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(IRIX) To Introduce Four New Products At Annual AAO Meeting
Fifteen physicians, seven new to the IRIDEX podium, will discuss their experiences using MicroPulse™ for retinal and glaucoma therapies
MOUNTAIN VIEW, Calif., Nov. 13, 2013 — IRIDEX Corporation (Nasdaq:IRIX) today announced that it would introduce four new products at the annual meeting of the American Academy of Ophthalmology to be held November 16-19 at the Ernest N. Morial Convention Center in New Orleans. There will also be several presentations featuring IRIDEX products and its proprietary MicroPulse laser for retinal and glaucoma treatments.
The products include:
- A new version of the TxCell™ Pattern Scanning Laser Delivery System. The new iteration of the high-speed delivery device is compatible with the largest market of physician-owned slit lamps.
- A new IRIDEX MicroPulse Laser Trabeculoplasty (MLT) lens manufactured by Ocular Instruments. The new product, distributed exclusively through IRIDEX, is designed to increase efficiency and precision of MLT for the treatment of glaucoma.
- A portfolio of single-use 27-gauge laser probes, Peregrine Surgical-branded, that are compatible with the growing number of 27-gauge vitrectomy systems used in retina surgery.
- A GreenTip™ Membrane Scraper, available in 23 & 25 gauges, offering a single-use surgical device intended for specialized retinal surgery. The new device is designed to maximize visualization against the retina and is a derivative of the proprietary GreenTip product family.
“These are each significant new products that represent what we see as important niches and opportunities in the ophthalmology marketplace,” said Will Moore, IRIDEX President and CEO. “Furthermore, they are prime examples of our ability to identify growing needs in the marketplace and quickly design and launch consumable products to meet those needs.”
To schedule a demonstration of IRIDEX products in advance, click on the following link: http://www.iridex.com/Contact/ScheduleADemo.aspx.
IRIDEX also announced the growing number of new speakers to its podium regarding its proprietary MicroPulse solutions for physicians challenged with a growing number of patients suffering from glaucoma and retinal diseases. Select presentations from this year’s program include the following:
- MicroPulse Laser in the Forefront of Macular Disease Treatment (in Portuguese), presented by Alessandro Dare, M.D., Ph.D., head of Retina Department of Hospital Olhos do Interior Paulista, Sao Paulo, Brazil; and Renato Peroni, M.D., Retina Department, Ophthalmology, Santa Casa de Jau, Sao Paulo; Hospital de Ohlos de Araraquara, Araraquara, Sao Paulo, Ophthalmology Department University of Sao Paulo; 10 a.m. Sunday, Nov. 17.
- Laser-Assisted, Non-Incisional Glaucoma Therapy Benefits of Versatile Laser Systems for TSCPC & MLT Procedures in the MIGS World, presented by Iqbal (Ike) Ahmed, MD, FRCSC, Assistant Professor and Research Fellowship Director, Department of Ophthalmology, University of Toronto; and Nathan M. Radcliffe, M.D., Assistant Professor of Ophthalmology, Weill Cornell Medical College, New York-Presbyterian Hospital; 1 p.m. Sunday, Nov. 17.
- MicroPulse Laser Therapy for the Comprehensive Ophthalmologist: From the Anterior to the Posterior Segment, presented by David Gossage, D.O., FAOCO, FAAO, Medical Director, Gossage Eye Institute, Hillsdale, MI; 1 p.m. Saturday Nov. 16.
For a complete program of speakers, go to http://www.iridex.com/speakersforum. The IRIDEX booth at the conference will be located in Hall E, Booth #1135.
About IRIDEX
IRIDEX Corporation was founded in 1989 and is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market. We maintain a deep commitment to the success of our customers, with comprehensive technical, clinical, and service support programs. IRIDEX is dedicated to a standard of excellence, offering superior technology for superior results. IRIDEX products are sold in the United States through a direct sales force and internationally through a combination of a direct sales force and a network of approximately 70 independent distributors into over 100 countries. For further information, visit the IRIDEX website at http://www.iridex.com/.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, relating to the Company’s anticipated product releases and the markets for the Company’s products. These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors. Please see a detailed description of these and other risks contained in our Annual Report on Form 10-K for the fiscal year ended December 29, 2012, and our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 30, 2013, June 29, 2013, and September 28, 2013, each of which was filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and will not be updated.
(BSPM) Regains Compliance With NASDAQ $1.00 Minimum Bid Price Rule
XIANYANG, China, Nov. 13, 2013 — Biostar Pharmaceuticals, Inc. (NASDAQ: BSPM) (“Biostar”), a PRC-based manufacturer and marketer of pharmaceutical and health supplement products in China for a variety of diseases and conditions, today announced that on November 11, 2013, NASDAQ notified the Company that it had regained compliance Rule 5550(a)(2), which requires a minimum bid price of $1.00 for continued listing on the NASDAQ Stock Market and that the matter was now closed.
Ronghua Wang, Biostar’s Chairman, commenting on the announcement, stated: “We strongly believe that regaining compliance with NASDAQ’s continued listing requirements is an important achievement for the Company. Having resolved this issue, we can continue focusing on maximizing shareholder value and strengthening the Company’s business going forward.”
About Biostar Pharmaceuticals, Inc.
Biostar Pharmaceuticals, Inc., through its wholly owned subsidiary and controlled affiliate in China, develops, manufactures and markets pharmaceutical and health supplement products for a variety of diseases and conditions. The Company’s most popular product is its Xin Aoxing Oleanolic Acid Capsule, an over-the-counter medicine for chronic hepatitis B, a disease affecting approximately 10% of the Chinese population. For more information please visit: http://www.biostarpharmaceuticals.com.
Safe Harbor relating to the Forward-Looking Statements
Certain statements in this release concerning our future growth prospects are forward-looking statements, within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, which involve a number of risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The company uses words and phrases such as “guidance,” “forecasted,” “projects,” “is expected,” “remain confident,” “will” and similar expressions to identify forward-looking statements in this press release, including forward-looking statements. Undue reliance should not be placed on forward-looking information. Forward-looking information is based on current expectations, estimates and projections that involve a number of risks, which could cause actual results to vary and in some instances to differ materially from those anticipated by Biostar and described in the forward-looking information contained in this news release. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding the Company’s ability to complete the contemplated clinical trials and capitalize on such opportunities, the Company’s ability to recover its sales and revenue, the state of consumer confidence and market demand or the Company’s products, success of our investments, risks and uncertainties regarding fluctuations in earnings, our ability to sustain our previous levels of profitability including on account of our ability to manage growth, intense competition, wage increases in China, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, our ability to successfully complete and integrate potential acquisitions, withdrawal of governmental fiscal incentives, political instability and regional conflicts and legal restrictions on raising capital or acquiring companies outside China. Additional risks that could affect our future operating results are more fully described in our United States Securities and Exchange Commission filings including our most recent Annual Report on Form 10-K for the year ended December 31, 2012, and other subsequent filings. These filings are available at www.sec.gov. We may, from time to time, make additional written and oral forward-looking statements, including statements contained in our filings with the Securities and Exchange Commission and our reports to shareholders. We do not undertake to update any forward-looking statements that may be made from time to time by or on our behalf.
For more information contact:
Biostar Pharmaceuticals, Inc.
Ally Gong
Tel: +86-29-3368-6638
Email: office@aoxing-group.com
(SINA) Proposed Offering of US$600 Million Convertible Senior Notes
SHANGHAI, Nov. 13, 2013 — SINA Corporation (NASDAQ: SINA) (“SINA” or the “Company”), a leading Internet media company serving China and the global Chinese communities, today announced that it proposes to offer up to US$600 million in aggregate principal amount of convertible senior notes due 2018 (the “notes”), subject to market conditions. The conversion rate and other terms of the notes have not been finalized and will be determined at the time of pricing of the offering. The Company intends to grant to the initial purchaser a 30-day option to purchase up to an additional US$90 million principal amount of notes solely to cover over-allotments, if any. The notes will be convertible into the Company’s ordinary shares (“ordinary shares”), at the option of the holders, in integral multiples of US$1,000 principal amount, at any time prior to the close of business on the second business day immediately preceding the maturity date. SINA will not have the right to redeem the notes prior to maturity except for certain circumstances involving changes in the tax laws for the relevant taxing jurisdiction. Holders of the notes will have the right to require the Company to repurchase for cash all or part of their notes on December 1, 2016 or upon the occurrence of certain fundamental changes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the repurchase date.
The Company plans to use $100 million of the net proceeds from the offering to concurrently repurchase its own outstanding ordinary shares. The remainder of the net proceeds of the offering will be used for general corporate purposes, including working capital needs and potential acquisition of complementary businesses.
The notes, the ordinary shares deliverable upon conversion of the notes, have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws. They may not be offered or sold within the United States or to U.S. persons, except to qualified institutional buyers in reliance on the exemption from registration provided by Rule 144A under the Securities Act, or in reliance on other exemptions from registration under the Securities Act.
This press release shall not constitute an offer to sell or a solicitation of an offer to purchase any of these securities, in the United States or elsewhere, and shall not constitute an offer, solicitation or sale of the notes, the ordinary shares in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. Any public offering of securities to be made in the United States will be made by means of a prospectus that may be obtained from the issuer or the selling security holder and that will contain detailed information about the company and management, as well as financial statements.
This press release contains information about the pending offering of the notes, and there can be no assurance that the offering will be completed.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “may,” “will,” “expect,” “anticipate,” “future,” “intend,” “plan,” “believe,” “estimate,” “is/are likely to,” “confident” or other similar statements. SINA may also make forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. All information provided in this press release is as of the date of the issuance, and SINA assumes no obligation to update the forward-looking statements in this press release and elsewhere except as required under applicable law. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Potential risks and uncertainties include, but are not limited to: SINA’s limited operating history in certain new businesses; the global financial and credit market crisis and its impact on the Chinese economy; the uncertain regulatory landscape in China; fluctuations in the Company’s quarterly operating results; the Company’s reliance on online advertising sales and MVAS for a majority of its revenues; failure to successfully develop, introduce, drive adoption of or monetize new features and products, including portal, Weibo and MVAS products; failure to enter and develop the small and medium enterprise market by the Company or through cooperation with third parties, such a Alibaba; the Company’s reliance on mobile operators in China to provide MVAS and changes in mobile operators’ policies for MVAS in China; failure to successfully integrate acquired businesses; risks associated with the Company’s investments, including equity pick-up and impairment; and failure to compete successfully against new entrants and established industry competitors. Further information regarding these and other risks is included in SINA’s annual report on Form 20-F for the year ended December 31, 2012 and other filings with the Securities and Exchange Commission.
For further information, please contact:
Investor Relations
SINA Corporation
Phone: 8610-8262-8888 x 3112
Email: ir@staff.sina.com.cn
(HOTR) Announces Closing of Private Placement With Accredited Investors
CHARLOTTE, NC–(November 13, 2013) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (“Chanticleer Holdings” or “the Company”), headquartered in Charlotte, North Carolina, announced today that it closed a private offering, whereby the Company entered into a Subscription Agreement with three accredited investors, pursuant to which the Company sold to the Investors an aggregate of 160,000 Units at a purchase price of $5.00 per Unit, closing a $800,000 private placement. Each Unit consists of (a) 1 share of the Company’s common stock, $0.001 par value per share and (b) 1 5-year warrant to purchase 1 share of common stock. 80,000 warrants are available at an initial exercise price of $5.50, while the remaining 80,000 warrants are available at an initial exercise price of $7.00. Please see the accompanying Form 8-K filed for more details.
Mike Pruitt, the Company’s CEO stated, “Having access to capital at favorable rates allows us to continue to pursue opportunities as they present themselves.”
About Chanticleer Holdings, Inc.
Chanticleer Holdings (NASDAQ: HOTR) is focused on expanding the Hooters® casual dining restaurant brand in international emerging markets and American Roadside Burgers Inc (“ARB”), a Charlotte, N.C. based chain. Chanticleer currently owns in whole or part of the exclusive franchise rights to develop and operate Hooters restaurants in South Africa, Hungary and parts of Brazil, and has joint ventured with the current Hooters franchisee in Australia, while evaluating several additional international opportunities. The Company currently owns and operates in whole or part of six Hooters restaurants in its international franchise territories: Durban, Johannesburg, Cape Town and Emperor’s Palace in South Africa; Campbelltown in Australia; and Budapest in Hungary. ARB, purchased by Chanticleer Holdings on October 1, 2013, has a total of 5 casual restaurants — 1 location in Smithtown, N.Y., 2 locations in Charlotte, N.C., 1 location in Columbia, S.C., and the newest location is in Greenville, S.C. The Company also owns a majority interest in JF Restaurants, LLC and JF Franchising Systems, LLC, a fresh food-focused casual dining establishment with 5 restaurant locations.
For further information, please visit www.chanticleerholdings.com
Facebook: www.Facebook.com/ChanticleerHOTR
Twitter: http://Twitter.com/ChanticleerHOTR
Google+: https://plus.google.com/u/1/b/118048474114244335161/118048474114244335161/posts
Forward-Looking Statements:
Any statements that are not historical facts contained in this release are “forward-looking statements” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing or required licenses, competition, general economic conditions and other factors that are detailed in our periodic reports and on documents we file from time to time with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the companies do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Contact:
Chanticleer Holdings, Inc.
Mike Pruitt
Chairman/CEO
Phone: 704.366.5122 x 1
mp@chanticleerholdings.com
(BTHE) Reports Corporate Update and Financial Results
MANCHESTER, NH–(Nov 13, 2013) – Boston Therapeutics, Inc. (OTCQB: BTHE) (“Boston Therapeutics” or “the Company”), an innovator of drugs that address diabetes using complex carbohydrate chemistry, reports its corporate update and financial results for the three and nine months ended September 30, 2013.
David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, “During the third quarter, we continued to build upon the positive results for PAZ320 obtained in our Phase IIa safety and efficacy trial. Specifically, with the initiation of our Phase IIb trial in France and the ongoing preparation for our planned Phase III multinational trial, we continue to develop what we believe will be a significant new tool as an adjunctive therapy in combination with metformin to treat Type 2 diabetes. I am especially excited about our new research study at the University of Minnesota, which we believe will give us deeper insights into how well PAZ320’s mechanism of action works non-systemically in the gastro-intestinal tract to block the uptake of glucose into the bloodstream.
“We also are enhancing our outreach programs at diabetes conferences, to the media to communicate the importance of our drug development initiatives to address a large unmet medical need, and to build awareness of who we are and what we do to the investment community. I am confident that we are on the right track and will continue to make progress in the months and years ahead,” he concluded.
Corporate Update:
- As of September 30, 2013, we had cash of approximately $3.9 million and current liabilities of approximately $340 thousand.
- Began enrollment for Phase IIb trial in France to assess the efficacy and safety of PAZ320 in patients with Type 2 diabetes as adjunctive therapy in combination with metformin.
- Began preparation for IND submission to the U.S. FDA for Phase III trial in the U.S., Europe, Hong Kong, and China to evaluate the effects of PAZ320 on post-meal glucose levels in patients with Type 2 diabetes as adjunctive therapy in combination with metformin.
- Initiated research study at the University of Minnesota to provide molecular-level data on PAZ320 and its mechanism of action, specifically to better characterize PAZ320 galactomannan and assess interactions of PAZ320 with various carbohydrate-hydrolyzing enzymes.
- Positive results from Phase II clinical trial was published by the principal investigator evaluating the safety and efficacy of PAZ320 (demonstrating significant 40% reduction in elevation of post-meal blood glucose) with no serious adverse events in patients in the July/August issue of peer-reviewed journal Endocrine Practice.
- Appointed Ed Shea, (25 years of bio-pharmaceutical experience in business development, sales and marketing, including 15 years with Glaxo Smithkline), as new Vice President of Business Development and Tina Gagnon (former Corporate Controller for Micronetics, Inc.) as new Director of Finance.
- Featured positive results from Phase II clinical trial at the 2013 American Association of Diabetes Educators Annual Meeting & Exhibition in Philadelphia.
Financial Results for the Third Quarter and Nine Months Ended September 30, 2013:
- Significantly strengthened the balance sheet with the closing of approximately $5.3 million in total gross proceeds from private placement of common stock and warrants to existing and new accredited investors. Use of proceeds is to primarily fund the Company’s ongoing clinical trials for PAZ320.
- Revenue for the third quarter was $217,520, compared with $2,520 in the prior year’s quarter. Nine-month revenue was $242,974, compared with $23,750 in the prior year’s nine-month period. The increase was primarily the result of shipments of the Company’s over-the-counter product to one customer.
- Gross margin for the three months ended September 30, 2013 was $99,005 as compared with a negative gross margin of ($6,600) for the three months ended September 30, 2012. Gross margin for the nine months ended September 30, 2013 was $68,550 as compared to negative gross margin of $(17,127). The increase is primarily related to the shipment of product during the third quarter. The negative gross margin for the three months and nine months ended September 30, 2012 was primarily the result of fixed overhead costs related to moving to a new fulfillment operation and manufacturing scale-up from small to production grade equipment exceeding revenue.
- Research and development expense for the three months ended September 30, 2013 was $151,946, an increase of $125,830 as compared to $26,116 for the three months ended September 30, 2012. Research and development expense for the nine months ended September 30, 2013 was $200,428, an increase of $54,760 as compared with $145,668 for the nine months ended September 30, 2012. The increase is primarily the result of increased activity for PAZ320’s Phase IIb trial in France and in preparation of PAZ320’s Phase III international trial.
- Sales and marketing expense for the three months ended September 30, 2013 was $102,840, an increase of $9,321 or 10% as compared with $93,519 for the three months ended September 30, 2012. Sales and marketing expense for the nine months ended September 30, 2013 was $251,236, an increase of $23,639 or 10% as compared with $227,597 for the nine months ended September 30, 2012. The expense consists primarily of costs incurred with third parties for product marketing and public relations.
- General and administrative expense for the three months ended September 30, 2013 was $954,261, an increase of $719,629 as compared with $234,632 for the three months ended September 30, 2012. Approximately $407,000 of the increase is related to non-cash stock-based compensation which includes $252,000 of expense due to the future vesting of stock options of a terminated employee and expense associated with stock option grants. Consulting and professional services increased $135,000 for investor relations and maintenance of the SUGARDOWN® website, accounting and legal professional fees increased $91,000 and payroll and payroll related expense increased $82,000 due to additional personnel.
