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(MYL) Announces Worldwide Collaboration with (MNTA)
Partnership Builds on Successful Existing Collaboration with Biocon and Positions Mylan as a World Leader in Biosimilars
HERTFORDSHIRE, England and PITTSBURGH, Jan. 8, 2016 — Mylan N.V. (NASDAQ, TASE: MYL) today announced that it has entered into an exclusive global collaboration agreement with Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) to develop, manufacture and commercialize six of Momenta’s current biosimilar candidates, including Momenta’s biosimilar candidate, ORENCIA® (abatacept).
Mylan CEO Heather Bresch commented, “Mylan’s long-stated strategy has been to strategically invest in the long-term drivers of our future growth, both through our strong internal focus on R&D and through external collaboration with industry-leading partners. Biosimilars have long been one of these areas of important future growth, both for our company and our industry, given the rapidly growing market for biologic products, the undeniable patient need for more affordable versions of these life-saving medicines, and the attractive competitive landscape for the companies that are able to successfully bring these complex products at scale to the global market. This collaboration with Momenta, which is highly complementary to our partnership with Biocon, will position us as a definitive world leader in biosimilars, with a broad portfolio of 15 biosimilar/insulin analog generic products in development and the scale required to maximize investment in this area. Looking forward, Mylan will continue to expand and diversify its portfolio into such complex products, further differentiating us from other leading generics companies and establishing us at the forefront of the biologics space, while also ensuring we maintain one of the broadest, highest quality portfolios in our industry.”
“This exciting collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan, leveraging Momenta’s unique technology capabilities and Mylan’s strong science, biosimilar-development experience, operational excellence and expansive global commercial footprint. Importantly, this collaboration builds upon Mylan’s existing successful biologics and insulins collaboration with Biocon, which is focused on more near-term biosimilar opportunities. Through these partnerships, as well as the strong internal capabilities we have cultivated, Mylan is further expanding what is already one of the industry’s most robust and diverse biosimilar portfolios and helping to ensure we can deliver enhanced access to these critical products to patients around the world,” continued Ms. Bresch.
Craig A. Wheeler, president and chief executive officer of Momenta Pharmaceuticals, said, “We are thrilled to welcome Mylan as our new collaboration partner for biosimilars. Our two companies have a common focus on building an industry-leading biosimilar portfolio that offers safe, effective and affordable products to the patients that need them. By combining Momenta’s proven capabilities in complex-product development and Mylan’s world-class global R&D, supply chain and commercial infrastructure, we are well positioned to become a strong competitor in this developing field. Our joint vision is to bring high quality, cost-effective biosimilar products to markets worldwide, and we believe our success will deliver a strong return to our companies’ stakeholders.”
Under the agreement with Momenta, Mylan will make an up-front cash payment of $45 million and up to $200 million in contingent milestone-related payments to Momenta, with each company sharing equally in the costs and profits with respect to the products. The companies will be jointly responsible for product development, and Mylan will lead worldwide commercialization efforts. All other financial terms and product details remain confidential.
Mylan’s collaboration with Momenta builds upon Mylan’s existing biologics and insulin analog partnership with Biocon. The Biocon partnership includes six biosimilar programs (trastuzumab, pegfilgrastim, adalimumab, bevacizumab, etanercept and filgrastim) and three insulin analogs (glargine, lispro and aspart). Five of these biosimilar programs have successfully completed Phase I clinical trials, and four of the programs are in active Phase III testing. Mylan and Biocon plan on submitting three biosimilar applications and one insulin application in the U.S. and Europe in 2016. Mylan already has successfully launched its trastuzumab biosimilar product in India and other emerging markets.
Mylan President Rajiv Malik commented, “Mylan has been fully engaged in the development of biosimilars with our partner Biocon for the last six years. During that time, Mylan has cultivated strong experience and expertise in the development of biosimilar products, and is executing on our programs with the scientific and analytical rigor required to fulfill health-authority expectations. Based upon our proactive and informative interactions with global health authorities on our nine active programs, we are extremely optimistic about the strength of our current development programs with Biocon, and we look forward to deploying our expertise in our collaboration with Momenta.”
Momenta also is providing information regarding the collaboration on its website.
Forward Looking Statement for Mylan
This press release includes statements that constitute “forward-looking statements,” including with regard to statements that biosimilars has long been an area of important future growth, both for Mylan and its industry, given the rapidly growing market for biologic products, the undeniable patient need for more affordable versions of these medicines, and the attractive competitive landscape for the companies that are able to successfully bring these complex products at scale to the global market; that the collaboration with Momenta, which is highly complementary to Mylan’s partnership with Biocon, will position Mylan as a definitive world leader in biosimilars with a broad portfolio of 15 biosimilar/insulin analog generic products in development and the scale required to maximize investment in this area; that Mylan will continue to expand and diversify its portfolio into such complex products, further differentiating it from other leading generics companies and establishing us at the forefront of the biologics space, while also ensuring it maintains one of the broadest, highest quality portfolios in its industry; that the collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan, leveraging Momenta’s unique technology capabilities and Mylan’s strong science, biosimilar development experience, operational excellence and expansive global commercial footprint; that through Mylan’s partnerships, as well as the strong internal capabilities it has cultivated, Mylan is further expanding what is already one of the industry’s most robust and diverse biosimilar portfolios and helping to ensure we can deliver enhanced access to these critical products to patients around the world; that Mylan and Momenta have a common focus on building an industry leading biosimilar portfolio that offers safe, effective and affordable products to the patients that need them; that Mylan and Momenta’s joint vision is to bring high quality, cost effective biosimilar products to markets worldwide and they believe their success will deliver a strong return to their respective stakeholders; that Mylan and Biocon plan on submitting three biosimilar applications and one insulin application in the U.S. and Europe in 2016; that Mylan is executing on its programs with the scientific and analytical rigor required to fulfill health authority expectations; and that Mylan is extremely optimistic about the strength of its current development programs with Biocon and looks forward to deploying its expertise in our collaboration with Momenta. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any changes in or difficulties with Mylan’s or its partners’ ability to develop, manufacture, and commercialize biosimilar candidates; any regulatory, legal, or other impediments to Mylan’s or its partners’ ability to bring biosimilar candidates to market; Mylan’s and its partners’ ability to protect intellectual property and preserve intellectual property rights, including with respect to biosimilar candidates; the effect of any changes in Mylan’s or its partners’ customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan’s or its partners’ business; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; risks associated with international operations; clearance under the Hart-Scott-Rodino Antitrust Improvements Act; other uncertainties and matters beyond the control of management; and the other risks detailed in Mylan’s filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release.
Forward Looking Statement for Momenta Pharmaceuticals
Statements in this press release regarding management’s future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements about our and Mylan’s ability to successfully develop and commercialize high quality, cost-effective biosimilar products; compete successfully in biosimilars; and increase shareholder value. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, including receiving clearance under the Hart-Scott-Rodino Antitrust Improvements Act and those referred to under the section “Risk Factors” in Momenta’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 filed with the Securities and Exchange Commission, as well as other documents that may be filed by Momenta from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, or the risks and factors noted above by Mylan, Momenta’s actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Momenta is providing information in this press release as of this date and assumes no obligations to update the information or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,400 generic and branded pharmaceuticals, including antiretroviral therapies on which nearly 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in approximately 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 30,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.
(EXFO) to Present at Needham Growth Conference
QUEBEC CITY, Jan. 8, 2016 – EXFO Inc. (NASDAQ: EXFO, TSX: EXF) announced today that Germain Lamonde, Chairman, President and CEO, will make a presentation on behalf of the company at the annual Needham Growth Conference on January 12, 2016, 12:50 p.m. Eastern time, in New York.
Mr. Lamonde will outline EXFO’s investment proposition, market opportunities and competitive advantages to institutional investors on-site.
An audio Webcast of the presentation will be available live at www.EXFO.com, under the Investors section. It will also be archived for a limited period.
IR Calendar
- Annual Needham Growth Conference, January 12, 2016, 12:50 p.m. Eastern time, New York (Audio Webcast: www.EXFO.com/investors).
About EXFO
EXFO enables extraordinary experiences over global networks. Our test, service assurance and network visibility solutions allow network operators and equipment manufacturers to deliver a wealth of services to consumers, while increasing network capacity and reducing operating costs. From a company executive holding a telepresence meeting with overseas staff to a runner transferring data from wearable technology, EXFO’s inherent expertise and powerful analytics render these events commonplace. Simply put, we have evolved over our 30-year history to ensure unmatched quality of service and quality of experience on next-generation fixed and mobile networks. EXFO has a staff of approximately 1500 people in 25 countries, supporting more than 2000 customers worldwide. For more information, visit www.EXFO.com and follow us on the EXFO Blog, Twitter, LinkedIn, Facebook, Google+ and YouTube.
(CYBE) Announces $2.0 Million Follow-On Order for 3D AOI Systems
CyberOptics Corporation (Nasdaq: CYBE) today announced an order valued at approximately $2.0 million for SQ3000 automated optical inspection (AOI) systems, based upon the company’s 3D MRS inspection technology platform. Scheduled for shipment in the first quarter of 2016, this order follows a previously reported $750,000 order for SQ3000 systems that shipped in the fourth quarter of 2015.
Subodh Kulkarni, president and chief executive officer, said: “As evidenced by these recent sizeable orders, our differentiated 3D MRS technology is enabling CyberOptics to gain share in the global AOI market. This order activity reaffirms our confidence in CyberOptics’ future.”
About CyberOptics
CyberOptics Corporation (www.cyberoptics.com) is a leading global developer and manufacturer of high precision sensing technology solutions. CyberOptics’ sensors are used in general purpose metrology and 3D scanning, surface mount technology (SMT) and semiconductor markets to significantly improve yields and productivity. By leveraging its leading edge technologies, the company has strategically established itself as a global leader in high precision 3D sensors, allowing CyberOptics to further increase its penetration of key vertical markets. Headquartered in Minneapolis, Minnesota, CyberOptics conducts worldwide operations through its facilities in North America, Asia and Europe.
Statements regarding the Company’s anticipated performance are forward-looking and therefore involve risks and uncertainties, including but not limited to: market conditions in the global SMT and semiconductor capital equipment industries; increasing price competition and price pressure on our product sales, particularly our SMT systems; the level of orders from our OEM customers; the availability of parts required to meet customer orders; unanticipated product development challenges; the effect of world events on our sales, the majority of which are from foreign customers; rapid changes in technology in the electronics markets; product introductions and pricing by our competitors; the success of our 3D technology initiatives; expectations regarding LDI and its impact on our operations; integration risks associated with LDI and other factors set forth in the Company’s filings with the Securities and Exchange Commission.
CyberOptics Corporation
Jeffrey A. Bertelsen, 763-542-5000
Chief Financial Officer
or
Equity Market Partners
Richard G. Cinquina, 904-415-1415
(GLUU) Announces Date of Fourth Quarter and Full Year 2015 Financial Results
Glu Mobile Inc. (NASDAQ:GLUU), a leading global developer and publisher of free-to-play games for smartphone and tablet devices, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2015 after the U.S. markets close on Wednesday, February 3, 2016.
In conjunction with this announcement, Glu will host a conference call on February 3, 2016 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) to discuss the company’s financial results. To access this call, dial (866) 582-8907 (domestic), or (760) 298-5046 (international), with conference ID #22306718. A replay of this conference call will be available between 4:30 p.m. PT February 3, 2016 and 8:59 p.m. PT, February 10, 2016 by calling (855) 859-2056, or (404) 537-3406, with conference ID #22306718. A live webcast of this conference call will also be available on the investor relations portion of the company’s website at www.glu.com, and a replay will be archived on the website as well.
About Glu Mobile
Glu Mobile (NASDAQ:GLUU) is a leading global developer and publisher of free-to-play games for smartphone and tablet devices. Glu is focused on creating compelling original IP games such as CONTRACT KILLER, COOKING DASH, DEER HUNTER, DINER DASH, DINO HUNTER: DEADLY SHORES, ETERNITY WARRIORS, FRONTLINE COMMANDO, RACING RIVALS, TAP SPORTS BASEBALL, and TAP SPORTS FOOTBALL, and branded IP games including KIM KARDASHIAN: HOLLYWOOD, KATY PERRY POP, JAMES BOND: WORLD OF ESPIONAGE, MISSION IMPOSSIBLE: ROGUE NATION and SNIPER X WITH JASON STATHAM on the App Store, Google Play, Amazon Appstore, Facebook, Mac App Store, and Windows Phone. Glu’s unique technology platform enables its titles to be accessible to a broad audience of consumers globally. Founded in 2001, Glu is headquartered in San Francisco with major U.S. offices outside Seattle and in Long Beach, and international locations in Canada, China, India, Japan, Korea, and Russia. Consumers can find high-quality entertainment wherever they see the ‘g’ character logo or at www.glu.com.
For live updates, please follow Glu via Twitter at www.twitter.com/glumobile or become a Glu fan at www.facebook.com/glumobile.
CONTRACT KILLER, COOKING DASH, DEER HUNTER, DINER DASH, DINO HUNTER: DEADLY SHORES, ETERNITY WARRIORS, FRONTLINE COMMANDO, RACING RIVALS, TAP SPORTS BASEBALL, TAP SPORTS FOOTBALL, SNIPER X, GLU, GLU MOBILE, and the ‘g’ character logo are trademarks of Glu Mobile Inc.
Investor Relations:
ICR, Inc.
Seth Potter, 646-277-1230
ir@glu.com
(ATHX) & Healios Enter Into Regenerative Medicine Partnership
Alliance to Focus on Development and Commercialization of Regenerative Medicine Products for Stroke and Other Potential Indications Using New Regulatory Framework in Japan
CLEVELAND and TOKYO, Jan. 08, 2016 — Healios K.K. (“Healios”) (Tokyo Stock Exchange:4593) and Athersys, Inc. (“Athersys”) (NASDAQ:ATHX) have announced a partnership and license agreement that will focus on the development and commercialization of novel cell therapy treatments, including MultiStem® for the treatment of ischemic stroke and potentially other indications, in Japan. The partnership involves MultiStem, a proprietary, patented off-the-shelf stem cell therapy being developed by Athersys, with an initial focus on treating ischemic stroke.
