Archive for March, 2016
XI’AN, China, March 16, 2016 — SkyPeople Fruit Juice, Inc. (NASDAQ: SPU) (“SkyPeople” or “the Company”), a producer of fruit juice concentrates, fruit juice beverages and other fruit-related products, today announced that on March 11, 2016, SkyPeople Juice International Holding (HK) Limited (“SkyPeople HK”), a wholly owned subsidiary of the Company and a 99.78% owner of SkyPeople Juice Group Co., Ltd. (“SkyPeople China”) entered into a share transfer agreement and a capital contribution agreement with Shenzhen TianShunDa Equity Investment Fund Management Co., Ltd. (“TSD Investment Fund”), a limited liability corporation registered in China.
Pursuant to the approval certificate and business license requirements of Shaanxi Province, where SkyPeople China is registered to do business, SkyPeople HK was required to contribute RMB 427,000,000 (approximately $65,698,308), and Hongke Xue, a director of the Company was required to contribute RMB 1,000,000 (approximately $153,846), to SkyPeople China for this purpose.
However, as of March 10, 2016, SkyPeople HK had contributed only RMB 314,190,900 (approximately $48,337,062) to SkyPeople China, and not the remaining RMB 112,809,100 (approximately $17,355,246) as payment for the remaining 112,809,100 shares of SkyPeople China so as to fulfill the requirements of the Chinese regulations.
To address this capital shortage and comply with the requirements of local laws and regulations, SkyPeople HK entered into agreements with TSD Investment Fund whereby TSD Investment Fund will acquire 112,809,100 shares of SkyPeople China from SkyPeople HK, and in exchange, will make a capital contribution of RMB 131,761,028.80 (approximately $20,270,928) to SkyPeople China. The capital contribution by TSD Investment Fund, as approved by the Company’s Board of Directors, was calculated as eight times SkyPeople China’s net profit per share for fiscal 2014 (about RMB 0.146 per share) multiplied by 112,809,100 shares to equal a total capital contribution of RMB 131,761,028.80 (approximately $20,270,928).
Of the total capital contribution of RMB 131,761,028.80 (approximately $20,270,928) by TSD Investment Fund, RMB 112,809,100.00 (approximately $17,355,246) will be used as payment for the outstanding amount due to SkyPeople China by SkyPeople HK. The remaining RMB 18,951,928.80 (approximately $2,915,681) will be used as an additional capital contribution to SkyPeople China and deposited into SkyPeople China’s capital surplus account. Upon the effectiveness of the agreements between SkyPeople HK and TSD Investment Group, on or about April 1, 2016, SkyPeople HK will own 314,190,900 shares, or 73.42%, of SkyPeople China, TSD Investment Group will own 112,809,100 shares, or 26.36%, of SkyPeople China and Mr. Hongke Xue will own 1,000,000 shares, or 0.22%, of SkyPeople China.
About SkyPeople Fruit Juice, Inc.
SkyPeople Fruit Juice, Inc., a Florida company, through its wholly-owned subsidiary Pacific Industry Holding Group Co., Ltd. (“Pacific”), a Vanuatu company, and SkyPeople Juice International Holding (HK) Ltd., a company organized under the laws of Hong Kong Special Administrative Region of the People’s Republic of China and a wholly owned subsidiary of Pacific, holds 99.78% ownership interest in SkyPeople Juice Group Co., Ltd. (“SkyPeople (China)”). SkyPeople (China), together with its operating subsidiaries in China, is engaged in the production and sales of fruit juice concentrates, fruit beverages, and other fruit related products in the PRC and overseas markets. Its fruit juice concentrates are sold to domestic customers and exported directly or via distributors. Fruit juice concentrates are used as a basic ingredient component in the food industry. Its brands, “Hedetang” and “SkyPeople,” which are registered trademarks in the PRC, are positioned as high quality, healthy and nutritious end-use juice beverages. For more information, please visit http://www.skypeoplefruitjuice.com.
Safe Harbor Statement
Certain of the statements made in this press release are “forward-looking statements” within the meaning and protections of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions, and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause the actual results, performance, capital, ownership or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “will,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “estimate,” “continue,” “plan,” “point to,” “project,” “could,” “intend,” “target” and other similar words and expressions of the future.
All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary notice, including, without limitation, those risks and uncertainties described in our annual report on Form 10-K for the year ended December 31, 2014 and otherwise in our SEC reports and filings, including the final prospectus for our offering. Such reports are available upon request from the Company, or from the Securities and Exchange Commission, including through the SEC’s Internet website at http://www.sec.gov. We have no obligation and do not undertake to update, revise or correct any of the forward-looking statements after the date hereof, or after the respective dates on which any such statements otherwise are made.
For more information, please contact:
COMPANY
Hanjun Zheng, Interim Chief Financial Officer
SkyPeople Fruit Juice, Inc.
Tel: China + 86-29-8837-7161
Email: hanjun.zheng@skypeoplefruitjuice.com
Web: http://www.skypeoplefruitjuice.com
NEW YORK, March 15, 2016 — Mangrove Partners (“Mangrove”) today announced that it intends to make a cash tender offer for up to 3,000,000 shares of common stock of Asta Funding, Inc. (NASDAQ: ASFI) (“Asta”) at a price of $9.00 per share. The offer price represents a 6.13% premium over Asta’s closing stock price of $8.48 on March 14, 2016 and a 20.32% premium over Asta’s closing stock price on March 2, 2016, the day upon which Mangrove filed a Schedule 13D.
The shares to be purchased pursuant to the offer represent approximately 24.8% of the outstanding shares of Asta common stock. Mangrove currently owns 2,102,427 shares of Asta common stock, which represents approximately 17.4% of the outstanding shares. Upon completion of the offer, assuming all shares offered for are tendered, Mangrove would beneficially own 5,102,427 shares of Asta common stock, or approximately 42.2% of the outstanding shares.
Once the tender offer is commenced, offering materials will be mailed to Asta shareholders and filed with the Securities and Exchange Commission. Asta shareholders are urged to read the offering materials when they become available because they will contain important information.
MANGROVE’S OFFER WILL NOT BE SUBJECT TO FINANCING.
The tender offer will be held open for at least twenty business days following its commencement, and tenders of shares must be made prior to the expiration of the tender offer period.
Important Information about the Tender Offer
THE TENDER OFFER REFERRED TO IN THIS PRESS RELEASE HAS NOT YET COMMENCED. THIS PRESS RELEASE IS FOR INFORMATIONAL PURPOSES ONLY AND DOES NOT CONSTITUTE AN OFFER TO SELL OR PURCHASE, OR THE SOLICITATION OF TENDERS WITH RESPECT TO THE SHARES OF Asta. NO OFFER, SOLICITATION, PURCHASE OR SALE WILL BE MADE IN ANY JURISDICTION IN WHICH SUCH AN OFFER, SOLICITATION, PURCHASE OR SALE WOULD BE UNLAWFUL. THE OFFER WILL BE MADE SOLELY PURSUANT TO THE OFFERING DOCUMENTS. THESE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TENDER OFFER AND SHAREHOLDERS ARE STRONGLY ENCOURAGED TO EVALUATE CAREFULLY ALL INFORMATION IN THE OFFERING DOCUMENTS AND TO CONSULT THEIR INVESTMENT AND TAX ADVISORS BEFORE MAKING ANY DECISION REGARDING THE TENDER OF THEIR SHARES. IF THE TENDER OFFER IS COMMENCED, A TENDER OFFER STATEMENT ON SCHEDULE TO (THE “TENDER OFFER STATEMENT”) WILL BE FILED WITH THE SECURITIES AND EXCHANGE COMMISSION (THE “SEC”). THE TENDER OFFER STATEMENT, INCLUDING THE OFFER TO PURCHASE, THE LETTER OF TRANSMITTAL, AND OTHER RELATED MATERIALS, WILL ALSO BE AVAILABLE TO ASTA’S SHAREHOLDERS AT NO CHARGE ON THE SEC’S WEBSITE AT WWW.SEC.GOV.
Forward-looking Statements
This press release may contain forward-looking statements, including, but not limited to, statements regarding Mangrove’s offer to acquire shares of Common Stock of Asta. Forward-looking statements may be identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of Mangrove and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, those relating to the contemplated tender offer described in this press release, including uncertainty about the timing of the tender offer, that, if the tender offer is commenced, the conditions to closing the tender offer may not be satisfied, uncertainties as to the amount of shares that will be tendered in the tender offer and Mangrove’s ownership interest in Asta following the tender offer, and the risk that the expected benefits to Mangrove from the tender offer may not be realized or maintained. Mangrove undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
Mangrove Partners
Nathaniel August / Philip Lee 212-897-9535
NEW YORK, March 15, 2016 —
What: |
Carver Federal Savings Bank (Nasdaq:CARV) will host an informational workshop designed to help small business entrepreneurs make sound decisions about accessing capital to start, sustain or grow their businesses. During this free workshop, Carver will provide participants with the tools needed to develop, manage and understand the business solutions available in today’s market. |
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This “Access to Capital for Small Business Entrepreneurs” workshop is being offered by Carver in tandem with Greater Jamaica Development Corporation, New York Business Development Corporation, and the New York State Small Business Development Center. The workshop will cover the following topics: |
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· How do I get “credit ready” |
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· Eligibility requirements for SBA loans and other alternative loan products |
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· Financing opportunities available for start-ups and existing businesses |
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· Programs and services available for small business owners |
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· Introduction to Carver’s full suite of lending products |
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To register for the Access to Capital for Small Business Entrepreneurs workshop, please email rsvp@carverbank.com or contact Zenja Quarles of Carver at (212) 360-8860. |
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Where: |
Carver Jamaica Center Branch, 158-45 Archer Avenue @ 160th Street, Brooklyn, NY 11217 |
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When: |
Tuesday, March 22 from 6:00 p.m. to 8:00 p.m. |
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About Carver Federal Savings Bank
Carver Bancorp, Inc. is the holding company for Carver Federal Savings Bank, a federally chartered stock savings bank. Carver was founded in 1948 to serve African-American communities whose residents, businesses, and institutions had limited access to mainstream financial services. In light of its mission to promote economic development and revitalize underserved communities, Carver has been designated by the U.S. Department of the Treasury as a community development financial institution. Carver is among the largest African- and Caribbean-American managed banks in the United States, with nine full-service branches in the New York City boroughs of Brooklyn, Manhattan, and Queens. For further information, please visit the Company’s website at www.carverbank.com.
About Greater Jamaica Development Corporation
Greater Jamaica Development Corporation is one of the nation’s first community development corporations. Under the stewardship of Carlisle Towery for more than 40 years, GJDC has been in the forefront of encouraging private and public investment in a way which enhances the quality of life for the people who live and work in Jamaica, Queens. For many years, that struggle focused on encouraging private businesses to remain and revitalize what had once been a flourishing commercial hub. http://gjdc.org/.
About New York Business Development Corporation
New York Business Development Corporation’s (NYBDC) goal is to promote the business prosperity and economic welfare of the State of New York by providing loans to small businesses including start-up, early stage and mature businesses, with a particular emphasis on minority and women owned businesses. NYBDC provides opportunities to access capital to create or preserve job opportunities and to stimulate the growth, expansion and modernization of small businesses in New York State. For more information, please visit NYBDC’s website at www.nybdc.com/.
About New York State Small Business Development Center
The New York State Small Business Development Center (New York SBDC) – the premier business assistance organization in New York State – provides expert management and technical assistance to start-up and existing businesses across the state. The New York SBDC is administered by State University of New York and funded by the U.S. Small Business Administration, the State of New York, and host campuses. For more information, please visit the SBDC’s website at www.nyssbdc.org/.
Contact Details for Carver Federal Savings Bank:
Zenja Quarles
Assistant Vice President, Marketing Manager
(212) 360-8860
zenja.quarles@carverbank.com
Media
Michael Herley/Ruth Pachman
Kekst
(212) 521-4897/4891
michael.herley@kekst.com
ruth.pachman@kekst.com
SECAUCUS, N.J., March 15, 2016 — The Children’s Place, Inc. (Nasdaq:PLCE), the largest pure-play children’s specialty apparel retailer in North America, today announced that its Board of Directors has increased the Company’s quarterly dividend to $0.20 per share from $0.15 per share.
Jane Elfers, President and Chief Executive Officer, commented, “This increase in our quarterly dividend is a further reflection of our confidence in our ability to execute on our growth strategies and our continuing commitment to return excess capital to shareholders. The Children’s Place has a profitable business model which generates strong cash flow. Over the past seven years, we have returned nearly $624 million to shareholders through dividends and share repurchases,” concluded Ms. Elfers.
The Board declared a quarterly cash dividend of $0.20 per share to be paid April 28, 2016 to shareholders of record at the close of business on April 7, 2016. Future declarations of quarterly dividends and the establishment of future record and payment dates are subject to approval by the Company’s Board of Directors based on a number of factors, including business and market conditions, the Company’s future financial performance and other investment priorities.
About The Children’s Place, Inc.
The Children’s Place is the largest pure-play children’s specialty apparel retailer in North America. The Company designs, contracts to manufacture, sells at retail and wholesale, and licenses to sell fashionable, high-quality merchandise at value prices, primarily under the proprietary “The Children’s Place,” “Place” and “Baby Place” brand names. As of January 30, 2016, the Company operated 1,069 stores in the United States, Canada and Puerto Rico, an online store at www.childrensplace.com, and had 102 international points of distribution open and operated by its 6 franchise partners in 16 countries.
Forward Looking Statements
This press release (and the above referenced call) may contain certain forward-looking statements regarding future circumstances, including statements relating to the Company’s strategic initiatives and adjusted net income per diluted share. These forward-looking statements are based upon the Company’s current expectations and assumptions and are subject to various risks and uncertainties that could cause actual results and performance to differ materially. Some of these risks and uncertainties are described in the Company’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of its annual report on Form 10-K for the fiscal year ended January 31, 2015. Included among the risks and uncertainties that could cause actual results and performance to differ materially are the risk that the Company will be unsuccessful in gauging fashion trends and changing consumer preferences, the risks resulting from the highly competitive nature of the Company’s business and its dependence on consumer spending patterns, which may be affected by the weakness in the economy that continues to affect the Company’s target customer, the risk that the Company’s strategic initiatives to increase sales and margin are delayed or do not result in anticipated improvements, the risk that the cost of raw materials or energy prices will increase beyond current expectations or that the Company is unable to offset cost increases through value engineering or price increases, and the uncertainty of weather patterns. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to release publicly any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. The inclusion of any statement in this release (or on the above referenced call) does not constitute an admission by the Company or any other person that the events or circumstances described in such statement are material.
Contact: Robert Vill, Group Vice President, Finance, (201) 453-6693
Gold Prepaid Sales Financing Arrangements of up to $120 Million Fekola Mining Equipment Facility for $81 million Increase in the Otjikoto Equipment Facility
VANCOUVER, BRITISH COLUMBIA–(March 15, 2016) – B2Gold Corp. (“B2Gold” or the “Company”) (TSX:BTO)(NYSE MKT:BTG)(NAMIBIAN:B2G) is pleased to announce that it has received approvals for Gold Prepaid Sales Financing Arrangements (“Prepaid Sales”) of up to $120 million, has signed a commitment letter to enter into a Euro equivalent of $81 million term mining Equipment Facility (“The Facility”) and has increased the size of the Otjikoto Equipment Loan Facility. All dollar figures are in United States dollars unless otherwise indicated.