- General and administrative expense for the nine months ended September 30, 2013 was $1,904,008, an increase of $1,405,405 as compared with $498,603 for the nine months ended September 30, 2012. Approximately $677,000 of the increase is related to non-cash stock-based compensation which includes $252,000 of expense due to future vesting of stock options of a terminated employee and expense associated with stock option grants during 2012 and 2013. Additionally, consulting and professional fees increased approximately $345,000 for investor relations and maintenance of the SUGARDOWN® website, payroll and related payroll expense increased $162,000 due to additional personnel, accounting and legal professional fees increased $114,000 due to increased business operations and rent expense increased $50,000 due to the new office facility.
- Net loss for the third quarter 2013 was $1,116,863 or $0.04 per share, compared with a net loss of $366,334, or $0.02 per share in the prior year’s third quarter. For the nine-month period, net loss was $2,303,532, or $0.11 per share, compared with $905,728 or $0.05 per share in 2012. Non-cash stock-based compensation of $472,820 and $857,851 is included in the net loss for the three months and nine months ended September 30, 2013.
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Manchester, NH (OTCQB: BTHE), is an innovator in designing drugs using complex carbohydrate chemistry. The Company’s product pipeline is focused on developing and commercializing therapeutic molecules that address Type 2 diabetes, including: PAZ320, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. More information is available at www.bostonti.com.
Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of our drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in the trials could delay obtaining meaningful results from Phase II and/or preparing for Phase III with the current cash on hand.
Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from this proposed indication. Plans regarding development, approval and marketing of any of our drugs, including PAZ320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2012, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
Contact:
Boston Therapeutics, Inc.
Anthony Squeglia
Vice President of Strategic Planning
Phone: 603-935-9799
Email: anthony.squeglia@bostonti.com
www.bostonti.com
(JBLU) to Fly to 25 Caribbean Destinations This Winter
An Average of 200 Daily Flights Scheduled This Winter to, From, and Within Caribbean; New Destinations Available With Cape Air, LIAT, and Seaborne Airlines
An Average of 200 Daily Flights Scheduled This Winter to, From, and Within Caribbean; New Destinations Available With Cape Air, LIAT, and Seaborne Airlines
NEW YORK, NY–(November 12, 2013) – JetBlue Airways (NASDAQ: JBLU) today announces its expanded winter schedule in the Caribbean, featuring more flights than ever before. With the planned launch of service to two new island destinations, JetBlue will serve the Caribbean region this winter with an average of 200 daily flights.
In addition to its own network growth, JetBlue also announces the signing of two new interline agreements in the Caribbean, with LIAT and Seaborne Airlines, and a growth of its existing partnership with Cape Air. This expands the single-ticket options for JetBlue customers into a number of additional Caribbean destinations.
Two new cities and five new routes planned
JetBlue has announced five new Caribbean routes that will launch in the coming months, including service to two new destinations: Port-au-Prince, Haiti and Port of Spain, Trinidad and Tobago (a). New routes include:
- Chicago (ORD) – San Juan, Puerto Rico (starts Nov. 20)
- Fort Lauderdale-Hollywood – Port-au-Prince, Haiti (starts Dec. 5) (a)
- Fort Lauderdale-Hollywood – Port of Spain, Trinidad and Tobago (starts May 1) (a)
- New York (JFK) – Port-au-Prince, Haiti (starts Dec. 5) (a)
- New York (JFK) – Port of Spain, Trinidad and Tobago (starts Feb. 24) (a)
Five destinations to see added capacity with larger aircraft
JetBlue plans to meet peak winter demand this winter by deploying its brand new Airbus A321 aircraft to a variety of Caribbean destinations. The A321 is outfitted with 190 seats, featuring the most legroom in coach (b), and boosting the number of seats per departure by 40 compared to JetBlue’s current 150-seat A320 aircraft. The following destinations will see select flights to/from New York (JFK) operated by the larger A321:
- Bridgetown, Barbados
- Nassau, Bahamas
- San Juan, Puerto Rico
- Santiago, Dominican Republic
- Santo Domingo, Dominican Republic
Additionally, JetBlue will offer even more frequencies between New York (JFK) and Barbados during peak holiday times, including President’s Day and Easter.
JetBlue’s A321s will be operating fresh from the factory and will not yet have in-flight television, radio or movies.
More destinations with new and expanded interline partnerships
JetBlue has added two new interline agreements, with LIAT and Seaborne Airlines, and expanded its existing partnership with Cape Air, bringing a number of new Caribbean destinations within reach for JetBlue customers.
LIAT now offers JetBlue customers connections to several new destinations including Antigua, Grenada, St. Kitts, and Saint Vincent and the Grenadines, when transferring at Barbados and St. Maarten. Founded in 1956, LIAT is one of the largest and most experienced carriers in the Caribbean region. Tickets are now available for sale through travel agencies.
Seaborne Airlines also opens up several new destinations for JetBlue customers, including St. Kitts, Dominica, and Guadeloupe and Martinique in the French Caribbean, all via San Juan, as well as connections to La Romana, Dominican Republic on a daily basis. In addition, Seaborne will offer more flight options for customers connecting at San Juan to/from both the U.S. and British Virgin Islands. Seaborne’s regional network includes 11 destinations from San Juan and a total of 625 weekly departures. JetBlue-Seaborne itineraries are now available for sale through travel agencies.
JetBlue’s longstanding partnership with Cape Air also expands this winter, with new destinations available via San Juan: Culebra, Puerto Rico, and Virgin Gorda in the British Virgin Islands. With service to these two unspoiled island destinations, which is expected to kick off in early 2014, Cape Air will serve a total of nine destinations from San Juan including options like Anguilla and Nevis. Tickets for travel to all Cape Air destinations in the Caribbean are available for sale at www.jetblue.com.
“It’s shaping up to be a great winter in the Caribbean region, with more JetBlue flights and more choices for travelers than ever before,” said Scott Laurence, JetBlue’s vice president of network planning. “Destination after destination, the Caribbean continues to embrace JetBlue’s unique brand of service. We’re excited to offer flights to 25 great getaways this winter plus even more destinations through our partnerships with Cape Air, LIAT, and Seaborne Airlines.”
About JetBlue in the Caribbean and Latin America
JetBlue is a leading airline in the Caribbean, soon offering nonstop service to 25 destinations across the region including Aguadilla; Aruba; Barbados; Bermuda; Cancún; Cartagena; Grand Cayman; Kingston; La Romana; Montego Bay; Nassau; Ponce; Port-au-Prince (a); Port of Spain (a); Providenciales; Puerto Plata; Punta Cana; Saint Lucia (Hewanorra); Samaná; San Juan; Santiago; Santo Domingo; St. Croix; St. Maarten; and St. Thomas. This winter JetBlue will operate an average of 200 flights to, from, and within the region.
The carrier operates one of its six focus cities at San Juan’s Luis Muñoz Marín International Airport, where it offers more flights to more destinations than any other carrier. In fact, this winter JetBlue will connect San Juan to 17 cities across the United States and Caribbean with an average of 40 daily departures. JetBlue is also a leading carrier in the Dominican Republic, serving more airports and offering more flights and more seats than any other U.S. carrier.
(a) Subject to receipt of government approval.
(b) Based on average fleet-wide seat pitch of U.S. airlines.
About JetBlue Airways
As New York’s Hometown Airline™ and a leading carrier in Boston, Fort Lauderdale-Hollywood, Los Angeles/Long Beach, Orlando and San Juan, JetBlue carries 30 million customers a year to 80 cities in the U.S., Caribbean and Latin America with an average of 750 daily flights. With JetBlue, all seats are assigned, all fares are one-way, and an overnight stay is never required. JetBlue’s fleet totals 191 aircraft, comprising 130 Airbus A320s, 1 A321 and 60 Embraer 190s. Upcoming destinations include Detroit, Mich. and Savannah, Ga.; as well as Port-au-Prince, Haiti; Port of Spain, Trinidad and Tobago; and Lima, Peru, subject to receipt of government approval. For more information please visit JetBlue.com.
MEDIA CONTACTS
JetBlue Corporate Communications
Tel: +1 718 709 3089
corpcomm@jetblue.com
(FUEL) to Present at Upcoming Investor Conferences
REDWOOD CITY, Calif., Nov. 12, 2013 — Rocket Fuel Inc. (Nasdaq:FUEL), a leading provider of artificial intelligence (AI) advertising solutions for digital marketers, today announced that members of the senior management team will present to the investment community at the following investor conferences:
Credit Suisse Annual Technology Conference |
Date: Wednesday, December 4, 2013 |
Time: 10:30 AM MST (fireside chat) |
Location: The Phoenician Hotel, Scottsdale, AZ |
NASDAQ OMX 30th Investor Program |
Date: Wednesday, December 4, 2013 |
Time: 8:00 AM GMT (company presentation) |
Location: The Waldorf Hilton, London, UK |
BMO Capital Markets Technology & Digital Media Conference |
Date: Tuesday, December 10, 2013 |
Time: 11:00 AM EST (fireside chat) |
Location: The Grand Hyatt Hotel, New York, NY |
Webcasts will be accessible on the investor relations section of the Rocket Fuel website (http://investor.rocketfuel.com). Archived replays of the webcasts will be available following the live presentations.
About Rocket Fuel
Rocket Fuel delivers a leading programmatic media-buying platform at Big Data scale that harnesses the power of artificial intelligence to improve marketing ROI in digital media across web, mobile, video, and social channels. Rocket Fuel powers digital advertising and marketing programs globally for customers in North America, Europe, and Japan. Customers use Rocket Fuel’s Advertising That Learns ® platform to achieve brand and direct-response objectives in diverse industries from luxury cars to groceries to retail. Rocket Fuel currently operates in more than 20 offices worldwide and trades on the NASDAQ Global Select Market under the ticker symbol “FUEL.” For more information, please visit http://www.rocketfuel.com.
Rocket Fuel and Advertising That Learns are trademarks or registered trademarks of Rocket Fuel Inc. in the United States and other countries.
CONTACT: Investor Relations: Alex Wellins The Blueshirt Group (415) 217-5861 ir@rocketfuel.com
(NSTG) Launches the nCounter Dx Analysis System for U.S. Market
NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced the availability of the nCounter® Dx Analysis System for high-complexity, CLIA-certified laboratories. The nCounter Dx Analysis System is the only platform 510(k) cleared by the U.S. Food and Drug Administration to run the Prosigna™ Prognostic Breast Cancer Gene Signature Assay. For clinical laboratories that value flexibility, the FLEX configuration offered on the nCounter Dx Analysis System supports other translational research applications, and facilitates the ability of laboratories to develop their own assays. NanoString will showcase the new nCounter Dx Analysis System and its advanced capabilities at this week’s annual Association for Molecular Pathology (AMP) conference in Phoenix, Arizona.
The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The nCounter Dx Analysis System supports the Prosigna Breast Cancer Prognostic Gene Signature Assay, an in vitro diagnostic assay that uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. Using the nCounter Dx Analysis System, the Prosigna Assay can be performed in qualified clinical laboratories throughout the U.S. and countries that accept the CE Mark, empowering oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients for determining the risk of distant disease recurrence.
The nCounter Dx Analysis System is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the “Life Sciences” mode, process translational research experiments and multiplexed assays developed by the clinical laboratory. The nCounter Elements™ General Purpose Reagents (GPRs) offered by NanoString provide further flexibility by enabling laboratories to develop their own gene expression, copy number variation, and gene fusion signatures.
“We have received significant interest from laboratories seeking to perform the Prosigna Breast Cancer Assay as well as run genomic assays that they have developed independently,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “With the nCounter Dx Analysis System’s FLEX configuration, the Prosigna Breast Cancer Assay, and with our recently launched nCounter Elements GPRs, we have a compelling suite of products for these laboratories. We expect the versatility of this offering to help drive the adoption of the Prosigna Breast Cancer Assay and be particularly appealing to high-complexity CLIA laboratories in major U.S. cancer centers.”
“We’re excited to be the first laboratory in the U.S. to adopt the nCounter Dx Analysis System,” said Dr. Edward E. Partridge, Director of the University of the Alabama Comprehensive Cancer Center. “In addition to running the Prosigna Assay, which we believe will help inform the treatment decisions clinicians and patients make regarding breast cancer care, we find great value in also using the system to translate our research into our own Laboratory Developed Tests.”
When used together, the nCounter Dx Analysis System and Prosigna Breast Cancer Prognostic Gene Signature Assay provide the following key features:
- High-throughput workflow allowing each nCounter Dx Analysis System to perform the Prosigna Assay on up to 30 patient samples per eight hour work day and obtain assay results in as little as two days
- Ready-to-use Prosigna Assay consumables, including RNA extraction kits, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue
- Automated generation of personalized full-color Prosigna Assay patient reports that can be quickly and easily shared electronically with ordering oncologists, and which includes the patient’s Prosigna Score and risk category
The nCounter Dx Analysis System is now available for purchase or through reagent rental arrangements in the U.S. and countries that accept the CE Mark. Prosigna testing services are expected to be available from qualified laboratories in the U.S. beginning in the first quarter of 2014.
About the Prosigna™ Breast Cancer Prognostic Gene Signature Assay
Prosigna provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score, which are then used to assess a patient’s risk of distant recurrence. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma.
The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.
The Prosigna Assay will be available for diagnostic use when ordered by a physician in the U.S. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark and in which Prosigna is registered.
Prosigna™ Breast Cancer Prognostic Gene Signature Assay Intended Use:
The Prosigna™ Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic assay which uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence. The assay measures the gene expression profile using RNA extracted from formalin-fixed, paraffin embedded (FFPE) breast tumor tissue. This qualitative assay utilizes gene expression data, weighted together with clinical variables to generate a risk category and numerical score, for assessment of the risk of distant recurrence of disease. The assay is performed on the NanoString nCounter® Dx Analysis System using FFPE breast tumor tissue previously diagnosed as invasive breast carcinoma.
The Prosigna Breast Cancer Prognostic Gene Signature Assay is indicated in female breast cancer patients who have undergone either mastectomy or breast-conserving therapy in conjunction with locoregional treatment consistent with standard of care, either as:
1. | A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with hormone receptor-positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. | |
2. | A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with hormone receptor-positive (HR+), lymph node-positive (one to three positive nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes. |
Special Conditions for Use:
Prosigna is not intended for diagnosis, to predict or detect response to therapy, or to help select the optimal therapy for patients.
For more information, please visit www.prosigna.com.
About NanoString Technologies, Inc.
NanoString Technologies provides life science tools for translational research and molecular diagnostic products. The company’s nCounter® Analysis System, which has been employed in basic and translational research since it was first introduced in 2008 and cited in more than 300 peer-reviewed publications, has also now been applied to diagnostic use as the nCounter Dx Analysis System. The company’s technology offers a cost-effective way to easily profile the expression of hundreds of genes, miRNAs, or copy number variations, simultaneously with high sensitivity and precision. The company’s technology enables a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The nCounter-based Prosigna™ Breast Cancer Prognostic Gene Signature Assay is the first in vitro diagnostic assay to be marketed through the company’s diagnostics business. The nCounter Dx Analysis System is FDA 510(k) cleared for use with the Prosigna Breast Cancer Prognostic Gene Signature Assay. To date, it has not been cleared by the FDA for other indications or for use with other assays.
For more information, please visit www.nanostring.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected market acceptance of the nCounter Dx Analysis System, the Prosigna Assay, and nCounter Elements GPRs, and the expected adoption of the Prosigna Assay by clinicians and their patients. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with keeping pace with rapidly changing technology and customer requirements; risks regarding our ability to successfully introduce new products; risks that new market opportunities may not develop as quickly as expected; risks associated with competition in marketing and selling products; risks of increased regulatory requirements; as well as the other risks set forth in the company’s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. NanoString Technologies disclaims any obligation to update these forward-looking statements.
The NanoString Technologies logo, NanoString, NanoString Technologies, nCounter, Prosigna, and nCounter Elements are trademarks or registered trademarks of NanoString Technologies, Inc. in various jurisdictions.
(MPAA) Announces Refinancing of Credit Facility
LOS ANGELES, Nov. 12, 2013 – Motorcar Parts of America, Inc. (Nasdaq:MPAA) today announced it has entered into an amended and restated $125 million credit facility, comprised of a $95 million term loan and a $30 million revolving credit facility with Cerberus Business Finance, LLC as collateral agent and PNC Bank National Association, a member of the PNC Finance Services Group, Inc. (NYSE:PNC), as administrative agent. The amended and restated credit facility replaces a previous $125 million credit facility, comprised of a $105 million term loan and a $20 million revolver.
Based on current interest rates, the interest rate for the new term loan is 6.75 percent, consisting of a LIBOR floor of 1.50 percent plus a margin of 5.25 percent. The revolving credit facility interest rate is LIBOR plus a margin of 2.50 percent. This represents a saving of approximately 3.75 percent for the term loan and 0.5 percent on the revolver. At closing, the company had a $95 million term loan outstanding in addition to $10 million of borrowings on the revolving credit facility, with a blended interest rate currently of approximately 6.4 percent. The company had approximately $30 million of cash on hand at closing.
“The amended and restated credit facility reduces our blended rates by approximately 4 percent and also gives the company the flexibility to repurchase stock and to pay down an incremental $10 million of the term loan within the next 120 days. The new facility will result in reduced interest expense and provides greater financial flexibility to execute management’s strategic growth plans,” said Selwyn Joffe, chairman, president and chief executive officer.
In conjunction with entering into the amended and restated financing agreement, the company incurred various fees and expenses, including a pre-payment premium stipulated in the original loan agreement of approximately $3.0 million on the company’s prior credit facility.
About Motorcar Parts of America
Motorcar Parts of America, Inc. is a remanufacturer, manufacturer and distributor of automotive aftermarket parts – comprised of alternators, starters and wheel hub assembly products utilized in imported and domestic passenger vehicles, light trucks and heavy duty applications. Motorcar Parts of America’s products are sold to automotive retail outlets and the professional repair market throughout the United States and Canada, with remanufacturing facilities located in California, Mexico and Malaysia, and administrative offices located in California, Tennessee, Mexico, Singapore and Malaysia. Additional information is available at www.motorcarparts.com.
CONTACT: Gary S. Maier Maier & Company, Inc. (310) 471-1288
(BTHE) Enrolls Patients With Type 2 Diabetes in a Phase IIb Clinical Trial With PAZ320
MANCHESTER, NH–(Nov 12, 2013) – Boston Therapeutics, Inc. (OTCQB: BTHE) (“Boston Therapeutics” or “the Company”), an innovator in designing drugs that address diabetes using complex carbohydrate chemistry, today began enrolling patients in a Phase IIb clinical study on PAZ320, a complex carbohydrate-based drug designed to reduce the elevation of post-meal blood glucose by blocking the action of carbohydrate-hydrolyzing enzymes.
