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(OGXI) Update on Phase 3 ENSPIRIT Trial Of Custirsen In Lung Cancer
BOTHELL, Wash. and VANCOUVER, British Columbia, Aug. 21, 2014 — OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the Phase 3 ENSPIRIT trial, evaluating custirsen in the treatment of non-small cell lung cancer (NSCLC), is continuing as planned per the recommendation of the Independent Data Monitoring Committee (IDMC) based upon completion of the first interim futility analysis.
“While the results of the study remain blinded to OncoGenex and Teva, we are very pleased that ENSPIRIT has passed this important early interim futility analysis,” said Scott Cormack, President and CEO of OncoGenex. “We remain strong in our belief that targeting mechanisms of treatment resistance is a critical path forward in the fight against cancer and we continue to actively pursue this approach through the two ongoing Phase 3 trials of custirsen and the seven Phase 2 trials of apatorsen in four tumor types.”
The Phase 3 ENSPIRIT trial is an international, randomized, open-label trial designed to evaluate a survival benefit for custirsen in the treatment of advanced or metastatic non-small cell lung cancer in 1,100 patients who have progressed after initial chemotherapy treatment. Patients are randomized to receive custirsen plus docetaxel or docetaxel alone. Patient enrollment to ENSPIRIT was initiated by Teva in September 2012. Two interim futility analyses are planned for stopping the trial. The first of these two futility analyses has now been completed which allows for acceleration of further enrollment. A second futility analysis will be conducted later in the trial. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the evaluation of custirsen in the ENSPIRIT trial.
Custirsen is also being evaluated in the ongoing Phase 3 AFFINITY trial with second-line chemotherapy in men with metastatic castrate-resistant prostate cancer. The expected timing of AFFINITY results is based on a pre-specified number of death events, however the Company currently expect final results to be announced in late 2015 or early 2016.
About Custirsen
Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance. Clusterin is upregulated in tumor cells in response to treatment interventions such as chemotherapy, hormone ablation and radiation therapy and has been found to be overexpressed in a number of cancers, including prostate, lung, breast and bladder. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration. By inhibiting clusterin, custirsen is designed to alter tumor dynamics, slowing tumor growth and resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.
As part of Phase 1 and Phase 2 clinical trials, custirsen was administered to 294 patients with various types of cancer. The majority of adverse events were mild. The most common adverse events associated with custirsen consisted of flu-like symptoms. The most common serious adverse events (SAE) associated with custirsen were febrile neutropenia, fever, pleural effusion, and dyspnea. Each SAE event was observed in approximately 2%-4% of patients. In the Phase 3 SYNERGY trial in men with metastatic CRPC, adverse events observed were similar to custirsen’s known adverse event profile.
About OncoGenex
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. OncoGenex and Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) have entered a global collaboration and licensing agreement to develop and commercialize OncoGenex’ lead drug candidate, custirsen. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. Apatorsen is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com and at the company’s Twitter account https://twitter.com/OncoGenex_IR.
OncoGenex’ Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning our anticipated product development activities, such as expected clinical trial completion and design, statements regarding timing of enrollment and trial completion and statements regarding the potential benefits and potential development of our product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that our product candidates will not demonstrate the hypothesized or expected benefits, the risk of delays in our expected clinical trials, the risk that new developments in the rapidly evolving cancer therapy landscape require changes in our clinical trial plans or limit the potential benefits of our product, the risk that we are unable to complete enrollment in our clinical trials in the expected timeframe and the other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
(PLCE) Partners With Arvind Lifestyle Brands Limited to Expand Into India
SECAUCUS, N.J., Aug. 21, 2014 — The Children’s Place, Inc. (Nasdaq:PLCE), the largest pure-play children’s specialty apparel retailer in North America, today announced that it entered into a franchise agreement with Arvind Lifestyle Brands Limited to open stores in India, with the potential to open 50 stores over time beginning in the Fall of 2015.
Jane Elfers, President and Chief Executive Officer of The Children’s Place, stated, “We are excited to be partnering with Arvind, which has a proven track record of operating successful apparel brands in India. We are making significant strides in our International franchise business, and we remain focused on providing great fashion and value for kids around the world.”
Commenting on the new partnership, Mr. Sanjay Lalbhai, Chairman & Managing Director of Arvind Limited, stated, “The Children’s Place will be the first of its kind children’s retail format in India. It will be a one stop shop for children sizes 0 to 14, and we are delighted to bring The Children’s Place to India.”
About The Children’s Place, Inc.
The Children’s Place is the largest pure-play children’s specialty apparel retailer in North America. The Company designs, contracts to manufacture, sells and licenses to sell fashionable, high-quality merchandise at value prices, primarily under the proprietary “The Children’s Place,” “Place” and “Baby Place” brand names. As of August 2, 2014, the Company operated 1,113 stores in the United States, Canada and Puerto Rico, an online store at www.childrensplace.com, and had 54 International stores open and operated by its franchise partners.
About Arvind Lifestyle Brands Limited
Arvind Lifestyle Brands Limited is a subsidiary of Arvind Limited which is India’s largest integrated textile enterprise and is one of the oldest groups in the textile business in India. Arvind is also one of the largest producers of denim fabric and is supplier to a large number of fashion brands worldwide. Arvind has been a pioneer in bringing international brands to India, beginning in 1993, and has licensing relationships with many U.S. and European brands. Arvind also has its own portfolio of 12 brands, operates the India retail operations of large British retailers and operates India’s largest value retail chain.
Forward Looking Statements
This press release may contain certain forward-looking statements regarding future circumstances, including statements relating to the Company’s strategic initiatives and adjusted net income per diluted share. These forward-looking statements are based upon the Company’s current expectations and assumptions and are subject to various risks and uncertainties that could cause actual results and performance to differ materially. Some of these risks and uncertainties are described in the Company’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of its annual report on Form 10-K for the fiscal year ended February 1, 2014. Included among the risks and uncertainties that could cause actual results and performance to differ materially are the risk that the Company will be unsuccessful in gauging fashion trends and changing consumer preferences, the risks resulting from the highly competitive nature of the Company’s business and its dependence on consumer spending patterns, which may be affected by the weakness in the economy that continues to affect the Company’s target customer or by other factors such as increases in the cost of gasoline and food, the risk that the Company’s strategic initiatives to increase sales and margin are delayed or do not result in anticipated improvements, the risk that the cost of raw materials or energy prices will increase beyond current expectations or that the Company is unable to offset cost increases through value engineering or price increases, and the uncertainty of weather patterns. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to release publicly any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. The inclusion of any statement in this release does not constitute an admission by the Company or any other person that the events or circumstances described in such statement are material.
(TRUE) Serving Targeted Manufacturer Incentives To Customers Of Insurance Affinity Partners
TrueCar Helps Automakers More Efficiently Target Their $40 Billion Annual Incentive Spend While Enabling Insurance Partners to Delight Total Loss Customers
SANTA MONICA, Calif., Aug. 21, 2014 — TrueCar, Inc. (NASDAQ: TRUE), the negotiation-free car buying and selling platform, today announced that it has launched major enhancements to the auto buying programs for its insurance affinity partners, specifically the integration of exclusive incentives from automakers uniquely tailored to the needs of total-loss customers. Through the TrueCar platform, automakers now have the ability to deploy marketing resources in a fully accountable manner by offering targeted incentives to customers who suffered a total loss to a vehicle and are unexpectedly in-market for a replacement vehicle. GEICO is the first of TrueCar’s 13 insurance affinity partners to adopt these enhancements, and through the remainder of 2014, TrueCar plans to roll out these platform enhancements to these additional insurance partners, who collectively underwrite over 50% of the automobile policies on the road today.
“More than three million U.S. car owners suffer crashes that result in total losses each year, and most need replacement vehicles right away. Whereas insurance companies have traditionally handed the customer a settlement check and a rental car voucher, TrueCar’s insurance affinity partners are now going above and beyond to help the customer put a new replacement vehicle in the garage and assist them in getting a great deal,” said John Krafcik, TrueCar President. “In addition to helping automakers target their $40 billion incentive budgets, TrueCar enables our insurance affinity partners to provide a delightful customer experience while reducing the incremental costs incurred as a customer recovers from a total-loss event.”
With the new program enhancements, customers of TrueCar’s affinity insurance partners are now able to receive offers and savings directly from participating automakers. In working with their launch partner GEICO and the Chrysler Group, which includes Chrysler, Jeep, Dodge, Ram, and FIAT vehicles, TrueCar has integrated its auto-buying platform with the GEICO claims system to enable eligible GEICO total loss customers to receive a $1,000 incentive on any Chrysler Group vehicle, which can also be combined with other discounts or incentives available at the time of purchase.
“The experience of replacing a total loss vehicle is often a difficult and painful one,” said Jeffrey Kommor, Vice President of U.S Sales Operations for Chrysler Group LLC. “We’re now able to offer total loss customers significant savings on the purchase of a new vehicle, and help make the replacement process much easier for them.”
“We are excited to be the first insurance company to offer this unique targeted incentive with Chrysler to help our customers in time of need to get back on the road quickly,” said Seth Ingall, Senior Vice President at GEICO. “TrueCar’s negotiation-free platform really helps save our customers not only time but also money.”
In addition to exclusive incentives from automakers, TrueCar has also launched an interface that allows insurance affinity partners to integrate TrueCar’s referral tool, called Fast Track, into their claims workflow system. Insurance affinity partners will also be able to take advantage of a new online application that helps total loss customers find their ideal replacement vehicles more quickly and get negotiation-free guaranteed savings off MSRP for new cars at either standard TrueCar Certified Dealers or dealer-owned resource centers that specialize in serving total loss customers.
For more information about TrueCar, please visit www.TrueCar.com, follow @TrueCar on Twitter, or become a fan of TrueCar on Facebook.
About TrueCar
TrueCar, Inc. (NASDAQ: TRUE) is the negotiation-free car buying and selling platform. TrueCar enables a negotiation-free car buying experience by giving buyers transparent insight into what others actually paid (price confidence), upfront pricing information (price discovery), and access to a network of trusted TrueCar Certified Dealers who provide guaranteed savings certificates and seamlessly complete the car purchase. The reality is that buying a car is painful and buyers fear they are going to overpay or be surprised with hidden fees. TrueCar’s transparent upfront pricing information makes the car buying process simple so there are no surprises and buyers never overpay. TrueCar’s mission is to make car buying simple, fair and fun. Its national network of more than 8,000 TrueCar Certified Dealers, including both new car franchise dealers and non-franchise dealers, is committed to providing negotiation-free savings off MSRP and upfront pricing information for all car-buyers, including members of some of the country’s largest membership and service organizations such as AARP, American Express, AAA, and USAA. Note: Not all program features are available in all states. Go to www.truecar.com for program details. TrueCar is headquartered in Santa Monica, Calif., with offices in Santa Barbara, Calif., San Francisco, Calif., and Austin, Texas.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained or referred to in this press release, including statements or references to adoption of enhancements to the TrueCar platform by our partners and the ability of such partners to take advantage of such enhancements are forward-looking statements. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions that may prove incorrect, any of which could cause our results to differ materially from those expressed or implied by such forward-looking statements. Among the risks and uncertainties that could cause our results to differ materially from those expressed or implied by such forward-looking statements include: our ability to successfully roll-out program enhancements to additional insurance partners, the rate of adoption of such platform enhancements into their claims workflow, and other risks and uncertainties described more fully under the heading “Risk Factors” in TrueCar’s registration statement on Form S-1 and its quarterly report on Form 10-Q, each filed with the Securities and Exchange Commission. All forward-looking statements included or referred to in this press release are based on information available to us as of the date hereof, and we assume no obligation to update these forward-looking statements, which speak only as of their respective dates.
(AMSC) Receives $15 Million Follow-On Order From Inox Wind
DEVENS, Mass., Aug. 21, 2014 — AMSC (Nasdaq:AMSC), a global solutions provider serving wind and power grid industry leaders, today announced that it has received a $15 million order for wind turbine electrical control systems (ECS) from Inox Wind Limited, part of India’s Inox Group of Companies. The Company expects the majority of shipments under this contract to occur during fiscal year 2015. This is the seventh order that AMSC has received from Inox since the company began volume production of its 2 megawatt (MW) wind turbines, which were licensed from AMSC in May 2009.
“Together with AMSC’s wind turbine design expertise and smart electrical control systems, Inox is delivering wind turbines with some of the highest availability, reliably and power in India,” said Devansh Jain, director of Inox Wind Limited. “We have been successful in growing our business and taking market share in India as we continue to work towards our goal of being the preferred wind solutions provider to independent power producers, utilities, and large corporations.”
According to Bloomberg New Energy Finance (BNEF), India has more than 20 gigawatts (GW) of installed wind capacity. The government recently restored a tax incentive that benefits the wind industry. BNEF expects this incentive to result in wind installations of 2.6 GW in 2014, which would be a three year high for the country. Wind installations are expected to increase steadily to 3.5 GW of installations in 2016.
“The effects of this most recent order from Inox are to extend our existing backlog and provide us greater visibility into fiscal 2015 revenues,” said Daniel P. McGahn, President and CEO, AMSC. “Inox continues to execute on its ambitious growth plan and its planned IPO later this year is expected to provide the capital needed to continue on its path of being a major player in the Indian wind market.”
AMSC’s ECS are an integrated, high-performance suite of power electronics systems that include the wind turbine power converter cabinet, internal power supply and various controls. Together, these systems serve as the “brains” of the wind turbine and enable reliable, high-performance operation by controlling power flows, regulating voltage, monitoring system performance, controlling the pitch of the wind turbine blades and the yaw of the turbines to maximize efficiency.
AMSC reiterates its full year fiscal 2014 expectation of flat to slightly down revenues as compared to fiscal 2013.
About Inox Wind Limited
Inox Wind Limited is part of the Inox Group of Companies. Inox Group is a $2 billion+, professionally managed business group, with interests in diverse businesses including Industrial Gases, Refrigerants, Engineering Plastics, Chemicals, Carbon Credits, Cryogenic Engineering, Renewable Energy and Entertainment. The INOX Group employs close to 9,000 people at more than 150 business units across the country and has a distribution network that is spread across more than 50 countries around the globe. Each INOX Group company is characterized by three distinct characteristics – early identification of a winning business idea, building it to a size of dominant market leadership in that segment, and attaining a profit leadership position through cutting-edge efficiency in operations. The Inox Group of Companies, besides Inox Wind Limited, includes Inox Air Products Limited, Gujarat Fluorochemicals Limited, Inox India Limited, Inox Renewables Limited, Inox Leisure Limited and Fame India limited. More information is available at www.inoxwind.com.
About AMSC (Nasdaq:AMSC)
AMSC generates the ideas, technologies and solutions that meet the world’s demand for smarter, cleaner … better energy. Through its Windtec™ Solutions, AMSC provides wind turbine electronic controls and systems, designs and engineering services that reduce the cost of wind energy. Through its Gridtec™ Solutions, AMSC provides the engineering planning services and advanced grid systems that optimize network reliability, efficiency and performance. The company’s solutions are now powering gigawatts of renewable energy globally and enhancing the performance and reliability of power networks in more than a dozen countries. Founded in 1987, AMSC is headquartered near Boston, Massachusetts with operations in Asia, Australia, Europe and North America. For more information, please visit www.amsc.com.
AMSC, Windtec, ECS, Gridtec, and Smarter, Cleaner … Better Energy are trademarks or registered trademarks of American Superconductor Corporation. All other brand names, product names, trademarks or service marks belong to their respective holders.
