Archive for October, 2013
(ACHN) Sued by Investors After Stock Drops 58%
SAN DIEGO and NEW HAVEN, Conn., Oct. 14, 2013 — Shareholder rights law firm Robbins Arroyo LLP announces that an investor of Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) has filed a federal securities fraud class action complaint in the U.S. District Court, District of Connecticut. The complaint alleges that the company and certain of its officers violated the Securities and Exchange Act of 1934 between April 21, 2012 and September 27, 2013 (the “Class Period”).
Learn more about our investigation on our Shareholder Rights Blog: http://www.robbinsarroyo.com/shareholders-rights-blog/achillion-pharmaceuticals-inc/
Achillion Accused of Misleading Investors Regarding Viability of Sovaprevir
Shares of Achillion fell $4.22 per share, or more than 58%, on September 27, 2013, after the company disclosed that the U.S. Food and Drug Administration (“FDA”) continued its clinical hold on sovaprevir, its premier investigative drug for the treatment of hepatitis. This steep decline comes just two months after Achillion experienced an initial 25% decline per share on the announcement that the FDA instituted the clinical hold on July 1, 2013.
According to the complaint, defendants made false and/or misleading statements and failed to disclose material adverse facts about the company’s business, operations, and prospects, including the safety and suitability of sovaprevir. Defendants failed to inform investors that sovaprevir did not interact well with other drugs commonly administered to treat hepatitis and/or HIV, and misled investors to believe that even though patients in the company’s clinical trials for sovaprevir had elevations in liver enzymes, that these liver enzymes elevations were transient and returned to baseline values and were attributable to non-drug-related factors.
If you invested in Achillion and would like to discuss your shareholder rights please contact attorney Darnell R. Donahue at (800) 350-6003, DDonahue@robbinsarroyo.com, or via the shareholder information form on the firm’s website.
Robbins Arroyo LLP is a nationally recognized leader in securities litigation and shareholder rights law. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits, and has helped its clients realize more than $1 billion of value for themselves and the companies in which they have invested. For more information, please go to http://www.robbinsarroyo.com.
Attorney Advertising. Past results do not guarantee a similar outcome.
Contact:
Darnell R. Donahue
Robbins Arroyo LLP
DDonahue@robbinsarroyo.com
(619) 525-3990 or Toll Free (800) 350-6003
www.robbinsarroyo.com
(NFLX) Orders Psychological Thriller Series From “Damages” Creators
Original Series from Todd A. Kessler, Daniel Zelman and Glenn Kessler to Premiere Only on Netflix
BEVERLY HILLS, Calif., Oct. 14, 2013 — Netflix (NASDAQ: NFLX) has ordered a new psychological thriller series from “Damages” creators Todd A. Kessler, Daniel Zelman and Glenn Kessler (“KZK”) that centers on a family of adult siblings whose secrets and scars are revealed when their black sheep brother returns home. The 13-episode first season, from Sony Pictures Television, will premiere exclusively for Netflix members to watch instantly in all Netflix territories.
“We were spellbound after hearing Todd, Glenn and Daniel’s pitch, and knew Netflix was the perfect home for this suspenseful family drama that is going to have viewers on the edge of their seats,” said Cindy Holland, vice president of original content for Netflix. “Their work on ‘Damages’ was truly ahead of its time and we’re proud to be bringing our viewers this upcoming series.”
“We are absolutely thrilled to be creating an original series for Netflix — a company committed to cutting-edge storytelling in a vibrant, new space. We’re equally excited about our relationship with Sony Pictures TV, which continues to provide us with unwavering creative support. We’ve always wanted to put our spin on a family saga and examine universal themes of family in a way that has never been seen before on television. The series is a tightly wound thriller that explores the complex bonds between parents and children, brothers and sisters, and the rivalries, jealousies, and betrayals at the core of every family,” said Todd A. Kessler, Daniel Zelman and Glenn Kessler.
“The guys worked so hard to come up with the right idea after the success of Damages,” said Jamie Erlicht, president of programming and production for Sony Pictures Television. “It took almost a year to fully develop the pitch and their patience paid off with the incredible reaction in the community, especially at Netflix, the perfect home for this show.”
Set to begin production in early 2014, the series explores the wounds and emotional demons that lie at the core of a contemporary American family. Kessler, Zelman and Kessler will serve as executive producers of the one-hour drama that will be produced by Sony Pictures Television for Netflix.
Together, the Emmy® and Golden Globe® nominated Writers/Executive Producers Todd A. Kessler, Daniel Zelman, and Glenn Kessler co-created the award winning legal thriller “Damages.” Todd A. Kessler also wrote and produced the second and third seasons of HBO’s “The Sopranos”; Michael Mann’s “Robbery Homicide Division,” and the first season of NBC’s “Providence.” Kessler began his career as a playwright working with David Rabe, and segued into film and television when Spike Lee hired him as a screenwriter. Kessler graduated Magna Cum Laude from Harvard University with a degree in Dramatic Literature and Playwriting, and has twice been a Visiting Artist at Harvard, teaching screenwriting seminars. He has been nominated for seven Emmys® and three Golden Globe Awards®, as well as a Writers Guild of America Award and a Producers Guild Award. Daniel Zelman has co-authored seven screenplays. Zelman’s first collaboration with the Kesslers was on “The Inside,” a series the brothers created for FOX. Before turning to writing, Zelman received his master of fine arts degree from New York University’s Tisch School of Arts Graduate Acting Program. Zelman went on to appear as an actor in film, television and on-stage in New York, where he acted in many Off- Broadway Plays and on Broadway in Tony Kushner’s Angels in America. Zelman has been nominated for three Emmy® Awards, a Golden Globe® award, a Writers Guild of America Award and a Producers Guild Award. Glenn Kessler began his career as a playwright and an actor in film, television, and on stage. He segued into television writing working on Michael Mann’s CBS drama Robbery Homicide Division. Since then, Kessler has created dramas for 20th Century Fox, Universal, USA, and Imagine Television. Kessler holds a Master in Fine Arts from New York University’s Tisch School of the Arts Graduate Acting Program. He graduated with honors from Harvard University where he earned a degree in English and American Literature. Kessler has been nominated for three Emmy® Awards, a Golden Globe® award as well as a Writers Guild of America Award and a Producers Guild Award.
About Netflix, Inc.
Netflix is the world’s leading Internet television network with more than 37 million members in 40 countries enjoying more than one billion hours of TV shows and movies per month, including original series. For one low monthly price, Netflix members can watch as much as they want, anytime, anywhere, on nearly any Internet-connected screen. Members can play, pause and resume watching, all without commercials or commitments.
About Sony Pictures Television
Sony Pictures Television is one of the television industry’s leading content providers, producing and distributing programming worldwide in every genre including comedy, drama and reality series, telefilms and theatrical releases, for every platform. SPT is a leader in local language production around the world with 19 production companies outside the US, and also sells SPE-owned formats in approximately 88 countries. SPT’s worldwide television networks portfolio includes 124 channel feeds, which are available in 159 countries reaching more than 800 million households. Additionally, SPT owns multiplatform video service Crackle and is a part owner of GSN, 3net, FEARnet, and ITN Networks, Inc.
(ATOS) Gregory L. Weaver Joins Board of Directors
SEATTLE, WA–(Oct 14, 2013) – Atossa Genetics Inc. (NASDAQ: ATOS), The Breast Health Company™, announced today that Gregory L. Weaver has joined the Company’s Board of Directors and has been appointed a member of the Audit Committee.
“Greg brings a wealth of financial and operational experience in the Life Sciences industry to Atossa’s Board of Directors and Audit Committee, including mergers and acquisitions, licensing transactions, regulatory approvals, and new product launches, as well as strategic planning and cost control efforts,” said Steven C. Quay, Chairman, President & CEO. “Greg’s experience will be invaluable to the Board and to management as we continue to build the Company.”
Weaver has built a successful career in executive financial and operations management serving as CFO of small to mid-cap public and private biotechnology companies. He currently serves as Chief Financial Officer, Senior Vice President, Treasurer and Corporate Secretary of Fibrocell Science, Inc. Prior to joining Fibrocell Science in September 2013, he served as CFO with the following public companies: Celsion Corp., Poniard Pharmaceuticals, Sirna Therapeutics (acquired by Merck), Nastech Pharmaceuticals, and ILEX Oncology (acquired by Genzyme), and venture funded firms Talyst, Inc. and Prism Technologies. In addition, Greg served as a director and audit committee chairman of Celsion from 2005-2011, as a director with the Washington State WBBA, and has consulted with other biotech companies throughout his career. Greg began his career as a Certified Public Accountant with Arthur Andersen. He has a Master of Business Administration from Boston College and Bachelor of Science from Trinity University.
“I appreciate the opportunity to join the Board of Directors of Atossa Genetics at this important juncture,” commented Weaver. “Atossa has the potential to make a significant contribution toward women’s breast health and I look forward to the future success of the Company.”
About Atossa Genetics, Inc.
Atossa Genetics, Inc. is focused on the commercialization of patented, diagnostic medical devices and, through its wholly-owned subsidiary, The National Reference Laboratory for Breast Health, Inc. (NRLBH), patented, laboratory developed tests. The NRLBH is a CLIA-certified high-complexity molecular diagnostic laboratory located in Seattle, Washington.