Under the terms of the agreement, Healios will gain exclusive rights for the development of MultiStem for treating ischemic stroke in Japan. Healios will develop and commercialize the product in Japan, and Athersys will provide the manufactured product and support to Healios, while retaining all rights outside of Japan. In addition, Healios will obtain an exclusive option for development of two additional MultiStem clinical indications in Japan, including the treatment of Acute Respiratory Distress Syndrome (“ARDS”), which is currently in clinical development by Athersys in the United States (“U.S.”) and the United Kingdom (“U.K.”), and another indication in the orthopaedic area. Healios will also obtain an exclusive license to incorporate Athersys technology in the development and commercialization of its proprietary Healios “organ bud” technology, initially for transplantation to treat liver disease or dysfunction, which may be expanded upon exercise of the option.
“Stroke represents a major problem, both in Japan and globally. Currently available treatments such as tPA and mechanical thrombectomy must be administered within the first several hours after the stroke occurs, limiting treatment to a small percentage of patients, and such interventions may also pose certain risks,” observed Dr. Kiyohiro Houkin, Chairman and Professor of Neurosurgery of Hokkaido University Medical School, and President of Hokkaido University Hospital. “The recently conducted international clinical study by Athersys in the U.S. and the U.K. suggests that intravenous administration of MultiStem within 36 hours of the occurrence of a stroke is safe, well-tolerated, and is a beneficial and effective treatment. The off-the-shelf administration of the product could be a simple and universal approach for treating acute stroke patients. Furthermore, it could be administered to patients that do not arrive at the hospital in time to receive current standard of care, or alternatively could be administered in addition to tPA or mechanical reperfusion, potentially enhancing outcomes for patients that have suffered significant strokes. If efficacy is confirmed in additional studies, it is possible that this therapy could become the new standard of care for treating stroke,” concluded Dr. Houkin.
As part of the license, Athersys will receive an initial license fee of $15 million, as well as have the opportunity to earn milestone and royalty payments upon the successful accomplishment of specific development and commercialization objectives, including the achievement of certain sales milestones. Development and approval milestones for stroke could total $30 million, in addition to sales milestones that could reach $185 million based on successful commercialization and the achievement of substantial sales of an approved product for treating stroke in Japan. Athersys will also receive tiered, double-digit royalties increasing into the high teens on product sales and will be responsible for providing manufactured product to Healios, subject to receiving reimbursement under a manufacturing supply arrangement. Furthermore, if Healios elects to expand the partnership following the successful completion of Athersys’ ongoing clinical trial in ARDS, Athersys will receive a license expansion fee of $10 million for the exclusive rights to two additional indications in Japan, with the corresponding potential for further milestones based on successful achievement of specific development and commercialization objectives. As part of the expanded alliance, Healios will also have the right to incorporate Athersys technology in other organ bud indications.
Japan currently represents the second largest national market for prescription biopharmaceuticals in the world. The country is also experiencing a significant demographic shift that is resulting in a rapid and unprecedented expansion of the elderly population in Japan, which threatens to pose significant challenges for the national healthcare system over the next several decades. In order to help address the challenges posed by the potential increased demand for healthcare resources as a result of this expanding population, over the past two years policy-makers in Japan have revised the regulatory framework to focus on promoting the development of innovative new therapies that are demonstrated to be safe and that also provide promising signs of effectiveness. These recently implemented regulatory reforms, which are specifically designed to promote development of novel regenerative medicine therapies, are intended to speed the development of promising new medicines for patients where there is substantial unmet medical need.
Athersys’ proprietary cell therapy product, MultiStem, has been evaluated in a Phase 2 clinical study for ischemic stroke in the U.S. and U.K. and is also in clinical development in several other indication areas, including the treatment of ARDS, myocardial infarction, and for transplant support, including prevention of Graft versus Host Disease and liver transplant support. Athersys has begun preparations for clinical development in Japan, including engagement with the Pharmaceuticals and Medical Devices Agency in Japan (“PMDA”). Healios and Athersys have already met jointly with PMDA and plan to complete additional preparations for initiation of a clinical study in Japan for stroke, with commencement of the study expected in the second half of 2016.
“I am very pleased that an exclusive licensing contract has been concluded with Athersys over development and distribution in Japan of MultiStem, a candidate pharmaceutical product for innovative cytotherapy having undergone phase 2 clinical trials in U.S. and U.K. There seems to be a large market need for MultiStem that can expand the period allowed before the start of treatment for ischemic stroke. Successful development of this product under the new regenerative medicine framework in Japan could accelerate Healios’ ability to help patients, achieve profitable operations and deliver substantial value to our shareholders,” commented Dr. Tadahisa “Hardy” Kagimoto, President of Healios. “Beyond stroke, the technology by Athersys is expected to improve the efficiency of production also when we prepare the organ as a platform for clinical transplantation programs. In essence, Healios has acquired a catalyst that can accelerate commercialization in the field of iPSC-based regenerative medicine products.”
Healios is recognized as a leading regenerative medicine company in Japan, with a technology portfolio that includes the development of retinal pigmented epithelia cells produced from induced pluripotent stem cells for the treatment of age related macular degeneration (“AMD”). Healios obtained a license to the technology from RIKEN to develop a novel treatment for AMD in 2013. Healios has also licensed additional technology from Yokohama City University related to the development of organ buds for transplantation indications. Healios is partnered with Sumitomo Dainippon Pharma Co., Ltd. and SHIBUYA CORPORATION (a leading robotics company in Japan), as well as NIKON CORPORATION and Osaka University who are focused on the joint development of advanced manufacturing capabilities for regenerative medicine therapies.
“Athersys is excited to be working with Healios for the development of MultiStem in Japan with an initial focus on treating patients that have suffered an ischemic stroke. Healios has an experienced and accomplished leadership team that recognizes the importance and transformational potential of the regenerative medicine field. They also have a compelling vision for our collaboration that includes the potential to work together across several important indication areas in a highly focused and efficient manner, which is why we selected them as our new partner,” said Dr. Gil Van Bokkelen, Chairman and CEO at Athersys. “They have a strong balance sheet, an excellent network of institutional partners and collaborators, and they are committed to rapid and efficient development under the new regulatory framework in Japan, all of which are key factors for success.”
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 many stroke victims. Currently, there are more than 15 million people that suffer a stroke globally and more than two million stroke victims each 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 therapies, administration of the clot dissolving agent tPA, or “thrombolytic,” or surgical intervention using mechanical reperfusion to remove the clot, must be conducted 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 Healios K.K.
Healios is a biotechnology venture leading the field of developing iPS cell-based products for regenerative medicine. It was founded in 2011 and listed on the stock exchange (Tokyo Security Exchange Mothers:4593) in 2015. In Japan, the company is developing a product for treatment of age-related macular degeneration (an intractable ocular disease) jointly with Suimitomo Dainippon Pharma Co., Ltd., under the plan of obtaining approval of its manufacture/distribution in 2020. In fields other than ophthalmology, the company has started R&D of products for regenerative medicine capable of creating functional human organs (three-dimensional organs) jointly with Yokohama City University. The company may be viewed as an enterprise providing products for regenerative medicine as a solution to the significant global issue “aging of the society.” See the website (https://www.healios.co.jp/) for details.
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 stroke, 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 Healios, including our ability to reach milestones and receive milestone payments, and whether Healios elects to expand the partnership or 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 Healios K.K. Corporate Communication Group Tel: 81-(0) 3-5777-8308 Fax: 81-(0) 3-3434-7231 pr@healios.jp
(CPAH) Leverages Channel Strategy to Focus on Small to Large Enterprise
Company Focuses on Three-Pronged Go-To-Market Strategy to Set the Stage for Further Growth
VANCOUVER, BRITISH COLUMBIA–(Jan. 7, 2016) – CounterPath Corporation (NASDAQ:CPAH)(TSX:CCV), a global provider of award-winning over-the-top (OTT) Unified Communications solutions for enterprises and carriers, today announced a three-pronged go-to-market channel strategy to expand Bria and Stretto distribution globally.
The key tenants of the approach enable CounterPath to reach small through large enterprises with a scalable solution aimed at accentuating the value proposition for each segment:
- Free Users to Paid Users via CounterPath e-store site: CounterPath has provided tens’ of millions of downloads and has millions of active users through its X-Lite free product and e-store channel sales of Bria products. This footprint primes the market for channel driven sales and lays the foundation for services that create incremental and recurring revenue and stickiness for all of CounterPath’s products. The CounterPath e-store services small to lower mid-market business users.
- Market development via strategic OEMs: CounterPath is working with strategic OEMs to forge new market opportunities by co-developing highly differentiated solutions that outperform the competition at a fraction of the cost. As an example, earlier this year, CounterPath announced its relationship with Alcatel-Lucent to focus on a next generation solution for large enterprises. Alcatel-Lucent and other OEMs typically focus on the large Enterprise.
- Recruitment of VAR/VADs to scale revenue: Over the last two years, CounterPath has signed up over 50 channel partners to help the distribution channel augment existing and new deployments with complete desktop to mobile communication solutions across the most popular call servers. The CounterPath distribution channels typically service mid-market enterprise customers.
“CounterPath continues to innovate and invest in a product portfolio that leverages the most popular call server platforms on the market” said Todd Carothers, EVP of Marketing and Products at CounterPath. “This enables CounterPath’s end-user customers to enhance their current voice offerings and extend to video, messaging, presence and collaboration offerings across desktop, tablet and mobile platforms. We have defined this highly differentiated product category as Enterprise OTT – our solution works over-the-top of virtually any network, any device and any platform.”
The combination of CounterPath’s go-to-market strategy and product innovation addresses the multibillion dollar unified communications market. According to Gartner, this exciting market is expected to grow to $42.4 billion by 2019, fueled by demand for cloud-based services as organizations digitalize their business workflows. The highest growth will come from emerging markets in Asia/Pacific and Africa.
CounterPath anticipates announcing strategy updates with go-to-market partners over 2016.
About CounterPath
CounterPath’s Unified Communications solutions are changing the face of telecommunications. An industry and user favorite, Bria softphones for desktop, tablet and mobile devices, together with Stretto Platform™ server solutions, enable enterprises, carriers and OEMs around the globe to offer a seamless and unified over-the-top (OTT) communications experience across both fixed and mobile networks. The Bria and Stretto combination enable an improved user experience as an overlay to the most popular telephony and applications servers on the market today enabling a leading voice, video, messaging, presence and collaboration user experience. Standards-based, cost-effective and reliable, CounterPath’s award-winning solutions power the voice and video calling, messaging, and presence offerings of customers such as Alcatel-Lucent, Aspect, AT&T, Avaya, BroadSoft, Bosch, Broadview, BT, Cisco Systems, Citi Group, Comcast, Ericsson, Five9, GENBAND, Genesys, MegaPath, NEC, NTT, Network Norway, Rogers and Verizon.
For more information about CounterPath’s Bria softphone applications and provisioning solutions, visit: www.counterpath.com/products.
This news release contains “forward-looking statements”. Statements in this news release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, outlook, expectations or intentions regarding the future such as (1) CounterPath anticipates announcing strategy updates with go-to-market partners over 2016.
It is important to note that actual outcomes and the Company’s actual results could differ materially from those in such forward-looking statements. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others: (1) the variability in CounterPath’s sales from reporting period to reporting period due to extended sales cycles as a result of selling CounterPath’s products through channel partners or the length of time of deployment of CounterPath’s products by its customers, (2) the Company’s ability to manage its operating expenses, which may adversely affect its financial condition, (3) the Company’s ability to remain competitive as other better financed competitors develop and release competitive products, (4) a decline in the Company’s stock price or insufficient investor interest in the Company’s securities which may impact the Company’s ability to raise additional financing as required or be delisted from a stock exchange on which its common stock trades, (5) the impact of intellectual property litigation that could materially and adversely affect CounterPath’s business, (6) the success by the Company of the sales of its current and new products, (7) the impact of technology changes on the Company’s products and industry, (8) the failure to develop new and innovative products using the Company’s technologies, and (9) the potential dilution to shareholders or overhang on the Company’s share price of its outstanding stock options. Readers should also refer to the risk disclosures outlined in the Company’s quarterly reports on Form 10-Q, or in the annual reports on Form 10-K, and the Company’s other disclosure documents filed from time-to-time with the Securities and Exchange Commission at http://www.sec.gov and the Company’s interim and annual filings and other disclosure documents filed from time-to-time on SEDAR at www.sedar.com.
CounterPath Corporation
Todd Carothers
Executive Vice President of Marketing and Products
tcarothers@counterpath.com
(BIOC) Launches Blood-based Test for Prostate Cancer, Expands Offering in Breast Cancer
Introduction of blood-based assay to detect androgen receptor expression builds on leading position in detecting and monitoring cancer through liquid biopsy
SAN DIEGO, Jan. 7, 2016 — Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing biomarkers to improve the detection and treatment of cancer, announces the launch of the CLIA-validated androgen receptor expression assay using a patient’s blood for the detection and monitoring of late-stage prostate cancer and a certain form of breast cancer.
“This test represents a significant milestone in which we expand into prostate cancer and further demonstrate the versatility of our proprietary liquid biopsy platforms,” said Michael W. Nall, President and CEO of Biocept. “We continue to build on our leadership position in the emerging liquid biopsy field with commercialized tests for detection and monitoring of lung, breast, colon, gastric and now prostate cancers.”
The Biocept assay uses circulating tumor cells (CTCs) from a simple blood draw to detect androgen receptor expression, which is prevalent in patients with advanced prostate cancer. Prostate cancer is the second leading cause of male cancer-related death and the second most commonly diagnosed cancer among men in the U.S. with 220,800 cases identified in 2014, according to the American Cancer Society. Approximately one in every seven men in the U.S. will be diagnosed with prostate cancer during his lifetime.
Androgen receptor is also found in a subset of patients with estrogen receptor negative, progesterone receptor negative and Her2 negative breast cancer, known as triple negative breast cancer. Triple negative breast cancer accounts for 10-20% of breast cancer patients, who typically have a poorer prognosis than patients with other forms of breast cancer.