Prepaid Sales
On March 14, 2016, the Company received approvals for Prepaid Sales Financing Arrangements of up to $120 million from members of its Revolving Credit Facility (“RCF”) Bank Syndicate, led by HSBC Bank USA, N.A. The Prepaid Sales, in the form of metal sales forward contracts, allow the Company to deliver pre-determined volumes of gold on agreed future delivery dates in exchange for an upfront cash pre-payment (“Prepaid Amount”).
Gold delivery volumes were determined based on the achievable forward price at the time of execution, net of average all-in-funding costs of 4.00%. The Prepaid Sales Arrangements have a term of 33 months commencing March 2016, and settlement will be in the form of physical deliveries of unallocated gold from any of the Company’s mines in 24 equal monthly installments during 2017 and 2018.
Initial Prepaid Sales contracts have been entered into for the delivery of approximately 43,100 ounces of gold in each of 2017 and 2018, for total cash Prepaid Amount proceeds of $100 million. The number of ounces to be delivered was based on an average forward price of $1,248 per ounce of gold. The ounces to be delivered represent approximately 7% and 5% of forecast consolidated gold production in 2017 and 2018 respectively. Proceeds from the Prepaid Sales will be used for the construction of the Company’s Fekola Project in Mali. The Company expects to enter into additional Prepaid Sales Arrangements totaling $20 million. The Company believes that with the receipt of cumulative cash Prepaid Sales funds of $120 million, closing of the $81 million Fekola Equipment Facility discussed below, and based on current assumptions, that the construction of the Fekola Project is fully funded and remains on schedule to commence gold production in late 2017.
The Company expects to record the Prepaid Amount as deferred revenue that will be amortized, and the revenue recognized, when the physical deliveries of unallocated gold are settled under the Prepaid Sales.
The Prepaid Sales are a flexible way of generating additional funding today from the Company’s existing operations. Execution of the Prepaid Sales with members of the Company’s RCF Bank Syndicate further reinforces the support the Company has received from and the working relationship the Company has developed with its core lending group.
Fekola Equipment Facility
On March 14, 2016, the Company signed a commitment letter to enter into a Euro equivalent of $81 million term Equipment Facility (“The Facility”) with Caterpillar Financial SARL (“Caterpillar”), as Mandated Lead Arranger, and Caterpillar Financial Services Corporation, as original lender. The aggregate principal amount of up Euro equivalent of $81 million is to be made available to the Company’s majority-owned subsidiary, Fekola S.A. to finance or refinance the mining fleet and other mining equipment at the Company’s Fekola Project in Mali.
The Facility shall be available for a period commencing on the closing date of The Facility and ending on the earlier of the day when the Facility is fully drawn and 30 months from the closing date of The Facility. Completion and funding under the Facility are subject to normal conditions precedent, including the preparation and execution of definitive documentation, due diligence and receipt of any necessary regulatory approvals.
The Facility may be drawn in installments of not less than Euro 5 million, and each such installment shall be treated as a separate equipment loan.
Each equipment loan is repayable in 20 equal quarterly installments. The final repayment date shall be five years from the first disbursement under each equipment loan.
The Facility has an interest rate of EURIBOR plus a margin of 3.85% on equipment loans advanced under The Facility and a commitment fee of 1.15% per annum on the undrawn balance of The Facility for the first 24 months of the availability period and 0.5% thereafter, each payable quarterly.
The Facility with Caterpillar underscores the continued support of another of the Company’s long-term business partners and secures the funding of the Fekola Project Mining Fleet and other equipment.
The 2016 construction and development budget for the Fekola Project totals approximately $233 million. In 2016, the Company expects to continue to construct the project with work in all major areas. Earthworks continues ahead of schedule with the completion of the access road, airstrip, camp pad, and mill area. On-going earthworks includes the tailings facility (west wall complete, Southern wall at more than 60% complete), and process water dam (vegetation removed and overburden stockpiled). Additionally, Phase 1 of the open pit is being cleared so that the material can be used to backfill the run of mine stockpile area. In the mill area, piling installation continues and is on schedule. Concrete work has commenced in the crushing and reclaim stockpile areas. Phase 1 of the permanent camp is almost complete and it is anticipated that the camp will be opened at the beginning of the second quarter of 2016. Based on current assumptions the Fekola Project remains on schedule to commence production in late 2017.
Otjikoto Equipment Facility
The Otjikoto Equipment Loan Facility, entered into on December 4, 2013 between B2Gold Namibia Minerals (Proprietary) Limited (“B2Gold Namibia”), a subsidiary of The Company, and Caterpillar Financial SARL as Mandated Lead Arranger, and Caterpillar Financial Services Corporation, as original lender, has been increased by $4.5 million to $45.4 million. This will allow B2Gold Namibia to finance or refinance 2016 mining fleet and equipment at the Company’s Otjikoto Mine in Namibia. Completion and funding under the facility are subject to conditions precedent, including the preparation and execution of definitive documentation and due diligence.
Summary
B2Gold’s ability to secure funding for the construction of the Fekola Project on attractive terms without a dilutive equity financing, combined with a strong growth in the Company’s production profile, clearly demonstrates that the Company’s construction and growth strategy is effective and successful. It is this strategy that continues to strengthen the Company via accretive acquisitions, exploration success and the demonstrated ability to reduce operating costs. The Company’s Otjikoto Mine was a key contributor towards the Company’s overall production growth profile in 2015, and is projected to be the Company’s lowest cost producing mine in 2016. By adding what will be another low-cost producing mine to the Company’s production profile, the Fekola Project that is currently in construction and scheduled to commence production in late 2017, will enable the Company to further increase its production base and reduce its consolidated cash operating costs and all-in sustaining costs.
Based on current assumptions, the Company is projecting gold production in 2016 of between 510,000 to 550,000 ounces, increasing to between 800,000 to 850,000 ounces in 2018.
Fourth Quarter and Year End 2015 Financial Results – Conference Call Details
B2Gold Corp. will release its fourth quarter and year end 2015 results before the North American markets open on March 16, 2016.
B2Gold executives will host a conference call to discuss the results on Thursday March 17, 2016 at 10:00 am PST/1:00 pm EST. You may access the call by dialing the operator at 416-340-8527 or toll free at 800-355-4959 prior to the scheduled start time or, you may listen to the call via webcast by clicking http://www.investorcalendar.com/IC/CEPage.asp?ID=174647. A playback version of the call will be available for one week after the call at 905-694-9451 or toll free at 800-408-3053 (pass code: 1816855).
About B2Gold Corp.
B2Gold is a Vancouver-based gold producer with four mines (two in Nicaragua, one in the Philippines and one in Namibia) and one mine under construction in Mali. In addition, the Company has a portfolio of development and exploration assets in Mali, Nicaragua, Namibia, the Philippines, Colombia and Burkina Faso.
ON BEHALF OF B2GOLD CORP.
Mike Cinnamond, Senior Vice President, Finance and Chief Financial Officer
For more information on B2Gold please visit the Company web site at www.b2gold.com.
The Toronto Stock Exchange neither approves nor disapproves the information contained in this News Release.
This news release includes certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation, including statements regarding the Fekola Project being fully funded, the construction of the Fekola Project, including completion of the camp, and the Fekola Project being on schedule to commence gold production in late 2017, the number of ounces to be delivered under the Prepaid Sales Arrangements representing approximately 7% and 5% of forecast consolidated gold production in 2017 and 2018, the entering of additional Prepaid Sales Arrangements, the accounting treatment of the Prepaid amount, satisfaction of conditions precedent, including the completion and terms of definitive documentation, and completion and funding under the Facility and Otjikoto facility and projections regarding future production and production costs, including Otjikoto being the Company’s lowest cost producer in 2016 and Fekola increasing the Company’s production base and decreasing consolidated operating and sustaining costs. Forward-looking statements are statements that are not historical facts and are generally, although not always, identified by words such as “expect”, “plan”, “anticipate”, “project”, “target”, “potential”, “schedule”, “forecast”, “budget”, “estimate”, “intend” or “believe” and similar expressions or their negative connotations, or that events or conditions “will”, “would”, “may”, “could”, “should” or “might” occur. All such forward-looking statements are based on the opinions and estimates of management as of the date such statements are made. Forward-looking statements necessarily involve assumptions, risks and uncertainties, certain of which are beyond B2Gold’s control, including risks associated with the ability of B2Gold to satisfy the conditions precedent for completion of the Facility and Otjikoto facility and to receive funding under them; the volatility of metal prices; risks and dangers inherent in exploration, development and mining activities; risks of not achieving production or cost estimates; uncertainty of mineral reserve and mineral resource estimates; material differences for reporting mineralized material between United States reporting standards and the Canadian standards; risks related to hedging activities and ore purchase commitments; the ability to obtain and maintain any necessary permits, consents or authorizations required for mining activities;
inability to comply with Philippines regulations related to ownership of natural resources and operation, management and control of the Company’s business; risks related to environmental regulations or hazards and compliance with complex regulations associated with mining activities; the ability to replace mineral reserves and identify acquisition opportunities or complete desirable acquisitions; the failure to integrate businesses and assets that B2Gold has acquired or may acquire in the future; unknown liabilities of companies that B2Gold has acquired; fluctuations in exchange rates; availability of financing and financing risks; risks related to operations in foreign countries and compliance with foreign laws including changes in such laws; risks related to remote operations and the availability of adequate infrastructure, fluctuations in price and availability of energy and other inputs necessary for mining operations; shortages or cost increases in necessary equipment, supplies and labour; regulatory, political and country risks including the risk of terrorist activity; climate change risks; volatility of global financial conditions; disruptions arising from conflicts with small scale miners in certain countries; risks related to reliance upon contractors, third parties and joint venture partners; challenges to title or surface rights; dependence on key personnel; risks associated with conflicts of interest among the Company’s directors and officers; the risk of an uninsurable or uninsured loss; litigation risk; taxation, including changes in tax laws and interpretation of tax laws; difficulty in achieving and maintaining the adequacy of internal control over financial reporting as required by the Sarbanes-Oxley Act; risks related to the ongoing epidemic of the Ebola virus disease in West Africa; community support for the Company’s operations including risks related to strikes and the halting of such operations, from time to time; as well as other factors identified and as described in more detail under the heading “Risk Factors” in B2Gold’s most recent Annual Information Form and the Company’s other filings with Canadian securities regulators and the SEC, which may be viewed at www.sedar.com and www.sec.gov, respectively.
The list is not exhaustive of the factors that may affect the Company’s forward-looking statements. There can be no assurance that such statements will prove to be accurate, and actual results, performance or achievements could differ materially from those expressed in, or implied by, these forward-looking statements. Accordingly, no assurance can be given that any events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what benefits or liabilities B2Gold will derive therefrom. The Company’s forward-looking statements reflect current expectations regarding future events and operating performance and speak only as of the date hereof and the Company does not assume any obligation to update forward-looking statements if circumstances or management’s beliefs, expectations or opinions should change other than as required by applicable law. For the reasons set forth above, undue reliance should not be placed on forward-looking statements.
B2Gold Corp.
Ian MacLean
Vice President, Investor Relations
604-681-8371
B2Gold Corp.
Katie Bromley
Manager, Investor Relations & Public Relations
604-681-8371
www.b2gold.com
Former President of Pepperidge Farm and SVP Global Baking and Snacking, Campbell Soup Co.
Solazyme, Inc. (Nasdaq:SZYM), now known as TerraVia™, a pioneer in algae innovation and a food, nutrition and specialty ingredients company, has announced last week that former President, Pepperidge Farm, Senior Vice President of Global Baking and Snacking at the Campbell Soup Company, Irene Chang Britt, has joined the Solazyme (TerraVia) Board of Directors.
“We are excited to welcome Irene to the board. With her deep experience in the food industry, Irene understands how our innovative algae ingredients address key market needs in the food industry,” said Jonathan Wolfson, CEO, TerraVia. “We look forward to her insight and guidance as we focus on growing our food and nutrition business under TerraVia.”
“Companies across the food industry are increasingly focused on delivering truly innovative products that transform the nutrition profile of the foods we all love without sacrificing their great taste,” said Britt. “TerraVia’s ingredients platform is well-positioned to help the food industry get there today, and I look forward to adding my expertise and voice to the board.”
Over the course of her nearly 30-year career, Irene Chang Britt has a history of leading and transforming businesses in the food and consumer product industries. She spent the last decade of her career at Campbell Soup, where in her most recent role she concurrently led the Connecticut-based Pepperidge Farm business and held oversight for Campbell’s Global Baking and Snacking business. Previously, as Campbell’s Chief Strategy Officer, Ms. Chang Britt designed and implemented the company’s global strategy, with a major focus on consumer-driven innovation in products and packaging as the primary driver of growth. Before Campbell, Ms. Chang Britt worked at both Kraft and Nabisco, where she held a number of senior management roles in the U.S. and Canada. She also is a seasoned board professional, currently serving on the boards of Dunkin Brands Group Inc. and Tailored Brands Inc., and formerly on the board of Sunoco Inc. She holds a Master of Business Administration from the University of Western Ontario.
Ms. Chang Britt will be joining current Board members Michael Arbige, Vice President, Research and Development, DuPont Industrial Biosciences; Ian Clark, CEO of Genentech; James Craigie, Chairman and former CEO of Church & Dwight Co.; Jerry Fiddler, founder and former CEO of Wind River Systems; Gary Pfeiffer, former CFO of DuPont; and Jonathan Wolfson, Chairman, CEO and co-founder of Solazyme.
About TerraVia™
Solazyme (to be renamed TerraVia™), is a next generation food, nutrition and specialty ingredients company that harnesses the power of algae, the mother of all plants and earth’s original superfood. With a portfolio of breakthrough ingredients and manufacturing, the Company is well positioned to help meet the growing need of consumer packaged goods and established and emerging food manufacturers to improve the nutritional profile of foods without sacrificing taste, and to develop select consumer brands. The Company also manufacturers a range of specialty personal care ingredients for key strategic partners. Headquartered in South San Francisco, the Company’s mission is to create products that are truly better for people and better for the planet. For additional information, please visit TerraVia’s website at www.terravia.com.
Oakridge Global Energy Solutions: A New Era in Battery Manufacturing
Palm Bay, Florida, March 15, 2016
Oakridge Global Energy Solutions, Inc.
Info@oakg.net
Oakridge Global Energy Solutions:
A New Era in Battery Manufacturing
Oakridge Announces Strategic Business Alliance Agreement with Major Japanese Trading House
FOR IMMEDIATE RELEASE
Oakridge Corporate Headquarters
March XX, 2016 Palm Bay, Florida – Oakridge Global Energy Solutions, Inc. (OTCQB: “OGES”) is excited to announce a Strategic Business Alliance Agreement with Sojitz Machinery Corporation (“Sojitz”) of Tokyo, Japan to provide equipment, materials, and financing to support the planned growth of Oakridge in the lithium ion battery market.
Sojitz Group is a general trading company based in Tokyo, Japan, with a worldwide network comprising approximately 400 group companies and operations in 50 countries, including the US. The Group has over 15,000 employees worldwide, and has a long international history, tracing its origins back to the late 19th century, resulting from the merger of Nichimen Corporation (1892), Iwai Sangyo Company (1896) and Nissho Company (1902), to form Sojitz Corporation in 2005.