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 (the “Exchange Act”). Any statements in this release regarding the Company’s expectations as to when the majority of shipments will be completed under the Supply Contract; projections regarding wind installations in India; Inox’s ability to provide the capital needed to continue to be a major player in the Indian wind market; expectations regarding fiscal 2014 revenues; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements represent management’s current expectations and are inherently uncertain. There are a number of important factors that could materially impact the value of our common stock or cause actual results to differ materially from those indicated by such forward-looking statements. Such factors include: We have a history of operating losses, which may continue in the future. Our operating results may fluctuate significantly from quarter to quarter and may fall below expectations in any particular fiscal quarter; we have a history of negative operating cash flows, and we may require additional financing in the future, which may not be available to us; Our Term Loans include certain covenants and other events of default. Should we not comply with these covenants or incur an event of default, we may be required to repay our obligation in cash, which could have an adverse effect on our liquidity; We may be required to issue performance bonds or provide letters of credit, which restricts our ability to access any cash used as collateral for the bonds or letters of credit; Changes in exchange rates could adversely affect our results from operations; If we fail to maintain proper and effective internal controls over financial reporting, our ability to produce accurate and timely financial statements could be impaired and may lead investors and other users to lose confidence in our financial data; Our success in addressing the wind energy market is dependent on the manufacturers that license our designs; Our success is dependent upon attracting and retaining qualified personnel and our inability to do so could significantly damage our business and prospects; We may not realize all of the sales expected from our backlog of orders and contracts; Our financial condition may have an adverse effect on our customer and supplier relationships; Failure to successfully execute the consolidation of our Grid manufacturing operations or achieve expected savings could adversely impact our financial performance; Our business and operations would be adversely impacted in the event of a failure or security breach of our information technology infrastructure; We may not be able to launch operations at our newly leased manufacturing facility in Romania, and, if we are able to do so, we may have manufacturing quality issues, which would negatively affect our revenues and financial position; We rely upon third-party suppliers for the components and subassemblies of many of our Wind and Grid products, making us vulnerable to supply shortages and price fluctuations, which could harm our business; Many of our revenue opportunities are dependent upon subcontractors and other business collaborators; If we fail to implement our business strategy successfully, our financial performance could be harmed; Problems with product quality or product performance may cause us to incur warranty expenses and may damage our market reputation and prevent us from achieving increased sales and market share; New regulations related to conflict-free minerals may force us to incur significant additional expenses; Our contracts with the U.S. government are subject to audit, modification or termination by the U.S. government and include certain other provisions in favor of the government. The continued funding of such contracts remains subject to annual congressional appropriation which, if not approved, could reduce our revenue and lower or eliminate our profit; Many of our customers outside of the United States are, either directly or indirectly, related to governmental entities, and we could be adversely affected by violations of the United States Foreign Corrupt Practices Act and similar worldwide anti-bribery laws outside the United States; We have limited experience in marketing and selling our superconductor products and system-level solutions, and our failure to effectively market and sell our products and solutions could lower our revenue and cash flow; We may acquire additional complementary businesses or technologies, which may require us to incur substantial costs for which we may never realize the anticipated benefits; Our success depends upon the commercial use of high temperature superconductor (HTS) products, which is currently limited, and a widespread commercial market for our products may not develop; Growth of the wind energy market depends largely on the availability and size of government subsidies and economic incentives; We have operations in and depend on sales in emerging markets, including China and India, and global conditions could negatively affect our operating results or limit our ability to expand our operations outside of these countries. Changes in China’s or India’s political, social, regulatory and economic environment may affect our financial performance; Our products face intense competition, which could limit our ability to acquire or retain customers; Our international operations are subject to risks that we do not face in the United States, which could have an adverse effect on our operating results; Adverse changes in domestic and global economic conditions could adversely affect our operating results; We may be unable to adequately prevent disclosure of trade secrets and other proprietary information; Our patents may not provide meaningful protection for our technology, which could result in us losing some or all of our market position; There are a number of technological challenges that must be successfully addressed before our superconductor products can gain widespread commercial acceptance, and our inability to address such technological challenges could adversely affect our ability to acquire customers for our products; We have not manufactured our Amperium wire in commercial quantities, and a failure to manufacture our Amperium wire in commercial quantities at acceptable cost and quality levels would substantially limit our future revenue and profit potential; Third parties have or may acquire patents that cover the materials, processes and technologies we use or may use in the future to manufacture our Amperium products, and our success depends on our ability to license such patents or other proprietary rights; Our technology and products could infringe intellectual property rights of others, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages and disrupt our business; We have filed a demand for arbitration and other lawsuits against our former largest customer, Sinovel, regarding amounts we contend are overdue. We cannot be certain as to the outcome of these proceedings; We have been named as a party in various legal proceedings, and we may be named in additional litigation, all of which will require significant management time and attention, result in significant legal expenses and may result in an unfavorable outcome, which could have a material adverse effect on our business, operating results and financial condition; Our common stock has experienced, and may continue to experience, significant market price and volume fluctuations, which may prevent our stockholders from selling our common stock at a profit and could lead to costly litigation against us that could divert our management’s attention.
These and the important factors discussed under the caption “Risk Factors” in Part 1. Item 1A of our Form 10-K for the fiscal year ended March 31, 2014, and our other reports filed with the SEC, among others, could cause actual results to differ materially from those indicated by forward-looking statements made herein and presented elsewhere by management from time to time. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
CONTACT: AMSC Contact: Kerry Farrell Phone: 978-842-3247 Email: kerry.farrell @ amsc.com
(EVRY) Agrees to Sell UK Business
LANCASTER, Ohio, Aug. 21, 2014 — EveryWare Global, Inc. (“EveryWare” or the “Company”) (Nasdaq:EVRY), today announced that its wholly-owned subsidiary Oneida International has entered into an agreement to sell its United Kingdom business to HUK 54 Limited. EveryWare retains all rights to the brands ONEIDA®, Anchor Hocking® and Sant’ Andrea®.
Sam Solomon, Chief Executive Officer of EveryWare, stated, “This transaction represents another step toward building a profitable future for EveryWare. We are confident that there remain long-term opportunities to build and grow our brands internationally. Our energies are currently focused on solidifying our core North American operations, and this sale ensures that our resources are dedicated to those initiatives.”
For additional detail on the transaction, please refer to the Form 8-K filed today with the Securities and Exchange Commission.
About EveryWare
EveryWare (Nasdaq:EVRY) is a leading marketer of tabletop and food preparation products for the consumer, foodservice, and specialty markets. The Company offers a comprehensive line of tabletop and food preparation products, such as bakeware, beverageware, serveware, storageware, flatware, dinnerware, crystal, banquetware, and hollowware; premium spirit bottles; cookware; gadgets; candle and floral glass containers; and other kitchen products. Additional information can be found on EveryWare’s Investor Relations Website: http://investors.everywareglobal.com/.
Forward-Looking Statements
This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbors created under the Securities Act of 1933 (the “Securities Act”) and the Securities Exchange Act of 1934 (the “Exchange Act”). All statements other than statements of historical facts are statements that could be deemed forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the industries in which we operate and the beliefs and assumptions of our management. Words such as “tentative,” “proposal,” “offers,” “expects,” “anticipates,” “targets,” “goals,” “projects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “continues,” “endeavors,” “strives,” “may,” variations of such words, and similar expressions are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, our anticipated growth and trends in our businesses, covenant compliance, liquidity and other characterizations of future events or circumstances are forward-looking statements.
Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties, and assumptions that are difficult to predict. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason. For a description of the risks, uncertainties, and assumptions that may impact our actual results or performance, see the Company’s Annual Report on Form 10-K for 2013, filed with the Securities and Exchange Commission, as it may be updated in subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with or furnished to the Securities and Exchange Commission.
CONTACT: Erica Bartsch Sloane & Company ebartsch@sloanepr.com
(PBCP) Retirement of Chief Executive Officer and Appointment of Interim CEO
Polonia Bancorp, Inc. (the “Company”) (NASDAQ Capital Market: PBCP), the holding company of Polonia Bank (the “Bank”), announced today that Anthony J. Szuszczewicz advised the Board of Directors that he is retiring as President and Chief Executive Officer and from the Boards of Directors of the Company and the Bank effective August 31, 2014. The Company accepted Mr. Szuszczewicz’ retirement letter and thanked him for his years of service and leadership. Because of his strong ties to the communities in which the Bank operates, Mr. Szuszczewicz is expected to continue to be affiliated with the Bank in an advisory role.
The Company also announced that the Board of Directors has appointed Paul D. Rutkowski, the Company’s Chief Financial Officer, to the position of Chief Executive Officer on an interim basis while the Board of Directors conducts a search for a permanent President and Chief Executive Officer. Mr. Rutkowski has served as Chief Financial Officer of Polonia Bank since 2005 and Corporate Secretary since 2006. Mr. Rutkowski served as Controller and Treasurer of Polonia Bank from 1992 to 2005 and has served as Chief Financial Officer and Corporate Secretary of Polonia Bancorp (and its predecessor) since 2007.
The Bank also announced today that the Board of Directors voted Robert J. Woltjen, a current director, as the Chairman of the Board of the Company and the Bank, replacing Mr. Szuszczewicz.
Polonia Bancorp, Inc. is the holding company for Polonia Bank. Polonia Bank is headquartered in Huntingdon Valley, Pennsylvania and has provided community banking services to customers for almost 91 years. We currently operate five full-service locations in Montgomery and Philadelphia Counties, Pennsylvania.
(IDN) Lenel Factory Certification under Lenel’s OpenAccess Alliance Program
Intellicheck Mobilisa Inc. (NYSE MKT:IDN), a global leader in identity solutions and wireless security systems, has received Lenel factory certification and joined the Lenel OpenAccess Alliance Program (OAAP). Intellicheck Mobilisa’s mobile handheld readers IM2610, IM2620 and IM2800h interface with the Lenel OnGuard access control system and allow a security guard to scan a security badge and check access permissions from the OnGuard security platform in areas where there is no connectivity available.
“Intellicheck Mobilisa has completed required factory testing at Lenel to validate the functionality of its interface to the OnGuard system. By making ‘offline’ security badge validation possible, their mobile handheld readers offer a new level of convenience to security guards and badge holders alike,” said Gidon Lissai, director of strategic alliances, Lenel. “We look forward to their continued involvement in the Lenel OpenAccess Alliance Program.”
“Interfacing with Lenel’s OnGuard access control security system demonstrates the versatility of our mobile handheld readers and provides us the opportunity to showcase our technology to a new market segment,” stated Nelson Ludlow, president and CEO of Intellicheck Mobilisa. “We are grateful for the opportunity to work with Lenel and look forward to working together in the future.”
A link to Intellicheck Mobilisa’s Mobile Reader follows:
About Intellicheck Mobilisa
Intellicheck Mobilisa is a leading technology company providing wireless technology and identity systems for various applications, including mobile and handheld access control and security systems for the government, military and commercial markets. Products include the Fugitive Finder system, an advanced ID card access control product currently protecting military bases and secure federal locations; ID Check, a patented technology that instantly reads, analyzes, and verifies encoded data in magnetic stripes and barcodes on government-issued IDs, designed to improve the Customer Experience for the financial, hospitality and retail sectors; barZapp™, an ID-checking mobile app that allows a user’s smartphone to check an ID card. For more information on Intellicheck Mobilisa, please visit www.icmobile.com.
Safe Harbor Statement
Certain statements in this press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. When used in this press release, words such as “will,” “believe,” “expect,” “anticipate,” “encouraged,” and similar expressions, as they relate to the company or its management, as well as assumptions made by and information currently available to the company’s management identify forward-looking statements. Actual results may differ materially from the information presented here. Additional information concerning forward-looking statements is contained under the heading of risk factors listed from time to time in the company’s filings with the SEC. We do not assume any obligation to update the forward-looking information.
Lenel and OnGuard are registered trademarks of Lenel Systems International Inc. in the United States and/or other countries.
(HPJ) To Power Timex Smartwatches w/ Advanced, Compact Rechargeable Lithium Batteries
SAN FRANCISCO and SHENZHEN, China, Aug. 20, 2014 — Highpower International, Inc. (NASDAQ: HPJ), a developer, manufacturer, and marketer of lithium and nickel-metal hydride (Ni-MH) rechargeable batteries, and a battery management systems and battery recycling provider, today announced that it started shipping its advanced compact lithium battery product developed for the newly introduced TIMEX® IRONMAN® ONE GPS+, a smartwatch offering consumers stand-alone wireless connectivity without a phone.
Mr. George Pan, Chairman and CEO of Highpower, commented, “Timex is an iconic watch brand. We are excited to work with Timex as a contributor to this innovative smartwatch technology. We feel that wearables represent an exciting area of growth for mobile devices, and smartwatches could provide a natural progression from current applications to help consumers further embrace wearable technology. We feel that our battery performance, seamlessness of services, and quality will allow us to compete for a proportionate market share of batteries for these products. Highpower is a flexible battery manufacturer capable of applying our expertise to a number of different markets, and this initial order is strong evidence that our product offering is gaining traction in the rapidly growing wearable device market.”
The TIMEX® IRONMAN® ONE GPS+ will be available for purchase this fall at timex.com, att.com, AT&T stores, select sports specialty and electronic stores.
About Highpower International, Inc.
Highpower International was founded in 2001 and produces high-quality Nickel-Metal Hydride (Ni-MH) and lithium-based rechargeable batteries used in a wide range of applications such as electric buses, bikes, energy storage systems, power tools, medical equipment, digital and electronic devices, personal care products, and lighting, etc. Highpower’s target customers are Fortune 500 companies, and top 10 companies in each vertical segment. With advanced manufacturing facilities located in Shenzhen, Huizhou, and Ganzhou of China, Highpower is committed to clean technology, not only in the products it makes, but also in the processes of production. The majority of Highpower International’s products are distributed to worldwide markets mainly in the United States, Europe, China and Southeast Asia.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995 that are not historical facts. These statements can be identified by the use of forward-looking terminology such as “believe,” “expect,” “may,” “will,” “should,” “project,” “plan,” “seek,” “intend,” or “anticipate” or the negative thereof or comparable terminology, and include discussions of strategy, and statements about industry trends and the Company’s future performance, operations and products. Such statements involve known and unknown risks, uncertainties and other factors that could cause the Company’s actual results to differ materially from the results expressed or implied by such statements. For a discussion of these and other risks and uncertainties see “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s public filings with the SEC. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update the forward-looking information contained in this press release.
CONTACT:
Highpower International, Inc.
Fendi Yang
+86-755-8968-6521
ir@highpowertech.com
INVESTOR RELATIONS:
The Equity Group Inc.
In China
Katherine Yao, Associate
+86-10-6587-6435
kyao@equityny.com
In U.S.
Adam Prior, Senior Vice President
(212) 836-9606
aprior@equityny.com
(FOLD) Announces Positive Phase 3 Data From Fabry Monotherapy Study 012
Migalastat Successfully Meets Both Co-Primary Endpoints of Comparability to Enzyme Replacement Therapy (ERT) on Both Key Measures of Kidney Function
Comparability to ERT Also Demonstrated in Important Fabry Disease Biomarker, Plasma Lyso-Gb3
Proceeding with Centralized Procedure for European MAA Submission
Conference Call and Webcast Today at 8:00 a.m. ET
CRANBURY, N.J., Aug. 20, 2014 — Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced positive 18-month data from its second Phase 3 study (Study 012) of the oral small molecule chaperone migalastat HCl (“migalastat”) in Fabry patients with amenable mutations. Detailed results of this second Phase 3 monotherapy study are available in a slide presentation that will be shared by the Amicus management team on a conference call today at 8:00 a.m. ET. Please visit http://ir.amicustherapeutics.com/events.cfm.