“Studying various forms of androgen receptor expression could play a future role in personalized medicine for patients with metastatic prostate cancer, castration-resistant prostate cancer and triple negative breast cancer,” said Veena Singh, MD, Senior Vice President and Senior Medical Director of Biocept. “Androgen receptor expression has a long established role in prostate cancer, with published and ongoing studies examining its status in triple negative breast cancer suggest possible prognostic and predictive value in these patients.”
About Biocept
Biocept, Inc. is a commercial-stage molecular diagnostics company that utilizes a proprietary technology platform and a standard blood sample to provide physicians with important prognostic and predictive information to enhance individual treatment of patients with cancer. Biocept’s patented technology platform captures and analyzes circulating tumor DNA, both in CTCs and in plasma (ctDNA). Biocept currently offers assays for gastric cancer, breast cancer, lung cancer, colorectal cancer, prostate cancer and melanoma, and plans to introduce additional CLIA-validated assays in the near term. For additional information, please visit www.biocept.com.
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 our ability to improve the detection and treatment of cancer, the role of androgen receptor expression in personalized medicine and its prognostic and predictive value, our impact on diagnostic strategies, our ability to enhance individual cancer treatments and planned future offerings, 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 Securities and Exchange Commission (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 SEC, which can be accessed over the Internet at the SEC’s website located at www.sec.gov.
(MMYT) Ctrip Announces Investment in MakeMyTrip
SHANGHAI, Jan. 7, 2016 — Ctrip.com International, Ltd. (NASDAQ: CTRP) (“Ctrip”) today announced that it will invest US$180 million in MakeMyTrip Limited (NASDAQ: MMYT) (“MakeMyTrip”) , India’s largest online travel company, via convertible bonds. In addition, MakeMyTrip has granted Ctrip permission to acquire MakeMyTrip shares in the open market, so that combined with shares convertible under the convertible bonds, Ctrip may beneficially own up to 26.6% of MakeMyTrip’s outstanding shares. Upon completion of the investment, Ctrip will acquire the right to appoint a director to the MakeMyTrip board of directors.
Deep Kalra, Founder and Group CEO, MakeMyTrip said, “We are delighted to have Ctrip invest in us. Ctrip is the dominant market leader in the online travel market in China. We believe there are many similarities in the Indian and Chinese online travel markets and we expect this strategic relationship between two market leaders to be mutually beneficial.”
“Today’s announcement marks the beginning of the strategic relationship between Ctrip and MakeMyTrip. Through this transaction, Ctrip has now gained exposure to India’s fast growing online travel market,” said James Liang, Co-founder, Chairman, and CEO of Ctrip.
About Ctrip.com International, Ltd.
Ctrip.com International, Ltd. is a leading travel service provider of accommodation reservation, transportation ticketing, packaged tours, and corporate travel management in China. It is the largest online consolidator of accommodations and transportation tickets in China in terms of transaction volume. Ctrip enables business and leisure travelers to make informed and cost-effective bookings by aggregating comprehensive travel related information and offering its services through an advanced transaction and service platform consisting of its mobile apps, Internet websites and centralized, toll-free, 24-hour customer service center. Ctrip also helps customers book vacation packages and guided tours. In addition, through its corporate travel management services, Ctrip helps corporate clients effectively manage their travel requirements. Since its inception in 1999, Ctrip has experienced substantial growth and become one of the best-known travel brands in China.
For further information, please contact:
Investor Relations
Ctrip.com International, Ltd.
Tel: (+86) 21 3406 4880 X 12300
Email: iremail@ctrip.com
(DVAX) Reports Top Line Results of Phase 3 HEPLISAV-B(TM) Study
BLA Resubmission Targeted for End of Q1 2016; Webcast Conference Call to Review Clinical Data Scheduled for Today at 8:30 am ET
BERKELEY, CA–(January 07, 2016) – Dynavax Technologies Corporation (NASDAQ: DVAX) today reported preliminary top-line results from HBV-23, a Phase 3 trial of the safety and immunogenicity of its investigational hepatitis B vaccine, HEPLISAV-B, compared with a currently marketed vaccine, Engerix-B® , in adults 18 to 70 years of age. HEPLISAV-B participants received two doses, at zero and one month, and Engerix-B participants received three doses, at zero, one and six months. Both co-primary endpoints were met. The rates of clinically significant adverse events were consistent with randomization and similar to rates in prior trials and HEPLISAV-B provided a statistically significant higher rate of seroprotection than Engerix-B in diabetic participants and in all participants as a group.
Safety results from HBV-23
The co-primary endpoint of HBV-23 was to evaluate the overall safety of HEPLISAV-B with respect to clinically significant adverse events. Participants were randomized to HEPLISAV-B or Engerix-B in a two to one ratio. HEPLISAV-B participants were followed for 52 weeks after the last dose and Engerix-B participants were followed for 28 weeks after last dose. All adverse events considered to represent potential autoimmune disorders (Adverse Events of Special Interest, or AESIs) were reviewed by an independent panel of experts from the Mayo Clinic.
Preliminary safety evaluation results include:
- 22 HEPLISAV-B participants experienced an AESI and 11 Engerix-B participants experienced an AESI. All were classified as not related to vaccination.
- Of the 33 AESIs in the study, 21 were adjudicated to be autoimmune events by the independent panel, with 11 reported in participants who received HEPLISAV-B and 10 in participants who received Engerix-B.
- In a secondary safety endpoint, there were no cases of Wegener’s Granulomatosis (granulomatosis with polyangiitis) or Tolosa Hunt syndrome.
- One event in the HEPLISAV-B arm of the study was coded by a site investigator based solely on a radiological diagnosis as a rare autoimmune disease, Takayasu’s arteritis. The independent panel of experts concluded the diagnostic criteria for the initial radiological diagnosis were not met and adjudicated the event as not related to vaccination.
The total safety database for HEPLISAV-B now comprises 10,038 participants.
Seroprotection results from HBV-23
The co-primary endpoint of noninferiority of seroprotection in participants with diabetes mellitus was met and the greater percentage of seroprotection provided by HEPLISAV-B compared to Engerix-B was statistically significant.
Immunogenicity data from the trial demonstrated:
- The peak seroprotection rate (SPR) in participants with type 2 diabetes mellitus who received HEPLISAV-B was 90.0% compared to 65.1% for Engerix-B, demonstrating non-inferiority and a statistically significant higher percentage of seroprotection provided by HEPLISAV-B compared to Engerix-B
- In additional secondary endpoints:
- The peak SPR in the entire HBV-23 HEPLISAV-B group (95.4%) was statistically significantly higher than the peak SPR in the Engerix-B group (81.3%)
- The peak SPR in the HEPLISAV-B group was statistically significantly higher than the peak SPR in the Engerix-B group in each age decile
- The peak SPR in the HEPLISAV-B group was statistically significantly higher than the peak SPR in the Engerix-B group in each prespecified subpopulation analyzed, including by sex, body mass index, and smoking status
“We are delighted to report these topline results from HBV-23 and confirm our intention to resubmit the HEPLISAV-B BLA by the end of March. These results support our belief that HEPLISAV-B, if approved, could offer benefits to adults at risk for hepatitis B, particularly given that these significant differences in seroprotection were demonstrated in a controlled setting, where compliance is optimized,” said Eddie Gray, Chief Executive Officer.
“These topline results are consistent with our expectations. With regard to the principal safety focus, Adverse Events of Special Interest, the results reflect a distribution consistent with randomization. To see such statistically significant differences in immunogenicity so consistently and across all groups and patient subsets, confirms the potential of HEPLISAV-B for people in need of protection,” said Robert Janssen, Chief Medical Officer.
Dynavax plans to resubmit the HEPLISAV-B Biologics License Application (BLA) at the end of the first quarter of 2016 and anticipates a six-month review by the FDA. In the revised BLA, Dynavax plans to address all issues raised by the FDA in a February 2013 Complete Response Letter by submitting the results of HBV-23, integrated with previous clinical data, and responses to CMC issues in the Complete Response Letter.
Conference Call Today
Dynavax management will host a conference call today, January 7, 2016 at 8:30 a.m. Eastern Time and individuals may participate in the conference call by dialing (877) 479-1857 (domestic) or (503) 343-6309 (international). The passcode is 16055092.
To access a live audio webcast of the conference call, please visit the Company’s website at http://investors.dynavax.com/events.cfm
A replay of the webcast will be available on the Dynavax website approximately two hours after the conference call concludes and can be accessed for one week. The replay numbers are (855) 859-2056 (domestic) or (800) 585-8367 (international). The passcode is 16055092.
About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
About Dynavax
Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax’s lead product candidates are HEPLISAV-B™, a Phase 3 investigational adult hepatitis B vaccine and SD-101, an investigational cancer immunotherapeutic currently in several Phase 1/2 studies. For more information, visit www.dynavax.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding preliminary results from HBV-23 and whether those results will be confirmed in final analysis, the timing of Dynavax’s BLA submission to the FDA, the duration of FDA review of the BLA and whether the FDA will find the resubmission sufficient for regulatory approval. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether there will be changes in the data or interpretation, whether the final study results will be deemed satisfactory by the FDA; whether additional studies or manufacturing process enhancements will be required or other issues will arise that will delay the BLA resubmission or review or negatively impact the acceptance, review and approval by the FDA; initiation, enrollment and completion of pre-clinical studies and clinical trials of our other product candidates, including SD-101; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; and other risks detailed in the “Risk Factors” section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax’s website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.
Contact:
Jennifer Williams
Cook Williams Communications, Inc.
360-668-3701
Email contact
Contact:
Michael Ostrach
Chief Financial Officer
510-229-2907
Email contact
(INVT) Amends Patent Purchase Agreement and Reduces Liabilities by $17.3 Million
Amended Agreement Significantly Strengthens Company’s Financial Position
CAMPBELL, CA–(Jan 7, 2016) – Inventergy Global, Inc., a Silicon Valley intellectual property company, (NASDAQ: INVT) (“Inventergy” or the “Company”) is pleased to report that it has reached an agreement with one of its patent partners to amend the parties’ patent purchase agreement. Under the amended agreement, the guaranteed minimum payments, and related accrued interest thereon, owed by the Company to the third party have been eliminated. Future payments to this third party will be based exclusively on, and are fully contingent on, future patent monetization transactions such as licensing and sales agreements.
As a result of the amendment, the Company’s liabilities have been reduced by $17.3 million, including the elimination of $1.0 million of accrued interest expense, resulting in a significantly strengthened balance sheet. In addition, by eliminating these liabilities, the company avoids future interest expense in the amount of $120,000 per month. The above amounts are calculated as of December 31, 2015. Final year-end amounts are expected to be reported in late March 2016.
Joe Beyers, Chairman and CEO of Inventergy, said, “This amendment puts Inventergy in a stronger financial position and better enables us to execute our business strategy of obtaining value for our rich intellectual property portfolio. With our balance sheet now strengthened and a significant amount of interest expense avoided going forward, the positive results we anticipate from our future monetization efforts we believe should improve our stockholders’ equity in a more meaningful way. We are very grateful to our patent partner for their support and confidence in our patent monetization program and look forward to a very exciting year ahead.”
About Inventergy Global, Inc.
Inventergy Global, Inc. (“Inventergy”) is a Silicon Valley-based intellectual property company dedicated to identifying, acquiring and licensing patented technologies of market-significant technology leaders. Led by IP industry pioneer and veteran Joe Beyers, the Company leverages decades of corporate experience, market and technology expertise, and industry connections to assist Fortune 500 companies in leveraging the value of their innovations to achieve greater returns.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements, estimates, forecasts and projections with respect to future performance and events, which constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent and belief or current expectations of the Company and its affiliates and subsidiaries and their respective management teams. Forward-looking statements are not statements of historical fact and often contain words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “will,” “should,” “seek” and similar expressions. Investors and prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including the risk factors set forth from time to time in our filings with the Securities and Exchange Commission. These risks could cause actual results to differ materially from those expressed or implied in the forward-looking statements. We make forward-looking statements based on currently available information, and we assume no obligation to, and expressly disclaim any obligation to, update or revise publicly any forward-looking statements made in this release, whether as a result of new information, future events or otherwise, except as required by law.
For more information about Inventergy, visit www.inventergy.com.
(OGES) Announces New Corporate Image, Branding and Media Communications Tools
MELBOURNE, FL–(Jan 7, 2016) – Oakridge Global Energy Solutions, Inc. (OTCQB: OGES) is pleased to announce its new corporate image, branding and media communications tools in conjunction with its ramp up to full production of its best in class lithium-ion “Proudly Made in USA” batteries and energy storage products.
As a key part of its new corporate image and branding, Oakridge now has a sharp new-look website (www.OakRidgeGlobalEnergy.com) that highlights the company’s global market and presence, and which is in keeping with its corporate mission to become the leading “Made in USA” producer of lithium-ion batteries and energy storage products. The new website now also contains easy-to-access product details for the reference of wholesale consumers and direct customers alike. The revamped site can also be accessed by using Oakridge’s old domain name, www.OakG.net.
Oakridge has also partnered with DreamTeamNetwork (“DTN”) to create an innovative Investor relations (IR) package that provides excellent detail for potential customers and investors regarding the company and its products.
This new IR package can be viewed at http://OGES.QualityStocks.net/ir/
“Having successfully completed a total revamp of the company’s business and products during 2014 and 2015, Oakridge continues to improve every aspect of its business, and media and communications tools like these are no exception,” says OGES executive chairman and CEO Steve Barber. “These new tools are fantastically well-designed and provide improved information regarding all aspects of our business. The new website and IR package provide Oakridge with a major point of differentiation over our competitors in the Far East, and these media and communications tools that we have just launched are absolutely best in class. Being in the battery business, we have reviewed websites from over 100 companies that are in the industry worldwide. Investors and customers demand easy access and good communication and we again lead the industry by delivering these tools.”
The new branding also addresses increasing interest and demand for information on Oakridge’s revolutionary energy storage technology.