Sojitz Corporation is publicly traded on the Tokyo Stock Exchange (27680, Sojitz Corporation) with annual revenues exceeding $35 billion USD, with a credit rating of BBB+ .
The Sojitz Corporation website is: http://www.sojitz.com/en/
Sojitz Group is a major international participant in many sectors, and is comprised of the following business divisions:
- Automotive Division (vehicle export, local vehicle assembly, manufacturing & sales);
- Aerospace & IT Division (commercial sales representative for Boeing, Bombardier; military aircraft and business jets; ship building, owning and chartering; IT solutions and data centers);
- Infrastructure and Environment Division (power, steel, fertilizer, chemical and energy plants; transportation, water and renewable energy; industrial machinery and production systems);
- Energy Division (oil & gas, LNG, petroleum products, nuclear fuel cycle services and equipment);
- Metal and Coal Division (coal, iron ore, rare metals, industrial minerals and non-ferrous metals);
- Chemicals Division (industrial chemicals and plastics, rare chemical resources including lithium and barite, medical and healthcare including pharmaceuticals and hospital management, cosmetics);
- Foods & Agriculture Division (agribusiness, grain & feed material, foodstuffs – production, sales, trading);
- Lifestyle Commodities and Materials Division (afforestation and woodchips, textiles, apparel brand business – eg., Sojitz has contributed to the global expansion of the Nike brand since Nike was founded);
- Retail Division (logistics and wholesale of foodstuffs globally, development and operation of industrial parks, airport and urban infrastructure, including shopping centers and condominiums)
The Sojitz Group creates global value by generating earnings through its corporate business activities and through strong, long-term trust-based relationships with strategic business partners, while pursuing mutually beneficial outcomes that create future value and prosperity.
Sojitz Machinery Corporation is a 100% solely owned subsidiary of Sojitz Corporation. The Sojitz Machinery team specializes in the design and sourcing of industrial plant and machinery, and through the broader Sojitz Group can arrange the supply of all relevant production raw materials for the expansion of the Oakridge business strategy in the lithium ion battery sector. Through this Strategic Business Alliance Agreement, Sojitz joins Oakridge and its existing Japanese business advisory team to advise and supply Oakridge with the latest technology lithium ion battery manufacturing equipment, the highest quality raw materials, and to also provide Oakridge with the latest information on the global battery market, including the latest technologies, and will also support the marketing of all Oakridge battery products, as well as assisting Oakridge with trade and capital equipment finance.
“We at Oakridge regard our relationship with Sojitz as highly important because of the high profile global presence that Sojitz has in all the many business divisions listed above, its vast experience in the worldwide equipment and materials supply markets, and it immense network of relationships within the global lithium battery sector, not to mention its high reputation for integrity globally in all its dealings,” said Oakridge Executive Chairman and CEO, Steve Barber. “We are excited and honored to be working with one of the leading Japanese trading houses as we work together with Sojitz on a long-term basis to grow our battery business and fulfil our strategic growth objectives to be THE “Made in USA” lithium ion battery producer.”
“At Oakridge, we strive to align ourselves with the leaders in industry from suppliers to customers to business partners. Our relationship with Sojitz Machinery Corporation is further testament to this philosophy as Sojitz Group is a leading global organization of the highest standards, and with an experienced, dynamic and well-connected team. There is a lot of synergy between our two companies and we look forward to a mutually beneficial relationship as we move forward over the coming years,” adds Mr. Barber, who notes that Sojitz Group’s corporate byline summarizes the importance of this Strategic Business Alliance Agreement: “New Way, New Value: creating value and prosperity by connecting the world with a spirit of integrity”.
Oakridge is currently supplying products in the lithium battery market from its 70,000 square foot factory facility in Palm Bay, Florida, including battery systems for motorcycles and recreational vehicles, golf cars, unmanned radio controlled vehicles, and living space power. Oakridge has also announced the launch of its thin film solid state battery product line for 2017. The company is also engaged in product development for several other markets including electric vehicles.
About Oakridge Global Energy Solutions, Inc.
Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 200,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakridgeglobalenergy.com
Forward-Looking Statements Disclaimer: This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.
Contact:
Oakridge Global Energy Solutions, Inc.
www.oakridgeglobalenergy.com
3520 Dixie Highway
Palm Bay, 32905, Florida, USA
Ph: (321) 610-7959
Email: ir@oakg.net
Investor Inquiries:
Benchmark Advisory Partners LLC
Timothy Connor
Toll Free: (866) 703-4778
admin@bmarkadvisory.com
And:
Dutch DeWaard
Business Development
DreamTeamNetwork (DTN)
Austin, TX
www.DreamTeamNetwork.com
512.758.8877 Office
480.734.5834 Mobile
Dutch@DTN.fm
And:
Mike King
Princeton Research
www.princetonresearch.com
702.650.3000
mike@princetonresearch.com
Oakridge Global Energy Solutions: A New Era in Battery Manufacturing
Palm Bay, Florida, March 15, 2016
Oakridge Global Energy Solutions, Inc.
Info@oakg.net
Oakridge Global Energy Solutions:
A New Era in Battery Manufacturing
Oakridge Announces Strategic Business Alliance Agreement with Major Japanese Trading House
FOR IMMEDIATE RELEASE
Oakridge Corporate Headquarters
March XX, 2016 Palm Bay, Florida – Oakridge Global Energy Solutions, Inc. (OTCQB: “OGES”) is excited to announce a Strategic Business Alliance Agreement with Sojitz Machinery Corporation (“Sojitz”) of Tokyo, Japan to provide equipment, materials, and financing to support the planned growth of Oakridge in the lithium ion battery market.
Sojitz Group is a general trading company based in Tokyo, Japan, with a worldwide network comprising approximately 400 group companies and operations in 50 countries, including the US. The Group has over 15,000 employees worldwide, and has a long international history, tracing its origins back to the late 19th century, resulting from the merger of Nichimen Corporation (1892), Iwai Sangyo Company (1896) and Nissho Company (1902), to form Sojitz Corporation in 2005.
Sojitz Corporation is publicly traded on the Tokyo Stock Exchange (27680, Sojitz Corporation) with annual revenues exceeding $35 billion USD, with a credit rating of BBB+ .
The Sojitz Corporation website is: http://www.sojitz.com/en/
Sojitz Group is a major international participant in many sectors, and is comprised of the following business divisions:
- Automotive Division (vehicle export, local vehicle assembly, manufacturing & sales);
- Aerospace & IT Division (commercial sales representative for Boeing, Bombardier; military aircraft and business jets; ship building, owning and chartering; IT solutions and data centers);
- Infrastructure and Environment Division (power, steel, fertilizer, chemical and energy plants; transportation, water and renewable energy; industrial machinery and production systems);
- Energy Division (oil & gas, LNG, petroleum products, nuclear fuel cycle services and equipment);
- Metal and Coal Division (coal, iron ore, rare metals, industrial minerals and non-ferrous metals);
- Chemicals Division (industrial chemicals and plastics, rare chemical resources including lithium and barite, medical and healthcare including pharmaceuticals and hospital management, cosmetics);
- Foods & Agriculture Division (agribusiness, grain & feed material, foodstuffs – production, sales, trading);
- Lifestyle Commodities and Materials Division (afforestation and woodchips, textiles, apparel brand business – eg., Sojitz has contributed to the global expansion of the Nike brand since Nike was founded);
- Retail Division (logistics and wholesale of foodstuffs globally, development and operation of industrial parks, airport and urban infrastructure, including shopping centers and condominiums)
The Sojitz Group creates global value by generating earnings through its corporate business activities and through strong, long-term trust-based relationships with strategic business partners, while pursuing mutually beneficial outcomes that create future value and prosperity.
Sojitz Machinery Corporation is a 100% solely owned subsidiary of Sojitz Corporation. The Sojitz Machinery team specializes in the design and sourcing of industrial plant and machinery, and through the broader Sojitz Group can arrange the supply of all relevant production raw materials for the expansion of the Oakridge business strategy in the lithium ion battery sector. Through this Strategic Business Alliance Agreement, Sojitz joins Oakridge and its existing Japanese business advisory team to advise and supply Oakridge with the latest technology lithium ion battery manufacturing equipment, the highest quality raw materials, and to also provide Oakridge with the latest information on the global battery market, including the latest technologies, and will also support the marketing of all Oakridge battery products, as well as assisting Oakridge with trade and capital equipment finance.
“We at Oakridge regard our relationship with Sojitz as highly important because of the high profile global presence that Sojitz has in all the many business divisions listed above, its vast experience in the worldwide equipment and materials supply markets, and it immense network of relationships within the global lithium battery sector, not to mention its high reputation for integrity globally in all its dealings,” said Oakridge Executive Chairman and CEO, Steve Barber. “We are excited and honored to be working with one of the leading Japanese trading houses as we work together with Sojitz on a long-term basis to grow our battery business and fulfil our strategic growth objectives to be THE “Made in USA” lithium ion battery producer.”
“At Oakridge, we strive to align ourselves with the leaders in industry from suppliers to customers to business partners. Our relationship with Sojitz Machinery Corporation is further testament to this philosophy as Sojitz Group is a leading global organization of the highest standards, and with an experienced, dynamic and well-connected team. There is a lot of synergy between our two companies and we look forward to a mutually beneficial relationship as we move forward over the coming years,” adds Mr. Barber, who notes that Sojitz Group’s corporate byline summarizes the importance of this Strategic Business Alliance Agreement: “New Way, New Value: creating value and prosperity by connecting the world with a spirit of integrity”.
Oakridge is currently supplying products in the lithium battery market from its 70,000 square foot factory facility in Palm Bay, Florida, including battery systems for motorcycles and recreational vehicles, golf cars, unmanned radio controlled vehicles, and living space power. Oakridge has also announced the launch of its thin film solid state battery product line for 2017. The company is also engaged in product development for several other markets including electric vehicles.
About Oakridge Global Energy Solutions, Inc.
Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 200,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakridgeglobalenergy.com
Forward-Looking Statements Disclaimer: This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.
Contact:
Oakridge Global Energy Solutions, Inc.
www.oakridgeglobalenergy.com
3520 Dixie Highway
Palm Bay, 32905, Florida, USA
Ph: (321) 610-7959
Email: ir@oakg.net
Investor Inquiries:
Benchmark Advisory Partners LLC
Timothy Connor
Toll Free: (866) 703-4778
admin@bmarkadvisory.com
And:
Dutch DeWaard
Business Development
DreamTeamNetwork (DTN)
Austin, TX
www.DreamTeamNetwork.com
512.758.8877 Office
480.734.5834 Mobile
Dutch@DTN.fm
And:
Mike King
Princeton Research
www.princetonresearch.com
702.650.3000
mike@princetonresearch.com
Inotek Pharmaceuticals Corporation (NASDAQ:ITEK), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for ocular diseases, today announced that Cadmus Rich, MD, MBA, Vice President, Medical Affairs and Clinical Development, will present at GTCbio’s 8th Ocular Diseases and Drug Discovery Conference. The presentation, “Modulation of IOP by Adenosine Mimetics: A New Ocular Drug Target,” will take place on March 21, 2016 at 4:55pm PT at The Westin San Diego in San Diego, California.
In addition, Dr. Rich will moderate a panel discussion titled “Leveraging CROs to Externalize Research” on March 22, 2016 at 11:25am PT.
About Inotek Pharmaceuticals Corporation
Inotek Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for glaucoma and other eye diseases. The Company’s lead product candidate, trabodenoson, is a first-in-class selective adenosine mimetic currently in Phase 3 development. Trabodenoson was developed in Inotek’s laboratories and is designed to restore the eye’s natural pressure control mechanism. Additionally, the Company is evaluating the potential for selective adenosine mimetics to address optic neuropathies and other degenerative retinal diseases. For more information, please visit www.inotekpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are subject to substantial risks, uncertainties and assumptions. These forward-looking statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Inotek:
Claudine Prowse, Ph.D., 781-552-4305
Vice President, Strategy and Investor Relations Officer
cprowse@inotekpharma.com
Solazyme, Inc. (Nasdaq:SZYM), now known as TerraVia™, a pioneer in algae innovation and a food, nutrition and specialty ingredients company, has signed a definitive multi-year global supply agreement with Unilever. The five-year agreement provides for Unilever to purchase renewable algae oils for use in personal care products and reflects the culmination of more than seven years of collaboration between Solazyme and Unilever.
This new agreement builds upon Solazyme’s initial supply relationship with Unilever for renewable algae oils, which Unilever began incorporating into its products in 2014. These oils are being produced and delivered to Unilever routinely from the Solazyme Bunge Renewable Oils facility. This new five-year, multi-oil supply agreement includes a broad portfolio of oils for use in its personal care products. Production of these oils will take place at the Solazyme Bunge Renewable Oils facility in Brazil and pricing terms are based upon variable production cost plus a defined contribution margin. Oils purchased under this new supply agreement are expected to represent total revenue of more than $200 million over the term of the agreement.
Jonathan Wolfson, TerraVia’s CEO, commented, “Our mission is to deliver products from algae that are better for people and better for our planet. We are proud to partner with Unilever, a global leader in health and wellbeing, whose products touch over 2 billion people on any given day. The growth of our partnership reflects over seven years of collaboration during which we have demonstrated our ability to develop and deliver unique, high performance, and highly sustainable oils at scale, as we continue our shift to focusing on higher value products.”
Alan Jope, Personal Care President of Unilever said, “The decision to use algae oils is fully aligned with the Unilever Sustainable Living Plan and with our goal to grow the business while reducing our overall environmental footprint. We have been working with Solazyme for many years to develop novel ingredients from algae, which improve the performance and sustainability profile of our personal care products. Solazyme has already been delivering consistent, sustainable and high performing algae oils, and we look forward to this next and greatly expanded commercial phase of the relationship.”
The Solazyme Bunge Renewable Oils facility in Brazil produces more oil per hectare/acre with a lower greenhouse gas footprint than nearly all major commercially available plant oils. The Brazil facility embodies the principles of sustainable production and is co-located with a Bonsucro®-certified sugarcane mill that uses the waste sugarcane material (bagasse) as an efficient, renewable source of energy.
About TerraVia™
TerraVia™ (formerly Solazyme®), is a next generation food, nutrition and specialty ingredients company that harnesses the power of algae, the mother of all plants and earth’s original superfood. With a portfolio of breakthrough ingredients and manufacturing, the Company is well positioned to help meet the growing need of consumer packaged goods and established and emerging food manufacturers to improve the nutritional profile of foods without sacrificing taste, and to develop select consumer brands. The Company also manufactures a range of specialty personal care ingredients for key strategic partners. Headquartered in South San Francisco, the Company’s mission is to create products that are truly better for people and better for the planet. For additional information, please visit TerraVia’s website at www.terravia.com.
Solazyme®, TerraVia™, the Solazyme logo and other trademarks or service names are the trademarks of Solazyme, Inc.