For additional information please visit www.atossagenetics.com.
Forward-Looking Statements
Forward-looking statements in this Press Release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions by the FDA, the outcome or timing of regulatory clearances needed by Atossa to sell its products, responses to regulatory matters, Atossa’s ability to continue to manufacture and sell its products, recalls of products, the efficacy of Atossa’s products and services, the market demand for and acceptance of Atossa’s products and services, performance of distributors, estimated future expenses and cash needs, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.
Contact:
Atossa Genetics Inc.
Kyle Guse
CFO and General Counsel
(O) 800-351-3902
Email Contact
MBS Value Partners
Matthew D. Haines (Investors)
Managing Director
(O) 212-710-9686
Email Contact
JQA Partners
Jules Abraham (Media)
Principal
(O) 917-885-7378
Email Contact
(PETX) Agrees to Acquire Vet Therapeutics, Inc.
Adds Biologics to its Pet Therapeutics Platform Announces $19.75M Equity Financing and $5M Expansion of Existing Debt Facility Aratana to Host Conference Call Monday, October 14 at 8:00 a.m. Eastern Time
KANSAS CITY, Kan. and BOSTON, Oct. 14, 2013 — Aratana Therapeutics, Inc. (Nasdaq: PETX), a biopharmaceutical company focused on the licensing, development and commercialization of innovative medications for pets (pet therapeutics), today announced that it has entered into a merger agreement providing for the strategic acquisition of Vet Therapeutics, Inc., a San Diego-based company with a proprietary antibody-based biologics platform. Under the agreement, Aratana plans to continue to advance the pipeline of high value biologic drugs, including its lymphoma franchise. Importantly, the acquisition of Vet Therapeutics is expected to significantly accelerate Aratana’s pathway toward becoming a commercial-stage pet therapeutics company.
Vet Therapeutics’ canine antibody product intended as an aid for the treatment of canine T-cell lymphoma in dogs has been submitted to the U.S. Department of Agriculture for review. The company’s canine monoclonal antibody intended as an aid for the treatment of B-cell lymphoma in dogs has been granted a conditional license by the USDA. The product is commercialized under a distribution agreement with a large animal health company in certain territories. Beyond these products, Vet Therapeutics’ current pipeline includes biologics for the treatment of other cancers, atopic dermatitis and other immune conditions. After the closing of the acquisition, Genevieve Hansen, Ph.D., founder, President and Chief Scientific Officer of Vet Therapeutics, is expected to become Aratana’s Head of Biologics, and continue to manage Vet Therapeutics, Inc. as a wholly owned subsidiary of Aratana.
Lymphoma is the most common blood cancer in dogs, accounting for an estimated 6% of total dog cancers. With more than 150,000 dogs treated with standard of care chemotherapy per year, it is also the most treated dog cancer in the United States, with treatment costs ranging between $3,500 and $10,000. Vet Therapeutics’ canine-specific monoclonal antibodies for B-cell and T-cell diseases are first-in-class biologic product candidates that have shown potent activity in studies against validated cancer targets.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, stated, “Biologics represent an extremely promising new frontier for treating important diseases in pets. We are proud to be expanding our leadership in pet therapeutics by acquiring a leader in pet biologics development, Vet Therapeutics, and expect to offer an even more robust, complementary pet therapeutics pipeline. We are particularly excited about the lead B-cell lymphoma product, as we strongly believe a canine-specific antibody therapy could achieve the same therapeutic success in dogs that Genentech’s Rituxan® has achieved in human lymphoma. After the closing, we look forward to continuing to work with Vet Therapeutics’ large animal health collaborator in bringing canine specific versions of some of the most innovative molecules in biotech for the treatment of Lymphoma to these members of our family.”
“Beyond the product candidates already in development, we believe that the addition of an internal development platform and manufacturing capability for biologics represents an attractive growth opportunity for Aratana that is characterized by fast-to-market, targeted therapies. We view biologics as a valuable complement to our in-licensing strategy for small molecules.”
Dr. Hansen stated, “Aratana has the vision and drive to bring our biologic products to market and the ability to leverage and defend our proprietary antibody platform over the years to come. As we near reaching the market with our lead programs, we are excited to partner with such a committed group to support the development and commercialization of these innovative therapies. As part of Aratana after the closing, we look forward to continuing our work of enhancing the quality of care for pets.”
Aratana also announced that it has entered into a share purchase agreement providing for a $19.75 million private placement of shares of its common stock. The company agreed to issue 1,234,375 shares for a purchase price of $16.00 per share. The financing is expected to close on or prior to October 17, 2013. Pursuant to the share purchase agreement, Aratana agreed to register all of such shares for resale. The investors agreed not to sell any of such shares before the date that is 90 days after the closing date of the Vet Therapeutics acquisition. Aratana also announced a $5 million expansion of its existing venture debt facility with Square 1 Bank to partially fund the acquisition.
Under the terms of the merger agreement for the Vet Therapeutics acquisition, Aratana agreed to pay to Vet Therapeutics’ equity holders at the closing $30 million in cash, issue 625,000 shares of common stock and issue a promissory note for $3 million with a maturity date of December 31, 2014, subject to prepayment in the event of specified equity financings. Aratana also agreed to pay up to $5 million in contingent cash consideration upon the achievement of certain regulatory and manufacturing milestones for the B-cell lymphoma product. The Board of Directors and stockholders of Vet Therapeutics have approved the merger. The closing is subject to other customary closing conditions and is expected to occur on Tuesday, October 15. Upon the closing of the acquisition, Vet Therapeutics will become a wholly owned subsidiary of Aratana, and is expected to continue to operate out of its San Diego location.
Aratana also announced today that Stifel, Nicolaus & Company, Incorporated and Lazard Capital Markets LLC, the lead book-running managing underwriters in the Company’s recent public offering of 6,612,500 shares of common stock, are releasing a lock-up restriction with respect to the shares of the Company’s common stock held by the Company’s officers and directors and each of the other stockholders of the Company who signed a lock-up agreement. The release will take effect at 4:00 p.m., New York City time, on December 9, 2013, and the shares may be sold on or after such time. However, each of the Company’s officers and directors and several other stockholders (representing a total of approximately 14 million shares) have agreed with the Company to a new lock-up restriction for a period of 90 days after the closing of the acquisition of Vet Therapeutics. As a result, the lock-up restriction from the Company’s initial public offering on approximately 4 million shares will be released at 4:00 p.m., New York City time, on December 9, 2013.
Aratana is also providing the following additional information regarding Vet Therapeutics and the terms of the acquisition, some of which will also be included in a Current Report on Form 8-K expected to be filed with the Securities and Exchange Commission on Tuesday, October 15:
- Vet Therapeutics has six programs in development, focused on the following indications:
- B-cell Lymphoma
- T-cell Lymphoma
- Diagnostic to support lymphoma phenotyping
- Mast Cell Tumor
- Atopic Dermatitis
- Feline Lymphoma
- We believe the existing market in the United States for pet oncology treatment is approximately $2 billion based on off-label use of human chemotherapy products. We believe species-specific antibodies represent a large opportunity.
- Vet Therapeutics believes it has the leading intellectual property estate in pet therapeutics:
- An issued patent (US Patent No. 8,337,842) related to the speciesization of antibodies; expiration date of 2029. Claims are directed to heterochimeric antibodies, and covers all of Vet Therapeutics’ products. The patent also has claims directed to both canine CD20 & CD52 and a divisional directed to methods of treatment.
- Filed patents related to antibody constant domain regions and uses thereof which similarly covers all Vet Therapeutics products, and has notice of allowance until 2030.
- Filed patents that cover canine monoclonal antibodies directed to canine CD20 (at least 2031) and canine CD52 (at least 2031).
- Unpublished patent applications for pet-specific monoclonal antibodies directed against IL-6 and the Her2 Receptor.
- A leading proprietary platform, with pet-specific antibodies covering over 85% of pet sequences, including the Fc region, and an effective IgG sequence, which we believe are highly specific, potent, cost-effective and compatible with pet immune systems.
- Responses seen to date in dogs treated with B-cell Lymphoma product in combination with chemotherapy showed a significant increase in remission time in studies initiated by Board certified veterinary oncologists.
- Treated dogs received a reduced chemotherapy treatment alone followed by several cycles of antibody therapy alone.
- Treated dogs had significantly longer remission times when compared to dogs treated only with chemotherapy.
- T- cell Lymphoma proposed product addresses a significant need in dogs.
- A study has been conducted wherein dogs were treated with antibody as monotherapy.
- The primary endpoint (survival) was met and the product was well tolerated.
- We believe that some of the side effects in humans of Campath (an antibody to human CD52) may not be applicable in canines and are potentially treatable, if seen.
- Attractive double-digit percentage royalties and low single-digit milestones (in millions of dollars) from a large animal health company for the B-cell Lymphoma product in certain geographies.
- Aratana sales force will initiate commercialization for the T-cell lymphoma product following its licensure from the USDA, if received (typically, within twelve months of submission).
- Aratana anticipates hiring a 10-15 person commercial team in 2014 which will be doubled in 2015 in anticipation of a full approval in 2016.