Study 012 compared oral migalastat to standard-of-care enzyme replacement therapies (ERTs) for Fabry disease (Fabrazyme® and Replagal®). The co-primary outcome measures were the mean annualized changes in estimated glomerular filtration rate (eGFR) and measured (iohexol) GFR (mGFR) assessed by descriptive comparisons of migalastat and ERT over 18 months. The study enrolled 60 patients (26 males and 34 females) with Fabry disease with amenable mutations in a clinical trial assay who had been treated with ERT for a minimum of 12 months prior to study entry. These patients were randomized 1.5:1 to switch to migalastat (36 patients) or remain on ERT (24 patients) for the primary 18-month treatment period, after which they were eligible to receive migalastat in a 12-month extension phase. Among the 60 patients enrolled, 56 (34 in the migalastat group and 22 in the ERT group) had amenable mutations in a GLP-validated human embryonic kidney (HEK) cell-based in vitro assay (“GLP HEK-amenable”). The statistical analysis plan pre-specified that all efficacy measures would be based on the results from patients with GLP HEK-amenable mutations.
Summary of Study 012 18-Month Results
- Migalastat had a comparable effect to ERT on patients’ kidney function as measured by the change in eGFR and mGFR.
- Levels of plasma lyso-Gb3, an important biomarker of disease, remained low and stable in patients with amenable mutations who switched from ERT to migalastat.
- Migalastat was generally safe and well-tolerated.
- Of 48 patients with GLP HEK-amenable mutations who completed Study 012, 46 (96%) elected to continue with the 12-month treatment extension and 45 remain on migalastat today as their only treatment for Fabry disease.
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, “We believe that this multi-year study unequivocally demonstrates that a Fabry patient on ERT with an amenable mutation can switch safely and effectively from ERT to migalastat to treat their Fabry disease. Today is a great day for the Fabry community and for Amicus. This study was resoundingly positive and met our pre-defined criteria for success in terms of the co-primary endpoints of kidney function. These results clearly show that migalastat is comparable to ERT in slowing the progression of Fabry disease and continues to demonstrate a favorable safety profile. With every-other-day oral administration and a differentiated mechanism of action, migalastat may offer significant advantages for patients without the need for bi-weekly infusions with ERT. Combined with our previous Phase 3 results from Study 011, we have a compelling and consistent data set from both treatment-naïve and ERT-experienced patients. Given these results and the great need for new and effective medicines, we plan to work with European and U.S. regulators to determine the fastest way to get migalastat approved for all amenable Fabry patients.”
Raphael Schiffmann, M.D., M.H.Sc., an investigator with the Institute of Metabolic Disease, Baylor Research Institute, Dallas, TX stated, “I believe the results from Study 012 show a positive treatment effect of migalastat in Fabry patients with amenable mutations. The stabilization of renal function and the maintenance of substrate levels as measured by lyso-Gb3 provide further clinical evidence that supports my experience over the last eight years in treating Fabry patients with migalastat in various clinical studies. When combined with the favorable safety profile, the totality of the data from Study 012 and Study 011 indicate that migalastat should become an important new oral treatment option for Fabry patients.”
Dr. Schiffmann added, “Given the choice, I would use migalastat over ERT for the treatment of Fabry patients with amenable mutations.”
Study 012 Kidney Function Data in GLP HEK-Amenable Patients
Among patients with GLP HEK-amenable mutations in Study 012, kidney function was comparable to ERT over 18 months following treatment with migalastat. Decline in kidney function is a key cause of mortality in patients with Fabry disease.
Overlap of 95% Confidence Intervals |
Difference Between Migalastat and ERT |
Mean Values ± SEM | Median Values | |||
(means) | (means) | Migalastat group (n=34) |
ERT group (n=18) |
Migalastat group (n=34) |
ERT group (n=18) |
|
Estimated GFR (eGFR) (CKD-epi) |
100% | +0.63 | -0.40 ± 0.93 | -1.03± 1.29 | -1.29 | -0.87 |
Measured GFR (mGFR) (iohexol) |
100% | -1.11 | -4.35 ± 1.64 | -3.24 ± 2.27 | -3.23 | -3.57 |
As pre-specified in the final statistical analysis plan, the co-primary outcome measures of efficacy in Study 012 were the descriptive assessments of comparability of the mean annualized change in eGFR and mGFR for migalastat and ERT. Both eGFR and mGFR are considered important measures of renal function. Comparability on eGFR and mGFR was defined in two ways:
- A ≥50% overlap in the confidence intervals between the migalastat and ERT treatment groups; and
- Whether the mean annualized changes for patients receiving migalastat are within 2.2 mL/min/1.73 m2/yr of patients receiving ERT.
“These data mark an exciting day for the Fabry community and validate our long-term commitment to work in partnership with industry toward our goal of multiple treatment options and improved medicines for all people living with Fabry disease,” said Jack Johnson, Founder and Executive Director, Fabry Support & Information Group. “We await the regulatory agencies’ review of these data, and we are grateful to the many people with Fabry disease, families and volunteers who have committed so much of themselves to help accelerate efforts to bring a more convenient and effective therapy to people living with the disease.”
About GLP HEK-Amenable Mutations
Amenable mutations are defined as having an absolute increase of 3% of wild type alpha-Gal A enzyme activity and a relative increase of 20% when exposed to migalastat in a cell-based in vitro assay. All patients enrolled in Study 012 had amenable mutations in the clinical trial HEK assay available at study initiation (“clinical trial assay”). Following the completion of enrollment, a GLP HEK assay was developed with a third party to measure the criteria for amenability with more quality control and rigor. However, approximately 10% of mutations in the HEK database switched categorization between “amenable” and “non-amenable” when moving from the clinical trial assay to the GLP HEK assay. Therefore there were changes in categorization from amenable to non-amenable in 4 patients in Study 012.
Overall based on results from mutations tested in the GLP HEK assay, Amicus continues to believe that approximately 30% to 50% of the Fabry population have mutations that are amenable to migalastat.
Conference Call and Webcast
Amicus Therapeutics will host a conference call and audio webcast today, August 20, 2014 at 8:00 a.m. ET to discuss positive results from Study 012. Interested participants and investors may access the conference call at 8:00 a.m. ET by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international). The slide presentation for the conference call is available at http://ir.amicustherapeutics.com/events.cfm.
An audio webcast can also be accessed via the Investors section of the Amicus Therapeutics corporate web site at http://ir.amicustherapeutics.com/events.cfm, and will be archived for 30 days. Web participants are encouraged to go to the web site 15 minutes prior to the start of the call to register, download and install any necessary software. A telephonic replay of the call will be available for seven days beginning at 11:00 a.m. ET today. Access numbers for this replay are 855-859-2056 (U.S./Canada) and 404-537-3406 (international); participant code 90825426.
About Amicus Therapeutics
Amicus Therapeutics (Nasdaq:FOLD) is a biopharmaceutical company at the forefront of therapies for rare and orphan diseases. The Company is developing novel, first-in-class treatments for a broad range of human genetic diseases, with a focus on delivering new benefits to individuals with lysosomal storage diseases. Amicus’ lead programs include the small molecule pharmacological chaperones migalastat as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease; and AT2220 (duvoglustat) in combination with ERT for Pompe disease.
Forward-Looking Statements
This press release contains, and the accompanying conference call will contain, “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of Amicus’ candidate drug products, the timing and reporting of results from preclinical studies and clinical trials evaluating Amicus’ candidate drug products and the projected cash position for the Company. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation by Amicus that any of its plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Amicus might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the goals, progress, timing and outcomes of discussions with regulatory authorities and the potential goals, progress, timing and results of preclinical studies and clinical trials, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the business of Amicus, including, without limitation: the potential that results of clinical or pre-clinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; the potential that regulatory authorities may not grant or may delay approval for our product candidates; the potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; the potential that we will need additional funding to complete all of our studies and, our dependence on third parties in the conduct of our clinical studies. Further, the results of earlier preclinical studies and/or clinical trials may not be predictive of future results. With respect to statements regarding projections of the Company’s cash position, actual results may differ based on market factors and the Company’s ability to execute its operational and budget plans. In addition, all forward looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2013. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Amicus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
FOLD–G
CONTACT: Investors/Media: Chip Baird cbaird@amicusrx.com (609) 662-2063 Media: Dan Budwick dan@purecommunicationsinc.com (973) 271-6085
(CPAH) Contract/Strategic Channel Agreement w/ Large Network Equipment Provider
Company leverages patent portfolio and success of Operator and Enterprise Over the Top (OTT) deployments to secure an agreement to sell CounterPath’s unified communications solution to operators worldwide
VANCOUVER, BRITISH COLUMBIA–(Aug 20, 2014) – CounterPath Corporation (NASDAQ:CPAH)(TSX:CCV), a leading developer of award-winning UC over-the-top (OTT) solutions for desktop, tablet and mobile solutions for operators and enterprises, today announced that a major supplier of networking equipment and solutions has signed a definitive agreement with the company to market and sell CounterPath’s OTT communications solutions to operators worldwide.
Enterprise and Operator OTT solutions are key for customers that want to differentiate their UC and IMS (IP Multimedia Subsystem) based deployments. In the case of deployments like Rogers One Number, operators have experienced a positive upturn in subscriber growth and reduced usage of Internet OTT services such as Skype or Apple’s Facetime.
“Carriers and Enterprises are looking for market tested Unified Communications solutions that they can confidently roll out to their end users,” said Donovan Jones, President and Chief Executive Officer. “By taking our client-centric, platform agnostic approach and extending it to our server platform we can offer a solution which not only overlays to any network deployment but greatly enhances the user experience, providing a highly differentiated service for operators and enterprises. This new relationship opens up a significant market opportunity for CounterPath, once again demonstrating the industry’s trust in the value and reliability of our applications and solutions.”
The signed agreement covers all of CounterPath’s products and services that comprise Operator and Enterprise OTT solutions enabling voice, video, presence and messaging over the most popular operating systems and devices across any IP network.
About CounterPath
CounterPath’s SIP-based VoIP softphones are changing the face of telecommunications. An industry and user favorite, Bria softphones for desktop and mobile devices, together with the Company’s server applications and Fixed Mobile Convergence (FMC) solutions, enable service providers, OEMs and enterprises large and small around the globe to offer a seamless and unified communications experience across both fixed and mobile networks. 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, AT&T, Avaya, BroadSoft, BT, Cisco Systems, GENBAND, Metaswitch Networks, Mitel, NEC, Network Norway, Rogers and Verizon.
For more information about CounterPath’s Bria softphone applications and provisioning solutions, visit: www.counterpath.com/products.
CounterPath Corporation
Kasia Finkelstein
Marketing & PR
(604) 628-9378
kfinkelstein@counterpath.com
CounterPath Corporation
Steven Hards
Investor Relations
(604) 637-6498
shards@counterpath.com
www.counterpath.com
(GSIT) Receives Unsolicited Acquisition Proposal
SUNNYVALE, CA–(Aug 19, 2014) – GSI Technology, Inc. (NASDAQ: GSIT) today announced that it has received from GigOptix, Inc. an unsolicited, non-binding and conditional proposal to acquire the company for per share consideration of $6.50 per share consisting of a combination of cash and GigOptix common stock.
GSI Technology’s Board of Directors will promptly and carefully review and consider the GigOptix proposal consistent with its fiduciary duties and in consultation with its financial and legal advisors. Following its review, the GSI Technology Board will respond to the proposal and advise its stockholders of the Board’s response.
About GSI Technology
Founded in 1995, GSI Technology, Inc. is a leading provider of high-performance static random access memory, or SRAM, products primarily incorporated in networking and telecommunications equipment. Headquartered in Sunnyvale, California, GSI Technology is ISO 9001 certified and has worldwide factory and sales locations. For more information, please visit www.gsitechnology.com.
Forward-Looking Statements
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements included in this press release are based upon information available to GSI Technology as of the date hereof, and GSI Technology assumes no obligation to update any such forward-looking statements. Forward-looking statements involve a variety of risks and uncertainties, which could cause actual results to differ materially from those projected. These risks include the possibility that the unsolicited proposal by GigOptix may not be supported by the GSI Technology Board and that one or more of the conditions to the proposal may not be satisfied. Further information regarding other risks relating to GSI Technology’s business is contained in the Company’s filings with the Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in such filings.
GSI Technology, Inc.
Douglas Schirle
Chief Financial Officer
408-331-9802
(CLIR) Contracts with Aera Energy On Next-Gen NOx Control Tech
SEATTLE, Aug. 19, 2014 — ClearSign Combustion Corporation <http://www.clearsign.com/> (NASDAQ: CLIR), an emerging leader in combustion and emissions control technology for industrial, commercial and utility markets, announced today that it has entered into a Field Test Agreement withAera Energy LLC <http://www.aeraenergy.com/who-we-are.asp> to demonstrate and test its proprietary Duplex™ tile combustion technology in oil fields located inKern County in central California.
The agreement also specifies pricing and delivery conditions that would apply if Aera purchases an agreed upon number of systems if ordered and installed within a specified period of time following successful completion of the demonstration and tests.
Under the terms of the agreement, ClearSign and its subcontracted field engineering team will retrofit an existing steam generator unit with ClearSign’s Duplex tile technology to test capability to achieve ultra-low emissions (5 ppm) of nitrogen oxides, or NOx. The Duplex will be paired with an existing forced draft burner and will operate at a heat release of 30 to 60 MMBtu/hr (roughly equivalent to 9 to 18 MW). This will represent the largest scale demonstration under process conditions of the company’s Duplex tile technology to date.
ClearSign plans to begin the project before the end of the current quarter.
As testing progresses, ClearSign will provide additional detail regarding their plans to enter the OTSG market, including identifying distribution partners.
About Enhanced Oil Recovery (EOR)
The so-called “heavy oil” that comprises the oil sand reserves in areas like theSan Joaquin Valley and Alberta, Canada is so thick that its viscosity must be reduced in order to recover, process or transport it. Steam is generated in large units called once through steam generators (OTSGs) and then pumped into the oil reservoir to heat the oil to allow it flow more easily.
Worldwide, 96.5% of Enhanced Oil Recovery (EOR) is performed via steam generation, of which 65% occurs inNorth America alone. In the United States, 94% of EOR occurs inCalifornia’s San Joaquin Valley where 303,000 barrels per day (bpd) of oil are produced using 768 OTSGs, each averaging ~ 60 MMBtu/hr. InCanada, virtually all EOR occurs in Northern Alberta where almost four times (1.2 million bpd) the amount of oil is produced using 250 much larger OTSGs, each of which is over ~ 250 MMBtu/hr. Retrofit activity is expected to be a key market driver inthe United States where the San Joaquin Valley Air Pollution Control District’s Reg. 4320 mandates reductions in NOx to 9ppm or below. According to Visiongain, an explosion in new-build activity will characterize the market inNorthern Alberta with the number of very large OTSGs expected to almost triple – to over 650 units – by 2023.
Note the existence of this agreement was disclosed during the Company’s second quarter results call onAugust 12, 2014, however this announcement contains new information, including identifying Aera Energy LLC and other details.
About ClearSign Combustion Corporation
ClearSign Combustion Corporation designs and develops technologies that aim to improve key performance characteristics of combustion systems including energy efficiency, emissions control, fuel flexibility and overall cost effectiveness. Our Duplex™ Burner Architecture and Electrodynamic Combustion Control™ (ECC™) platform technologies improve control of flame shape and heat transfer and optimize the complex chemical reactions that occur during combustion in order to minimize harmful emissions. For more information about the Company, please visitwww.clearsign.com <http://www.clearsign.com/>
Cautionary note on forward-looking statements
This press release includes forward-looking information and statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding our assumptions, projections, expectations, targets, intentions or beliefs about future events that are based on management’s belief, as well as assumptions made by, and information currently available to, management. While we believe that our expectations are based upon reasonable assumptions, there can be no assurances that our goals and strategy will be realized. Numerous factors, including risks and uncertainties, may affect our actual results and may cause results to differ materially from those expressed in forward-looking statements made by us or on our behalf. Some of these factors include the acceptance of existing and future products, the impact of competitive products and pricing, general business and economic conditions, and other factors detailed in our Quarterly Report on Form 10-Q and other periodic reports filed with the SEC. We specifically disclaim any obligation to update or revise any forward-looking statement whether as a result of new information, future developments or otherwise.