Forward Looking Statements
This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 about Solazyme, including statements that involve risks and uncertainties concerning: the aggregate value of future revenue under the supply agreement; the timing and ramp-up of sales under the agreement; expected product development and offering plans; its transition of corporate identity; and the future production efficiency, greenhouse gas footprint of the Brazilian facility. When used in this press release, the words “will”, “expects”, “intends” and other similar expressions and any other statements that are not historical facts are intended to identify those assertions as forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any such statement may be influenced by a variety of factors, many of which are beyond the control of Solazyme, that could cause actual outcomes and results to be materially different from those projected, described, expressed or implied in this press release due to a number of risks and uncertainties. Potential risks and uncertainties include, among others: Solazyme’s limited operating history; its limited history in manufacturing and commercializing products; its ability to successfully transition its corporate identity; production management risks; implementation risk in deploying new technologies; its limited experience in constructing, ramping up and operating commercial manufacturing facilities; its ability to successfully develop and commercialize products; its ability to sell its products at a profit; delays related to ramp-up and optimization of production facilities; availability of consistent, reliable power and steam; its ability to manage costs; its ability to enter into and maintain strategic collaborations; successful product trials by its customers and market acceptance and adoption of its products by end-users; its ability to obtain requisite regulatory approvals; and its access, on favorable terms, to any required financing. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on the results of operations or financial condition of Solazyme.
In addition, please refer to the documents that Solazyme, Inc. files with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q and Annual Report on Form 10-K, as updated from time to time, for a discussion of these and other risks. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this press release. Solazyme is not under any duty to update any of the information in this press release.
— Oral Presentation and Poster of Study Results on April 19, 2016 —
Flex Pharma, Inc. (NASDAQ: FLKS) announced today that the recently completed study in nocturnal leg cramps (NLC) has been selected for late-breaking oral and poster presentations at the American Academy of Neurology (AAN) 68th Annual Meeting being held in Vancouver, B.C., Canada. Only 14 abstracts are selected as late-breaking presentations at the AAN annual meeting. Flex Pharma is a biotechnology company developing innovative and proprietary treatments for NLC, cramps and spasms associated with severe neuromuscular conditions, and exercise-associated muscle cramps. Details from the study, titled “Orally-administered TRPV1 and TRPA1 activators reduce Night Leg Cramps in a randomized, blinded, placebo-controlled, crossover human trial,” will be presented on Tuesday, April 19, 2016, during the Emerging Science Session at 6:21 p.m. PDT, followed by a poster presentation from 6:30-7:15pm PDT.
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On February 2, 2016, the Company announced that its extract formulation demonstrated efficacy in treating subjects with NLC in a randomized, controlled, blinded study. Statistically significant effects (p<0.05) were demonstrated on key endpoints: muscle cramp frequency; cramp-free days; the physician-rated Clinical Global Impression of Change (CGI-C); specific sleep disturbance measures; and specific pain measures. Additionally, the product appeared to be safe and well-tolerated and there were no serious adverse events reported. The magnitude of efficacy in this study on reduction in muscle cramps appears similar to published quinine efficacy studies. Quinine, the only therapeutic intervention for leg cramps with randomized, controlled, blinded study support for efficacy, is associated with serious adverse events and was banned for the treatment of leg cramps by the FDA.
The Company estimates that NLC affects four million Americans nightly; there is no approved therapeutic in the United States to treat this condition. The randomized, blinded, controlled, crossover study evaluated 50 healthy subjects (50-77 years of age) who experienced nocturnal leg cramps at least four nights per week. After an initial placebo run-in period, the subjects were randomized to either control or study product for two weeks. Subjects were then crossed over to the other treatment for another two-week period so that each subject acted as his or her own control.
Flex Pharma plans to initiate its next study in nocturnal leg cramps later this year with a single molecule, selective and specific transient receptor potential (TRP) ion channel agonist. Additionally, studies in MS and ALS with its drug candidate, FLX-787, are expected to initiate outside the U.S. this year.
About Flex Pharma
Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for nocturnal leg cramps, cramps and spasms associated with severe neuromuscular conditions such as ALS and MS, and exercise-associated muscle cramps. Flex Pharma was founded by National Academy of Science members Rod MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D., recognized leaders in the fields of ion channels and neurobiology, along with Chair and CEO Christoph Westphal, M.D., Ph.D.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our expectations regarding future studies of our current product candidates, including the success and timing of these studies; our beliefs regarding the potential benefits of our current product candidates; and expectations regarding the number of individuals that may suffer from nocturnal leg cramps. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation: the status, timing, costs, results and interpretations of our clinical studies; the uncertainties inherent in conducting clinical studies, including receiving regulatory approval to conduct these studies; the fact that we rely on third parties to manufacture and conduct the clinical studies of our product candidates, which could delay or limit future development or regulatory approval; results from ongoing and planned preclinical development; expectations of our ability to make regulatory filings and obtain and maintain regulatory approvals; our ability to develop and commercialize our consumer product; anticipated positioning and product attributes of our consumer product; results of early clinical studies as indicative of results of future trials; the inherent uncertainties associated with intellectual property; and other factors discussed in greater detail under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent filings with the Securities and Exchange Commission (SEC). You are encouraged to read Flex Pharma’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor Relations & Corporate Communications
irdept@flex-pharma.com
– Study in the treatment of Dravet syndrome – a rare and severe form of epilepsy in children with no FDA-approved treatments –
– Primary endpoint achieved with high statistical significance (p=0.01) showing that Epidiolex treatment reduces convulsive seizures in children compared to placebo –
– Company to hold investor conference call today at 8:00 a.m. EDT/12:00 Noon GMT –
LONDON, March 14, 2016 — GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces the positive results of the first pivotal Phase 3 study of its investigational medicine Epidiolex® (cannabidiol or CBD) for the treatment of Dravet syndrome. In this study, Epidiolex achieved the primary endpoint of a significant reduction in convulsive seizures assessed over the entire treatment period compared with placebo (p=0.01). Epidiolex has both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) in the treatment of Dravet syndrome, a rare and debilitating type of epilepsy for which there are currently no treatments approved in the U.S.
“The results of this Epidiolex pivotal trial are important and exciting as they represent the first placebo-controlled evidence to support the safety and efficacy of pharmaceutical cannabidiol in children with Dravet syndrome, one of the most severe and difficult-to-treat types of epilepsy,” said Orrin Devinsky, M.D., of New York University Langone Medical Center’s Comprehensive Epilepsy Center. “These data demonstrate that Epidiolex delivers clinically important reductions in seizure frequency together with an acceptable safety and tolerability profile, providing the epilepsy community with the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol being made available by prescription in the future.”
“The positive outcome of this Phase 3 trial is a significant milestone in the development of Epidiolex as a potential new treatment for patients suffering from Dravet syndrome. We are excited about the potential for Epidiolex to become the first FDA approved treatment option specifically for Dravet syndrome patients and their families,” stated Justin Gover, GW’s Chief Executive Officer. “In light of this positive data, we will now request a pre-NDA meeting with the FDA to discuss our proposed regulatory submission. We also look forward with excitement to the upcoming results from the two Phase 3 trials in Lennox-Gastaut syndrome and the second pivotal trial in Dravet syndrome.”
“Dravet syndrome is one of the most catastrophic types of epilepsy in children and safe and effective treatments are desperately needed. We are thrilled to learn of these positive results, which bring much needed hope to the children and families who have been living with these debilitating seizures,” said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation.
Study Overview
The Phase 3 study randomized 120 patients into two arms, Epidiolex 20mg/kg/day (n=61) and placebo (n=59). Epidiolex or placebo was added to current anti-epileptic drug (AED) treatment regimens. On average, patients were taking approximately 3 AEDs, having previously tried and failed an average of more than 4 other AEDs. The average age of trial participants was 10 years and 30 percent of patients were less than 6 years of age. The median baseline convulsive seizure frequency per month was 13.
The primary efficacy endpoint was a comparison between Epidiolex and placebo measuring the percentage change in the monthly frequency of convulsive seizures during the 14-week treatment period compared with the 4-week baseline observation period. In this study, patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39 percent compared with a reduction on placebo of 13 percent, which was highly statistically significant (p=0.01). A series of sensitivity analyses of the primary endpoint confirmed the robustness of this result. The difference between Epidiolex and placebo emerged during the first month of treatment and was sustained during the entire treatment period.
Results from secondary efficacy endpoints reinforced the overall effectiveness observed with Epidiolex.
Epidiolex was generally well tolerated in this study. The most common adverse events (occurring in greater than 10 percent of Epidiolex-treated patients) were: somnolence, diarrhea, decreased appetite, fatigue, pyrexia, vomiting, lethargy, upper respiratory tract infection and convulsion. Of those patients on Epidiolex that reported an adverse event, 84 percent reported it to be mild or moderate. Ten patients on Epidiolex experienced a serious adverse event compared with three patients on placebo. Eight patients on Epidiolex discontinued treatment due to adverse events compared with one patient on placebo.
Further data will be presented in future publications and medical meetings.
In addition to this first Phase 3 trial, GW is conducting a second Phase 3 trial in Dravet syndrome which is recruiting 150 patients.
GW Clinical Trial Programs in Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex
In addition to the Dravet syndrome trials, GW is conducting the largest global pivotal clinical trial program to date in Lennox-Gastaut syndrome, another rare and severe form of epilepsy. The first Phase 3 trial is a placebo-controlled trial of Epidiolex (at a dose of 20 mg/kg) over a 14-week treatment period and has randomized 171 patients. This trial is expected to report top-line results in the second quarter of 2016. The second placebo-controlled trial has randomized a total of 225 patients and is expected to report top-line results mid-2016. The primary measure of efficacy in these two trials will be the comparison between Epidiolex and placebo in the percentage change in number of monthly drop seizures during the 14-week treatment period compared with the 4-week baseline observation period.
Based on the findings of the physician-led expanded access program, GW continues to identify additional development targets for Epidiolex within the field of childhood-onset epilepsy disorders. A Phase 3 trial in a third epilepsy indication, Tuberous Sclerosis Complex, is due to commence imminently and clinical development in a fourth indication is expected to commence in the second half of 2016.
Investor Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast for analysts and investors to discuss the results from this initial Phase 3 study today at 8:00 a.m. EDT /12:00 Noon GMT. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada), or 0800-756-3429 (toll free from the UK) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free): 1-877-660-6853, (international): 1-201-612-7415. For both dial-in numbers please use conference ID # 13632627.
About Dravet Syndrome
Dravet syndrome is a severe infantile-onset and highly treatment-resistant epileptic syndrome frequently associated with a genetic mutation in sodium channels. Onset of Dravet syndrome occurs during the first year of life in previously healthy and developmentally normal infants. Initial seizures are often temperature related, severe, and long-lasting. Over time, people with Dravet syndrome can develop multiple types of seizures, including tonic-clonic, myoclonic, and atypical absences and are prone to bouts of prolonged seizures called status epilepticus, which can be life threatening. Risk of premature death including SUDEP (sudden expected death in epilepsy) is elevated in people with Dravet syndrome. Additionally, the majority will develop moderate to severe intellectual and development disabilities and require lifelong supervision and care. There are currently no FDA-approved treatments and nearly all patients continue to have uncontrolled seizures and other medical needs throughout their lifetime.
About Epidiolex (cannabidiol)
Epidiolex, GW’s lead cannabinoid product candidate, is a liquid formulation of pure plant-derived CBD, which is in development for the treatment of a number of rare childhood-onset epilepsy disorders. GW has conducted extensive pre-clinical research of CBD in epilepsy since 2007. This research has shown that CBD has significant anti-epileptiform and anticonvulsant activity using a variety of in vitro and in vivo models and has the ability to treat seizures in acute animal models of epilepsy with significantly fewer side effects than existing anti-epileptic drugs. To date, GW has received Orphan Drug Designation from the FDA for Epidiolex in the treatment of both Dravet syndrome and Lennox-Gastaut syndrome. Additionally, GW has received Fast Track Designation from the FDA and Orphan Designation from the European Medicines Agency for Epidiolex for the treatment of Dravet syndrome. GW is currently evaluating additional clinical development programs in other orphan seizure disorders.
About GW Pharmaceuticals plc
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 28 countries outside the United States. GW is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome and Lennox-Gastaut syndrome and which is also expected to enter Phase 3 clinical trials in the treatment of Tuberous Sclerosis Complex. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, type 2 diabetes, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.
Forward-looking statements
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of the company’s investigational drug Epidiolex®, the development and commercialization of Epidiolex, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex®, Epidiolex®, and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
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GW Pharmaceuticals plc |
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Ben Atwell / Simon Conway |
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FleishmanHillard (U.S. Media) |
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— First therapy to demonstrate statistically significant improvement in overall survival and induction response rate in a pivotal Phase 3 trial in high-risk AML — — NDA submission for VYXEOS planned for later this year — — Conference Call on Tuesday, March 15, 2016 at 8:00am EDT —
EWING, N.J., March 14, 2016 — Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced positive results from the Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML) compared to the standard of care regimen of cytarabine and daunorubicin known as 7+3. The trial met its primary endpoint demonstrating a statistically significant improvement in overall survival. Data will be submitted for presentation at the American Society of Clinical Oncology 2016 Annual Meeting.
The median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving 7+3, representing a 3.61 month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005) which represents a 31 percent reduction in the risk of death versus 7+3. The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.
“The overall survival advantage seen with CPX-351 compared to 7+3, along with a superior response rate and no increase in serious toxicity indicates that we’ll likely have a new standard of care for treating older patients with secondary AML,” said Jeffrey E. Lancet, M.D., senior member and chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center and the principal investigator for the study. “This represents a major step forward for a very difficult-to-treat patient population.”
VYXEOS also demonstrated a statistically significant improvement in induction response rate (CR+CRi of 47.7% versus 33.3%; p=0.016) and this significance was maintained for the analysis of CR alone (CR of 37.3% versus 25.6%, p=0.040).
Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS.
No substantial difference in Grade 3 or higher adverse events was observed between VYXEOS and 7+3. In the intent-to-treat population, Grade 3 or higher, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events. In the intent-to-treat population, Grade 3 or higher, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.
“These findings confirm that VYXEOS provides the first opportunity we’ve had in decades to extend survival for patients with high-risk AML,” added Gail Roboz, M.D., Professor of Medicine and Director of the Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York. “Also, more patients in remission means more who are eligible for potentially curative therapy.”
Based on these results the company expects to submit a New Drug Application (NDA) for VYXEOS with the U.S. Food and Drug Administration (FDA) later this year and submit a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first quarter of 2017.
“The successful outcome of this Phase 3 trial represents an important advance for AML patients, their families and clinicians,” said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. “It also marks a major milestone for Celator, for VYXEOS, and for our CombiPlex® platform. We offer our sincere thanks to the patients and investigators who participated in this study and we will work closely with regulatory authorities to make this new treatment available to the AML community as soon as possible.”
The clinical trial was conducted in partnership with The Leukemia & Lymphoma Society® (LLS) through its Therapy Acceleration Program (TAP), which has supported the clinical development of VYXEOS beginning in Phase 2.
Conference Call Information
Celator will host a conference call and live audio webcast on Tuesday, March 15, 2016 at 8:00am EDT to discuss the results of the Phase 3 trial. To participate in the conference call, please dial 877-303-6316 (domestic) or 650-521-5176 (international) and refer to conference ID 71930208. The live webcast of the call can be accessed in the Investors section of Celator’s website at www.celatorpharma.com. An archived webcast will be available on Celator’s website beginning approximately two hours after the event.
About VYXEOS
VYXEOS (cytarabine:daunorubicin) Liposome for Injection, also known as CPX-351, is a nano-scale co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ration. VYXEOS represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nano-scale liposome in order to maintain the desired ratio following administration. VYXEOS was granted orphan drug status by the FDA and the European Commission for the treatment of acute myeloid leukemia (AML). VYXEOS was also granted Fast Track designation for the treatment of elderly patients with secondary AML. In addition to the Phase 3 trial, Celator published results from two randomized, controlled, Phase 2 trials with VYXEOS. The first trial was conducted in newly diagnosed elderly AML patients and the second trial was conducted in patients with AML in first relapse.
