected with fallopian tube cancer at any time in the United States. The median survival of women in the U.S. with fallopian tube cancers is 58 months, or just under five years.
About Oncolytics Biotech® Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of later-stage, randomized human trials in various indications using REOLYSIN®, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements within the meaning of the U.S. Securities Act of 1933, as amended, and U.S. Securities Exchange Act of 1934, as amended, and forward-looking information within the meaning of Canadian securities laws. Statements, other than statements of historical facts, included in this press release that address activities, events or developments that Oncolytics expects or anticipates will or may occur in the future, including such things as, the Company’s expectations related to the granting of Orphan Drug Designation for REOLYSIN®, the Company’s belief as to the potential of REOLYSIN® as a cancer therapeutic, and other such matters are forward-looking statements and forward-looking information and involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements and forward-looking information. Such risks and uncertainties include, among others, risks related to the statistical sufficiency of patient enrollment numbers in separate patient groups, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the tolerability of REOLYSIN® outside a controlled test, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals and uncertainties related to the regulatory process. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements and forward-looking information. Investors are cautioned against placing undue reliance on forward-looking statements and forward-looking information. The Company does not undertake to update these forward-looking statements and forward-looking information, except as required by applicable laws.
(ROVI) Announces Pricing of $300 Million in Convertible Senior Notes
Rovi Corporation (NASDAQ:ROVI) announced today the pricing of $300 million principal amount of 0.500% Convertible Senior Notes due 2020 (the “Notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). In addition, Rovi has also granted the initial purchasers for the offering an option to purchase up to an additional $45 million principal amount of Notes from Rovi solely to cover over-allotments. The sale of the Notes is expected to close on March 4, 2015, subject to customary closing conditions.
The Notes will be general unsecured obligations of Rovi, and interest will be payable semi-annually in arrears on March 1 and September 1 of each year, beginning on September 1, 2015, at a rate of 0.500% per year. The Notes will mature on March 1, 2020, unless earlier repurchased or converted in accordance with their terms. The initial conversion rate will be 34.5968 shares of Rovi’s common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $28.90 per share of Rovi’s common stock). The initial conversion price represents a premium of approximately 26% to the $22.94 per share closing price of Rovi’s common stock on The NASDAQ Global Select Market on February 26, 2015. Prior to the close of business on the business day immediately preceding December 1, 2019, the Notes will be convertible at the option of the holders only upon the satisfaction of certain conditions. Thereafter, the Notes will be convertible at the option of the holders at any time until the close of business on the second scheduled trading day immediately preceding maturity on March 1, 2020. The Notes will be convertible into cash up to the aggregate principal amount of the Notes to be converted and shares of Rovi’s common stock in respect of the remainder, if any, of Rovi’s conversion obligation in excess of the aggregate principal amount of the Notes being converted.
In connection with the pricing of the Notes, Rovi has entered into privately negotiated convertible note hedge transactions with one or more affiliates of certain of the initial purchasers (the “Option Counterparties”). The convertible note hedge transactions are expected generally to reduce the potential dilution to Rovi’s common stock upon any conversion of Notes. Rovi has also entered into privately negotiated warrant transactions with the Option Counterparties. The strike price for the warrant transactions will initially be $40.1450 per share, which represents a 75% premium to the closing sale price of Rovi’s common stock on The NASDAQ Global Select Market on February 26, 2015. The warrant transactions will separately have a dilutive effect to the extent that the market price per share of Rovi’s common stock exceeds the applicable strike price of the warrants. If the initial purchasers exercise their option to purchase additional Notes, Rovi expects to enter into additional convertible note hedge transactions and additional warrant transactions with the Option Counterparties.
Rovi expects that in connection with establishing their initial hedge of the convertible note hedge transactions and warrant transactions, the Option Counterparties or their respective affiliates will enter into various derivative transactions with respect to Rovi’s common stock and/or purchase Rovi’s common stock prior to, concurrently with or shortly after the pricing of the Notes. This activity could increase (or reduce the size of any decrease in) the market price of Rovi’s common stock or the Notes at that time, and could result in a higher effective conversion price for the Notes.
In addition, Rovi expects that the Option Counterparties or their respective affiliates will modify their hedge positions by entering into or unwinding various derivatives with respect to Rovi’s common stock and/or by purchasing or selling Rovi’s common stock or other securities of Rovi in secondary market transactions following the pricing of the Notes and prior to the maturity of the Notes (and are likely to do so during any observation period relating to a conversion of the Notes or in connection with any repurchase of Notes by Rovi). This activity could also cause or avoid an increase or a decrease in the market price of Rovi’s common stock or the Notes, which could affect the ability of noteholders to convert the Notes and, to the extent the activity occurs during any observation period related to a conversion of the Notes, it could affect the amount of cash and number of shares, if any, that noteholders will receive upon conversion of the Notes.
Rovi estimates that the proceeds from this offering will be approximately $291.3 million, or $335.2 million if the initial purchasers exercise their over-allotment option in full, after deducting initial purchasers’ discounts and estimated offering expenses.
Rovi intends to use a portion of the net proceeds from the offering to pay the cost of the convertible note hedge transactions described above (after such cost is partially offset by the proceeds to Rovi from the warrant transactions described above). Rovi expects to use approximately $100.1 million of the net proceeds from the offering to repay certain borrowings and accrued interest under its revolving credit facility, which were incurred to finance in part the repurchase on February 20, 2015 of approximately $287.4 million principal amount of its 2.625% Convertible Senior Notes due 2040. In addition, Rovi expects to use approximately $25.0 million of the net proceeds from the offering to repurchase shares of its common stock in privately negotiated transactions effected through Morgan Stanley & Co. LLC or one of its affiliates as Rovi’s agent. Rovi expects to repurchase such shares from purchasers of the Notes in the offering at a purchase price per share equal to $22.94 per share, the closing price of Rovi’s common stock on The NASDAQ Global Select Market on February 26, 2015. Rovi intends to use the remainder of the net proceeds from the offering for general corporate purposes.
