Archive for March, 2014
(RGDO) FDA Designates Regado’s REG1 in PCI as a Fast Track Development Program
Enrollment in the Phase 3 REGULATE-PCI Trial is Ongoing for Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention
BASKING RIDGE, N.J., March 10, 2014 — Regado Biosciences, Inc. (Nasdaq: RGDO), a biopharmaceutical company focused on the development of actively controllable therapeutics, today announced that the United States Food and Drug Administration (FDA) has designated REG1 for anticoagulant therapy to be used in patients with coronary artery disease during percutaneous coronary interventions (PCI) as a Fast Track development program. The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions that fill an unmet medical need, with the overall goal of getting new drugs to patients earlier.
“We are pleased that the FDA has designated REG1 as a Fast Track development program in our lead indication of PCI,” said David J. Mazzo, Ph.D., Chief Executive Officer of Regado Biosciences. “We continue to believe that REG1 has the potential to become a new standard of care for anticoagulation in interventional cardiology. We intend to continue our Phase 3 REGULATE-PCI study with the goal of bringing this important new therapy to patients as quickly as possible.”
Robert M. Califf, M.D., Professor of Medicine at the Duke University Medical Center in Durham, N.C., Chairman of Regado Biosciences’ Medical Advisory Board and recognized thought leader, said, “If REGULATE-PCI meets its primary endpoints, REG1 will offer a clinically meaningful advantage versus currently available therapies by enabling interventional cardiologists to actively control anticoagulation during PCI. Fast Track designation is an important step in the process of demonstrating REG1’s promise to improve outcomes for patients.”
REG1 is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen, for use during revascularization procedures such as PCI. These procedures put patients at risk for therapy-related ischemic and bleeding complications. REG1 is designed to improve patient outcomes, enable physicians to have direct therapeutic control and provide efficiencies leading to significant pharmacoeconomic benefits. REG1 is currently being evaluated in the Phase 3 REGULATE-PCI trial.
(For more information on REGULATE-PCI, please visit: http://www.clinicaltrials.gov/ct2/show/NCT01848106)
ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc., is a biopharmaceutical company focused on the discovery and development of novel, oligonucleotide-based actively controllable therapeutics. Our initial focus is on applications in the acute and sub-acute cardiovascular therapeutic area. The company’s lead product candidate, REG1, is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen. REG1 is currently being evaluated in the REGULATE-PCI trial, a worldwide Phase 3 study enrolling 13,200 patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), a hospital-based procedure used to mechanically open or widen obstructed coronary arteries. Regado’s actively controllable product candidates have the potential to improve patient outcomes and enhance the patient experience, provide direct therapeutic control to physicians and reduce overall treatment costs. More information can be found at www.regadobio.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing of the REGULATE-PCI trial, the effect of the FDA’s fast track designation for REG1, and the timing of and prospects for any regulatory approval of REG1. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from those projected in forward-looking statements include the “Risk Factors” described in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on Nov. 8, 2013, and in the Company’s other periodic filings with the SEC. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company has no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Media Contacts:
David Schull or Lena Evans
Russo Partners
212-845-4271
212-845-4262
david.schull@russopartnersllc.com
lena.evans@russopartnersllc.com
Investor Relations Contacts:
Tricia Truehart or Chelsea Wheeler
Trout Group
646-378-2953
646-378-2941
regadobio@troutgroup.com
(UQM) Achieves ISO/TS 16949 Certification
UQM Technologies, Inc. (NYSE MKT: UQM) today announced that it has reached a significant milestone with the official registration for the ISO/TS 16949:2009 Quality Standard. This registration is considered the highest level of quality standards for the automotive industry and encompasses UQM’s entire operation including the design, manufacturing and service of the company’s distinctive product offerings.
“After a rigorous, year-long process, attaining the ISO/TS 16949 registration is a significant achievement and a critical step in our progression in the industry to position UQM as a world class supplier of electric drive components and systems,” said Eric Ridenour, UQM Technologies’ President and Chief Executive Officer. “With this announcement, we have not only validated the quality of our operation, but also demonstrated our commitment to meeting the demands and expectations of existing and potential customers of all size and volume.”
UQM Technologies now offers customers the assurance of an accredited quality management system in addition to highly-efficient, power-dense electric motors and controllers, as well as volume production capacity.
About UQM
UQM Technologies is a developer and manufacturer of power-dense, high-efficiency electric motors, generators and power electronic controllers for the automotive, commercial truck, bus, marine and military markets. A major emphasis for UQM is developing propulsion systems for electric, hybrid electric, plug-in hybrid electric and fuel cell electric vehicles. UQM is located in Longmont, Colorado.
This Release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act. These statements appear in a number of places in this Release and include statements regarding our plans, beliefs or current expectations; including those plans, beliefs and expectations of our management with respect to, among other things, new product developments, future orders to be received from our customers, sales of products from inventory, future financial results, liquidity and the continued growth of the electric-powered vehicle industry. Important Risk Factors that could cause actual results to differ from those contained in the forward-looking statements are contained in our annual report on Form 10-K for the fiscal year ended March 31, 2013 and our Form 10-Q filed on January 30, 2014, which is available through our website at www.uqm.com or at www.sec.gov.
(MEIL) Starts Manufacturing Process of One Denami 600 for Aruba Client
LAS VEGAS, NV–(Mar 10, 2014) – Methes Energies International Ltd. (NASDAQ: MEIL), a renewable energy company that offers an array of products and services to biodiesel fuel producers, today announced it has received a deposit from Antilla Energy VBA (formally known as BioFuel Aruba) to start the manufacturing process of one Denami 600 to be delivered to Aruba.
The Denami 600 is expected to be delivered in September 2014. Antilla will utilize locally collected waste cooking oil to produce biodiesel that will then be blended with diesel fuel and distributed to clients across the island.
Nicholas Ng, President of Methes Energies, said, “We’re very excited about this project as it fits well with our business model. I believe that this is the first of many more manufacturing orders we will receive this year. We have been working with several clients that are, just like Antilla, at a point where they now need to order their Denami. It is a sometime a long process but at the end it is very rewarding for our clients and our company.”
Gregory Fung-A-Fat, Managing Director of Antilla Energy VBA, added, “Our due diligence exercise took a bit longer than we first anticipated, but we are finally there and ready to go. We now look forward to receiving delivery of our first Denami with commissioning happening in the fourth quarter of this year. The plan is to grow our facility to about 6 million gallons per year so we are setting up in a way that will make it easy and cost effective to add 4 more Denami’s 600’s as the market conditions allow. We’re glad to be doing our part to help Aruba reach its Green Aruba 2020 targets.”
About Antilla Energy VBA
Antilla Energy VBA is a national company which is focused on the development and implementation of island-based biodiesel projects utilizing non-food crop biodiesel feedstocks such as used cooking oil, and algae oil.
Founded by life-long biodiesel activist Gregory Fung-A-Fat, Antilla Energy VBA believes that the use of sustainably-produced biodiesel in combination with demand reduction measures such as mass-transit and transportation alternatives and in concert with technological advances such as diesel hybrids and light rail systems, can create an Aruba that is both energy independent and sustainable.
Antilla Energy VBA also believes that all used cooking oil generated by Aruba’s restaurants should be captured and processed into biodiesel as part of this national sustainability strategy.
About Methes Energies International Ltd.
Methes Energies International Ltd. is a renewable energy company that offers a variety of products and services to biodiesel fuel producers. Methes also offers biodiesel processors that are unique, truly compact, fully automated state-of-the-art and continuous flow that can run on a wide variety of feedstocks. Methes markets and sells biodiesel fuel produced at its showcase production facility in Mississauga, Ontario, Canada, and at its 13 MGY facility in Sombra, Ontario, to customers in the U.S. and Canada, as well as providing multiple biodiesel fuel solutions to its clientele. Among its services are selling commodities to its network of biodiesel producers, selling their biodiesel production and providing clients with proprietary software to operate and control their processors. Methes also remotely monitors the quality and characteristics of its clients’ production, upgrades and repairs their processors and advises clients on adjusting their processes to use varying feedstock to improve the quality of their biodiesel. For more information, please visit www.methes.com.
Forward-looking Statements
This press release contains forward-looking statements regarding future events and financial performance. In some cases, you can identify these statements by words such as “may,” “might,” “will,” “should,” “except,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” the negative of these terms and other comparable terminology. These statements involve a number of risks and uncertainties and are based on numerous assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. There are or may be important factors that could cause our actual results to materially differ from our historical results or from any future results expressed or implied by such forward looking statements. These factors include, but are not limited to, those discussed under the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended November 30, 2012, filed on February 25, 2013, as amended, which is available at the U.S. Securities and Exchange Commission website at www.sec.gov. The forward-looking statements in this press release are based upon management’s reasonable belief as of the date hereof. The Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
Contacts:
Methes Energies International Ltd.
Michel G. Laporte
Chairman and CEO
702-932-9964
(NVFY) Announces Participation at March Conference and Media Event
LOS ANGELES, March 7, 2014 — Nova LifeStyle, Inc. (NASDAQ-GM: NVFY), a U.S.-based fast growing, innovative designer and manufacturer of modern LifeStyle furniture, today announced that management will be conducting investor meetings as well as participating in the following events on March 10, 2014:
- Wall Street Multimedia, Inc. Conference, from 8:00 a.m. – 11:30 a.m. Eastern at the New York Stock Exchange, New York, NY; and
- Live interview by FinancialBuzz.com at 12:15 p.m. Eastern on the Floor of the NASDAQ Exchange, New York, NY.
Representing the Company will be Ms. Tawny Lam, President of Nova LifeStyle, Inc., who will discuss results for the first nine months of fiscal 2013, and provide updates on recent initiatives by the Company aimed at continuing its strong growth.
Ms. Lam stated, “We are excited about the opportunities we see before us and remain focused on executing against our strategic initiatives in order to drive growth through product innovation, developing new channels of distribution and further penetration into existing channels, as well as growth via acquisition.”
A copy of the Company’s Investor Presentation can be found on its investor relations site at: http://novalifestyle.com/investor-relations
About Nova LifeStyle, Inc.
Nova LifeStyle, Inc., a NASDAQ Global Markets Exchange listed company headquartered in California, is a fast growing, innovative designer and manufacturer of modern LifeStyle furniture; primarily sofas, dining rooms, cabinets, office furniture and related components, bedrooms, and various accessories in matching collections. Nova’s products are made in the US, Europe, and Asia and include LifeStyle brands such as Diamond Sofa, Colorful World, Giorgio Mobili, Nova QwiK, and Bright Swallow International. Nova’s products feature urban contemporary styles that integrate comfort and functionality incorporating upscale luxury designs appealing to LifeStyle-conscious middle and upper middle-income consumers in the U.S., China, Europe, and elsewhere in the world. To learn more about Nova LifeStyle, Inc., please visit our website at www.NovaLifeStyle.com.
Safe Harbor Statement
All statements in this press release that are not historical are forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. There can be no assurance that actual results will not differ from the company’s expectations. You are cautioned not to place undue reliance on any forward-looking statements in this press release as they reflect Nova’s current expectations with respect to future events and are subject to risks and uncertainties that may cause actual results to differ materially from those contemplated. Potential risks and uncertainties include, but are not limited to, the risks described in Nova’s filings with the Securities and Exchange Commission.
Investor Contact:
ICR, Inc.
Anne Rakunas
Tel: (310) 954-1113
Anne.Rakunas@icrinc.com
(HAWK) on Parent Company Safeway’s Spin-Off Announcement
PLEASANTON, Calif., March 7, 2014 — Blackhawk Network Holdings, Inc. (Nasdaq:HAWK) parent company Safeway Inc. affirmed in a press release on March 6, 2014 its intention to distribute its 37.8 million shares of Blackhawk common stock to Safeway shareholders and further indicated that it expects to complete the distribution by mid-April. In addition, in a separate transaction Safeway announced that it has entered into a definitive agreement to merge with Albertsons which, if consummated, may allow Blackhawk to obtain a step-up in the tax basis of its assets, anticipated to provide significant incremental long-term tax benefits to Blackhawk. The distribution of Blackhawk shares is not dependent upon the completion of Safeway’s merger with Albertsons and is being undertaken for independent business reasons.
Impact on Blackhawk
Blackhawk’s day-to-day operations of its prepaid products business have been conducted independently for the past two years, except for sharing tax and treasury management functions. As a result, Safeway’s change in ownership will not adversely impact Blackhawk’s operations and the distribution by Safeway will complete Blackhawk’s independence as a stand-alone public company. Bill Tauscher, Blackhawk CEO, commented, “Safeway has been a tremendous asset as Blackhawk’s parent company and we’ve worked closely together to build a powerful prepaid payments company. But Safeway also recognized early on that, in order for Blackhawk to build a leading third-party gift card business, Blackhawk would need to operate independently and partner with many grocery retailers that compete with Safeway. Safeway’s Board of Directors recently concluded that to further build on Blackhawk’s past successes and maximize our value, Safeway’s divestiture of its remaining ownership in Blackhawk would open up additional market opportunities for us.”
Blackhawk previously announced on February 20, 2014 that, in anticipation of Safeway’s distribution of its ownership in Blackhawk, the Company has executed a non-binding term sheet and is currently negotiating a credit agreement of up to $475 million with a group of banks led by Wells Fargo Bank, N.A. The facility includes a $175 million 4-year term loan and a revolving credit facility of up to $200 million with up to an additional $100 million during the year-end holiday period for specific settlement related requirements. The completion of the facility is subject to final negotiation, due diligence and various closing conditions, including termination of Blackhawk’s current cash management and treasury services agreement and revolving credit facility with Safeway. This credit facility is currently expected to close by the end of March 2014, and will allow Blackhawk to independently finance its currently anticipated operating needs and investment opportunities. As previously announced at its Investor Conference on February 20, 2014, Blackhawk’s estimated interest expense under the facility would total approximately $5.0 million to $5.2 million in fiscal 2014 representing the financing cost for its two recent acquisitions, borrowings for normal working capital needs and other credit support.