Phase 3 Trial Design
The randomized, controlled, Phase 3 trial (Protocol NCT01696084), enrolled 309 patients at 39 sites in the United States and Canada, and compared VYXEOS to the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy in older (60-75 years of age) patients with high-risk (secondary) AML. Patients were stratified for age (60 to 69 and 70 to 75 years of age) and AML type; treatment-related AML, AML with documented history of MDS with prior treatment with hypomethylating agent therapy, AML with documented history of MDS without prior hypomethlyating agent therapy, AML with a documented history of chronic myelomonocytic leukemia (CMMoL), and de novo AML with a karyotype characteristic of myelodysplastic syndrome (MDS).
Patients were randomized 1:1 to receive either VYXEOS or 7+3. Patients could receive one or two inductions, and responding patients could receive one or two consolidations. First induction for VYXEOS was 100u/m2; days 1, 3, and 5 by 90-minute infusion and for the control arm was cytarabine 100mg/m2/day by continuous infusion for 7 days and daunorubicin 60mg/m2 on days 1, 2, and 3 (7+3). Second induction for VYXEOS-treated patients was 100u/m2 on days 1 and 3 and the control arm was cytarabine 100mg/m2/day by continuous infusion for 5 days and daunorubicin 60mg/m2 on days 1 and 2 (5+2).
Only patients with documented CR or CRi were eligible to receive chemotherapy consolidation. Consolidation for VYXEOS-treated patients was 65u/m2 on days 1 and 3 and the control arm was cytarabine 100mg/m2/day by continuous infusion for 5 days and daunorubicin 60mg/m2 on days 1 and 2 (5+2).
About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. The American Cancer Society estimates that there will be 19,950 new cases of AML and 10,430 deaths from AML in the U.S. in 2016. In Europe the number of new cases is estimated to be 18,000 and in Japan the number is 5,500. The Company estimates that nearly 70 percent of AML patients are over the age of 60, and approximately 75 percent are intermediate or high risk. Furthermore, approximately half of those patients are considered suitable for intensive treatment.
Even with current treatment, overall survival for AML is poor. In patients over 60 years of age, the 5 year survival rate is less than 10%. In high-risk (secondary) AML, overall survival is lower, resulting in an acute need for new treatment options for these patients.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is an oncology-focused biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. Celator’s proprietary technology platform, CombiPlex®, enables the rational design and rapid evaluation of optimized combinations of anti-cancer drugs, incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anti-cancer activity. CombiPlex addresses several fundamental shortcomings of conventional combination regimens, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination after administration and ensuring exposure of this ratio to the tumor. Celator’s pipeline includes the lead product, VYXEOS™ (also known as CPX-351), a nano-scale liposomal formulation of cytarabine:daunorubicin being studied for the treatment of acute myeloid leukemia; CPX-1, a nano-scale liposomal formulation of irinotecan:floxuridine studied in colorectal cancer; and a preclinical stage product candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation. The Company is advancing its CombiPlex platform and broadening its application to include molecularly targeted therapies. The Company is seeking research and development collaborations with other biotechnology/pharmaceutical companies where its proprietary technology may provide benefit.
For more information, please visit Celator’s website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.
Forward-Looking Statements:
To the extent that statements contained in this press release are not descriptions of historical facts regarding Celator, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding the safety, potential efficacy, therapeutic potential, and commercial potential of VYXEOS™ (also known as CPX-351), our expectations regarding the timing of our regulatory filings, our expectations regarding our research and development programs and advancing our CombiPlex platform and the potential to establish research and development collaborations applying our proprietary technologies with other biotechnology/pharmaceutical companies. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our development programs, future results, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of clinical studies, whether clinical study results obtained to date will be predictive of future results, whether the final results of our clinical studies will be supportive of regulatory approval to market VYXEOS and other matters that could affect the commercial potential of our drug candidates. Celator undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Celator’s Form 10-K for the year ended December 31, 2014, subsequent reports on Form 10-Q and 8-K, and other filings by the company with the U.S. Securities and Exchange Commission.
CONTACTS:
Media:
Mike Beyer
Sam Brown, Inc.
312-961-2502
mikebeyer@sambrown.com
Investors:
Adam Krop
The Trout Group
646-378-2963
akrop@troutgroup.com
Spin-off from Greatbatch creates new stand-alone neurostimulation company
PLANO, Texas, March 14, 2016 — Nuvectra Corporation (NASDAQ:NVTR), formerly QIG Group, LLC, announced today the completion of its spin-off from Greatbatch, Inc. (NYSE:GB) into an independent, publicly-traded neurostimulation medical device company. Nuvectra shares commenced “regular way” trading today on the NASDAQ Global Market (NASDAQ) under the symbol “NVTR”.
The spinoff was accomplished by the distribution of all shares of Nuvectra’s common stock to Greatbatch’s stockholders on the basis of one share of Nuvectra common stock for every three shares of Greatbatch common stock held on March 7, 2016, the record date of the distribution.
“Today marks the beginning of an exciting new chapter for our company,” said Scott F. Drees, Chief Executive Officer of Nuvectra. “I would like to thank all of our employees for their hard work and dedication that prepared us to become an independent public company. With the spin behind us, we will focus our efforts on the U.S. launch of our proprietary Algovita® Spinal Cord Stimulation system. Algovita is a powerful, versatile, patient-centric system designed to provide broad and flexible pain control, while fitting into a patient’s everyday lifestyle.”
The Algovita system has been available in Europe since late 2014 and received U.S. Food and Drug Administration (FDA) approval in November 2015. In addition, Nuvectra will continue development of its innovative proprietary technology platform for additional indications, including sacral nerve stimulation and deep brain stimulation.
Nuvectra’s Board of Directors is chaired by Joseph Miller, PhD, former Director and Chair of the Technology, Strategy and Investment Committee for Greatbatch, Inc. Dr. Miller retired in April 2012 as Executive Vice President and Chief Technology Officer for Corning Inc., a position in which he had served since 2001.
“The Nuvectra board is excited to support the creation of a new public company in the neurostimulation space, which represents a large and growing market opportunity,” said Dr. Miller. “Being a stand-alone company will allow Nuvectra to better focus on the needs of its clinician and patient customers.”
The new company is headquartered in Plano, Texas with additional locations in Denver, Minneapolis and Ann Arbor. For more information about Nuvectra, its management team and board of directors, and the Algovita Spinal Cord Stimulation system, visit www.nuvectramed.com.
About Nuvectra Corporation
Nuvectra™ is a neurostimulation company committed to helping physicians improve the lives of people with chronic neurological conditions. The Algovita® Spinal Cord Stimulation (SCS) System is our first commercial offering and is CE marked and FDA approved for the treatment of chronic pain of the trunk and/or limbs. Our innovative technology platform also has capabilities under development to support other neurological indications such as sacral nerve stimulation (SNS), and deep brain stimulation (DBS). In addition, our NeuroNexus subsidiary designs, manufactures and markets leading-edge neural-interface technologies for the neuroscience clinical research market. Visit the Nuvectra website at www.nuvectramed.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements,” including statements we make regarding the outlook for Nuvectra as an independent publicly-traded company. Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions, and therefore they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and may be outside of our control. Our actual performance may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us is based only on information currently available to us and speaks only as of the date on which it is made. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include: (i) the timing of the commercial launch of Algovita in the United States; (ii) our ability to successfully commercialize Algovita and develop and commercialize enhancements to Algovita; (iii) the outcome of our development plans for our neurostimulation technology platform, including our ability to identify additional indications or conditions for which we may develop neurostimulation medical devices or therapies and seek regulatory approval thereof; (iv) our ability to identify business development and growth opportunities and to successfully execute on our strategy, including our ability to seek and develop strategic partnerships with third parties to, among other things, fund clinical and development costs for new product offerings; (v) the performance by our development partners, including Aleva Neurotherapeutics, S.A., of their obligations under their agreements with us; (vi) the scope of protection for our intellectual property rights covering Algovita and other products using our neurostimulation technology platform, along with any product enhancements; (vii) our ability to successfully build an effective commercial infrastructure and sales force in the United States; (viii) our compliance with all regulatory and legal requirements regarding implantable medical devices and interactions with healthcare professionals; and (ix) any product recalls or the receipt of any warning letters from any governmental or regulatory agency. Please see the sections entitled “Cautionary Statement Concerning Forward-Looking Statements” and “Risk Factors” in Nuvectra’s Registration Statement on Form 10 for a description of these and other risks and uncertainties. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Company Contacts:
Nuvectra Corporation
Walter Berger, Chief Financial Officer
(972) 668-4106
wberger@nuvectramed.com
Jennifer Armstrong, Media Relations
(214) 618-4823
jarmstrong@nuvectramed.com
Investor Contacts:
The Ruth Group
Nick Laudico
(646) 536-7030
nlaudico@theruthgroup.com
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com
AHA Products Group (AHA), a recognized technology leader in satellite core systems, announced today that it will demonstrate its DVB-S2X prototype, using the Ettus x310 USRP, at the Wireless Innovation Forum Conference (WinnComm’16) Innovation Showcase. This demonstration will show DVB-S2X system developers how using the AHA4709E2IQ, Ethernet to IQ modem core, can increase system performance while reducing development time and cost. The DVB-S2X prototype modem can reach speeds of 324 Mbps while maintaining high spectral efficiency. The Innovation Showcase will take place on March 16 and 17 at the Sheraton Reston 11810 Sunrise Valley Drive, Reston, Virginia. A description of the demo can be found on the WinnComm website and full details of the project on the AHA website.
About AHA Products Group
For almost three decades, AHA has been the global leader in Lossless Data Compression and Forward Error Correction and now supports full digital modem solutions and crypto acceleration technologies. Based in Moscow, Idaho, the design center develops and markets ICs, PCBs, and IP Cores for commercial and government customers worldwide. AHA products are used in Network Transmission, WAN Optimization, Enterprise Storage, Satellite and Terrestrial Communications, and a wide variety of other systems where data throughput and integrity are vital. A recognized technology innovator, AHA has a reputation for exceptional product quality, reliability, outstanding customer support and is an AS9100 certified manufacturer. AHA Products Group is a part of Comtech EF Data Corp., a wholly owned subsidiary of Comtech Telecommunications Corp. (NASDAQ:CMTL). For more information, please visit www.aha.com.
Comtech EF Data Corporation
Joel Bifford, 208-892-5600
Inside Sales Manager
AHA Products Group
sales@aha.com
SOUTH SAN FRANCISCO, Calif., March 11, 2016 — Five Prime Therapeutics, Inc. (Nasdaq:FPRX) (Five Prime), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, today announced that Aron Knickerbocker, Executive Vice President and Chief Business Officer, will present at the Barclays Global Healthcare Conference on Thursday, March 17, 2016 at 10:45 AM Eastern Daylight Time.
The live webcast will be accessible at http://investor.fiveprime.com/events.cfm or directly at https://cc.talkpoint.com/barc002/031516a_ae/?entity=133_M336FR1. Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.
About Five Prime
Five Prime Therapeutics, Inc. discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime’s comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company’s R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.
CONTACT:
Heather Rowe, Investor Relations
415-365-5737
heather.rowe@fiveprime.com
SAN DIEGO, March 11, 2016 — Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS), a leading National Security Solutions provider, announced today that its Defense & Rocket Support Services (DRSS) Division has been awarded a contract by the U.S. Naval Surface Warfare Center, Port Hueneme Division for Oriole Thrust Vector Control (TVC) Systems valued at $5.49 million. Under the awarded contract DRSS will deliver several Oriole TVC systems to support ongoing experimental, test and other support missions. The Oriole TVC system provides increased capability and dispersion reduction for Kratos’ Oriole solid propellant rocket motor. DRSS is a leading provider of products, solutions and services in support of ballistic missile defense, hypersonic, directed energy, electromagnetic rail gun, weapon system and other national security related systems.
Mr. Joshua Peterson, Vice President Rocket Support Services, stated that, “Kratos is committed to providing low cost, highly capable systems to our Government customers for Ballistic Missile Defense System Testing and Hypersonic Research.”
About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (Nasdaq:KTOS) is a mid-tier government contractor at the forefront of the Department of Defense’s Third Offset Strategy. Kratos is a leading technology, intellectual property and proprietary product and solution company focused on the United States and its allies’ national security. Kratos’ primary focus areas are unmanned systems, satellite communications, microwave electronics, cyber security/warfare, missile defense and combat systems. Kratos has primarily an engineering and technically oriented work force of approximately 2,900. Substantially all of Kratos’ work is performed on a military base, in a secure facility or at a critical infrastructure location. Kratos’ primary end customers are National Security related agencies. News and information are available at www.KratosDefense.com.
Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include the proposed timing and expiration date of the Company’s tender offer to repurchase the Notes. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 27, 2015, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
Press Contact:
Yolanda White
858-812-7302 Direct
Investor Information:
877-934-4687
investor@kratosdefense.com
Company Presentation Scheduled for Friday, March 11, 2016 at 8:30 AM ET
NEW YORK, NY–(March 11, 2016) – Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) (“Actinium”), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers announced today that it will be presenting at the 23rd Annual BioCentury Future Leaders in the Biotech Industry Conference being held Friday, March 11, 2016 in New York. Actinium’s Executive Chairman, Sandesh Seth, will present a corporate overview of the Company.
The conference is being held at the Millennium Broadway Hotel & Conference Center and Actinium’s presentation will be delivered at 8:30 am ET in Room 302/303. Management will be available for 1-on-1 meetings with conference attendees. To schedule a meeting with management contact Steve O’Loughlin, Vice President, Finance and Corporate Development at soloughlin@actiniumpharma.com.
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company’s second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.
Forward-Looking Statement for Actinium Pharmaceuticals, Inc.
This news release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Actinium Contact:
Steve O’Loughlin
Vice President, Finance and Corporate Development
Actinium Pharmaceuticals, Inc.
soloughlin@actiniumpharma.com
Company Will Be Changing Name to TerraVia™ to Reflect Focus on Food, Nutrition and Specialty Ingredients
- TerraVia’s algae-based platform is poised to transform our food system by bringing together better nutrition and great taste, along with economic and environmental sustainability.
- As the pioneer in algae technology and innovation, the Company now has commercial scale food grade manufacturing in operation, breakthrough ingredients with regulatory clearance, and validation by established and cutting-edge consumer brands. TerraVia is positioned to capitalize on healthier eating and lifestyle trends and the accelerating demand for plant-based foods and nutrition.
- Leading investors and entrepreneurs in food, nutrition, and innovation invest approximately $28 million.
- Jonathan Wolfson, CEO and co-founder, appointed Chairman of the Board of Directors. TerraVia to begin a search for new CEO that aligns with the Company’s refined focus in food. Following appointment of a new CEO, Wolfson will remain full time with the Company as Executive Chairman.
- Irene Chang Britt, Former President of Pepperidge Farm and senior executive at companies and brands including Campbell Soup Company, Kraft, and Nabisco, joins TerraVia’s Board of Directors.
- With its refined focus on food, nutrition, and specialty ingredients, the Company will pursue strategic alternatives for its industrial businesses to maximize value.