Rovi has agreed not to sell or issue other equity securities during the 60-day period beginning February 26, 2015, subject to certain exceptions, including an exception that Rovi may issue up to $125.0 million aggregate principal amount of additional convertible notes during the lock-up period to a commercial customer. Any such additional notes would contain substantially the same terms as the Notes, with the net proceeds from any such issuance to be applied to reduce outstanding indebtedness and pay the cost of any additional convertible note hedge transactions Rovi may enter into in connection with such additional notes. Rovi has not entered into any agreement to issue any such additional notes, and there can be no assurance that Rovi will issue any such additional notes.
Morgan Stanley, J.P. Morgan and BofA Merrill Lynch are acting as book-running managers for the offering, and Barclays is acting as a co-manager for the offering.
The Notes, the convertible note hedge transactions, the warrants and any shares of Rovi’s common stock underlying these securities (including any shares of Rovi’s common stock issuable upon conversion of the Notes) have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States without registration or an applicable exemption from registration requirements.
This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall 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 the registration or qualification under the securities laws of any such state or jurisdiction.
Forward-Looking Statements
This press release contains forward-looking statements including, among other things, statements relating to the expected closing of the offering and the expected use of proceeds from the offering. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially, including, but not limited to, whether or not Rovi will consummate the offering, the expected use of the proceeds of the offering and the impact of general economic, industry or political conditions in the United States or internationally as well as other risks and uncertainties described in Rovi’s filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2014. Rovi assumes no obligation to update any such forward-looking statements after the date of this release.
About Rovi Corporation
Rovi is leading the way to a more personalized entertainment experience. Rovi’s pioneering guides, data and recommendations continue to drive program search and navigation on millions of devices across the globe. With a new generation of cloud-based discovery capabilities and emerging solutions for interactive advertising and audience analytics, Rovi is enabling premier brands worldwide to increase their reach, drive consumer satisfaction and create a better entertainment experience across multiple screens. Rovi holds over 5,000 issued or pending patents worldwide and is headquartered in Santa Clara, California.
Rovi Corporation
Peter Halt, +1 818-295-6800
Peter Ausnit, +1 818-565-5200
(NATH) Announces Proposed Offering of Senior Secured Notes due 2020
JERICHO, N.Y., Feb. 27, 2015 — Nathan’s Famous, Inc. (NASDAQ: NATH) (“Nathan’s”) announced today that it intends to offer, subject to market and other conditions, $125.0 million aggregate principal amount of Senior Secured Notes due 2020 (the “Notes”) in a private offering. The Notes are being offered only to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”) and outside the United States in reliance on Regulation S under the Securities Act. The interest rate and other terms of the Notes will be determined based on prevailing market conditions.
Nathan’s intends to use the net proceeds of the Notes offering to pay a special dividend of up to approximately $116.0 million to Nathan’s stockholders of record and the remaining net proceeds for general corporate purposes, including working capital. If the Notes offering is consummated, the Nathan’s board of directors will set the record date and the payment date of the dividend following closing.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the Notes, nor shall there be any sale of the Notes in any state or jurisdiction in which such offer, solicitation or sale would be unlawful. Any offers of the Notes will be made only by means of a private offering memorandum. The Notes have not been registered under the Securities Act or the securities laws of any state or other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements under the Securities Act and applicable state securities laws.
About Nathan’s Famous, Inc.
Nathan’s is a Russell 2000 Company that currently distributes its products in 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, the Cayman Islands and ten foreign countries through its restaurant system, foodservice sales programs and product licensing activities. Last year, over 480 million Nathan’s Famous hot dogs were sold. Nathan’s was ranked #22 on the Forbes 2014 list of the Best Small Companies in America and was listed as the Best Small Company in New York State in October 2013. For additional information about Nathan’s please visit our website at www.nathansfamous.com. The contents of our website have not been incorporated into and do not form a part of this press release.
Forward-Looking Statements
Except for historical information contained in this news release, the matters discussed are forward looking statements that involve risks and uncertainties. Words such as “anticipate”, “believe”, “estimate”, “expect”, “intend”, and similar expressions identify forward-looking statements, which are based on the current belief of Nathan’s management, as well as assumptions made by and information currently available to Nathan’s management. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, statements regarding Nathan’s ability to complete the offer of the Notes and other risks and factors identified from time to time in Nathan’s filings with the SEC. You are cautioned not to place undue reliance on any forward-looking statements contained in this press release. Nathan’s does not undertake any obligation to update such forward-looking statements.
Contact information:
Investors: Ronald DeVos, Chief Financial Officer, (516) 338-8500
(UPLD) to Present at the 27th Annual ROTH Conference
AUSTIN, Texas, Feb. 27, 2015 — Upland Software, Inc. (Nasdaq: UPLD), a leader in cloud-based Enterprise Work Management applications, today announced that Jack McDonald, Upland’s Chairman and CEO, is scheduled to present at the 27th Annual ROTH Conference on Tuesday, March 10th at 8:30 a.m. Pacific Time. The conference is being held at The Ritz-Carlton Laguna Niguel in Dana Point, California.
The presentation will be webcast live and accessible on Upland’s website at investor.uplandsoftware.com. In addition to the live webcast, a recorded replay will be available on Upland’s website for 30 days following the event.
About Upland Software
Upland (Nasdaq: UPLD) is a leading provider of cloud-based Enterprise Work Management software. Our family of applications connects people through technology, automates the flow of work and brings visibility to all aspects of the organization. With more than 1,200 enterprise customers around the globe, and over 200,000 users, Upland helps teams in IT, marketing, finance, professional services and process excellence run their operations smoothly, adapt to change quickly and achieve better results every day. To learn more, visit www.uplandsoftware.com.