A total of 24 patients with Type 2 diabetes currently being treated with metformin will be administered PAZ320 under double-blind, placebo-controlled conditions. Patients’ blood glucose will be monitored using continuous glucose monitors (CGM) and their postprandial (after-meal) blood glucose levels will be measured following a test meal. The primary endpoint of the study is the evaluation of the effect of PAZ320 compared to placebo in the area under the curve (AUC) of glucose and on insulin levels in the blood for four hours following intake of the meal. The study is being conducted at Centre Hospitalier Robert Bisson, Lisieux, France.
David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, “This trial is designed to build upon the positive results from our Dartmouth Medical Center Phase IIa trial for PAZ320, recently published in the peer-reviewed journal, Endocrine Practice. In the Phase IIa study, PAZ320 was well tolerated in patients taking various anti-diabetic agents, including metformin. The Phase IIb trial, which focuses on patients taking only metformin, is the next step in the investigation of this compound as a potential adjunct to metformin in patients living with Type 2 diabetes. We believe it is important to better control glucose levels throughout the day, given the many complications that stem from uncontrolled diabetes.”
Metformin is the most widely prescribed drug for diabetes and often the first drug prescribed to newly diagnosed diabetes patients.
About PAZ320
PAZ320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. PAZ320 is a proprietary polysaccharide to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down complex carbohydrates into simple sugars, reducing the availability of glucose for absorption into the bloodstream.
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is an innovator in designing drugs using complex carbohydrate chemistry. The Company’s product pipeline is focused on developing and commercializing therapeutic molecules that address Type 2 diabetes, including: PAZ320, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. More information is available at www.bostonti.com.
Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of our drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in the trials could delay obtaining meaningful results from Phase II and/or preparing for Phase III with the current cash on hand.
Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from this proposed indication. Plans regarding development, approval and marketing of any of our drugs, including PAZ320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2012, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
Contact:
Boston Therapeutics, Inc.
Anthony Squeglia
Vice President of Strategic Planning
Phone: 603-935-9799
Email: anthony.squeglia@bostonti.com
www.bostonti.com
(GWPH) Commences Phase 1b/2a Clinical Trial In Glioblastoma Multiforme
-Study Features THC and CBD as the Primary Cannabinoids-
LONDON, Nov. 11, 2013 — GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW”) a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced today it has commenced a Phase 1b/2a clinical trial for the treatment of Recurrent Glioblastoma Multiforme (GBM).
Glioma describes any tumor that arises from the glial tissue of the brain. GBM is a particularly aggressive tumor that forms from abnormal growth of glial tissue. According to the New England Journal of Medicine, GBM accounts for approximately 50% of the 22,500 new cases of brain cancer diagnosed in the United States each year. Treatment options are limited and expected survival is a little over one year. GBM is considered a rare, or orphan, disease by the FDA and the European Medicines Agency, or EMA.
This study follows several years of pre-clinical research conducted by GW in the field of glioma which has demonstrated that cannabinoids inhibit the viability of glioma cells both in vitro and in vivoi,ii via apoptosis or programmed cell death, may also affect angiogenesis, and have demonstrated tumor growth-inhibiting action and an improvement in the therapeutic efficacy of temozolomide, a standard treatment for glioma. In addition, GW has shown tumor response to be positively associated with tissue levels of cannabinoids. GW has identified the putative mechanism of action for our cannabinoid product candidate, where autophagy and programmed cell death are stimulated via stimulation of the TRB3 pathway.
“We are very excited about moving this compound into further human study and the prospects of cannabinoids as new anti-cancer treatments. This is GW’s first clinical study of cannabinoids as a potential treatment to inhibit tumor growth,” stated Dr. Stephen Wright, Director of Research and Development at GW. “We believe this clinical program demonstrates the flexibility and broad application of GW’s cannabinoid platform to treat significant, unmet therapeutic needs.”
This study is a 20-patient, multicentre, two part study with an open-label phase to assess safety and tolerability of GW cannabinoids in combination with temozolomide, and a double blind, randomised, placebo-controlled phase with patients randomised to active or placebo, and with a primary outcome measure of 6 month progression free survival. The study objective is to assess the tolerability, safety and pharmacodynamics of a mixture of two principal cannabinoids, THC and CBD in a 1:1 allocation ratio, in combination with temozolomide in patients with recurrent GBM. Secondary endpoints include additional pharmacokinetic and biomarker analyses and additional measurable outcomes of tumor response.
References:
i. Parolaro D, Massi P, Rubino T, Monti E. Endocannabinoids in the immune system and cancer. Prostaglandins Leukot Essent Fatty Acids 2002;66(2-3):319-32.
ii. Guzman M. Cannabinoids: potential anticancer agents. Nat Rev Cancer 2003;3(10):745-55.
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 22 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has established a world leading position in the development of plant-derived cannabinoid therapeutics and has a deep pipeline of additional clinical-stage cannabinoid product candidates targeting epilepsy (including an orphan pediatric epilepsy program), Type 2 diabetes, ulcerative colitis, glioma and schizophrenia. 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 our clinical goals, our plans for a clinical trial, the ability to conduct clinical trials sufficient to achieve positive completion, and the therapeutic and commercial value of the company’s compounds. To the degree we are able to conduct clinical trials, we may have difficulty in enrolling candidates for testing and we may not be able to achieve the desired results. 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® 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, including the prospectus related to the NASDAQ offering filed by GW with the SEC on May 1, 2013. 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.
(UNIS) Supply Agreement with MedImmune for Wearable Injectable Drug Delivery Devices
YORK, Pa., Nov. 11, 2013 — Unilife Corporation (NASDAQ: UNIS, ASX: UNS), a U.S. based designer, developer and manufacturer of injectable drug delivery systems, today announced an agreement with MedImmune, the global biologics research and development arm of AstraZeneca, to customize and supply devices from its platform of wearable injectors for use with molecules in MedImmune’s pipeline.
Under this agreement, Unilife will supply MedImmune with customized devices from its platform of ReadyToGo™ wearable injectors. Several drug candidates from MedImmune’s portfolio may be selected for use with Unilife’s wearable injectors under the agreement.
Mr. Alan Shortall, Chief Executive of Unilife, said, “This is the dawn of a new era for injectable drug delivery where a very sophisticated new class of wearable, disposable devices will allow patients to deliver the most advanced therapies with maximum comfort and convenience. I am delighted that Unilife is setting the standard in serving biotech customers, such as MedImmune, and their patients within this category.”
“We are pleased that MedImmune selected Unilife’s technology after conducting a thorough evaluation process to identify simple and convenient wearable injectors that can be used to administer an injectable therapy wherever the patient is,” Mr. Shortall concluded.
Unilife will generate revenue starting in the first quarter of fiscal 2014 on the basis of the customization and supply of its products to MedImmune. Additional terms of the contract have not been disclosed.
The wearable injection category is expected to generate device sales in excess of $3 billion within five to seven years.
Conference Call Information
Unilife is hosting its quarterly earnings conference call at 4:30 p.m. U.S. EST today, during which the Unilife management team will review its financial results for the quarter ended September 30, 2013, this contract, other commercial partnerships and its future outlook. To listen, please go to: http://ir.unilife.com/events.cfm.
About the ReadyToGo Wearable Injectors
The Unilife portfolio of ReadyToGo wearable injectors is a game-changing platform that addresses the unmet needs of biotech customers in delivering high-dose volume therapies wherever the patients are. The ReadyToGo wearable injectors are supplied to the patient prefilled with the drug and ready-for-injection with no extra steps or parts required. Only three simple steps are required to inject the dose: peel, stick, click, with an on-body safety interlock, a Flexwear™ comfort catheter and an electronic user interface among an array of features that maximize patient comfort and awareness during all stages of use. The devices are designed to minimize disruption to a patient’s normal daily lifestyle during the period of dose delivery.
The ReadyToGo wearable injectors are designed for integration with standard filling processes, utilize standard materials in the primary drug container and require no terminal sterilization. A fully programmable delivery regimen allows the bolus, basal or variable rate of dose delivery to be customized to specific customer, therapy and patient requirements. The electronics in the device can be easily detached and disposed for markets that require special electronics disposal procedures. A video of Unilife’s platform of wearable injectors can be viewed on the Unilife website at http://bit.ly/19MYWTA.
About Unilife Corporation
Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of injectable drug delivery systems. Unilife’s broad portfolio includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors, ocular delivery systems and novel devices. Each of these innovative, differentiated platforms can be customized by Unilife to address specific customer, drug and patient requirements. Unilife’s global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information, please visit www.unilife.com or download the Unilife IRapp on your iPhone, iPad or Android device.
Forward-Looking Statements
This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management’s beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in “Item 1A. Risk Factors” and elsewhere in our Annual Report on Form 10-K and those described from time to time in other reports which we file with the Securities and Exchange Commission.
General: UNIS-G
Investor and PR Contacts (US): | Analyst Enquiries | Investor Contacts (Australia) |
Todd Fromer / Garth Russell | Lynn Pieper | Jeff Carter |
KCSA Strategic Communications | Westwicke Partners | Unilife Corporation |
P: + 1 212-682-6300 | P: + 1 415-202-5678 | P: + 61 2 8346 6500 |
(SLTM) to Present at CanaccordGenuity Medical Technology & Diagnostics Forum
HAYWARD, Calif., Nov. 11, 2013 — Solta Medical, Inc. (NASDAQ: SLTM), a global leader in the medical aesthetics market, today announced that it will present at the CanaccordGenuity Medical Technology & Diagnostics Forum in New York on Thursday, November 14, 2013 at 11:00 am ET. Mark Sieczkarek, Interim Chief Executive Officer of Solta Medical, will participate in a fireside chat to discuss the Company’s business strategy and recent corporate events.
Solta will offer a live audio webcast of the presentation that may be accessed on the Investor Relations section of the Company’s website at www.solta.com or by using the following link: http://wsw.com/webcast/canaccord12/. A replay of the webcast also will be archived and available for 90 days.
About Solta Medical, Inc.
Solta Medical, Inc. is a global leader in the medical aesthetics market providing innovative, safe, and effective solutions for patients that enhance and expand the practice of medical aesthetics for physicians. The Company offers aesthetic energy devices for skin resurfacing and rejuvenation, acne reduction, body contouring and skin tightening, as well as tools and accessories to optimize the latest liposuction techniques. Each brand is an established category leader, and together comprise of a comprehensive platform to address a range of aesthetic skin and body issues. Fraxel® delivers minimally-invasive clinical solutions to resurface aging and sun damaged skin. Clear + Brilliant® is a cost-effective, non-ablative laser treatment uniquely designed to improve skin tone and radiance. Isolaz® acne treatment combines vacuum and painless broadband light to address a wide variety of acne types. CLARO® is an FDA-cleared personal care acne device that uses heat and light to clear skin quickly and naturally. Thermage® is a non-invasive radiofrequency procedure that improves the appearance of wrinkles, which can result in smoother, more contoured skin. Liposonix® is a non-surgical single-treatment procedure that uses advanced high-intensity focused ultrasound technology to destroy targeted fat beneath the skin. VASERshape™ is a complementary non-invasive treatment that combines low frequency, non-focused ultrasound and lymphatic massage to temporarily reduce the appearance of cellulite and improve blood circulation with minimal pain or no downtime. The VASERlipo™ system uses ultrasound technology to selectively remove unwanted body fat. It includes VentX® technology that powers an aspiration system for quiet, efficient removal of fatty tissue and precision vented cannulas to maximize aspiration efficiency and speed. VASERsmooth™ is a unique body sculpting add-on tool for use with the VASERlipo system. PowerX® is a power-assisted liposuction system that uses a unique rotational motion which can be used with the VASERlipo system or to enhance traditional liposuction systems. The TouchView® system fits between the fingers and provides diagnostic imaging of subcutaneous structures during procedures. Both the VASERlipo system and traditional liposuction systems can utilize the Origins™ products, a complete line of custom liposuction infiltration, re-injection and aspiration cannulas and accessories. More than two and a half million procedures have been performed with Solta Medical’s portfolio of products around the world.
For more information about Solta, call 1-877-782-2286 or log on to www.Solta.com.
(SMSI) and Gemalto Join Forces to Help Mobile Operators Monitor Mobile Network Traffic
Gemalto Expands Its Robust Connectivity Platform to Include Smith Micro’s Solution for Network Traffic Management
Gemalto Expands Its Robust Connectivity Platform to Include Smith Micro’s Solution for Network Traffic Management
ALISO VIEJO, CA–(Nov 11, 2013) – Smith Micro Software, Inc. (NASDAQ: SMSI) today announced its NetWise™ solutions for network and device management are now offered by Gemalto, the world leader in digital security, to help operators across the globe manage data traffic across 3G, 4G and Wi-Fi networks more efficiently.
Gemalto provides advanced mobile solutions to 450 mobile operators around the world. By integrating Smith Micro’s NetWise platform with Gemalto’s LinqUs™ Advanced Connectivity Offer, Gemalto will enable their customers to enforce traffic management policies and seamlessly offload subscribers to Wi-Fi networks to ensure the best possible quality of service.
“With the exploding growth of mobile data traffic around the world, it is critical for operators to efficiently utilize Wi-Fi networks as part of their overall network strategy. Cooperation with Smith Micro allows Gemalto to expand its portfolio of advanced mobile solutions. Our combined technologies will give operators a flexible, targeted approach to traffic management that is highly effective in addressing mobile data congestion and quality of service,” said Jean-François Schreiber, SVP Telecom BU, Solutions and Services at Gemalto.
“The NetWise platform was designed to provide intelligent, policy-driven connectivity to meet the unique needs of each operator. This joint effort with Gemalto enables us to expand our global footprint and gain leverage from their extensive operator relationships. Our collaboration is already bearing fruit, as we’ve already signed up a joint customer,” said Dan Rawlings, Chief Revenue Officer at Smith Micro.
The NetWise platform includes network and device management solutions that help operators control network connections and meet data traffic challenges head-on. For more information visit:
About Smith Micro Software, Inc.:
Smith Micro Software provides solutions that simplify, secure and enhance the mobile experience. Our portfolio includes a wide range of applications that manage broadband connectivity, data traffic, devices, voice and video communications over wireless networks. With 30 years of experience developing world-class client and server software, Smith Micro helps the leading mobile network operators, device manufacturers and enterprises increase efficiency and capitalize on the growth of mobile-connected consumers and workforces. For more information, visit smithmicro.com. (NASDAQ: SMSI)
Safe Harbor Statement:
This release contains forward-looking statements that involve risks and uncertainties, including without limitation, forward-looking statements relating to the company’s financial prospects and other projections of its performance, the existence of new market opportunities and interest in the company’s products and solutions, and the company’s ability to increase its revenue and regain profitability by capitalizing on these new market opportunities and interest and introducing new products and solutions. Among the important factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements are changes in demand for the company’s products from its customers and their end-users, customer concentration given that the majority of our sales depend on a few large client relationships, including Sprint, new and changing technologies, customer acceptance and timing of deployment of those technologies, new and continuing adverse economic conditions, and the company’s ability to compete effectively with other software companies. These and other factors discussed in the company’s filings with the Securities and Exchange Commission, including its filings on Forms 10-K and 10-Q, could cause actual results to differ materially from those expressed or implied in any forward-looking statements. The forward-looking statements contained in this release are made on the basis of the views and assumptions of management regarding future events and business performance as of the date of this release, and the company does not undertake any obligation to update these statements to reflect events or circumstances occurring after the date of this release.
Smith Micro, VIDIO, and the Smith Micro logo are registered trademarks or trademarks of Smith Micro Software, Inc. All other trademarks and product names are the property of their respective companies.
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Smith Micro Software, Inc.
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(GALE) Initial Folate Binding Protein Vaccine Phase 1 Trial Results Presented
- Folate Binding Protein (FBP) shown to be safe and immunogenic in its Phase 1 trial
- Phase 2a trial expected to initiate by year end
PORTLAND, Ore., Nov. 11, 2013 — Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced a poster presentation at the Society for Immunotherapy of Cancer (SITC) Conference 2013 on November 7-10, 2013, in National Harbor, Maryland. The data presented are the results of the Phase 1 portion of the trial for the Folate Binding Protein (FBP) vaccine. FBP is a folate receptor alpha-derived, peptide-based cancer immunotherapy administered to HLA A2 positive patients in combination with granulocyte macrophage-colony stimulating factor (GM-CSF) as an adjuvant treatment to prevent recurrences in high-risk, endometrial and ovarian cancer patients rendered disease-free after completing standard of care therapy.
The poster presentation entitled “Phase 1 Trial Results of a Folate Receptor Alpha-directed Cancer Vaccine (E39) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence,” showed that the FBP vaccine is both safe and immunogenic. The primary outcome of the Phase 1 trial was to determine safety and the optimal dose, with a secondary outcome to look for an initial efficacy signal and immunological response. The optimal dose was determined to be 500 mcg peptide combined with 250 mcg GM-CSF. FBP proved to be well tolerated, with largely Grade 1 toxicities, primarily consisting of injection site reactions. After a median follow-up of six months, there have been 2 recurrences (13.3%; n=15) in the vaccine group vs. 4 recurrences (25%, n=16) in the control group, although the trial was not powered for any efficacy measurements.
“New approaches are needed for ovarian and endometrial cancer patients who face a high risk of disease recurrence. The initial results from the Phase 1 trial show that the FBP vaccine may be a potential cancer immunotherapy treatment to prevent recurrence in these high risk patient populations,” concluded Dr. Erika J. Schneble, San Antonio Military Medical Center, San Antonio, TX who presented the results at the SITC conference.
The Phase 1 component was a 3×3, dose-escalation, safety trial enrolling disease-free endometrial and ovarian cancer, HLA-A2 positive patients into the vaccine group, while HLA-A2 negative patients were being followed prospectively as an untreated control group. Six monthly intradermal inoculations of either 100mcg, 500mcg, or 1000mcg of peptide vaccine + 250 mcg GM-CSF immunoadjuvant were administered during the primary vaccine series. Immunologic responses were assessed by both local reaction after each inoculation and by delayed-type hypersensitivity (DTH) reaction measured pre-vaccination and after the primary vaccine series. Recurrences are determined clinically. Thirty-one patients were enrolled in the Phase 1 trial: 15 in the vaccine group and 16 in the active control group. There were no significant differences in age, grade, stage, or nodal status between groups. Overall, the vaccine was well tolerated with the majority of local and systemic toxicities Grade 1 (maximum local toxicity: 93% Grade 1; maximum systemic toxicity: 60% Grade 1). Local skin reactions increased from the first to the third injections, and then plateaued for the remainder of therapy.