“This new corporate image and branding, embodied in the dramatic, crisp new website and the matching investor relations package were inspired by requests and questions from our various customers, investors and suppliers about the company and its game-changing ‘Made in USA’ lithium-ion battery and energy storage products,” said vice president of Oakridge Corporate Communications Suzanna Barber. “Our goal is to be a global leader in all aspects of the world battery market, and our new media and communications tools are a key part in that process of getting the exciting Oakridge message out and allowing Oakridge to take its rightful place in the global marketplace.”
DTN Managing Director Mike McCarthy adds, “We’ve worked closely with Oakridge for several months now and are increasingly impressed with the company’s technology, vision, and capability to execute its expansion strategies. Management is a pleasure to work with and we’re proud to put our name and resources behind the Oakridge brand. The sleek new website and factual IR kit demonstrate Oakridge’s commitment to clear communication and presentation.”
Oakridge continues to grow and expand as planned. During 2015 and into 2016 Oakridge has continued to exceed targets for hiring of employees, acquisition of capital equipment for factory automation, and providing innovative and informative tools to keep stakeholders fully engaged in company activities. This is another example of how this “Proudly Made In The USA” manufacturing company is aggressively serving its target markets. Oakridge is fully engaging with the world lithium battery market in every aspect. The new 69,000-square-foot facility at 3520 Dixie Highway in Melbourne, Florida, is now fully operational with production ramping up rapidly since reopening after the Christmas period on January 4. Oakridge will also be attending several major industry trade shows in the first quarter of 2016 to roll out exiting new products.
About Oakridge Global Energy Solutions, Inc.
Oakridge Global Energy Solutions Inc. is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 250,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakridgeglobalenergy.com
Forward-Looking Statements Disclaimer: 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. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.
(VUZI) and APX Labs’ Future Proof Enterprise Smart Glasses
Customers can deploy Skylight and Vuzix M100 today and upgrade to next-gen Vuzix M300 Smart Glasses seamlessly
ROCHESTER, N.Y., Jan. 6, 2016 — Vuzix® Corporation (NASDAQ: VUZI), (“Vuzix” or, the “Company”), a leading supplier of video eyewear and smart glasses products in the consumer, enterprise and entertainment markets, and APX Labs, (“APX”), the developer of the Skylight platform for enterprise wearable technology, today announced their Future Proof offer, which allows customers to begin deployments with Skylight and the Vuzix M100 smart glasses today and upgrade to the next generation Vuzix M300 seamlessly when they begin shipping to customers in Summer 2016. The advanced design of the new M300 combined with the latest release of the Skylight software platform will enable large Enterprise Smart Glasses deployments to leverage the latest technology while continuing to use the Vuzix M100 concurrently within the same system.
“Vuzix and APX have created an industry leading solution that enables large Enterprise clients to deploy Vuzix Smart Glasses to their hands-on workforce and get in-view instructions, conduct video calls, and access live secure data feeds,” said Paul Travers, President and Chief Executive Officer of Vuzix. “In production use today on our current M100, Skylight is the software application that Enterprise clients rely on for forward and backward compatibility across hardware upgrades, such as the new Vuzix M300, in essence making our clients’ current deployments ‘Future Proof’.”
The new Vuzix M300, being shown for the first time at CES 2016, is the next evolution of Vuzix Smart Glasses designed specifically for industrial use. The M300’s design is born from real world client feedback and industry requirements culminating from over two years of productive use of the Vuzix M100. The technical advances and ergonomic flexibility of the M300 will answer Enterprise clients’ needs in a way that fosters large scale adoption in many industry sectors. For further information, a product brochure and video overview, please visit Vuzix M300 Smart Glasses.
“With Skylight, the same solution you deploy with the M100 will work with the M300. You get real business benefits today and a seamless upgrade path to new hardware tomorrow,” said Brian Ballard, CEO and co-founder of APX. “This truly is a ‘Future Proof’ offer for the enterprise. APX is proud to be the first to announce support for the Vuzix M300. With a new form factor, improved interactivity, and top of the line specs, Vuzix is raising the bar for industrial grade enterprise wearable devices.”
APX’s Skylight is the most comprehensive and widely used enterprise wearables platform, enabling people to do important hands-on jobs using a range of wearable devices. Companies using Skylight have realized significant operational benefits, including improved process efficiency, less downtime, higher production quality and lower costs. It was recently recognized by industry analyst, Frost & Sullivan as the category-leading product in enterprise wearable software.
To learn more about the joint solution between Vuzix and APX and get started now, please visit www.apx-labs.com/landing/vuzix-m300/.
About APX Labs
Since 2010, APX Labs has been the market leader in developing wearable technology for the hands-on workforce. APX Labs’ Skylight software product runs on many types of devices, integrates with existing business systems, and is used today in a wide range of industrial operations including manufacturing, field service, repair, training, and compliance. For additional information, visit www.apx-labs.com.
About Vuzix Corporation
Vuzix is a leading supplier of Video Eyewear and Smart Glasses products in the consumer, commercial and entertainment markets. The Company’s products include personal display and wearable computing devices that offer users a portable high quality viewing experience, provide solutions for mobility, wearable displays and virtual and augmented reality. Vuzix holds 42 patents and 8 additional patents pending and numerous IP licenses in the Video Eyewear field. The Company has won Consumer Electronics Show (or CES) awards for innovation for the years 2005 to 2015 and several wireless technology innovation awards among others. Founded in 1997, Vuzix is a public company (NASDAQ: VUZI) with offices in Greater Rochester, NY, Oxford, UK and Tokyo, Japan.
Forward-Looking Statements Disclaimer
Certain statements contained in this news release are “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. Forward looking statements contained in this release relate to Forward looking statements contained in this release relate to Vuzix’ new M300 Smart Glasses and its market success with APX’s Skylight solutions for it and the M100, the technological advancements of the new Vuzix products, and among other things the Company’s leadership in the Video Eyewear, VR and AR display industry. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and MD&A filed with the United States Securities and Exchange Commission and applicable Canadian securities regulators (copies of which may be obtained at www.sedar.com or www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
For further information:
Media and Investor Relations Contact:
Andrew Haag
Managing Partner
IRTH Communications
vuzi@irthcommunications.com
Tel: (866) 976-4784
Vuzix Corporation
25 Hendrix Road, Suite A
West Henrietta, NY 14586 USA
Investor Information – Grant Russell
IR@Vuzix.com
Tel: (585) 359-7562
www.vuzix.com
APX Media Contact:
Katherine Verducci
MIX Public Relations
apxlabs@mix-pr.com
For further sales, and product information, please visit:
North America:
http://www.vuzix.com/contact/
Europe/UK:
https://www.vuzix.eu/contact/
(HOFT) Agrees to Acquire Home Meridian International
MARTINSVILLE, Va., Jan. 06, 2016 — Major casegoods and upholstery importer and manufacturer Hooker Furniture Corporation (NASDAQ:HOFT) (“the Company”) is poised to more than double its size and become one of the top five sources for the U.S. furniture market with an agreement to purchase the business of Home Meridian International, Inc. (“HMI”).
In what would be the largest acquisition in Hooker Furniture Corporation’s 91-year history, the Company has entered into an asset purchase agreement to acquire substantially all of the assets and certain liabilities of HMI for approximately $100 million, comprised of $85 million in cash and $15 million of newly-issued HOFT stock. Both the cash portion and the stock portion of the purchase price are subject to customary working capital adjustments.
It is anticipated that HMI will operate autonomously as a division of Hooker Furniture Corporation, which, with the acquisition, is expected to surpass the half-billion-dollar sales mark. The combined companies had revenues over the trailing twelve months ending October 31, 2015, in excess of $550 million. During the same time period operating income for the combined companies, which includes approximately $3.5 million of deal related costs, was $35.6 million.
“We are unbelievably excited at the prospect of having the individual businesses that comprise Home Meridian International become part of our Hooker Furniture Corporation stable of brands,” said Paul B. Toms Jr., chairman and chief executive officer. “Pulaski Furniture (PFC), Samuel Lawrence Furniture (SLF), Prime Resources (PRI), Sourcing Solutions Group (SSG), Right 2 Home (RTH) and Samuel Lawrence Hospitality (SLH) are all vibrant, well-run businesses addressing more moderate price points and some channels of distribution not currently served by the Hooker Furniture, Sam Moore, Bradington-Young, Homeware and/or H Contract brands,” he added.
“HMI’s strategy of providing proprietary products and custom business solutions to large customers and alternative channels of distribution, as well as growth in its traditional business, has yielded a compound average annual sales growth rate of over 15% during the last four years,” Toms said. “Growing sales at three times industry average is validation of their strategy,” he said.
Hooker Furniture Corporation expects to operate HMI as a stand-alone business led by its current chief executive officer, George Revington, and his current management team. Revington will serve as president and chief operating officer of the HMI division, with no visible changes to customers of either company. Revington will report to Paul Toms, Hooker Furniture Corporation chairman and chief executive officer.
“The HMI team is excited to join with Hooker Furniture Corporation to become one of the largest players in the industry,” said Revington. “The success of these two companies is directly related to how they serve their customers and the new combination will make us even more effective and provides a great platform for future growth.”
Added Toms, “We are particularly impressed with the depth and experience of the HMI management team and excited about having this level of talent join us as we plan for the future. HMI has a significant presence in Vietnam, China and Malaysia, which Hooker will look to leverage for enhanced vendor management and customer service.”
The HMI division’s headquarters will continue to be located in High Point, N.C., and Hooker Furniture Corporation’s headquarters will remain in Martinsville, Va.
The combined global footprint of the companies will include upholstery manufacturing facilities in Hickory, N.C., and Bedford, Va., showrooms in High Point and Ho Chi Minh City, Vietnam, and eight distribution centers in North Carolina, Virginia, California, China and Vietnam.
Once combined, Hooker Furniture will have approximately 900 employees worldwide.
The companies’ existing ERP operating systems and sales forces will remain in place and operate separately.
“While there will be no merger of operations or change in customer-facing services, we do see opportunity to improve each company by sharing best practices and looking for ways to work together to lower costs, improve efficiency and grow sales,” Toms said.
“Although Hooker Furniture Corporation has been debt-free for some time, we look at this acquisition as an excellent way to put excess capital to work and use our pristine balance sheet to layer in a manageable amount of low-cost debt,” Toms said. “We expect the transaction to be accretive to earnings immediately.” The transaction is expected to close in the first quarter of 2016 but not prior to February 1, 2016, subject to, among other things, an anti-trust regulatory review and other customary closing conditions. The transaction does not require approval by Hooker’s shareholders.
In connection with the agreement to purchase the business of HMI, Hooker also entered into a commitment letter with Bank of America, N.A. (“BofA”) pursuant to which BofA has committed to provide debt financing for the transactions contemplated in the form of a $90,000,000 senior credit facility. The obligation of BofA to provide this debt financing is subject to a number of customary conditions.
Ranked among the nation’s top 10 largest publicly traded furniture sources based on 2014 shipments to U.S. retailers, Hooker Furniture Corporation is a residential wood, metal and upholstered furniture resource in its 91st year of business. Major casegoods product categories include home entertainment, home office, accent, dining, and bedroom furniture primarily in the upper-medium price points sold under the Hooker Furniture brand. Hooker’s residential upholstered seating product lines include: Bradington-Young, a specialist in upscale motion and stationary leather furniture; Sam Moore Furniture, a specialist in fabric upholstery with an emphasis on cover-to-frame customization; and Hooker Upholstery, which focuses on imported leather upholstered furniture targeted at the upper-medium price-range. The Homeware product line offers direct-to-consumer, customer-assembled, modular upholstered and casegoods products. The H Contract product line supplies upholstered seating and casegoods to upscale senior living facilities.
Home Meridian International is the parent company of 5 business units including Pulaski Furniture, Samuel Lawrence Furniture, Samuel Lawrence Hospitality, Prime Resources International and Right 2 Home. In addition. Sourcing Solutions Group and Right 2 Home provide customized and proprietary products and services to HMI partners. HMI has a unique business model which allows the company to create global sourcing solutions for major customers and multiple channels of distribution. The organization has a deep understanding of the furniture market, products and customers. This business model, global sourcing and broad experience have allowed HMI to adapt and gain significant market share within the industry. HMI was consistently been recognized as an industry and regional leader in sales gain and growth. Headquartered in High Point, N.C., HMI has distribution centers on both coasts and Asian operations in China, Vietnam and Malaysia.
Forward Looking Statements
This release includes certain forward-looking information that is subject to various risks and uncertainties. Words such as “expect,” “target,” “would,” “will,” “anticipate,” “believe,” “estimate,” “intend,” “may,” “plan,” “predict,” “project,” “should” and similar terms and phrases are used to identify forward-looking statements. There are a number of factors that could cause actual results to differ from those in the forward-looking statements. For example, the parties may not be able to obtain any necessary regulatory or third-party consents or approvals or delays in obtaining any such consents or approvals may delay the closing of, or cause the parties to abandon, the transactions contemplated by the asset purchase agreement, or conditions to the closing of the transactions contemplated by the asset purchase agreement or the committed debt financing may not be satisfied. Accordingly, forward-looking statements are not guarantees or assurances of future outcomes and actual results could differ materially from those indicated by the forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which it is made.
For more information, contact: Paul B. Toms Jr., Chairman and Chief Executive Officer, or Paul Huckfeldt, Chief Financial Officer; Phone: 276-632-2133
(CCCL) Completes Production Line for New Roofing Products
JINJIANG, China, Jan. 6, 2016 — China Ceramics Co., Ltd. (NASDAQ Global Market: CCCL) (“China Ceramics” or the “Company”), a leading Chinese manufacturer of ceramic tiles used for exterior siding and for interior flooring and design in residential and commercial buildings, today announced that it has completed a new production line to manufacture glazed brick ceramic tiles in its Hengdali facility in Gaoan, Jiangxi Province, China.
“We are excited about the addition of glazed brick ceramic tiles to our product portfolio as it is engineered to be a highly effective and customized roofing solution for both high-rise apartment buildings and housing projects. Further, it complements our existing ceramic tile building products and provides a competitively-priced solution for property developers,” said Mr. Jiadong Huang, Chief Executive Officer of China Ceramics. “Once in production, we believe that this new product will be one of the highest quality roofing bricks available in the building materials market and we are pleased that it further broadens our already extensive product line.”