(LPCN) Announces Presentation of LPCN 1021 Clinical Data at ENDO 2015
SALT LAKE CITY, Feb. 27, 2015 — Lipocine Inc. (Nasdaq:LPCN), a specialty pharmaceutical company, today announced that data from its ongoing Study of Oral Androgen Replacement (“SOAR”) pivotal Phase 3 clinical study (http://clinicaltrials.gov/show/NCT02081300) evaluating efficacy and safety of LPCN 1021, an Oral Testosterone product, in hypogonadal men with low testosterone (“Low T”) will be presented at ENDO 2015 in San Diego, CA. As previously announced, overall, the study demonstrated positive results with respect to the trial’s primary efficacy endpoint with no drug related serious adverse events to date.
Presentation details are as follows:
| Session: | Testosterone Replacement Therapy: Risks and Benefits |
| Title: | Efficacy and Pharmacokinetics of LPCN 1021, a Novel Oral Testosterone Replacement |
| Therapy (TRT) in Hypogonadal Men: Study of Androgen Replacement (SOAR) | |
| Date/Time: | Saturday, March 7, 2015, 11:30 am – 1:00 pm PT |
| Oral Session Number: | OR34-5 |
| Presenter: | Christina Wang, MD |
| Associate Director | |
| UCLA Clinical and Translational Science Institute | |
| Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute | |
| Professor of Medicine | |
| David Geffen School of Medicine at UCLA |
About LPCN 1021
The current testosterone market is dominated by topical products that are associated with poor patient compliance and FDA “black box” warnings related to inadvertent transfer of testosterone. LPCN 1021 is a twice-a-day, oral product candidate with three simple oral dosing options that we expect will overcome the major shortcomings of existing products.
About Lipocine
Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. Lipocine’s lead product candidate, LPCN 1021, demonstrated positive top-line efficacy results in Phase 3 testing and is targeted for testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy product with once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth, and is currently in Phase 1 testing.
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 and include statements that are not historical facts relating to expectations regarding clinical trials, the potential uses and benefits of Lipocine’s product candidates, and product development and commercialization efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks related to our products, expected product benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, the receipt of regulatory approvals, the results of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the Company’s website at www.lipocine.com or on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.
CONTACT: Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
Email: mb@lipocine.com
John Woolford
Phone: (443) 213-0500
john.woolford@westwicke.com
(CVM) Key Milestone with Clearance to Conduct Phase III Trial in 21 Countries
CEL-SCI Corporation (NYSE MKT: CVM) today announced the Ministry of Health of the Republic of Belarus has cleared the Company to commence patient enrollment for its Phase III head and neck cancer trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Belarus is the 21th country to approve CEL-SCI’s Phase III trial.
“This means that CEL-SCI has now reached a key milestone in this pivotal Phase III clinical trial, receiving clearance in the planned 20 countries in addition to the United States. Well over 10 countries have been added to the study since we dismissed the prior clinical research organization (CRO). With the very large increase in enrollment in the study under the new CRO, we now also see strong interest from doctors and clinical centers in other countries too. Therefore, we are working on further expanding this global trial beyond the 21 countries in which we are already cleared to conduct the study. We expect that expanding the geography of the trial will yet further accelerate patient recruitment,” stated CEL-SCI Chief Executive Officer Geert Kersten.
About Multikine Phase III Study
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.
About Multikine
Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI’s clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body’s natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015.
In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. The Phase I trial started enrolling patients in September 2014. CEL-SCI also entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in HIV/HPV co-infected women and for peri-anal warts in HIV/HPV co-infected men and women.
About CEL-SCI Corporation
CEL-SCI’s work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. CEL-SCI believes that the best way may be to activate the immune system of patients before they have received surgery, radiation and/or chemotherapy. Its lead investigational therapy Multikine (Leukocyte Interleukin, Injection) is currently being studied in a pivotal Phase III clinical trial against head and neck cancer. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA.
CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. CEL-SCI received a Phase I SBIR Grant from the National Institutes of Health to develop LEAPS as a potential treatment for rheumatoid arthritis with researchers from Rush University Medical Center in Chicago, Illinois. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
When used in this report, the words “intends,” “believes,” “anticipated”, “plans” and “expects” and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company’s potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation’s SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 2014. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
CEL-SCI Corporation
Gavin de Windt, 703-506-9460
(AVEO) Conference Call Final Results P2 Biomarker Analysis Of Tivozanib In Colorectal Cancer
AVEO Oncology (NASDAQ:AVEO) today announced that management will host a conference call and webcast on Friday, March 6, 2015, at 8:00 a.m. Eastern Time to discuss the presentation of final results and a predefined biomarker analysis of its BATON-CRC study, a randomized Phase 2 clinical trial of modified FOLFOX6 combined with tivozanib or bevacizumab in metastatic colorectal cancer. The presentation, titled “Neuropilin-1 as a potential biomarker of progression-free survival benefit for tivozanib + mFOLFOX6 versus bevacizumab + mFOLFOX6 in metastatic colorectal cancer: post-hoc biomarker analysis of BATON-CRC Phase 2 trial,” will be presented in a poster session on March 6 at the American Association for Cancer Research (AACR) Tumor Angiogenesis and Vascular Normalization Conference in Orlando, FL.
The call can be accessed by dialing 1-877-280-4954 (domestic) or 1-857-244-7311 (international) five minutes prior to the start of the call and providing the passcode 38640881. A replay of the call will be available two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), providing the passcode 54500453. The replay will be available for two weeks from the date of the live call.