Potential Tax Benefit
Independent of its merger with Albertsons, Safeway previously announced its intention to spin-off its ownership in Blackhawk. If the merger is completed, it is expected that the distribution of Blackhawk shares will be taxable to Safeway and its shareholders. As part of the merger agreement, the buyer will assume the corporate tax on the distribution of Blackhawk shares to Safeway shareholders. It is also anticipated that there will be a step-up in the tax basis of Blackhawk’s assets that could generate approximately $30 million in cash tax savings per annum for Blackhawk. On a present value basis, using a 10% discount rate, over 15 years this tax savings is valued at approximately $230 million or approximately $4.50 per Blackhawk share. The actual benefits realized will be dependent upon, among other things, Blackhawk generating adequate taxable income to fully utilize the deductions and the value of Blackhawk at the time of the distribution.
Extension of Distribution Agreement with Safeway
Blackhawk also recently extended its distribution agreement with Safeway Inc. to be its exclusive provider of prepaid products in all its U.S. grocery stores through 2019 (presently 1,335 stores). Under the agreement, Safeway will continue to sell Blackhawk’s full range of prepaid products including prepaid gift cards, prepaid telecom products and general purpose reloadable debit products. All other terms of the agreement remain unchanged. Talbott Roche, Blackhawk President, said, “As we do with all our partners, we will continue to work very closely with Safeway to maximize the effectiveness of its prepaid products programs. This extension also reinforces Safeway’s faith in Blackhawk as the premier supplier of prepaid products.”
Blackhawk is also the prepaid products supplier to Albertsons. Together, Safeway and Albertsons operate under a variety of banners in 34 states and the District of Columbia.
Additional Information
Blackhawk will continue to provide updates as additional details and the dates regarding the spin-off are finalized. Blackhawk management also plans to hold investor information webcasts or meetings prior to Safeway’s completion of its distribution in mid-April.
About Blackhawk Network
Blackhawk Network Holdings, Inc. is a prepaid payment network which supports the physical and digital distribution of a variety of prepaid products. Blackhawk Network utilizes proprietary technology to provide consumers a wide selection of gift cards, prepaid telecom handsets, airtime cards and general purpose reloadable cards across a global network totaling over 180,000 stores. Through Blackhawk’s digital platform, the Company supports prepaid products and offers across a growing network of digital distribution partners including leading etailers, financial service providers, social apps, mobile wallets and other integrated physical-to-digital channels. Founded in 2001, Blackhawk Network is headquartered in Pleasanton, California, and offers products and services in the United States and 20 other countries. For more information, please visit www.blackhawknetwork.com and www.giftcardmall.com. Blackhawk is a majority-owned subsidiary of Safeway Inc. (NYSE:SWY). More information is available at www.blackhawknetwork.com.
Forward Looking Statements
This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are indicated by words or phrases such as “guidance,” “believes,” “expects,” “anticipates,” “estimates,” “plans,” “continuing,” “ongoing,” and similar words or phrases and the negative of such words and phrases. Forward-looking statements are based on our current plans and expectations and involve risks and uncertainties which are, in many instances, beyond our control, and which could cause actual results to differ materially from those included in or contemplated or implied by the forward-looking statements. Such risks and uncertainties include the following: our ability to achieve the tax benefits related to the announced transaction involving Safeway and Albertsons, including the ultimate closing of that transaction and the timing of the spin-off of our shares by Safeway, our ability to complete negotiation of the contemplated credit facility, our ability to grow adjusted operating revenues and adjusted net income as anticipated, our ability to grow at historic rates or at all, the consequences should we lose one or more of our top distribution partners or fail to attract new distribution partners to our network or if the financial performance of our distribution partners’ businesses decline, our reliance on our content providers, the demand for their products and our exclusivity arrangements with them, our reliance on relationships with card issuing banks, the consequences to our future growth if our distribution partners fail to actively and effectively promote our products and services, the requirement that we comply with applicable laws and regulations, including increasingly stringent money-laundering rules and regulations, risks related to our ongoing relationship with Safeway and other risks and uncertainties described in our reports and filings with the Securities and Exchange Commission, including the registration statement filed in connection with our initial public offering and our subsequent Quarterly Reports on Form 10-Q. We undertake no obligation to update forward-looking statements to reflect developments or information obtained after the date hereof and disclaim any obligation to do so other than as may be required by law.
CONTACT: INVESTORS/ANALYSTS: Patrick Cronin (925) 226-9973 investor.relations@bhnetwork.com MEDIA: Teri Llach (925) 226-9028 Teri.llach@bhnetwork.com
(OHRP) Publishes March 2014 Macroeconomic & Investment Newsletter
Topics Include: Monthly Macroeconomic Commentary, Investment Considerations, Adtech, Biotechnology, Travel, Energy, Healthcare, Natural Resources & More
SAN FRANCISCO, CA–(Mar 7, 2014) – Vista Partners (“Vista”) announced today that it published its FREE Macroeconomic & Investment Monthly Newsletter for the month of March. Each monthly newsletter from Vista contains macroeconomic thoughts from Principal Analyst Ross Silver, investment considerations, monthly highlights of each covered company and other broad based commentary.
In the March 2014 Macroeconomic & Investment Newsletter, Mr. Silver states, “Over the past month, I have been asked by both institutional and individual investors my thoughts on whether or not global central bankers have convinced investors (and themselves) that their policies can recreate a semblance of the old ‘normal’ economy. I provide my thoughts in our free March Newsletter.” Mr. Silver concludes, “The outperformance in 2013 has carried over into 2014, as many of the companies we cover have seen their share price increase significantly already in 2014. Cytosorbents Corporation (OTCBB: CTSO) share price has doubled, Mast Therapeutics, Inc. (NYSE MKT: MSTX) and Ohr Pharmaceutical, Inc. (NASDAQ: OHRP) are both up approximately 85% and Accelerize New Media, Inc. (OTCBB: ACLZ) is up 20%.”
To read more, please download the FREE March 2014 Macroeconomic & Investment Newsletter available at http://www.vistapglobal.com and click “Download Research & Newsletter” to gain access.
The Companies featured in the FREE March 2014 Newsletter are: Adriana Resources, Inc., Accelerize New Media, Inc., Cytosorbents Corporation, Mast Therapeutics, Inc., Ohr Pharmaceutical, Inc., Soligenix, Inc., Targeted Medical Pharma Inc., Uranerz Energy Corp and Power Solutions International Inc. Other companies mentioned are General Motors, Roche, Novartis, Selexys, Regeneron, Pfizer, Aramark, OpthoTech Corporation and others.
About Vista Partners:
Vista Partners LLC, founded in 2005, is a Registered Investment Advisor in the States of California and Oregon. The firm’s professional staff has backgrounds in finance, corporate communications and investment banking. Vista focuses on investing in and providing investment considerations on publicly traded companies through a platform of stock research reports, newsletters, company specific webpages and daily commentary. The platform of products is meant to serve as potential tools for investors to learn about investment considerations. It is Vista’s mission to provide investors with tools that may enable them to make profitable investment decisions with the goal to deliver investment considerations that outperform small, mid and large cap equity indexes. Website: http://www.vistapglobal.com
Please follow us on Twitter @VistaPResearch & Facebook at Vista-Partners to receive updates, thoughts and ideas about and our coverage universe of companies and more.
Disclaimer & Disclosure:
We encourage readers to view a complete list of disclaimers and disclosures on our website: www.vistapglobal.com.
Contact:
Vista Partners LLC
877.215.4813
Email Contact
(FCEL) Share Value Falls 27% Amid Disappointing 4Q Results
On Mar. 6, xG Technology Inc. (NASDAQ: XGTI) share volume skyrocketed, with 6,350,258 shares changing hands, more than eight times its three-month average volume of 770,391shares.
At the same time, XGTI’s share value closed at $3.65, down $1.33, or 27%, from its closing price of $4.98 the previous day, with both the high volume and share value loss fueled by xG Technology’s Mar. 6 fourth-quarter 2013 results.
Review of Results
On a reported basis, spectrum access solutions company’s total fourth quarter 2013 revenues were $373,000 compared to $0.0 revenue in the fourth quarter of 2012. The components of fourth quarter revenue were $323,000 from sales of equipment and $50,000 from engineering and consulting services agreement.
On a pro forma basis, assuming the recognition of $480,000 of deferred revenue in the quarter, total fourth quarter 2013 revenues were $853,000 compared to $0.0 revenue in the fourth quarter of 2012. The components of fourth quarter revenue were $778,000 from sales of equipment and $75,000 from engineering and consulting services agreement. Gross margin in the quarter was 53%.
Pro forma operating loss was $2.6 million compared to operating loss of $4.2 million in the fourth quarter of 2012. This decreased loss is attributable to the recording of cost of components and personnel associated with the recording of revenue and higher depreciation and amortization costs as the Company began to amortize capitalized costs as they became available for sale, offset by lower general and administrative, development, and stock based compensation expenses in the quarter relative to last year.
Find out what could be the best investor’s move when it comes to XGTI by getting the complete report here, or by cutting and pasting the following link in your Web browser:
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Pro forma net loss was $3.6 million, or $(0.23) per share compared to $4.7 million, or $(0.78) per share in the fourth quarter of 2012. Included in this operating loss was $0.3 million in expenses associated with our November follow-on offering. Weighted average number of shares outstanding for the quarter ended December 31, 2013 was 15.394 million compared to 6.04 million for the quarter ended December 31, 2012.
On a reported basis, total 2013 revenues were $406,000 compared to $0.0 million in 2012. The components of 2013 revenue were $323,000 from sales of equipment and $83,000 from an engineering services agreement.
Net Loss Up
On a pro forma basis, assuming the recognition of $480,000 of deferred revenue in the quarter, total 2013 revenues were $886,000 compared to $0.0 million in 2012. The components of 2013 revenue were $778,000 from sales of equipment and $108,000 from an engineering services agreement.
Pro forma 2013 operating loss was $13.7 million compared to operating loss of $13.0 million in 2012. This increased loss is attributable to the abovementioned recording of cost of components and personnel, higher development costs associated with the readying of products for sale, higher amortization and depreciation as mentioned above, and higher general and administrating and stock based compensation costs.
Pro forma 2013 net loss was $27.3 million, or $(2.84) per share, compared to net loss of $13.8 million, or $(2.29) per share for 2012. The 2013 net loss includes non-cash expense of $10.1 million.
Weighted average number of shares outstanding for the year ended December 31, 2013 was 9.598 million compared to 6.03 million for the year ended December 31, 2012.
xG ended fourth quarter 2013 with $5.5 million in cash, up from $271,000 at December 31, 2012.
Analysts’ consensus
Feltl & Co., the one analyst firm covering XGTI, recommends a “buy.”
Find out what could be the best investor’s move when it comes to XGTI by getting the complete report here, or by cutting and pasting the following link in your Web browser:
http://www.sixfigurestockpicks.com/
Completion of South Korean Fuel-Cell Park
Meanwhile, FuelCell Energy Inc. (NASDAQ: FCEL) share volume also soared with 49,253,816 shares change hands, more than five times three-month average volume of 9.700,000 shares.
Update on Asian Market
This upsurge in volume comes about two weeks after the Danbury-Conn. fuel-cell maker’s announced a series of updates about its Asian market. They include the completion of the world’s largest fuel cell park in South Korea, the sale of 3.7 megawatts of fuel cell modules to POSCO Energy in the first quarter of 2014 to meet increasing demand and a 19.6 megawatt fuel cell park to be constructed in Seoul City, South Korea.
The Gyeonggi Green Energy fuel cell park, located in Hwasung City, South Korea, is fully operational. The largest fuel cell park in the world, the facility consists of 21 FuelCell Energy DFC3000 power plants, rated at 2.8 megawatts each, requiring only about 5.1 acres of land for 59 megawatts of new and renewable power. The fuel cell park provides continuous base load electricity to the South Korean electric grid and usable high quality heat for a district heating system. POSCO Energy commenced construction on this project in November 2012 and finished in only 13 months, illustrating the ability to rapidly construct multi-megawatt fuel cell installations that enhance grid resiliency.
“The scale of this installation is contributing to the power and heating needs of an urban population and generating the electricity in a highly efficient and ultra-low emission profile that supports our National renewable portfolio standard,” said Tae-Ho Lee, chief executive at Gyeonggi Green Energy.
In order to meet the accelerating market demand in Asia, FuelCell Energy sold two 1.4 megawatt and three 300 kilowatt fuel cell modules to POSCO Energy during the first quarter of 2014. These modules are in addition to the monthly fuel cell kit shipments under an existing 122 megawatt order that was signed in October 2012.
Potential Influx of $26 million
On Jan. 23, the Danbury-Conn. fuel-cell maker’s announced a public offering of 22 million shares of its common stock at a price of $1.25 a share. The net proceeds from the sale of the shares, after deducting the underwriters’ discounts and other expenses are estimated to be $26 million. FuelCell has also granted the underwriters a 30-day option to purchase up to an additional 3.3 million shares of common stock offered in the public offering to cover over-allotments, if any, which would result in additional gross proceeds of about $4.1 million if exercised in full.
FuelCell said it plans to use the infusion of 26 million for project development, project finance, working capital support and general corporate purposes.
Fruition of Dominion Deal
FuelCell’s public offering came only a few weeks after it announced the completion of its 14.9 megawatt fuel-cell park on schedule for Dominion. The project is located on a remediated brownfield site in an industrial area of Bridgeport, Conn., using only about 1.5 acres of land to provide the renewable power.