The new production line is optimized to manufacture customized size ranges of glazed brick ceramic tiles in a manner that maximizes production efficiency and output. It also increases the Company’s total number of production lines from sixteen to seventeen. The new production line will undergo extensive testing procedures in the current quarter and full production is expected to begin in the second quarter of 2016.
Although there are currently some pre-orders for glazed brick ceramic tiles, we do not expect sales to ramp until the second quarter of 2016. We have incurred capital expenditures of RMB 93.0 million (US$ 14.6 million) to date in connection with the new production line, although additional expenditures are possible prior to the production line being fully operational. The new glazed brick ceramic tiles will be sold alongside our existing ceramic tile products to property developers on a direct basis and by our network of distributors throughout China.
Safe Harbor Statement
Certain of the statements made in this press release are “forward-looking statements” within the meaning and protections of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions, and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause the actual results, performance, capital, ownership or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements in this press release include, without limitation, the continued stable macroeconomic environment in the PRC, the PRC real estate and construction sectors continuing to exhibit sound long-term fundamentals, our ability to bring additional capacity online going forward as our business improves, our customers continuing to adjust to our product price increases, our ability to sustain our average selling price increases and to continue to build volume in the quarters ahead, and whether our enhanced marketing efforts will help to produce wider customer acceptance of the new price points. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “will,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “estimate,” “continue,” “plan,” “point to,” “project,” “could,” “intend,” “target” and other similar words and expressions of the future.
All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary notice, including, without limitation, those risks and uncertainties described in our annual report on Form 20-F for the year ended December 31, 2014 and otherwise in our SEC reports and filings. Such reports are available upon request from the Company, or from the Securities and Exchange Commission, including through the SEC’s Internet website at http://www.sec.gov. We have no obligation and do not undertake to update, revise or correct any of the forward-looking statements after the date hereof, or after the respective dates on which any such statements otherwise are made.
About China Ceramics Co., Ltd.
China Ceramics Co., Ltd. is a leading manufacturer of ceramic tiles in China. The Company’s ceramic tiles are used for exterior siding, interior flooring, and design in residential and commercial buildings. China Ceramics’ products, sold under the “Hengda” or “HD”, “Hengdeli” or “HDL”, the “TOERTO” and “WULIQIAO” brands, and the “Pottery Capital of Tang Dynasty” brands, are available in over 2,000 style, color and size combinations and are distributed through a network of exclusive distributors as well as directly to large property developers. For more information, please visit http://www.cceramics.com.
Contact Information:
China Ceramics Co., Ltd.
Edmund Hen, Chief Financial Officer
Email: info@cceramics.com
Precept Investor Relations LLC
David Rudnick, Account Manager
Email: david.rudnick@preceptir.com
Phone: +1 917-864-8849
(EMAN) Inks Licensing Agreement for Immersive Headset Intellectual Property
eMagin Corporation (NYSE MKT:EMAN) has signed a non-exclusive intellectual property (IP) licensing agreement for its unique 4 MegaPixel per eye immersive virtual reality headset technology with an undisclosed company. The deal includes an upfront licensing fee of $1M and a commitment to use eMagin’s 2,000 x 2,000 pixel full color displays in the company’s headsets. eMagin’s OLED microdisplays are the superior choice for the emerging Virtual Reality (VR) and Augmented Reality (AR) markets with features such as their speed (which helps prevent nausea), small size, low power consumption, high brightness and high contrast. These features make eMagin’s microdisplays a better choice than alternative liquid crystal based display technologies like LCOS or LCD.
“This licensing agreement confirms that our immersive headset technology is unique in the VR market,” said Andrew G. Sculley, CEO of eMagin Corporation. “Our immersive headset has four times the resolution of alternative cellphone based VR headsets and provides a more realistic, “screen-door”- free image. This agreement also demonstrates that eMagin’s OLED microdisplays are the right choice for VR applications, giving eMagin the opportunity to jump into the market with its highest resolution microdisplay offering.”
About eMagin Corporation
A leader in OLED microdisplay technology, OLED microdisplay manufacturing know-how and mobile display systems, eMagin manufactures high-resolution OLED microdisplays and integrates them with magnifying optics to deliver virtual images comparable to large-screen computer and television displays in portable, low power consumption, lightweight personal displays. eMagin microdisplays provide near-eye imagery in a variety of products from military, industrial, medical and consumer OEMs. More information about eMagin is available at www.emagin.com.
Forward-Looking Statements
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, including those regarding eMagin Corporation’s expectations, intentions, strategies and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors, including those described in the Company’s most recent filings with the SEC. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such statements should not be regarded as a representation by the Company, or any other person, that such forward-looking statements will be achieved. The business and operations of the Company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future events or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements. OLED-XL, Color OLED-XLS and True Black are trademarks of eMagin Corp. OLED-ULT is trademark pending. All other names are the products of their respective owners.
eMagin Corporation:
Jeffrey Lucas, 845-838-7900
jlucas@emagin.com
(COOL) Announces Special Dividend
SOUTH PLAINFIELD, NJ–(Jan 6, 2016) – Majesco Entertainment Company (NASDAQ: COOL) (the “Company”), an innovative provider of downloadable games for the mass market, announced today that its Board of Directors has authorized a special dividend of approximately $0.33 per common share (including common share equivalents) in cash, payable on January 15, 2016 to shareholders of record as of January 14, 2016.
Barry Honig, Co-Chairman and Chief Executive Officer, commented: “This special dividend is another step in returning value to shareholders. We will continue to explore options for delivering value with our low overhead and cash position.”
The exact dividend amount is subject to final calculation. Shareholders do not need to take any action to receive the dividend. Shares held in brokerage accounts and street name should receive the dividend by credit to their brokerage account. Equity Stock Transfer has been appointed paying agent for administration of the dividend and any questions should be directed to the attention of Nora Marckwordt at 212-575-5757.
About Majesco Entertainment Company
Majesco Entertainment Company is an innovative developer, marketer, publisher and distributor of interactive entertainment for consumers around the world. Building on more than 25 years of operating history, Majesco develops and publishes a wide range of video games on digital networks through its Midnight City label. Majesco is headquartered in Plainfield, New Jersey, and its shares are traded on The Nasdaq Capital Market under the symbol: COOL. More info can be found online at majescoent.com or on Twitter at twitter.com/majesco.
Forward-Looking Statements
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this release relate to, among other things, the Company’s ongoing compliance with the requirements of The NASDAQ Stock Market. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should'” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
(OGES) Providing Batteries for Unmanned Maritime Vessels
Oakridge Global Energy Solutions, Inc.
Info@oakg.net
Oakridge Global Energy Solutions:
A New Era In Battery Manufacturing
Oakridge Providing Batteries for Unmanned Maritime Vessels
January 6, 2016 Melbourne, Florida – Oakridge Global Energy Solutions, Inc. (OGES) is excited to announce that it has received a supplier agreement from an industry leader in the unmanned maritime market space, Maritime Tactical Systems, Inc., MARTAC. MARTAC is a Melbourne, Florida based company that designs and produces the Man-Portable Tactical Autonomous Systems (MANTIS) that can reach speeds in excess of 75 miles per hour. These vehicles are designed to be used in numerous applications including mine warfare, port and harbor security patrol, anti-piracy, search and rescue, and many others.
“This is an outstanding local company that develops and produces highly innovative and exciting game-changing products with very important strategic applications,” said OGES Executive Chairman and CEO, Steve Barber. “We are pleased to provide batteries for their products and welcome the opportunity to work together. We at Oakridge love high speed vehicles whether on the ground or in the water, and these products are absolutely best in class.”
On January 4, 2016 Oakridge Global Energy Solutions entered into the full scale production phase of the company restructuring as planned out by Barber and his team. The company forecasts having solid revenues in January and growing rapidly each month thereafter.
“Oakridge is an incredible company to work with. Their engineering team reviewed our applications and immediately started work on a fantastic solution that exceeded our expectations and strengthened our product offerings. It is absolutely wonderful to have a strong lithium battery manufacturing facility in the U.S.” says MARTAC President/CEO Bruce Hanson. “We look forward to a long and successful relationship with the Oakridge team!”
About Oakridge Global Energy Solutions, Inc.
Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 250,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakg.net.
Forward-Looking Statements Disclaimer: 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. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.
Contact:
Oakridge Global Energy Solutions, Inc.
www.oakg.net
3520 Dixie Highway
Palm Bay, 32905, Florida, USA
Ph: (321) 610-7959
(AMIC) & (IHC) Announce Sale of Stop Loss Business
STAMFORD, Conn. and NEW YORK, Jan. 05, 2016 — Independence Holding Company (NYSE:IHC) and American Independence Corp. (NASDAQ:AMIC) today announced that they have entered into an agreement to sell the stock of IHC Risk Solutions LLC (RS) and co-insure to Swiss Re Corporate Solutions’ largest US carrier, Westport Insurance Corporation, all of the in-force stop-loss business of Standard Security Life Insurance Company of New York (SSL) and Independence American Insurance Company (IAIC) produced by RS, as of January 1, 2016, for an aggregate of $152,500,000 in cash. AMIC and its subsidiaries, including IAIC, are expected to receive approximately 89% of the purchase price with the balance being paid to SSL. The transaction has been approved by the independent members of the Boards of Directors of IHC, AMIC and SSL and by the holders of approximately 92% of the outstanding stock of AMIC. It is anticipated that the transaction, which is subject to certain closing conditions including applicable regulatory approvals, will close in the first quarter of 2016. This transaction will result in very significant gains in both income and book value of both IHC and AMIC, which amounts will not be fully determined until after closing of the transaction.
Roy T. Thung, Chief Executive Officer of IHC and AMIC, commented, “We are delighted that this transaction will unlock significant value for the shareholders of both AMIC and IHC and will materially increase liquidity in both companies. We will continue to focus on growing our specialty health, group life and disability, DBL and occupational accident lines of business through organic growth and acquisitions. In addition, the IHC Board of Directors has appointed a special committee of independent directors which has been authorized to hire independent advisors to recommend to the full Board of Directors the price at which IHC would take AMIC private in 2016. After completion of the going private transaction, IHC will own 100% of SSL, IAIC and Madison National Life Insurance Company, Inc.”
About Independence Holding Company
Independence Holding Company (NYSE:IHC) is a holding company principally engaged in the life and health insurance business through its insurance company subsidiaries (Standard Security Life Insurance Company of New York, Madison National Life Insurance Company, Inc. and Independence American Insurance Company) and its marketing and administrative affiliates. Standard Security Life furnishes medical stop-loss, group limited medical, short-term medical, group long-term and short-term disability, group life, statutory disability benefit policies (DBL) in New York, group and individual dental, vision and various supplemental products. Madison National Life sells group life and disability, group limited medical, group and individual dental, and various supplemental products. Independence American offers pet insurance, non-subscriber occupational accident, short-term medical, medical stop-loss, group and individual dental and various supplemental products. IHC owns certain subsidiaries through its majority ownership of American Independence Corp. (NASDAQ:AMIC), which is a holding company principally engaged in the insurance and reinsurance business.
About American Independence Corp.
American Independence Corp. (NASDAQ:AMIC) is a holding company principally engaged in health insurance and reinsurance. It provides specialized health coverage and related services to commercial customers and individuals. Through Independence American Insurance Company and its other subsidiaries, it offers medical stop-loss, non-subscriber occupational accident, pet insurance, group major medical, short-term medical, vision, dental and various supplemental products, which are marketed through its subsidiaries IHC Specialty Benefits, Inc., IPA Direct, LLC and IPA Family, LLC. AMIC markets medical stop-loss through its marketing and administrative company IHC Risk Solutions, LLC.
Forward-looking Statements
Certain statements and information contained in this release may be considered “forward-looking statements,” such as statements relating to management’s views with respect to future events and financial performance. Such forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from historical experience or from future results expressed or implied by such forward-looking statements. Potential risks and uncertainties include, but are not limited to, economic conditions in the markets in which Independence Holding Company (IHC) and American Independence Corp (AMIC) and operates, new federal or state governmental regulation, IHC’s and AMIC’s ability to effectively operate, integrate and leverage any past or future strategic acquisition, and other factors which can be found in IHC’s and AMIC’s other news releases and filings with the Securities and Exchange Commission. IHC and AMIC expressly disclaims any duty to update its forward-looking statements unless required by applicable law.