The live webcast of the conference call can be accessed by visiting the investors section of the AVEO website at www.aveooncology.com. A replay of the webcast will be archived on the AVEO website for two weeks following the call.
A copy of the poster presentation will be made available on AVEO’s website at www.aveooncology.com.
About AVEO
AVEO Oncology (NASDAQ:AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO’s proprietary Human Response Platform™ has delivered unique insights into cancer and related disease biology that are being leveraged in the clinical development strategy of its therapeutic candidates. For more information, please visit the company’s website at www.aveooncology.com.
Company, Media and Investor Contact:
Argot Partners
David Pitts, 212-600-1902
aveo@argotpartners.com
(SPLK) Introduces Pricing for Enterprise-wide Deployments
New License Model Accelerates Adoption and Value of Splunk Enterprise Across the Organization
Splunk Inc. (NASDAQ:SPLK), provider of the leading software platform for real-time Operational Intelligence, today announced that customers of any size can now purchase unlimited licenses of Splunk® Enterprise and benefit from fixed, predictable costs as they expand their use of Splunk software. By offering unlimited enterprise adoption agreements (EAAs), Splunk is providing customers with an additional, new licensing option that is independent of data volumes and use cases, providing pricing predictability as organizations drive broad-based adoption across all of their machine data use cases. Unlimited EAAs increase the value organizations can gain from Splunk software by collecting, analyzing and acting on machine data generated across a wide variety of use cases – without license limits on the amount of data they are ingesting.
“Our customer base is experiencing explosive data growth and needs Splunk to help them tap into the value of all of their machine data,” said Godfrey Sullivan, Chairman and CEO, Splunk. “Splunk has always embraced simple pricing to help fuel our customers’ success, and we have been focused on continually driving down the cost of collecting, indexing and analyzing data in Splunk software. This new licensing model further removes barriers and encourages organizations to gain insights from all of their machine-generated big data by standardizing on Splunk Enterprise.”
An unlimited EAA enables organizations to deliver the most value from their machine data by utilizing Splunk Enterprise as a platform for machine data for the entire business and across diverse, high-value use cases such as IT operations, application delivery, security, business analytics and the Internet of Things. The unlimited EAAs also include support, education and professional services to help customers realize the maximum value from their Splunk investment. The unlimited EAA is Splunk’s latest move to make it easier for organizations to take advantage of their machine data. Last year, Splunk doubled license capacity at entry levels of Splunk Enterprise and also reduced the cost of Splunk Cloud by 33 percent.
Contact Splunk Sales to inquire about an unlimited EAA, or visit the pricing page on the Splunk website for other pricing options. Splunk does not charge for data sources, data types, number of users, number of searches or alerts, total data stored or other charges often added on to software licenses.
About Splunk Inc.
Splunk Inc. (NASDAQ:SPLK) provides the leading software platform for real-time Operational Intelligence. Splunk® software and cloud services enable organizations to search, monitor, analyze and visualize machine-generated big data coming from websites, applications, servers, networks, sensors and mobile devices. More than 8,400 enterprises, government agencies, universities and service providers in more than 100 countries use Splunk software to deepen business and customer understanding, mitigate cybersecurity risk, prevent fraud, improve service performance and reduce cost. Splunk products include Splunk® Enterprise, Splunk Cloud™, Hunk®, Splunk MINT Express™ and premium Splunk Apps. To learn more, please visit http://www.splunk.com/company.
Social Media: Twitter | LinkedIn | YouTube | Facebook
Splunk, Splunk>, Listen to Your Data, The Engine for Machine Data, Hunk, Splunk Cloud, Splunk Storm, SPL, Splunk MINT Express and Splunk MINT Enterprise are trademarks and registered trademarks of Splunk Inc. in the United States and other countries. All other brand names, product names, or trademarks belong to their respective owners. © 2015 Splunk Inc. All rights reserved.
Splunk Inc.
Tom Stilwell, 415-852-5561
tstilwell@splunk.com
Investor Contact
Ken Tinsley, 415-848-8476
ktinsley@splunk.com
(CYBX) & Sorin Group To Merge, Creating Premier Global Medical Technology Company
Diverse product portfolio and scale across geographies to drive shareholder value Focused innovation platform to exploit market opportunities and accelerate product development in heart failure, sleep apnea and percutaneous mitral valve to improve patient outcomes All-stock transaction resulting in pro forma combined equity value of $2.7 billion Transaction expected to enhance revenue growth, drive cash flow generation and be accretive to cash EPS for all shareholders from 2016
MILAN and HOUSTON, Feb. 26, 2015 — Sorin S.p.A. (“Sorin”), (MTA; Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, and Cyberonics Inc. (NASDAQ: CYBX), a medical device company with core expertise in neuromodulation, today announced their merger plan to create a new global leader in medical technologies with a combined equity value of approximately $2.7 billion (€2.4 billion1) based on the closing price of Sorin and Cyberonics shares on 25 February.
The proposed transaction has been unanimously approved by the boards of directors of both companies. Under the terms of the transaction, Sorin and Cyberonics will combine under a newly formed holding company, “NewCo”, which the parties will name prior to closing. Each Cyberonics stockholder will receive one ordinary share of NewCo for every share of Cyberonics owned. Each Sorin shareholder will receive a fixed ratio of 0.0472 ordinary shares of NewCo for every Sorin share owned. Following completion of the transaction, assuming no withdrawal rights under Italian law are exercised by Sorin shareholders with respect to the merger, Sorin shareholders will own approximately 46 percent of NewCo, and Cyberonics shareholders will own approximately 54 percent, on a fully diluted basis.
The proposed transaction will bring together global leaders in cardiac surgery and neuromodulation, and the combined company will also be a major player in cardiac rhythm management, especially in Europe and Japan. NewCo will have several promising opportunities focused on multi-billion dollar markets, including complementary research programs addressing heart failure, with an initial commercial launch in Europe anticipated in the coming weeks. Both companies bring minority equity investments that are complementary in different forms of sleep apnea. Sorin, in addition, has opportunities that address mitral valve regurgitation.