“We are encouraged by the initial results of our Phase 1 trial with the FBP vaccine, showing that it is well-tolerated and demonstrated promising immune responses in high risk gynecological cancers,” said Mark J. Ahn, President and Chief Executive Officer of Galena Biopharma. “As a result, we are moving forward with the Phase 2a component which will be initiated by year end and will include the enrollment of additional patients at the optimal dose as well implementing a booster regimen.”
About Folate Binding Protein (FBP)
Folate Binding Protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is a well-validated therapeutic target. FBP is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy presenting FBP-expressing cancer cells. The FBP vaccine consists of the FBP peptide(s) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). Galena’s FBP vaccine is currently in a Phase 1/2 trial in two gynecological cancers: ovarian and endometrial adenocarcinomas.
About Ovarian/Endometrial Cancers
Ovarian cancer occurs in over 22,000 patients per year in the U.S. and is the most lethal gynecologic cancer. Despite the incidence of ovarian cancer being only approximately 20% of that of breast cancer, the number of patients that die from ovarian cancer is nearly 50% of that of breast cancer. Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease. These patients have their tumors routinely surgically debulked to minimal residual disease, and then are treated with platinum- and/or taxane-based chemotherapy. While most patients respond to this treatment regimen and become clinically free-of-disease, the majority of these patients will relapse, and once the disease recurs, the treatment options and successes drop dramatically.
Endometrial cancer is the most common gynecologic cancer and occurs in over 46,000 women, with over 8,000 deaths, in the U.S. annually. There are two basic types of endometrial cancer: endometriod and papillary serous. The latter has a much more aggressive clinical course and the majority of these patients will die of this form of the disease.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit: www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the preliminary results Galena’s clinical trials and planned additional trials. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2012 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena 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 press release.
CONTACT: Remy Bernarda Senior Director, Communications (503) 405-8258 rbernarda@galenabiopharma.com
(OXBT) Receives $6 Million in Net Proceeds from Warrant Exercises
Oxygen Biotherapeutics, Inc., (NASDAQ:OXBT) a developer of oxygen-carrying therapeutics, today announced the Company has received approximately $6 million through the exercise of 2,294,874 warrants between November 4, 2013 and November 6, 2013. These warrants were issued by the Company in connection with its July 2013 Series C 8% Convertible Preferred Stock financing. Following these warrant exercises, 9,112,307 shares of the Company’s common stock were issued and outstanding as of November 7, 2013.
“The exercise of these warrants increases our current cash on hand to approximately $8.4 million. Upon closing of the previously announced Phyxius Pharma transaction, we expect to be in a position to commence the Phase 3 FDA trial of levosimendan for the prevention and treatment of low cardiac output syndrome in heart surgery patients,” stated Michael Jebsen, Oxygen Biotherapeutics President, CFO and Interim CEO.
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is developing medical products that efficiently deliver oxygen to tissues in the body. The company has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte® that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke. The company is also developing PFC-based creams and gels for topical delivery to the skin for dermatologic conditions and potentially wound care.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, the likelihood of the consummation of the Phyxius transaction, as well as the successful integration of Phyxius into the Company, the Company’s actual cash flows following consummation of the Phyxius transaction, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in our filings with the Securities and Exchange Commission, including in the current Form 10-Q filed on September 17, 2013, and our annual report on Form 10-K filed on June 26, 2013, as well as other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
(YOD) Goes Mobile in China with Huawei
NEW YORK, Nov. 8, 2013 — YOU On Demand Holdings, Inc. (NASDAQ: YOD) (“YOU On Demand” or “the Company”), a leading mobile entertainment and Video On Demand platform in China, today announced a distribution agreement with Huawei, a leading global information and communications technology (ICT) solutions provider and the third largest global smartphone manufacturer, to offer feature films through YOU On Demand’s newly launched mobile application (App), YOU Cinema.
Beginning Monday, November 11th, the YOU Cinema App will come preloaded on Huawei Mate smartphones and will feature recently released and library movie titles from YOU On Demand content partners, including Paramount Pictures.
Engineered to offer a first-class mobile viewing experience, the Mate will be marketed to Chinese consumers as the “Movie Phone.” Owners of the device will be the first in China to experience YOU Cinema’s extensive and groundbreaking movie service, which will offer such blockbuster titles as G.I. Joe: Retaliation and Star Trek Into Darkness. The Mate will be available for purchase on Huawei’s VMall B2C e-commerce platform and website, www.vmall.com.
“In order to adapt to the revolutionary changes that are taking place in the information industry, we all have to make strategic moves in addressing today’s consumer needs. This in-depth cooperation with YOU On Demand to launch the first Movie Phone on VMall is part of our continuous innovation driven by what mobile consumers demand. This is a milestone in developing our cloud service. This bridge between movie content and device provides greater flexibility and convenience for watching movies. It is also extremely important for us in bringing users quality mobile service anytime and anywhere in the mobile internet era. At the same time, this is the first step of our strategic initiative of open cooperation with content partners and also symbolizes a new stage of our open platform strategy,” said Guoqiang Rong, CEO of Device Cloud Business, Huawei Consumer Business Group.
“We are extremely proud to be chosen by Huawei for this strategic partnership. This partnership marks the next step in YOU On Demand’s commitment and goal to provide rich and diverse content to customers anytime and anywhere on a wide variety of platforms,” said Weicheng Liu, CEO of YOU On Demand. “It has always been our mission and focus to deliver the best user experience via digital cable television, IPTV and OTT Video On Demand. This cooperation with Huawei expands our services into mobile phones, which will become the centerpiece of consumer content consumption on multiple screens across multiple platforms.”
Huawei will host an official launch event on November 8, 2013 in Beijing to promote the YOU Cinema movie App on the Huawei Mate, with representatives from Huawei and YOU On Demand scheduled to attend the event.
Since overtaking the U.S. last year in shipment volume, China’s smartphone market is now the world’s largest. Shipments are projected to grow 25% next year to 450 million units from a forecast of 360 million for this year, according to market research firm IDC.
About Huawei (www.huawei.com/en)
Huawei is a leading global ICT solutions provider. Through our dedication to customer-centric innovation and strong partnerships, we have established end-to-end capabilities and strengths across the carrier networks, enterprise, consumer, and cloud computing fields. We are committed to creating maximum value for telecom carriers, enterprises and consumers by providing competitive ICT solutions and services. Our products and solutions have been deployed in over 140 countries, serving more than one third of the world’s population.
Huawei’s vision is to enrich life through communication. By leveraging our experience and expertise in the ICT sector, we help bridge the digital divide by providing opportunities to enjoy broadband services, regardless of geographic location. Contributing to the sustainable development of society, the economy, and the environment, Huawei creates green solutions that enable customers to reduce power consumption, carbon emissions, and resource costs.
About YOU On Demand Holdings, Inc. (www.yod.com)
YOU On Demand (NASDAQ: YOD), is a leading multi-platform entertainment company delivering premium content, including leading Hollywood and China-produced movie titles, to customers across China via Subscription Video On Demand and Transactional Video On Demand. The Company has secured alliances with leading global media operators and content developers. YOU On Demand has content distribution agreements in place with many of Hollywood’s top studios including Disney Media Distribution, Paramount Pictures, NBC Universal, Warner Bros., Miramax Films, Lionsgate and Magnolia Pictures, as well as a broad selection of the best content from Chinese filmmakers. The Company has a comprehensive end-to-end secure delivery system, governmental partnerships and approvals and offers additional value-added services. YOU On Demand has strategic partnerships with the largest media entities in China, a highly experienced management team with international background and expertise in Cable, Television, Film, Digital Media, Internet and Telecom. YOU On Demand is headquartered in New York, NY with its China headquarters in Beijing.
Safe Harbor Statement
This press release contains certain statements that may include “forward looking statements.” All statements other than statements of historical fact included herein are “forward-looking statements.” These forward looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements
CONTACT:
Jason Finkelstein
YOU On Demand
212-206-1216
jason.finkelstein@yod.com
@youondemand
(CXM) Announces Publication On Use Of Excellagen For Managing Chronic Pressure Ulcers
SAN DIEGO, Nov. 8, 2013 – Cardium Therapeutics (NYSE MKT: CXM) today announced the publication of a case study, “Serial Sharp Debridement and Formulated Collagen Gel to Treat Pressure Ulcers in Elderly Long-term Care Patients”, in the peer-reviewed November 2013 issue of Ostomy Wound Management Ostomy Wound Manage. 2013;59(11):43–49. The electronic publication of the study is available at http://www.o-wm.com/article/serial-sharp-debridement-and-formulated-collagen-gel-treat-pressure-ulcers-elderly-long-term. The paper highlights Excellagen’s capability of promoting rapid granulation and healing in chronic pressure ulcers in elderly long-term care facility residents.
The study involved patients with chronic, non-healing pressure ulcers of over 18 months duration, despite the use of a variety of treatments, including negative pressure wound therapy. The weekly treatment regimen consisted of sharp debridement and application of Cardium’s advanced wound care product, Excellagen. All patients studied exhibited significant formation of new granulation tissue within their previously non-healing pressure wounds, which led to either complete wound closure or substantial wound reduction within 5 to 6 weeks of treatment. The study also gathered feedback from the study nurses via questionnaire. The study nurses agreed that weekly use of Excellagen “required less time and was more compatible with their busy schedules than standard care of daily (or multiple times daily) dressing changes.”
The study’s co-author, Jennifer K. Agosti, RN, Certified Wound Care Associate and Certified Foot and Nail Care Nurse, and the President of Nurse Sharks, Inc., a company focused on wound care management and infection control in long-term care facilities, stated, “I was impressed with the response to Excellagen and the dramatic speed of granulation tissue growth in these chronic wounds which had not responded to multiple other treatment interventions for over 18 months. We believe Excellagen is a potential cost-effective therapy for the treatment of pressure ulcers and although not included in the paper, we calculated that the total costs of the previous year of treatment in these patients compared to Excellagen ranged between $10,800 and $16,500 per patient.”
Lois A. Chandler, PhD, Cardium’s Vice President, Biologics Development and co-author of the article, stated “We appreciate the contributions of the team at Nurse Sharks and look forward to the opportunity to work together on ongoing and additional case studies for the treatment of non-healing pressure ulcers in long-term care patients. These complex and challenging wounds are generally difficult to heal, and long-term care facilities represent a setting where the cost- and resource-effectiveness of Excellagen can provide significant benefits to both the patient and the facility.”
According to the Agency for Healthcare Research and Quality, more than 2.5 million people in the U.S. develop pressure ulcers, and approximately 60,000 patients die annually as a result of them. Lawsuits related to pressure ulcers total 17,000 annually and account for the most common claim after wrongful death. Despite best efforts to implement guidelines for the prediction and prevention of ulcers, the prevalence remains high in long-term care facility residents. In the acute care and long-term care settings, pressure ulcers affect more than one million patients and the annual costs of treating pressure ulcers are projected to be between $1.3 billion and $6.8 billion.
About Ostomy Wound Management
Ostomy Wound Management was founded in March of 1980 as “Ostomy Management.” In 1985, the journal expanded its content and readership by embracing the overlapping disciplines of ostomy care, wound care, incontinence care, and related skin and nutritional issues, and became the premier journal of its kind. Ostomy Wound Management’s readers include healthcare professionals from multiple disciplines and its readers benefit from contemporary and comprehensive review and research papers that are practical, clinically oriented, and cutting edge. Each published article undergoes a rigorous double-blind peer review by members of both the Editorial Advisory Board and the Ad-Hoc Peer Review Panel. More information is located at http://www.o-wm.com/.
About Excellagen
Excellagen is a syringe-based, professional-use, pharmaceutically-formulated 2.6% fibrillar Type I bovine collagen homogenate that functions as an acellular biological modulator to activate the wound healing process and significantly accelerate the growth of granulation tissue. Excellagen’s FDA clearance provides for very broad labeling including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds. Excellagen is intended for professional use following standard debridement procedures in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors. Excellagen’s unique fibrillar Type I bovine collagen homogenate formulation is topically applied through easy-to-control, pre-filled, sterile, single-use syringes and is designed for application at only one-week intervals. Additional information about Excellagen is available at www.excellagen.com.
About Cardium
Cardium is an asset-based health sciences and regenerative medicine company focused on the acquisition and strategic development of innovative products and businesses with the potential to address significant unmet medical needs and having definable pathways to commercialization, partnering or other economic monetizations. Cardium has four private company business units in its medical opportunities portfolio: (1) LifeAgain® Insurance Solutions, Inc., which is focused on the development and commercialization of its medical data analytics platform, including the Company’s recently-launched BlueMetric Select term life insurance program for men with prostate cancer; (2) Angionetic Therapeutics™, which includes Cardium’s late-stage DNA-based Generx® cardiovascular biologic product candidate; (3) Activation Therapeutics™, which includes the Company’s regenerative medicine wound healing technology platform, including its Excellagen® advanced wound care product; and (4) To Go Brands®, which includes the Company’s health sciences and nutraceutical business. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. For more information, visit www.cardiumthx.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that results or trends observed in a clinical study or follow-on case studies will be reproduced in subsequent studies or in actual use; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that our partners will be successful in obtaining the necessary approvals or clearances from international health authorities or they can successfully commercialize Excellagen; that the company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive or blocked by third party proprietary rights or other means; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized and their use reimbursed, or will enhance our market value; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to maintain our stock exchange listing or adequately fund ongoing operations; or that we will not be adversely affected by these or other risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2013 Cardium Therapeutics, Inc. All rights reserved.
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Cardium Therapeutics®, Generx®, Excellagen®, LifeAgain®, BlueMetric™, Decision Rule Adaption™, ADAPT™, Angionetic Therapeutics™, Activation Therapeutics™ are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company. To Go Brands®, High Octane®, Green Tea Energy Fusion™, Acai Natural Energy Boost™, Greens to Go®, Extreme Berries to Go®, Healthy Belly®, VitaRocks®, Smoothie Complete®, Trim Green Coffee Bean™, and Trim Energy®, are trademarks of To Go Brands, Inc. Other trademarks belong to their respective owners.
(CLDX) CDX-1127 Well Tolerated and Demonstrates Anti-Tumor Activity
Very favorable safety profile; no evidence of immune related toxicities
Three patients with significant tumor shrinkage, including an ongoing CR in Hodgkin disease
Eight patients with stable disease or better; PFS range of 3.0 to 14+ months
Immune monitoring data in patients confirms CDX-1127 mechanism of action
PHILLIPSBURG, N.J., Nov. 7, 2013 — Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported data from its ongoing Phase 1 dose-escalation study of the fully human monoclonal antibody CDX-1127. The results suggest an excellent safety profile and demonstrate clear biologic activity and promising signs of clinical activity in an advanced, refractory patient population. No maximum tolerated dose has been reached to date. The data will be presented in two poster sessions (poster #144 and 146) at the 2013 Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 7 – 10, 2013. In addition, a third poster (#85) will be presented on preclinical combination studies of CDX-1127 with chemotherapies and checkpoint inhibitors. The Company will host a webcast/conference call at 8:30 am ET today to discuss the results (details provided below).
“CDX-1127 has exceeded our expectations thus far in this ongoing Phase 1 dose-escalation study,” said Thomas Davis, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. “Our primary goal was to establish a favorable safety profile, a challenge that other agonist antibodies in this class have not been able to meet. To date, CDX-1127 has demonstrated minimal toxicity and, importantly, no evidence of worrisome overlap with toxicities seen with other immunotherapies—a critical hurdle for combination therapy. We were also very pleased to see clear evidence of biologic and anti-cancer activity in a heavily pretreated patient population. While future data from the expansion cohorts will be important to understanding single-agent activity, we are confident based on the dose-escalation data we have seen to date that we are well positioned to initiate combination studies of CDX-1127, with a particular interest in immune modulators.”
“We are encouraged by the initial safety and activity profile observed to date and believe CDX-1127 could play an important role in the field of cancer immunotherapy,” said Howard A. “Skip” Burris, III, MD, Chief Medical Officer and Executive Director of the Drug Development Program at Sarah Cannon Research Institute and a lead investigator of the Phase 1 CDX-1127 study. “An agonist with this safety and biologic activity profile has potential, particularly in combination with checkpoint inhibitors, where the ability to mount an immune response could expand the effectiveness of these compounds for more patients.”
CDX-1127 is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes. CD27 can be effectively manipulated with activating antibodies to induce potent anti-tumor responses, and may result in less toxicities due to its restricted expression and regulation. CDX-1127 is a potent anti-CD27 agonist that induces activation and proliferation of human T cells when combined with T-cell receptor stimulation. In lymphoid malignancies that express CD27 at high levels, CDX-1127 has an additional mechanism through a direct anti-tumor effect.
Study Overview:
The Phase 1 dose-escalation study of CDX-1127 includes two arms—solid tumors and lymphoid malignancies and is designed to evaluate five doses (0.1, 0.3, 1, 3, 10 mg/kg). Enrollment is complete in the solid tumor dose-escalation arm (n=25) and expansion cohorts are ongoing in metastatic melanoma and renal cell carcinoma. In the dose-escalation lymphoid malignancies arm (n=17), enrollment recently initiated in the 10 mg/kg cohort and expanded development is being planned. Currently, first response assessments are pending for four patients across the 1 and 3 mg/kg cohorts and all patients in the 10 mg/kg cohort in the lymphoid malignancies arm. Patients enrolled in the study across both arms had advanced disease and most were heavily pretreated. Patients progressed on previous therapies and had no remaining approved treatment options before study entry. The median number of prior therapies is 5 anti-cancer (3 cytotoxic) for solid tumors and 4 anti-cancer (3 cytotoxic) for lymphoid malignancies.
Safety and Immune Monitoring Overview:
In the solid tumor dose-escalation phase, CDX-1127 was associated with minimal toxicity including at the highest dose levels through multiple cycles. No maximum tolerated dose was reached. The most common treatment-related adverse events were decreased appetite (12%) and fatigue (12%). One patient experienced a dose limiting toxicity (DLT), a Grade 3 transient asymptomatic hyponatremia 14 days after a single 1.0 mg/kg dose of CDX-1127. Hyponatremia has not been attributed to CDX-1127 in any other patient. The safety data from the lymphoid malignancies arm also show that CDX-1127 has been well tolerated with no DLTs to date.