INDEPENDENCE HOLDING COMPANY 96 CUMMINGS POINT ROAD STAMFORD, CONNECTICUT 06902 NYSE: IHC CONTACT: LOAN NISSER (646) 509-2107 www.IHCGroup.com AMERICAN INDEPENDENCE CORP. 485 MADISON AVENUE NEW YORK, NEW YORK 10022 NASDAQ: AMIC CONTACT: LOAN NISSER (646) 509-2107 www.americanindependencecorp.com
(CNAT) Positive Results with Emricasan in Initial Stage of Phase 2 Trial
– Consistent Treatment Effect Observed on Biomarkers in Overall Patient Population –
– Emricasan Improves Key Measures of Liver Function in High Medical Need Subgroup –
– Conference Call and Webcast Presentation at 4:30 p.m. ET Today –
SAN DIEGO, Jan. 05, 2016 — Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) today announced that the three-month, double-blind, placebo-controlled stage of the company’s multicenter Phase 2 Liver Cirrhosis clinical trial showed a statistically significant reduction in caspase-cleaved cytokeratin 18 (cCK18) vs. placebo (p=0.04) in the overall patient population when adjusted for differences between treatment and placebo groups in baseline Model for End-stage Liver Disease (MELD)1 score and disease etiology as specified in the trial statistical analysis plan. cCK18 is a mechanism-specific biomarker of caspase-driven cell death. Multiple additional liver disease biomarkers achieved statistically significant reductions vs. placebo in the overall patient population after three months of treatment, while others achieved positive trends. The company believes that the consistent pattern of improvement across these biomarkers in the overall patient population provides strong evidence of a favorable treatment effect with emricasan, the company’s first-in-class, orally-active pan-caspase inhibitor.
| Overall Patient Population |
Placebo (N=42) | Emricasan (N=44) | p-value* | ||||||
| Baseline | Change at Month 3† |
Baseline | Change at Month 3† |
||||||
| cCK18 (U/L) | 296 | +9.3 | % | 289 | ‒4.6% | 0.04 | |||
| Caspase 3/7 (RLU) | 2503 | +8.8 | % | 2656 | ‒45.5% | <0.0001 | |||
| flCK18 (U/L) | 582 | ‒3% | 714 | ‒18% | 0.005 | ||||
| ALT (U/L) | 25.5 | ‒1.0 | 27.5 | ‒3.0 | 0.03 | ||||
| AST (U/L) | 41.5 | ‒1.5 | 50.0 | ‒5.0 | 0.08 | ||||
| *p-values for treatment effect at Month 3, adjusting for baseline, MELD, etiology; not adjusted for multiple testing. †Based on last observation carried forward. Data presented are geometric mean for baseline cCK18, caspase 3/7, flCK18, and median change for ALT and AST. |
|||||||||
Collectively, two key secondary endpoints and clinically relevant measures of liver function, MELD score and Child-Pugh-Turcotte (Child-Pugh)2 score, along with other key liver function parameters, demonstrated favorable trends vs. placebo in the overall patient population after three months of treatment.
| Overall Patient Population |
Placebo (N=42) | Emricasan (N=44) | p-value* | ||
| Baseline | Change at Month 3† |
Baseline | Change at Month 3† |
||
| MELD score | 12.9 | +0.1 | 12.8 | ‒0.1 | 0.50 |
| Child-Pugh score | 6.9 | +0.1 | 6.9 | ‒0.2 | 0.10 |
| Total bilirubin (mg/dL) | 2.59 | +0.07 | 2.25 | ‒0.05 | 0.19 |
| INR | 1.31 | +0.02 | 1.33 | ‒0.02 | 0.12 |
| Albumin (g/dL) | 3.48 | +0.06 | 3.46 | +0.02 | 0.38 |
| *p-values for treatment effect at Month 3, adjusting for baseline, MELD, etiology; not adjusted for multiple testing. †Based on last observation carried forward. |
|||||
Exploratory Subgroup Analyses Yield Clinically Meaningful Results
Importantly, the trends in the overall patient population were driven by statistically significant improvements in a subgroup of patients with baseline MELD scores ≥15, the established prerequisite for listing a patient for liver transplant. This pattern of greatest responses in highest need patients is consistent with the results from the company’s Phase 2 Portal Hypertension clinical trial announced in the third quarter of 2015.
| Baseline MELD Score ≥15 Patient Population |
Placebo (N=10) | Emricasan (N=9) | p-value* | ||
| Baseline | Change at Month 3† |
Baseline | Change at Month 3† |
||
| MELD score | 16.3 | +0.6 | 16.0 | ‒1.6 | 0.003 |
| Child-Pugh score | 8.2 | +0.6 | 7.8 | ‒0.6 | 0.003 |
| Total bilirubin (mg/dL) | 4.30 | ‒0.06 | 3.17 | ‒0.55 | 0.03 |
| INR | 1.45 | +0.06 | 1.54 | ‒0.14 | 0.0004 |
| Albumin (g/dL) | 3.19 | +0.05 | 3.41 | +0.07 | 0.78 |
| *p-values for treatment effect at Month 3, adjusting for baseline, MELD, etiology; not adjusted for multiple testing. †Based on last observation carried forward. |
|||||
Additional analyses of the three-month data showed the following broadly evident treatment effects in this subgroup:
- 1.6 reduction in mean MELD score with emricasan vs. 0.6 increase with placebo (p=0.003)
- Patients achieving at least 2-point reductions in MELD score
- 6 of 9 with emricasan vs. 2 of 10 with placebo
- Patients achieving reductions in MELD score to ≤14
- 4 of 9 with emricasan vs. 1 of 10 with placebo
- Patients achieving at least 2-point reductions in MELD score
- 0.6 reduction in mean Child-Pugh score with emricasan vs. 0.6 increase with placebo (p=0.003)
- Patients achieving at least 1-point changes in Child-Pugh score
- 4 of 9 had decreases with emricasan vs. 2 of 10 with placebo
- 0 of 9 had increases with emricasan vs. 4 of 10 with placebo
- Patients achieving at least 1-point changes in Child-Pugh score
Consistent with the company’s previous 15 clinical trials, emricasan was generally well-tolerated in the placebo-controlled stage of the Liver Cirrhosis clinical trial, and the overall safety profile was similar in the emricasan and placebo groups with regard to both serious and other adverse events.
“The improvement after only three months of treatment in patients with cirrhosis and impaired hepatic function in nearly all of the mechanism-specific and mechanism-independent biomarkers, as well as favorable overall trends driven by statistically significant subgroup improvements in clinically relevant markers of liver function – MELD and Child Pugh scores – is highly encouraging,” said David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus. “The magnitude of the treatment effect was much more meaningful in patients with high baseline MELD scores. We believe these results, if confirmed and sustained, will be very important clinically. We look forward to the availability of the six-month data from this clinical trial to understand whether longer dosing may also demonstrate a treatment effect as measured by MELD and Child-Pugh in patients with lower baseline MELD scores and the overall patient population.”
“With these latest results, we have now demonstrated emricasan’s ability to cause meaningful improvements in targeted patient populations using all three measures identified by the FDA (U.S. Food and Drug Administration) as potentially acceptable surrogate endpoints for clinical trials in patients with liver cirrhosis,” said Conatus co-founder, President and Chief Executive Officer Steven J. Mento, Ph.D. “The evidence of emricasan’s clinical activity across the spectrum of liver disease continues to build. Over the past year, we have generated clinical data defining acceptable emricasan dosing in patients with all levels of liver function impairment, and confirming that emricasan is active across multiple etiologies of liver disease. The two latest clinical trials demonstrate emricasan’s ability to provide statistically significant improvements rapidly in clinically important validated surrogate endpoints of portal hypertension and liver function in the subgroups of patients with highest medical need. These results reinforce our commitment to the further development of emricasan with a focus on an initial registration in liver cirrhosis. We believe the planned ENCORE liver cirrhosis and nonalcoholic steatohepatitis (NASH) fibrosis clinical trials announced in November offer the optimal path forward toward that objective. We expect that the upcoming six-month Liver Cirrhosis clinical trial data will allow us to determine, with the continued engagement of the regulatory authorities, whether the ENCORE-LF clinical trial – originally planned as a Phase 2 clinical trial – may be redesigned to qualify as Phase 3. We are advancing well with our plans to initiate the ENCORE clinical trials on a staggered basis through early 2017.”
Liver Cirrhosis Trial
The double-blind, placebo-controlled Phase 2 Liver Cirrhosis clinical trial was conducted at 26 U.S. sites and enrolled 86 patients with liver cirrhosis due to different etiologies, mild to moderate liver impairment and baseline MELD scores of 11 to 18. In the double-blind and placebo-controlled stage, patients were randomized 1:1 to receive either 25 mg of emricasan or placebo orally twice daily for three months. The primary endpoint was change from baseline in cCK18. Secondary endpoints included changes from baseline in MELD and Child-Pugh scores, which include laboratory parameters associated with liver synthetic and excretory function, such as serum albumin levels, international normalized ratio (INR) and total bilirubin levels. In the open-label stage, all patients either on emricasan or placebo receive emricasan for an additional three months. Six-month data from patients who continued treatment and three-month data from placebo patients who crossed over to emricasan treatment are expected in the second quarter of 2016.
Among the 86 subjects enrolled and dosed, liver cirrhosis etiologies included alcohol (38%), hepatitis C virus, or HCV (29%), NASH (23%), and other causes (9%). Baseline MELD scores were ≤14 in 78% of enrolled subjects and ≥15 in 22% of enrolled subjects. Baseline Child-Pugh status was A (Child-Pugh score of 5-6) in 43% of subjects and B (Child-Pugh score of 7-9) in 56% of subjects.
Conference Call/Webcast/Presentation
Conatus will host a conference call and webcast at 4:30 p.m. Eastern Time today, January 5, to discuss the initial top-line results. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 17708674. An associated presentation and live and archived audio webcast of the call will be available in the Investors section of the company’s website at http://ir.conatuspharma.com/events.cfm.
About Emricasan Clinical Development
To date, emricasan has been studied in over 650 subjects in sixteen clinical trials across a broad range of liver disease etiologies and stages of progression. In multiple clinical trials, emricasan has demonstrated statistically significant, rapid and sustained reductions in elevated levels of key biomarkers of inflammation and apoptosis that are implicated in the severity and progression of liver disease. Importantly, these key biomarkers are known to be elevated and to have prognostic value in multiple hepatic indications that Conatus is currently pursuing. The company also is evaluating emricasan’s potential longer-term effects on liver structure in its ongoing Phase 2b clinical trial in post-orthotopic liver transplant (POLT) recipients who have reestablished liver fibrosis or cirrhosis post-transplant as a result of recurrent HCV infection and have successfully achieved a sustained viral response following HCV antiviral therapy (POLT-HCV-SVR). In November 2015, the company announced plans to conduct multiple clinical trials covering various liver cirrhosis patient populations for different chronic dosing periods using different endpoints – the ENCORE trials – as a strategy for initial registration of emricasan as a potential treatment for patients with liver cirrhosis.
About Conatus Pharmaceuticals
Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease. Emricasan is a first-in-class, orally active pan-caspase inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Conatus believes that by reducing the activity of these enzymes, emricasan has the potential to interrupt the disease progression across the spectrum of liver disease. For additional information, please visit www.conatuspharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward looking statements, including statements regarding: improvements in biomarkers as evidence of a favorable treatment effect with emricasan; the clinical importance of the three-month results if confirmed and/or sustained over longer treatment periods with emricasan; the use of the six-month data from the Liver Cirrhosis trial to determine whether longer dosing with emricasan may lead to improvements in patients with lower baseline MELD scores and the overall patient population; the potential of measures identified by the FDA to be used as surrogate endpoints in future clinical trials in patients with liver cirrhosis; further development of emricasan with a focus on an initial registration in liver cirrhosis; the planned ENCORE clinical trials being the optimal registration path forward for emricasan; the ability of the six-month Liver Cirrhosis trial data to allow the company, with continued engagement of the regulatory authorities, to determine whether the ENCORE-LF clinical trial may be redesigned as a Phase 3 trial; the planned initiation of the ENCORE trials through early 2017; the expected results of the six-month data from patients who continued treatment and the three-month data from placebo patients who crossed over to emricasan treatment in the Liver Cirrhosis trial in the second quarter of 2016; the company’s plans to conduct multiple clinical trials covering various liver cirrhosis patient populations for different chronic dosing periods using different endpoints as a strategy for initial registration of emricasan as a potential treatment for patients with liver cirrhosis; and emricasan’s potential to interrupt the disease progression across the spectrum of liver disease. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including: Conatus’ ability to initiate and successfully complete current and future clinical trials; the potential that further analysis of the data described herein or additional data may yield different results; Conatus’ ability to evaluate emricasan’s potential medium-term and longer-term effects on liver function and liver structure in its other two ongoing clinical trials; Conatus’ ability to develop and implement a registration strategy and pathway for emricasan; FDA’s and other regulatory agencies’ interactions and guidance relating to the development of emricasan; Conatus’ dependence on its ability to obtain regulatory approval for, and then successfully commercialize emricasan, which is Conatus’ only drug candidate; Conatus’ reliance on third parties to conduct its clinical trials, enroll subjects, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of emricasan, if approved; the potential that earlier clinical trials may not be predictive of future results; potential adverse side effects or other safety risks associated with emricasan that could delay or preclude its approval; results of future clinical trials of emricasan; the potential for competing products to limit the clinical trial enrollment opportunities for emricasan in certain indications; the uncertainty of the FDA’s and other regulatory agencies’ approval processes and other regulatory requirements; Conatus’ ability to fully comply with numerous federal, state and local laws and regulatory requirements applicable to it; Conatus’ limited operating history and its ability to operate successfully as a public company; Conatus’ ability to obtain additional financing in order to complete the development and commercialization of emricasan; and those risks described in Conatus’ prior press releases and in the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in Conatus’ forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Conatus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
1 MELD score is a numerical value ranging from 6 (less ill) to 40 (gravely ill) calculated by a formula using three routine serum biomarkers: total bilirubin, creatinine, and INR, and used to position patients on the liver transplant waiting list. Biomarker values below 1 are rounded to 1 to avoid negative values in the MELD formula. Scores of 15 or greater are required for listing eligibility.
2 Child-Pugh score is a numerical value ranging from 5 (least severe) to 15 (most severe) calculated by totaling the individual scores on a 1-3 scale for three routine serum biomarkers: bilirubin, INR, and albumin; and two clinical factors: encephalopathy and ascites. Scores of 5-6 are classified as Child-Pugh A (mild liver impairment); scores of 7-9 are classified as Child-Pugh B (moderate liver impairment); scores of 10-15 are classified as Child-Pugh C (severe liver impairment).
MEDIA: David Schull Russo Partners, LLC (858) 717-2310 David.Schull@RussoPartnersLLC.com INVESTORS: Alan Engbring Conatus Pharmaceuticals Inc. (858) 376-2637 aengbring@conatuspharma.com
(AKTX) Announces Additional Data from Non-Human Primate Safety Study
Safety Study Demonstrating Equivalent Coversin Efficacy in Both Elisa CH50 and Hemolytic SRBC Assays
NEW YORK and LONDON, Jan. 05, 2016 — Akari Therapeutics (NASDAQ:AKTX), an emerging growth, development-stage biopharmaceutical company, announced an update from its 28 day non-human primate (NHP) safety study that Coversin demonstrated complete inhibition of complement C5 whether measured by Elisa CH50 or Sheep Reb Blood Cell (SRBC) lytic assay (see Figure 1 below). The study tested Coversin daily subcutaneous injection for 28 days at a low and high dose versus placebo in 24 non-human primates and demonstrated no safety issues, adverse events or injection site reactions. Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including paroxysmal nocturnal hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).