(SYN) Late-Breaking Poster Presentation for C. difficile Program at 54th ICAAC
— Two of Company’s Anti-Infective Programs to be Presented at Highly Regarded Scientific Conference: Pertussis and C. difficile —
ROCKVILLE, Md., Aug. 19, 2014 — Synthetic Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing novel anti-infective biologic and drug programs targeting specific pathogens that cause serious infections and diseases, announced today that its novel C. difficile development program will be highlighted at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 5-9, in Washington D.C.
Synthetic Biologics’ Senior Vice President, Research & Development, Mike Kaleko, M.D., Ph.D., will present a late-breaking poster related to the Company’s C. difficile program. The poster will be available for viewing in Exhibit Hall A on Saturday, September 6, from 12:00pm to 2:00pm Eastern Time, as part of the “Agents Targeting Clostridium difficile” session.
Title: P4A, a Novel Oral Beta-Lactamase for the Prevention of Cephalosporin-Induced C. difficile Infection
Authors1: M. Kaleko, J. A. Bristol, S. Connelly, P. Koski
Poster: F-250c
“We are thrilled to have the opportunity to present research from our novel C. difficile program at ICAAC. This conference is known for its high academic standards and draws the infectious disease field’s foremost leaders. We look forward to presenting our findings that support the development of our prophylactic to protect the GI microflora from the effects of certain IV antibiotics for the prevention of C. difficile infection,” stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “This scientific presentation is very relevant, as we continue to advance our innovative C. difficile program toward clinical trials during 2014.”
The Company previously announced that Synthetic Biologics’ academic collaborator, Jennifer Maynard, Ph.D., of The University of Texas at Austin’s McKetta Department of Chemical Engineering will highlight Synthetic Biologics’ SYN-005 monoclonal antibody (mAb) combination for the treatment of Pertussis (whooping cough) in an oral presentation scheduled for Sunday, September 7, at 9:45am Eastern Time in Room 209A as part of the “Neonatal Infections and the Case for Maternal Immunization” session.
Title: Rational Design of Antibody Cocktails to Treat Disease Caused by Bordetellae
Authors: M. Kaleko1, A. Nguyen2, E. Wagner2, J. Laber2, L. Goodfield3, W. Smallridge3, E. T. Harvill3, R. F. Wolf4, J. C. Papin4, J. A. Maynard2
1Synthetic Biologics, Rockville, MD, 2Universty of Texas at Austin, Austin, TX, 3Penn State Univ., University Park, PA, 4Univ. of Oklahoma Hlth. Sci. Ctr., Oklahoma City, OK
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases. The Company is developing an oral biologic to protect the gastrointestinal microflora from the effects of IV antibiotics for the prevention of Clostridium difficile (C. difficile) infection, an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS), a series of monoclonal antibodies for the treatment of Pertussis and Acinetobacter infections, and a biologic targeted at the prevention and treatment of a root cause of a subset of IBS. In addition, the Company is developing an oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.
This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding Synthetic Biologics’ continued advancement of its C. difficile program toward clinical trials. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, the additional clinical studies and results not meeting expectations and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2013 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
(SLXP) Announces Early Termination of HSR Waiting Period for Pending Transaction
Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) today announced that it has received notice of the early termination of the waiting period for U.S. antitrust review under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, relating to its previously announced combination transaction with Cosmo Pharmaceuticals S.p.A. (SIX: COPN). The waiting period was scheduled to expire on August 21, 2014. Termination of the waiting period satisfies a condition to the closing of the transaction. Completion of the transaction remains subject to approval by Salix’s stockholders and certain other closing conditions.
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products and medical devices for the prevention and treatment of gastrointestinal diseases. Salix’s strategy is to in-license or acquire late-stage or marketed proprietary therapeutic products, complete any required development and regulatory submission of these products, and commercialize them through Salix’s 500-member specialty sales force.
Salix markets XIFAXAN® (rifaximin) tablets 200 mg and 550 mg, MOVIPREP® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution, 100 g/7.5 g/2.691 g/1.015 g/5.9 g/4.7 g), OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) tablets, APRISO® (mesalamine) extended-release capsules 0.375 g, UCERIS® (budesonide) extended release tablets, for oral use, GIAZO® (balsalazide disodium) tablets, COLAZAL® (balsalazide disodium) Capsules, GLUMETZA® (metformin hydrochloride extended-release tablets) 500 mg and 1000 mg, ZEGERID® (omeprazole/sodium bicarbonate) Powder for Oral Suspension, ZEGERID® (omeprazole/sodium bicarbonate) capsules, METOZOLV® ODT (metoclopramide hydrochloride), RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, FULYZAQ® (crofelemer) delayed-release tablets, SOLESTA®, DEFLUX®, RUCONEST® (C1 esterase Inhibitor (Recombinant) 50 IU/kg, PEPCID® (famotidine) for Oral Suspension, DIURIL® (chlorothiazide) Oral Suspension, AZASAN® (azathioprine) tablets, USP, 75/100 mg, ANUSOL-HC® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg, CYCLOSET®(bromocriptine mesylate) tablets, FENOGLIDE® (fenofibrate) tablets. UCERIS (budesonide) rectal foam, RELISTOR®, encapsulated bowel preparation and rifaximin for additional indications are under development.
For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for OSMOPREP, AZASAN, GLUMETZA and METOZOLV, please visit www.salix.com, where Salix promptly posts press releases, SEC filings and other important information, or contact Salix at (919) 862-1000.
Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP”.
For more information, please visit our Website at www.salix.com or contact Salix at (919)-862-1000. Follow us on Twitter (@SalixPharma) and Facebook (www.facebook.com/SalixPharma). Information on our Twitter feed, Facebook page and web site is not incorporated in our filings with the SEC.
About Cosmo
Cosmo Pharmaceuticals S.p.A. is a specialty pharmaceutical company headquartered in Lainate, Italy. The company’s proprietary clinical development pipeline specifically addresses innovative treatments for the gastrointestinal tract, specifically inflammatory bowel diseases, colon infections and colon diagnosis, as well as selected topically treated skin disorders. Cosmo’s proprietary MMX® technology, designed to deliver active ingredients in a targeted manner in the colon, is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. Currently, Cosmo, through its appointed partners, has three products on the market and six in clinical development. For further information on Cosmo, please visit the Company’s website: www.cosmopharma.com.
No Offer or Solicitation
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval in any jurisdiction pursuant to the merger or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Cautionary Statement Regarding Forward-Looking Statements
As previously announced on July 8, 2014, Salix, Cosmo Pharmaceuticals S.p.A. and Irish domiciled Cosmo Technologies Limited entered into an Agreement and Plan of Merger and Reorganization, pursuant to which a subsidiary of Cosmo Technologies Limited will merge with and into Salix, with Salix as the surviving entity, and Salix will become an indirect, wholly-owned subsidiary of Cosmo Technologies Limited, which will change its name to Salix Pharmaceuticals, plc.
Please Note: The statements provided herein that are not historical facts are or might constitute projections and other forward-looking statements regarding future events. Although we believe the expectations reflected in such forward-looking statements are based on reasonable assumptions, our expectations might not be attained. Forward-looking statements are just predictions and are subject to known and unknown risks and uncertainties that could cause actual events or results to differ materially from expected results. Factors that could cause actual events or results to differ materially from those described herein include, among others: uncertainties as to the ability to successfully complete the proposed transaction in accordance with its terms and in accordance with the expected schedule; the possibility that competing offers will be made; the possibility that various closing conditions for the proposed transaction may not be satisfied or waived, including that a governmental entity may prohibit or refuse to grant any approval required for the consummation of the proposed transaction; the unpredictability of the duration and results of regulatory review of New Drug Applications, Biologics License Agreements, and Investigational NDAs; generic and other competition in an increasingly global industry; litigation and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global industry; the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; post-marketing approval regulation, including the ongoing Department of Justice investigation of Salix’s marketing practices; market acceptance for approved products; revenue recognition and other critical accounting policies; the need to acquire new products; changes in tax laws or interpretations thereof; general economic and business conditions; and other factors. Readers are cautioned not to place undue reliance on the forward-looking statements included herein, which speak only as of the date hereof. Salix does not undertake to update any of these statements in light of new information or future events, except as required by law. The reader is referred to the documents that Salix files from time to time with the SEC.
Important Additional Information and Where to Find It
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. In connection with the proposed transaction and required stockholder approval, Cosmo Pharmaceuticals S.p.A., Cosmo Technologies Limited and Salix will file relevant materials with the SEC, including a proxy statement/prospectus contained in a registration statement on Form S-4, which will be mailed to the stockholders of Salix after the registration statement is declared effective. The registration statement has not yet become effective.
SALIX STOCKHOLDERS ARE ADVISED TO READ THE PROXY STATEMENT/PROSPECTUS, AS IT MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TRANSACTION, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO.
Salix stockholders may obtain a free copy of the proxy statement/prospectus, when it becomes available, and other documents filed by Salix at the SEC’s web site at www.sec.gov. Copies of Salix’s filings with the SEC may be obtained free of charge at the “Investors” section of Salix’s website at www.salix.com or by contacting the Investor Relations Department of Salix at 919-862-1000.
Participants in the Solicitation
Salix and its directors, executive officers and certain other members of its management and employees may be deemed to be participants in the solicitation of proxies from its stockholders in connection with the proposed transaction. Information regarding the interests of such directors and executive officers was included in Salix’s Proxy Statement for its 2014 Annual Meeting of Stockholders filed with the SEC on April 28, 2014 and information concerning the participants in the solicitation will be included in the proxy statement/prospectus relating to the proposed transaction when it becomes available. Each of these documents is, or will be, available free of charge at the SEC’s website at www.sec.gov and from Salix on its website or by contacting the Investor Relations Department at the telephone number above.
(HGSH) Signed its First Shanty Area Rebuilding Project Agreement
HANZHONG, China, Aug. 19, 2014 — China HGS Real Estate, Inc. (NASDAQ: HGSH) (“China HGS” or the “Company”), a leading regional real estate developer headquartered in Hanzhong City, Shaanxi Province, China, today announced that the Company signed its first shanty area rebuilding framework agreement with the Hantai District government of Hanzhong City.
Pursuant to the agreement, the Company is engaged in developing the shanty areas surrounding Liang Zhou Road located in the Hantai District, Hanzhong City. The estimated investment in the project is approximately US$580 million. The local government will coordinate with the Company to implement the reform plan.
“We are excited about signing the Liang Zhou Road shanty area rebuilding project agreement,” said Mr. Xiaojun Zhu, Chief Executive Officer of China HGS Real Estate, Inc. “As a leading regional real estate developer, we believe that the rebuilding plan will provide the Company with promising business opportunities in the local real estate market. We will contribute great efforts in building a better community for the local residence,” stated Mr. Xiaojun Zhu.
Safe Harbor Statement
This press release contains forward-looking statements, which are subject to change. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All “forward-looking statements” relating to the business of China HGS Real Estate, Inc., which can be identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involve known and unknown risks and uncertainties which could cause actual results to differ. These factors include but are not limited to: the uncertain market for the Company’s business, macroeconomic, technological, regulatory, or other factors affecting the profitability of real estate business; and other risks related to the Company’s business and risks related to operating in China. Please refer to the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2013, as well as the Company’s Quarterly Reports on Form 10-Q that have been filed since the date of such annual report, for specific details on risk factors. Given these risks and uncertainties, you are cautioned not to place undue reliance on forward-looking statements. The Company’s actual results could differ materially from those contained in the forward-looking statements. The Company undertakes no obligation to revise or update its forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.
About China HGS Real Estate, Inc.
China HGS Real Estate, Inc. (NASDAQ: HGSH), founded in 1995 and headquartered in Hanzhong City, Shaanxi Province, is a leading real estate developer in the region and holds the national grade I real estate qualification. The Company focuses on the development of high-rise, sub-high-rise residential buildings and multi-building apartment complexes in China’s Tier 3 and Tier 4 cities and counties with rapidly growing populations driven by increased urbanization. The Company provides affordable housing with popular and modern designs to meet the needs of multiple buyer groups. The Company’s development activity spans a range of services, including land acquisition, project planning, design management, construction management, sales and marketing, and property management. For further information about China HGS, please go to www.chinahgs.com.
Company contact:
Randy Xiong,
President of Capital Market
China Phone: (86) 091-62622612
Email: randy.xiong@chinahgs.com
(VSTAD) Notice of Allowance Canadian Patent Further Expanding Stem Cell Platform
SOUTH SAN FRANCISCO, CA–(Aug 19, 2014) – VistaGen Therapeutics, Inc. (OTCQB: VSTAD), a biotechnology company applying pluripotent stem cell technology for drug rescue, drug discovery and regenerative medicine, today announces that the Canadian Intellectual Property Office has issued a Notice of Allowance for Canadian Patent Application No. 2,487,058, entitled “Mesoderm and Definitive Endoderm Cell Populations.” This patent, which is licensed exclusively to VistaGen by the Icahn School of Medicine at Mount Sinai in New York, will further expand VistaGen’s intellectual property portfolio for pluripotent stem cell culture systems that produce human cells of the endoderm lineage, including liver, lung, pancreas, parathyroid and thyroid cells.
Together with the Company’s recently announced Notice of Allowance for related Canadian Patent Application 2,684,022, this most recent Canadian patent allowance strengthens VistaGen’s intellectual property relating to several key pluripotent stem cell research projects the Company is contemplating in Canada, including innovative projects involving liver safety, liver toxicity-based drug rescue, customized drug discovery assays for therapies to treat liver disease and diabetes, and exploratory nonclinical studies for potential regenerative medicine applications involving beta islet cells and other cells of the endoderm lineage.
About VistaGen Therapeutics
VistaGen is a stem cell company focused on drug rescue, drug discovery and regenerative medicine. We believe better cells lead to better medicines™ and that the key to making better cells is precisely controlling the differentiation of human pluripotent stem cells, which are the building blocks of all cells of the human body. For over 15 years, our stem cell research and development teams and collaborators have developed proprietary methods for controlling the differentiation of human pluripotent stem cells and the production and maturation of numerous specific types of adult human cells that we use, or plan to use, to reproduce complex human biology and disease and assess, in vitro, potential therapeutic benefits and safety risks of new drug candidates, including new chemical entities we are focused on producing through drug rescue. These are intended to be novel, proprietary and safer variants of once-promising small molecule drug candidates discovered, developed and optimized for efficacy by pharmaceutical and biotechnology companies, the U.S. National Institutes of Health, or academic laboratories, but discontinued prior to FDA approval due to unexpected heart or liver safety concerns.
Visit VistaGen at www.VistaGen.com, follow VistaGen at www.twitter.com/VistaGen or view VistaGen’s Facebook page at www.facebook.com/VistaGen.
Cautionary Statement Regarding Forward-Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the success of VistaGen’s drug and regenerative medicine research, discovery, development and rescue activities, its ability to enter into strategic licensing and partnering arrangements, risks and uncertainties relating to its protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the foregoing activities. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
For more information:
Shawn K. Singh, J.D.