The preliminary assessment of pharmacokinetics demonstrates significant exposure to CDX-1127 throughout the duration of the study period. Immune monitoring assessments conducted in the solid tumor arm support the overall safety profile and also demonstrate that CDX-1127 induces immunologic activity in patients that is consistent with both its mechanism of action and preclinical models, including an increase in Natural Killer cells and in T cells that express the activation marker, HLA-DR. The study also identified the serum chemokine, interferon-gamma inducible protein 10 (IP-10) as a significant biomarker for CDX-1127 treatment. Of note, the study confirms that CDX-1127 does not induce major lymphocyte depletion, but does reduce the number of regulatory T cells, which are thought to have immune suppressive activity. Taken together, these markers demonstrate clear evidence of lymphocyte activation—the direct purpose of CDX-1127 therapy.
Clinical Activity Overview:
Across both arms, eight patients experienced stable disease or better with a PFS range of 3.0 to 14+ months. In addition, three patients experienced significant tumor shrinkage, including a complete response as outlined below.
- A 28 year old female with Stage IV Hodgkin lymphoma achieved a complete response, including complete resolution of B symptoms (drenching sweats, pruritus and weight loss)—an important marker of disease activity in Hodgkin disease, after three cycles of CDX-1127 (0.3 mg/kg). The patient remains in remission at 8.6+ months. During treatment, the area of measurable lesions first increased and then regressed. This pattern is consistent with the current perception of an immune mediated response. The patient was heavily pretreated, including high dose chemotherapy with autologous marrow transplantation, and most recently had progressed after less than one month on Adcetris™ plus chemotherapy.
- A 69 year old male with Stage IV colorectal cancer metastatic to the liver, lung and peritoneum was treated with CDX-1127 (1 mg/kg) and had a 33% unidimensional shrinkage of measurable disease and a PFS of 5.7 months. The shrinkage was associated with small, new lesions representing a mixed response. The patient had previously received multiple agents, including Avastin® and most recently had progressed through Xeloda®/radiation at two weeks.
- A 67 year old male with Stage III marginal zone B-cell lymphoma who received CDX-1127 (0.3 mg/kg) experienced a 36% shrinkage of measurable disease, including complete disappearance of disease in the inguinal and iliac regions and had a PFS of 5.6 months. The patient was very heavily pretreated with 10 prior regimens of cytotoxic, radiation and Rituxan® therapy.
Two patients received all five cycles of treatment and were on trial for greater than a year, including:
- An 83 year old male with Stage IV renal cell carcinoma metastatic to liver and lung who remains progression-free at 14+ months after study entry, and
- A 52 year old male with Stage IV follicular lymphoma who had a PFS of 14 months.
The Company also reported very early data from the solid tumor expansion cohorts, where CDX-1127 has been well-tolerated to date. The melanoma cohort has accrued 14 patients at 3 mg/kg with eight patients continuing treatment, seven who have not yet been seen for the first assessment of response. One patient with uveal melanoma who is entering the third round of treatment has experienced a 12% shrinkage of measurable disease by RECIST and stable disease is ongoing at 5.7 months. The renal cell carcinoma arm has accrued eight patients at 3 mg/kg with seven continuing treatment, all of whom have not yet been seen for the first assessment of response.
In a separate poster, the Company reported new data of CDX-1127 in combination therapy using mouse tumor models. Agents that induce tumor killing to provide a source of antigen and agents that block T cell inhibitory molecules were chosen for their potentially complementary mechanisms of action. Employing challenging treatment settings where single agent activity is limited, a clear survival benefit was observed with CDX-1127 combinations of cyclophosphamide or checkpoint blockade. These studies, together with the favorable safety profile and activity data from the Phase 1 trial with CDX-1127, support the initiation of combination trials with conventional and immune-based therapies.
Webcast/Conference Call Information:
Celldex management will host a conference call/webcast at 8:30 am ET today to discuss the CDX-1127 program. Mario Sznol, MD, Professor, Internal Medicine, Vice-Chief, Section of Medical Oncology, Co-director, Yale Spore in Skin Cancer and Translational Research Leader, Melanoma Program at Yale Cancer Center and Dr. Madhav Dhodapkar, MBBS, Professor of Medicine and Chief, Section of Hematology at Yale Cancer Center will join the call.
The conference call and presentation will be webcast live over the Internet and can be accessed by logging on to the Events & Presentations section under “Investors and Media” of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 93902541.
A replay of the call will be available approximately one week after the live call concludes through November 14, 2013. To access the replay, dial 855-859-2056 (within the United States) or 404-537-3406 (outside the United States). The passcode is 93902541. The webcast will also be archived on the Company’s website.
Adcetris is a registered trademark of Seattle Genetics; Avastin and Xeloda are registered trademarks of Roche; Rituxan is a registered trademark of Biogen.
About Celldex Therapeutics, Inc.
Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline is built from a proprietary portfolio of antibodies and immunomodulators used alone and in strategic combinations to create novel, disease-specific therapies that induce, enhance or suppress the body’s immune response. Visit www.celldex.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company’s strategic focus and the future development and commercialization (by Celldex and others) of rindopepimut (CDX-110), Glembatumumab vedotin (“glemba”; CDX-011), CDX-1135, CDX-1401, CDX-1127, CDX-301, Belinostat and other products. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of rindopepimut, glemba and other drug candidates, our ability to obtain additional capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; our ability to adapt our APC Targeting TechnologyTM to develop new, safe and effective vaccines against oncology and infectious disease indications; our ability to successfully complete product research and further development of our programs; the uncertainties inherent in clinical testing; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage research and development efforts for multiple products at varying stages of development; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; and other factors listed under “Risk Factors” in our annual report on Form 10-K.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Sarah Cavanaugh Vice President of Investor Relations & Corp Communications Celldex Therapeutics, Inc. (781) 433-3161 scavanaugh@celldex.com
(NURO) to Present at Canaccord Genuity Medical Technology & Diagnostics Forum
NeuroMetrix, Inc. (Nasdaq: NURO), www.neurometrix.com, a medical device company focused on the treatment and management of the neurological complications of diabetes, today announced that Shai N. Gozani M.D., Ph.D., President and Chief Executive Officer, is scheduled to speak at the Canaccord Genuity Medical Technology & Diagnostics Forum at The Westin Grand Central, New York, NY on November 14, 2013. Dr. Gozani intends to provide an update on the Company’s business activities with particular emphasis on its SENSUS™ pain management system for relief of chronic intractable pain, including pain associated with diabetic neuropathy.
NeuroMetrix’s presentation is scheduled for Thursday, November 14, 2013 at 8:00 am (Eastern Daylight Time). A live audio webcast will be available on the investor relations section of the corporate website – www.neurometrix.com. This webcast will be archived after the live event.
About NeuroMetrix
NeuroMetrix is a medical device company that develops and markets home use and point-of-care devices for the treatment and management of chronic pain, peripheral neuropathies, and associated neurological disorders. The Company is presently focused on diabetic neuropathies, which affect over 50% of people with diabetes. If left untreated, diabetic neuropathies trigger foot ulcers that may require amputation and cause disabling chronic pain. The annual cost of diabetic neuropathies has been estimated at $14 billion in the United States. The company markets the SENSUS™ Pain Management System for treating chronic pain, focusing on physicians managing patients with painful diabetic neuropathy. The company also markets the DPNCheck® device, which is a rapid, accurate, and quantitative point-of-care test for diabetic neuropathy. This product is used to detect diabetic neuropathy at an early stage and to guide treatment. For more information, please visit http://www.neurometrix.com.
(CYTR) MissionIR Releases Exclusive Audio Interview With CytRx Management
ATLANTA, GA–(Nov 7, 2013) – MissionIR today announces the online availability of its interview with CytRx Corp. (NASDAQ: CYTR) President and Chief Executive Officer Steven Kriegsman, as well as the company’s Vice President of Business Development and Investor Relations David Haen. The full audio interview is available at: http://cytr.missionir.com/interview.html.
CytRx is a biopharmaceutical R&D company developing cancer drugs for several indications. The company’s primary focus is on its proprietary delivery technology for potent oncology therapies.
The company’s lead candidate, aldoxorubicin, is an improved version of the widely used chemotherapy agent, doxorubicin. A pivotal Phase 3 trial with a special protocol assessment is scheduled to begin in the first quarter of 2014 and top-line Phase 2b results are expected in December 2013. These are just a few developments in the company’s pipeline, which are further detailed in the interview.
“We have a technology that allows us to optimize chemotherapy agents as well as other anti-cancer agents,” Haen stated in the interview, describing aldoxorubicin and reinforcing Kriegsman’s statements. “We’re not seeing nearly the systemic toxicity one typically thinks of when you hear of chemotherapy… here we think we have a way to optimize it. Aldoxorubicin is really the proof of principal and the goal is to work with our collaborators in Freiburg, Germany, to develop additional molecules based on other chemotherapy payloads.
Kriegsman and Haen discuss their own backgrounds and experience in the industry, as well as detail the rest of the company’s management team.
Wrapping up the interview, Kriegsman highlights 2013 achievements and provides insight to recent company news and important upcoming developments.
Interview Transcript
Stuart Smith:
Welcome one, welcome all, to this online business briefing where we shine a spotlight on today’s smartest plays in the market. Today we are speaking with CytRx Corporation. The company is traded on the NASDAQ CM market under the ticker symbol CYTR. We are joined by two guests from the company. The President and CEO of the company, Steven Kriegsman, as well as David Haen. He’s the Vice President of Business Development and Investor Relations. Let’s go ahead and welcome Steven. First Steven, how you doing today?
Steven Kriegsman:
Very well, Stuart.
Stuart Smith:
Thank you so much for taking your time. And David, let’s hear from you. How are you doing out there in Los Angeles today?
David Haen:
Doing well, thank you sir.
Stuart Smith:
Alright. Great. Thank you, gentlemen for taking time from your busy schedule to stop by and speak to your shareholders as well as the listeners to this program. For those listeners that may not be familiar with your company yet. Steven, if you would, tell us a little bit about the company’s business model and market.
Steven Kriegsman:
Well, we’re a pure play oncology company. We develop cancer drugs for a number of different indications. And we have focused on the enhanced delivery of potent oncology therapies. We have a proprietary delivery technology with demonstrated efficacy. You know, that’s a platform for many different drugs and many different cancers, both hematological cancers, and solid tumors. We have a late stage clinical program with Phase 2B data globally coming in the fourth quarter of 2013.
First let’s talk about our novel oncology delivery platform. It can be used with a variety of oncology compounds. It most importantly concentrates drug release at the tumor, and it provides partnership opportunities for anticancer agents that are losing patent protection. We are a late stage technology validating pipeline company. Our lead program is a drug called Aldoxorubicin. It’s in a Phase 3 with a special protocol assessment to start in the first quarter of next year. We’re gearing up for that. We also will have Phase 2B top line progression-free survival results, and they’re expected in December 2013.
And we have two Phase 2 clinical trials starting this quarter. One in glioblastoma multiforme, more easily referred to as brain cancer, and the other one an HIV-related Kaposi’s sarcoma.
What’s great about CytRx is we have a risk-mitigated strategy, and our strategy is to create potential blockbuster oncology therapies from known chemotherapy payloads reducing both development and regulatory risks.
Stuart, let me take you through our pipeline. We have a second line soft tissue sarcoma pivotal trial under a special protocol assessment agreement with the FDA beginning in the first quarter of 2014. We have a first line soft tissue sarcoma trial, a Phase 2B global trial with top line data coming in the fourth quarter of 2013. We have glioblastoma multiforme trial beginning this quarter, and a Kaposi’s sarcoma trial also beginning this quarter. Both of them will be Phase 2 trials. And finally we have a pharmacokinetics study going on at Cedars-Sinai Medical Center. It’s a Phase 1 ongoing study, and that study is wrapping up.
In addition we have preclinical work that we’re doing in delivery-enhanced platinum, another chemotherapeutic, and delivery-enhanced Topotecan. They’re in ovarian cancers, small cell lung cancer, and colorectal cancer.
And to take you through our technology platform and how it operates, I’m going to have David Haen, our VP of Business Development and Investor Relations, explain that so that the listeners will have an opportunity to understand how powerful our platform is with delivery of enhanced chemotherapeutics.
Stuart Smith:
Very good. Well, David, let’s hear from you then.
David Haen:
Okay. Great. So as Steve mentioned, we have a technology that allows us to optimize chemotherapy agents as well as other anticancer agents. And what we do is we put a linker onto the molecule and we’re starting with well known cancer agents that have decades of experience of use in most cases, so we know which types of tumors respond to treatment with them. We also have a sense of the safety and what we should be looking for for side effects. And then with our linker, what we’re able to do is infuse the equivalent of 2 1/2 to four times the standard amount of that drug. And really the lead program Aldoxorubicin, besides being a very broad acting drug in and of itself, it’s really proving the principle of this platform. So once we have our molecule and it’s infused into the patient, it binds to a protein that’s already in the bloodstream. That protein helps transport it to the tumor, and it’s taken into the tumor, and then due to the environment within that cancer cell, you get release of our linker, and now we’ve preferentially released the drug at the tumor site. And we’re not seeing nearly the systemic toxicities that one typically thinks of when you hear of chemotherapy and someone being diagnosed with cancer. I think everyone’s first thought is I’m in for some rough treatment, and that is the case, but here we think we have a way to optimize it. Aldoxorubicin is really the proof of principle, and the goal is to work with our collaborators in Freiburg, Germany and continue to develop additional molecules based on other chemotherapy payloads.
Stuart Smith:
Well David, thank you so much for that. In our next section we’d like to learn about the leadership of the company, and you’re our guest today as the Vice President of Business Development and Investor Relations, let’s learn a little bit about your background before we learn about the rest of the team from Steven. Go ahead, David.
David Haen:
Thank you. I’ve been with CytRx now since 2003 and helped get us to where we are today through some of the various iterations. And I think you know, again the company’s in the strongest place it’s been in the time that I’ve been associated with the company. Prior to that I did work in an investment banking advisory firm here in Los Angeles focused primarily in healthcare companies as well as some other industries as well.
Stuart Smith:
Well, thank you, David. Steven, you’re the President and CEO. Let’s learn a little bit more about you, the rest of the management team, and let’s also talk a little bit about the board that you’ve assembled there as well. Go ahead, Steven.
Steven Kriegsman:
Well, you know, first turning to the management team and the board. We have a very, very experienced management team, particularly as it relates to developing cancer drugs. Dr. Dan Levitt, who’s our Executive Vice President and Chief Medical Officer, ran worldwide oncology at Sandoz and U.S. oncology at Hoffmann-LaRoche, and then he was President of Protein Design Lab’s research and development. So he has developed five cancer drugs, and one transplant drug, and one kidney drug. He’s had seven approvals already, which is quite amazing. In addition, he’s supported by a clinical and regulatory team that has a great deal of experience working at big pharma, big biotech, and smaller companies like ours.
We do everything in-house, so we have a Chief Counsel, Benjamin Levin. We have a CFO, John Caloz. We have an accounting department, a legal department. We have clinical and regulatory. We have investor relations, business development, and Human Resources. The only functions that we outsource are manufacturing. Our main manufacturer is Baxter Oncology based outside Dusseldorf, Germany. And we also have preclinical in Freiburg, Germany. And then finally we outsource the CRO function for clinical trials because we’re doing trials globally.
So we’re able to manage this company on a worldwide basis with approximately seventeen employees, and outsource what otherwise requires probably another 100 employees. So we’ve got a unique team. Most of the people have been with us for at least five to ten years. And the key to any organization not only are the drugs which we believe we have, but the team that works together to build CytRx into a major oncology company — and that we have.
In addition supporting that team is a very blue chip Board of Directors that’s been together for approximately ten years. Our Chairman of the Board is Dr. Max Link. He was Chairman and CEO of Sandoz-Novartis. And Dr. Link is on the Board of Alexion. He’s chaired Centerpulse in the past, and a number of other prominent companies including Protein Design Labs and Human Genome Sciences. He is a legendary executive in the pharma field, and brings tremendous experience to the board.
In addition, we have Dr. Joe Rubinfeld who’s a cofounder of Amgen and SuperGen, and previously help build the oncology business at Bristol-Myers.
We have the only Nobel laureate in the history of UCLA in physiology and medicine, Dr. Louis Ignarro, who won the prize in 1998 for oncology. And in addition, rounding out the board is Mr. Marvin Selter, who was a pioneer in employee leasing, and sold his company to a Goldman-Sachs-backed organization. And Richard Wennekamp, who was President Ford’s assistant in the White House, and then was a senior banking executive of Bank of America, and represents and has represented the Ford family since he was with President Ford. That’s the group.
Stuart Smith:
Very good. Well, it sounds like a well established esteem board as well as such a massive management team within your own house. That’s great. One way to streamline and keep those expenses down, that’s for sure.
Well Steven, again thank you for that segment. Let’s talk a little bit now about the achievements for the company so far here in 2013. Go ahead.
Steven Kriegsman:
Well so far in 2013 we achieved a special protocol assessment in a negotiation with the FDA granting us the right to do a global pivotal Phase 3 trial in second line soft tissue sarcoma. Then in addition, we provided additional information on our drug Aldoxorubicin, additional clinical data at the large ASCO conference in June in Chicago. We also announced some compelling preclinical glioblastoma multiforme data which was announced in July 2013. We had three posters presented at ESMO, the equivalent of ASCO in Europe, and this week we will announce in addition to our second quarter earnings release we will announce the results of our poster at CTOS, the Connective Tissue conference which will be going on in New York beginning on Thursday.
Stuart Smith:
Well Steven, now let’s get your vision for the company here for the remainder of 2013. We’re just about to enter November, so if you want to touch a little bit about Q1, calendar Q1 in 2014, that’s fair game as well. Go ahead, Steven.
Steven Kriegsman:
So in the fourth quarter of 2013, we’re going to start the Phase 2 brain cancer trial with our drug Aldoxorubicin. It’ll be at three centers. It’ll be at LSU center in Louisiana. It’ll be at the John Wayne Cancer Center in Los Angeles. And it’ll be at the City of Hope in Los Angeles.
And in addition we will start our Phase 2 HIV Kaposi’s sarcoma trial, and that’ll be at LSU. Finally and most importantly we will have in the fourth quarter of 2013, probably around mid-December, top line results. That’ll be progression-free survival from our Phase 2B global trial and first line soft tissue sarcoma.
Stuart Smith:
Well listeners, let’s jump into some of the recent news for the company. The company had a press release out. You want to use that ticker symbol CYTR. It came out on October 23rd, global Phase 2 clinical data for CytRx’s Aldoxorubicin to be featured at the connective tissue oncology society’s annual meeting. David, give us your insight into this press release.