Andre-Michel Ballester, Chief Executive Officer of Sorin, will serve as Chief Executive Officer of NewCo and Dan Moore, Chief Executive Officer of Cyberonics, will become non-executive Chairman.
Commenting on the announcement, Andre-Michel Ballester said:
“I am delighted to announce this transformational merger between Sorin and Cyberonics, which we expect to create significant value for shareholders. As one company we will be able to leverage our combined strengths, capture new opportunities and create new solutions to benefit patients and healthcare professionals alike. This is particularly exciting for our employees, who will be able to share technical expertise and innovate faster, ensuring that we serve our customers by remaining at the forefront of new product development which continues to be the foundation of our success.”
Dan Moore said:
“This transformational transaction maximizes both companies’ strengths and leadership positions for the benefit of patients and our shareholders. Sorin is an ideal partner, given its heart failure programs and the ability to combine Vagus Nerve Stimulation with cardiac rhythm management technology. Sorin’s well-established international operations are expected to accelerate our epilepsy growth strategy by enabling us to reach a larger number of potential new patients in the underpenetrated markets outside the U.S. while integrating Sorin’s technology expertise into future neuromodulation products. While each company has a strong track record of execution on its own, the geographic diversification, benefits of scale and strong financial profile of the combined company will create tremendous new opportunities to drive growth and build significant shareholder value.”
Strategic rationale
The proposed transaction will create a global leader in the large and growing markets for cardiac surgery and neuromodulation and a leading innovator in cardiac rhythm management with a diversified product portfolio, leveraging product technologies and complementary marketing capabilities. The potential combination of product development, clinical and regulatory expertise will accelerate time to market across worldwide geographies and will leverage the combined group’s extensive relationships with healthcare professionals globally, as well as patient education and awareness initiatives.
In particular NewCo will have several exciting opportunities focused on three multi-billion dollar product categories: heart failure, sleep apnea and percutaneous mitral valve. In heart failure, NewCo will have promising products with European market entry starting as early as 2015. Cyberonics recently received CE Mark approval of its VITARIA™ device delivering autonomic regulation therapy for the treatment of chronic heart failure and will commence a limited market launch in Europe in the coming weeks. Recently, Sorin announced the first successful implants of its Equilia™ Vagus Nerve Stimulation system for heart failure patients. NewCo is expected to benefit from the developing market for active implantable treatments for sleep apnea with investments aimed at the under-addressed obstructive sleep apnea (OSA) market, and also in central sleep apnea (CSA), recently launched in selected European countries. In addition, NewCo is expected to have new percutaneous mitral valve replacement/repair products with estimated initial market entry in 2017.
Financial highlights
The combined company will have pro-forma revenues of approximately $1.3 billion2, and the merger is expected to drive significant cash flow generation. The proposed transaction is expected to be cash EPS3 accretive to all shareholders from 2016.
The merger presents the opportunity to achieve significant revenue and cost synergies. Approximately $80 million of annual pre-tax synergies are expected to be delivered by the end of calendar year 2018 as the combined company leverages an efficient corporate structure and a global operational platform with the commercial, regulatory, supply chain, R&D and manufacturing capabilities to drive growth and efficiencies.
NewCo’s strong cash flow generation and robust balance sheet with essentially no net debt will enable investment in new medical technology solutions for patients and customers and provide the ability to fund future growth opportunities. NewCo will have a sound financial profile with a larger market capitalization and the opportunity to attract a wider, global investor base.
Cyberonics and Sorin currently have different fiscal year ends and report under different accounting standards and currencies. After the closing of the transaction, NewCo is expected to report on a calendar year basis, with reporting in US$ and on US Generally Accepted Accounting Principles (GAAP).
Governance and organizational structure
Upon closing of the transaction, the Board of Directors of NewCo will be equally balanced between Sorin and Cyberonics, with four directors designated by Sorin and four by Cyberonics. One additional Board member will be jointly selected.
NewCo will operate as three business units: Cardiac Surgery, Cardiac Rhythm Management and Neuromodulation, with operating headquarters in Mirandola (Italy), Clamart (France) and Houston (U.S.) respectively. The combined company will have a strategic presence in over 100 countries on five continents around the world with approximately 4,500 employees.
Additional transaction details
Under the terms of the proposed transaction, Cyberonics and Sorin will combine under NewCo, which will be domiciled in the UK and will apply for dual-listing on NASDAQ and the London Stock Exchange (LSE). The all-stock transaction will be implemented through two mergers, which will occur in immediate succession: first, Sorin will be merged with and into NewCo by means of an EU cross-border merger, with NewCo as the surviving company in the merger, and immediately thereafter, a wholly owned subsidiary of NewCo will be merged with and into Cyberonics, with Cyberonics surviving the merger as a wholly owned subsidiary of NewCo. At the closing of the transaction, Cyberonics shares will cease trading on NASDAQ and Sorin shares will cease trading on the Borsa Italiana (MTA).
For Sorin shareholders, the exchange ratio implies a per share valuation of Sorin that represents approximately 14.2 percent premium to Sorin’s closing share price on 25 February, 2015, the last trading day prior to the parties announcing the agreement.
The merger will trigger the withdrawal right, which can be exercised by any Sorin shareholder who does not attend the shareholders’ meeting called to approve the merger of Sorin into Newco, or abstains or votes against the merger. There is no cap linked to the exercise of withdrawal rights.