This press release is not an offer or sale of the securities in the United States or in any other jurisdiction where such offer or sale is prohibited. Neither the shares to be issued pursuant to the share purchase agreement, nor the shares to be issued in connection with the merger have been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.
Investors and other interested participants may access the conference call by dialing 1-877-870-4263 (U.S.), or 1-412-317-0790 (international). A live audio webcast will be accessible via the Investor Relations section of the Aratana web site, http://aratana.investorroom.com.
A telephonic replay of the call will be available beginning approximately one hour after the conference call ends. Access numbers for this replay are 1-877-344-7529 (U.S./Canada) and 1-412-317-0088 (international); conference ID: 10035489. The webcast replay will remain available in the Investor Relations section of the Aratana web site for 14 days.
JMP Securities LLC acted as financial advisor and Latham & Watkins LLP served as legal counsel to Aratana in the transaction.
About Aratana Therapeutics
Aratana Therapeutics is a biopharmaceutical company focused on the licensing, development and commercialization of innovative medications for pets, or pet therapeutics. Aratana believes that it can leverage the investment in the human biopharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. Aratana’s strategy is to in-license proprietary compounds from human biopharmaceutical companies and to develop these product candidates into therapeutics specifically for use in pets. Aratana believes the development and commercialization of these therapeutics will permit veterinarians and pet owners to manage pets’ medical needs safely and effectively, resulting in longer and improved quality of life for pets.
About Vet Therapeutics
Vet Therapeutics is developing antibody-based therapies to treat pet cancer and chronic conditions. The company is committed to bringing the same modality of products that constitute the standard of care in humans to animal health by applying world-class science to new products for companion animals. The Vet Therapeutics team has more than 30 years’ experience and a successful track record at developing antibody-based biologics for humans, which is directed towards the development of pet-specific biologics to treat pet cancer and chronic conditions.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our proposed acquisition of Vet Therapeutics; proposed private placement of shares of common stock; expectations regarding the approval of products; the prospects for Vet Therapeutics; expected future cash balance and liquidity; expectations regarding development programs, trials, studies, and approval; expectations regarding in-license initiatives; and expectations regarding the Company’s plans and opportunities.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; our lack of commercial sales; our failure to obtain any necessary additional financing; our substantial dependence on the success of our current compounds, AT-001, AT-002 and AT-003, which are still in development; our inability to identify, license, develop and commercialize additional product candidates; our inability to obtain regulatory approval for our existing or future product candidates; the lack of commercial success of our current or future product candidates; uncertainties regarding the outcomes of studies regarding our products; effects of competition; our failure to attract and keep senior management and key scientific personnel; our complete reliance on third-party manufacturers and third parties to conduct all our target animal studies and certain other development efforts; our lack of a sales organization; our significant costs of operating as a public company; our lack of effective internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of our customers; impacts of generic products; unanticipated safety or efficacy concerns; our limited patents and patent rights; our failure to comply with our intellectual property license obligations; our infringement of third party patents and challenges to our patents or rights; our failure to comply with regulatory requirements; our failure to report adverse medical events related to our products; legislative or regulatory changes; the volatility of our stock price; our status as an “emerging growth company,” as defined in the JOBS Act; the potential for dilution if we sell shares of our common stock in future financings; the significant control over our business by our principal stockholders and management; the potential that a significant portion of our total outstanding shares could be sold into the market in the near future; effects of anti-takeover provisions in our charter documents and under Delaware law; and our intention not to pay dividends. These and other important factors discussed under the caption “Risk Factors” in the Company’s final prospectus filed with the Securities and Exchange Commission, or SEC, on June 27, 2013 relating to its Registration Statement on Form S-1, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Contacts:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D. (investors)
jdrumm@tiberend.com; (212) 375-2664
Andrew Mielach (media)
amielach@tiberend.com; (212) 375-2694
(GEOS) Order for 9,000 Stations of Three-Channel GSX Wireless Recording System
Geospace Technologies Corporation (NASDAQ: GEOS) today announced the receipt of an order from Dawson Geophysical for 9,000 stations of its three-channel GSX wireless recording system. The order includes sensors, batteries, trailers and accompanying system electronics. Delivery of the $18.1 million order is expected to occur in the company’s first quarter ending December 31, 2013.
Geospace Technologies Corporation designs and manufactures instruments and equipment used by the oil and gas industry to acquire seismic data in order to locate, characterize and monitor hydrocarbon producing reservoirs. The company also designs and manufactures non-seismic products, including industrial products, offshore cables, thermal printing equipment and film.
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact included herein including statements regarding potential future products and markets, our potential future revenues, future financial position, business strategy, future expectations and estimates and other plans and objectives for future operations, are forward-looking statements. We believe our forward-looking statements are reasonable. However, they are based on certain assumptions about our industry and our business that may in the future prove to be inaccurate. Important factors that could cause actual results to differ materially from our expectations include the level of seismic exploration worldwide, which is influenced primarily by prevailing prices for oil and gas, the extent to which our new products are accepted in the market, the availability of competitive products that may be more technologically advanced or otherwise preferable to our products, tensions in the Middle East and other factors disclosed under the heading “Risk Factors” and elsewhere in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, which are on file with the Securities and Exchange Commission. Further, all written and verbal forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by such factors. We assume no obligation to revise or update any forward-looking statement, whether written or oral, that we may make from time to time, whether as a result of new information, future developments or otherwise.
(AMRS) Meets Major Milestone at Its Farnesene Production Facility
Amyris CEO to Speak at Advanced Biofuels Leadership Conference on Strong Performance of Amyris’s Renewable Hydrocarbon Production in Brazil
EMERYVILLE, Calif., Oct. 11, 2013 — Amyris, Inc. (Nasdaq:AMRS), a leading renewable chemicals and fuels company, announced that its farnesene plant in Brazil has achieved the production run rate of 1 million liters over a 45-day period. Amyris’s Chief Executive Officer John Melo will speak later today at the Advanced Biofuels Leadership Conference (ABLCNext) today in San Francisco, California.
“Our farnesene plant in Brazil is operating well, meeting our technology, volumetric and cost targets. With all six fermentors running as planned and with our ongoing production rate, we are on track to achieve our year-end cost targets. Our plant at Brotas is expected to produce more farnesene this year than we produced in our entire prior contract manufacturing operations combined. All told, we have surpassed the 5 million liter production mark,” said John Melo in his prepared remarks.
“More importantly, we are growing the market with new, innovative products. Using a blend of renewable diesel, public transit buses in Brazil’s largest cities have logged well over 15 million miles, improving performance while reducing emissions. Our cosmetics business has grown over 80% year-on-year following the introduction of Neossance® Squalane, our renewable version of this premium emollient,” Amyris’s CEO added.
The Amyris production facility, located adjacent to the Paraiso sugarcane mill in Brotas, Sao Paulo in Brazil, began commercial operations at the beginning of 2013 and had all six fermentors running in July to align with commercial volume needs. Amyris’s farnesene is a renewable hydrocarbon molecule addressing growing demand in a broad range of applications, from diesel and jet fuel to high-performance materials.
ADDITIONAL FUNDING RECEIVED
Amyris’s CEO also noted the Company’s successful efforts to secure financing saying, “As we announced earlier this week, we received a $35 million loan to provide bridge financing until the closing of the first tranche of our pending convertible note financing, which we expect in the coming weeks.”
“By producing 1 million liters of farnesene in a 45-day period, we have surpassed the production performance milestones under the purchase agreement for the financing and are on track to meet the remaining milestones,” Melo concluded.
In August 2013, Amyris entered into an agreement for a private placement of senior convertible promissory notes for approximately $60 million in cash proceeds. Two of Amyris’s leading stockholders committed to purchase the notes in two tranches. By achieving 1 million liters of production in a 45-day period, Amyris satisfied one of the two conditions required to avoid a reduction in the conversion price of the first-tranche notes (the other being a target for gross margins from product sales) and one of the key closing conditions for the second tranche. Additional information regarding the terms of the financing, including detailed discussion of the triggers for conversion price adjustments and additional closing conditions, is provided in Amyris’s regulatory filings.
ONLINE WEBCAST
Amyris is participating in the Advanced Biofuels Leadership Conference taking place from October 9-11 in San Francisco.
Amyris’s CEO John Melo will make a presentation at 9:45 AM PT (12:45 PM ET) on Friday, October 11 at the Intercontinental Hotel in San Francisco regarding the Company’s performance. The remarks will be webcast on Amyris’s Investor Relations website at http://investors.amyris.com.
A replay of the webcast will be available in the Investor Relations section of the Company’s website approximately two hours after the conclusion of the event and will remain available for approximately 60 calendar days.
About Amyris
Amyris (Nasdaq:AMRS) is an integrated renewable products company focused on providing sustainable alternatives to a broad range of petroleum-sourced products. Amyris uses its industrial synthetic biology platform to convert plant sugars into a variety of hydrocarbon molecules—flexible building blocks that can be used in a wide range of products. Amyris is commercializing these products both as No Compromise® renewable ingredients in cosmetics, flavors and fragrances, polymers, lubricants and consumer products, and also as No Compromise renewable diesel and jet fuel. Amyris Brasil Ltda., a subsidiary of Amyris, oversees the establishment and expansion of Amyris’s production in Brazil. Amyris also has fuel distribution capabilities in the United States through its subsidiary, Amyris Fuels, LLC. More information about Amyris is available at www.amyris.com.