David Haen:
Well, the press release was to announce that we are presenting data from the ongoing Phase 2B clinical trial with Aldoxorubicin. This is the head-to-head comparison of our drug, Aldoxorubicin, versus generic Doxorubicin. And the patients we’re treating are first line soft tissue sarcoma patients. We had previously announced at the end of September a difference in the response rates between the two arms treated in this study, and at that time the response rate was 22% of the patients receiving our drug, Aldoxorubicin, had a partial response whereas those receiving Doxorubicin 0% had any response at that time.
So the data that’s being presented at the CTOS meeting on Thursday, this will be an update of both the response rates as well as giving a broader picture of the data from that study, including adverse events as well as number of cycles completed. So you know, this is leading up to the real data that Steve mentioned, which is coming in December which is the progression-free survival which is the primary endpoint for this trial. All of this will be a way to educate the follower of the drug as well as potential and existing shareholders on the activity of the drug in the trial.
Stuart Smith:
Hey David, you mentioned a partial response. For the listeners that may not be familiar, and including myself, tell us a little bit. What does that mean?
David Haen:
Great. A partial response is defined as a tumor shrinkage of greater than 30%. So again, you can have a little bit of fluctuation from various times when the patient comes in to receive their treatment, and they get scanned to see you know, how the tumors are going. Are they shrinking? Are they growing? And as we said, in the trial we saw a 22% partial response rate with our drug versus 0% with the comparative drug.
And those were data that the scans had been sent to an independent review which was blinded so the reviewers there didn’t know who was receiving which drug. So therefore, we think that the data are very robust and solid data, you know, and eliminating any bias potentially from the clinical site.
Stuart Smith:
Well David, thank you so much on explaining about partial response. Now you also mentioned earlier about a reduction in the side effects, and I know you’re presenting on that as well. Why don’t you talk to me a little bit about that reduction of side effects and any other ancillary benefits that we can talk about here. Go ahead, David.
David Haen:
Okay. As mentioned earlier, because our drug binds to a protein in the bloodstream, we’re not kind of getting the global side effects that are traditionally seen with this class of drug. One of the biggest limitations for Doxorubicin, which is the comparator in our ongoing trial, and the payload from our conjugate, is that Doxorubicin has a cumulative dose limit, meaning the patient once they hit that threshold isn’t allowed to get additional drugs because of cardio toxicity or heart toxicity that can lead to congestive heart failure, cardiomyopathy, et cetera.
So what we’ve shown, we’re going several-fold above this black box warning, this traditional limitation for this generic drug called Doxorubicin. And in the ongoing study we’re doing a head-to-head trial looking at you know, how do the drugs look against each other after six cycles? But in previous studies and other studies like the PK trial, we’ve shown that we can go beyond this traditional limitation in terms of number of cycles, and we’ve gone to eight cycles with soft tissue sarcoma. We have one patient in the PK study who’s now approaching I think fifteen cycles. And in the Phase 2 glioblastoma trial which we’re getting ready to start, we will be able to continue dosing until progression.
Again, this might be able to keep someone’s tumor either at bay or maybe it’s slowly shrinking, but it takes some time, and we might be able to achieve these partial responses and hopefully if the drug is very powerful, we may even be fortunate to see a complete response in the future.
Stuart Smith:
Well listeners, once again, we are speaking with CytRx. The company is traded under the ticker symbol CYTR. You can learn more about the company at their website. It’s Cytrx.com. That’s C Y T R X dot com. If you’d like to reach out to the company directly, well you can reach out to our guest, David Haen. Again, Vice President of Business Development, as well as Investor Relations. He’s available at (310) 826-5648, extension 304.
We have been speaking once again to David as well as to the CEO of the company, and I want to thank you both for coming on. Steven, thank you so much for your time here at SmallCapVoice.com. As President and CEO I’m sure you’re a welcome voice to your shareholders, and potential investors as well. Thank you, Steven.
Steven Kriegsman:
Thank you, Stuart.
Stuart Smith:
And David, thank you so much for your personal time and insight into this company’s exciting story. Sounds like a game-changer. Really loved hearing from you here today as well.
David Haen:
Thank you.
Stuart Smith:
Alright, for David and Steven, this is Stuart Smith saying thanks so much for listening.
[End of Audio]
About CytRx Corp.
CytRx Corporation (NASDAQ: CYTR) is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx is conducting a global Phase 2b clinical trial with aldoxorubicin as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and has completed a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a potential pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx also is initiating Phase 2 clinical trials with aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and AIDS-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib.
For additional information, please visit the Company’s corporate Website: www.Cytrx.com
Safe-Harbor Statement
This press release may contain “forward-looking statements.” Expressions of future goals and similar expressions reflecting something other than historical fact are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. These forward-looking statements may include, without limitation, statements about our market opportunity, strategies, competition, expected activities and expenditures as we pursue our business plan. Although we believe that the expectations reflected in any forward-looking statements are reasonable, we cannot predict the effect that market conditions, customer acceptance of products, regulatory issues, competitive factors, or other business circumstances and factors described in our filings with the Securities and Exchange Commission may have on our results. The company undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this press release.
CytRx Corp.
Los Angeles, Calif.
www.Cytrx.com
310-826-5648
info@Cytrx.com
Mission Investor Relations
Atlanta, Georgia
http://www.MissionIR.com
404-941-8975
Investors@MissionIR.com
(TRAK) to Present at Upcoming Investor Conferences in New York
Dealertrack Technologies, Inc. (NASDAQ: TRAK) today announced that Mark O’Neil, chairman, president and chief executive officer, and Eric Jacobs, chief financial and administrative officer, will present at two upcoming investor conferences in New York. The conferences include:
- Wells Fargo Technology, Media & Telecom Conference, New York
November 12, 2013; 11:15 a.m. ET - Barclays Select Growth Conference, New York
November 18, 2013; 1:55 p.m. ET
Each presentation will be webcast live and available in the Investor Relations section of the Company’s website under “Investor Events” or by clicking here. All times listed are local.
About Dealertrack Technologies (www.dealertrack.com)
Dealertrack Technologies’ intuitive and high-value web-based software solutions and services enhance efficiency and profitability for all major segments of the automotive retail industry, including dealers, lenders, OEMs, third-party retailers, agents and aftermarket providers. In addition to the industry’s largest online credit application network, connecting more than 20,000 dealers with more than 1,300 lenders, Dealertrack Technologies delivers the industry’s most comprehensive solution set for automotive retailers, including Dealer Management System (DMS), Inventory, Sales and F&I, Interactive, and Registration and Titling solutions. For more information visit www.dealertrack.com.
(ECYT) to Present at the 2013 Credit Suisse Healthcare Conference
WEST LAFAYETTE, Ind., Nov. 6, 2013 — Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced that Ron Ellis, president and CEO of Endocyte, will present at the 2013 Credit Suisse Healthcare Conference on Wednesday, Nov.13, at 8:30 a.m. MST. The conference will be held at The Phoenician Hotel in Phoenix, Arizona.
A live audio webcast of the Company’s presentation can be accessed under “Events & Presentations” in the Investor Relations section of Endocyte’s website at www.endocyte.com. The webcast will be archived shortly after the live event and a replay will be available on the Company’s website for 90 days following the conference.
About Endocyte
Endocyte is a biopharmaceutical company and leader developing targeted therapies for the treatment of cancer and other serious diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging diagnostics for personalized targeted therapies. The company’s SMDCs actively target receptors that are over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly active drugs at greater doses, delivered more frequently and over longer periods of time than would be possible with the untargeted drug alone. The companion imaging diagnostics are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment. For additional information, please visit Endocyte’s website at www.endocyte.com.
CONTACT: Stephanie Ascher, Stern Investor Relations, Inc. (212) 362-1200 stephanie@sternir.com Martina Schwarzkopf, Ph.D., Russo Partners (212) 845-4292 martina.schwarzkopf@russopartnersllc.com Tony Russo, Ph.D., Russo Partners (212) 845-4251 tony.russo@russopartnersllc.com
(LOOK) Announces Reverse Stock Split
SAN FRANCISCO, Nov. 6, 2013 – LookSmart, Ltd. today announced that LookSmart has determined to effect a 1-for-3 reverse stock split of its outstanding common stock, which is expected to become effective at 5:00 P.M. (Eastern Time) on November 5, 2013.
The common stock is expected to begin trading on a split-adjusted basis when the market opens on November 6, 2013. The reverse stock split will not change the authorized number of shares of common stock or preferred stock of the Company or the par value of the common stock or preferred stock.
Stockholders who hold their shares in brokerage accounts or “street name” will not be required to take any action to effect the exchange of their shares. Holders of share certificates will receive instructions from the Company’s transfer agent regarding the process for exchanging their shares.
About LookSmart, Ltd.
LookSmart is a pioneer in online advertising. Founded in 1997, LookSmart has been connecting advertisers and agencies to high quality sources of inventory for performance marketing, and helps online publishers monetize their inventory through our award winning Ad Center platform. LookSmart’s highly scalable technology processes billions of search queries on a daily basis, enabling marketers to bid in real-time across search and display inventory, and leverage intent data to get performance that meets aggressive campaign goals. LookSmart also operates Syncapse, a technology-enabled solutions company that uses social media data to help some of the world’s most valuable brands understand their customer needs and improve performance, and Clickable, a technology-enabled services company that helps companies and agencies manage their online marketing for themselves and their clients. LookSmart is based in San Francisco, California. For more information, visit www.looksmart.com or call (415) 348-7000.
Forward-Looking Statements
This press release contains forward-looking statements that are subject to factors that could cause actual results to differ materially from the results contemplated by the forward-looking statements, including assumptions that may or may not be correct or accurate due to the inherent uncertainty of future events, the actions of third parties we cannot control or predict with certainty, and other factors that may cause us to change our plans.
(ENDP) to Acquire Specialty Pharmaceutical Company Paladin Labs
MALVERN, Pa. and MONTREAL, Nov. 5, 2013 —
- Accelerates Endo’s transformation to leading global specialty healthcare company and creates platform for future growth
- Paladin Labs’ proven Canadian franchise, robust near-term pipeline and emerging market business complement Endo’s U.S. strengths
- Combined company expects to grow presence in North America and internationally
- Stock and cash transaction values Paladin Labs at $77.00 (CAD) per share
- Expected to be immediately accretive to Endo’s 2014 adjusted EPS
Endo Health Solutions (NASDAQ: ENDP) (“Endo”) today announced that it has reached a definitive agreement to acquire Paladin Labs Inc. (TSX: PLB), (“Paladin Labs”) a leading Canada-based specialty pharmaceutical company, in a stock and cash transaction valued at approximately $1.6 billion of which approximately 98% will be paid in shares of stock as described below. The acquisition accelerates Endo’s strategic transformation to a leading global specialty healthcare company and creates a platform for future growth in North America and internationally. Pursuant to the acquisition, each of Endo and Paladin Labs will be acquired by a newly-formed Irish holding company (“New Endo”). At $77.00 (CAD) per Paladin Labs share, the transaction represents a 20% premium to Paladin Labs’ share price of $63.91 as of November 4, 2013, and is expected to be immediately accretive to Endo’s 2014 adjusted earnings per share.
“The acquisition of Paladin Labs accelerates Endo’s transformation from an integrated health solutions company to a top tier global specialty healthcare leader,” said Rajiv De Silva, president and CEO of Endo. “Together with our sharpened focus, lean operating model and improved execution within our core businesses, strategic acquisitions will continue to play a key role in maximizing our growth potential and cash flow generation to drive future value for Endo shareholders. Paladin Labs has a proven track record of acquiring and in-licensing innovative new products, and developing international growth platforms. Paladin Labs’ stable and growing cash flows and strong Canadian franchise complement our existing portfolio and further diversify our pharmaceutical product mix and geographic reach. The compelling financial and operational platform we are creating through this combination will leave the new Endo well positioned to continue to offer products that make a difference in the lives of patients while generating superior growth and returns for our shareholders.”
“The transaction with Endo provides Paladin Labs shareholders an attractive current premium for their shares while allowing for ongoing participation in the upside potential of the combined company,” said Jonathan Ross Goodman, Chairman and Founder of Paladin Labs. “We are confident that our 17 years of consecutive record revenues will continue unabated under Endo’s stewardship. With a relentless focus on execution, talented and tenacious people, and a proven strategy, Paladin Labs has become one of Canada’s leading publicly traded pharmaceutical companies.”
Paladin Labs is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and world markets. With over 60 marketed drugs, proven sales and marketing capabilities, and strong partnerships with leading global pharmaceutical companies, Paladin Labs has a track record of enhancing the performance of existing and newly acquired products. Key products serve growing drug markets including ADHD, pain, urology and allergy, with a strong pipeline of new product launches over the next 12 months. In addition to its Canadian operations, Paladin Labs owns a controlling stake in Laboratorios Paladin, S.A. de C.V. in Mexico and a 61.5% ownership stake in publicly traded Litha Healthcare Group Limited in South Africa.
Following completion of the transaction, New Endo will be led by Endo’s current management team. Paladin Labs will be a separate operating company under New Endo and will continue to be led by Paladin Labs’ current management team and will maintain its current headquarters location in Montreal. Its Canadian operations will continue under the Paladin Labs name. Operational and tax synergies as a result of the transaction are expected to total at least $75 million of after tax savings on an annual basis. The savings are not expected to materially impact Paladin Labs’ Canadian operations, and it is Endo’s intention to continue to expand Paladin Labs’ presence in the Canadian market.
Transaction Details
Under the terms of the transaction, which has been unanimously approved by the boards of both companies, Paladin Labs shareholders will receive 1.6331 shares of New Endo stock and $1.16 (CAD) in cash, subject to adjustment, for each Paladin Labs share they own upon closing, pursuant to a plan of arrangement under Canadian law. The transaction values each Paladin Labs share at $77.00 (CAD), based on the 5-day volume weighted average share price for Endo and the 5 day average currency exchange rate calculated at close of market on Friday, November 1. Current Endo shareholders will receive one share of New Endo for each share of Endo they own at closing. Upon closing, current Endo shareholders will own approximately 77.5% of the New Endo, and current Paladin Labs shareholders will own approximately 22.5% of the New Endo.
In addition, pursuant to the plan of arrangement, for each Paladin Labs share owned at closing, shareholders of Paladin Labs will also receive one share of Knight Therapeutics Inc., (“Knight Therapeutics”) a newly formed Canadian company that will be separated as part of the transaction. Knight Therapeutics will hold Impavido®, Paladin Labs’ product for the treatment of leishmaniasis.
The cash consideration to be received by Paladin Labs shareholders will be increased if Endo’s volume weighted average share price during an agreed reference period declines more than 7%. Cash compensation will be provided by Endo to Paladin shareholders if the share price declines more than 7% but less than 20%. If Endo’s share price declines between 20% and 24% during the agreed reference period, Endo will provide partial cash compensation to Paladin shareholders. Any decline in Endo’s share price beyond 24% will not be subject to further cash compensation to Paladin Labs shareholders. The maximum amount by which the aggregate cash consideration to be received by Paladin shareholders would be increased by this price protection mechanism is approximately $233 million.
The company does not expect the transaction, as structured, to be taxable to U.S. shareholders of Endo. However, the ultimate tax treatment of the transaction is not certain, could be affected by actions taken by the company and other events, and cannot be determined until the end of the year in which the transaction is completed which Endo expects will be 2014.
Endo remains committed to a disciplined capital allocation process which is focused on growth of the base business, acquisitions and debt pay-down. The Company is continuing to evaluate strategic alternatives for its HealthTronics business and its branded pharmaceutical early stage discovery platform. Endo will continue to review all of its businesses within the context of the company’s strategic direction and capital allocation framework.
While the Paladin acquisition is primarily equity based, Endo will adjust certain parts of its capital structure to complete the transaction. Endo has secured committed financing that will be used to refinance certain elements of the company’s existing indebtedness and the early repurchase of its convertible notes due April 2015. The repurchase of the convertible notes would be subject to market conditions. The changes to the capital structure related to the transaction are not expected to have a material impact on the overall leverage profile of Endo.
Approvals
The transaction is expected to close in the first half of 2014, subject to certain conditions and approvals, including regulatory approvals in the U.S., Canada and South Africa, the approval of both companies’ shareholders, the approval of the Superior Court of Quebec, the registration and listing of New Endo shares and customary closing conditions. Shareholders representing approximately 34 percent of Paladin Labs outstanding shares have agreed to vote in favor of the transaction. These shareholders have the right to terminate this voting agreement if Endo’s volume weighted average share price declines more than 24 percent during an agreed reference period. Shares of New Endo are expected to trade on NASDAQ.
Deutsche Bank Securities Inc., Skadden Arps, Torys LLP and KPMG acted as advisors to Endo. Deutsche Bank and RBC Capital Markets have agreed to provide committed financing to Endo as part of this transaction. Houlihan Lokey Financial Advisors, Inc. also acted as an advisor to Endo. Credit Suisse, Davies Ward Phillips & Vineberg LLP, and EY acted as Advisors to Paladin Labs.
Conference Call
Endo will conduct a conference call with financial analysts to discuss this news release today at 8:00 a.m. ET. Investors and other interested parties may call 866-515-2911 (domestic) or +1 617-399-5125 (international) and enter passcode 70911744. Please dial in 10 minutes prior to the scheduled start time.
A replay of the call will be available from November 5, 2013 at 10:30 a.m. ET until 11:59 p.m. ET on November 19, 2013 by dialing 888-286-8010 (domestic) or +1 617-801-6888 (international) and entering passcode 53605349.
A simultaneous webcast of the call can be accessed by visiting www.endo.com. In addition, a replay of the webcast will be available until 11:59 p.m. ET on November 19, 2013. The replay can be accessed by clicking on “Events” in the Investor Relations section of the website.
About Endo:
Endo Health Solutions Inc. is a U.S.-based specialty healthcare company with four distinct business segments that are focused on branded and generic pharmaceuticals, devices and services, each providing quality products to our customers while improving the lives of patients. Through our operating companies – AMS, Endo Pharmaceuticals, HealthTronics and Qualitest – Endo is dedicated to finding solutions for the unmet needs of patients. Learn more at www.endo.com.
About Paladin Labs:
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and world markets. With this strategy, a focused national sales team and proven marketing expertise, Paladin Labs has evolved into one of Canada’s leading specialty pharmaceutical companies. Paladin Lab’s shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin Labs, please visit the Company’s web site at www.paladin-labs.com.