The transaction is currently expected to be completed by the end of the third calendar quarter of 2015 and is subject to approval by both Sorin and Cyberonics’ shareholders, the receipt of required antitrust and regulatory clearances, and other customary closing conditions. Where required by local law, including in France, Sorin will initiate a consultation on the proposed transaction with its relevant works councils, trade unions and other employee organizations. Once the works council consultation process in France is completed, the parties anticipate entering into a definitive agreement.
Mittel S.p.A. and Equinox Two S.C.A., which control Bios S.p.A. and Tower 6 Bis S.a.r.l., holding in total 25.6 percent of Sorin’s outstanding shares, have entered into a support agreement with Cyberonics pursuant to which they have agreed to vote in favor of the transaction and not to sell their shares until the closing of the transaction. Mittel S.p.A. and Equinox Two S.c.a. are expected to hold approximately 11.5 percent of NewCo’s ordinary shares following the closing of the proposed transaction. In addition, the Chairman and CEO of each of Sorin and Cyberonics have also entered into support agreements in favor of the proposed transaction.
The above undertakings will be disclosed to the public pursuant to article 122 of Legislative Decree no. 58 of 24 February, 1998 and its implementing regulations.
In connection with this transaction, Rothschild is serving as financial advisor to Sorin, and Latham & Watkins is serving as its primary legal advisor. Piper Jaffray is serving as financial advisor to Cyberonics, and Sullivan & Cromwell is serving as its legal advisor, with Legance advising Cyberonics on Italian law matters.
Investor Call
Sorin and Cyberonics will hold a joint investor conference call to discuss the combination today at 2:00PM Central European Time, 7:00AM U.S. Central Time, 8:00AM U.S. Eastern Time. To access the call, please use one of the following dial-in numbers: 877-638-4557 (toll-free U.S. and Canada), and 001-914-495-8522 (International), and enter the Conference ID number 61678386.
Prior to the conference call, an Investor Presentation will be available on the Investor Relations sections of Sorin’s and Cyberonics’ websites and on the authorized storage mechanism 1Info (www.1Info.it). A telephone replay of the call will be available within 24 hours on each company’s Investor Relations sections.
About Sorin Group
Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With approximately 3,900 employees worldwide, the Company focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment). Every year, over one million patients are treated with Sorin Group devices in more than 100 countries.
About Cyberonics
Cyberonics Inc., (NASDAQ: CYBX) is a medical device company with core expertise in neuromodulation. The company developed and markets the Vagus Nerve Stimulation (VNS) Therapy system, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy system uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy system in selected markets worldwide. Cyberonics also has CE Mark for VITARIA™, providing autonomic regulation therapy for chronic heart failure.
Important Information for Investors and Shareholders
This press release is for informational purposes only and is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote in any jurisdiction pursuant to the proposed transactions or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and applicable European regulations. Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, the public offer will not be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction. This press release does not represent an investment solicitation in Italy, pursuant to Section 1, letter (t) of Legislative Decree no. 58 of February 24, 1998, as amended.
NewCo will file with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4, which will include a proxy statement of Cyberonics that also constitutes a prospectus of NewCo (the “proxy statement/prospectus”). INVESTORS AND SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT SORIN GROUP, CYBERONICS, NEWCO, THE PROPOSED TRANSACTIONS AND RELATED MATTERS.
Investors and shareholders will be able to obtain free copies of the proxy statement/prospectus and other documents filed with the SEC by the parties through the website maintained by the SEC at www.sec.gov. In addition, investors and shareholders will be able to obtain free copies of the proxy statement/prospectus and other documents filed with the SEC on Cyberonics’s website at www.cyberonics.com or within the “Investor Relations” section or by contacting Cyberonics’s Investor Relations (for documents filed with the SEC by Cyberonics) or on Sorin Group’s website at www.sorin.com (for documents filed with the SEC by NewCo).
The release, publication or distribution of this press release in certain jurisdictions may be restricted by law, and therefore persons in such jurisdictions into which this press release is released, published or distributed should inform themselves about and observe such restrictions.
Italian CONSOB Regulation No. 11971 of May 14, 1999
Prior to the meeting of Sorin Group shareholders, Sorin will voluntarily make available an information document pursuant to Article 70, paragraph 6, of the CONSOB Regulation on Issuers (CONSOB Regulation no. 11971 of May 14, 1999, as amended), in accordance with applicable terms.
Italian CONSOB Regulation No. 17221 of March 10, 2010
Pursuant to Article 6 of the CONSOB Regulation no. 17221 of March 12, 2010 (as amended, the “CONSOB Regulation”), NewCo is a related party of Sorin, being a wholly owned subsidiary of Sorin Group. The merger agreement providing for the terms and conditions of the transaction, which exceeds the thresholds for “significant transactions” pursuant to the Regulation, was approved unanimously by the board of directors of Sorin Group. The merger of Sorin into NewCo is subject to the exemption set forth in Article 14 of the CONSOB Regulation and Article 13.1.(v) of the “Procedura per operazioni con parti correlate” (“Procedures for transactions with related parties”) adopted by Sorin on October 26, 2010 and published on its website (www.sorin.com). Pursuant to this exemption, Sorin will not publish an information document (documento informativo) for related party transactions as provided by Article 5 of the CONSOB Regulation. Prior to the meeting of Sorin shareholders, Sorin will make available an information document pursuant to Article 70, Pararaph 6, of the CONSOB Regulation on Issuers (CONSOB Regulation no. 11971 of May 24, 1999, as amended), in accordance with applicable terms.
Participants in the Distribution
Sorin, Cyberonics and NewCo and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Cyberonics with respect to the proposed transactions contemplated by the proxy statement/prospectus. Information regarding the persons who are, under the rules of the SEC, participants in the solicitation of proxies from the shareholders of Cyberonics in connection with the proposed transactions, including a description of their direct or indirect interests, on account of security holdings or otherwise, will be set forth in the proxy statement/prospectus when it is filed with the SEC. Information regarding Cyberonics’ directors and executive officers is contained in Cyberonics’s Annual Report on Form 10-K for the year ended on April 25, 2014 and its Proxy Statement on Schedule 14A, dated July 30, 2014, which are filed with the SEC and can be obtained free of charge from the sources indicated above.