Renewable energy slow to yield profits
While both these events are positive news for FuelCell, the unpleasant reality that’s being ignored in their releases is the fact that renewable energy companies have barely broke even, never mind turn significant profits. The fuel-cell industry’s total gross sales in 2012 were $120.6 million, while its costs were 120.2 million, according to the Dept. of Energy.
Analysts’ consensus
Of the four analysts covering FuelCell’s stock, three of them recommend “a strong buy” on the stock, while one recommends a “hold.”
On Mar 6, FCEL share price closed at $2.99, down 14 cents from its closing price of $3.13 the previous day.
Find out what could be the best investor’s move when it comes to FCEL by getting the complete report here, or by cutting and pasting the following link in your Web browser:
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Ceres Inc. Public Offering to Generate $20 Million
Finally, Ceres Inc. (NASDAQ: CERE) share volume surged, with 2.8 million shares changing hands, more than five times its three-month average of 502,511 shares.
Pricing of Public Offering
The high volume is being fueled in part by the Thousand Oaks, Calif.-based biotechnology company’s Mar. 4 announcement that the pricing of an underwritten public offering of 20,000,000 shares of common stock will have a public offering price of $1.00 per share.
Ceres also granted the underwriters a 45-day option to purchase up to 3,000,000 additional shares of common stock to cover over-allotments, if any. Ceres expects to receive approximately $20 million in gross proceeds, before deducting underwriting discounts and commissions and offering expenses payable by the company. Ceres intends to use the net proceeds from this offering for general corporate purposes, including working capital.
The offering is expected to close on or about Mar. 10, 2014, subject to the satisfaction of customary closing conditions. Aegis Capital Corp is acting as sole book-running manager for the offering. Trout Capital LLC acted as financial advisor to Ceres.
Ceres sells seeds that produce renewable biomass feedstocks that can enable the large-scale replacement of petroleum and other fossil fuels.
On Mar 6, CERE share price closed at $1.05, up 3 cents from its closing price of $1.02 the previous day.
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(SKUL) Announces Participation in the 26th Annual ROTH Growth Stock Conference
PARK CITY, Utah, March 7, 2014 — Skullcandy, Inc. (Nasdaq:SKUL) today announced that the Company will make a presentation at the 26th Annual ROTH Growth Stock Conference at The Ritz Carlton in Dana Point, California. Jason Hodell, Chief Financial Officer, will host the presentation currently scheduled for Tuesday, March 11, 2014 at 2:30 p.m. Pacific Time.
The audio portion of the presentation will be webcast live at www.skullcandy.com under the Investor Relations section. An archived replay will be available approximately two hours after the conclusion of the live event.
ABOUT SKULLCANDY, INC.
Skullcandy is the original lifestyle and performance audio brand inspired by the creativity and irreverence of youth culture. Skullcandy designs, markets and distributes audio and gaming headphones and other accessory related products under the Skullcandy, Astro Gaming and 2XL by Skullcandy brands. Skullcandy was launched in 2003 and quickly became one of the world’s most distinct audio brands by bringing unique technology, color, character and performance to an otherwise monochromatic space; helping to revolutionize the audio arena by introducing headphones, earbuds and other audio and wireless lifestyle products that possess unmistakable style and exceptional performance. The Company’s products are sold and distributed through a variety of channels in the U.S. and approximately 80 countries worldwide. Visit skullcandy.com, or join us at facebook.com/skullcandy or on Twitter @skullcandy.
CONTACT: ICR Brendon Frey / Joe Teklits 203-682-8200 Brendon.Frey@icrinc.com Joseph.Teklits@icrinc.com
(TAT) Announces Quarterly Earnings Call
HAMILTON, Bermuda, March 7, 2014 — TransAtlantic Petroleum Ltd. (TSX:TNP) (NYSE-MKT:TAT) (the “Company” or “TransAtlantic”) today announced that it expects to issue its earnings release for the fourth quarter of 2013 after the market closes on Thursday, March 13, 2014.
The Company will host a live webcast and conference call on Friday, March 14, 2014 at 7:30 a.m. Central (8:30 a.m. Eastern) to discuss fourth quarter 2013 financial results and provide an operations update. Investors who would like to participate in the conference call should dial (877) 878-2762 or (678) 809-1005 approximately 10 minutes prior to the scheduled start time and ask for the TransAtlantic conference call. The conference ID is 5078259.
An enhanced live webcast of the conference call and replay will be available through the Company’s website at www.transatlanticpetroleum.com. To access the webcast and replay, click on “Investors,” select “Events & Presentations,” and click on “Listen to webcast” under the event listing. The webcast requires iOS, Microsoft Windows Media Player or RealOne Player.
A telephonic replay of the call will be available through March 21, 2014 and may be accessed by dialing (855) 859-2056 or (404) 537-3406. The conference ID is 5078259.
About TransAtlantic
TransAtlantic Petroleum Ltd. is an international oil and natural gas company engaged in the acquisition, exploration, development and production of oil and natural gas. The Company holds interests in developed and undeveloped properties in Turkey and Bulgaria.
(NO STOCK EXCHANGE, SECURITIES COMMISSION OR OTHER REGULATORY AUTHORITY HAS APPROVED OR DISAPPROVED THE INFORMATION CONTAINED HEREIN.)
Forward-Looking Statements
This news release contains statements concerning the issuance of earnings releases, timing of earnings conference calls, and other expectations, plans, goals, objectives, assumptions or information about future events, conditions, results of operations or performance that may constitute forward-looking statements or information under applicable securities legislation. Such forward-looking statements or information are based on a number of assumptions, which may prove to be incorrect. In addition to other assumptions identified in this news release, assumptions have been made regarding, among other things, the ability of the Company to continue to develop and exploit attractive foreign initiatives.
Although the Company believes that the expectations reflected in such forward-looking statements or information are reasonable, undue reliance should not be placed on forward-looking statements because the Company can give no assurance that such expectations will prove to be correct. Forward-looking statements or information are based on current expectations, estimates and projections that involve a number of risks and uncertainties which could cause actual results to differ materially from those anticipated by the Company and described in the forward-looking statements or information. These risks and uncertainties include, but are not limited to, market prices for natural gas, natural gas liquids and oil products; estimates of reserves and economic assumptions; the ability to produce and transport natural gas, natural gas liquids and oil; the results of exploration and development drilling and related activities; economic conditions in the countries and provinces in which the Company carries on business, especially economic slowdowns; actions by governmental authorities, receipt of required approvals, increases in taxes, legislative and regulatory initiatives relating to fracture stimulation activities, changes in environmental and other regulations, and renegotiations of contracts; political uncertainty, including actions by insurgent groups or other conflict; outcomes of litigation; the negotiation and closing of material contracts; shortages of drilling rigs, equipment or oilfield services.
The forward-looking statements or information contained in this news release are made as of the date hereof and the Company undertakes no obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.
CONTACT: Taylor Miele Director of Investor Relations (214) 265-4746 Wil Saqueton Vice President and Chief Financial Officer (214) 220-4323 TransAtlantic Petroleum Ltd. 16803 Dallas Parkway Addison, Texas 75001 http://www.transatlanticpetroleum.com
(ARTX) Battery Division Announces Successful Lab Test of Iron Flow Battery for Grid Storage
The market for flow batteries is expected to exceed $400 billion by 2020 Arotech’s battery offers promise of substantial benefits over current technologies
ANN ARBOR, Mich., March 6, 2014 — Arotech Corporation (NasdaqGM: ARTX), a provider of quality defense and security products for the military, law enforcement and homeland security markets, announced today that its Battery and Power Systems Division has advanced its development of an iron flow battery to provide storage for grid power, following promising results in lab tests. Arotech has filed a patent application covering this new technology.
The highly variable supply of electricity generated from renewable sources requires a buffer for the relatively flat demand for energy. Arotech believes it has developed a potentially revolutionary new technology that can combine highly significant cost savings, performance advantages and potentially greater efficiency, with a more environmentally-friendly profile.
Robert S. Ehrlich, Arotech’s Chairman and Chief Executive Officer commented, “We are very pleased with the results from lab tests on this new technology, which opens a huge new market for us. While flow batteries themselves are not new technologies, with over fifty flow batteries installed globally as at the end of last year, our design uses a patent-pending iron chemistry providing the highest ROI, with the lowest total lifecycle, capital and maintenance costs. While this will be a multi-year development effort until commercialization, we believe that given the sheer size of the market, which is expected to exceed $400 billion by 2020, this is a project highly worthy of our R&D investment. I applaud the capabilities of our R&D team in their ongoing development and ability to push the realms of possibility in the battery space.”
Arotech has posted a more detailed competitive analysis online at the following link: http://gkir.us/flowbattery.pdf
About Arotech Corporation
Arotech Corporation is a leading provider of quality defense and security products for the military, law enforcement and homeland security markets, including multimedia interactive simulators/trainers and advanced zinc-air and lithium batteries and chargers. Arotech operates two major business divisions: Training and Simulation and Battery and Power Systems.
Arotech is incorporated in Delaware, with corporate offices in Ann Arbor, Michigan, and research, development and production subsidiaries in Alabama, Michigan, and Israel. For more information on Arotech, please visit Arotech’s website at www.arotech.com.
Investor Relations Contacts:Ehud Helft & Kenny Green
GK Investor Relations Tel: 1 646 201 9246 |
Except for the historical information herein, the matters discussed in this news release include forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, readers are cautioned not to place undue reliance on these forward-looking statements, as they are subject to various risks and uncertainties that may cause actual results to vary materially. These risks and uncertainties include, but are not limited to, risks relating to: product and technology development; the uncertainty of the market for Arotech’s products; changing economic conditions; delay, cancellation or non-renewal, in whole or in part, of contracts or of purchase orders (including as a result of budgetary cuts resulting from automatic sequestration under the Budget Control Act of 2011); and other risk factors detailed in Arotech’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2012, as amended, and other filings with the Securities and Exchange Commission. Arotech assumes no obligation to update the information in this release. Reference to the Company’s website above does not constitute incorporation of any of the information thereon into this press release.
(BSPM) Partners with Shaanxi University of Chinese Medicine to Co-develop Liver Cancer Drug
XIANYANG, China, March 6, 2014 — Biostar Pharmaceuticals, Inc. (NASDAQ: BSPM) (“Biostar” or “corporation”), a China-based manufacturer and marketer of pharmaceutical and health supplement products for a variety of diseases and conditions, announced that it has signed a letter of intent with the Research Institute of Pharmaceuticals at Shaanxi University of Chinese Medicine to develop a new liver cancer drug based on Oleanolic Acid injection.
In recent years, the new cancer cases and fatalities have been increasing sharply around the world, with China bearing the heaviest toll of this increase. According to the World Health Organization (WHO), there were 14 million new cancer cases and 8.2 million deaths around the world in 2012. China accounted for 3.07 million those new cancer cases, or 21.8% of the total, and 2.2 million deaths, or 26.9% of the worldwide figure. China’s own estimates for the same periods are slightly higher than the WHO figures. New cases of cancer totalled 3.5 million with 2.5 million fatalities in 2012 according to records from China’s National Cancer Registry.
The latest edition of the World Cancer Report also shows that, liver cancer, among lung, oesophagus and stomach, were the most common cancers for Chinese population. In 2012, about 50% of global liver cancer cases and 51% of worldwide deaths caused by liver cancer were recorded in China. One of the major causes for such alarming statistics is that China has more than 40 million Hepatitis B patients. Many of these Hepatitis B patients did not receive timely and proper care and treatment and, which as a result, lead to worsening their health conditions, including, among others, liver cancer.
The research of applying Oleanic acid to treat liver cancer has been well reported in United States in recent years. Biostar’s research scientists have discovered that the “AO” factor existing in the Oleanic acid is remarkably effective in killing the Hepatitis B virus (HBV), and it may also be used to kill cancer cells.
“We are very glad to team up with Shaanxi University of Chinese Medicine to jointly develop Oleanolic Acid injection drug for liver cancer after numerous rounds of market research and in-depth discussion with many research institutions in China,” commented Mr. Ronghua Wang, Chairman & CEO of Biostar Pharmaceuticals, Inc. ” Research and development of a new medicine to treat and, hopefully, cure liver cancer has been the dream of our company for years. In order to make it successful, we intend to invest large amount of capital and resources to support this exciting research project in the near future.”
About Biostar Pharmaceuticals, Inc.
Biostar Pharmaceuticals, Inc., through its wholly owned subsidiary and controlled affiliate in China, develops, manufactures and markets pharmaceutical and health supplement products for a variety of diseases and conditions. The Company’s most popular product is its Xin Aoxing Oleanolic Acid Capsule, an over-the-counter medicine for chronic Hepatitis B, a disease affecting approximately 10% of the Chinese population. For more information please visit: http://www.biostarpharmaceuticals.com.
Safe Harbor Relating to the Forward-Looking Statements
Certain statements in this release concerning our future growth prospects are forward-looking statements, within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, which involve a number of risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The company uses words and phrases such as “guidance,” “forecasted,” “projects,” “is expected,” “remain confident,” “will” and similar expressions to identify forward-looking statements in this press release, including forward-looking statements. Undue reliance should not be placed on forward-looking information. Forward-looking information is based on current expectations, estimates and projections that involve a number of risks, which could cause actual results to vary and in some instances to differ materially from those anticipated by Biostar and described in the forward-looking information contained in this news release. These results are preliminary and are subject to change, possibly material in nature, following completion of the audit for the year ended December 31, 2013. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding the Company’s ability to achieve the projected sales in the recently opened sales offices, to complete the contemplated clinical trials and capitalize on such opportunities, the Company’s ability to recover its sales and revenue for the gel capsule segment of its business, the state of consumer confidence and market demand or the Company’s products, success of our investments, risks and uncertainties regarding fluctuations in earnings, our ability to sustain our previous levels of profitability including on account of our ability to manage growth, intense competition, wage increases in China, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, our ability to successfully complete and integrate potential acquisitions, withdrawal of governmental fiscal incentives, political instability and regional conflicts and legal restrictions on raising capital or acquiring companies outside China. Additional risks that could affect our future operating results are more fully described in our United States Securities and Exchange Commission filings including our most recent Annual Report on Form 10-K for the year ended December 31, 2012, and other subsequent filings. These filings are available at www.sec.gov. We may, from time to time, make additional written and oral forward-looking statements, including statements contained in our filings with the Securities and Exchange Commission and our reports to shareholders. We do not undertake to update any forward-looking statements that may be made from time to time by or on our behalf.