Amyris Forward-Looking Statements
This release contains forward-looking statements, and any statements other than statements of historical facts could be deemed to be forward-looking statements. These forward-looking statements include, among other things, statements regarding future events (such as achieving production cost and volume targets and closing of a pending financing) that involve risks and uncertainties. These statements are based on management’s current expectations and actual results and future events may differ materially due to risks and uncertainties, including those associated with any delays or failures in development, production or commercialization of products, liquidity and ability to fund capital expenditures, Amyris’s reliance on third parties to achieve its goals, and other risks detailed in the “Risk Factors” section of Amyris’s Form 10-Q, as filed on August 9, 2013. Amyris disclaims any obligation to update information contained in these forward-looking statements whether as a result of new information, future events, or otherwise.
Amyris, the Amyris logo and No Compromise are trademarks or registered trademarks of Amyris, Inc.
CONTACT: Amyris, Inc. Joel Velasco (510) 740-7481 investor@amyris.com
(OCLR) II-VI Incorporated Announces Signing of Agreement to Purchase
PITTSBURGH, Oct. 10, 2013 — II-VI Incorporated (Nasdaq:IIVI) announced today that it has signed an asset purchase agreement to acquire the fiber amplifier and micro-optics business (the “Business”) of Oclaro, Inc. (Nasdaq:OCLR) in a transaction valued at $88.6 million. The effective date of the closing is dependent upon the receipt of certain regulatory clearances and is expected to close on or about November 1, 2013. II-VI had previously disclosed its interest in the Business on September 12, 2013 when II-VI disclosed it had purchased for $5 million an exclusive option to acquire the Business.
The acquisition of the Business will complement the Zurich, Switzerland–based semiconductor laser business of Oclaro that was acquired by II-VI on September 12, 2013 and is consistent with the Company’s strategy to focus on precision engineered materials and opto-electronic component businesses. The Business will be included in the Company’s Active Optical Products Segment for financial reporting purposes.
Francis J. Kramer, president and chief executive officer of II-VI Incorporated, stated “We are pleased to add a broad portfolio of world-class, fully customized solutions to provide customers with end-to-end design and manufacturing support to enable the rapid realization of customer-specific amplification and micro-optics solutions. We will leverage the telecom laser pump product line we recently purchased from Oclaro, and the Business will benefit from the complementary product portfolio and capabilities of our Photop business unit. The Business and its team come to us as a recognized industry leader, and are well positioned with a broad technology and product portfolio which is underpinned by over 400 patents. We look forward to serving the customers of the Business, and we welcome our most recent employees to the II-VI family of companies.”
Additional Transaction Details
At closing, II-VI will pay $79.6 million in cash to Oclaro, $4 million of cash will be held back by II-VI until December 31, 2014, and the remaining $5 million was previously paid to Oclaro on September 12, 2013 as an option to purchase the Business.
II-VI will finance the acquisition with available cash from its recently expanded credit facility. Assuming that the transaction receives regulatory approvals on or about November 1, 2013, for the remainder of II-VI’s fiscal year ending June 30, 2014 the Business is currently expected to generate between $60 and $65 million in revenues and to be neutral to earnings after the impact of one-time transactions expenses is included. II-VI expects the acquisition to become accretive to earnings during the fiscal year ending June 30, 2015.
Forward-looking Statements
This press release contains forward-looking statements based on certain assumptions and contingencies that involve risks and uncertainties. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and relate to the Company’s performance on a going-forward basis. The forward-looking statements in this press release involve risks and uncertainties, which could cause actual results, performance or trends to differ materially from those expressed in the forward-looking statements herein or in previous disclosures. The Company believes that all forward-looking statements made by it have a reasonable basis, but there can be no assurance that management’s expectations, beliefs or projections as expressed in the forward-looking statements will actually occur or prove to be correct. In addition to general industry and global economic conditions, factors that could cause actual results to differ materially from those discussed in the forward-looking statements in this press release include, but are not limited to: (i) the failure of any one or more of the assumptions stated above to prove to be correct; (ii) the risks relating to forward-looking statements and other “Risk Factors” discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2013; (iii) the purchasing patterns from customers and end-users; (iv) the timely release of new products, and acceptance of such new products by the market; (v) the introduction of new products by competitors and other competitive responses; (vi) the Company’s ability to devise and execute strategies to respond to market conditions; and/or (vii) the Company’s ability to assimilate recently acquired businesses, and risks, costs and uncertainties associated with such acquisitions. The Company disclaims any obligation to update information contained in these forward-looking statements whether as a result of new information, future events or developments, or otherwise.
About II-VI Incorporated
II-VI Incorporated, a global leader in engineered materials and opto-electronic components, is a vertically-integrated manufacturing company that creates and markets products for diversified markets including industrial manufacturing, optical communications, military and aerospace, high-power electronics, semiconductor laser and thermoelectronics applications. Headquartered in Saxonburg, Pennsylvania, with manufacturing, sales, and distribution facilities worldwide, the Company produces numerous crystalline compounds including zinc selenide for infrared laser optics, silicon carbide for high-power electronic and microwave applications, and bismuth telluride for thermoelectric coolers.
In the Company’s infrared optics business, II-VI Infrared manufactures optical and opto-electronic components for industrial laser and thermal imaging systems and HIGHYAG Lasertechnologie GmbH (HIGHYAG) manufactures fiber-delivered beam delivery systems and processing tools for industrial lasers.
In the Company’s near-infrared optics business, Photop Technologies, Inc. (Photop) manufactures crystal materials, optics, microchip lasers and opto-electronic modules for use in optical communication networks and other diverse consumer and commercial applications. Photop Aegis, Inc. (Aegis) manufactures tunable optical devices required for high speed optical networks that provide the bandwidth expansion necessary for increasing internet traffic. Through its Australian subsidiary, Photop AOFR Pty Limited, Aegis also manufactures fused fiber components, including those required for fiber lasers for material processing applications, as well as optical couplers used primarily in the optical communication industry.
In the Company’s military & materials business, LightWorks Optical Systems, Inc. (formerly Exotic Electro-Optics and LightWorks Optics, Inc.) manufactures products for military applications and precision optical systems, and components for defense, aerospace, industrial and life science applications. Pacific Rare Specialty Metals & Chemicals (PRM) produces and refines a rare earth element and selenium, Max Levy Autograph, Inc. (MLA) manufactures micro-fine conductive mesh patterns for optical, mechanical and ceramic components for applications such as circuitry, metrology standards, targeting calibration and suppression of electro-magnetic interference. VLOC manufactures near-infrared and visible light products for military applications and laser gain materials and products for solid-state YAG and YLF lasers.
In the Company’s advanced products group, the Wide Bandgap Materials (WBG) group manufactures and markets single crystal silicon carbide substrates for use in the solid-state lighting, wireless infrastructure, RF electronics and power switching industries. Marlow Industries, Inc. (Marlow) designs and manufactures thermoelectric cooling and power generation solutions for use in defense, space, photonics, telecommunications, medical, consumer and industrial markets. Worldwide Materials Group (WMG) provides expertise in materials development, process development and manufacturing scale up. M Cubed Technologies, Inc. (M Cubed) develops and markets advanced composite materials serving the semiconductor, display, industrial and defense markets.
In the Company’s active optical products segment, II-VI Laser Enterprise, GmbH is an industry-leading manufacturer of high-power semiconductor laser components enabling fiber and direct diode laser systems for material processing, medical, consumer and printing applications. In addition, II-VI Laser Enterprise GmbH manufactures pump lasers for optical amplifiers for both terrestrial and submarine applications and vertical cavity surface emitting lasers (VCSELS) for optical navigation, optical interconnects and optical sensing applications.
CONTACT: II-VI Incorporated Craig A. Creaturo, Chief Financial Officer and Treasurer (724) 352-4455 ccreaturo@ii-vi.com Homepage: www.ii-vi.com
(SCTY) Announces Key Operating Metrics for Third Quarter 2013
Company Exceeds Guidance With 78 Megawatts (MW) Deployed in Q3 2013, Reaffirms FY2013 Guidance of 278 MW Deployed, and Establishes Range for FY2014 Guidance of 475 MW – 525 MW Deployed
SAN MATEO, Calif., Oct. 11, 2013 — SolarCity Corp. (Nasdaq:SCTY) , a leading provider of clean, distributed energy, today announced key operating metrics for the third quarter of its fiscal 2013, confirmed guidance for fiscal 2013 and established guidance for 2014 MW deployed.
Third Quarter 2013 Operating Metrics
- In the third quarter of 2013, the Company deployed 78 MW.
- As of September 30, 2013, cumulative energy contracts reached 72,506, and cumulative customers rose to 82,235.
- Estimated nominal contracted payments remaining were $1,737 million as of September 30, 2013.
Fiscal Years 2013 and 2014 Guidance
- The Company continues to expect to achieve 278 MW deployed for its current fiscal year 2013.