Solazyme (NASDAQ:SZYM) announced that it is focusing the Company exclusively on food, nutrition and specialty ingredients, harnessing the power of its transformational algae innovation platform. The evolution leverages over a decade of R&D and product development on an innovative suite of algae-based food, nutrition and specialty ingredients, as well as extensive investment in building manufacturing facilities, obtaining regulatory approvals, and commercializing initial products. With these foundational elements in place, the Company is positioned to create value and impact in the rapidly growing plant-based food, nutrition and specialty ingredients sectors. Solazyme will be renamed “TerraVia™” to reflect the refined focus and journey to improve the lives of people and the planet.
“By unlocking the power of algae, the mother of all plants and earth’s original superfood, we are bringing much-needed innovation in food and nutrition,” said Jonathan Wolfson, the Company’s co-founder and CEO. “Our new generation of breakthrough ingredients and foods delivers on nutrition, flavor and texture all with an unparalleled sustainability profile, and these products are already beginning to penetrate a market that is demanding healthier alternatives. Over more than 13 years we have invested in developing a unique understanding and expertise around algae. Today the pieces are in place for the Company to fulfill its mission and create substantial value for customers and shareholders.”
TerraVia PORTFOLIO
TerraVia’s proven portfolio of ingredients and products include:
- Specialty Food Ingredients, including the AlgaVia® Whole Algae ingredients (lipid rich powder and protein) and AlgaWise™ Algae Oils (cooking and high stability oils). Each of these products has obtained key regulatory clearances and have been incorporated into products by established food companies such as Hormel and Utz, as well as by leading edge, plant-based food companies such as Enjoy Life, So Delicious, Soylent and Follow Your Heart during the past six to nine months.
- Consumer Food Products, where the Company will leverage its unique ingredients to incubate select consumer brands, including Thrive® Culinary Algae Oil.
- Animal Nutrition Ingredients, a new area for the Company, where initial products and partnerships will be announced soon.
- Specialty Personal Care Ingredients, including AlgaPur Oils, which are marketed and sold alongside food ingredients and where the Company has major customers including Unilever.
“There are opportunities for our algae-based ingredients across every aisle of the grocery store, driven by consumer demand for clean labels and an increasing focus on plant-based foods with great taste,” said Mark Brooks, SVP and General Manager of Food Ingredients at Solazyme. “We are enhancing a new generation of foods that deliver better flavor and nutrition, including healthier fats and enhanced protein, fiber and micronutrients. In addition to products incorporating our ingredients on store shelves today, we are currently in active development projects with major CPG companies for new products such as salad dressings and gluten-free bakery products that are healthier and offer the taste and texture that consumers demand.”
Prior to joining Solazyme, Brooks was the Global Business Director of Truvia®, where he led the business to over $100 million in global retail sales.
STRATEGIC FINANCING
The Company has entered into a definitive purchase agreement for a strategic financing round of approximately $28 million in newly issued, no-coupon convertible preferred shares with a conversion price of $2.00 per common share, which represents an approximately 25% premium over the 15-day trading average of Solazyme’s common stock. The investment was funded by an outstanding and accomplished group of leading investors and entrepreneurs in food, nutrition and innovation. The investor group includes:
- Glenhill Capital (active consumer investor including seed investor in Boulder Brands)
- VMG Partners (premier consumer private equity fund: KIND, Pretzel Crisp, Pirate’s Booty, Natural Balance)
- PowerPlant Ventures (founders of Zico Coconut Water and the Veggie Grill)
- Charles Chang, founder and former CEO of Vega (Lyra Growth Partners)
- ARTIS Ventures (investors in food and technology, including Juicero, ChefsFeed and Modern Meadow)
- Simon Equities (investors in food and consumer products, including Plum Organic, Method, Shinola)
- Jack Davis (retired CEO of Ventura Foods, the largest maker of vegetable oil-based products in the U.S.)
- Keith Belling (founder and former CEO of Popchips)
“I was fortunate to be at the forefront of the amazing growth in the coconut category,” said Zico Founder, Mark Rampolla, “and I am excited to have the chance to be a part of the next generation in food and nutrition that TerraVia and its suite of algae ingredients represents.”
MANAGEMENT AND BOARD APPOINTMENTS
Co-founder and longtime CEO, Jonathan S. Wolfson has notified the Board of Directors that as part of this transition he will shift his focus from daily operations to strategy and special projects including those with a consumer focus. At his request, a search for a new CEO will begin immediately. Mr. Wolfson has been appointed Chairman of the Board and will remain as CEO while the search is underway. He will assume the full-time role of Executive Chairman effective upon the placement of the new CEO. Jerry Fiddler will remain on the board and has assumed the role of lead independent director.
Mr. Wolfson said, “We have worked hard for more than a decade building a transformational algae-based food and specialty ingredients platform. Over the last six months, the key elements that we have been working on have fallen into place, ranging from regulatory clearances and manufacturing capability to validation of our key ingredients in cutting-edge consumer brands. As we focus the Company on food, nutrition and specialty ingredients, it is an ideal time to bring in a leader who has the industry experience and skills to enable TerraVia to deliver on a truly transformational opportunity. I am excited to be continuing on in a full-time capacity as Executive Chairman once the new CEO is in place.
“I also want to thank Jerry for his 13 years of tireless service and fantastic vision as Chairman,” Wolfson concluded.
Jerry Fiddler noted, “Jonathan leads with creativity, passion, drive and skill. I’m proud of what he has accomplished, and happy that he is reaffirming his commitment to the Company as Executive Chairman once the new CEO is in place. I am very optimistic about the future of TerraVia — the products are wonderful, they’re in production now, and they’re market-ready in a strong and receptive industry. I look forward to continuing to serve as lead independent director going forward.”
The Company also announced the strengthening of foods expertise on its Board of Directors with the addition of seasoned food industry executive, Irene Chang Britt. Britt is a past President of Pepperidge Farm; SVP, Chief Strategy Officer, Campbell’s Soup Company; General Manager, Kraft Foods and VP at Nabisco.
“Companies across the food industry are increasingly focused on delivering truly innovative products that transform the nutrition profile of the foods we all love without sacrificing their great taste,” said Britt. “TerraVia’s ingredients platform is well-positioned to help the food industry get there today, and I look forward to adding my expertise and voice to the board.”
SOLAZYME INDUSTRIALS
Over its history Solazyme has invested in, and developed products, technology and market opportunities in industrial markets including fuels, industrial oils, and the oilfield/Encapso™ business. Moving forward, these initiatives will be grouped together as “Solazyme Industrials” and will not be part of TerraVia’s refined focus. Solazyme believes these businesses have tremendous opportunity to develop into large and profitable entities, while improving the lives of people and the planet. The Company will be pursuing strategic alternatives over the next 12-18 months to unlock the value created. Solazyme’s objective is to identify partners who have the operational capabilities needed to realize the potential of those businesses.
MOVING FORWARD AS TerraVia
“We are moving forward with a strong business foundation and clear vision,” said Tyler Painter, Chief Financial and Operating Officer. “We have invested significant time and capital in the development of our innovation platform and large-scale manufacturing capability. We enjoy long-standing commitments from partners, led by Bunge and Unilever, who have helped bring our vision to life. Importantly, we have also learned significant lessons in scale-up and commercialization, helping to de-risk the inherent challenges in bringing disruptive products to market. These strengths combined with our refined focus, a proven suite of products and the expanded market knowledge we gain with our new investors and board member, position us well to execute on our opportunities in food, nutrition and specialty ingredients.”
About TerraVia
Solazyme (to be renamed TerraVia™), is a next generation food, nutrition and specialty ingredients company that harnesses the power of algae, the mother of all plants and earth’s original superfood. With a portfolio of breakthrough ingredients and manufacturing, the Company is well positioned to help meet the growing need of consumer packaged goods and established and emerging food manufacturers to improve the nutritional profile of foods without sacrificing taste, and to develop select consumer brands. The Company also manufacturers a range of specialty personal care ingredients for key strategic partners. Headquartered in South San Francisco, the Company’s mission is to create products that are truly better for people and better for the planet. For additional information, please visit TerraVia’s website at www.terravia.com.
Forward Looking Statements
This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 about Solazyme, including statements that involve risks and uncertainties concerning: the ability of algae-based foods to transform the food system; the attributes of algae-based foods, including as to economic and environmental sustainability; the future employment status of Jonathan Wolfson with Solazyme; its ability to find strategic alternatives for its industrials business and the timing and value of those alternatives; the ability of its business to bring value to customers and shareholders; the attributes of Solazyme’s next CEO; its ability to close its strategic financing; its commercialization and production plans; the ramping up of facilities; meeting commercialization and technology targets; successful product trials and market acceptance and adoption of its products; and Solazyme’s ability to maintain its relationships with its partners. When used in this press release, the words “will”, “expects”, “intends” and other similar expressions and any other statements that are not historical facts are intended to identify those assertions as forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any such statement may be influenced by a variety of factors, many of which are beyond the control of Solazyme, that could cause actual outcomes and results to be materially different from those projected, described, expressed or implied in this press release due to a number of risks and uncertainties. Potential risks and uncertainties include, among others: Solazyme’s limited operating history; its limited history in commercializing products; implementation risk in deploying new technologies; its limited experience in constructing, ramping up and operating commercial manufacturing facilities; its ability to successfully develop and commercialize products; its ability to sell its products at a profit; delays related to construction, start-up and ramp-up of production facilities; its ability to manage costs; its ability to enter into and maintain strategic collaborations; successful product trials by its customers and market acceptance and adoption of its products by end-users; its ability to obtain requisite regulatory approvals; and its access, on favorable terms, to any required financing. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on the results of operations or financial condition of Solazyme.
In addition, please refer to the documents that Solazyme, Inc. files with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q and Annual Report on Form 10-K, as updated from time to time, for a discussion of these and other risks. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this press release. Solazyme is not under any duty to update any of the information in this press release.
BEDFORD, Texas, March 10, 2016 — State National Companies, Inc. (NASDAQ:SNC), a leading specialty provider of property and casualty insurance, today announced that Matt Beard has been named Senior Vice President of Business Development of its Program Services segment, which provides fronting capacity by offering broad licensing authority and national access to insurance products and markets to clients.
“Matt’s extensive industry experience strengthens our Program Services segment and further develops State National’s relationships with managing general agents and reinsurance intermediaries,” said Terry Ledbetter, Chairman and CEO of State National Companies. “He brings expertise in pairing program managers with reinsurance capacity and has a proven track record in working with both U.S. and international markets.”
Mr. Beard has extensive insurance and reinsurance experience, specializing in program business. Most recently, he served as President for Assure Re Intermediaries, Inc. in Dallas, Texas. Previously he assisted in forming and developing Assure Re Intermediaries, Inc. and held positions at BMS Intermediaries in both London and Dallas. Mr. Beard started his career with EWI Re.
State National’s Program Services business provides fronting to general agents and insurance carriers to leverage its “A” (Excellent) A.M. Best rating with its expansive licenses and trusted reputation to provide access to the U.S. property and casualty insurance market in exchange for a ceding fee. State National issues the policy, and the reinsurer assumes the risk.
“I am excited to join the market leader in the fronting and Program Services segment and to join a company with such a remarkable history of success. I look forward to working with this team of experienced professionals and assisting State National’s clients to achieve their goals and objectives,” said Mr. Beard.
About State National Companies, Inc.
State National Companies, Inc. (NASDAQ:SNC) is a leading specialty provider of property and casualty insurance operating in two niche markets across the United States. In its Program Services segment, the company leverages its “A” (Excellent) A.M. Best rating, expansive licenses and reputation to provide access to the U.S. property and casualty insurance market in exchange for a ceding fee. In its Lender Services segment, the company specializes in providing collateral protection insurance, which insures personal automobiles and other vehicles held as collateral for loans made by credit unions, banks and specialty finance companies. To learn more, please visit www.statenational.com
Media Contact:
(800) 877-4567, ext. 1190
Mike Gallagher
mgallagher@statenational.com
ISFIYA, Israel, March 10, 2016 — Check-Cap Ltd. (Nasdaq: CHEK, CHEKW), a clinical stage medical diagnostics company engaged in the development of an ingestible capsule for preparation-free, colorectal cancer screening, today announced that Bill Densel, Chief Executive Officer, will present at the 28th Annual ROTH Conference on Wednesday, March 16, 2016 at 9:30am PT, 12:30pm ET. The conference will be held on March 13-16, 2016 at the Ritz Carlton in Dana Point, California.
To access a live webcast of this presentation, please visit http://ir.check-cap.com/. A replay will be available for 90 days following the presentation.
Check-Cap’s system utilizes an ingestible X-ray scanning capsule and proprietary software that is designed to detect and image the presence of growths along the inner lining of the colon, which may be pre-cancerous polyps or cancers. Unlike other imaging examinations, Check-Cap’s technology does not require prior bowel preparation, fasting, or other disruptions to normal daily routines.
Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States, and the second leading cause of cancer-related deaths when both genders are combined. The American Cancer Society recommends regular screening starting at age 50 for all men and women at average risk for developing colorectal cancer. However, more than one-third of Americans in this group are not up-to-date with testing recommendations that can prevent colorectal cancer. Check-Cap believes that its less-invasive, preparation-free alternative will address many of the personal perceptions and barriers that affect willingness to be screened.
About Check-Cap
Check-Cap is a clinical stage medical diagnostics company developing the first system for preparation-free scanning and imaging of the inner colon to identify precancerous polyps and cancers while being less invasive than traditional procedures. The Company is developing an ingestible capsule that utilizes proprietary, ultra-low-dose X-ray technology to safely generate high-resolution, 3-dimensional imagery of the interior of the colon. Without requiring bowel preparation or diet and activity modifications, Check-Cap’s system is designed to increase patient acceptance and adherence to colorectal cancer screening recommendations. The Check-Cap system is currently not cleared for marketing in any jurisdiction.
Legal Notice Regarding Forward-Looking Statements
This press release contains “forward-looking statements.” Words such as “may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, often signify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information that the Company has when those statements are made or management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. For a discussion of these and other risks that could cause such differences and that may affect the realization of forward-looking statements, please refer to the “Special Note On Forward-looking Statements” and “Risk Factors” in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
CONTACT:
Investors
David Carey
Lazar Partners Ltd.
212-867-1768
dcarey@lazarpartners.com
Media
Danielle Lewis
Lazar Partners Ltd.
212-843-0211
dlewis@lazarpartners.com
PENNINGTON, N.J., March 10, 2016 — Ocean Power Technologies, Inc. (Nasdaq:OPTT) today announced that it has entered into a Letter of Intent with Mitsui Engineering and Shipbuilding (MES) to conduct funded pre-work tasks and to negotiate a definitive agreement that would allow for the lease of the APB350 PowerBuoy for a project off the coast of Kozu-island in Japan. The letter of intent addresses the parties’ intention to lease an APB350 PowerBuoy and provide required engineering support for application development and to ensure optimum operational performance. The OPT project scope would also include associated deployment planning and logistics, ocean performance data collection and processing. OPT and MES anticipate jointly developing and testing an advanced control algorithm with the goal of assessing increasing ocean wave capture and electric power generation.
The lease and deployment of the APB350 PowerBuoy in Japan, which would take place upon execution of the definitive documents as well as a successful completion of a stage gate review, is regarded as a critical spring board for OPT’s commercialization strategy to demonstrate the ability to apply the technology in a variety of markets in Japan and other parts of the world. Market applications could include national defense and security, such as early detection and warning systems for subsea and surface threats, or oil field management and metocean applications for the oil and gas industry and scientific communities.