(BUR) ADM Announces Intention to Expand Commercial Production of CLARISOY™
VANCOUVER, British Columbia, March 6, 2014 — Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR), a leader in functional, renewable plant proteins, is pleased to announce that it has received written notice from Archer Daniels Midland Company (“ADM”) that ADM intends to expand to full-commercial scale production of CLARISOY™ soy protein.
ADM’s intention to expand commercial production of CLARISOY™ ensures that its production capability meets the required obligations under the existing License & Production Agreement to retain its exclusive license for CLARISOY™. To protect the parties’ competitive interests, Burcon and ADM have agreed to not disclose the planned production capacity of the expansion.
“ADM and Burcon have contributed considerable resources and valuable efforts to bring CLARISOY soy protein to the global food and beverage market. ADM’s notice of its intention to expand to full-commercial-scale production of CLARISOY marks a defining step for Burcon and for this revolutionary protein,” said Johann Tergesen, Burcon’s president and chief operating officer. “We are delighted with the progress made by ADM since March 2011 in building a solid foundation for the future and continued growth of CLARISOY.”
ADM and Burcon first teamed to commercialize CLARISOY in 2010, and the first products reached the market in June 2012, winning numerous product-innovation awards. The CLARISOY portfolio, marketed by ADM’s Foods & Wellness group, is based on a patented process developed by Burcon that offers a highly soluble and versatile protein ingredient that, due to its clean flavor profile, can be incorporated into a diverse range of products such as sports drinks, fruits and vegetable juices, or to replace dairy proteins.
About Burcon NutraScience Corporation
Burcon NutraScience is a leader in developing functionally and nutritionally valuable plant-based proteins. The company has developed a portfolio of composition, application, and process patents originating from a core protein extraction and purification technology. Burcon’s CLARISOY™ soy protein offers clarity and high-quality protein nutrition for low-pH beverage systems and excellent solubility and exceptionally clean flavor at any pH; Peazazz® is a uniquely soluble and clean-tasting pea protein; and Puratein®, Supertein™ and Nutratein® are canola protein isolates with unique functional and nutritional attributes. For more information about the company, visit www.burcon.ca.
ON BEHALF OF THE BOARD OF DIRECTORS
“Johann F. Tergesen”
Johann F. Tergesen
President and Chief Operating Officer
The TSX has not reviewed and does not accept responsibility for the adequacy of the content of the information contained herein. This press release contains forward-looking statements or forward-looking information. Forward-looking statements or forward-looking information involve risks, uncertainties and other factors that could cause actual results, performances, prospects and opportunities to differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements, including, without limitation, statements regarding plans and timing for the introduction or enhancement of our products, statements about future market conditions, supply and demand conditions, and other expectations, intentions and plans contained in this press release. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements or information. Important factors that could cause actual results to differ materially from Burcon’s plans and expectations include the actual results of marketing activities, adverse general economic, market or business conditions, regulatory changes and other risks and factors detailed herein and from time to time in the filings made by Burcon with securities regulators and stock exchanges, including in the section entitled “Risk Factors” in Burcon’s annual information form dated June 25, 2013. Any forward-looking statement or information only speaks as of the date on which it was made and, except as may be required by applicable securities laws, Burcon disclaims any intent or obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Although Burcon believes that the assumptions inherent in the forward-looking statements are reasonable, forward-looking statements are not guarantees of future performance and accordingly undue reliance should not be put on such.
CLARISOY is a trademark of Archer Daniels Midland Company.
CONTACT: Media & Industry Contact: Michael Kirwan Director, Corporate Development Burcon NutraScience Corporation Tel (604) 733-0896, Toll-free (888) 408-7960 mkirwan@burcon.ca www.burcon.ca Investor Relations Contact: Matt Glover or Michael Koehler Liolios Group Inc. (949) 574-3860 bur@liolios.com
(SGMO) Presents Clinical Data On SB-728-T In HIV At CROI 2014
Company Outlines Future Plans for HIV “Functional Cure”
RICHMOND, Calif., March 6, 2014 — Sangamo BioSciences, Inc. (Nasdaq: SGMO) today announced the presentation of data from its SB-728-T program to develop a ‘functional cure’ for HIV/AIDS at the Conference on Retroviruses and Opportunistic Infections (CROI 2014). The conference is being held in Boston from March 3 to 6, 2014. Data from an earlier Phase 1 clinical study in this program were also published in the March 6, 2014 issue of the New England Journal of Medicine (NEJM).
“The achievement of over 7 months of ongoing functional control of viral load without antiretroviral therapy and the progress that we are making in understanding how to best deploy this novel therapy are very exciting,” commented Gary Blick, M.D., AAHIVS, Medical & Research Director, CIRCLE CARE Center, who presented the data at CROI and is an investigator on both studies that were reported at the meeting. “The data that have been generated over the course of the clinical investigation of SB-728-T demonstrate immune reconstitution, enhanced survival of the zinc finger nuclease-modified T-cells in the presence of the virus and associated reductions in viral load and the levels of viral reservoir, all of which are necessary to provide functional control of the virus.”
At CROI, data were reported from a Phase 1 /2 clinical trial, SB-728-1101, designed to evaluate the effect of increasing doses of Cytoxan preconditioning as a method to increase the numbers of circulating T-cells, including cells that were zinc finger nuclease (ZFN) modified at the CCR5 gene (SB-728-T). The data demonstrate that increasing doses of Cytoxan preconditioning prior to a single infusion of SB-728-T led to a dose-dependent increase in both engraftment of CCR5-modified cells and notable increases in total CD4 cells above the baseline. In addition, researchers observed the greatest decrease in viral load (VL) (a drop of 1.9 logs from peak) during a treatment interruption (TI) from antiretroviral therapy (ART) at the highest Cytoxan dose (1.0 g/m2). Two of the three subjects treated at this dose remain on TI with detectable but stable VLs of several weeks duration. In addition, Sangamo updated the status of a subject from its SB-728-902, Cohort 5 study, who has demonstrated ongoing control of VL for 31 weeks without ART, and who remains on TI.
SB-728-T is an autologous CD4+ T-cell product in which the gene for CCR5, a co-receptor for HIV entry, is modified via ZFN-mediated genome editing to prevent the CCR5 protein from being expressed, mimicking a natural mutation (CCR5 delta-32). Individuals that carry the CCR5 delta-32 mutation on both of their CCR5 genes are protected from infection by the most common strain of HIV. Sangamo is developing SB-728-T as a potential functional cure for HIV/AIDS and has been conducting clinical trials that are designed to expand findings of a study that was published today in the NEJM. In this study, researchers observed that ZFN-modified cells (SB-728-T) had a selective advantage over non-modified cells such that they survived longer when exposed to the virus. Several of the six subjects that underwent a 12-week TI experienced a drop from peak in their VL, including one subject who achieved a decrease in VL to a level that was below the limit of quantification. This subject was later found to carry the CCR5 delta-32 mutation in one of the two CCR5 genes (making the individual a CCR5 delta-32 heterozygote). Thus, following exposure to the ZFNs targeting CCR5, this subject had a greater percentage of T-cells that were modified at both sites (biallelic modification) and were therefore fully resistant to HIV infection. Subsequent analyses have shown statistically significant relationship between estimated level of circulating cells with biallelic modification of CCR5 and control of VL. Sangamo has been carrying out clinical studies in HIV-infected subjects who have one copy of the natural mutation, so called CCR5 delta-32 heterozygotes (SB-728-902, Cohort 5), and in subjects undergoing Cytoxan pre-conditioning (SB-728-1101) to further study this relationship.
“Using our ZFN genome editing technology we can engineer immune system cells to achieve control of the virus without ART,” said Geoff Nichol, M.B., Ch.B., Sangamo’s executive vice president of research and development. “Our studies have generated valuable data that will enable us to maximize the potential of this novel immunologic therapy for HIV and help optimize patient selection and treatment. We now better understand the baseline immunologic parameters that are required for viral control, including the threshold level of T-cells that have undergone biallelic modification; the capability of the immune system to respond to the virus; the size of the viral reservoir and the inflammatory status of the HIV-infected individual as identified by cell surface marker and gene expression profiles of immune system cells.”
Dr. Nichol added, “In addition, having established that SB-728-T treatment is safe and well tolerated, Sangamo has developed a new proprietary manufacturing process to use mRNA delivery of the ZFNs used in CCR5 genome modification of the T-cells. This modification to the protocol will enable retreatment, if necessary, and offers the potential for greater CCR5 biallelic modification. We have expanded our SB-728-1101 study of Cytoxan preconditioning to six more subjects to determine the optimal Cytoxan dose, and plan to treat an additional 12 subjects through 2014. These further studies are designed to provide proof of principle, and will incorporate much of what we have learned thus far in previous trials. We expect to enroll these additional studies by the end of 2014.”
Cytoxan at doses up to 1.0 g/m2 was shown to be safe and well tolerated in HIV infected subjects, although as expected, nausea and vomiting increased with dose, necessitating the use of a prophylactic anti-emetic. The trial has been extended to study six additional subjects in order to determine the optimal dose of Cytoxan. Early data from this cohort suggest that an optimal dose may lie between 1.0 and 2.0 g/m2, as more Cytoxan side-effects, particularly severe symptoms of nausea, were observed at 2.0 g/m2. At the optimal Cytoxan dose a further 12 subjects will be treated.
“The data presented at CROI and published today in the New England Journal of Medicine support our development program for SB-728-T as a potential functional cure for HIV/AIDS,” stated Edward Lanphier, Sangamo’s president and CEO. “In the next clinical trial of SB-728-T, which is expected to begin in the first half of 2014, we will implement mRNA delivery of the ZFNs to the cells, which will provide both process- and cost-saving advantages over viral delivery as well as the potential to re-dose. With positive data from this study, Sangamo intends to seek a partner for further development.”
Clinical Data Summary
Abstract #141: Cyclophosphamide Enhances SB-728-T Engraftment to Levels Associated With HIV-RNA Control
Thursday, March 6, 2014
HIV-infected subjects were enrolled in a Phase 1/2 clinical trial (SB-728-1101) in three cohorts. Each received a single dose of SB-728-T (5 to 30 billion cells) after a dose of Cytoxan 200 mg (n=3), 500mg/m2 (n=6) or 1.0 g /m2(n=3). All subjects were on ART and had stably controlled undetectable levels of HIV in their blood.
The study evaluated safety and tolerability, changes in CD4+ T-cell counts and the ratio of CD4+ to CD8+ T-cells, as well as levels of SB-728-T in the blood and viral loads during a 16 week TI that began six weeks post SB-728-T treatment.
Analysis of data from subjects in the study presented today demonstrated:
- Cytoxan was well tolerated at all doses, except for low grade gastrointestinal side-effects which were treated with anti-emetics.
- A dose-related increase in total CD4 count and engraftment of CCR5 modified cells was observed with engraftment of estimated bi-allelic CCR5 modified CD4 cells at the 1.0 g/m2 Cytoxan dose, approaching levels associated with pronounced anti-viral effects in CCR5 delta-32 heterozygote HIV subjects.
- An approximately 0.8 to 1.1-log VL reduction from peak was observed in two subjects at the 500 mg/m2 dose level and in a 1.9 log decrease in another subject at the 1.0 g/m2 dose level during a 16 week TI.
- Two subjects in the 1.0 g/m2 dose level experienced stable reduced levels of virus and remain on TI.
- Cytoxan conditioning may be a useful strategy to 1) maximize the engraftment and anti-viral effects of SB-728-T adoptive T-cell therapy in HIV subjects and 2) may be an important immunomodulatory chemotherapeutic agent for immunotherapy in HIV.
In addition, data were presented at CROI 2014 from Sangamo scientists and collaborators in the following abstracts:
Abstract #294. Monocyte Activation Markers in HIV Infected Subjects: A Biomarker for HIV Immunotherapy
Wednesday, March 5, 2014
Previous studies had found that baseline levels of monocyte activation inversely correlated with levels of SB-728-T engraftment as well as with levels of long-term CD4 T cell reconstitution (years 1 and 3) in immunologic non –responders enrolled in the SB-728-902 study (Cohorts 1-3). A similar correlation was observed when this analysis was extended to Cohort 5 from this trial. This study was undertaken in order to better understand and define the optimal host environment for cure-related gene therapy such as SB-728-T. The findings provide guidance for identifying HIV- infected individuals who may have a more intact immune system and are thus more suitable for HIV immunotherapy.
Abstract #419. Modeling Functional Cure of HIV in Nonhuman Primates Using Gene-Modified Hematopoietic Stem Cells
Wednesday, March 5 (Poster); Thursday, March 6, 2014 (Themed Discussion)
To better understand the mechanism of hematopoietic stem cell (HSC)-driven HIV control, researchers in collaboration with Sangamo scientists developed a model of ART-suppressed HIV infection in the pigtailed macaque which is applicable to an HSC-transplant-based cure strategy such as our SB-728-HSC application. Initial findings demonstrate that bone marrow transplant alone is not sufficient to produce lasting viral control and suggests that cell must be protected by either natural resistance to the virus or by genome modification to engineer such protection, such as by ZFN-modified CCR5 disruption. Sangamo expects to file an Investigational New Drug application for this program in 2014.