- For its fiscal year 2014, the Company expects to deploy between 475 MW and 525 MW.
About SolarCity
SolarCity® (Nasdaq:SCTY) provides clean energy. The company has disrupted the century-old energy industry by providing renewable electricity directly to homeowners, businesses and government organizations for less than they spend on utility bills. SolarCity gives customers control of their energy costs to protect them from rising rates. The company offers solar power, energy efficiency and electric vehicle services, and makes clean energy easy by taking care of everything from design and permitting to monitoring and maintenance. SolarCity currently serves 14 states and signs a new customer every five minutes. Visit the company online at www.solarcity.com and follow the company on Facebook & Twitter.
Forward Looking Statements
This release contains forward-looking statements including, but not limited to, statements regarding 2013 and 2014 megawatt deployment, plans for investment, growth and future operations, and assumptions relating to the foregoing. Forward-looking statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved, if at all. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward looking statements. As of the date hereof, we have bookings and financing for only a small percentage of the orders needed to achieve our 2014 megawatt projections and therefore expect the megawatts deployed in 2014 to be sourced almost exclusively from new deployments of solar systems not currently under contract. In order to meet our projections, we will need to substantially expand our workforce, increase our installation efficiency and exceed our existing bookings rate relative to what we have achieved to date. Additional key risks and uncertainties include, but are not limited to, the level of demand for our solar energy systems, the availability of a sufficient and timely supply of solar panels and balance of system components, changes in federal tax treatment, the effect of electric utility industry regulations, net metering and related policies, the availability and amount of rebates, tax credits and other financial incentives, the availability and amount of financing from fund investors, the retail price of utility-generated electricity or the availability of alternative energy sources, the completion of year-end accounting procedures and the year-end audit and other factors. You should read the section entitled “Risk Factors” in our registration statement on Form S-1 related to our proposed offering of convertible notes and refer to our most recent Quarterly Report on Form 10-Q, which have been filed with the Securities and Exchange Commission, which identify certain of these and additional risks and uncertainties. We do not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as otherwise required by law.
CONTACT: Investor Relations Contact: Aaron Chew SolarCity (650) 963-5662 investors@solarcity.com
(PTOO) PITOOEY!, Inc. Providing Mobile Web Platform for Frys.com Open
PHOENIX, AZ–(Oct 11, 2013) – PITOOEY!, ™ Inc. (OTCBB: PTOO) (the “Company”), through its wholly-owned subsidiary, Choice One Mobile, Inc., is pleased to be providing ongoing support to the Fry’s.com Open, which began Monday, October 7, continuing through Sunday, October 13.
This event, hosted by the Corde Valle Golf Club in San Martin, California, will kick-off the 2013-2014 PGA tour. Choice One Mobile, which developed the current mobile platform for this client, will be providing continued support and maintenance for the Frys.com Open mobile agenda.
PITOOEY’s January 2013 involvement in the Waste Management Phoenix Open showcased the Company’s strategies in optimizing engagement from a variety of mobile devices. Specifically, self-optimization, which allows the mobile site to actively adjust its configuration to display relevant and pertinent information to visitors — time of day, weather forecast, recent searches, et cetera.
Brian E. Fisher V, Director of Creative Content and Development, remarked, “Choice One Mobile is delivering innovative social media and mobile platform solutions to business clients. We are honored to be working with the Frys.com Open and are committed to showcasing the abilities of our staff to incorporate leading-edge technologies into our array of work products.”
About Frys.com Open
The Frys.com Open leads the new, reconfigured 2013-2014 PGA TOUR schedule as the tournament returns to Corde Valle Golf Club October 7-13, 2013. Launched in 2006, the Frys.com Open is an official PGA TOUR tournament benefiting many local and national charities that are working to improve the lives of others. Title sponsor Fry’s Electronics is a privately-owned retailer with 34 nationwide locations headquartered in San Jose, California. Information is available on FrysOpenGolf.com or on Facebook and Twitter.
About PITOOEY!™, Inc.
PITOOEY!, Inc., via its wholly-owned subsidiaries, PITOOEY! Mobile, Inc. and Choice One Mobile, Inc., is a complete digital marketing agency offering businesses unique service packages based on the client’s requests. These requests, including the type of following or reach desired, are filtered through the Company’s subsidiaries to provide the perfect fit.
For more information, please visit:
www.PitooeyInc.com
Safe Harbor
This release contains statements that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements appear in a number of places in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of PITOOEY!, Inc., its directors or its officers with respect to, among other things: (i) financing plans; (ii) trends affecting its financial condition or results of operations; (iii) growth strategy and operating strategy. The words “may,” “would,” “will,” “expect,” “estimate,” “can,” “believe,” “potential” and similar expressions and variations thereof are intended to identify forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond PITOOEY!, Inc.’s ability to control and their actual results may differ materially from those projected in the forward-looking statements as a result of various factors. More information about the potential factors that could affect the business and financial results is and will be included in PITOOEY!, Inc.’s filings with the Securities and Exchange Commission.
For further information contact:
PITOOEY!, Inc.
Corporate Communications
Phoenix, AZ
www.PitooeyInc.com
480-999-6025
investorrelations@pitooey.com
(GALT) PLOS ONE Preclinical Data Show Its Galectin Inhibitors Reverse Cirrhosis
Findings Suggest Role for GR-MD-02 and GM-CT-01 in Treatment of Liver Fibrosis and Cirrhosis in Humans
NORCROSS, Ga., Oct. 10, 2013 — Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that new preclinical data show its galectin inhibitors, GR-MD-02 and GM-CT-01, have significant therapeutic effects on fibrosis regression and cirrhosis reversal. Results were published in an article titled “Regression of Fibrosis and Reversal of Cirrhosis in Rats by Galectin Inhibitors in Thioacetamide-Induced Liver Disease” in PLOS ONE, an international, open-access journal with rigorous peer review.
In the preclinical study, fibrosis was induced in rats by injecting thioacetamide (TAA) into the abdominal cavity. Rats were then treated with GR-MD-02 (galactoarabino-rhamnogalaturonan) or GM-CT-01 (galactomannan). In the initial part of the study, rats that completed eight weeks of thioacetamide injections were given four weeks of treatment with GR-MD-02; results showed an almost 50 percent reduction in collagen content, a marker of chronic fibrosis. Rats were then exposed to additional thioacetamide injections and developed extensive fibrosis (cirrhosis); treatment with four once weekly doses of GR-MD-02 or GM-CT-01 while continuing treatment with the toxin TAA led to marked reduction in fibrosis and reversal of cirrhosis. Overall, the study demonstrated that GR-MD-02 or GM-CT-01 led to significantly reduced fibrosis, reversal of cirrhosis and a significant reduction in portal hypertension.
“These preclinical data suggest a potential role for GR-MD-02 and GM-CT-01 in the treatment of liver fibrosis and cirrhosis in humans,” said Peter G. Traber, MD, President, Chief Executive Officer and Chief Medical Officer, Galectin Therapeutics Inc. “There are currently no approved therapies for fibrosis. Encouraging data like these published in PLOS ONE increase the body of scientific knowledge of galectin inhibitors and add momentum to Galectin Therapeutics’ development program. We recently announced that GR-MD-02 received Fast Track designation from the FDA for fatty liver disease with advanced fibrosis.”
The preclinical study was conducted predominantly at the Icahn School of Medicine at Mount Sinai in New York City. The senior author, Dr. Scott Friedman of Mount Sinai, is an international expert in the pathogenesis and treatment of liver fibrosis. The PLOS ONE article can be found online at http://dx.plos.org/10.1371/journal.pone.0075361
GM-CT-01 and GR-MD-02 are proprietary molecules, which are generated from naturally occurring carbohydrate polymers using proprietary processes, and possess the property of binding to and inhibiting galectin proteins, predominantly galectin-3. In July, the Company successfully dosed the first patient in a Phase 1 clinical trial of GR-MD-02 and enrollment is ongoing.
About Galectin Therapeutics
Galectin Therapeutics (Nasdaq:GALT) is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company’s unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.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. These statements include those regarding the potential role for GR-MD-02 and GM-CT-01 in the treatment of liver fibrosis and cirrhosis in humans. 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 any potential therapeutic uses and benefits of our drugs and any future pre-clinical or clinical studies are subject to factors beyond our control. Future clinical studies may not begin or produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of our drugs are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. Regardless of the results of current or future studies, we may be unsuccessful in developing partnerships with other companies or obtaining capital that would allow us to further develop and/or fund any studies or trials. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be impacted by our ability to manage costs and finance our continuing operations. For a discussion of additional factors impacting 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: Galectin Therapeutics Inc. Peter G. Traber, MD, 678-620-3186 President, CEO, & CMO ir@galectintherapeutics.com
(RCON) Announces Recently Developed Shale Gas Automation System
BEIJING, Oct. 10, 2013 — Recon Technology, Ltd. (NASDAQ ‘RCON’), an oilfield service company provider (the “Company”) operating primarily in the People’s Republic of China, announced today the successful deployment of a new automation product for extraction of shale using a highly specialized supervisory control and data acquisition system (“SCADA”). This important achievement related to gas field exploitation and production comes on the heels of the introduction of Baker-Hughes fracturing technology to China Petroleum and Chemical Corporation’s (“Sinopec”) Zhongyuan Oilfield. Based on the unique characteristics of various shale gas strata, the SCADA system was developed by Recon to monitor and control the operation of on-site equipment to optimize automation through the use of an intelligent production process that is expected to provide a powerful new tool for the delivery of a safe and efficient method of a shale based gas field production.