Chief Executive Officer
VistaGen Therapeutics, Inc.
www.VistaGen.com
650-577-3613
Investor.Relations@VistaGen.com
Mission Investor Relations
IR Communications
Atlanta, Georgia
www.MissionIR.com
404-941-8975
Investors@MissionIR.com
(CLRB) to Host Conference Call on August 20th
MADISON, Wis., Aug. 18, 2014 — Cellectar Biosciences, Inc. (Nasdaq:CLRB), a biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced that management will host a conference call and live webcast to discuss second quarter 2014 financial results and provide an update on each of its development programs on Wednesday, August 20th at 5:00 PM ET.
Event Details:
Interested investors may participate in the conference call by dialing 888-646-8293 (domestic) or 973-453-3065 (international). A replay will be available for one week following the call by dialing 855-859-2056 for domestic participants or 404-537-3406 for international participants and entering conference ID 90511388 when prompted. Participants may also access both the live and archived webcast of the conference call on the investor relations section of Cellectar’s web site, www.cellectar.com.
To Ask Questions:
Following prepared remarks and time permitting, management will provide an opportunity for participants dialed into to the live teleconference to ask questions. Investors may also e-mail their questions to ir@cellectar.com. E-mail questions will be accepted until 12:00 noon ET on Wednesday, August 20, 2014.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing agents to detect, treat and monitor a broad spectrum of cancers. Using a novel phospholipid ether analog (PLE) platform technology as a targeted delivery and retention vehicle, Cellectar’s compounds are designed to be selectively taken up and retained in cancer cells including cancer stem cells. With the ability to attach both imaging and therapeutic agents to its proprietary delivery platform, Cellectar has developed a portfolio of product candidates engineered to leverage the unique characteristics of cancer cells to “find, treat and follow” malignancies in a highly selective way. I-124-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted PET imaging agent currently being evaluated in a Phase II glioblastoma imaging trial. I-124-CLR1404 has been granted Orphan status as a diagnostic for the management of gliomas from the US FDA. Additionally, multiple investigator-sponsored Phase I/II clinical trials are ongoing across 11 solid tumor indications. I-131-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that delivers cytotoxic radiation directly and selectively to cancer cells including cancer stem cells. A Phase Ib dose-escalation trial of I-131-CLR1404 in patients with advanced solid tumors was completed in the first quarter of 2014 and results presented at the American Society of Clinical Oncology (ASCO) 2014 Annual Meeting. CLR1502 is a preclinical, cancer-targeted, non-radioactive optical imaging agent for intraoperative tumor margin illumination and non-invasive tumor imaging. For additional information please visit www.cellectar.com
This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2013. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking.
CONTACT: INVESTOR CONTACT Kate McNeil Vice President of IR, PR & Corporate Communications Cellectar Biosciences, Inc. Phone: (347) 204-4226 Email: kmcneil@cellectar.com
(KNDI) First 208 EVs Delivered to Launch Shanghai Car-Share Program
JINHUA, China, Aug. 18, 2014 — Kandi Technologies Group, Inc. (the “Company” or “Kandi”) (Nasdaq:KNDI), today announced that the first 208 Kandi brand electric vehicles (“EV”) were delivered as the official launch of Shanghai Jinshan public pure EV sharing program (the Shanghai Jinshan “Car-Share” Program) and Long-term Group Leasing Program. On August 14, 2014, ZuoZhongYou (Shanghai) Electric Vehicle Service Co., Ltd. (“ZZY-Shanghai”), which was formally established on June 16, 2014 in Shanghai by Zhejiang ZuoZhongYou Electric Vehicle Service Co., Ltd. (the “Service Company” or “ZZY”) hosted a launching ceremony at Jinshan District in Shanghai. All of 208 EVs were sent to rental stations in Zhu Jing, Shi Hua, Feng Jing and Ting Lin, four towns at Jinshan for users’ immediate use.
As previously announced on April 14, 2014, Mr. Ma Jing the Deputy Director of Electric Vehicles Development from the Shanghai Municipal Commission of Economic and Information Technology and his delegation group visited Kandi Electric Vehicles (Shanghai) Co., Ltd. (“Kandi Shanghai”)’s production base and initiated Shanghai Public EV Sharing System Pilot Project. During the visit, Mr. Ma Jing laid out the targeted plan for the delivery of 3000-5000 Kandi Brand pure EVs by the end of 2014.
“The official launch of Shanghai Jinshan Car-Share Program has demonstrated the expansion of Hangzhou Car-Share Program into other major cities in China as the most preferred business model for EV development. We anticipate to see more and more cities adapting the Car-Share Program and Long-term Group Leasing Program in the near future,” Mr. HuXiaoming, Chairman and Chief Executive Officer of Kandi Technologies, commented.
About the Car-Share Program
Zhejiang ZuoZhongYou Electric Vehicle Service Co., Ltd. (“ZZY”) is the first in market to initiate the public pure EV sharing program (the “Car-Share” Program). Kandi Technologies, through its 50% ownership interest in Kandi Electric Vehicles Group Co., Ltd. (the “JV Company”), indirectly holds a 9.5% interest in ZZY.
Individually driven pure EVs are used in the Car-Share Program. The charging/parking stations which provide a variety of services, such as charging, maintenance, battery recycling, are located at airports, train stations, hotels, business centers, selected residential areas and other places that are typically congested. A network system provides EV rental service to individual drivers in and around the city. It also provides EV maintenance and battery charging to self-service users. Lastly, a tracking system allows the Car-Share Program management to keep a close watch at the status and precise location of each vehicle.
This Car-Share Program model has been implemented in Hangzhou since the second half of 2013, and has now begun to expand into other major cities in China.
The Group Long-term Lease Project is a lease model that uses enterprise, community or village as a lease unit and each unit leases a minimum of 100 EVs with a group lease term at a minimum of three years.
About Kandi Technologies Group, Inc.
Kandi Technologies Group, Inc. (Nasdaq:KNDI), headquartered in Jinhua, Zhejiang Province, is engaged in the research and development, manufacturing and sales of various vehicles. Kandi has established itself as one of the world’s largest manufacturers of pure electric vehicle (EV) products, Go-Kart vehicles, and tricycle and utility vehicles (UTVs), among others. More information can be viewed at its corporate website is http://www.kandivehicle.com. Kandi routinely posts important information on its website.
Safe Harbor Statement
This press release contains certain statements that may include “forward-looking statements.” All statements other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including the risk factors discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on the SEC’s website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
CONTACT: Kandi Technologies Group, Inc. Ms. Kewa Luo Phone: 1-212-551-3610 Email: IR@kandigroup.com
(CLDN) Closing of Public Offering of Common Stock
SAN DIEGO, Aug. 18, 2014 — Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company applying its leadership position in the field of gene therapy and calcium dysregulation, today announced the closing of its underwritten public offering of 4,600,000 shares of its common stock at $9.50 per share, including 600,000 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares, resulting in gross proceeds from the offering of $43.7 million before deducting underwriting discounts and commissions and other offering expenses payable by Celladon.
Credit Suisse and Jefferies LLC acted as joint book-running managers for the offering and Stifel and Wedbush PacGrow Life Sciences acted as co-managers.
A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on August 12, 2014. The offering was made only by means of a prospectus forming part of the effective registration statement. Copies of the final prospectus relating to the offering may be obtained from Credit Suisse Securities (USA) LLC at Eleven Madison Avenue, Level 1B, New York, NY 10010, Attn: Prospectus Department, by calling toll free 1-800-221-1037, or by e-mail at newyork.prospectus@credit-suisse.com, or alternatively from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 1-877-547-6340, or by email at Prospectus_Department@Jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
CONTACT: Fredrik Wiklund Vice President, Corporate Development and Investor Relations (858) 432-7215 fwiklund@celladon.com
(CTP) Leslie Cook Joins as a Principal in Consumer and Retail Practice
Insider Perspective and Knowledge of Specialty Retail Sector
CTPartners (NYSE MKT: CTP), a leading global retained executive search firm, today announced that Leslie Cook has recently joined the Global Consumer and Retail Practice as a Principal in New York.
With over 20 years’ experience in executive search, Leslie has focused exclusively on the consumer, retail and wholesale sectors. She has spearheaded executive searches spanning all aspects of management including merchandising, design, marketing, product development, sourcing/production, operations management, human resources, and planning and allocation.
Prior to joining CTPartners, Leslie led her own independent search consultancy, Leslie Cook Partners, LLC. Additionally, Leslie spent 17 years as a Senior Vice President with Kirk Palmer and Associates.
Leslie’s executive search work is further informed by her nine years in the retail industry at Jordan Marsh, Inc., where she held roles of increasing responsibility in sales management and merchandising. Her human resources experience there included assignments in executive recruitment, executive placement and career development, and finally, as the Director of Corporate Human Resources.
Tim Boerkoel, Global Head of the Consumer and Retail Practice said, “Leslie Cook is an accomplished executive search professional who is well known within the retail and consumer industry. She possesses rich experience and understanding of partnering closely with both clients and candidates and is a trusted advisor to many. We are thrilled to have Leslie be part of our growing Consumer and Retail Team and we value her as a true asset to our practice.”
About CTPartners
CTPartners is a leading global executive search firm that is designed to deliver in-depth expertise, creative strategies, and outstanding results to clients worldwide. Committed to a philosophy of partnering with its clients, CTPartners offers a proven track record in C-Suite, top executive, and board searches, as well as extensive experience in serving private equity and venture capital firms.
From its 30 offices in 18 countries, CTPartners serves clients with a global organization of more than 500 professionals and employees, offering expertise in board advisory services, key leadership functions, and executive recruiting services in the financial services, life sciences, industrial, professional services, retail and consumer, and technology, media and telecom industries.
For more information visit CTPartners (www.ctnet.com). Connect with CTPartners on LinkedIn, Twitter and Facebook to follow ongoing news developments and insights about the latest industry trends.
(DWA) Appoints Fazal Merchant As Chief Financial Officer
Current CFO Lew Coleman Shifts Focus to Global Growth in New Role as Vice Chairman
GLENDALE, Calif., Aug. 18, 2014 — Fazal Merchant is joining DreamWorks Animation as the company’s Chief Financial Officer. Merchant joins DreamWorks following current CFO Lew Coleman’s shift earlier this month to the role of Vice Chairman, where he will focus on global growth initiatives. Merchant will officially start on September 15, 2014.
“As we transition and augment our executive leadership team to best fit the needs of the company, I’m thrilled to welcome Fazal into the role of CFO,” said Lew Coleman, DreamWorks Animation Vice Chairman and Acting Chief Accounting Officer. “He brings with him not only passion for our business, but also experience drawn from senior leadership roles across multiple industries, which will be an incredible asset as we continue to grow and diversify.”
Merchant comes to DreamWorks Animation from DIRECTV, where he was most recently SVP and CFO of DIRECTV Latin America; until April 2014, Merchant also held the title of SVP, Treasurer & Corporate Development. Prior to joining DIRECTV in July 2012, Merchant was a managing director and group head at the Royal Bank of Scotland. Prior to that, he was a managing director in the Investment Banking Division of Barclays Capital, where he spent seven years advising clients on strategy, financing, and risk solutions. Merchant also spent nine years at Ford Motor Company in various treasury and finance management positions across functions in the U.S. and Europe.
About DreamWorks Animation
DreamWorks Animation (Nasdaq: DWA) creates high-quality entertainment, including CG animated feature films, television specials and series and live entertainment properties, meant for audiences around the world. The Company has world-class creative talent, a strong and experienced management team and advanced filmmaking technology and techniques. DreamWorks Animation has been named one of the “100 Best Companies to Work For” by FORTUNE® Magazine for five consecutive years. In 2013, DreamWorks Animation ranked #12 on the list. All of DreamWorks Animation’s feature films are produced in 3D. The Company has theatrically released a total of 29 animated feature films, including the franchise properties of Shrek, Madagascar, Kung Fu Panda, How to Train Your Dragon, Puss In Boots, and The Croods.
(WPCS) Shareholder Approval for the Sale of Seattle Operations
Divestiture Will Provide Over $1.5 Million in Working Capital
EXTON, PA–(Aug 18, 2014) – WPCS International Incorporated (NASDAQ: WPCS) (the “Company”), which specializes in contracting services for communications infrastructure and the development of a digital currency trading platform, today announced that on August 15, 2014 the Company held a special meeting of stockholders at which a majority of the Company’s shareholders overwhelmingly approved the sale of substantially all of the assets of its wholly-owned subsidiary WPCS International — Seattle, Inc. (the “Seattle Operations”). Over 94% of the total shares voted by the majority of shareholders in this special meeting were in favor of this transaction.
The agreement proposes that EC Company, an Oregon-based electrical contracting company, will purchase substantially all of the assets and assume certain liabilities of the Seattle Operations, in an all-cash transaction, at a target sales price of approximately $2.7 million, subject to certain adjustments based upon the closing date balance sheet of the Seattle Operations. The Company expects that this transaction will close on or around August 31, 2014 and that it will generate over $1.5 million in working capital.
According to Sebastian Giordano, Interim CEO of WPCS, “On behalf of the Board of Directors and entire management team, we want to thank our shareholders for demonstrating their support, evidenced by their voting in favor of the sale of our Seattle Operations. This is yet another critical milestone in our overall restructuring plan, and it will provide the Company with, amongst other benefits, some much needed working capital.”
About WPCS International Incorporated
WPCS operates in two business segments: (1) providing communications infrastructure contracting services to the public services, healthcare, energy and corporate enterprise markets worldwide; and (2) developing a digital currency trading platform. For more information, please visit www.wpcs.com, www.btxtrader.com and www.gocelery.com.
Statements about the Company’s future expectations, including future revenue and earnings and all other statements in this press release, other than historical facts, are “forward looking” statements and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time. The Company’s actual results could differ materially from expected results. In reflecting subsequent events or circumstances, the Company undertakes no obligation to update forward-looking statements.
INVESTOR CONTACT:
Capital Markets Group, LLC
Valter Pinto
PH: (914) 669-0222 or (212) 398-3486
Email Contact
(JRJC) Launches China’s First Integrated, Web-Based Securities Trading Service Platform
CITIC Securities Named as an Inaugural Partner
BEIJING, Aug. 18, 2014 — China Finance Online Co. Limited (“China Finance Online”, or the “Company”) (NASDAQ GS: JRJC), a leading web-based financial services company that provides Chinese retail investors online access to stocks, commodities and wealth management products, today announced that it has launched China’s first independent web-based securities trading platform, “Zhengquantong (“Securities Master”)”, on the leading financial portals it operates, www.jrj.com and www.stockstar.com. Securities Master is the product of a new strategic partnership China Finance Online has entered into with the largest brokerage firm in China, CITIC Securities Co., Ltd. (SHA: 600030) (“CITIC”), to seamlessly integrate China Finance Online’s state-of-the-art, web-based architecture with CITIC’s robust trading and settlement system.
Securities Master has been designed as a fully integrated securities-trading platform that will be easily accessible to investors through a highly-intuitive user interface via computers, smartphones, tablets, and smart TVs. By creating a simple and seamless experience for retail investors to access market information, open accounts and trade in real-time, investors will be able to manage their finances more effectively and efficiently via Securities Master. For the first time, active investors will have fast access to online securities trading with professional-level market data, analytics, research reports, as well as real-time online advisory services to facilitate trading decisions.
“We are extremely excited to form this groundbreaking partnership with CITIC, given China’s accelerating financial and investment reforms and the liberalization of financial instruments available to Chinese investors,” stated Mr. Zhiwei Zhao, Chairman and CEO of China Finance Online. “By bringing together leaders in both brokerage services and internet finance, we are creating a leading-edge integrated financial service ecosystem for Chinese investors. In addition to enhancing our online trading capabilities, we will also collaborate with our partners in wealth management, investment advisory and other value-added internet finance service offerings. Going forward, we will continue to leverage, expand and optimize our innovative and comprehensive financial platform for China’s growing population of retail investors, further strengthening our foundation for monetization.”