Abstract #431. Cross-Clade Inhibition of HIV on Primary Cells by CXCR4 or CCR5 Fused To the C34 Peptide From gp41HR2
Thursday, March 6, 2014
The data demonstrate potent inhibition of HIV infection in cells expressing a chimeric protein comprising a portion of the HIV envelope fused to either the CXCR4 or CCR5 HIV co-receptors. Scientists fused the C34 peptide from the gp41portion of the HIV envelope to the amino terminus of either the CXCR4 (C34-X4) or CCR5 (C34-R5) proteins. Importantly, both C34-X4 and C34-R5 demonstrated potent inhibition of infection by either anX4-tropic or R5-tropic HIV-1 isolate in primary CD4+ T cells, the natural target of HIV.
Webcasts of all the presentations at CROI 2014 can be accessed via the following link: http://www.croiwebcasts.org/
About SB-728-T
SB-728-T is an autologous CD4+ T-cell product in which the gene for CCR5, a co-receptor for HIV entry, is modified via ZFN-mediated genome editing to disrupt the CCR5 protein. T-cells with a disrupted CCR5 protein are resistant to infection by the most common strain of HIV.
About the SB-728-1101 Study
SB-728-1101 is an open-label, dose escalation, multi-center study designed primarily to evaluate the safety and tolerability of escalating doses of cyclophosphamide (Cytoxan) administered prior to SB-728-T infusion. Cytoxan is a drug that is used to transiently reduce the numbers of T-cells in the body, which then rapidly repopulate once the drug is discontinued, and it is into this “growth” environment that SB-728-T is infused. Such lymphodepletive treatment has been used to enhance engraftment of adoptively transferred T-cells in the treatment of cancer and as therapy for numerous autoimmune diseases. The drug has been previously used in HIV-infected individuals and studies demonstrate that, while the drug was transiently lymphodepleting, it did not significantly reduce total CD4 T-cell counts over the long term and was adequately tolerated.
In addition to safety, the study is evaluating the effect of escalating doses of Cytoxan on SB-728-T engraftment, the effect of SB-728-T treatment on viral load following ART interruption, the change in CD4+ T-cell counts in peripheral blood and the long-term persistence of SB-728-T.
By protocol, nine HIV-infected subjects on ART were enrolled into three dose-escalating cohorts (three subjects/cohort), and received intravenous Cytoxan (200 mg, 500 mg/m2 or 1.0 g/m2). In cohort two, an additional three subjects were evaluated on an improved anti-emetic protocol due to an adverse event of Grade 2 nausea observed in two subjects at that dose level. Within each cohort, treatment was staggered so that each subsequent subject was infused with Cytoxan two weeks after the preceding subject. One to three days after receiving Cytoxan, subjects were infused with SB-728-T (8.2 to 36.2 billion cells). Six weeks after SB-728-T infusion, subjects with CD4 cell counts ≥500 cells/mm3underwent a 16 week TI during which time their anti-retroviral therapy was discontinued. ART was reinstituted in subjects whose CD4 T-cell counts dropped to <500 cells/mm3and/or whose HIV-RNA increased to >100,000 copies/mL for three consecutive measurements. At the end of the TI, subjects with a sustained detectable viral load >10,000 copies/mL or CD4 T-cell count <500 cells/mm3 were reinstituted on ART. Subjects with a viral load >10,000 copies/mL and CD4 T-cell count >500 cells/mm3 can remain off ART until HIV RNA levels are >10,000 copies/mL for three consecutive weeks or their CD4 T-cell count drops below 500 cells/mm3 for two consecutive weekly measurements.
About Sangamo
Sangamo BioSciences, Inc. is focused on Engineering Genetic CuresTM for monogenic and infectious diseases by deploying its novel DNA-binding protein technology platform in therapeutic gene regulation and genome editing. The Company has ongoing Phase 2 clinical trials to evaluate the safety and efficacy of a novel ZFP Therapeutic® for the treatment of HIV/AIDS (SB-728-T) and NGF-AAV for Alzheimer’s disease (CERE-110). Sangamo’s other therapeutic programs are focused on monogenic and rare diseases. The company has formed a strategic collaboration with Shire International GmbH to develop therapeutics for hemophilia, Huntington’s disease and other monogenic diseases, and with Biogen Idec for hemoglobinopathies, such as sickle cell disease and beta-thalassemia. The Company has also established strategic partnerships with companies, including Dow AgroSciences and Sigma-Aldrich Corporation, in non-therapeutic applications of its technology. For more information about Sangamo, visit the Company’s website at www.sangamo.com.
ZFP Therapeutic® is a registered trademark of Sangamo BioSciences, Inc.
This press release may contain forward-looking statements based on Sangamo’s current expectations. These forward-looking statements include, without limitation, references relating to research and development of novel ZFP TFs and ZFNs and therapeutic applications of Sangamo’s ZFP technology platform for the treatment of HIV/AIDS, including a potential functional cure of HIV/AIDS, the expansion of clinical studies of SB-728-T in HIV-infected individuals, expected timing for the presentation of clinical trial data, the expansion of studies to treat additional subjects, the future plans for the HIV/AIDS program, including potential partners for the program, and the initiation of additional preclinical and clinical studies of ZFN-gene modification. Actual results may differ materially from these forward-looking statements due to a number of factors, including uncertainties relating to the initiation and completion of stages of our clinical trials, whether the clinical trials will validate and support the tolerability and efficacy of ZFNs, technological challenges, Sangamo’s ability to develop commercially viable products and technological developments by our competitors. For a more detailed discussion of these and other risks, please see Sangamo’s SEC filings, including the risk factors described in its Annual Report on Form 10-K and its most recent Quarterly Report on Form 10-Q. Sangamo BioSciences, Inc. assumes no obligation to update the forward-looking information contained in this press release.
(BJRI) Comments on Director Nominations
HUNTINGTON BEACH, Calif., March 6, 2014 — BJ’s Restaurants, Inc. (Nasdaq:BJRI) (“BJ’s”) today reported that PW Partners Atlas Fund II LP, in conjunction with Luxor Capital Partners, LP, which collectively own approximately 12.4% of BJ’s outstanding shares, has stated its intention to nominate five representatives to stand for election to BJ’s Board of Directors at the Company’s 2014 Annual Meeting of Shareholders. BJ’s also reported today that Clinton Relational Opportunity Master Fund, L.P., has separately informed the Company that it owns approximately 0.48% of BJ’s outstanding shares and intends to nominate five representatives to stand for election to BJ’s Board at the Company’s 2014 Annual Meeting.
BJ’s has always been committed to engagement with its shareholders, including regarding corporate governance matters. The Board remains highly focused on creating the optimal conditions to generate long-term value and will continue to take actions that support the interests of all shareholders.
The Board’s Governance and Nominating Committee will review these director nominations and will present its recommendations to BJ’s Board for inclusion in BJ’s definitive proxy statement and other materials, to be filed with the Securities and Exchange Commission (the “SEC”). The date of BJ’s 2014 Annual Meeting has not yet been announced, and shareholders are not required to take any action at this time.
About BJ’s Restaurants, Inc.:
BJ’s Restaurants, Inc. currently owns and operates 147 casual dining restaurants under the BJ’s Restaurant & Brewery®, BJ’s Restaurant & Brewhouse®, BJ’s Pizza & Grill® and BJ’s Grill® brand names. BJ’s Restaurants offer an innovative and broad menu featuring award-winning, signature deep-dish pizza complemented with generously portioned salads, appetizers, sandwiches, soups, pastas, entrees and desserts, including the Pizookie® dessert. Quality, flavor, value, moderate prices and sincere service remain distinct attributes of the BJ’s experience. The Company operates several microbreweries in addition to using independent third party brewers to produce and distribute BJ’s critically acclaimed proprietary craft beers throughout the chain. The Company’s restaurants are located in California (64), Texas (29), Florida (15), Arizona (6), Colorado (5), Nevada (5), Ohio (4), Washington (4), Oklahoma (3), Oregon (3), Kentucky (2), Virginia (2), Indiana (1), Kansas (1), Louisiana (1), Maryland (1) and New Mexico (1). Visit BJ’s Restaurants, Inc. on the Web at http://www.bjsrestaurants.com.
Important Additional Information:
The Company, its directors and certain of its executive officers may be deemed to be participants in the solicitation of proxies from the Company’s shareholders in connection with the matters to be considered at the Company’s upcoming annual meeting. Information concerning such participants is available in the Company’s proxy statement for the 2013 annual meeting of shareholders filed with the SEC on April 26, 2013, and in subsequent SEC filings on Forms 3 and 4. The Company intends to file a proxy statement and proxy card with the SEC in connection with any such solicitation of proxies from the Company’s shareholders. SHAREHOLDERS OF THE COMPANY ARE STRONGLY ENCOURAGED TO READ SUCH PROXY STATEMENT, ACCOMPANYING PROXY CARD AND ALL OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION, INCLUDING INFORMATION WITH RESPECT TO THE ABOVE MENTIONED PARTICIPANTS. Shareholders will be able to obtain any proxy statement, any amendments or supplements to the proxy statement and other documents filed by the Company with the SEC at no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge at the Company’s website at www.bjsrestaurants.com in the section “Investors.”
CONTACT: Investor Contacts: Greg Levin BJ's Restaurants, Inc. (714) 500-2400 JCIR (212) 835-8500 bjri@jcir.com Media Contacts: Sard Verbinnen & Co John Christiansen / Michael Henson (415) 618-8750 / (212) 687-8080
(NEWL) Announces 1-for-10 Reverse Split of Common Shares
PIRAEUS, Greece, March 6, 2014 — NewLead Holdings Ltd. (NASDAQ: NEWL) (“NewLead” or the “Company”) today announced that a 1-for-10 reverse stock split of its common shares has been approved by the Company’s Board of Directors and by written consent of a majority of shareholders, effective upon the commencement of trading today, March 6, 2014.
The reverse split will consolidate every ten common shares into one common share, par value of $0.10 per share. As a result of the reverse stock split, the number of common shares outstanding will be reduced from 53,721,525 to approximately 5,372,153 shares, subject to rounding up of all fractional shares to the nearest whole share. In respect to the underlying common shares associated with any derivative securities, such as warrants, options and convertible notes, the conversion and exercise prices and number of common shares issuable generally will be adjusted in accordance to the 1:10 ratio. The number of authorized common shares and preferred shares of NewLead will not be affected by the reverse split.
It is anticipated that the transaction will establish a higher market price for the Company’s common shares and reduce per share transaction fees as well as certain administrative costs. The reverse stock split is being undertaken in an effort to regain compliance with the continued listing standards of Nasdaq.
NewLead’s transfer agent, Continental Stock Transfer & Trust Co (“Continental”), will also act as exchange agent for the reverse stock split. After the reverse split takes effect, shareholders will receive information from Continental regarding the process for exchanging their common shares. Continental will notify shareholders of record that hold physical certificates as of the effective time to transmit outstanding share certificates, and, unless requested, will subsequently issue new book entry statements of holding representing one post-split common share for every ten common shares held of record as of the effective time. Shareholders that currently hold common shares in book entry form will receive updated statements of holding reflecting the reverse split and need not take any action.
About NewLead Holdings Ltd.
NewLead Holdings Ltd. is an international, vertically integrated shipping and commodity company that manages product tankers and dry bulk vessels. NewLead currently owns three dry bulk vessels, which includes one newbuilding. NewLead owns a wash plant and two mines in Kentucky, USA. NewLead’s common shares are traded under the symbol “NEWL” on the NASDAQ Global Select Market. To learn more about NewLead Holdings Ltd., please visit the new website at www.newleadholdings.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release includes assumptions, expectations, projections, intentions and beliefs about future events. These statements, as well as words such as “anticipate,” “estimate,” “project,” “plan,” and “expect,” are intended to be ”forward-looking” statements. We caution that assumptions, expectations, projections, intentions and beliefs about future events may vary from actual results and the differences can be material. Forward-looking statements include, but are not limited to, such matters as the creditworthiness of our counterparties, the reliability of reserve reports, our ability to extract or acquire coal to fulfill contracts, the consummation of conditional contracts, future operating or financial results; our liquidity position and cash flows, our ability to borrow additional amounts under our revolving credit facility and, if needed, to obtain waivers from our lenders and restructure our debt, and our ability to continue as a going concern; statements about planned, pending or recent vessel disposals and/or acquisitions, business strategy, future dividend payments and expected capital spending or operating expenses, including dry-docking and insurance costs; statements about trends in the product tanker and dry bulk vessel shipping segments, including charter rates and factors affecting supply and demand; expectations regarding the availability of vessel acquisitions; completion of repairs; length of off-hire; availability of charters; and anticipated developments with respect to any pending litigation. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, management’s examination of historical operating trends, data contained in our records and other data available from third parties. Although NewLead believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, NewLead cannot assure you that it will achieve or accomplish these expectations, beliefs or projections described in the forward looking statements. Important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements include the strength of world economies and currencies, general market conditions, including changes in charter rates and vessel values, failure of a seller to deliver one or more vessels, and other factors discussed in NewLead’s filings with the U.S. Securities and Exchange Commission from time to time. NewLead expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in NewLead’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.
Investor and Media Relations:
Elisa Gerouki
NewLead Holdings Ltd.