Miles Nunn, Chief Scientific Officer of Akari Therapeutics, said, “At steady state we see comparable complement inhibition in non-human primates dosed subcutaneously once a day with Coversin whether complement activity is measured by Elisa CH50 U Eq/ml assay or sheep red blood cell lytic CH50 assay. We believe the lytic assay provides a more sensitive measure of residual complement activity than the Elisa assay, and these data at steady state show that complement is completely and tightly inhibited in non-human primates given daily Coversin.”
Figure 1
http://www.globenewswire.com/NewsRoom/AttachmentNg/576a4864-596c-4ed9-bdcd-f2268f5071fa
Figure legend: Comparison of the complement activity present in the serum of non-human primates dosed daily with saline control or high dose Coversin and measured by Elisa Quidel CH50 assay or sheep red blood cell (SRBC) lytic CH50 assay. Activity is expressed as the average percentage of complement activity (with CH50 value determined by Elisa or 3-point SRBC lytic assay) at days 2, 15 and 28 compared to baseline (day 0). Vertical bars show standard error of the mean.
“We believe these data demonstrating that Coversin completely inhibited complement C5 activity whether measured by Elisa CH50 or SRBC lytic assays highlights the potential for Coversin to be the best-in-class second generation complement C5 inhibitor in development,” said Gur Roshwalb, Chief Executive Officer of Akari Therapeutics. “The non-human primate safety and complement inhibition data strengthen our belief that daily subcutaneous administration of Coversin in humans at an appropriate dose, to be determined in our upcoming Phase 1b study, should provide the complete and highly stable chronic complement inhibition needed to effectively treat complement driven diseases.”
Full data from this safety study will be presented at a future scientific forum.
About CH50 Testing
CH50 assays measure the activity of the classical complement activation pathway and are sensitive to the reduction, absence and/or inactivity of any component (including inhibited components) of the pathway.
The CH50 assay is often currently performed by an Elisa assay that measures terminal complement complex (TCC) which is formed of complement components C5b-9 (also known as the membrane attack complex or MAC). In the Elisa assay, complement in serum at a single dilution is activated by immunoglobulin either in solution or directly on the ELISA plate leading to formation of TCC. The TCC is captured on the plate and is measured and compared to a series of standards of known TCC concentration. The TCC concentration is described in units of CH50 U Eq/ml and equates directly to a CH50 value determined using the traditional CH50 assay.
The traditional CH50 assay tests the functional capability of serum complement components of the classical pathway to lyse sheep red blood cells (SRBC) pre-coated with rabbit anti-sheep red blood cell antibody (haemolysin). When antibody-coated SRBC are incubated with test serum, the classical pathway of complement is activated and hemolysis results. If a complement component is absent, the CH50 level will be zero; if one or more components of the classical pathway are decreased or inhibited, the CH50 will be decreased. The amount of complement activity is determined by examining the capacity of various dilutions of test serum to lyse antibody coated SRBC. The serum fold-dilution which causes 50% lysis of the SRBC is the CH50 value.
About Akari Therapeutics Plc
Akari is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases. Akari’s lead drug product, Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including paroxysmal nocturnal hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on
the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to realize any value of Coversin and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market;
risks resulting from unforeseen side effects; risk that the market for Coversin may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; our inability to obtain
additional capital on acceptable terms, or at all; unexpected cost increases and pricing pressures; uncertainties of cash flows and inability to meet working capital needs; and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our Quarterly Report on Form 10-Q filed on November 23, 2015. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
Contact: Investor & Media Contact: Akari Therapeutics Plc Gur Roshwalb, MD, CEO 646-350-0702 info@AkariTx.com
(AETI) Announces New $8.5 Million Credit Facility
New Relationship With Frost Bank Facilitates Company’s Global Growth Strategy
HOUSTON, Jan. 05, 2016 — American Electric Technologies Inc. (Nasdaq:AETI), a leading provider of power delivery solutions for the global energy industry, announced today the Company has entered into a new $8.5 million credit facility (“Credit Facility”) with Frost Bank of Texas.
The new Credit Facility consists of a $4.0 million revolving line of credit with a two-year term and a $4.5 million declining revolving line of credit.
“This new Credit Facility with Frost Bank provides us the liquidity and the flexibility to execute our growth strategy in the oil and natural gas and power generation and distribution sectors of the energy industry,” said Bill Brod, AETI’s Senior Vice President and Chief Financial Officer.
“We are pleased to work with the AETI management team as they execute their growth strategy,” said Michael Aubuchon, Frost Bank’s Market President. “Frost Bank has helped Texas businesses and manufacturing clients with their financial needs for 148 years. This new AETI facility is a great example of the flexibility that we provide to our clients.”
This Credit Facility replaces the Company’s prior credit facility with another bank which was scheduled to mature on December 31, 2015.
American Electric Technologies, Inc. (NASDAQ:AETI) is a leading provider of power delivery solutions for the global energy industry. AETI offers M&I Electric™ power distribution and power conversion products, control and automation systems, Power Distribution Centers (PDCs) and E&I services. South Coast Electric Systems L.L.C., a subsidiary, services Gulf Coast marine and vessel customers.
AETI is headquartered in Houston and has global operations in Beaumont, Texas; Bay St. Louis, Mississippi, and Rio de Janeiro and Macae, Brazil. In addition, AETI has minority interests in two joint ventures, which have facilities located in Xian, China and Singapore. AETI’s SEC filings, news and product/service information are available at www.aeti.com.
Investor Contacts: American Electric Technologies, Inc. Bill Brod 713-644-8182 investorrelations@aeti.com
(OGES) Sells Interest in Leclanche S.A., Releasing Funding for Corporate Growth
MELBOURNE, FL–(Jan 5, 2016) – Oakridge Global Energy Solutions, Inc. (OTCQB: OGES) is excited to announce that it has sold its entire interest, 11,000,000 shares, of European battery manufacturing company Leclanché (LECN), with financial close dated December 30, 2015. While details of this transaction are under non-disclosure with the buyer, Golden Partner Management SPC of Luxemburg, the purpose of the sale is to make available the necessary capital to fund Oakridge’s previously announced expansion strategy.
Proceeds of the sale will sufficiently fund Oakridge’s growth plans and operations going forward, and the Company has launched full production in the first quarter of 2016.
The sale has also enabled Oakridge to bring all outstanding payables to current status and also completely pay out its long-standing $2 million loan to Expedia Holdings Limited.
As a result of this transaction, Oakridge enters into 2016 completely debt-free and funded for growth.
“In the process of growing Oakridge from an R&D company to a production company we have had, like all growth companies, our share of speed bumps. However, with the infusion of cash from this sale of our holdings in Leclanché, we are now debt-free, well-funded and self-sustaining for the first time in Oakridge’s corporate history. Pivoting from here, we will continue to follow our previously announced goals and expansion plans for our existing manufacturing facilities in Florida. We are now well on our way to becoming a major player in the world lithium-ion battery manufacturing space. The addition of this significant capital into Oakridge provides the liquidity that we needed to launch this company from small scale production to one of the largest lithium battery manufacturing facilities in the world,” says Oakridge CEO Steve Barber.
On January 4, 2016, Oakridge entered into the full-scale production phase of the Company’s restructuring, as planned out by Barber and his team. The company forecasts solid revenues in January and rapid growth each month thereafter.
“Oakridge is a fantastic place to work. The business is really taking off and we are all glad to be a part of it,” says Oakridge employee Idelfonso Silva. “The addition of this new infusion of capital has will allow us to go from producing a small number of units each day to producing large scale quantities. It is a very exciting time to be at Oakridge!”
About Oakridge Global Energy Solutions, Inc.
Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 250,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s new website at http://oakridgeglobalenergy.com/
Forward-Looking Statements Disclaimer: 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. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.
(QUIK) to Present at the 18th Annual Needham & Company Growth Conference
SUNNYVALE, CA–(Jan 4, 2016) – QuickLogic Corporation (NASDAQ: QUIK), the innovator of ultra-low power programmable sensor processing solutions, today announced that Mr. Andy Pease, QuickLogic’s President and CEO, Mr. Brian Faith, Vice President of Worldwide Marketing, and Dr. Sue Cheung, the company’s Principal Accounting Officer and Corporate Controller, are scheduled to present at the Needham & Company Growth Conference in New York on January 13, 2016.
The presentation will cover how the company’s Sensor Processing Solutions create more immersive consumer experiences in smartphones and enable up to six months of battery life in wearable and IoT devices. QuickLogic’s combination of patent-pending sensor processor architecture, ultra-low power System on Chips (SoCs), and world-class sensor software algorithm library is unique in the industry and differs significantly from traditional MCU-based approaches. The recently announced EOS™ Sensor Processing Platform is designed specifically to address the emerging requirements of always-on contextual awareness and voice recognition use cases in the smartphone, wearable and IoT markets.
Location:
The Lotte New York Palace, 455 Madison Avenue, New York
Presentation:
Wednesday, January 13 at 4:50 p.m. EST
Webcast URL:
http://wsw.com/webcast/needham75/quik
(This presentation will be archived for 90 days.)
The slide presentation will be followed by a question and answer session. Individual one-on-one meetings can be arranged through Needham & Company.
About QuickLogic
QuickLogic Corporation is a leading provider of ultra-low power, customizable sensor processing platforms, Display, and Connectivity semiconductor solutions for smartphone, tablet, wearable, and mobile enterprise OEMs. Called Customer Specific Standard Products (CSSPs), these programmable ‘silicon plus software’ solutions enable our customers to bring hardware-differentiated products to market quickly and cost effectively. For more information about QuickLogic and CSSPs, visit www.quicklogic.com.
QuickLogic, the QuickLogic logo, and ArcticLink are registered trademarks and EOS is a trademark of QuickLogic Corporation. All other brands or trademarks are the property of their respective holders and should be treated as such.
Code: QUIK-G
Contact:
Andrea Vedanayagam
Veda Communications
(408) 656-4494
Email Contact
(RPRX) Updates Enclomiphene Program
- Repros expects to meet with FDA to discuss “Complete Response Letter” for enclomiphene NDA during February 2016
- Marketing Authorization Application (MAA) for enclomiphene planned for submission in Europe mid-2016
THE WOODLANDS, Texas, Jan. 04, 2016 — Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it has been granted a meeting with the Division of Bone, Reproductive and Urologic Products (DBRUP) of the FDA to discuss aspects of the “Complete Response Letter” received on Nov. 30, 2015 for the enclomiphene NDA. The meeting will be held during February 2016.
European MAA
The Company plans a central filing in Europe for an indication of enclomiphene for the treatment of secondary hypogonadism. The remaining item on the critical path to the submission is manufacture of finished drug product in Europe meeting EU requirements. The Company believes the MAA will be submitted mid-2016. The review cycle for a central filing is 17 months.
About Repros Therapeutics Inc.®
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Forward-Looking Statements
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should” or similar expressions. These statements are based on assumptions that the Company has made in light of the Company’s experience in the industry, as well as the Company’s perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to its plans to meet with the FDA to discuss the Complete Response Letter and to the eventual submission and review of the MAA. Such statements are based on current expectations that involve a number of known and unknown risks, uncertainties and other factors that may cause actual events to be materially different from those expressed or implied by such forward-looking statements, including risks that the EMA will not ultimately approve the MAA, the risk that the MAA, if granted, may have significant limitations on use, that even if the MAA is approved, the Company may not be able to successfully commercialize the product candidate, risks relating to the Company’s ability to protect its intellectual property rights and such other risks as are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Investor Relations: Thomas Hoffmann The Trout Group (646) 378-2931 thoffmann@troutgroup.com
(FCEL) Announces 5.6 Megawatt Fuel Cell Project With (PFE)
- 5.6 megawatt fuel cell system to supply ultra-clean electricity and steam to Pfizer’s research and development site in Groton, Connecticut under a power purchase agreement
- Reducing energy costs while improving carbon footprint and supporting clean air initiatives
- Grid-independent capability provides power reliability to 160 acre campus
DANBURY, Conn., Jan. 04, 2016 — FuelCell Energy, Inc. (Nasdaq:FCEL), a global leader in the design, manufacture, operation and service of ultra‐clean, efficient and reliable fuel cell power plants, announced plans for the installation of a 5.6 megawatt fuel cell power generation system for Pfizer Inc., one of the world’s largest biopharmaceutical companies, to provide reliable and low carbon electricity and steam for its 160 acre research and development facility in Groton, Connecticut. Pfizer will purchase the power and steam under a 20 year power purchase agreement that will lead to a reduction in energy costs while enhancing power reliability from on-site power generation. The highly efficient combined heat and power (CHP) fuel cell system will be configured to operate continuously, in parallel with the grid during normal operation and independently supplying electricity to campus loads during grid outages, while supporting Pfizer’s commitment to sustainability with power generation that is low carbon and efficient. The fuel cell installation is expected to be fully operational by summer 2016.
“This power purchase model delivers immediate value while increasing electrical reliability by providing the security of on-site power with a financial structure that avoids an investment in power generation assets, and FuelCell Energy installs, operates and maintains the fuel cell power plants,” said Chip Bottone, President and Chief Executive Officer, FuelCell Energy, Inc. “Affordably addressing both energy and sustainability goals is an attractive value proposition offered by FCE.”
The fuel cell system will include two DFC3000® fuel cell power plants, each rated at 2.8 megawatts that operate in tandem to generate 5.6 megawatts of clean power and steam and will supply a portion of the Pfizer Groton facility’s energy needs. Generating both power and steam from the same unit of fuel reduces heating costs and the associated pollutants and carbon emissions from more traditional combustion-based boiler systems. The fuel cells will operate parallel with the electric grid and, in the event of a grid disturbance, continue to provide power to Pfizer’s Groton facility by switching to what is termed an ‘island’ mode that is grid independent.