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”)) concerning Cyberonics, Sorin Group, NewCo, the proposed transactions and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise. They are based on current beliefs of the management of Cyberonics and Sorin Group as well as assumptions made by, and information currently available to, such management, and therefore, you are cautioned not to place undue reliance on them. These forward-looking statements are subject to various risks and uncertainties, many of which are outside the parties’ control. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. None of Cyberonics, Sorin Group or NewCo undertake any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Forward-looking statements are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about the business and future financial results of the medical device industry, and other legal, regulatory and economic developments. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe harbor provisions of the PSLRA. Factors that could cause actual results to differ materially from those in the forward-looking statements include the failure to obtain applicable regulatory or shareholder approvals in a timely manner or otherwise, or the requirement to accept conditions that could reduce the anticipated benefits of the proposed transactions as a condition to obtaining regulatory approvals; the failure to satisfy other closing conditions to the proposed transactions; the length of time necessary to consummate the proposed transactions, which may be longer than anticipated for various reasons; risks that the new businesses will not be integrated successfully or that the combined companies will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected; the inability of Cyberonics and Sorin Group to meet expectations regarding the timing, completion and accounting and tax treatments with respect to the proposed transactions; risks relating to unanticipated costs of integration, including operating costs, customer loss or business disruption being greater than expected; reductions in customer spending, a slowdown in customer payments and changes in customer demand for products and services; unanticipated changes relating to competitive factors in the industries in which the companies operate; the ability to hire and retain key personnel; the potential impact of announcement or consummation of the proposed transactions on relationships with third parties, including customers, employees and competitors; the ability to attract new customers and retain existing customers in the manner anticipated; reliance on and integration of information technology systems; changes in legislation or governmental regulations affecting the companies; international, national or local economic, social or political conditions that could adversely affect the companies or their customers; conditions in the credit markets; risks to the industries in which Cyberonics and Sorin Group operate that are described in the “Risk Factors” section of the Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time to time with the SEC by Cyberonics and NewCo and the analogous section from Sorin Group’s annual reports and other documents filed from time to time with the Italian financial market regulator (CONSOB); risks associated with assumptions the parties make in connection with the parties’ critical accounting estimates and legal proceedings; the parties’ international operations, which are subject to the risks of currency fluctuations and foreign exchange controls; and the potential of international unrest, economic downturn or effects of currencies, tax assessments, tax adjustments, anticipated tax rates, raw material costs or availability, benefit or retirement plan costs, or other regulatory compliance costs. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the parties’ businesses, including those described in Cyberonics’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from time to time with the SEC and those described in Sorin Group’s annual reports, registration documents and other documents filed from time to time with CONSOB. Nothing in this press release is intended, or is to be construed, as a profit forecast or to be interpreted to mean that earnings per Sorin share or Cyberonics share for the current or any future financial years or those of the combined group, will necessarily match or exceed the historical published earnings per Sorin share or Cyberonics share, as applicable. Neither Cyberonics nor Sorin gives any assurance (1) that either Cyberonics, Sorin or Newco will achieve its expectations, or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results.
Contacts:
| For Sorin Group | |
| InvestorsDemetrio Mauro
CFO Sorin Group Tel: +39 02 69969 512 e-mail: investor.relations@sorin.com
Media Gabriele Mazzoletti Director, Corporate Communications Sorin Group Tel: +39 02 69 96 97 85 Mobile: +39 348 979 22 01 e-mail: corporate.communications@sorin.com
|
Francesca RambaudiDirector, Investor Relations
Sorin Group Tel: +39 02 69969716 e-mail: investor.relations@sorin.com
|
| Edward SimpkinsFinsbury (London)
Tel: +44 7958 421 519 e-mail: edward.simpkins@finsbury.com
|
Kal GoldbergFinsbury (New York)
Tel: +(1) 646-805-2000 e-mail: Kal.Goldberg@finsbury.com
|
| For Cyberonics Inc: | |
| Investors | Media |
| Greg BrowneChief Financial Officer
Cyberonics, Inc. Tel: +(1) 281-228-7262 e-mail: ir@cyberonics.com |
Andrew Cole/Chris KittredgeSard Verbinnen & Co (New York)
Tel: +(1) 212-687-8080 London: Conrad Harrington Tel: +44 (0)20 3178 8914
|
1 Translated at €/$ exchange rate as of 25 February, 2015.
2 Based on the last four quarters reported ended January 23, 2015 for Cyberonics and preliminary financial results presented by Sorin as of December 31, 2014 at an average exchange rate of €1/$1.33
3 Cash EPS is based on US GAAP, excluding transaction related expenses, purchase accounting and stock based compensation expenses. Calculated on a fully-diluted basis
(MNDO) Reports Record Revenue of $25 Million in 2014, Board Declares Cash Dividend
YOQNEAM, ISRAEL–(February 26, 2015) – MIND C.T.I. LTD. – (NASDAQ: MNDO), a leading provider of convergent end-to-end prepaid/postpaid billing and customer care product based solutions for service providers as well as unified communications analytics and call accounting solutions for enterprises, today announced results for the fourth quarter and year ended December 31, 2014.
The following will summarize our business in the fourth quarter of 2014 and provide a more detailed review of the financial results for the quarter. The financial results can be found in the Investors section www.mindcti.com/investor/PressReleases.asp and in our Form 6-K.
Financial Highlights of Q4 2014
- Revenues of close to $6.5 million, same as the third quarter of 2014, and up 28% from $5.1 million in the fourth quarter of 2013.