Telephone: + 30 213 014 8023
Email: egerouki@newleadholdings.com
(ANIP) Announces Pricing Of Public Offering Of Common Stock
BAUDETTE, Minn., March 5, 2014 — ANI Pharmaceuticals, Inc. (the “Company”) (NASDAQ: ANIP) today announced that it has priced a firm commitment underwritten public offering of 1,402,525 shares of the Company’s common stock at a purchase price to the public of $31.00 per share, resulting in net proceeds to the Company of $43.5 million (before estimated offering expenses payable by us). Oppenheimer & Co. Inc. and Roth Capital Partners are acting as joint book-running managers for the offering. The offering is expected to close on or about March 10, 2014, subject to customary closing conditions. The Company also granted the underwriters a 30-day option to purchase up to an additional 210,378 shares. The Company expects to use the net proceeds of the offering to research, develop, commercialize and expand its drug products, to acquire complementary businesses and technologies and for working capital and general corporate purposes.
The securities described above are being offered by the Company pursuant to a “shelf” registration statement previously filed with and declared effective by the Securities and Exchange Commission (SEC) on June 17, 2011. A prospectus supplement and an accompanying prospectus will be filed with the SEC in connection with the offering. Once filed, the prospectus supplement and accompanying prospectus may be obtained by sending a request to Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8563, or by email at EquityProspectus@opco.com, or from Roth Capital Partners, LLC, Attention: Equity Capital Markets, 888 San Clemente Drive, Newport Beach, CA 92660, (800) 678-9147, rothecm@roth.com, or by accessing the SEC’s website at www.sec.gov.
Before investing in the offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the company and the offering.
This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About ANI Pharmaceuticals
The Company is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company’s targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. The Company has its own research and development team, manufacturing facilities, and sales and regulatory compliance personnel.
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. Such statements include, but are not limited to, statements about the potential benefits of the recent Merger, the Company’s plans, objectives, expectations and intentions with respect to future operations and products, the anticipated financial position, operating results and growth prospects of the Company and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, subject to change. You should not place undue reliance on those statements because they are subject to numerous uncertainties, risks and other factors relating to the Company’s operations and business environment and other factors, all of which are difficult to predict and many of which are beyond the Company’s control.
Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may in the future face increased difficulty in importing raw materials and/or increased competition, for its Esterified Estrogen with Methyltestosterone Tablet product; competitive conditions for the Company’s other products may intensify; the Company may be required to seek the approval of the U.S. Food and Drug Administration (“FDA”) for its unapproved products or withdraw such products from the market; general business and economic conditions; the Company’s expectations regarding trends in markets for the Company’s current and planned products; the Company’s future cash flow and its ability to support its operations; the Company’s ability to obtain additional financing as needed; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance of such products; and the marketing success of the Company’s licensees or sublicensees.
These factors should not be construed as exhaustive and should be read in conjunction with the Company’s other disclosures, including but not limited to the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on February 28, 2014, including the factors described in “Item 1A. Risk Factors.” Other risks may be described from time to time in our filings made under the securities laws, including our quarterly reports on Form 10-Q and our current reports on Form 8-K. There may be additional risks, uncertainties and factors that we do not currently view as material or that are not known. The forward-looking statements contained in this document are made only as of the date of this document. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information about ANI, please contact:
Arthur S. Przybyl
(218) 634-3608
arthur.przybyl@anipharmaceuticals.com
(BV) to Present at the Piper Jaffray Technology, Media & Telecommunications Conference
AUSTIN, Texas, March 5, 2014 — Bazaarvoice, Inc. (Nasdaq:BV), the network connecting brands and retailers to the authentic voices of consumers wherever they shop, today announced that Gene Austin, chief executive officer and president, and Jim Offerdahl, chief financial officer will present at the Piper Jaffray Technology, Media & Telecommunications Conference in New York, NY.
The presentation is scheduled for Wednesday, March 12, 2014 at 10:00 a.m. Eastern Time, or 9:00 a.m. Central Time. A live webcast, as well as a replay, of the presentation will be accessible from the investor relations page of the Bazaarvoice website at investors.bazaarvoice.com.
About Bazaarvoice
Bazaarvoice is a network that connects brands and retailers to the authentic voices of people where they shop. Each month, more than 400 million people view and share authentic opinions, questions and experiences about tens of millions of products in the Bazaarvoice network. The company’s technology platform amplifies these voices into the places that influence purchase decisions. Network analytics help marketers and advertisers provide more engaging experiences that drive brand awareness, consideration, sales and loyalty. Headquartered in Austin, Texas, Bazaarvoice has offices across North America, Europe and Asia-Pacific. For more information, visit www.bazaarvoice.com, read the blog at www.bazaarvoice.com/blog, and follow on Twitter at www.twitter.com/bazaarvoice.
CONTACT: Investor Relations Contact: Linda Wells Bazaarvoice, Inc. 415-489-6045 linda.wells@bazaarvoice.com Media Contact: Matt Krebsbach Bazaarvoice, Inc. 512-551-6612 matt.krebsbach@bazaarvoice.com
(MXWL) Ultracapacitor-Based Engine Start Module, Medium Duty Diesel Trucks
New ULTRA 31/900 Effectively Eliminates Jump-Starts; Decreases Total Cost of Ownership in Class 3 through 6 Trucks
SAN DIEGO, March 5, 2014 — Maxwell Technologies, Inc. (Nasdaq: MXWL) is expanding its ultracapacitor-based Engine Start Module (ESM) product line to provide the same benefits to class 3 through 6 medium duty trucks that it has been offering previously to class 7 and 8 heavy duty diesel trucks. Consistent with the current ESM product, the new ESM ULTRA 31/900 provides the following features and benefits:
- 900 cold cranking amperes (CCA), or a three-second crank;
- Reliable starting for diesel engines up to 9.9 liters at temperatures -40°C to 65°C (-40°F to 149°F);
- Low maintenance operation and life-of-the-vehicle reliability;
- Industry standard Group 31 battery form factor for easy integration with battery systems;
- Built-in quick charging system (15 minutes or less);
- Extended battery life, full compatibility with existing battery systems; and
- Four year unlimited warranty.
Maxwell’s ESM ULTRA 31/900 assumes the starting responsibility for the truck and effectively eliminates cranking problems that come from weak or discharged batteries. Consistent with Maxwell’s current award-winning ESM product, the ESM ULTRA 31/900 delivers the quick-burst power trucks need to crank their engines in extreme cold, down to -40°F. The new ESM is rugged and lightweight (16 lbs.). It delivers reliable starts and allows extensive use of lift-gates and buckets while the engine is off without fear of the truck not starting.
“In order to maximize on-time service and deliveries, fleet owners need their medium duty trucks to perform reliably in any conditions,” said Jeremy Cowperthwaite, vice president and general manager of Maxwell’s Engine Starting Group. “Maxwell’s ultracapacitor-based ESM starting solutions are the best options in the market for ensuring engine start reliability while also lowering the overall cost of operations. Now, with the introduction of the ESM ULTRA 31/900, we’re extending the same benefits to class 3 through 6 medium duty diesel trucks.”
The ESM ULTRA 31/900 is a no-acid, lead-free energy storage solution that weighs less than one-fourth of the Group 31 lead-acid battery it replaces. It stays fully charged even when the truck’s lead-acid battery is as low as 9.5V.
Maxwell will introduce the new ultracapacitor-based ESM ULTRA 31/900 at the Work Truck Show, March 5 through 7 in Indianapolis at booth 3026.
Additional Maxwell Technologies information:
- Features and downloads for the ESM line: http://www.maxwell.com/esm
- Maxwell Technologies on Twitter: https://twitter.com/Maxwell_Tech
- Maxwell Technologies on Facebook: http://on.fb.me/10e2nPA
- Maxwell Technologies on LinkedIn: http://linkd.in/Z4737Y
About Maxwell Technologies: Maxwell Technologies is a global leader in the development and manufacture of innovative, cost-effective energy storage and power delivery solutions. Our ultracapacitor products provide safe and reliable power solutions for applications in consumer and industrial electronics, transportation and telecommunications. Our CONDIS® high-voltage grading and coupling capacitors help to ensure the safety and reliability of electric utility infrastructure and other applications involving transport, distribution and measurement of high-voltage electrical energy. Our radiation-mitigated microelectronic products include power modules, memory modules and single board computers that incorporate powerful commercial silicon for superior performance and high reliability in aerospace applications. For more information, visit www.maxwell.com.
For more information, contact:
Maxwell Technologies
Media: Rachel Sullivan, Metis Communications: +1 (617) 236-0500, maxwell@metiscomm.com
Investor: Michael Sund: +1 (858) 503-3233, msund@maxwell.com
OEM/Distribution Sales Manager: Chris Fischbach: +1 (858) 503-3343, cfischbach@maxwell.com
Inside Sales Representative: Kristy LaPage: +1 (858) 503-3469, klapage@maxwell.com
Eastern Region Key Account Manager: Bradley Czernejewski: +1 858-249-9686, bczernejewski@maxwell.com
Central Region Key Account Manager: Michael Padrnos: +1 (858) 230-2115, mpadrnos@maxwell.com
Western Region Key Account Manager: David Yacobucci: +1 (949) 246-2460, dyacobucci@maxwell.com
(TKMR) Receives Fast Track Designation From FDA for Its Anti-Ebola Viral Therapeutic
VANCOUVER, British Columbia, March 5, 2014 — Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of TKM-Ebola, an anti-Ebola viral therapeutic.
The FDA’s Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.1
“This is an important milestone for Tekmira and our TKM-Ebola program. Receiving a Fast Track designation from the FDA supports our work to advance the development of this therapeutic as quickly as possible. Our leadership in developing anti-viral therapies has been supported by our collaboration with the U.S. Department of Defense, which is funding the development of TKM-Ebola,” said Dr. Mark J. Murray, Tekmira’s President and CEO.
“In January, we announced that the first subject had been dosed in a Phase I clinical trial evaluating the safety of our TKM-Ebola therapeutic, which utilizes a third-generation LNP formulation. We continue to enroll subjects and remain on track to have data from this trial available in the second half of this year,” added Dr. Murray.
Tekmira’s anti-viral product platform includes RNAi therapeutics addressing chronic Hepatitis B infection and lethal hemorrhagic fever viruses, including Ebola and Marburg.
About the TKM-Ebola Phase I Clinical Trial
The TKM-Ebola Phase I clinical trial is a randomized, single-blind, placebo-controlled study involving single ascending doses and multiple ascending doses of TKM-Ebola. The study is assessing the safety, tolerability and pharmacokinetics of administering TKM-Ebola to healthy adult subjects. Four subjects are planned per cohort. There are four planned cohorts for a total of 16 subjects in the single dose arm, and three planned cohorts for a total of 12 subjects in the multiple dose arm of the trial. Each cohort will enroll three subjects who receive TKM-Ebola, and one who will receive a placebo.
About TKM-Ebola, an Anti-Ebola Virus RNAi Therapeutic
TKM-Ebola, an anti-Ebola virus RNAi therapeutic, is being developed under a $140 million contract with the U.S. Department of Defense’s Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office. Earlier preclinical studies were published in the medical journal The Lancet and demonstrated that when siRNA targeting the Ebola virus and delivered by Tekmira’s LNP technology were used to treat previously infected non-human primates, the result was 100 percent protection from an otherwise lethal dose of Zaire Ebola virus (Geisbert et al., The Lancet, Vol 375, May 29, 2010). Tekmira’s productive collaboration with the MCS-BDTX was modified and expanded in 2013 to include significant advances in LNP formulation technology since the initiation of the program in 2010.
About Joint Project Manager Medical Countermeasure Systems (JPM-MCS)
This work is being conducted under contract with the U.S. Department of Defense Joint Project Manager Medical Countermeasure Systems (JPM-MCS). JPM-MCS, a component of the Joint Program Executive Office for Chemical and Biological Defense, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance our nation’s biodefense response capability. For more information, visit www.jpeocbd.osd.mil.
About RNAi and Tekmira’s LNP
RNAi therapeutics have the potential to treat a broad number of human diseases by “silencing” disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi therapeutics, such as “siRNAs,” require delivery technology to be effective systemically. Tekmira believes its LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira’s LNP platform is being utilized in multiple clinical trials by both Tekmira and its partners. Tekmira’s LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles that are effective in delivering RNAi therapeutics to disease sites in numerous preclinical models. Tekmira’s LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible, and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
Forward-Looking Statements and Information
This news release contains “forward-looking statements” or “forward-looking information” within the meaning of applicable securities laws (collectively, “forward-looking statements”). Forward-looking statements in this news release include statements about the FDA’s Fast Track designation of TKM-Ebola; Phase I human clinical trial of TKM-Ebola and the contract with the U.S. Department of Defense; timing and availability of data from the Phase I human clinical trial; future RNAi-based anti-viral therapeutics; and Tekmira’s strategy, future operations, prospects and the plans of management.
With respect to the forward-looking statements contained in this news release, Tekmira has made numerous assumptions regarding, among other things: LNP’s status as a leading RNAi delivery technology; and the timing and quantum of payments to be received under contracts with Tekmira’s partners. While Tekmira considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Tekmira’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: TKM-Ebola may not prove to be an effective anti-viral therapy for hemorrhagic fever viruses; data from the TKM-Ebola Phase I human clinical trial may not be available as currently anticipated, or at all; the U.S. Department of Defense may suspend or terminate its participation in the TKM-Ebola program; the Fast Track designation from the FDA may not result in faster development times or earlier approvals; and Tekmira’s products may not prove to be effective or as potent as currently believed.
A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira’s Annual Report on Form 20-F for the year ended December 31, 2012, which is available at www.sedar.com or at www.sec.gov/edgar. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Tekmira disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
1 Taken from FDA website at: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm
CONTACT: Investors Jodi Regts Director, Investor Relations Phone: 604-419-3234 Email: jregts@tekmirapharm.com Media David Ryan Longview Communications Inc. Phone: 416-649-8007 Email: dryan@longviewcomms.ca
(ZBB) Statement on Unusual Trading Activity
MILWAUKEE, WI–(Mar 5, 2014) – ZBB Energy Corporation (NYSE MKT: ZBB) announced that in view of the unusual market activity in the Company’s stock, NYSE MKT has contacted the company in accordance with its normal practice and requested the Company respond by press release. The Company stated that its policy is not to comment on unusual market activity.