The Chinese government has implemented policies to promote exploitation and subsequent utilization of shale gas by making subsidies available for gas development companies, encouraging efficiency and safety in gas production and incentivizing the use of gas for electricity production. To date current technology has proven inefficient in consideration of the challenges related to domestic shale strata; in particular equipment and related services have not provided an efficient solution.
“We have leveraged our recent experience and development investments to successfully deploy a new SCADA system for shale gas field well control and monitoring”, noted Mr. Chen Guang Qiang, CTO of Recon Technology. “Differing from the typical hydrocarbon drilling applications in current use, gas extraction in these shale strata based field requires a high continuity of production. If this process is suspended, the subterranean gas reservoir will likely be ‘choked off’ and subsequently destroyed by water after a protracted shut-in period. This will cause premature shuttering of the well and result in wasted quantities of gas which cannot be gathered in timely manner by means of the current technology causing likely economic losses. Proper deployment of our automated monitoring and control system can help to resolve this issue by providing exact well data which is generally the most common cause for gas well failure. In the event of a disruption in production our system can detect failures as they occur in real time allowing our service team to take steps to avoid such failures”.
Mr. Chen continued, “Our unique automation system has proven its ability to perform thus creating stability, reliability and scalability. As an enhancement to the development of China’s unconventional gas reserves, we expect the demand for related equipment and services will increase. Recon is uniquely positions to provide reliable solutions for these challenges and will work to turn this opportunity to its advantage in establishing a leadership position in the shale gas well automation segment.”
About Recon Technology, Ltd.
Recon Technology, Ltd. provides leading Chinese oil and gas companies with automation services designed to increase efficiency and profitability in relation to the exploration, extraction, production, refining and transportation of field based petroleum products for 10 years. Recon Technology is the first Chinese non-state-owned oil and gas service company to go public in the U.S. For additional information please visit us at www.recon.cn.
Investor Contact:
Recon Technology, Ltd
Tel: +86 (10) 84945799
Email: info@recon.cn; liu.jia@recon.cn
(DYSL) Forms Xcede Technologies Inc.
Mayo Clinic Participation
WATERTOWN, Mass., Oct. 10, 2013 — Dynasil Corporation of America (NASDAQ: DYSL) today announced that Dynasil Biomedical Corp (“DBM”) has established a new subsidiary, Xcede Technologies, Inc., and transferred patent pending biomaterials technology for use in tissue sealing and hemostasis. Xcede’s technology is a ready-to-use high-strength, fast-acting, combination hemostat/ sealant. The Xcede Patch, the first embodiment of the technology that Xcede plans to commercialize, requires minimal preparation time (less than 1 minute), is not dependent on patient coagulation and is highly effective on aggressive bleeding. The technology was initially invented by Dr. Daniel Ericson and acquired by Dynasil in 2011. Since 2011 Dynasil has further developed and refined the technology within its subsidiary, DBM, before contributing it to Xcede.
Xcede Technologies, headquartered in Rochester, MN, has also signed a License Agreement with Mayo Clinic, whereby Mayo will provide support assistance with clinical trials and physician involvement with the design and development of delivery tools and testing of clinical indications. Additionally, Xcede Technologies has initiated a convertible note financing of up to $2 million to fund its first in human trials. Participants in the financing include DBM, Mayo Clinical Ventures, Southern Initiative Minnesota Foundation and individual angel investors. Rochester Area Economic Development Inc. has also committed to provide debt financing.
“Our new subsidiary will allow for a singular focus on development of the tissue sealant technology in order to bring the Xcede Patch to market. Xcede will be separately funded, relieving Dynasil of the need to fund development going forward. Xcede has tremendous upside potential and all of the ingredients needed to revolutionize the $4.5 billion global fibrin sealants and hemostasis markets,” said Peter Sulick, Chairman and CEO of Dynasil. “This is the first spin out of technology developed internally at Dynasil. We are hopeful that we can employ this model in the future as other technology we are working on both within DBM and RMD, our large research organization, reach maturity.”
Mayo Clinic has a financial interest in the technology mentioned in this news release. Revenue Mayo receives is used to support the clinic’s not-for-profit mission in clinical practice, education and research.
About Dynasil
Dynasil Corporation of America (NASDAQ: DYSL) develops and manufactures detection and analysis technology, precision instruments and optical components for the homeland security, medical and industrial markets including medical imaging and sensors for non-destructive testing. Dynasil has an impressive and growing portfolio of issued and pending U.S. patents. The Company is based in Watertown, Massachusetts, with additional operations in MA, MN, NY, NJ and the United Kingdom. More information about the Company is available at www.dynasil.com.
Safe Harbor
This news release may contain forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements regarding future events and our future results are based on current expectations, estimates, forecasts, and projections and the beliefs and assumptions of our management, including, without limitation, our expectations regarding results of operations, the commercialization of our technology, in particular the Xcede patch, the success of our the efforts to fund the Xcede subsidiary, positive outcomes of our human trials, regulatory approvals and the strength of our intellectual property portfolio. These forward-looking statements may be identified by the use of words such as “plans”, “intends,” “may,” “could,” “expect,” “estimate,” “anticipate,” “continue” or similar terms, though not all forward-looking statements contain such words. The actual results of the future events described in such forward looking statements could differ materially from those stated in such forward looking statements due to a number of important factors. These factors that could cause actual results to differ from those anticipated or predicted include, without limitation, our ability to complete the convertible note financing, our ability to develop and commercialize the Xcede patch, including obtaining regulatory approvals, the size and growth of the potential markets for our products and our ability to serve those markets, the rate and degree of market acceptance of any of our products, our ability to address our material weaknesses in our internal controls, general economic conditions, costs and availability of raw materials and management information systems, our ability to obtain and maintain intellectual property protection for our products, competition, the loss of key management and technical personnel, our ability to obtain timely payment of our invoices to governmental customers, litigation, the effect of governmental regulatory developments, the availability of financing sources, our ability to identify and execute on acquisition opportunities and integrate such acquisitions into our business, and seasonality, as well as the uncertainties set forth in the Company’s 2012 Annual Report on Form 10 K, as amended on February 14, 2013, including the risk factors contained in Item 1a, the Company’s Quarterly Reports on Form 10-Q filed on February 13, 2013, May 15, 2013 and August 12, 2013 and from time to time in the Company’s other filings with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts:
Patty Kehe
Corporate Secretary
Dynasil Corporation of America
Phone: (617) 668-6855
pkehe@dynasil.com
(CAFI) Huntington Bancshares Acquisition
Huntington Bancshares Incorporated (NASDAQ:HBAN; www.huntington.com) and Camco Financial Corporation (NASDAQ:CAFI; www.camcofinancial.com) jointly announced today the signing of a definitive agreement under which Huntington will acquire Camco Financial, the parent company of Cambridge Ohio-based Advantage Bank, in a cash and stock transaction. As of June 30, 2013, Camco operated 22 banking offices throughout eastern and southern Ohio with $0.8 billion in total assets and $0.6 billion in total deposits.
“This is a great opportunity to enhance our presence in several areas within our existing footprint and to expand into several new attractive geographies,” said Steve Steinour, chairman, president and CEO of Huntington Bank. “We are pleased to welcome the more than 55,000 customers of Advantage Bank to Huntington. Our new customers will now have access to some of the highest rated customer service in the industry and to some of the most innovative banking products and services, which have helped to grow our customer base by more than 30 percent in the past three years. The acquisition will also give our current customers the convenience of more branches.”
“Huntington has a well-known legacy of investing in its customers and communities,” said Jim Huston, chairman, president and CEO of Camco Financial and Advantage Bank. “We believe our customers will enjoy excellent service along with Huntington’s broader suite of products.”
Under the terms of the agreement, which was unanimously approved by the boards of both companies, shareholders of Camco Financial may elect to receive 0.7264 shares of Huntington common stock, or $6.00 in cash, for each share of Camco Financial common stock, subject to proration provisions specified in the merger agreement that provide for a targeted aggregate split of total consideration of 80% common stock and 20% cash. Based upon the Wednesday, October 9, 2013, closing price of $8.12 per share of Huntington common stock, the transaction is valued at approximately $97 million, including outstanding options and warrants.
The transaction is expected to be completed in the first half of 2014, subject to the satisfaction of customary closing conditions, including regulatory approvals and the approval of the shareholders of Camco Financial. Given the size and structure, the transaction has a de minimis impact to tangible book value. With over 45% geographic overlap(1), Huntington expects the acquisition to be accretive to earnings per share in the first full year. In completing diligence, Huntington reviewed over 75% of the loan portfolio.