- Operating income was $2.5 million, up 15% sequentially from the third quarter of 2014 and compared to $1.0 million in the fourth quarter of 2013.
- Net income of $1.9 million or $0.10 per share, compared to $1.0 million or $0.05 per share in the fourth quarter of 2013.
- One modest win and multiple upgrades.
As of December 31, 2014 we had 352 employees, the same as of December 31, 2013.
Year 2014 Financial Highlights
- Revenues of $25 million, up 35% from $18.5 million in 2013.
- Operating income was $7.5 million, or 29.8% of revenue, compared to $2.2 million, or 11.7% of revenue, in 2013.
- Net income of $5.5 million, or $0.29 per share, compared to $2.2 million or $0.12 per share in 2013.
- Cash flow from operating activities was $3.8 million, compared to $5.2 million in 2013.
- Cash position of approximately $19.3 million as of December 31, 2014.
Monica Iancu, CEO, commented: “We are pleased that in 2014 we succeeded to translate the large deals we signed in 2013 into revenues through successful execution of the implementation of our projects milestones. While in 2014 we reached exceptional revenues and operating margins, some new deals that we expected to close in 2014 were delayed, thus our booking is lower than a year ago.”
Revenue Distribution for Q4 2014
Revenues in the Americas represented 54.5% of total revenues, revenues in Europe represented 34.2% and revenues in Israel represented 6.6% of total revenues.
Revenues from our customer care and billing software totaled $5.5 million, or 85% of total revenues, while revenues from our enterprise call accounting software were $1.0 million, or 15% of total revenues.
Revenues from licenses were $1.2 million, or 18% of total revenues, while revenues from maintenance and additional services were $5.3 million, or 82% of total revenues.
Revenue Distribution for Full Year 2014
Revenues in the Americas represented 57.6%, revenues in Europe represented 28.6% and revenues in Israel represented 9.0% of total revenue.
Revenues from our customer care and billing software totaled $21.0 million, or 84% of total revenues, compared with $14.2 million, or 77% of total revenues in 2013, while revenues from our enterprise call accounting software were $4.0 million, or 16% of total revenue, compared with $4.3 million or 23% of total revenues in 2013.
Revenues from licenses were $5.4 million, or 21.6% of total revenues, compared with $4.6 million, or 25% of total revenues in 2013 while revenues from maintenance and additional services were $19.6 million, or 78.4%, compared with $13.9 million or 75% of total revenues in 2013.
New Wins & Follow-on Orders in Q4 2014
In the fourth quarter we had one modest new win as well as some major upgrades from existing customers, the upgrades mainly for service enhancements and additional functionalities.
The new win is with a leading European global financial services company. PhonEX-ONE has been chosen for its advanced telecom business analysis and cost control management solution for global organizations.
One major upgrade includes enhancement of the MIND system to distinguish between data services (Internet, MMS, VoLTE), and to authorize and rate these differently. MIND will provide different configurable authorization amounts for “capping” the data services that will be offered by this customer.
Dividend Distribution
Since July 2003, when we first adopted a dividend policy, according to which we declare, subject to specific Board approval and applicable law, a dividend distribution once per year, we have distributed 11 yearly dividends with an average of 21 cents per share.
We continue to believe that our annual dividends enhance shareholders value and we plan to continue with yearly distributions.
Taking into consideration our dividend policy and the remaining cash after the distribution, our Board declared on February 26, 2015 a gross dividend of $0.30 per share. The record date for the dividend will be March 12, 2015 and the payment date will be March 26, 2015. Tax will be withheld at a rate of about 24%.
Investing in R&D
In order to maintain a state-of-the-art technology, each year we invest in R&D, sometimes adding new modules, sometimes in order to be compliant with new standards and many times to keep up with the new tools and new platforms that we use to build upon.
In 2014, along with supporting the additional needs defined by our customers, we invested significantly in a massive upgrade of the MINDBill infrastructure that includes technology updates of the entire spectrum, including application infrastructure, application server and database upgrades and improved monitoring.
New Office in Romania
Lately we started to analyze the option to open a new MIND office location in East Europe in order to enlarge and diversify our teams, mainly in the Professional Services department.
We checked the availability of qualified resources and office space in several locations, and we decided that Suceava, Romania is the preferred location. Our second location in Romania started to operate on February 16, 2015.
Monica concluded: “We are pleased as always with the growing recurring revenues and the follow-on orders that reconfirm our customer satisfaction. We operate in a very active market that shows continuous demand for our products and services and we expect that in 2015 we will be able to close new deals and significant follow-on orders. The valuable customer base, well supported by our devoted professional team and the ongoing investment in development of enhanced functionality and state-of-the-art technology are the basis for our expected long-term continuous performance.”
About MIND
MIND CTI Ltd. is a leading provider of convergent end-to-end billing and customer care product based solutions for service providers as well as unified communications analytics and call accounting solutions for enterprises. MIND provides a complete range of billing applications for any business model (license, managed service or complete outsourced billing service) for Wireless, Wireline, Cable, IP Services and Quad-play carriers in more than 40 countries around the world. A global company, with over thirteen years of experience in providing solutions to carriers and enterprises, MIND operates from offices in the United States, Romania and Israel.
Cautionary Statement for Purposes of the “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995: All statements other than historical facts included in the foregoing press release regarding the Company’s business strategy are “forward-looking statements.” These statements are based on management’s beliefs and assumptions and on information currently available to management. Forward-looking statements are not guarantees of future performance, and actual results may materially differ. The forward-looking statements involve risks, uncertainties, and assumptions, including the risks discussed in the Company’s filings with the United States Securities Exchange Commission. The Company does not undertake to update any forward-looking information.
For more information please contact:
Andrea Dray
MIND CTI Ltd.
Tel: +972-4-993-6666
investor@mindcti.com
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