No Offer or Solicitation
This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Additional Information
New Endo will file with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4 that will include the Joint Proxy Statement/Circular of Endo and Paladin Labs. Endo and Paladin Labs plan to mail their respective shareholders the Joint Proxy Statement/Circular in connection with the transactions. INVESTORS AND SHAREHOLDERS ARE URGED TO READ THE JOINT PROXY STATEMENT/CIRCULAR AND OTHER RELEVANT DOCUMENTS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT ENDO, PALADIN LABS, THE TRANSACTIONS AND RELATED MATTERS. Investors and security holders will be able to obtain free copies of the Joint Proxy Statement/Circular and other documents filed with the SEC by Endo through the website maintained by the SEC at www.sec.gov. Investors and security holders will be able to obtain free copies of the Joint Proxy Statement/Circular and other documents filed by Paladin Labs on the System for Electronic Document Analysis Retrieval (“SEDAR”) website maintained by the Canadian Securities Administrators at http://www.sedar.com. In addition, investors and shareholders will be able to obtain free copies of the Joint Proxy Statement/Circular and other documents filed by Endo with the SEC by contacting Endo Corporate Secretary or by calling (484) 216-0000, and will be able to obtain free copies of the Joint Proxy Statement/Circular and other documents filed by Paladin Labs on the SEDAR website by contacting Samira Sakhia or by calling (514) 669-5367.
Participants in the Solicitation
Paladin and Endo and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the respective shareholders of Paladin Labs and Endo in respect of the transactions contemplated by the Joint Proxy Statement/Circular. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the respective shareholders of Paladin and Endo in connection with the proposed transactions, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the Joint Proxy Statement/Circular when it is filed with the SEC. Information regarding Paladin’s directors and executive officers is contained in Paladin’s Annual Report for the year ended December 31, 2012, filed on the SEDAR website. Information regarding Endo’s directors and executive officers is contained in Endo’s Annual Report on Form 10-K for the year ended December 31, 2012, filed with the SEC.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “will,” “may,” “look forward,” “intend,” “guidance,” “future” or similar expressions are forward-looking statements. These forward-looking statements may include, without limitation, statements regarding the completion of the proposed transaction and other statements that are not historical facts. Although Endo and Paladin Labs each believe its forward-looking statements are reasonable, they are subject to important risks and uncertainties. Those include, without limitation, the failure to receive, on a timely basis or otherwise, the required approvals by Endo and Paladin Labs shareholders, the Superior Court of Quebec and applicable government and regulatory authorities, the terms of those approvals, the risk that a condition to closing contemplated by the arrangement agreement may not be satisfied or waived, the inability to realize expected synergies or cost savings or difficulties related to the integration of Endo and Paladin Labs operations, the ability of the combined company to retain and hired key personnel and maintain relationships with customers, suppliers or other business partners, or other adverse events, changes in applicable laws or regulations, competition from other pharmaceutical companies, and other risks disclosed in Endo and Paladin Labs’s public filings, any or all of which could cause actual results to differ materially from future results expressed, projected or implied by the forward-looking statements. The forward-looking statements in this press release are qualified by these risk factors. As a result of these risks and uncertainties, the proposed transaction could be modified, restructured or not be completed, and actual results and events may differ materially from the results and events contemplated in these forward-looking statements and from historical results. Neither Endo nor Paladin Labs assumes any obligation to publicly update any forward-looking statements, except as may be required under applicable securities laws, or to comment on expectations of, or statements made by the other party or third parties in respect of the proposed transaction. These forward-looking statements are not guarantees of future performance, given that they involve risks and uncertainties. Investors should not assume that any lack of update to previously issued forward-looking statement constitutes a reaffirmation of that statement. Continued reliance on forward-looking statements is at investors’ own risk.
For more information regarding these and other risks and uncertainties that Endo may face, see the section entitled “Risk Factors” in Endo’s Form 10-K, Form 10-Q and Form 8-K filings with the SEC and as otherwise enumerated herein or therein.
For more information regarding these and other risks and uncertainties that Paladin may face, see the section entitled “Risks Related to Paladin Labs’s Business” in Paladin’s Information Form for the year ended December 31, 2012 and the sections in Paladin’s Management’s Discussion and analysis entitled “Concentration of Credit Risk and Major Customers,” “Liquidity Risk,” “Foreign Exchange Risk,” “Interest Rate Risk,” and “Equity Price Risk” contained in Paladin’s Annual Report for the year ended December 31, 2012 filed on the SEDAR website.
(OSN) Announces Two New Steel Strand Supply Contracts
SHANGHAI, Nov. 5, 2013 — Ossen Innovation Co., Ltd. (“Ossen” or the “Company”) (Nasdaq: OSN), a China-based manufacturer of an array of plain surface, rare earth and zinc coated pre-stressed steel materials, today announced that it has been awarded two contracts to supply its plain surface steel strands for new infrastructure projects in Anhui Province. The first contract is to supply 2,500 tons of plain surface steel strands for the renovation of the G205 national highway’s Cihu to Caishi section. This renovation project, overseen by the Chinese Ministry of Transport, will use the steel strands for long span prestressed concrete structures of the overpass. The second contract is to supply 18,000 tons of plain surface steel strands for the construction of the Wangdong Yangtze River highway bridge upstream of the Wan River in Anhui Province. This construction project, overseen by the Anhui Province Planning Department, will use the steel strands for long span prestressed concrete structures of the bridge approach.
“Ossen is very pleased to announce these new contract wins,” said Dr. Liang Tang, Chairman of Ossen Innovation. “The G205 national highway renovation is an important and high profile project and the Wangdong Yangtze River highway bridge project is a key part of the Shangqiu-Jingdezheng Highway, which is a sub-section of the Ji’nan-Guangzhou national highway. The proximity of our Maanshan manufacturing facility to these infrastructure projects, along with Ossen’s brand recognition and reputation for manufacturing high quality products for similar infrastructure projects, allowed us to win these contracts. Based on information received from the Ministry of Transport and the Anhui Province Planning Department, respectively, Ossen expects to begin delivery of these plain surface steel strands in the first half of 2014. The selection of our products for use in major infrastructure projects in the region continues to affirm our product’s consistency, durability and reliability,” concluded Dr. Tang.
About Ossen Innovation Co., Ltd.
Ossen Innovation Co., Ltd. manufactures and sells a wide variety of plain surface pre-stressed steel materials and rare earth coated and zinc coated pre-stressed steel materials. The Company’s products are mainly used in the construction of bridges, as well as in highways and other infrastructure projects. Ossen has two manufacturing facilities located in Maanshan, Anhui Province, and Jiujiang, Jiangxi Province.
Safe Harbor Statements
This press release may contain 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, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those projected or anticipated, including risks outlined in the Company’s public filings with the Securities and Exchange Commission, including the Company’s annual report on Form 20-F. All information provided in this press release is as of the date hereof. Except as required by law, 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, after the date on which the statements are made or to reflect the occurrence of unanticipated events.
For more information, please contact: | |
Ossen Innovation Co., Ltd. | |
Feng Peng, Chief Financial Officer | |
Email: feng.peng@ossencorp.com | |
Phone: +86 (21) 6888-8886 | |
Web: www.osseninnovation.com | |
Investor RelationsFCC Group LLC
Phone: +1-347-850-7098 Email: ir@ossencorp.com |
(MSPD) Announces Definitive Agreement to Acquire Mindspeed Technologies
MACOM expects Non-GAAP EPS accretion between $0.15 and $0.20 in fiscal 2014
and between $0.25 and $0.30 in fiscal 2015
Mindspeed intends to sell its wireless business before closing
LOWELL, Mass., Nov. 5, 2013 — M/A-COM Technology Solutions Holdings, Inc. (Nasdaq:MTSI) (MACOM), a leading supplier of high performance RF, microwave, and millimeter wave products, today announced it has entered into a definitive agreement to acquire Mindspeed Technologies, Inc. (Nasdaq:MSPD) (Mindspeed), a leading supplier of semiconductor solutions for communications infrastructure applications, for $5.05 per share in a cash tender offer.
Mindspeed is also in advanced discussions with a potential strategic buyer for its wireless business, which it intends to sell prior to closing of the MACOM transaction.
Highlights of the transaction include:
- The companies’ combined trailing twelve months (TTM) revenue is approximately $451 million with non-GAAP gross margin of approximately 50%, excluding Mindspeed’s wireless business.
- Cash transaction valued at $272 million for Mindspeed’s $132 million in TTM revenue (excluding wireless business and non-recurring revenue from sales of intellectual property) and $26 million of cash and cash equivalents at September 27, 2013.
- MACOM expects substantial annual synergies from reduction in corporate overhead, corporate R&D overhead, SG&A and exiting underperforming businesses.
- Expected to be immediately accretive to MACOM’s non-GAAP earnings per share with expected non-GAAP EPS accretion between $0.15 and $0.20 per share in fiscal 2014 and between $0.25 and $0.30 per share in fiscal 2015.
- Positions MACOM to be a global leader in 100G optical networking and expands MACOM’s addressable market, moving from long-haul to data centers and metro markets.
- Complements MACOM’s current product offerings with a high performance analog (HPA) portfolio of low latency crosspoint switches, integrated optical physical media devices (PMDs) and low power signal conditioners.
- Diversifies MACOM’s served markets to include Enterprise applications.
- Expands MACOM’s addressable RF and Microwave market with the addition of high performance Silicon Germanium (SiGe) capability.
- Complements MACOM’s strong U.S. presence with a broadened customer footprint and strong sales channel in the Asia Pacific region.
Commenting on the transaction, John Croteau, President and Chief Executive Officer, stated, “This acquisition will position MACOM as a leading global provider of 100G optical solutions which underscores our growth strategy in commercial communications markets. Our interest in Mindspeed is the company’s high-growth, high-margin HPA business as well as its cash-generating VoIP business. The addition of the HPA portfolio, which consists of the world’s fastest crosspoint switches, ultra low power signal conditioners and industry-leading optical PMDs, aligns well with MACOM’s business model — offering non-GAAP gross margins approaching 70%, long product life cycles, and sticky customer relationships.”
Mindspeed also has a communications processor business, which currently does not align with MACOM’s long-term strategic focus, and therefore additional options will be explored while continuing to support its customers. Separately, in the event Mindspeed’s wireless business is not sold, it will be restructured and wound down while continuing to support its customers.
Mr. Croteau added, “Mindspeed’s leadership in SiGe-based products, along with its long-held position in enterprise video and metro markets, complements our strong position in long-haul modulator drivers based on Indium Phosphide (InP) and Gallium Arsenide (GaAs) technology. This will position MACOM as a clear leader across all 100G segments, all physical layer products, and all requisite technologies enabling us to capitalize on the expected decade-long build out of the 100G optical market.”
“This acquisition will diversify our served markets to include enterprise applications, while also enabling MACOM to strengthen our core RF and Microwave position with SiGe technology,” continued Mr. Croteau. “The transaction will also broaden our customer footprint and reach, by leveraging Mindspeed’s strong sales channel in Asia, which complements our strength in North America and other regions.”
MACOM estimates that the acquisition will result in substantial synergies from corporate overhead, SG&A, and exit from underperforming businesses. MACOM also expects that the acquisition will be accretive to non-GAAP earnings per share between $0.15 and $0.20 in fiscal 2014 and between $0.25 and $0.30 in fiscal 2015.
MACOM intends to commence a tender offer to purchase each outstanding common share of Mindspeed for $5.05 in cash, without interest, and MACOM will assume certain equity awards held by Mindspeed employees. The transaction value is approximately $272 million in diluted equity value, or $246 million net of Mindspeed’s cash position of approximately $26 million as of September 27, 2013. MACOM expects to finance the acquisition through a combination of cash on hand and its existing undrawn revolving credit facility. The boards of both companies have approved the transaction, which is subject to customary closing conditions and regulatory approvals. MACOM currently expects the transaction to close by the end of calendar 2013.
Barclays acted as exclusive financial advisor and Perkins Coie LLP acted as legal counsel to MACOM.
Conference Call and Slide Presentation Information
MACOM will host a conference call on Tuesday, November 5 at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) in conjunction with its fourth quarter and fiscal 2013 earnings conference call. The conference call will be broadcast live over the Internet with a slide presentation and can be accessed by all interested parties on the Investor section of MACOM’s website at http://ir.macomtech.com/. On the call John Croteau, MACOM’s President and Chief Executive Officer, and Conrad Gagnon, MACOM’s Chief Financial Officer, will discuss the proposed acquisition. Investors and analysts are invited to participate on the call. To listen to the live call, please go to the Investor section of MACOM’s website and click on the Conference Call link at least fifteen minutes prior to the start of the call to register, download, and install any necessary audio software.
When: Tuesday, November 5, 2013
Time: 5:00 p.m. Eastern Time
Dial in: 1-877-837-3908; outside the U.S. +1-973-872-3000
Participant Code: 91211532
Live Webcast: http://ir.macomtech.com/
For those unable to participate during the live broadcast, a replay will be available shortly after the call and will be available on MACOM’s website for 7 days. The replay dial-in number is 1-855-859-2056, and the pass code is 91211532. International callers should dial +1-404-537-3406 and enter the same pass code at the prompt. Additionally, the conference call will be broadcast live over the Internet and can be accessed by all interested parties for approximately 60 days in the Investor Relations section of the Company’s website at http://ir.macomtech.com/
Further details of the transaction are set out in MACOM’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 5, 2013.
About MACOM
M/A-COM Technology Solutions Holdings, Inc. (www.macomtech.com) is a leading supplier of high performance RF, microwave, and millimeter wave products that enable next-generation internet and modern battlefield applications. Recognized for its broad catalog portfolio of technologies and products, MACOM serves diverse markets, including CATV, wireless and optical communications infrastructure, satellite, radar, automotive, industrial, medical, and mobile devices. A pillar of the RF and microwave industry, we thrive on more than 60 years of solving our customers’ most complex problems.
Headquartered in Lowell, Massachusetts, MACOM is certified to the ISO9001 international quality standard and ISO14001 environmental management standard. MACOM has design centers and sales offices throughout North America, Europe, Asia and Australia.
MACOM, M/A-COM, M/A-COM Technology Solutions, M/A-COM Tech, Partners in RF & Microwave, The First Name in Microwave and related logos are trademarks of MACOM. All other trademarks are the property of their respective owners.
About Mindspeed Technologies
Mindspeed Technologies, Inc. (Nasdaq:MSPD) is a leading provider of network infrastructure semiconductor solutions to the communications industry. The company’s low-power system-on-chip (SoC) products are helping to drive video, voice and data applications in worldwide fiber-optic networks and enable advanced processing for 3G and long-term evolution (LTE) mobile networks. The company’s high-performance analog products are used in a variety of optical, enterprise, industrial and video transport systems. Mindspeed’s products are sold to original equipment manufacturers (OEMs) around the globe.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements based on MACOM management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements include, among others, statements concerning the Mindspeed transaction, including those regarding the potential date of closing of the acquisition, and any potential benefits and synergies, strategic plans, divestitures, restructuring, cost savings, accretion, and financial and business expectations associated with the acquisition, as well as any other statements regarding MACOM’s plans, beliefs or expectations regarding the transaction or its future business or financial results. Forward-looking statements include all statements that are not historical facts and generally may be identified by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “seeks,” “should,” “will,” “would” or similar expressions and the negatives of those terms.
Forward-looking statements contained in this press release reflect MACOM’s current views about future events and are subject to risks, uncertainties, assumptions and changes in circumstances that may cause those events or our actual activities or results to differ materially from those expressed in any forward-looking statement. Although MACOM believes that the expectations reflected in the forward-looking statements are reasonable, it cannot and does not guarantee future events, results, actions, levels of activity, performance or achievements, including the successful closing of the Mindspeed transaction or successful execution of any other divestment or restructuring plans described in this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. A number of important factors could cause actual results to differ materially from those indicated by the forward-looking statements, including, among others, costs associated with the merger, tender offer and financing of the Mindspeed transaction; the unsuccessful completion of the tender offer; matters arising in connection with the parties’ efforts to comply with and satisfy applicable regulatory approvals and closing conditions relating to the transaction, delays in or inability to complete anticipated divestiture and restructuring activities, failure to achieve expected synergies and other anticipated benefits of the transaction, the potential for weakness or less than expected strength in our catalog business, continued weakness in our Networks market, lower than expected demand in any or all of our four primary end markets or from any of our large OEM customers based on macro-economic weakness or otherwise, the potential for defense spending cuts, program delays, cancellations or sequestration, failures or delays by customers in winning business or to make purchases from us in support of such business, lack of adoption or delayed adoption by customers and industries we serve of GaN or other solutions offered by us, failures or delays in porting and qualifying GaN process technology to our Lowell, MA fabrication facility, lower than expected utilization and absorption in our manufacturing facilities, lack of success or slower than expected success in our new product development efforts, loss of business due to competitive factors, product or technology obsolescence, customer program shifts or otherwise, lower than anticipated or slower than expected customer acceptance of our new product introductions, the potential for a shift in the mix of products sold in any period toward lower-margin products or a shift in the geographical mix of our revenues, the potential for increased pricing pressure based on competitive factors, technology shifts or otherwise, the impact of any executed or abandoned acquisition, divestiture or restructuring activity, the impact of supply shortages or other disruptions in our internal or outsourced supply chain, the relative success of our cost-savings initiatives, the potential for inventory obsolescence and related write-offs, the expense, business disruption or other impact of any current or future investigations, administrative actions, litigation or enforcement proceedings we may be involved in, and the impact of any claims of intellectual property infringement or misappropriation, which could require us to pay substantial damages for infringement, expend significant resources in prosecuting or defending such matters or developing non-infringing technology, incur material liability for royalty or license payments, or prevent us from selling certain of our products, as well as those factors described in “Risk Factors” in MACOM’s filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q for the quarter ended June 28, 2013 as filed with the SEC on August 5, 2013. MACOM undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Notice to Investors
The tender offer for the outstanding shares of common stock of Mindspeed described in this communication has not yet commenced. This press release is for informational purposes only and is not an offer to purchase any shares of Mindspeed or a solicitation of an offer to sell securities. At the time the tender offer is commenced, MACOM will file a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, with the United States Securities and Exchange Commission (the “SEC”) and Mindspeed will file a solicitation/recommendation statement on Schedule 14D-9 with the SEC. The tender offer statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the solicitation/recommendation statement will contain important information that should be read carefully before any decision is made with respect to the tender offer. Such materials will be made available to Mindspeed stockholders at no expense to them. In addition, such materials (and all other offer documents filed with the SEC) will be available at no charge on the SEC’s website at www.sec.gov.