The CHP-configured fuel cell plants produce clean power and heat via an electrochemical process that avoids combustion and its associated pollutants, including nitrogen oxide (NOx) that causes smog, sulfur dioxide (SOx) that contributes to acid rain, and particulate matter that can aggravate asthma. The emissions profile of the fuel cells installed at the Pfizer facility will reduce greenhouse gas (GHG) emissions; avoiding more than 28,900 tons of CO₂ and more than 34 tons of NOx annually as compared to the average U.S. grid, which is equivalent to removing more than 5,300 cars from the road. These environmental benefits can be realized by Pfizer or sold to third parties through renewable energy certificates.
Fuel cells electrochemically convert a fuel source into electricity and heat in a highly efficient process that emits virtually no pollutants due to the absence of combustion. The Direct FuelCell® (DFC®) stationary fuel cell power plants manufactured by FuelCell Energy utilize carbonate fuel cell technology and provide continuous power located where the power is used, including both on-site applications and electric grid support. The combination of near-zero pollutants, modest land-use needs, and quiet operating nature of these stationary fuel cell power plants facilitates locating the power plants in urban locations. The power plants are fuel flexible, capable of operating on clean natural gas, on-site renewable biogas, or directed biogas.
About FuelCell Energy
Direct FuelCell® power plants are generating ultra-clean, efficient and reliable power at more than 50 locations worldwide. With more than 300 megawatts of power generation capacity installed or in backlog, FuelCell Energy is a global leader in providing ultra-clean baseload distributed generation to utilities, industrial operations, universities, municipal water treatment facilities, government installations and other customers around the world. The Company’s power plants have generated over four billion kilowatt hours of ultra-clean power using a variety of fuels including renewable biogas from wastewater treatment and food processing, as well as clean natural gas. For additional information, please visit www.fuelcellenergy.com, follow us on Twitter and view our videos on YouTube.
Direct FuelCell, DFC, DFC/T, DFC-H2 and FuelCell Energy, Inc. are all registered trademarks of FuelCell Energy, Inc. DFC-ERG is a registered trademark jointly owned by Enbridge, Inc. and FuelCell Energy, Inc.
FuelCell Energy, Inc. Kurt Goddard, Vice President Investor Relations 203-830-7494 ir@fce.com
(CERC) to Present at Biotech Showcase 2016 in San Francisco
Cerecor Inc. (NASDAQ:CERC), a clinical-stage biopharmaceutical company developing treatments to make a difference in the lives of patients with neurological and psychiatric disorders, today announced that it will present at Biotech Showcase 2016 on Tuesday, January 12, 2016. The presentation is scheduled at 11:30 a.m., PST, in the Parc 55 Hilton Hotel, San Francisco.
About Cerecor
Cerecor Inc. is a Baltimore-based biopharmaceutical company with the goal of becoming a leader in the development of innovative drugs that make a difference in the lives of patients with neurological and psychiatric diseases by addressing the unmet medical needs of underserved patient segments. We are committed to the development of drugs that improve lives by applying our extensive knowledge and experience in central nervous system disorders. For more information about the Company and its products, please visit: www.cerecor.com or contact Mariam E. Morris, Chief Financial Officer, at (443) 304-8002.
MacDougall Biomedical Communications
Doug MacDougall, 781-235-3060
or
Joe Rayne, 781-235-3060
jrayne@macbiocom.com
(AXSM) to Present at Biotech Showcase 2016
NEW YORK, Jan. 04, 2016 — Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical stage biopharmaceutical company developing novel therapies for the management of pain and other central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Executive Officer, will present at the 8th Annual Biotech Showcase 2016 conference on January 13, 2016 at 10:00 AM Pacific Time. Dr. Tabuteau will provide an overview of Axsome’s business and late-stage clinical product candidates, AXS-02 and AXS-05. The conference will be held at the Parc 55 Hotel in San Francisco, CA.
A live webcast and archive of the event can be viewed on the Company’s website at www.axsome.com.
For more information on Biotech Showcase 2016, please visit: www.ebdgroup.com/bts/index.php.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel therapies for the management of pain and other central nervous system (CNS) disorders. By focusing on this therapeutic area, Axsome is addressing significant and growing markets where current treatment options are limited or inadequate. Axsome’s product candidate portfolio includes two late-stage candidates, AXS-02 and AXS-05. AXS-02 is currently in a Phase 3 trial in complex regional pain syndrome (CRPS), with additional Phase 3 trials planned in knee osteoarthritis (OA) associated with bone marrow lesions (BMLs), and chronic low back pain (CLBP) associated with Modic changes (MCs). A Phase 3 trial in treatment resistant depression (TRD) is currently planned with AXS-05. Axsome aims to become a fully integrated biopharmaceutical company that develops and commercializes differentiated therapies that expand the treatment options available to caregivers and improve the lives of patients living with pain and other CNS disorders.
AXS-02 and AXS-05 are investigational medications not approved by the FDA. The safety and efficacy of AXS-02 and AXS-05 have not yet been established.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “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. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the trials; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s product candidates, if approved; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.
Axsome Contact: Mark Jacobson Vice President, Operations Axsome Therapeutics, Inc. 25 Broadway, 9th Floor New York, NY 10004 Tel: 212-332-3243 Email: mjacobson@axsome.com www.axsome.com Trout Group Contact: Marcy Beth Nanus Senior Vice President The Trout Group LLC Tel: 646-378-2927 Email: mnanus@troutgroup.com
(MOXC) Establishes Beijing Subsidiary, Defines Expansion Plans
BEIJING, CHINA–(Jan 4, 2016) – Moxian, Inc. (OTCQB: MOXC) is pleased to announce the formation of a new corporate subsidiary, Moxian Technologies (Beijing) Co. Ltd., located in the Dongcheng district of Beijing and in close proximity to the Guomao business district. Moxian Beijing is focused on growing Moxian sales in Beijing and aims to drive local merchants and users to its social marketing and promotion platform.
Moxian Beijing’s nearly 2,000-square-foot Beijing office is able to accommodate up to 80 employees. To-date, Moxian Beijing is staffed with 15 employees, a number the company expects to increase to both facilitate and accommodate corporate growth. In addition, the company expects to increase its in-house Beijing sales team to 50 salesman in 2016 as it pursues maximum market penetration.
As the capital of the People’s Republic of China (PRC) and home to 20 million residents, Beijing is the national political and cultural center of China — easily outpacing any other PRC city in terms of economic and commercial opportunity.
“We’re proud to set up our Moxian subsidiary company in Beijing — an impressively developed economy city with numerous opportunities for small and medium businesses like ours. The establishment of a Beijing office represents a qualitative leap and immeasurable bright future for Moxian,” states company CEO Tan Meng Dong James.
About Moxian
Moxian engages in the business of providing social marketing and promotion platforms to merchants who desire to promote their businesses through online social media. The company’s products and services aim to enhance the interaction between users and merchant clients by allowing merchant clients to study consumer behavior through data compiled from our database of users’ activities. Moxian designs its products and services to allow merchant clients to run advertising campaigns and promotions targeting their customers. Moxian’s platform is also designed and built to entice users to return frequently and to encourage new consumer users to subscribe to its website.
For more information visit: http://ir.moxian.com/html-en/
Forward-Looking Statements:
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
(RIBT) & Kentucky Equine Research Sign Exclusive Supply & Cooperation Agreement
World Leader in Equine Nutrition Partners with Technology Leader in Rice Bran Stabilization and Processing
SCOTTSDALE, Arizona, December 30, 2015 —
RiceBran Technologies (NASDAQ: RIBT and RIBTW) (the “Company” or “RBT”), a global leader in the production and marketing of value added products derived from rice bran, today announced that the Company has entered into a 10 year Exclusive Supply and Cooperation Agreement covering the North American equine market with Kentucky Equine Research (“KER”), an international equine nutrition, research, and consultation company serving horse owners and the feed industry.
Under the terms of the agreement, RBT will be the exclusive supplier of stabilized rice bran (“SRB”) endorsed by KER for use as a feed and supplement ingredient in equine products sold in North America. RBT will provide manufacturing, distribution, sales and marketing expertise and KER will contribute sales and marketing expertise, technical support and research and development to the partnership.
Dr. Joe Pagan, President and Founder of KER, commented: “We are excited to enter into this agreement with RiceBran Technologies. In addition to RBT being the technology leader in rice bran stabilization, their patented processes produce a range of unique rice bran derivatives that we will jointly develop with the aim of producing high value equine supplements with targeted nutritional applications.”
W. John Short, CEO & President of RBT, commented: “Dr. Pagan has built KER into the leading equine nutrition company in the world. It is a pleasure and an honor to have the opportunity to cooperate with Joe and KER to increase market penetration for both of our companies as we work to bring new, high value equine feeds and supplements to the North American equine market.”
About Kentucky Equine Research
Kentucky Equine Research (KER) is an international equine nutrition, research, and consultation company serving horse owners and the feed industry. KER’s goals are to advance the industry’s knowledge of equine nutrition and exercise physiology, apply that knowledge to produce healthier, more athletic horses, and support the nutritional care of all horses throughout their lives. For more information about KER, please visit https://ker.com .
About RiceBran Technologies
RiceBran Technologies is a human food ingredient and animal nutrition company focused on the procurement, bio-refining and marketing of numerous products derived from rice bran. RiceBran Technologies has proprietary and patented intellectual property that allows us to convert rice bran, one of the world’s most underutilized food sources, into a number of highly nutritious human food ingredient and animal nutrition products. Our target markets are human food ingredients and animal nutrition manufacturers and retailers, as well as natural food, functional food and nutritional supplement manufacturers and retailers, both domestically and internationally. More information can be found in the Company’s filings with the SEC and by visiting our website at http://www.ricebrantech.com .
Forward-Looking Statements
This release contains forward-looking statements, including, but not limited to, statements about RiceBran Technologies’ expectations regarding recovery of funds from an escrow account related to the 2008 purchase of Irgovel. These statements are made based upon current expectations that are subject to known and unknown risks and uncertainties. RiceBran Technologies does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in this press release and in RiceBran Technologies’ filings with the Securities and Exchange Commission, including its most recent periodic reports.
Investor Contact:
Ascendant Partners, LLC
Fred Sommer
+1-732-410-9810
fred@ascendantpartnersllc.com
(MTP) Completes Acquisition of (GALE) Zuplenz®
Further Product Acquisition Bolsters Marketed Oncology Portfolio
OXFORDSHIRE, United Kingdom, Dec. 30, 2015 — Midatech Pharma (“Midatech” or the “Company” or the “Group”) (AIM:MTPH) (Nasdaq:MTP), the international specialty pharmaceutical company focused on developing and commercialising products in oncology and other therapeutic areas, today announces the successful completion of its previously announced acquisition of Zuplenz® (ondansetron), a marketed oncology product from Galena Biopharma, Inc. (NASDAQ:GALE). Zuplenz® is marketed in the US for the prevention of chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV) and has a target market of $4.6bn by 2018.
As announced on 18 December 2015, Midatech expects the acquisition of Zuplenz® will leverage its commercial infrastructure in the US, following the recent acquisition of DARA BioSciences (now known as Midatech Pharma US Inc.).
Commenting on the announcement, Dr. Jim Phillips, CEO of Midatech Pharma, said: “We are pleased to complete the acquisition of Zuplenz®, which adds to our rapidly growing portfolio of marketed oncology products. We believe that our recent product acquisitions will help drive the Group towards sustainable profitability.”
References:
Antiemetic Drugs: World Industry and Market Analysis 2014-2024
About Midatech Pharma PLC
Midatech is an international specialty pharmaceutical company focused on oncology and other therapeutic areas with a commercial platform and four marketed products in the US. Midatech’s strategy is to develop products in-house in oncology and with partners in other indications, and to accelerate growth organically and through strategic acquisitions. The Company’s R&D activities are supported by two breakthrough drug delivery technologies. The Group, listed on AIM: MTPH and Nasdaq: MTP, employs c.100 staff in four countries. For further company information see: www.midatechpharma.com
About Zuplenz®
Zuplenz® was launched in the US in July 2015 and is an anti-emetic oral soluble film, which does not need to be injected or swallowed, offering patients a differentiated alternative to other treatments. Zuplenz® complements Midatech’s existing marketed oncology product portfolio and has patent protection until at least 2029. Zuplenz® is targeting an estimated $4.6bn market by 2018 and is expected to add to Midatech’s growing revenues.
Forward Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such forward-looking statements include, but are not limited to, statements regarding the anticipated benefits of the acquisition of Zuplenz®, our expected revenues, market and growth opportunities and other benefits associated with the acquisition of Zuplenz® and other statements that are not historical fact. Any forward-looking statements are based on currently available competitive, financial and economic data together with management’s views and assumptions regarding future events and business performance as of the time the statements are made and are subject to risks and uncertainties. We wish to caution you that there are some known and unknown factors that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements, including but not limited to, operational challenges in achieving our objectives with respect to Zuplenz®, achieving strategic objectives and executing plans, the risk that markets do not evolve as anticipated, the potential impact of the general economic conditions and competition in the industry.
Reference should be made to those documents that Midatech shall file from time to time or announcements that may be made by Midatech in accordance with the London Stock Exchange AIM Rules for Companies (“AIM Rules”), the Disclosure and Transparency Rules (“DTRs”) and the rules and regulations promulgated by the US Securities and Exchange Commission (“SEC”), which contains and identifies other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Midatech are expressly qualified in their entirety by the cautionary statements above. Except as may be required under the AIM Rules or the DTRs or by relevant law in the United Kingdom or the United States, Midatech does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or otherwise arising
For more information, please contact: Midatech Pharma PLC Jim Phillips, CEO Tel: +44 (0)1235 841575 www.midatechpharma.com Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) Corporate Finance Freddy Crossley / Adam James / Atholl Tweedie / Duncan Monteith Broking Tom Salvesen Tel: +44 (0)20 7886 2500 RBC Europe Limited (Joint Broker) Darrell Uden / Paul Tomasic / Rupert Walford / Thomas Stockman Tel: +44 (0)207 653 4000 Consilium Strategic Communications (Financial PR) Mary Jane Elliott / Ivar Milligan / Matthew Neal / Hendrik Thys Tel: +44 (0)20 3709 5700 Email: midatech@consilium-comms.com
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