As China’s leading financial information center, the Company’s portals, jrj.com and stockstar.com, have aggregated a large user base of over tens of millions of monthly active users. By providing accurate, consistent and reliable financial information to Chinese investors for over a decade, the Company’s expertise and value proposition in internet finance have been widely recognized by major financial services providers like CITIC, as well as the wider investment community. Through this partnership with CITIC, the new web-based securities trading platform will enable both companies to quickly transfer their current user bases to online securities trading system as well as to expand and attract new users.
Conference Call Information
The Company will hold a conference call on Tuesday, August 19, 2014 at 7:30 am Eastern Time or 7:30 pm Beijing Time to discuss the web-based financial portals in more detail.
United States: | +1-800-742-9301 |
International Dial-In: | +61-283733610 |
China Domestic: | 4001-203170 |
Hong Kong: | +800-906648 |
Conference ID: | #89855480 |
The replay will be accessible through August 26, 2014 by dialing the following numbers:
United States: | +1-855-452-5696 |
International: | +61-2-90034211 |
Conference ID: | #89855480 |
About China Finance Online
China Finance Online Co. Limited is a leading web-based financial services company that provides Chinese retail investors access to stocks, commodities and wealth management products. The Company’s two prominent flagship portal sites, www.jrj.com and www.stockstar.com, are ranked as top financial websites in China. In addition to the web-based securities trading platform, the Company offers basic financial software, information services and securities investment advisory services to retail investors in China. Through its subsidiary, Shenzhen Genius Information Technology Co. Ltd., the Company provides financial database and analytics to institutional customers including domestic financial, research, academic and regulatory institutions. China Finance Online also provides brokerage services in Hong Kong.
About CITIC Securities Co., Ltd.
CITIC Securities Co., Ltd. is the largest securities firm in China by total assets and market share with 271.4 billion RMB in total assets. Underwriting a total of 213.8 billion RMB, CITIC ranked No. 2 in equity underwriting and No. 1 in fixed income underwriting in 2013. Managing over 504.9 billion RMB, CITIC also ranked No. 1 in asset management. CITIC is the parent company of CLSA Asia Pacific Markets. CITIC is CITIC Group’s securities arm and CITIC Group is one of China’s largest state-owned financial conglomerates.
Safe Harbor Statement
This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, this release contains the following forward-looking statements regarding:
- our prospect on the newly launched web-based securities trading platform, “Zhengquantong (“Securities Master”)”, and its integration with our existing financial services and CITIC’s trading and settlement system;
- our prospect on the growth of our financial platform and online trading capabilities;
- our prospect on transferring CITIC’s and our user bases to the newly launched securities trading platform as well as expanding and attracting new users;
- our prospect on the collaboration with CITIC and our partners in wealth management, investment advisory and other value-added internet finance service offerings; and
- the market prospect of the business of internet finance.
Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, which risks and uncertainties include, among others, the following:
- the changing customer needs, regulatory environment and market condition that we are subject to;
- the uneven condition of the world and Chinese economy that could lead to volatility in the equity markets and affect our operating results in the coming quarters;
- the impact of the changing conditions of the Chinese stock market, Hong Kong stock market and global financial market on our future performance;
- the unpredictability of our strategic transformation and growth of new businesses, including our online securities trading services and platform;
- the degree to which our strategic collaborations with partners will yield successful outcome;
- the prospect of integrating Yinglibao with our newly launched web-based securities trading platform;
- the prospect for China’s high-net-worth and middle-class households;
- the prospect of equipping our customer specialists with new technology, tools and financial knowledge;
- the competition we are facing in the new business of internet finance and online securities trading;
- wavering investor confidence that could impact our business; and
- possible non-cash goodwill, intangible assets and investment impairment may adversely affect our net income.
Further information regarding these and other risks is included in the Company’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F under “Forward-Looking Information” and “Risk Factors”. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.
(NEO) Announces Pricing of $32.2 Million Public Offering
Seven Million Share Offering at $4.60 per Share
FT. MYERS, Fla., Aug. 15, 2014 — NeoGenomics, Inc. (NASDAQ: NEO) (the “Company”), a leading provider of cancer-focused genetic testing services, today announced that it has priced an underwritten public offering of 7.0 million shares of common stock at a price to the public of $4.60 per share. The transaction is expected to close on August 20, 2014 and will result in gross proceeds to NeoGenomics of $32.2 million. The net proceeds to the Company, after deducting the underwriters’ discounts and other estimated offering expenses, will be approximately $30.0 million. The Company plans to use the net proceeds for working capital, capital expenditures and for general corporate purposes, including potential acquisitions and the repayment of debt. NeoGenomics has granted the underwriters a 30-day option to purchase up to an additional 1.05 million shares of common stock to cover over-allotments, if any.
William Blair & Company, L.L.C. is the sole book-running manager and Craig-Hallum Capital Group LLC is co-lead manager for the offering. Stephens Inc., Roth Capital Partners, LLC, Sidoti & Company, LLC and Dawson James Securities, Inc. are serving as co-managers for the offering.
This offering is being conducted pursuant to a shelf registration statement that was declared effective by the U.S. Securities and Exchange Commission (“SEC”) on January 3, 2014. The offering is being made only by means of a prospectus supplement and accompanying prospectus, forming an effective part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to these securities have been filed with the SEC and are available at the SEC’s website at www.sec.gov. Before investing, you should read the prospectus supplement and the accompanying prospectus for information about NeoGenomics and this offering. Copies of the preliminary prospectus supplement, the final prospectus supplement (when available) and accompanying prospectus relating to these securities may also be obtained from William Blair & Company, L.L.C., Attention Prospectus Department, 222 West Adams Street, Chicago, Illinois 60606, by telephone at (800)-621-0687, or by email at prospectus@williamblair.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.
About NeoGenomics, Inc.
NeoGenomics, Inc. is a CLIA–certified clinical laboratory that specializes in cancer genetics testing, the fastest growing segment of the laboratory industry. The Company’s testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, immunohistochemistry, anatomic pathology and molecular genetic testing. Headquartered in Fort Myers, FL, NeoGenomics has laboratories in Nashville, TN, Irvine, Fresno and West Sacramento CA, Tampa and Fort Myers, FL. NeoGenomics services the needs of pathologists, oncologists, other clinicians and hospitals throughout the United States.
Forward Looking Statements
Except for historical information, all of the statements, expectations and assumptions contained in the foregoing are forward-looking statements. These forward looking statements involve a number of risks and uncertainties that could cause actual future results to differ materially from those anticipated in the forward looking statements. Actual results could differ materially from such statements expressed or implied herein. Factors that might cause such a difference include, among others, the Company’s ability to continue gaining new customers, offer new types of tests and otherwise implement its business plan. As a result, this press release should be read in conjunction with the Company’s periodic filings with the SEC.
(SYRG) Provides Production and Operations Update
PLATTEVILLE, CO–(August 15, 2014) – Synergy Resources Corporation (NYSE MKT: SYRG), a U.S. oil and gas exploration and production company focused in the Denver-Julesburg Basin, provides an update of its production and operations in the Wattenberg Field. Production rates for Synergy’s recent horizontal wells follow*:
Name of Pad | Number of wells | Average # of fracs per well | Days of Production | Average Daily (BOED) Production per well 8/8ths |
% Oil Cut |
Cost Per Well $MM |
Renfroe | 5 | 18 | 270 | 219 | 66% | $3.6 |
Leffler | 6 | 20 | 180 | 145 | 65% | $3.7 |
Phelps | 5 | 26 | 90 | 430 | 69% | $4.0 |
Union | 6 | 20 | 30 | 566 | 74% | $3.9 |
*For further production history details please refer to the corporate presentation at www.syrginfo.com
Also, the five wells on the Renfroe pad have paid back approximately 90% of all costs during the first eleven months of production.
Beginning with the Union pad, Synergy began drilling well bores 220 feet apart which is a more densely spaced drilling pattern and allows for up to 24 wells per 640 acres. This tighter spacing provides Synergy with a potential inventory of over 1,000 wells on its 27,386 net acres in the Wattenberg.
Horizontal drilling operations and completions are progressing according to plan. The four Kelly Farms wells are now in early production. The six Eberle wells, which include two mid reach 7,000 foot extended lateral wells with 45-47 frac stages each, are in the final completion stage and are flowing back or in initial production.
Synergy’s Wattenberg Field development continues with Rig #131 drilling the third well on the Kiehn pad where the company plans on a total of eight wells comprised of 4 Codell and 4 Niobrara C bench wells. Rig #134 is drilling the third well on the Weld 152 pad where the company plans on drilling six wells comprised of 3 Codell, 2 Niobrara B bench and 1 Niobrara C bench well. The third rig in Synergy’s operated program, Rig #138, is scheduled to move to the Wiedeman pad later this month and begin drilling eight wells in September. The Wiedeman pad will consist of 4 Codell and 4 Niobrara wells. Four of the Wiedeman wells are planned to be 9,000 foot extended reach lateral wells and the other four will be standard length lateral wells of 4,000 feet.
Depending on contribution from its non-operated horizontal wells and the performance of the Kelly Farms and Eberle wells, Synergy believes production for its fiscal fourth quarter ending August 31, 2014 will range between 5,800-6,200 BOED. With this new flush production coming on line from the Kelly Farms and Eberle pads, Synergy believes it will exit its fiscal year end at a production rate of between 8,000-9,500 BOED.
In the Northeast Wattenberg Extension Area (Extension Area) Synergy has reviewed the lab results from the core data taken from the vertical Buffalo Run test well and is currently preparing to permit 12 wells in the Extension Area. Once these permits are approved, Synergy plans on drilling a horizontal well targeting the Greenhorn formation. Depending on the results of the initial horizontal well, the company will move forward with multi-well pad drilling on its 25,765 net acres in this area.
Craig Rasmuson, Chief Operating Officer, of Synergy commented, “We are making tremendous strides in the development of our assets in the Wattenberg Field. In spite of continued challenges from mid-stream processing constraints, we are achieving record growth for the company in production and cash flow. The 30 day results from our most recent wells on the Union pad are the best we have achieved so far. We are doing so while maintaining a keen eye on controlling costs and developing our leases in a responsible manner. We are very pleased with the production rates from our horizontal pads and the high percentage of oil in the production mix, which is generating an attractive realized price per BOE for the company. We look forward to realizing further efficiencies on our mid and extended reach lateral wells in fiscal 2015. We continue to expand our foot print through organic leasing efforts and asset purchases. We are further accelerating our development with the addition of a third horizontal rig, Rig #138 which is moving to the Wiedeman pad, and by adding new permits. In addition to the aforementioned wells and pads, Synergy has 66 permits approved and another 120 permits in process for horizontal wells in the Wattenberg Field. In the Extension Area we are very excited about the prospects in the Greenhorn formation on our leasehold and the recent results from industry competitors in the Niobrara and Codell formations in the area. We look forward to keeping the market and our shareholders apprised of our progress.”
Synergy is presenting at Enercom’s The Oil & Gas Conference 19 ® 2014 at the Westin Hotel in Denver on Monday, August 18th at 11:20am. Interested parties may view the slide presentation and a link to the live audio webcast by going to Synergy’s website at http://www.syrginfo.com and clicking on the webcast link under the Investor Relations section of the website.
The live webcast will also be available on The Oil & Gas Conference 19 ® website at http://www.theoilandgasconference.com.
About Synergy Resources Corporation
Synergy Resources Corporation is a domestic oil and natural gas exploration and production company. Synergy’s core area of operations is in the Denver-Julesburg Basin, which encompasses Colorado, Wyoming, Kansas, and Nebraska. The Wattenberg field in the D-J Basin ranks as one of the most productive fields in the U.S. The company’s corporate offices are located in Platteville, Colorado. More company news and information about Synergy Resources is available at www.syrginfo.com.
Important Cautions Regarding Forward Looking Statements
This press release may contain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as “believes”, “expects”, “anticipates”, “intends”, “plans”, “estimates”, “should”, “likely” or similar expressions, indicates a forward-looking statement. These statements are subject to risk and uncertainties and are based on the beliefs and assumptions of management, and information currently available to management. The actual results could differ materially from a conclusion, forecast or projection in the forward-looking information. Certain material factors or assumptions were applied in drawing a conclusion or making a forecast or projection as reflected in the forward-looking information. The identification in this press release of factors that may affect the company’s future performance and the accuracy of forward-looking statements is meant to be illustrative and by no means exhaustive. All forward-looking statements should be evaluated with the understanding of their inherent uncertainty. Factors that could cause the company’s actual results to differ materially from those expressed or implied by forward-looking statements include, but are not limited to: the success of the company’s exploration and development efforts; the price of oil and gas; worldwide economic situation; change in interest rates or inflation; willingness and ability of third parties to honor their contractual commitments; the company’s ability to raise additional capital, as it may be affected by current conditions in the stock market and competition in the oil and gas industry for risk capital; the company’s capital costs, which may be affected by delays or cost overruns; costs of production; environmental and other regulations, as the same presently exist or may later be amended; the company’s ability to identify, finance and integrate any future acquisitions; and the volatility of the company’s stock price.
Investor Relations Contact:
Jon Kruljac
Synergy Resources Corporation
jkruljac@syrginfo.com
Tel (303) 840-8166
Company Contact:
Rhonda Sandquist
Synergy Resources Corporation
rsandquist@syrginfo.com
Tel (970) 737-1073
(TGTX) Novel “Chemo-free” Triple Therapy Combination
Represents the First Time Patients Will be Treated With the Combination of a Glycoengineered Anti-CD20 Monoclonal Antibody (TG-1101) With a PI3k Delta Inhibitor (TGR-1202) and a BTK-inhibitor (ibrutinib)
NEW YORK, Aug. 15, 2014 — TG Therapeutics, Inc. (Nasdaq:TGTX), today announced the commencement of a novel triple therapy clinical study that combines the Company’s two experimental drugs, TG-1101, a glycoengineered anti-CD20 monoclonal antibody, and TGR-1202 (ublituximab), a PI3K delta inhibitor, with the marketed BTK-inhibitor, ibrutinib (Imbruvica®). This is the first time that a BTK-inhibitor and a PI3k delta inhibitor have been used in combination with each other in patients. The trial is being led by Drs. Susan O’Brien and Nathan Fowler at MD Anderson, and Drs. Julie Vose and Matt Lunning of University of Nebraska, and will be run as a component of the previously announced and on-going Phase 1 study of the combination of TG-1101 and TGR-1202. The study will utilize fixed doses of TG-1101 and ibrutinib and will provide for dose escalation of TGR-1202.
As previously announced, preliminary data from this combination study of TG-1101 plus TGR-1202 was presented at the 2014 Pan Pacific Lymphoma Conference, where the combination appeared well-tolerated at the doses tested to date. Preliminary signs of efficacy in high-risk CLL patients were very encouraging with 4 of 5 patients from the CLL cohort achieving a partial response ( > 50% decrease in disease) at first assessment and the fifth patient achieving stable disease with a nodal reduction of nearly 45% awaiting a second efficacy assessment.
Additionally, at the European Hematology Association meeting in June, the Company announced preliminary data from an ongoing study utilizing the combination of TG-1101 plus ibrutinib. The combination appeared to be well-tolerated with minimal grade 3/4 events observed, and significant efficacy demonstrated with 10 of 10 patients achieving a complete or partial response (as updated on the Company’s recent quarterly conference call).
Given the favorable safety profile and significant activity of these two doublet combinations, it was hypothesized that the triple therapy may be safe and well-tolerated, and offer even greater activity over either doublet regimen.