CONTACT: Company Contact: M/A-COM Technology Solutions Holdings, Inc. Conrad Gagnon Chief Financial Officer P: 978-656-2550 E: Conrad.Gagnon@macomtech.com Investor Relations Contact: Shelton Group Leanne K. Sievers EVP, Investor Relations P: 949-224-3874 E: lsievers@sheltongroup.com
(OXYS) Oxygen Biotherapeutics (OXBT) Rise Sheds Light On OxySure
Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT) has risen more than 175% over the past week or so on massive trading volumes, after announcing a broadening of their product lines through a licensing agreement.
Broadening Product Lines
Oxygen Biotherapeutics’ recent move represents an addition to its original business developing medical products that promises to deliver oxygen to tissues in the body. The company’s flagship Oxycyte® technology is a systemic perfluorocarbon (“PFC”) that delivers oxygen to vital organs in the case of acute ischemia. Similar products are also in development for use in personal care, topical wound healing and other topical indications.
While Oxygen Biotherapeutics has been successful in two clinical trials and is currently being evaluated in a Phase IIB clinical trial for traumatic brain injury (“TBI”), management plans to focus the majority of its efforts on its two advanced topical products, Dermacyte® and Wundecyte®, given their significantly near-term potential. The firm is also developing Vitavent™, which is an oxygen exchange fluid for the treatment of lung conditions, and other products.
Benefiting from the Exposure OxySure Systems, Inc. (OTCBB: OXYS), a medical technology company focused on the design, manufacture and distribution of specialty medical and respiratory solutions, could benefit from the oxygen industry’s enhance exposure. The company pioneered an FDA-approved solution to produce medical pure oxygen from dry, inert powders for emergency and short-duration use, while the device itself can be used by any layperson in the event of a medical emergency.
With the potential to become the equivalent of the next AED in the medium term and the equivalent of a fire extinguisher in the long term, OxySure’s Model 615, already FDA approved for over the counter sale (no prescription required), has a significantly larger end market than Oxygen Biotherapeutics PFC-based drugs. The installed base for AEDs exceeds two million units, while fire extinguishers exceed 100 million units in the U.S. alone. Capturing just a fraction of this market with its unique emergency oxygen solution could represent a multi-billion dollar opportunity that could unlock significant long-term shareholder value. It is more likely than not that OxySure will capture a significant share of the market because it is the only player that has this product and technology. OxySure pioneered this technology, and owns numerous patents and patents pending around it, and has first mover advantage.
Potential Investment Opportunity
OxySure Systems represents a compelling investment opportunity, with a market capitalization of just $18 million. During the second quarter, the company reported revenues that soared more than 650% to $476,071, SG&A expenses that fell 18% to $194,803, interest expenses that fell 60% to $23,254, and a net loss that fell 11.8%. Recently, Sterling Investments analysts issued a buy rating on the stock with a $1.90 per share 12-month price target.
The positive financial momentum has been followed by a number of promising recent developments. In July, the company launched an AED/OxySure double wall cabinet to house its product next to the ubiquitous AED. In October, the firm announced a partnership that lets dozens of banks compete for leases on OxySure’s products with a simple 2-minute application. Creating the ability for customers to lease OxySure’s products significantly expands the market. Combined, these two developments could significant expand its market moving forward.
More Information:
Company Website – http://www.oxysure.com//Company presentation – http://www.oxysure.com/aed/presentation-8-12-13/Recent SEC Filings – http://secfilings.com/SearchResults.aspx?name=Oxysure%20Systems%20IncNews story about Baseball Player Saved by OxySure Model 615 – http://www.youtube.com/watch?v=iSSlxngn7egMatt Lauer Interviews Kylee Shea, Cardiac Arrest Survivor – http://www.youtube.com/watch?v=qGaTFFuRpDQ
About Emerging Growth LLC:
EGC is a marketing and consulting firm that specializes in creating ongoing communications strategies for public and private companies.
Disclosure:
Except for the historical information presented herein, matters discussed in this release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Emerging Growth LLC is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. For full disclosure please visit: http://secfilings.com/Disclaimer.aspx.
(GALE) Reports Third Quarter 2013 Results
PORTLAND, Ore., Nov. 6, 2013 — Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company commercializing and developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today reported its financial results for the three and nine months ended September 30, 2013 and provided a business update.
“Our commercial success to date with Abstral® has been very encouraging and we are excited to report initial revenues ahead of schedule. With our sales force and commercial organization fully deployed, we continue to make significant strides with physicians, payors and patients—and expect continuing strength with the launch,” said Mark J. Ahn, Ph.D., President and Chief Executive Officer. “We are also making steady progress in advancing our NeuVax™ and FBP cancer immunotherapy pipeline.”
Third Quarter 2013 Financial Highlights
Net revenue was $1.2 million for the three months ended September 30, 2013, the first quarter of Abstral® (fentanyl) sublingual tablet sales, ahead of our official launch and commencement of promotional efforts in the fourth quarter. Cost of revenue and gross profit for the three months ended September 30, 2013 were $0.3 and $0.9 million, respectively.
Operating loss for the three months ended September 30, 2013 was $6.9 million, including $0.5 million in stock-based compensation charges, compared with an operating loss of $5.5 million for the three months ended September 30, 2012, which includes $0.4 million in stock-based compensation charges. For the nine months ended September 30, 2013, operating loss from continuing operations was $21.5 million compared with $15.6 million for the nine months ended September 30, 2012.
Galena Biopharma also incurred income or expense due to non-cash charges related to changes in the fair value estimates of the Company’s warrant liabilities and contingent purchase price liability, as well as the realized gain from the sale of marketable securities, which is included in other income and expense. The non-cash expenses related to the changes in values of our warrant and contingent purchase price liabilities for the three months ended September 30, 2013 were $1.8 million versus $0.7 million for the three months ended September 30, 2012. These expenses for the nine months ended September 30, 2013 were $7.7 million versus $13.9 million for the nine months ended September 30, 2012. Other income from the realized gain on the sale of marketable securities was $0.8 million and $1.4 million for the three and nine months ended September 30, 2013, respectively.
Net loss for the three months ended September 30, 2013 was $9.3 million, or $0.11 per basic and diluted share, versus a net loss of $6.3 million, or $0.09 per basic and diluted share, for the three months ended September 30, 2012. Net loss for the nine months ended September 30, 2013 was $28.2 million, or $0.34 per basic and diluted share, versus a net loss (including both continued operations and discontinued operations) of $31.2 million, or $0.52 per basic and diluted share, for the nine months ended September 30, 2012.
As of September 30, 2013, Galena had cash, cash equivalents, marketable securities and net accounts receivable of $55.8 million, compared with $35.6 million as of December 31, 2012. Our marketable securities consisted of approximately 0.8 million shares of common stock in RXi Pharmaceuticals (OTCQX:RXII) with a market value of approximately $2.8 million as of September 30, 2013 and 33.5 million (1.1 million post reverse-stock split) shares of common stock of RXi with a market value of approximately $2.7 million as of December 31, 2012.
On May 8, 2013 Galena completed a debt financing of $15 million to fund the purchase and launch of Abstral, of which $10 million was drawn immediately and $5 million remains available.
Third Quarter and Recent Highlights
- Launched First Commercial Product: Abstral® (fentanyl) Sublingual Tablets for the Treatment of Breakthrough Cancer Pain. Galena acquired Abstral in March 2013 and formally launched the product in the U.S. in October. Abstral is a sublingual (under the tongue) fentanyl tablet indicated for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. Abstral can be prescribed by Risk Evaluation and Mitigation Strategy (REMS) certified healthcare professionals and is available to patients at all retail pharmacies nationwide.
- Initiated RELIEF Patient Registry for Abstral and Debuted Marketing Campaign at PAINWeek. RELIEF: Rapid Evaluation of Lifestyle, Independence, and Elimination of breakthrough cancer pain with Freedom from oral discomfort through the use of Abstral® (fentanyl) Sublingual Tablets. RELIEF is a post-marketing, multicenter trial to assess Abstral for breakthrough cancer pain (BTcP) in opioid-tolerant cancer patients. RELIEF is an observational registry study to be completed by enrolled patients over a thirty-day period while using Abstral for treatment of their BTcP. Approximately 2,500 patients are expected to enroll in the program.
- Strengthened leadership team with appointment of Dr. Brian Hamilton, M.D., Ph.D. to serve as Galena’s Executive Vice President and Chief Medical Officer. Dr. Hamilton has extensive academic and pharmaceutical experience in immunology, hematopoietic stem cell transplantation, and oncology. Having worked in both large pharmaceutical companies such as AstraZeneca and Wyeth, as well as biotech companies such as BioVex, Soligenix, and Onyx, he has experience with drug development across multiple therapeutic indications and platforms, including small molecules, biologics, oncolytic viruses, and vaccines. He has been a partner and Vice President of Biopharm Solutions, a private consulting firm in the life sciences industry, since 2001. Dr. Hamilton received his M.D. and Ph.D. from the University of Washington School of Medicine with extensive specialty training to include Pediatrics at the Children’s Medical Center in Dallas, Texas, Immunology at the Children’s Hospital Medical Center and Sidney Farber Cancer Center, and Allergy at the University of California-San Francisco. He has held academic appointments at the University of Washington and the University of Miami. Dr. Hamilton will replace Rosemary Mazanet M.D., Ph.D., whose employment with Galena will conclude November 7, 2013.
- Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) trial, under an SPA, continues to enroll at approximately 130 sites globally. Galena has partnered with Leica Biosystems to develop a reliable and reproducible HER2 companion diagnostic test to assure a uniform determination of patients’ HER2 status. The diagnostic will enable HER2 0, 1+, 2+ and 3+ differentiation to ensure Galena is enrolling the appropriate patients with low to intermediate HER2 expression into the PRESENT trial, and ultimately for treatment with the NeuVax vaccine. Leica’s Bond Oracle™ HER2 IHC System is a state-of-the-art diagnostic testing system that provides added assurance the patients enrolled in the trial have the appropriate HER2 expression level.
- Phase 2b NeuVax plus Herceptin® (trastuzumab; Genentech/Roche) 300 patient randomized, combination trial is enrolling at 9 sites in the US.
- Results from the Phase 1 portion of the Folate Binding Protein (FBP) trial will be presented at the Society for Immunotherapy of Cancer (SITC) conference taking place this weekend, November 7-10, 2013.
- Expanded NeuVax™ Intellectual Property With European Allowance. This Pharmaceutical Use Patent for NeuVax™ (nelipepimut-S) covers the use of NeuVax as a vaccine for the prevention of relapse in breast cancer patients with an immunochemistry (IHC) rating of 1+ or 2+ for HER2/neu protein expression and a fluorescence in situ hybridization (FISH) rating of less than 2.0 for HER2/neu gene expression. The intention to grant the patent was received in August 2013, with the official Decision to Grant received in October 2013. The patent affords protection in all of the European countries and will expire in April 2028.
- NeuVax Oral presentation at the American College of Surgeons Clinical Congress. NeuVax shown to induce a full immune response in treated patients and create an immune memory to target residual cancer cells. Additionally, the Phase 3 PRESENT HER2 1+/2+ patients confirmed as optimal treatment population.
- Completed $40 Million financing to significantly strengthen our balance sheet.
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the U.S. Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The PRESENT trial is ongoing and additional information on the study can be found at www.neuvax.com. A randomized, multicenter investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche).
According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets the approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.
About Folate Binding Protein (FBP)
Folate Binding Protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is a well-validated therapeutic target. FBP is the source of immunogenic peptides like E39 that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy preclinical FBP-expressing cancer cells. The FBP vaccine consists of the FBP peptide(s) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). Galena’s FBP vaccine, E39, is currently in Phase 1/2 trial in two gynecological cancers; ovarian and endometrial adenocarinomas.
About Abstral® (fentanyl) Sublingual Tablets
Abstral® (fentanyl) Sublingual Tablets are an important treatment option for inadequately controlled breakthrough cancer pain which impacts 40%-80% of cancer patients. Abstral is approved by the U.S. Food and Drug Administration, and is a sublingual (under the tongue) fentanyl tablet indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The innovative Abstral formulation delivers the analgesic power and increased bioavailability of micronized fentanyl in a more convenient sublingual tablet which rapidly dissolves under the tongue in seconds, provides rapid relief of breakthrough pain in minutes, and matches the duration of the entire pain episode. See full prescribing information at www.abstral.com.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information, visit www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of Abstral and development of Galena’s product candidates, including patient enrollment in our clinical trials, as well as statements about our expectations, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2012 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena 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 press release.
Galena Biopharma, Inc. | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) | ||||
(Amounts in thousands, except share and per share data) | ||||
Three Months Ended | Three Months Ended | Nine Months Ended | Nine Months Ended | |
September 30, 2013 | September 30, 2012 | September 30, 2013 | September 30, 2012 | |
Net revenue | $ 1,170 | $ — | $ 1,170 | $ — |
Cost of revenue | 301 | — | 301 | — |
Gross profit | 869 | — | 869 | — |
Operating expenses: | ||||
Research and development expense | 3,633 | 4,169 | 13,990 | 10,553 |
General and administrative expense | 4,129 | 1,359 | 8,369 | 5,068 |
Operating loss | 6,893 | 5,528 | 21,490 | 15,621 |
Other income (expense), net | (1,235) | (733) | (6,749) | (13,953) |
Income (loss) from continuing operations before income taxes | (8,128) | (6,261) | (28,239) | (29,574) |
Income tax expense (benefit) | 1,159 | — | (62) | — |
Net loss from continuing operations | (9,287) | (6,261) | (28,177) | (29,574) |
Discontinued operations | — | — | — | (1,644) |
Net loss | $ (9,287) | $ (6,261) | $ (28,177) | $ (31,218) |
Net loss per common share: | ||||
Basic and diluted per share, continuing operations | $ (0.11) | $ (0.09) | $ (0.33) | $ (0.49) |
Basic and diluted loss per share, discontinued operations | $ — | $ — | $ — | $ (0.03) |
Basic and diluted net loss per share | $ (0.11) | $ (0.09) | $ (0.33) | $ (0.52) |
Weighted-average common shares outstanding: basic and diluted | 87,319,450 | 67,265,470 | 84,678,612 | 60,150,658 |
Galena Biopharma, Inc. | ||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
(Amounts in thousands) | ||
September 30, 2013 | ||
(Unaudited) | December 31, 2012 | |
ASSETS | ||
Current assets: | ||
Cash and cash equivalents | $ 51,396 | $ 32,807 |
Restricted cash | 100 | 101 |
Marketable securities | 2,837 | 2,678 |
Accounts receivable | 1,543 | — |
Inventory | 425 | — |
Prepaid expenses and other current assets | 485 | 535 |
Total current assets | 56,786 | 36,121 |
Equipment and furnishings, net | 545 | 29 |
In-process research and development | 12,864 | 12,864 |
Abstral rights, net | 15,032 | — |
Goodwill | 5,898 | 5,898 |
Deposits | 129 | 74 |
Total assets | $ 91,254 | $ 54,986 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
Current liabilities: | ||
Accounts payable | $ 1,890 | $ 1,976 |
Accrued expense and other current liabilities | 8,889 | 2,038 |
Current maturities of capital lease obligations | 6 | 6 |
Fair value of warrants potentially settleable in cash | 24,267 | 10,964 |
Current portion of contingent purchase price consideration | 247 | 935 |
Current portion of long-term debt | 1,215 | — |
Total current liabilities | 36,514 | 15,919 |
Capital lease obligations, net of current maturities | 30 | 51 |
Deferred tax liability, non-current | 5,053 | 5,053 |
Contingent purchase price consideration, net of current portion | 6,454 | 6,207 |
Long-term debt, net of current portion | 8,583 | — |
Total liabilities | 56,634 | 27,230 |
Stockholders’ equity | 34,620 | 27,756 |
Total liabilities and stockholders’ equity | $ 91,254 | $ 54,986 |
CONTACT: Remy Bernarda Senior Director, Communications +1 (503) 405-8258 rbernarda@galenabiopharma.com
(HOTR) Completes the Acquisition of Nottingham, England Hooters Location
CHARLOTTE, NC–(Nov 7, 2013) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (“Chanticleer Holdings” or “the Company”), a franchisee of international Hooters® restaurants and a minority owner in the privately held parent company of the Hooters® brand, Hooters of America, announced the Company acquired the Nottingham England Hooters Location, effective today.
As part of this transaction, all leasehold and franchise rights to the location have been transferred to Chanticleer Holdings. Nottingham is Chanticleer’s second European and seventh international Hooters® location. The closing of the acquisition was pursuant to the Stock Purchase Agreement executed on October 24, 2013 for the purchase of 100% of the shares of West End Wings Limited (“WEW”), a company wholly owned by Manchester Wings Limited.
Mike Pruitt, CEO and President of Chanticleer Holdings, stated: “The Nottingham location is the fifteenth largest Hooters restaurant in terms of sales and Hooters’ fourth largest international store. This profitable location is an excellent addition to our restaurant portfolio. We look forward to continuing to work with the tremendous Nottingham management team to grow the location’s excellence in service and performance, as well as continue expansion in the United Kingdom.”
For further information, please visit www.chanticleerholdings.com
Facebook: www.Facebook.com/ChanticleerHOTR
Twitter: http://Twitter.com/ChanticleerHOTR
Google+: https://plus.google.com/u/1/b/118048474114244335161/118048474114244335161/posts
About Chanticleer Holdings, Inc.
Chanticleer Holdings (HOTR) is focused on expanding the Hooters® casual dining restaurant brand in international emerging markets and American Roadside Burgers Inc (“ARB”), a Charlotte, N.C. based chain. Chanticleer currently owns in whole or part of the exclusive franchise rights to develop and operate Hooters restaurants in South Africa, Hungary and parts of Brazil, and has joint ventured with the current Hooters franchisee in Australia, while evaluating several additional international opportunities. The Company currently owns and operates in whole or part of six Hooters restaurants in its international franchise territories: Durban, Johannesburg, Cape Town and Emperor’s Palace in South Africa; Campbelltown in Australia; and Budapest in Hungary. ARB, purchased by Chanticleer Holdings on October 1, 2013, has a total of 5 casual restaurants — 1 location in Smithtown, N.Y., 2 locations in Charlotte, N.C., 1 location in Columbia, S.C., and the newest location is in Greenville, S.C.
Forward-Looking Statements:
Any statements that are not historical facts contained in this release are “forward-looking statements” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing or required licenses, competition, general economic conditions and other factors that are detailed in our periodic reports and on documents we file from time to time with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the companies do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Contact:
Chanticleer Holdings, Inc.
Mike Pruitt
Chairman/CEO
Phone: 704.366.5122 x 1
mp@chanticleerholdings.com
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