About ZBB Energy Corporation
ZBB Energy Corporation (NYSE MKT: ZBB) designs, develops, and manufactures advanced energy storage, power electronic systems, and engineered custom and semi-custom products targeted at the growing global need for distributed renewable energy, energy efficiency, power quality, and grid modernization. ZBB and its power electronics subsidiary, Tier Electronics, LLC, have developed a portfolio of integrated power management platforms that combine advanced power and energy controls plus energy storage to optimize renewable energy sources and conventional power inputs whether connected to the grid or not. Tier Electronics participates in the energy efficiency markets through their hybrid vehicle control systems, and power quality markets with their line of regulation solutions. Together, these platforms solve a wide range of electrical system challenges in global markets for utility, governmental, commercial, industrial and residential end customers. Founded in 1986, ZBB’s platforms ensure optimal efficiencies today, while offering the flexibility to adapt and scale to future requirements. ZBB’s corporate offices, engineering and development, and production facilities are located in Menomonee Falls, WI, USA with a research facility also located in Perth, Western Australia. ZBB has a joint venture with Meineng Energy, a provider of leading-edge energy storage systems and solutions to the greater China market. For more information, visit: www.zbbenergy.com.
Safe Harbor Statement
Certain statements made in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expected operating losses, expected revenues, expected expenses and our expectations concerning our business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
(XGTI) to Present at The 26th Annual ROTH Conference
SARASOTA, Fla., March 5, 2014 — xG Technology, Inc. (“xG” or the “Company”) (Nasdaq: XGTI, XGTIW), a developer of wireless communications and spectrum sharing technologies, has announced that management will present at the 26th Annual ROTH Conference taking place in Dana Point, CA on March 9-12, 2014.
George Schmitt, Executive Chairman, John Coleman, CEO and Roger Branton, CFO, and James Woodyatt, President will attend. Management will present on Tuesday, March 11, 2014 at 5:30pm PT and conduct one-on-one meetings this same day. A webcast of the presentation will be available on xG’s website at http://www.xgtechnology.com/Company/investors-overview.html.
About xG Technology
xG Technology has created a broad portfolio of intellectual property that makes wireless networks more intelligent, accessible, affordable and reliable. The company has created xMax, a patented all-IP cognitive radio technology that enables spectrum sharing. xMax can solve the crisis facing the wireless industry caused by data-hungry devices and applications that are straining network capacity It eliminates the need to acquire scarce and expensive licensed spectrum, thus lowering the total cost of ownership for wireless broadband access. xG’s goal is to help wireless broadband network operators make more efficient use of their spectrum allocations and to create new opportunities for innovation in unlicensed spectrum. The xMax cognitive radio system incorporates advanced optimizing technologies that include spectrum sharing, interference mitigation, multiple-input multiple-output (MIMO) and software defined radio (SDR). xG offers solutions for numerous industries worldwide, including urban and rural wireless broadband, utilities, defense, emergency response and public safety.
Based in Sarasota, Florida, xG has 60 U.S. and over 130 international patents and pending patent applications, and its technology is available for licensing in both domestic and foreign markets. xG is a publicly traded company listed on the NASDAQ Capital Market where xG common stock is traded under the symbol XGTI and xG warrants are traded under the symbol XGTIW. For more information, please visit www.xgtechnology.com.
For More Information:
Media and Analyst Relations
David Worthington
Fusion PR
www.fusionpr.com
(212) 651-4200
Investor Relations
James Woodyatt
xG Technology
www.xGtechnology.com
(954) 572-0395
Jody Burfening/Carolyn Capaccio
LHA
ccapaccio@lhai.com
(212) 838-3777
(SARA) to Present at ROTH Capital Partners 26th Annual Growth Stock Conference
Saratoga Resources, Inc. (NYSE MKT: SARA; the “Company” or “Saratoga”) today announced they will present at ROTH Capital Partners 26th Annual Growth Stock Conference. The presentation will be at 8:00 AM PT (10:00 CT, 11:00 ET) on Monday March 10, 2014. Mr. Andy Clifford, President of Saratoga Resources, will be making the presentation which will be available for download at the Company website, www.saratogaresources.com, on the day of the presentation.
About Saratoga Resources
Saratoga Resources is an independent exploration and production company with offices in Houston, Texas and Covington, Louisiana. Principal holdings cover 52,033 gross/net acres, mostly held by production, located in the transitional coastline and protected in-bay environment on parish and state leases of south Louisiana and in the shallow Gulf of Mexico Shelf. Most of the company’s large drilling inventory has multiple pay objectives that range from as shallow as 1,000 feet to the ultra-deep prospects below 20,000 feet in water depths ranging from less than 10 feet to a maximum of approximately 80 feet. For more information, go to Saratoga’s website at www.saratogaresources.com and sign up for regular updates by clicking on the Updates button.
(CLMS) Value Product Renamed toCalamos Opportunistic Value Fund
NAPERVILLE, Ill., March 4, 2014 — www.calamos.com/value Calamos is pleased to announce it has changed the name of the Calamos Value Fund (A Shares: CVAAX; B Shares: CVABX; C Shares: CVACX; I Shares: CVAIX) to the Calamos Opportunistic Value Fund, effective March 1, 2014. The new name is intended to better reflect the investment approach and scope of the fund, which have not changed.
The Calamos Value Team joined the firm in 2012 and assumed management of the fund. The team’s approach to value investing contrasts with traditional buy-and-hold “deep value” funds, operating with higher turnover and utilizing option strategies to manage risk reward. The term “opportunistic” relates to ways in which the Calamos Value Team enters and exits positions in the fund, the speed at which the team does so, as well as the openness and agility used to react to new investment possibilities.
Jeff Miller, Senior Vice President and Co-Portfolio Manager of the fund, stated: “The Calamos Opportunistic Value Fund pursues a value style focused on investing in strong operating businesses with transient reasons for being undervalued, special situations like mergers and spinoffs, and complex or misunderstood companies. Furthermore, the fund deploys a trading strategy that includes the use of options strategies to manage risk and seek to enhance returns. As a result, the fund offers distinct characteristics and a dynamic approach that distinguishes it from its peer group. When opportunity knocks, the Calamos Value Team opens the door.”
For more information about the fund, including a video by Jeff Miller detailing the team’s opportunistic approach to value investing, please visit www.calamos.com/value.
About Calamos
Calamos Investments LLC is a diversified global investment firm offering innovative investment strategies including equity, fixed income, convertible and alternative investments. The firm offers strategies through separately managed portfolios, mutual funds, closed-end funds, private funds and UCITS funds. Clients include major corporations, pension funds, endowments, foundations and individuals. Headquartered in the Chicago metropolitan area, the firm also has offices in London and New York. For more information, visit www.calamos.com.
Important Risk Information
An investment in the Fund(s) is subject to risks, and you could lose money on your investment in the Fund(s). There can be no assurance that the Fund(s) will achieve its investment objective. Your investment in the Fund(s) is not a deposit in a bank and is not insured or guaranteed by the Federal Deposit Insurance Corporation (FDIC) or any other government agency. The risks associated with an investment in the Fund(s) can increase during times of significant market volatility. The Fund(s) also has specific principal risks, which are described below. More detailed information regarding these risks can be found in the Fund’s prospectus.
The principal risks of investing in the Calamos Opportunistic Value Fund include: equity securities risk consisting of market prices declining in general, value stock risk consisting of the potential that a company will never reach its calculated intrinsic value, small and mid-sized company risk, foreign securities risk and portfolio selection risk.
As a result of political or economic instability in foreign countries, there can be special risks associated with investing in foreign securities, including fluctuations in currency exchange rates, increased price volatility and difficulty obtaining information. In addition, emerging markets may present additional risk due to potential for greater economic and political instability in less developed countries.
The fund’s ability to close out its position as a purchaser or seller of an over-the-counter or exchange-listed put or call option is dependent, in part, upon the liquidity of the option market. There are significant differences between the securities and options markets that could result in an imperfect correlation among these markets, causing a given transaction not to achieve its objectives. The fund’s ability to utilize options successfully will depend on the ability of the fund’s investment adviser to predict pertinent market movements, which cannot be assured.
Before investing carefully consider the fund’s investment objectives, risks, charges and expenses. Please see the prospectus and summary prospectus containing this and other information or call 1-800-582-6959. Read it carefully before investing.
Calamos Financial Services LLC, Distributor
(OPHT) to Host R&D Day on March 7, 2014
Ophthotech Corporation (Nasdaq:OPHT) today announced that the Company will host a live webcast in conjunction with its Research and Development (R&D) Day on Friday, March 7, 2014, beginning at 8:30 a.m. ET. A panel featuring leading retinal specialists will discuss the company’s expanded clinical programs for Fovista™ anti-PDGF therapy in combination with anti-VEGF drugs for wet AMD. In addition, an update on Zimura™, an inhibitor of complement factor C5 for the dry and wet forms of AMD, will also be provided.
The live and archived webcast can be accessed through the Investor section of the Company’s website at www.ophthotech.com. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start. The archived webcast will remain available on the Company’s website for fourteen days following the call.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the development of novel therapeutics to treat diseases of the eye, with a focus on developing innovative therapies for age-related macular degeneration (AMD). Ophthotech’s most advanced product candidate, Fovista™ anti-PDGF therapy, is in Phase 3 clinical trials for use in combination with anti-VEGF drugs that represent the standard of care for the treatment of wet AMD. The Company’s second product candidate Zimura™, an inhibitor of complement factor C5, is being developed for the treatment of dry and wet forms of AMD. For more information, please visit www.ophthotech.com.
Forward-looking Statements
Any statements in this press release about Ophthotech’s future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent Ophthotech’s views only as of the date of this press release. Ophthotech anticipates that subsequent events and developments will cause its views to change. While Ophthotech may elect to update these forward-looking statements at some point in the future, Ophthotech specifically disclaims any obligation to do so.
(ARGS) New Clinical Data for AGS-004 Patient-Specific Immunotherapy in HIV
Clinical Results Showing Induction of Memory T Cell Responses in Acute and Chronic HIV Infected Patients Presented at Conference on Retroviruses and Opportunistic Infections (CROI) Meeting in Boston
DURHAM, N.C., March 4, 2014 — Argos Therapeutics Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today presented data from clinical studies of AGS-004, the company’s patient-specific immunotherapy currently in development for the treatment of HIV infection. Results were presented in two poster presentations at the Conference on Retroviruses and Opportunistic Infections (CROI) meeting in Boston.
The first poster, entitled Immune Function and Viral Load Post-AGS-004 Administration to Chronic HIV Subjects Undergoing STI, presents new findings from a Phase 2a clinical trial to assess safety and efficacy of AGS-004 during a 12-week antiretroviral therapy (ART) structured treatment interruption (STI) in chronic HIV-1 infected patients. The goal of intervention was to induce long-term immunity against each patient’s unique viral variants and determine the impact on viral load control after stopping ART drug therapy. Results showed that AGS-004 induced anti-HIV T memory stem cell-like immune responses (TSCM) that were associated with a longer time to viral rebound after ART treatment interruption. In addition, the longer time to viral rebound was also associated with lower expression of the checkpoint inhibitor PD-1 on activated CD8+ T cells.
“This is the first demonstration that AGS-004 can induce anti-viral TSCM-like immune responses in chronic HIV patients and that these responses are associated with viral load control in the absence of ART drugs. Establishing long-lasting immune memory is a critical component of durable viral load control and bodes well for our planned eradication and functional cure studies,” said Charles Nicolette, PhD, chief scientific officer and vice president of research and development for Argos Therapeutics.
The second poster, entitled Immunogenicity of AGS-004 Dendritic Cell Therapy in Patients Treated During Acute HIV Infection, highlights results from an open-label, single arm study where treatment with AGS-004 was administered to patients who initiated ART within 45 days of primary HIV infection. The study was led by David Margolis, MD, Joseph Eron, MD, Nancie Archin, PhD, and Cynthia Gay, MD, faculty at the University of North Carolina School of Medicine, and Charles B. Hicks, MD, professor of medicine at Duke University Medical Center. Results showed that new anti-HIV memory T cell immune responses were induced in all six patients treated. One patient was able to maintain sufficient viral control while off ART drugs for approximately five months and another patient continues ART treatment interruption after nearly nine months. Additionally, three of six patients had decreases in circulating CD4+ T cells containing HIV DNA of 25%, 47% and 63%, respectively, when measured after three doses of AGS-004 while on ART.
“This study demonstrates that AGS-004 can induce anti-viral memory T cell responses in acute patients and may result in depletion of persistent HIV infection in ART-suppressed patients in combination with anti-latency therapy,” said Dr. Margolis.
The Argos AGS-004 clinical research program is supported by funding from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. N01-AI-60019.
About the Arcelis™ Technology Platform
Arcelis is a fully personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers and infectious diseases and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies.
The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are collected and optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient’s plasma and administered via intradermal injection.
About Argos Therapeutics
Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform. Argos’ most advanced product candidate, AGS-003, is in a pivotal Phase 3 trial for the treatment of mRCC, and the company plans to have data from its Phase 2b trial of AGS-004 for the treatment of HIV in mid- 2014. For more information about Argos Therapeutics, visit www.argostherapeutics.com.