About Huntington
Huntington Bancshares Incorporated is a $56 billion regional bank holding company headquartered in Columbus, Ohio. The Huntington National Bank, founded in 1866, provides full-service commercial, small business, and consumer banking services; mortgage banking services; treasury management and foreign exchange services; equipment leasing; wealth and investment management services; trust services; brokerage services; customized insurance brokerage and service programs; and other financial products and services. The principal markets for these services are Huntington’s six-state banking franchise: Ohio, Michigan, Pennsylvania, Indiana, West Virginia, and Kentucky. The primary distribution channels include a banking network of more than 700 traditional branches and convenience branches located in grocery stores and retirement centers, and through an array of alternative distribution channels including internet and mobile banking, telephone banking, and more than 1,400 ATMs. Through automotive dealership relationships within its six-state banking franchise area and selected other Midwest and New England states, Huntington also provides commercial banking services to the automotive dealers and retail automobile financing for dealer customers.
(1) 45% geographic overlap defined as branches within 1.5 miles of a Huntington branch.
About Camco Financial Corporation
Camco Financial Corporation, holding company for Advantage Bank, is a multi-state bank holding company headquartered in Cambridge, Ohio. Advantage Bank offers community banking that includes commercial, business and consumer financial services and internet banking from 22 offices. Additional information about Camco Financial may be found on the Company’s web sites: www.camcofinancial.com or www.advantagebank.com.
Important Information for Investors and Shareholders
In connection with the proposed merger transaction, Huntington will file with the Securities and Exchange Commission a Registration Statement on Form S-4 that will include a Proxy Statement of Camco, and a Prospectus of Huntington, as well as other relevant documents concerning the proposed transaction. Shareholders are urged to read the Registration Statement and the Proxy Statement/Prospectus regarding the proposed merger when it becomes available and any other relevant documents filed with the SEC, as well as any amendments or supplements to those documents, because they will contain important information. A free copy of the Proxy Statement/Prospectus, as well as other filings containing information about Huntington and Camco, may be obtained at the SEC’s Internet site (http://www.sec.gov). You will also be able to obtain these documents, free of charge, from Huntington at www.Huntington.com under the tab “Investor Relations” and then under the heading “Publications and Filings”, from Huntington Investor Relations at 800-576-5007, and from Camco by accessing Camco’s website at https://www.advantagebankonline.com under the tab “Investor Relations” and then under the heading “SEC Filings”, or from Camco Investor Relations at 740-435-2020.
Huntington and Camco and certain of their directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Camco in connection with the proposed merger. Information about the directors and executive officers of Huntington is set forth in the proxy statement for Huntington’s 2013 annual meeting of shareholders, as filed with the SEC on Schedule 14A on March 7, 2013. Information about the directors and executive officers of Camco is set forth in the proxy statement for Camco’s 2013 annual meeting of shareholders, as filed with the SEC on a Schedule 14A on April 19, 2013. Additional information regarding the interests of those participants and other persons who may be deemed participants in the transaction may be obtained by reading the Proxy Statement/Prospectus regarding the proposed merger when it becomes available. Free copies of this document may be obtained as described in the preceding paragraph.
Forward looking statement
This document contains certain forward-looking statements, including certain plans, expectations, goals, projections, and statements, which are subject to numerous assumptions, risks, and uncertainties. Forward-looking statements may be identified by words such as expect, anticipate, believe, intend, estimate, plan, target, goal, or similar expressions, or future or conditional verbs such as will, may, might, should, would, could, or similar variations.
While there is no assurance that any list of risks and uncertainties or risk factors is complete, below are certain factors which could cause actual results to differ materially from those contained or implied in the forward-looking statements: (1) worsening of credit quality performance due to a number of factors such as the underlying value of collateral that could prove less valuable than otherwise assumed and assumed cash flows may be worse than expected; (2) changes in general economic, political or industry conditions; uncertainty in U.S. fiscal and monetary policy, including the interest rate policies of the Federal Reserve Board; volatility and disruptions in global capital and credit markets; (3) movements in interest rates; (4) competitive pressures on product pricing and services; (5) success, impact, and timing of our business strategies, including market acceptance of any new products or services implementing our “Fair Play” banking philosophy; (6) changes in accounting policies and principles and the accuracy of our assumptions and estimates used to prepare our financial statements; (7) extended disruption of vital infrastructure; (8) the final outcome of significant litigation; (9) the nature, extent, timing, and results of governmental actions, examinations, reviews, reforms, regulations, and interpretations, including those related to the Dodd-Frank Wall Street Reform and Consumer Protection Act and the Basel III regulatory capital reforms, as well as those involving the OCC, Federal Reserve, and CFPB; and (10) the outcome of judicial and regulatory decisions regarding practices in the residential mortgage industry, including among other things the processes followed for foreclosing residential mortgages. Additional factors that could cause results to differ materially from those described above can be found in Huntington’s 2012 Annual Report on Form 10-K, and documents subsequently filed by Huntington with the Securities and Exchange Commission. All forward-looking statements included in this document are based on information available at the time of the release. Huntington assumes no obligation to update any forward-looking statement.
(HOTR) Announces $1.6 Million Equity Financing
CHARLOTTE, NC–(October 10, 2013) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (“Chanticleer Holdings” or the “Company”), headquartered in Charlotte, N.C., announced today that the Company has successfully completed a $1.6 Million equity financing with accredited investors, meeting the minimum requirement for the Private Placement and enabling the Company to break escrow with the funds received. The proceeds will be used to continue the development of the Company’s restaurant locations as well as for general working capital purposes.
The successful private placement involved the sale of approximately 426,667 units of the Company’s common stock at a purchase price of $3.75 per unit. Each unit is comprised of one share of Chanticleer common stock and one common share warrant. Each warrant is exercisable for one common share, twelve months after the closing of the Private Placement, for a period of 5 years at a price of $5.00. The shares and underlying warrants have not been registered with the Securities and Exchange Commission. Currently there is an additional 240,000 units available under the terms of the financing agreement.
Mike Pruitt, Chairman and Chief Executive Officer of the Company, stated: “We are pleased to announce the closing of this financing with friendly accredited investors. The proceeds of this financing will allow Chanticleer to fund the completion of new locations. As we continue on our aggressive growth plan, it pleases me to know that new shareholders see value in our long-term growth strategy.”
For further information, please visit www.chanticleerholdings.com
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About Chanticleer Holdings, Inc.
Chanticleer Holdings (HOTR) is focused on expanding the Hooters® casual dining restaurant brand in international emerging markets. 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.
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
(BSDM) Promotion of MicroThermX® at CIRSE by Terumo Europe Successful
BSD Medical Corporation (NASDAQ: BSDM) (“Company” or “BSD”), today reported the successful promotion of the MicroThermX® Microwave Ablation System (MicroThermX) at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) conference in Barcelona, Spain. Terumo Europe NV (Terumo), a wholly owned subsidiary of Terumo Corporation, used CIRSE as the main launching pad to showcase BSD’s MicroThermX as an integral part of its branded Interventional Oncology Solutions (IOS). CIRSE is the world’s largest and most prestigious conference in the field of minimally invasive image-guided therapies.
Hundreds of physicians attended the MicroThermX symposium, including key physician opinion leaders throughout Europe. Terumo, the leader in interventional oncology, now features MicroThermX as one of the key products in its interventional oncology portfolio: http://www.terumo-europe.com/endovascular/interventional-oncology-solutions/.
“We see tremendous opportunity for fast adoption in Europe for our MicroThermX Microwave Ablation System because the structure of the healthcare systems in the area is focused on cost-effective solutions and faster adoption of new superior technology,” said Harold Wolcott, BSD President and CEO. “The physician response and interest in the MicroThermX far exceeded our expectations. We are very pleased with our relationship with Terumo.”
About Terumo Corporation
A world leader in state-of-the-art medical devices and interventional oncology, Tokyo-based Terumo Corporation (TYO: JP:4543) reported 2013 sales of nearly $5 billion and has a market cap in excess of $8 billion. Through the sale and promotion of a high quality line of devices used for tumor embolization, the closing or blocking of blood vessels, Terumo Europe NV has established itself as a pioneer in the field of interventional oncology.
About the MicroThermX® Microwave Ablation System
The MicroThermX is a compact, mobile, state-of-the-art, proprietary system that includes a microwave generator, single-patient-use disposable antennas, and a thermistor-based temperature monitoring system. The innovative design of the MicroThermX is the first of its kind that allows delivery of higher power levels using a single generator. The MicroThermX utilizes innovative synchronous phased array technology that was developed and patented by BSD to provide a wide range of uniform zones of ablation. The MicroThermX includes innovative, high-end disposables (SynchroWave antennas) that are used in each ablation treatment and will provide a significant ongoing revenue stream. The soft tissue (tumor) ablation world market potential is estimated to exceed $2.3 billion. The U.S. Food and Drug Administration (FDA) has granted the Company a 510(k) clearance to market the MicroThermX for ablation of soft tissue. BSD has also received CE Marking for the MicroThermX System, which allows BSD to market the MicroThermX in Europe. CE Marking is also recognized in many countries outside of the EU, providing BSD the ability to market the MicroThermX to a number of international markets.