George H. Kirby, President and Chief Executive Officer of OPT, stated, “This project and the anticipated first PowerBuoy lease represents the strength of our long-standing relationship with Mitsui Engineering and Shipbuilding. We are excited to support MES’s ocean project with our advanced APB350 PowerBuoy by providing a power and communications platform specific to Japanese conditions and applications. We believe that this is a major step toward accessing a potentially large market in Japan and throughout surrounding geographic areas. We are looking forward to working closely with MES to enable new and existing applications on a global scale.”
Mr. Toshihiko Maemura, Manager at Renewable Energy Project Group of MES, stated, “This project has been promoted by a relationship of a mutual strong trust between Ocean Power Technologies and MES. We would like to assure that this project will prove a high ability of our advanced control algorithm for state of calm sea off Kozu-island. We are looking forward to uniting our efforts with Ocean Power Technologies in order to develop a wave power generation system which is suited for Japanese sea conditions and others. Initial engineering tasks are planned to commence in March 2016 with PowerBuoy shipment to Japan and deployment expected in 2017.”
About Ocean Power Technologies
Headquartered in Pennington, New Jersey, Ocean Power Technologies (Nasdaq:OPTT) is a pioneer in ocean wave energy conversion. OPT’s proprietary PowerBuoy® technology is based on a scalable and modular design. OPT specializes in cost-effective and environmentally sound ocean wave based power generation and energy storage technology.
Forward-Looking Statements
This release may contain “forward-looking statements” that are within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by certain words or phrases such as “may”, “will”, “aim”, “will likely result”, “believe”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “plan”, “contemplate”, “seek to”, “future”, “objective”, “goal”, “project”, “should”, “will pursue” and similar expressions or variations of such expressions. These forward-looking statements reflect the Company’s current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the Company. Please refer to the Company’s most recent Forms 10-Q and 10-K and subsequent filings with the SEC for a further discussion of these risks and uncertainties. The Company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.
Company Contact:
Mark A. Featherstone
Chief Financial Officer of OPT
Phone:
609-730-0400
Investor Relations Contact:
Andrew Barwicki
Barwicki Investor Relations Inc.
Phone:
516-662-9461
Study including Classifier Score Data shows increased Sensitivity and Specificity
FDA Post-Approval Study Termination provides cost savings
Greater flexibility to explore strategic value of MelaFind System in Clinical Dermatology
HORSHAM, Pa., March 10, 2016 — STRATA Skin Sciences, Inc. (“STRATA”), (NASDAQ:SSKN), a medical technology company dedicated to developing and commercializing innovative products for the treatment and diagnosis of serious dermatological disorders, announced today that the U.S. Food and Drug Administration (FDA) approved STRATA’s PMA supplement for the MelaFind System.
MelaFind is a non-invasive, point-of-care instrument to aid in the detection of melanoma. The FDA approved MelaFind’s use of the “classifier score data”, a quantitative result derived by the MelaFind System that can be beneficially used in conjunction with the previously approved binary result (yes/no) from the instrument. With the Classifier Score, Dermatologists will be in possession of more complete information when utilizing MelaFind to aid in their decision to biopsy an ambiguous skin lesion.
To provide evidence to support the supplement, STRATA developed a reader study protocol in conjunction with the FDA and conducted a live study at the Fall Clinical Dermatology Conference that took place on October 1, 2015. This study measured the impact of the MelaFind binary result plus classifier score information on a dermatologist’s decision to biopsy suspicious pigmented skin lesions. A total of 160 Board Certified dermatologists participated.
The results of the study showed average sensitivity (ability to detect disease) increased from 76% before the utilization of MelaFind to 92% following the use of MelaFind. Average specificity (ability to rule out disease) increased from 52% before to 79% after MelaFind utilization. These statistically significant results satisfied the requirements for approval of the PMA Supplement. The full results of the study are being prepared for submission to a peer-reviewed publication.
In conjunction with the acceptance of these study results by the FDA, the Agency agreed that STRATA could terminate the previously required Post Approval Study for MelaFind (“PAS”) that had been underway since 2012 and was expected to continue for several additional years.
Michael R. Stewart, STRATA’s president and CEO commented: “We appreciate the FDA working with us to achieve approval of MelaFind’s classifier score labelling information that better assists dermatologists in the use of the MelaFind device and reaching agreement to terminate the post approval study. The study we conducted demonstrates the value of the MelaFind device in the hands of a dermatologist. Moreover, the opportunity to terminate the PAS eliminates future costs of millions of dollars to the Company that would have been associated with the continuation of the PAS.”
“The supplement approval gives us the flexibility to evaluate the potential for broader acceptance of the MelaFind device in the market as we continue to examine ways to create enhanced value for STRATA from this technology,” continued Mr. Stewart. “The Company’s primary focus near term remains on the growth of the XTRAC® system recurring revenues for the treatment of psoriasis and vitiligo. While the MelaFind is not expected to contribute materially to STRATA’s 2016 revenues, the receipt of the PMA supplement approval regarding the classifier score, and the associated meaningful results of the Reader study are positive steps in our strategic assessment of the MelaFind technology.”
About STRATA Skin Sciences, Inc. (Formerly MELA Sciences, Inc.)
(www.strataskinsciences.com)
STRATA Skin Sciences is a medical technology company focused on the therapeutic and diagnostic dermatology market. Its products include the XTRAC® laser and VTRAC® excimer lamp systems utilized in the treatment of psoriasis, vitiligo and various other skin conditions, and the MelaFind® system used to assist in the identification and management of melanoma skin cancer.
Safe Harbor
This press release includes “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to the Company’s plans, objectives, expectations and intentions and may contain words such as “will,” “may,” “seeks,” and “expects,” that suggest future events or trends. These statements, including the Company’s ability to generate the anticipated revenue stream, the Company’s ability to generate sufficient cash flow to fund the Company’s ongoing operations beginning at any time in the future, and the Company’s ability to build a leading franchise in medical dermatology, including the ability of the Company to advance and market the MelaFind technology, are based on the Company’s current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from the Company’s expectations due to financial, economic, business, competitive, market, regulatory and political factors or conditions affecting the Company and the medical device industry in general, as well as more specific risks and uncertainties set forth in the Company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all of these forward-looking statements may prove to be incorrect or unreliable. The Company assumes no duty to update its forward-looking statements and urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com.
Investor Contacts:
Study Meets Primary Endpoint of Reduction in Clinical Cardiac Events
CAMBRIDGE, Mass., March 10, 2016 — Vericel Corporation (NASDAQ:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced top-line results from the company’s Phase 2b ixCELL-DCM clinical trial of ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM). The trial met its primary endpoint of demonstrating a reduction in the total number of deaths, cardiovascular hospitalizations or unplanned outpatient and emergency department visits to treat acute decompensated heart failure during the 12 months following treatment with ixmyelocel-T compared to placebo. All clinical events in the primary and secondary endpoints were adjudicated in a blinded fashion by an independent adjudication committee. The incidence of adverse events, including serious adverse events, in patients treated with ixmyelocel-T was comparable to patients in the placebo group. Ixmyelocel-T has been granted orphan product designation by the U.S. Food and Drug Administration for use in the treatment of DCM.
“The results of the ixCELL-DCM study, which we believe is the largest randomized cell therapy trial to treat congestive heart failure completed to date, demonstrated a statistically significant and clinically meaningful reduction in cardiac events in patients who received treatment with ixmyelocel-T compared to placebo,” said Dr. David Recker, Vericel’s chief medical officer. “We are very excited about these study results given the lack of treatment options for end-stage heart failure patients.”
The Phase 2b ixCELL-DCM clinical trial is a multicenter, randomized, double-blind, placebo-controlled Phase 2b study designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo when administered via transendocardial catheter-based injections to subjects with end-stage heart failure due to ischemic DCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit. The trial was designed to provide approximately 80% power to show a 46% difference in cardiac events for ischemic DCM patients treated with ixmyelocel-T compared to placebo. A total of 114 patients were treated in the ixCELL-DCM clinical trial at 28 sites in the United States.
The full data results from the ixCELL-DCM trial are scheduled to be presented at the upcoming Late-Breaking Clinical Trial Sessions of the American College of Cardiology 65th Annual Scientific Session & Expo on April 4, 2016, and also will be submitted for publication.
About Dilated Cardiomyopathy
Dilated cardiomyopathy (DCM), a progressive disease of the heart, is a leading cause of heart failure and heart transplantation. DCM is characterized by weakening of the heart muscle and enlargement of the heart chambers, leading to systolic abnormalities (difficulty of the left ventricle to pump blood). Heart enlargement and poor function generally lead to progressive heart failure with further decline in the ability of the heart to pump blood efficiently throughout the body.
About Ixmyelocel-T
Ixmyelocel-T is a patient-specific, expanded multicellular therapy manufactured from the patient’s own bone marrow using Vericel’s proprietary, highly automated, fully closed cell-processing system. This process selectively expands the population of mesenchymal stromal cells and alternatively activated macrophages, which are responsible for production of anti-inflammatory and pro-angiogenic factors known to be important for repair of damaged tissue. Ixmyelocel-T has been designated as an orphan drug by the U.S Food and Drug Administration for use in the treatment of DCM.
About the ixCELL-DCM Clinical Trial
The ixCELL-DCM clinical trial is a multicenter, randomized, double-blind, placebo-controlled Phase 2b study designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to subjects with end-stage heart failure due to ischemic DCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit. The primary endpoint of the ixCELL-DCM clinical trial study is the number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient and emergency department visits to treat acute decompensated heart failure over the 12 months following administration of ixmyelocel-T compared to placebo.
About Vericel Corporation
Vericel Corporation is a leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. The company markets two autologous cell therapy products in the U.S.: Carticel® (autologous cultured chondrocytes), an autologous chondrocyte implant for the treatment of cartilage defects in the knee, and Epicel® (cultured epidermal autografts), a permanent skin replacement for the treatment of patients with deep-dermal or full-thickness burns comprising greater than or equal to 30% of total body surface area. Vericel is also developing MACI™, a third-generation autologous chondrocyte implant for the treatment of cartilage defects in the knee, and ixmyelocel-T, a patient-specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy. For more information, please visit the company’s website at www.vcel.com.
Epicel® and Carticel® are registered trademarks and MACI™ is a trademark of Vericel Corporation. © 2016 Vericel Corporation. All rights reserved.
This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of our products, intended product development, relative size of clinical trials, clinical activity timing and regulatory pathway and timing, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “can continue,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with clinical trial and product development activities and regulatory approval requirements. These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission (“SEC”) on March 25, 2015, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
CONTACT:
Chad Rubin
The Trout Group
crubin@troutgroup.com
(646) 378-2947
or
Lee Stern
The Trout Group
lstern@troutgroup.com
(646) 378-2922
CARLSBAD, CA–(March 10, 2016) – International Stem Cell Corporation (OTCQB: ISCO), a clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products , announced today it has entered into definitive agreements with two institutional healthcare investors and management for the private placement of $6.3 million of the Company’s convertible preferred stock and common stock purchase warrants to purchase up to an additional $25.7 million of the Company’s common stock. The gross proceeds for the initial purchase of securities consisted of $2.5 million in cash and conversion of $3.8 million debt. Dr. Andrey Semechkin, the Company’s Co-Chairman and Chief Executive Officer, purchased $4.3 million of the preferred stock (on the same terms as the outside investor) through conversion of the $3.8 million of indebtedness owed to him and $500,000 of cash. The closing of the offering is expected to occur on or about March 15, 2016, subject to satisfaction of customary closing conditions set forth in the Purchase Agreement.
“The recurring investment of these healthcare focused institutional investors is in support of and attests to the potential of our technology. The capital raised will help to drive our Phase 1 study of ISC-hpNSC® for the treatment of moderate to severe Parkinson’s disease. With enrollment of patients already underway, we look forward to the end of this year for preliminary safety and efficacy clinical data,” commented Dr. Andrey Semechkin, ISCO’s Co-Chairman and CEO.
Pursuant to the terms of the private placement, the Company will issue (i) 6,310 shares of Series I-1 and Series I-2 convertible preferred at a price of $1,000 per share, (ii) Series A Common Stock purchase warrants to purchase up to approximately 3.6 million shares of common stock at an initial exercise price of $3.65 per share with a term of five years, (iii) Series B Common Stock purchase warrants to purchase up to approximately 3.6 million shares of common stock at an initial exercise price of $1.75 per share with a term of six months and (iv) Series C Common Stock purchase warrants to purchase up to approximately 3.6 million shares of common stock at an initial exercise price of $1.75 per share with a term of twelve months. The Series I-1 and Series I-2 preferred stock are both convertible into shares of common stock of the Company at an initial conversion price of $1.75. $3,810,000 of the gross proceeds of this Offering will be satisfied by the forgiveness of the total principal balance of the Company’s bridge loan payable to Dr. Semechkin in the same amount.
The institutional investors have been granted resale registration rights with respect to the shares underlying the preferred stock and warrants, and all investors have been granted rights of participation in future offerings of the Company’s securities.
Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC is acting as the exclusive placement agent for the offering.
The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an exemption from such registration requirements. The company has agreed to file a registration statement with the SEC registering the resale of the shares of common stock underlying the securities to be sold to in this private placement to certain of the investors.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.
About International Stem Cell Corporation
International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
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Forward-looking Statements
Statements pertaining to anticipated developments, the expected timing and results of preclinical studies and subsequent regulatory filings, the potential proceeds upon exercise of warrants , and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.
Fuel Tech, Inc. (NASDAQ:FTEK), a world leader in advanced engineering solutions for the optimization of combustion systems and emissions control in utility and industrial applications, today announced the receipt of multiple air pollution control (APC) contracts from customers in the US, Europe and China. These awards have an aggregate value of approximately $4.4 million.
The US order is for conventional Selective Catalytic Reduction (SCR) systems on three gas-fired combustion turbines with heat recovery steam generators for a project at an industrial facility in the northeast. These systems include reactors and catalyst to reduce nitrogen oxide (NOx) emissions, along with flow mixing devices, aqueous ammonia feed systems and ammonia injection grids, all of which are key to optimal SCR performance. These systems also include catalyst to reduce carbon monoxide (CO) emissions. This is the equipment phase following the engineering order received earlier this year. Delivery of equipment is scheduled for the first quarter of 2017.
In the UK, a contract for a demonstration of Fuel Tech’s Advanced NOxOUT® Selective Non-Catalytic Reduction (ASNCR) technology was received for a large coal-fired unit. The ASNCR system utilizes proprietary state-of-the-art injectors and injection controls in combination with advanced temperature measurement techniques to provide NOx reduction efficiency well beyond conventional SNCR in difficult furnace environments. The demonstration is expected to occur in the first quarter of 2016.
In China, an order was received for multiple ULTRA™ systems that will be installed on units firing municipal solid waste, which are being retrofitted with NOx reduction technology. Fuel Tech’s ULTRA process provides for the safe and cost-effective on-site conversion of urea to ammonia for use as a reagent where SCR is used to reduce NOx, eliminating the hazards associated with the transport, storage and handling of anhydrous or aqueous ammonia. An additional award was received for Fuel Tech’s NOxOUT® Selective Non-Catalytic Reduction (SNCR) systems for multiple coal-fired utility boilers. Equipment deliveries for both contracts are expected to occur in the second quarter this year.