Michael S. Weiss, the Company’s Executive Chairman and Interim CEO, stated, “Our mission has been and continues to be to develop novel combination therapies for the treatment of B-cell malignancies that can provide better patient outcomes without the use of harsh chemotherapies. We believe that to achieve this goal, combinations of multiple targeted agents will be required, and we plan to continue to be the leader in exploring novel combinations exploiting a variety of mechanisms. The start of today’s triple therapy study marks the beginning of the next level of exploration and our commitment to patients living with this disease as well as demonstrates the speed at which we can move forward novel combinations. We are fortunate that our vision is shared by some of the leading investigators in the field of hematologic malignancies, and we thank the Study Chairs, Dr. O’Brien and Dr. Fowler, as well as all the investigators involved in this exciting combination trial for their continued support and enthusiasm to innovate and drive the field forward to next level.”
Dr. Susan O’Brien, Professor in the Department of Leukemia at MD Anderson Cancer Center and Study Chair for the CLL patient group stated, “We are thrilled to be able to move quickly and test this triple combination of chemo-free targeted agents, and feel TGR-1202, with its safety profile demonstrated to date, is uniquely suited to combination with ibrutinib. Chemotherapy combinations have long been the standard of care for patients with CLL, and with the development of these novel, targeted agents, we hope to induce greater responses and longer durations of remission without compromising safety.”
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. Currently, the company is developing two therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. The Company also has a pre-clinical program to develop IRAK4 inhibitors. TG Therapeutics is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials, the timing of commencing, completing or reporting such trials, the business prospects for TG-1101 and TGR-1202, the potential benefits of combining TG-1101 and TGR-1202 and the potential benefits that might be achieved with the micronized formulation and fed-state dosing may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101 and TGR-1202; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101 and TGR-1202 will not be reproduced in additional patients or in future studies; the risk that the enhanced absorption seen in the healthy human volunteer bioequivalence studies will not be seen in whole or in part when the modified formulation and fed-state dosing are studied in patients with B-cell malignancies; the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current phase 1 study; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that our ongoing or contemplated drug combinations may not prove tolerable or efficacious; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
TGTX – G
CONTACT: Jenna Bosco Director- Investor Relations TG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com
(ACHN) 100% Sustained Virologic Response Rate, Ribavirin-Free ACH-3102 and Sofosbuvir
Achillion to Begin a Six Week Treatment Regimen With Its Second-Generation NS5A Inhibitor ACH-3102 and Sofosbuvir
NEW HAVEN, Conn., Aug. 15, 2014 — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced interim results from an ongoing Phase 2 proxy study evaluating ACH-3102, Achillion’s second-generation NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus (HCV) infection. Of the 12 patients treated, 100 percent (n=12/12) remained HCV RNA undetectable four weeks after completing therapy (SVR4). Based upon these results, 12 additional patients will begin treatment with six weeks of once daily ACH-3102 and sofosbuvir.
“ACH-3102 continues to demonstrate good safety and tolerability through three Phase 2 studies. We believe these studies also confirm a differentiated efficacy profile for an NS5A inhibitor. Achieving 100% SVR4 with eight weeks of treatment with sofosbuvir serving as a nucleotide proxy indicate that dosing 50 mg once daily of ACH-3102 plus a nucleotide inhibitor has the potential to achieve commercially competitive results for curing HCV in a short duration, ribavirin-free doublet,” commented David Apelian, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Achillion. “In addition, understanding how ACH-3102 performs with sofosbuvir provides valuable insight for the design of our proprietary combination trial with ACH-3102 and ACH-3422, a uridine-analog nucleotide that continues to advance through its Phase 1 clinical development program.”
Milind Deshpande, Ph.D., President and Chief Executive Officer of Achillion commented, “As we continue to achieve clinical milestones, we remain focused on execution of the broader clinical development strategy for our HCV portfolio. We expect that Phase 1 proof-of-concept results with ACH-3422 will be reported during the fall of this year, which we anticipate will lead to the start of a Phase 2 combination program to evaluate our proprietary doublet regimen for an eight week, or potentially shorter, treatment regimen for HCV that will begin before the end of 2014.”
ACH-3102 – 017: Phase 2 pilot study evaluating eight week treatment in combination with sofosbuvir for genotype 1 treatment-naïve HCV
Achillion is conducting a Phase 2, open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight weeks or six weeks of ACH-3102 and sofosbuvir, a marketed nucleotide polymerase inhibitor, without ribavirin, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study is determination of sustained viral response 12 weeks (SVR12) after the completion of therapy. Eighteen patients were enrolled, including six observational patients. Twelve patients completed eight weeks of treatment consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir administered once daily while observational patients received no drug during this phase of the trial. Ten of the 12 patients receiving eight weeks of treatment had genotype 1a HCV with median HCV RNA at baseline of 7.22 log10 (range 5.5 – 7.8 log10). No on-treatment viral breakthrough or post-treatment viral relapse has been observed to date. ACH-3102 and sofosbuvir were well tolerated with no significant adverse events, ECG findings, or lab abnormalities observed during treatment.
Following achievement of the pre-specified response rate of 100 percent, the six observational patients plus six additional patients will be enrolled and receive six weeks of treatment consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir administered once daily. Achillion anticipates that SVR4 results from the crossover cohort will be reported by the end of 2014.
About HCV
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including more than 5 million people in the United States. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion’s discovery, clinical development, and commercial teams have advanced multiple novel product candidates with proven mechanisms of action into studies and toward the market. Achillion is focused on solutions for the most challenging problems in infectious disease including HCV and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to: the Company’s expectations that the Phase 1 study of ACH-3422 could inform the potential initiation of combination studies of ACH-3422 and ACH-3102; the Company’s expectations that it may report preliminary results from its Phase 1 program during the fall of 2014; the Company’s plan to initiate a Phase 2 combination study of ACH-3422 with ACH-3102 by year-end 2014; the Company’s goal to safely and expeditiously advance its all-oral regimens for the treatment of HCV and its expectation that the breadth of its portfolio could enable it to potentially develop commercially-competitive regimens that can be safe, effective, ribavirin-free and that can be used for eight weeks or less to potentially cure HCV. Achillion may use words such as “expect,” “anticipate,” “project,” “intend,” “plan,” “aim,” “believe,” “seek,” ” estimate,” “can,” “focus,” “will,” and “may” and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion’s ability to: demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; advance the preclinical and clinical development of its drug candidates, including ACH-3422, ACH-3102 and sovaprevir, under the timelines it projects in current and future clinical trials; obtain and maintain necessary regulatory approvals; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; manage expenses; manage litigation; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2013, and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any duty to update any forward-looking statement, except as required by applicable law.
CONTACT: Company Contact: Glenn Schulman Achillion Pharmaceuticals, Inc. Tel. (203) 624-7000 gschulman@achillion.com Media: Laurie Masonson Ogilvy PR Tel. (917)459-6164 laurie.masonson@ogilvy.com Investors: Mary Kay Fenton Achillion Pharmaceuticals, Inc. Tel. (203) 624-7000 mfenton@achillion.com Investors: Tricia Truehart The Trout Group, LLC Tel. (646) 378-2953 ttruehart@troutgroup.com
(ACTS) Issues Open Letter Detailing Latest Initiatives
ZHUHAI, China, Aug. 15, 2014 — Actions Semiconductor Co., Ltd. (Nasdaq: ACTS) (“Actions Semiconductor” or “the Company”), one of China’s leading fabless semiconductor companies that provides comprehensive portable multimedia and mobile internet system-on-a-chip (SoC) solutions for portable consumer electronics, is today providing an operational update and details of initiatives approved by its board of directors.
Dear Shareholders,
I am pleased to provide an update on certain initiatives we are taking. Some have needed and received approval by our board of directors. In the interest of providing further transparency, we are furnishing this letter to our shareholders as a press release and on Form 6-K with the SEC and have made it available on our website.
Our Headway from PMP to the Tablet Business
Actions has had significant success in the portable media player (PMP) market, where we established ourselves as the major provider of an integrated system-on-a-chip (SoC) solution platform. That platform became the foundation of an ecosystem that encompasses over one thousand third-party application developers, value-added distributors, system integrators and brand name manufacturers in China. We succeeded by utilizing a low margin sales strategy that rapidly established a significant market share and attracted a growing number of developers to our ecosystem. Like many of the markets we target, success breeds success. If you have the leading system in the field, then third party developers find the highest return on their time from developing applications for your system rather than rival systems. Our dominant position also allowed us to better tailor our R&D efforts to meet the evolving needs of our customers. In this way, as our existing products began to experience lower selling prices, we launched newer, more advanced products at higher initial prices and margin to offset the decline in selling prices from the previous generation products brought about by the intense competition that exists in this and many of the world’s chip markets.
After seeing strong potential in the rapidly growing tablet market, we entered the tablet business by employing a similar low margin sales strategy to the one we employed in the PMP market. Once again this strategy has brought meaningful success in establishing our platform. Today, the tablet business accounts for the significant portion of our total revenues. However, due to intense competition and newly announced entrants in this market, we have not been able to increase our margins as quickly as we would like. Although the tablet market experienced rapid growth in 2012 and 2013, competition among industry players along the supply chain has kept prices low. To put this in perspective, we are seeing locally-branded 7-inch tablets in China retailing below US$50. Just as with the PMP market, in order for us to maintain or increase our market share, we have to call on all of our internal R&D resources and potentially enter into strategic alliances to expand our sales channels, gain additional technical know-how and license our technologies to more developers in order to foster the continuing adoption of our platform. Accordingly, we are undertaking a number of initiatives that we expect to keep us in the leading group of tablet chip developers.
Restructuring Our Subsidiaries
During the past few years, we have established several sales and research centers throughout greater China. Our primary concern was to locate our manufacturing and research centers in close proximity to engineering talent and our sales centers near our customers. As our business expanded from PMPs into tablets, this group structure has become increasingly complicated. As a result, we have decided to streamline our corporate structure both in terms of reporting lines and re-designated several sales and research entities under our principal operating entity, Actions (Zhuhai) Technology Co., Limited (“Actions Technology”).
The real results we hope for are more clarity of structure among our legal entities and success in the constant competition for engineering and management talent. We believe a more streamlined reporting line will provide our engineers with greater clarity of their goals and responsibilities as well as foster a more collaborative environment for engineers in different departments. As competition for talent increases, our engineers have also requested that their equity incentive plans reflect the performance of their individual departments and projects that they have worked on. Our new corporate structure will allow our management to keep better track of team and individual performance and issue incentives accordingly.
To view a diagram of our group structure after the restructuring, please refer to the Form 6-K furnished to the SEC today.
Potential Strategic Alliances
We expect an additional effect of our unified corporate structure to be better management access to our product development and intellectual property portfolio assets, which, in turn, could also allow us to explore opportunities in packaged license deals, joint ventures and various forms of strategic alliances with other industry players. We note that joint research and development programs, cross holding of shares and board appointments have always been a development strategy among high-tech companies, including the recent collaboration between Intel and our competitor, Rockchip. While we are not entertaining a horizontal merger with a direct competitor at this time, our management has been tasked to seek potential strategic alliance partners along the supply chain that will help us expand our sales channels, enhance our technology base and create a larger ecosystem around our platform. Earlier today, we formally established a special committee, comprising solely of independent directors, to monitor and evaluate such options and proposals. Our new group structure that better reflects the purposes and functions of each subsidiary can also facilitate the formation of strategic alliances in the future.
Corporate Structure Options
We take our duty to maximize shareholder value seriously and are exploring a number of options to accomplish our strategic goals. One option involves dual listing on an Asian stock exchange, where the investors are more familiar with our market power in the PMP and tablet sectors and could give us a better valuation. Another option involves the listing of our subsidiaries, such as Actions Technology, in Asia, which could in turn increase the valuation of our ADSs listed in the US. We believe an equity incentive plan for Actions Technology will be necessary, as our employees will see their equity incentives tied to a subsidiary whose performance can more closely track their contributions and whose value is determined in an equity market with which they are familiar. While our management and directors have no current plan for a dual listing or to list any of our subsidiaries, and there are substantial legal obstacles to overcome, our special committee will actively evaluate listing options for us and our subsidiaries. Earlier today, our compensation committee approved the establishment of an option plan based on awarding the shares of Actions Technology to our employees. This option plan envisions awarding our employees up to 15% of the equity of Actions Technology over the next five years.
Capital Structure Options
As many of you know, optimizing our capital structure is an ongoing task of management and something about which I wrote in a recent comment letter. We always have the option to repurchase additional shares if we consider our cash position exceeds our foreseeable needs. At our 2014 annual general meeting, our shareholders approved a future repurchase program. On May 6, 2014, we increased our stock repurchase program from 30 million ADSs to 50 million ADSs. As of June 30, 2014, approximately 23.2 million ADSs have been repurchased under our current share buyback program. Concurrent with this press announcement, we are also formally announcing a self tender program. Please see our press release titled “Actions Semiconductor Announces Intention to Conduct Dutch Auction Tender Offer for Its Ordinary Shares (including Ordinary Shares represented by American Depositary Shares)” for the conditions and details of the self tender.
In closing, I along with the rest of the board and management continue to be mindful of the business challenges we face and are determined to enhance our competitive position, improve our financial performance and maximize value for our shareholders. We remain confident in China’s future, and expect continued, rapid economic growth. Our management team, along with our highly talented staff in China, will continue to create next generation products to meet the ever changing needs of the domestic and global markets.
Sincerely,
Mr. Hsiang-Wei Lee
Chairman of the Board
Actions Semiconductor Co., Ltd.
About Actions Semiconductor
Actions Semiconductor is one of China’s leading fabless semiconductor companies that provides comprehensive portable multimedia and mobile internet system-on-a-chip (SoC) solutions for portable consumer electronics. Actions Semiconductor products include SoCs, firmware, software, solution development kits, as well as detailed specifications of other required components. Actions Semiconductor also provides total product and technology solutions that allow customers to quickly introduce new portable consumer electronics to the mass market in a cost effective way. The Company is headquartered in Zhuhai, China, with offices in Shanghai and Shenzhen. For more information, please visit the Actions Semiconductor website at http://www.actions-semi.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
Statements contained in this release that are not historical facts are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements concerning the Actions ability to maintain or increase its market share in the tablet market, establish strategic alliances to expand its sales channels, enhance its technology base, and create a larger ecosystem around its tablet SoC platform and attract and retain engineering talent. Actions Semiconductor uses words like “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project” and similar expressions to identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are estimates reflecting current assumptions, expectations and projections about future events and involve significant risks, both known and unknown, uncertainties and other factors that may cause Actions Semiconductor’s actual performance, financial condition or results of operations to be materially different from those suggested by the forward-looking statements including, among others, customers’ cancellation or modification of their orders; our failure to accurately forecast demand for our products; the loss of, or a significant reduction in orders from, any of our significant customers; fluctuations in our operating results; our inability to develop and sell new products; defects in or failures of our products; the expense and uncertainty involved in our customer design-win efforts; the financial viability of the distributors of our products; consumer demand; worldwide economic and political conditions; fluctuations in our costs to manufacture our products; our reliance on third parties to manufacture, test, assemble and ship our products; our ability to retain and attract key personnel; our ability to compete with our competitors; and our ability to protect our intellectual property rights and not infringe the intellectual property rights of others. Other factors that may cause our actual results to differ from those set forth in the forward-looking statements contained in this press release and that may affect our prospects in general are described in our filings with the Securities and Exchange Commission, including our most recently filed Forms F-1, 20-F and 6-Ks. Other unknown or unpredictable factors also could have material adverse effects on Actions Semiconductor’s future results, performance or achievements. In light of these risks, uncertainties, assumptions and factors, the forward-looking events discussed in this press release may not occur. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date stated, or if no date is stated, as of the date of this press release. Except as required by law, Actions Semiconductor undertakes no obligation and does not intend to update or revise any forward-looking statement to reflect subsequent events or changed assumptions or circumstances.