Forward Looking Statement
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Argos Therapeutics’ filings with the Securities and Exchange Commission, including without limitation its most recently filed reports on Form 8-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. The investigative immunotherapies discussed in this press release are not approved by the U.S. Food and Drug Administration (FDA) and no conclusions should be drawn regarding their safety or effectiveness. All forward-looking statements contained in this press release speak only as of the date on which they were made. Argos undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT: Media contact: Andrea Coan Berry & Company Public Relations acoan@berrypr.com (212) 253-8881
(OXBT) Update on Communication with the FDA Regarding Oxycyte Development Program
Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, announced today that it has been notified by the U.S. Food and Drug Administration (the “FDA”) that the agency has completed its review of the September 2013 nonclinical submission and has lifted the clinical hold on Oxycyte®. Lifting of the clinical hold clears the company to proceed with the clinical development program in the US. The FDA communicated this information to the company during a conference call with the FDA on Friday, February 28, 2014. Written confirmation of the FDA’s decision is expected to be received within 30 days.
On September 23, 2013, the company announced that it had submitted to the FDA results from two series of animal studies designed to address FDA concerns regarding the use of Oxycyte in treating traumatic brain injury (TBI) patients. These studies were conducted to probe both the interactions between Oxycyte and the immune system, as well as assess the PFC-based emulsion’s potential to increase the risk of intracerebral hemorrhage (ICH). This submission has formed the basis for the FDA’s decision to lift the clinical hold. “We are pleased that the FDA has responded favorably to the data provided and removed the clinical hold to allow further clinical development of Oxycyte,” said John Kelley, CEO.
Prior to the initiation of any human clinical studies using Oxycyte in the US, the company will need to develop an FDA approved protocol which will incorporate FDA input on the design and safety measures to be utilized in such studies. Oxygen is currently enrolling patients outside of the US in a Phase II-b study to evaluate the safety and tolerability of Oxycyte in patients with severe non-penetrating traumatic brain injury (STOP-TBI). The study is currently enrolling patients in Israel for the second cohort of a three cohort trial.
About Oxygen Biotherapeutics
Oxygen Biotherapeutics, Inc. is developing medical products for the critical care market. The company recently acquired the North American rights to develop and commercialize levosimendan. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). In addition, the FDA has agreed to a Phase 3 protocol design under Special Protocol Assessment (SPA), and provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication. The company also has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte® that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, receipt of written confirmation of the FDA’s decision to lift the clinical hold on Oxycyte, our ability to successfully develop a protocol for the use of Oxycyte in human clinical studies that satisfies the FDA, matters beyond the company’s control that could lead to delays in the clinical studies, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in the company’s filings with the Securities and Exchange Commission, including in its quarterly report on Form 10-Q filed on December 17, 2013, and annual report on Form 10-K filed on June 26, 2013, as well as its other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
(CPST) Orders For 2.6MW From Regatta Solutions for Prominent Southern California Hospitals
CHATSWORTH, Calif., March 4, 2014 — Capstone Turbine Corporation (www.capstoneturbine.com) (Nasdaq:CPST), the world’s leading clean technology manufacturer of microturbine energy systems, announced today it received orders for two Capstone C800s and a Capstone C1000 to be used in two Southern California hospitals.
Regatta Solutions secured the first order for two Capstone C800 Natural Gas fueled microturbines to be installed at a Los Angeles hospital. The microturbines will be used in a CHP (Combined Heat and Power) application to offset the facility’s electric base load in addition to providing steam and hot water, boosting their overall site efficiency. The facility chose Capstone microturbines due to their low maintenance, low emissions, and high overall efficiency. Capstone microturbines do not require lubricants or coolants and have few maintenance intervals, providing the hospital with lower operating costs. This customer was also able to take advantage of California’s SGIP (Self-Generation Incentive Program), which provides incentives to support existing, new, and emerging distributed energy resources.
Vice President of Regatta Solutions, Kenda Burkhart, stated, “It is great to see the continued adoption of Capstone Turbine technology in the healthcare industry. The market as a whole is realizing that implementing clean and green CHP technology will deliver substantial improvements in their overall efficiency and reduce their facility’s operating expenses.” The site is expected to be commissioned in late 2014.
Regatta Solutions secured the second order for a Capstone C1000 natural gas microturbine to be installed at another hospital in Los Angeles. The microturbine will be deployed in a CCHP (Combined Cooling Heat and Power) application, offsetting the electric base load while also utilizing the exhaust heat to provide absorption chilling. By utilizing the microturbine in a CCHP configuration along with the added benefit of the project qualifying for over $500,000 in California SGIP incentives, the hospital is able to reduce the payback period, making it the clear choice from a financial standpoint. California has the strictest emission requirements in the world, making Capstone microturbines a clear choice because they can meet these standards without any pre or post treatment of the exhaust.
About Capstone Turbine Corporation
Capstone Turbine Corporation (www.capstoneturbine.com) (Nasdaq:CPST) is the world’s leading producer of low-emission microturbine systems and was the first to market commercially viable microturbine energy products. Capstone Turbine has shipped approximately 7,000 Capstone Microturbine systems to customers worldwide. These award-winning systems have logged millions of documented runtime operating hours. Capstone Turbine is a member of the U.S. Environmental Protection Agency’s Combined Heat and Power Partnership, which is committed to improving the efficiency of the nation’s energy infrastructure and reducing emissions of pollutants and greenhouse gases. A UL-Certified ISO 9001:2008 and ISO 14001:2004 certified company, Capstone is headquartered in the Los Angeles area with sales and/or service centers in the New York Metro Area, United Kingdom, Mexico City, Shanghai and Singapore.
The Capstone Turbine Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6212
This press release contains “forward-looking statements,” as that term is used in the federal securities laws, about the advantages of our products, adoption of our products in the healthcare industry and compliance with California emissions requirements. Forward-looking statements may be identified by words such as “expects,” “objective,” “intend,” “targeted,” “plan” and similar phrases. These forward-looking statements are subject to numerous assumptions, risks and uncertainties described in Capstone’s filings with the Securities and Exchange Commission that may cause Capstone’s actual results to be materially different from any future results expressed or implied in such statements. Capstone cautions readers not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Capstone undertakes no obligation, and specifically disclaims any obligation, to release any revisions to any forward-looking statements to reflect events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.
“Capstone” and “Capstone MicroTurbine” are registered trademarks of Capstone Turbine Corporation. All other trademarks mentioned are the property of their respective owners.
CONTACT: Capstone Turbine Corporation Investor and investment media inquiries: 818-407-3628 ir@capstoneturbine.com
(SUTR) to Supply New Products to SAMSUNG Group
CHANGSHU, China, March 4, 2014 — Sutor Technology Group Limited (the “Company” or “Sutor”) (Nasdaq: SUTR), a leading China-based manufacturer and distributor of high-end fine finished steel products used by a variety of downstream applications today announced that Changshu Huaye Steel Strip Co., Ltd., a subsidiary of Sutor, has entered into a supply contract with SAMSUNG Group to supply a total of 6,500 metric tons of aluminum-zinc alloy coated steel (also known as Galvalume). The contract is valued at approximately $5.2 million. According to the contract, the goods will be shipped to Samsung’s operating base in Brazil and the delivery is expected to begin in mid April 2014.
Mr. Zhuo Wang, CEO of Sutor, commented, “I am pleased to report that we achieved high product quality within such a short period of time for our Galvalume products. We started commercial production of Galvalume steel during the fourth quarter of fiscal 2013 and produced less than 200 tons of the products in fiscal 2013. We increased our production to approximately 6,000 tons in the second quarter of fiscal 2014. The contract with Samsung proves our ability to supply to the leading consumer products companies in the world and demonstrates our brand recognition, product quality and our ability to quickly commercialize new products.”
“We have a portfolio of products with flexible specifications and value added supplementary services targeting the consumer products markets. For example, our anti-fingerprints, anti-bacteria, and heat insulation lines of products allow us to gain access to a wide range of customers in a variety of sectors. With the new 500,000 metric tons cold-rolling production line expected to start commercial operation in May, we believe we would be in a better position to capitalize the economic transition in China,” Mr. Wang added.
About Sutor Technology Group Limited
Sutor is one of the leading China-based manufacturers and distributors of high-end fine finished steel products used by a variety of downstream applications. The Company utilizes a variety of in-house developed processes and technologies to convert steel manufactured by third parties into fine finished steel products, including hot-dip galvanized steel, pre-painted galvanized steel, acid-pickled steel, cold-rolled steel, and welded steel pipe products. To learn more about the Company, please visit http://www.sutorcn.com/en/index.php.
Forward-Looking Statements
This press release includes certain statements that are not descriptions of historical facts, but are forward-looking statements in nature within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, among others, those concerning our expected financial performance, liquidity and strategic and operational plans, our future operating results, our expectations regarding the market for our products, our expectations regarding the steel market, as well as all assumptions, expectations, predictions, intentions or beliefs about future events. You are cautioned that any such forward-looking statements are not guarantees of future performance and that a number of risks and uncertainties could cause our actual results to differ materially from those anticipated, expressed or implied in the forward-looking statements. These risks and uncertainties include, but not limited to, the factors mentioned in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended June 30, 2013, and other risks mentioned in our other reports filed with the Securities Exchange Commission (“SEC”). Copies of filings made with the SEC are available through the SEC’s electronic data gathering analysis retrieval system (EDGAR) at http://www.sec.gov. The words “believe,” “expect,” “anticipate,” “project,” “targets,” “optimistic,””intend,” “aim,” “will” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company assumes no obligation and does not intend to update any forward-looking statements, except as required by law.
For more information, please contact:
Investor Relations
Sutor Technology Group Limited
Tel: +86-512-5268-0988
Email: investor_relations@sutorcn.com
(IPWR) to Present at Two Investment Conferences in March
AUSTIN, TX–(Mar 4, 2014) – Ideal Power Inc. (NASDAQ: IPWR), a developer of a disruptive technology in the power conversion space, today announced that it will present at two investment conferences in March 2014: the 26th Annual ROTH Conference from March 9-11 and the Northland Capital Markets 2014 Growth Conference on March 12th. CEO Dan Brdar will make company presentations and host one-on-one meetings with investors.
26th Annual ROTH Conference
Date: Monday, March 10, 2014
Time: 5:00 pm PST
Location: Ritz-Carlton Laguna Niguel, Dana Point, CA (Track 8)
Northland Capital Markets 2014 Growth Conference
Date: Wednesday, March 12, 2014
Location: Omni Berkshire Palace Hotel, New York City
Meetings: Available for small group and one-on-one meetings
Conference participation is by invitation only and registration is required. For more information on the conferences or to schedule a one-on-one meeting, please contact your Northland Capital Markets’ and ROTH Capital representatives.
About Ideal Power Inc.
Ideal Power Inc. (NASDAQ: IPWR) has developed a novel, patented power conversion technology called Power Packet Switching Architecture™ (PPSA). PPSA improves the size, cost, efficiency, flexibility and reliability of electronic power converters. PPSA can scale across several large and growing markets, including solar photovoltaic generation, electrified vehicle charging, and commercial grid storage. Ideal Power also has a licensing-based, capital-efficient business model that can enable it to address these markets simultaneously. Ideal Power has won multiple grants for its PPSA technology, including a $2.5 million grant from the Department of Energy’s Advanced Research Projects Agency – Energy program, and market-leading customers are incorporating PPSA as a key component of their systems. For more information on Ideal Power, visit www.IdealPower.com.
Safe Harbor Statement
All statements in this release that are not based on historical fact are “forward looking statements”. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. These forward looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not limited to, whether the patents for our technology provide adequate protection and whether we can be successful in maintaining, enforcing and defending our patents, whether demand for our products, which we believe are disruptive, will develop and whether we can compete successfully with other manufacturers and suppliers of energy conversion products, both now and in the future, as new products are developed and marketed. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements.
Ideal Power Media Contact:
Mercom Communications
Wendy Prabhu
1.512.215.4452
Email Contact
www.mercomcapital.com
Investor Relations Contact:
MZ North America
Matt Hayden
1.949.259.4986
Email Contact
www.mzgroup.us
(IGLD) Announces Results of the Public Tender for its Debenture Offering in Israel
Internet Gold-Golden Lines Ltd. (NASDAQ and TASE: IGLD) (the “Company”), announced today the results of the public tender held on March 3, 2014 (the “Tender”) for its offering in Israel (the “Offering”) pursuant to a prospectus dated February 24, 2014 (the: “Prospectus”) of Series D Debentures, with a fixed annual interest rate of 6% (the “Debentures”). On February 27, 2014, the Company announced the results of the classified bidding for the Debentures.
In Tender, the Company accepted orders for 117,597 units of the non-convertible Debentures (each in the principal amount of NIS 1,000, the “Units”) for an aggregate principal amount of approximately NIS 117.5 million (approximately $33.7 million) at a price per Unit of NIS 1,070. The Company expects to receive gross offering proceeds of approximately NIS 125.8 million (approximately $36.1 million).
The Company will repay the principal amount of the Debentures in five installments as follows: (i) payments of 10% of the principal amount of the Debentures will be made on each of September 15, 2018 and 2019; (ii) payments of 30% of the principal amount of the Debentures will be made on each of September 15,2020 and 2021; and (iii) a final payment of 20% of the principal amount of the Debentures will be made on September 15, 2022.
Interest on the outstanding principal of the Debentures will be paid on March 15 and September 15 of each of the years 2014-2022, other than the first interest payment which will be made on September 15. 2014.
The principal and interest will be linked to the consumer price index of January 2014.
The newly issued Debentures will be listed on the Tel Aviv Stock Exchange (TASE). As previously reported, Midroog Ltd., an Israeli rating company affiliated with Moody’s, awarded a local Baa1 stable rating for the Debentures.
The Offering will be made in Israel only and not to U.S. persons. The Debentures will not be registered under the U.S. Securities Act of 1933, as amended, and will not be offered or sold in the United States without registration or applicable exemption from the registration requirements according to the U.S. Securities Act of 1933. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any debentures.
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