Vincent J. Arnone, President and Chief Executive Officer, commented, “These orders continue to demonstrate our capabilities to provide cost-effective technology solutions on a global basis. Our SCR technology opportunities continue to grow as the use of natural gas is expanding for both power generation and industrial applications, while our ULTRA technology simplifies on-site ammonia generation for SCR applications of all types. We are encouraged by the continuing interest in our ASNCR technology, which was first demonstrated in Europe during 2013. These demonstrations have generated permanent equipment orders for multiple units in the UK, and we see a variety of market segments that could potentially benefit from this next generation of our SNCR technology. ASNCR could also be applied to our existing large installed base of SNCR customers through system upgrades to provide additional NOx reduction or lower reagent operating costs.”
About Fuel Tech
Fuel Tech is a leading technology company engaged in the worldwide development, commercialization and application of state-of-the-art proprietary technologies for air pollution control, process optimization, and advanced engineering services. These technologies enable customers to produce both energy and processed materials in a cost-effective and environmentally sustainable manner.
The Company’s nitrogen oxide (NOx) reduction technologies include advanced combustion modification techniques and post-combustion NOx control approaches, including NOxOUT®, HERT™, and Advanced SNCR systems, ASCR™ Advanced Selective Catalytic Reduction systems, and I-NOx™ Integrated NOx Reduction Systems, which utilize various combinations of these systems, along with the ULTRA™ process for safe ammonia generation. These technologies have established Fuel Tech as a leader in NOx reduction, with installations on over 900 units worldwide.
Fuel Tech’s technologies for particulate control include Electrostatic Precipitator (ESP) products and services including complete turnkey capability for ESP retrofits, with experience on units up to 700 MW. Fuel gas conditioning (FGC) systems include treatment using sulfur trioxide (SO3) and ammonia (NH3) based conditioning to improve the performance of ESPs by modifying the properties of the fly ash particle. Fuel Tech’s particulate control technologies have been installed on more than 125 units worldwide.
The Company’s FUEL CHEM® technology revolves around the unique application of chemicals to improve the efficiency, reliability, fuel flexibility, boiler heat rate, and environmental status of combustion units by controlling slagging, fouling, corrosion, opacity and improving boiler operations. The Company has experience with this technology, in the form of a customizable FUEL CHEM program, on over 110 units.
Fuel Tech also provides a range of services, including boiler tuning and selective catalytic reduction (SCR) optimization services. In addition, flow corrective devices and physical and computational modeling services are available to optimize flue gas distribution and mixing in both power plant and industrial applications.
Many of Fuel Tech’s products and services rely heavily on the Company’s exceptional Computational Fluid Dynamics modeling capabilities, which are enhanced by internally developed, high-end visualization software. These capabilities, coupled with the Company’s innovative technologies and multi-disciplined team approach, enable Fuel Tech to provide practical solutions to some of our customers’ most challenging problems. For more information, visit Fuel Tech’s web site at www.ftek.com.
This press release may contain statements of a forward-looking nature regarding future events. These statements are only predictions and actual events may differ materially. Please refer to documents that Fuel Tech files from time to time with the Securities and Exchange Commission for a discussion of certain factors that could cause actual results to differ materially from those contained in the forward-looking statements.
Fuel Tech, Inc.
David S. Collins, 630-845-4500
Chief Financial Officer
or
The Equity Group Inc.
Devin Sullivan, 212-836-9608
Senior Vice President
SAN MATEO, CA–(Mar 9, 2016) – Determine (NASDAQ: DTRM), a leading global provider of SaaS enterprise Source to Pay and Enterprise contract lifecycle management (ECLM), including strategic sourcing, supplier management, contract management and procure-to-pay solutions, today announced President and CEO, Patrick Stakenas, will present at the 28th Annual ROTH Growth Stock Conference being held March 13-16, 2016 at the Ritz Carlton, Orange County, California.
Mr. Stakenas is scheduled to present on Wednesday, March 16th, 2016 9:30 am PT, in The Promenade/White room. Mr. Stakenas will discuss Determine’s decisive strategy to become the leader in source-to-pay, contract management and supply management cloud solutions. Mr. Stakenas will outline how the new Determine Cloud Platform will reshape and revolutionize the procurement and enterprise contract lifecycle management space through its truly integrated functional applications. “Determine is changing the way companies look at procurement and contract management with its new cloud technology,” stated Mr. Stakenas. “We are determined to move the bar higher in our market, with technology, user experience, functionality and service, while simultaneously bringing the business into line from a financial perspective.” He will be available for one-on-one meetings on Tuesday, March 15th at the conference.
About ROTH Conferences
ROTH Conferences are one of the largest in the nation for small-cap companies. We combine company presentations, Q&A sessions and management one-on-one meetings. Our events are also the primary platform for relationship building with existing and potential clients.
Our distinguished list of presenting companies have been identified by our award winning research team and are representative of a broad spectrum of sectors, including Business Services, Cleantech, Consumer, Electronics, Global Energy & Industrials, Gaming, Healthcare, Industrials, Media, Retail and Software.
For more information about the 28th Annual ROTH Growth Stock Conference, please visit roth.com.
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About Determine, Inc.
Determine (NASDAQ: DTRM) is a provider of leading enterprise cloud software solutions company who have brought together leading visionary technologies in the areas of strategic sourcing, enterprise contract lifecycle management, and procure to pay solutions. We provide the next generation of agile, enterprise cloud solutions for managing the procurement and contract management needs of modern business. Using our intuitive cloud platform, organizations can effectively manage the full scope of cloud source to pay and enterprise contract lifecycle management requirements using the Determine cloud platform.
The Determine cloud platform is an integrated open technology infrastructure based on smart process application models. The goal of our platform is to establish awareness of relevant data, manage business documents, embed analytical tools, create a means for collaboration, and provide advanced process management tools for fully integrating business processes through an open API infrastructure. Built on a unified and highly scalable cloud platform, we deliver deep and innovative capabilities in strategic sourcing, supplier management, enterprise contract lifecycle management, e-procurement, invoicing, and other business operation areas.
For more information, please visit: www.determine.com.
IRVINE, Calif., March 9, 2016 — Netlist, Inc. (NASDAQ: NLST), a leading provider of high performance and hybrid memory solutions for the cloud computing and storage markets, today announced that C.K. Hong, Netlist’s Chief Executive Officer, will be presenting at the 28th Annual ROTH Conference in Orange County, California at 7:00 a.m. PT (10:00 a.m. ET) on Monday, March 14, 2016.
A live broadcast and replay of the presentation will be made available to the public via audio webcast, which can be accessed by visiting the investor relations section of Netlist’s corporate website. The webcast will be archived for ninety days.
For more information and registration, please visit the conference website. Investors attending the conference who wish to meet with Mr. Hong should notify their ROTH representative.
About Netlist, Inc.
Netlist creates solutions that accelerate turning data into information. We design and manufacture controller and software-based memory solutions for our OEM and Hyperscale customers in the server and storage space. Flagship products NVvault® and EXPRESSvault™ accelerate system performance and provide mission critical fault tolerance. HyperVault®, Netlist’s next-generation architecture, expands the performance and capacity of memory channel storage. The company holds a portfolio of patents, many seminal, in the area of hybrid memory, rank multiplication and load-reduction, among others. To learn more, visit www.netlist.com.
Safe Harbor Statement:
This news release contains forward-looking statements regarding future events and the future performance of Netlist. A forward‑looking statement is neither a prediction nor a guarantee of future events or circumstances and is based on currently available market, operating, financial and competitive information and assumptions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expected or projected, including, among others, risks associated with the launch and commercial success of our products, programs and technologies; the success of product, joint development and licensing partnerships; continuing development, qualification and volume production of HyperVault™, EXPRESSvault™, NVvault®, HyperCloud® and VLP Planar-X RDIMM; the timing and magnitude of the continued decrease in our sales; our ability to leverage our NVvault® and EXPRESSvault™ technology in a more diverse customer base; our need to raise additional capital and our ability to obtain financing when necessary; the rapidly-changing nature of technology; risks associated with intellectual property, including patent infringement litigation against us as well as the costs and unpredictability of litigation over infringement of our intellectual property and the possibility of our patents being reexamined or reviewed by the United States Patent and Trademark office and the Patent Trial and Appeal Board; volatility in the pricing of DRAM ICs and NAND flash; changes in and uncertainty of customer acceptance of, and demand for, our existing products and products under development, including uncertainty of and/or delays in product orders and product qualifications; delays in our and our customers’ product releases and development; introductions of new products by competitors; changes in end-user demand for technology solutions; our ability to attract and retain skilled personnel; our reliance on suppliers of critical components and vendors in the supply chain; fluctuations in the market price of critical components; evolving industry standards; the political and regulatory environment in the People’s Republic of China; and general economic and market conditions. Other risks and uncertainties are described in our annual report on Form 10-K filed on March 4, 2016, and subsequent filings with the U.S. Securities and Exchange Commission we make from time to time. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please contact:
Brainerd Communicators, Inc.
Mike Smargiassi/Jenny Perales
NLST@braincomm.com
(212) 986-6667
Embracing open systems approach to propagate contributions throughout the community and accelerate innovation for fixed and mobile service providers
OCP U.S. Summit – Radisys® Corporation (NASDAQ: RSYS), the services acceleration company, today announced that it has joined the Open Compute Project (OCP) as a silver member, demonstrating its commitment and strategic focus on hyperscale computing and cloud-based solutions. The Open Compute Project, an initiative launched by Facebook in 2011 to increase technology efficiencies and reduce the environmental impact of data centers, has enjoyed widespread support in the IT industry and is growing in importance and relevance within the telecommunications market. Radisys recently announced its DCEngine data center solution, which is based on the principles evangelized by the Open Compute Project (OCP), and offers a disruptive cloud platform designed specifically to meet the unique needs of communication service providers as they transform their central offices to data centers.
“Radisys’ deep technical expertise and core competence in communications platforms and complex telecom software aligns perfectly with the evolving OCP mission and the interest of many of our newest communication service provider members,” said Amber Graner, Operations Director and Community Manager for the Open Compute Project Foundation. “We look forward to collaborating closely with the Radisys team and look forward to their participation in the OCP Community.”
Facebook and other founding members of the OCP originally defined their platform specifications around IT and Enterprise data center requirements. Communication service providers are increasingly incorporating OCP concepts into their next-generation telecom data centers and infrastructure requirements. However, telecom service providers deploying Network Functions Virtualization (NFV) often require higher levels of reliability, fault resilience and network I/O performance than OTT and IT data center applications using OCP platforms today. By joining OCP as a silver member, Radisys can better apply its experience in large-scale open communication platforms designed for the rigors and network performance constraints of telecom data center requirements.
“Radisys has been a leading supplier of open, high-performance platforms for the communications industry for over 25 years,” said Andrew Alleman, CTO, Radisys. “Our involvement in OCP reaffirms our commitment to the open hardware and open source movement, while giving Radisys an opportunity to influence OCP efforts to address the unique challenges of data centers designed for real-time communication services. Our market-leading portfolio of products that extend from access technologies (CellEngine), to the core of the network (DCEngine, FlowEngine) and into the IMS services plane (MediaEngine) enable Radisys to bring a relevant and unique perspective to OCP. We look forward to becoming an active contributor in the Open Compute community.”
About Open Compute Project Foundation
The Open Compute Project Foundation is a rapidly growing community of engineers around the world whose mission is to design and enable the delivery of the most efficient server, storage and data center hardware designs for scalable computing. We believe that openly sharing ideas, specifications and other intellectual property is the key to maximizing innovation and reducing operational complexity in the scalable computing space. The Open Compute Project Foundation provides a structure in which individuals and organizations can share their intellectual property with Open Compute Projects.
About Radisys
Radisys helps communications and content providers, and their strategic partners, create new revenue streams and drive cost out of their services delivery infrastructure. Radisys’ hyperscale software-defined infrastructure, service aware traffic distribution platforms, real-time media processing engines and wireless access technologies enable its customers to maximize, virtualize and monetize their networks. For more information about Radisys, please visit www.radisys.com.
Radisys® is a registered trademark of Radisys. All other trademarks are the property of their respective owners.
Network to include 20 ATSG-owned Boeing 767s, logistics support;
Amazon granted rights to purchase ATSG equity
Air Transport Services Group, Inc. (Nasdaq:ATSG) announced today agreements with Amazon Fulfillment Services, Inc., an affiliate of Amazon.com, Inc. (Nasdaq:AMZN), to operate an air cargo network to serve Amazon customers in the United States.
“Since last summer, we have been working closely with Amazon to demonstrate that a dedicated, fully customized air cargo network can be a strong supplement to existing transportation and distribution resources,” said Joe Hete, President and CEO of ATSG. “We are excited to serve Amazon customers by providing additional air cargo capacity and logistics support to ensure great shipping speeds for customers.”
The commercial agreements will include the leasing of 20 Boeing 767 freighter aircraft to Amazon Fulfillment Services, Inc. by ATSG’s Cargo Aircraft Management (CAM), the operation of the aircraft by ATSG’s airlines, ABX Air and Air Transport International, and gateway and logistics services provided by ATSG’s LGSTX Services. The duration of the 20 leases will be five to seven years; the agreement covering operation of the aircraft will be for five years.
“We offer Earth’s largest selection, great prices and ultra-fast delivery promises to a growing group of Prime members and we’re excited to supplement our existing delivery network with a great new provider, ATSG, by adding 20 planes to ensure air cargo capacity to support one and two-day delivery for customers,” said Dave Clark, Amazon senior vice president of worldwide operations and customer service.
In conjunction with the commercial agreements, ATSG also has agreed to grant Amazon warrants to acquire over a five-year period up to 19.9 percent of ATSG’s common shares at $9.73 per share, based on the closing price of ATSG common shares on February 9, 2016.
Additional information about these agreements will be provided in a Form 8-K that ATSG expects to file with the U.S. Securities & Exchange Commission later this week.
About ATSG
ATSG is a leading provider of aircraft leasing and air cargo transportation and related services to domestic and foreign air carriers and other companies that outsource their air cargo lift requirements. ATSG, through its leasing and airline subsidiaries, is the world’s largest owner and operator of converted Boeing 767 freighter aircraft. Through its principal subsidiaries, including two airlines with separate and distinct U.S. FAA Part 121 Air Carrier certificates, ATSG provides aircraft leasing, air cargo lift, aircraft maintenance services and airport ground services. ATSG’s subsidiaries include ABX Air, Inc.; Airborne Global Solutions, Inc.; Air Transport International, Inc.; Cargo Aircraft Management, Inc.; Airborne Maintenance and Engineering Services, Inc., and LGSTX Services, Inc. For more information, please see www.atsginc.com.
Except for historical information contained herein, the matters discussed in this release contain forward-looking statements that involve risks and uncertainties. There are a number of important factors that could cause Air Transport Services Group’s (“ATSG’s”) actual results to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the successful implementation and operation of the new air network provided for the customer described in this release; the cost and timing with respect to which we are able to purchase and modify aircraft to a cargo configuration; our airlines’ ability to maintain on-time service and control costs; and shareholder approval of the proposed equity arrangements with the customer described in this release; and other factors that are contained from time to time in ATSG’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Readers should carefully review this release and should not place undue reliance on ATSG’s forward-looking statements. These forward-looking statements were based on information, plans and estimates as of the date of this release. ATSG undertakes no obligation to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.
ATSG Inc. Chief Financial Officer
Quint O. Turner, 937-366-2303