Investor Contacts:
Elaine Ketchmere, CFA | Ally Xie, CA, CPA |
Compass Investor Relations | Actions Semiconductor |
eketchmere@compass-ir.com | investor.relations@actions-semi.com |
+1-310-528-3031 | +86-756-3392353*1018 |
(PFIE) Record Financial Results for Fiscal First Quarter of 2015
Fiscal First Quarter of 2015 Revenues Up 83% to Record $13.1 Million, Driving Net Income of $0.05 Per Share
LINDON, Utah, Aug. 14, 2014 — Profire Energy, Inc. (Nasdaq:PFIE), a technology company which creates, installs and services burner management systems and other combustion technologies for the oil and gas industry, reported financial results for its fiscal first quarter ended June 30, 2014.
Fiscal Q1 2015 Highlights vs. Same Year-ago Quarter
- Total revenues increased 83% to record $13.1 million.
- Net income increased 38% to $2.2 million or $0.05 per share.
- Extended product line with launch of proprietary valve-actuator.
- Opened new service center in Victoria, Texas, and upgraded Pennsylvania satellite office to a service center.
- Began testing a service-based, recurring-revenue model.
- Expanded sales team, now totaling over 20.
- PFIE added to Russell 2000®, Russell 3000®, and Russell Microcap® Indices.
Fiscal Q1 2015 Financial Results
Total revenues in the fiscal first quarter of 2015 increased 83% to a record $13.1 million from $7.2 million in the same year-ago quarter. The increase in revenues was primarily due to improved sales execution, and increased efficacy in a number of growing sales territories, including Texas, Colorado, and Pennsylvania. The increase is in part driven by leveraging new service personnel, as well as the expansion of existing sales and service territories.
Gross profit increased to $7.4 million or 57% of total revenues, compared to $4.2 million or 58% of total revenues in the year-ago quarter.
Total operating expenses increased to $4.0 million or 31% of total revenues from $1.8 million or 26% of total revenues in the same year-ago quarter. The increase in operating expenses was primarily due to expansion and opening of offices throughout the U.S., purchase of equipment for the Company’s expanding service team, and hiring of additional personnel, particularly in the Utah, Texas and Pennsylvania offices—ultimately to support long-term sales growth. The increase in total operating expenses was also driven by increased non-cash stock option expense, as well as increased research and development expense to support the introduction of the Company’s next generation burner management systems and other products.
Net income increased 38% to $2.2 million or $0.05 per share, compared to net income of $1.6 million or $0.04 per share in the same year-ago quarter
Cash and cash equivalents totaled $4.5 million at June 30, 2014, as compared to $1.7 in the comparable prior-year period. Subsequent to the fiscal first quarter of 2015, the Company completed an equity raise for gross proceeds of $18.0 million.
Management Commentary
“Our record first quarter reflects the expansion of our sales and service teams in the U.S., along with a new sales office in Pennsylvania and service center in Texas,” said Brenton Hatch, Chief Executive Officer of Profire Energy. “Also during the quarter, we began testing a new service program designed to generate recurring revenue, and also expanded our product line with the launch of a proprietary valve-actuator.
“The test program intends to offer a compelling value to the oil and gas service industry by regularly deploying our service teams throughout the year to help ensure our customers’ burners are operating optimally when using our latest burner management technology. The program includes calculating customer-specific savings derived from the use of Profire’s products and services, to help illustrate Profire’s value to the customer. We are already beginning to experience increasing service revenues as a result of leveraging new service personnel and expansion of new service territories, such as in Utah, Texas, and Pennsylvania, and hope to couple that expanding team with a growing line of service-products in the coming months.”
Andrew Limpert, the Company’s Chief Financial Officer, spoke to the general success of BMS in the industry:
“In many markets we are continuing to see growing adoption of burner management systems, primarily driven by their unique capability to make oil and gas production safer, more efficient, and more compliant with changing industry regulations,” said Limpert. “While Canada has had BMS-related regulation for years, the U.S. is just beginning to catch up. In fact, we are experiencing strong growth and expansion in Colorado with the state’s recently passed mandate for the use of ‘auto igniters.’ With the industry growth in the U.S.—recently demonstrated by becoming not only the world’s leading producer of gas, but also the leading producer of oil—we are confident in our market opportunities in coming years.
“Our systems not only auto-ignite, but also manage oilfield flames, providing temperature regulation and remote-monitoring capabilities. We also provide other combustion-related solutions to address challenging industry problems, as demonstrated by the recent introduction of our flare-stack igniter. By offering a portfolio of related, complementary products—with an experienced, strong service team behind them—we can more comprehensively understand and meet the industry’s needs. Our investment in—and management for—long-term stakeholder value creation will continue to be our key focus as an industry leader.
“As we look forward to the rest of the fiscal year, we plan to continue expanding our marketing, sales and service teams. The completed expansion of our Lindon, Utah warehouse in the fall will add increased efficiency and scalability to the delivery of our products. Supported by the growing industry demand for burner management systems, we expect these efforts to lead to another year of significant top- and bottom-line growth.”
Fiscal 2015 Outlook
As previously reported, Profire Energy currently expects fiscal 2015 total revenues to range between $46 million and $48 million, which represents an increase of 30% to 36% from the prior year. The Company also expects net income to range between $7 million and $9 million, which represents an increase of 25% to 61% from the prior year.
About Profire Energy, Inc.
Profire Energy assists energy production companies in the safe and efficient production and transportation of oil and natural gas. As energy companies seek greater safety for their employees, compliance with more stringent regulatory standards, and enhanced margins with their energy production processes, Profire Energy’s burner management systems are increasingly becoming part of their solution. Profire Energy has offices in Lindon, Utah; Houston, Texas; Victoria, Texas; Oklahoma City, Oklahoma; Tioga, Pennsylvania; and Edmonton, Alberta, Canada.
Cautionary Note Regarding Forward-Looking Statements. Statements made in this release that are not historical are forward-looking statements. This release contains forward-looking statements, including, but not limited to statements regarding its sales, marketing, and operational advancements/expansions, including, but not limited to, the continuation of increased sales efficacy or execution in any number of areas; the increased leveraging of personnel; the intention or success of the Company’s efforts to sustain long-term sales growth or the introduction of the Company’s next-generation of burner management systems and other products; the reflection of the first quarter on the expansion of the sales and/or service teams in the US, or the opening of any offices; the success of—or value provided by—the Company’s test program to generate recurring-revenues, and the intent to pursue, the features of, or efficacy of the test program; the Company’s hope to grow its line of service-products, or combine such with any other sales or service strategy; the adoption—or the Company’s assessment of such—of burner management systems throughout certain markets; the Company’s assessment of the regulations related to its industry or products; the relative position of the US in oil- or gas-production, or maintenance of the same; the Company’s plans to continue expanding its marketing, sales, and service teams; the expectation that the Company’s warehouse completion will add enhanced efficiency and scalability to the delivery of the Company’s products; or the Company’s expectation to realize another year of significant top- or bottom-line growth . Forward-looking statements are not guarantees of future results or performance and involve risks, assumptions and uncertainties that could cause actual events or results to differ materially from the events or results described in, or anticipated by, the forward-looking statements. Factors that could materially affect such forward-looking statements include certain economic, business, public market and regulatory risks and factors identified in the company’s periodic reports filed with the Securities Exchange Commission. All forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are made only as of the date of this release and the Company assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances, except as required by law. Readers should not place undue reliance on these forward-looking statements.
PROFIRE ENERGY, INC. AND SUBSIDIARY | ||
Condensed Consolidated Balance Sheets | ||
ASSETS | ||
June 30, | March 31, | |
2014 | 2014 | |
(Unaudited) | ||
CURRENT ASSETS | ||
Cash and cash equivalents | $ 4,570,088 | $ 4,456,674 |
Accounts receivable, net | 12,036,286 | 8,873,471 |
Inventories | 6,860,755 | 6,579,858 |
Deferred tax asset | 500,186 | 420,978 |
Prepaid expenses | 55,804 | 32,263 |
Total Current Assets | 24,023,119 | 20,363,244 |
PROPERTY AND EQUIPMENT, net | 5,398,904 | 4,385,881 |
TOTAL ASSETS | $ 29,422,023 | $ 24,749,125 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
CURRENT LIABILITIES | ||
Accounts payable | $ 1,890,021 | $ 1,461,138 |
Accrued liabilities | 212,066 | 193,727 |
Deferred income tax liability | 99,107 | 107,857 |
Income taxes payable | 2,892,183 | 1,605,133 |
Total Current Liabilities | 5,093,377 | 3,367,855 |
TOTAL LIABILITIES | 5,093,377 | 3,367,855 |
STOCKHOLDERS’ EQUITY | ||
Preferred shares: $0.001 par value, 10,000,000 shares authorized: no shares issued and outstanding | — | — |
Common shares: $0.001 par value, 100,000,000 shares authorized: 48,024,543 and 47,836,543 shares issued and outstanding, respectively | 48,024 | 47,836 |
Additional paid-in capital | 6,927,026 | 6,496,980 |
Accumulated other comprehensive income | 65,385 | (231,051) |
Retained earnings | 17,288,211 | 15,067,505 |
Total Stockholders’ Equity | 24,328,646 | 21,381,270 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 29,422,023 | $ 24,749,125 |
The accompanying notes are an integral part of these condensed consolidated financials statements. |
PROFIRE ENERGY, INC. AND SUBSIDIARY | ||
Condensed Consolidated Statements of Operations and Other Comprehensive Income | ||
(Unaudited) | ||
For the Three Months Ended | ||
June 30, | ||
2014 | 2013 | |
REVENUES | ||
Sales of goods, net | $ 12,316,512 | $ 6,838,961 |
Sales of services, net | 828,322 | 342,619 |
Total Revenues | 13,144,834 | 7,181,580 |
COST OF SALES | ||
Cost of goods sold-product | 5,067,627 | 2,724,480 |
Cost of goods sold-services | 640,107 | 268,197 |
Total Cost of Goods Sold | 5,707,734 | 2,992,677 |
GROSS PROFIT | 7,437,100 | 4,188,903 |
OPERATING EXPENSES | ||
General and administrative expenses | 2,409,069 | 839,123 |
Research and development | 271,227 | 95,930 |
Payroll expenses | 1,265,699 | 835,076 |
Depreciation expense | 124,715 | 61,328 |
Total Operating Expenses | 4,070,710 | 1,831,457 |
INCOME FROM OPERATIONS | 3,366,390 | 2,357,446 |
OTHER INCOME (EXPENSE) | ||
Interest expense | — | (10,467) |
Rental income | 3,121 | 615 |
Interest income | 237 | 801 |
Total Other Income (Expense) | 3,358 | (9,051) |
NET INCOME BEFORE INCOME TAXES | 3,369,748 | 2,348,395 |
INCOME TAX EXPENSE | 1,149,042 | 734,411 |
NET INCOME | $ 2,220,706 | $ 1,613,984 |
FOREIGN CURRENCY TRANSLATION GAIN (LOSS) | $ 296,436 | $ (110,033) |
TOTAL COMPREHENSIVE INCOME | $ 2,517,142 | $ 1,503,951 |
BASIC EARNINGS PER SHARE | $ 0.05 | $ 0.04 |
FULLY DILUTED EARNINGS PER SHARE | $ 0.05 | $ 0.04 |
BASIC WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | 47,922,059 | 45,250,000 |
FULLY DILUTED WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | 48,579,418 | 45,727,737 |
The accompanying notes are an integral part of these condensed consolidated financials statements. | ||
PROFIRE ENERGY, INC. AND SUBSIDIARY | ||
Condensed Consolidated Statements of Cash Flows | ||
(unaudited) | ||
For the Three Months Ended | ||
June 30, | ||
2014 | 2013 | |
OPERATING ACTIVITIES | ||
Net Income | $ 2,220,706 | $ 1,613,984 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation expense | 182,392 | 81,771 |
Stock options issued for services | 351,364 | 63,427 |
Changes in operating assets and liabilities: | ||
Changes in accounts receivable | (3,071,142) | (170,636) |
Changes in inventories | (187,668) | (1,110,448) |
Changes in prepaid expenses | (23,461) | (27,070) |
Changes in deferred tax asset | (79,208) | — |
Changes in accounts payable and accrued liabilities | 428,360 | (104,699) |
Changes in income taxes payable | 1,246,558 | 612,273 |
Net Cash Provided by Operating Activities | 1,067,901 | 958,602 |
INVESTING ACTIVITIES | ||
Purchase of fixed assets | (1,147,274) | (33,150) |
Net Cash Used in Investing Activities | (1,147,274) | (33,150) |
FINANCING ACTIVITIES | ||
Stock issued in exercise of stock options | 78,870 | — |
Net Cash Provided by Financing Activities | 78,870 | — |
Effect of exchange rate changes on cash | 113,917 | 56,929 |
NET INCREASE IN CASH | 113,414 | 982,381 |
CASH AT BEGINNING OF PERIOD | 4,456,674 | 808,772 |
CASH AT END OF PERIOD | $ 4,570,088 | $ 1,791,153 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION | ||
CASH PAID FOR: | ||
Interest | $ — | $ 10,467 |
Income taxes | $ (138,008) | $ 114,762 |
The accompanying notes are an integral part of these condensed consolidated financial statements. |
CONTACT: Profire Energy, Inc. Andrew Limpert, CFO (801) 796-5127 Profire Energy, Inc. Nathan McBride, VP Strategy & Finance (801) 796-5127 Liolios Group, Inc. Ron Both, Senior Managing Director (949) 574-3860 PFIE@liolios.com
(TEAR) to Host Analyst and Investor Day
SAN DIEGO, Aug. 14, 2014 — TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) (“TearLab” or the “Company”) announced today that it will host an “Analyst and Investor Day” in San Diego, CA on Tuesday, September 23, 2014. The event will be held at the Company’s offices at 9980 Huennekens St. from 10:00am to 4:00pm Pacific Time.
Presentations by TearLab’s senior management team will cover the Company’s current business and growth strategies, international market opportunities and recent R&D activities, including the development of a second-generation tear testing platform that combines a panel of tests, including Osmolarity, IgE and potentially other biomarkers and tiers, all on a single chip. Following the formal presentations, guests will be invited to participate in a Q&A session.
To attend the live event:
Those wishing to attend the live event should email skilmer@tearlab.com, and include name, title, company and complete contact information.
To access the webcast:
The event will be webcast live and archived for at least 90 days on the Company’s website at http://www.tearlab.com under the “Webcasts” tab in the Investors section.
About TearLab Corporation
TearLab Corporation (www.tearlab.com) develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve standard of care by objectively and quantitatively testing for disease markers in tears at the point-of-care. The TearLab® Osmolarity Test, for diagnosing Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System. Headquartered in San Diego, CA, TearLab Corporation’s common shares trade on the NASDAQ Capital Market under the symbol ‘TEAR’ and on the Toronto Stock Exchange under the symbol ‘TLB’.
Forward-Looking Statements
This press release may contain forward-looking statements. These statements relate to future events and are subject to risks, uncertainties and assumptions about TearLab. Examples of forward-looking statements in this press release include statements regarding the future potential of the TearLab Osmolarity System and the related impact on our sales. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. Many factors may cause our actual results to differ materially from any forward-looking statement, including the factors detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2013, filed with the SEC on March 17, 2014, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, filed with the SEC on August 8, 2014. We do not undertake to update any forward-looking statements.
CONTACT: Stephen Kilmer (647) 872-4849 skilmer@tearlab.com
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