About BSD Medical Corporation
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy delivered using focused radiofrequency (RF) and microwave energy. BSD’s product lines include both hyperthermia and ablation treatment systems. BSD’s hyperthermia cancer treatment systems, which have been in use for several years in the United States, Europe and Asia, are used to treat certain tumors with heat (hyperthermia) while increasing the effectiveness of other therapies such as radiation therapy. BSD’s microwave ablation system has been developed as a stand-alone therapy to employ precision-guided microwave energy to ablate (destroy) soft tissue. The Company has developed extensive intellectual property, multiple products in the market and established distribution in the United States, Europe and Asia. Certain of the Company’s products have received regulatory approvals and clearances in the United States, Europe and China. For further information visit BSD Medical’s website at www.BSDMedical.com.
This press release may be deemed to contain forward-looking statements, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including the expected use of proceeds relating to the recently completed offering. Readers are cautioned that these forward-looking statements are only predictions and may differ materially from actual future events or results due to a variety of factors, including, among other things, the demand for the Company’s products, the ability of the Company to produce the products to meet the demand, global economic conditions and uncertainties in the geopolitical environment and other risk factors set forth in the Company’s most recent reports on Form 10-K and Form 10-Q. Any forward-looking statements in this release are based on limited information currently available to the Company, which is subject to change, and the Company will not necessarily update the information
(CUR) Phase II ALS Stem Cell Trial, University Of Michigan First Patients
First of Five Cohorts Completed in Dose Escalation Trial
ROCKVILLE, Md., Oct. 9, 2013 — Neuralstem, Inc. (NYSE MKT: CUR) announced that the University of Michigan Health System, in Ann Arbor, Michigan, treated its first two patients in the Phase II trial testing NSI-566 neural stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). This completes the first cohort in Phase II, which is also being conducted at Emory University Hospital, in Atlanta, Georgia. Phase II is a dose escalation trial designed to treat up to 15 patients with a maximum of 40 injections and up to 400,000 cells per injection. All patients will be ambulatory and within approximately two years of the onset of disease symptoms. The trial is under the direction of Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute, Director of Research of the ALS Clinic at the University of Michigan Health System and the President of the American Neurological Association. Dr. Feldman is an unpaid consultant to Neuralstem.
About the Trial
Neuralstem’s NSI-566/ALS Phase II dose escalation trial is designed to treat up to 15 ambulatory patients in five different dosing cohorts, under an accelerated dosing and treatment schedule. The first 12 patients, divided into four cohorts, will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function. The first cohort, just completed, received 10 cervical region injections of 200,000 cells per injection. The trial will now progress to a maximum of 20 cervical injections of up to 400,000 cells per injection in the cervical-only cohort. The last three Phase II patients will receive injections in both the cervical and the lumbar spinal regions. These patients will receive 20 injections of 400,000 cells each in the lumbar region, in addition to the 20 injections they will already have received in their cervical region.
The trial also accelerates the treatment schedule, which is designed to progress at the rate of one cohort per month, with an observation period of one month between each cohort. Researchers expect all of the patients could be treated by the end of the second quarter in 2014.
Patients seeking information on the trial should contact the relevant center. For the University of Michigan Health System, please visit: https://umclinicalstudies.org/HUM00072488. For Emory Healthcare, please call (404) 778-7777.
About Neuralstem
Neuralstem’s patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem’s NSI-566 spinal cord-derived stem cell therapy is in an FDA-approved Phase II clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig’s disease. Neuralstem has been awarded orphan status designation by the FDA for its ALS cell therapy.
In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury and ischemic stroke. The company has received FDA approval to commence a Phase I safety trial in chronic spinal cord injury.
Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain’s capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company is conducting a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include traumatic brain injury (TBI), Alzheimer’s disease, and post-traumatic stress disorder (PTSD).
For more information, please visit www.neuralstem.com or connect with us on Twitter, Facebook and LinkedIn
Cautionary Statement Regarding Forward Looking Information
This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem’s technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the annual report on Form 10-K for the year ended December 31, 2012 and the Form 10-Q for the period ended June 30, 2013.
(CHTP) Announces FDA Advisory Committee to Review NORTHERA(TM) (droxidopa)
Panel Date Tentatively Set for January 14, 2014
CHARLOTTE, N.C., Oct. 9, 2013 — Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the New Drug Application (NDA) seeking approval to market NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) will be reviewed by the Cardiovascular and Renal Drug Advisory Committee (CRDAC). The meeting is tentatively scheduled for January 14, 2014.
The FDA recently assigned to NORTHERA™ a Prescription Drug User Fee Act (PDUFA) goal date of February 14, 2014. NORTHERA™ was previously granted Orphan Drug Designation and received Fast Track designation from the FDA. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.
About Symptomatic NOH
NOH is a chronic neurogenic disorder resulting from deficient release of norepinephrine that predominantly affects patients with primary autonomic failure, a group of diseases which includes Parkinson’s disease (PD), multiple system atrophy (MSA) and pure autonomic failure (PAF). Symptoms of NOH include: dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes when a person assumes a standing position, often severely limiting a person’s ability to perform routine daily activities that require standing or walking for both short and long periods of time.
About Northera
NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics’ pipeline, is currently in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure — an indication that includes a significant number of patients with Parkinson’s disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally.
Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd. (DSP), initially received Japanese approval in 1989 for the treatment of frozen gait and dizziness on standing associated with Parkinson’s Disease and for the treatment of orthostatic hypotension, syncope or dizziness on standing associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy. In 2000, Droxidopa received expanded marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.
About Chelsea Therapeutics
Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders. Chelsea is currently pursuing FDA approval in the U.S. for Northera™ (droxidopa), a novel, late-stage, orally-active therapeutic agent for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure. For more information about the Company, visit www.chelseatherapeutics.com.
This press release contains forward-looking statements regarding future events including our intention to pursue the development of Northera. These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include reliance on key personnel and our ability to attract and/or retain key personnel; the risk that the FDA will not agree that our clinical trial results demonstrate the safety and effectiveness of droxidopa; the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application; the risk that the FDA will not approve the resubmitted NDA; the risk that our resources will not be sufficient to conduct any study of Northera that will be acceptable to the FDA; the risk that we cannot complete any additional study for Northera without the need for additional capital; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated; our need to raise additional operating capital in the future; our reliance on our lead drug candidate droxidopa; risk that we will not be able to obtain regulatory approvals of droxidopa or our other drug candidates for additional indications; risk of volatility in our stock price, related litigation, and analyst coverage of our stock; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; and market acceptance for our products if any are approved for marketing.
CONTACT: Investors: Fara Berkowitz / Susan Kim Argot Partners 212-600-1902 fara@argotpartners.com susan@argotpartners.com Media: David Connolly LaVoie Group 617-374-8800 dconnolly@lavoiegroup.com
(CYTR) CEO Featured In Exclusive Interview With Equities.com
SANTA MONICA, Calif., Oct. 9, 2013 (GLOBE NEWSWIRE) — Equities.com, Inc., the Global Financial Network and the world’s premier social community for self-directed investors and public companies, is now featuring exclusive video interviews with key executives from presenting companies at the recent 2013 Aegis Capital Healthcare Conference. Chief among the interviews is CytRx Corp. (Nasdaq:CYTR)
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About Equities.com
Equities.com is a premier online financial resource platform that combines interactive social networking capabilities for investors and public companies to connect like never before. Our mission is to serve as the premier platform for the investment markets, enabling the world’s financial communities to communicate in one social ecosystem.
(HRT) Announces Second Quarter 2013 Results
FITCHBURG, MA–(Oct 8, 2013) – Arrhythmia Research Technology, Inc. (NYSE MKT: HRT) and its subsidiaries (the “Company”) announced today its results for the quarter ending June 30, 2013. The Company’s financial results reflect the consolidated results of Arrhythmia Research Technology, Inc. and its subsidiaries, including Micron Products, Inc. (“Micron”), and the discontinued operations of RMDDxUSA Corp. and RMDDx Corporation (collectively “WirelessDx”).
Quarter Ended June 30, 2013
The Company reported total consolidated revenue from continuing operations of $4,880,445 for the quarter ended June 30, 2013, compared to total consolidated revenue of $4,794,501 for the quarter ended June 30, 2012, an increase of $85,944 or 1.8%.
Net loss from continuing operations for the quarter ended June 30, 2013 was $2,877,383, or $1.06 per share compared to net loss from continuing operations of $287,796, or $0.10 per share for the quarter ended June 30, 2012.
Net loss from discontinued operations for the quarter ended June 30, 2013 was $12,808, or $0.00 per share compared to a net loss from discontinued operations of $757,287, or $0.27 per share for the quarter ended June 30, 2012.
Total net loss for the quarter ended June 30, 2013 increased $1,845,108 to $2,890,191, or $1.06 per share compared to a net loss of $1,045,083, or $0.37 for the quarter ended June 30, 2012.
Year to Date June 30, 2013
The Company reported total consolidated revenue from continuing operations of $10,523,634 for the six months ended June 30, 2013, compared to total consolidated revenue of $10,626,123 for the six months ended June 30, 2012, a decrease of $102,489 or 1.0%.
Net loss from continuing operations for the six months ended June 30, 2013 was $2,875,315, or $1.06 per share compared to net income from continuing operations of $46,322, or $0.02 per share for the six months ended June 30, 2012.
Net loss from discontinued operations for the six months ended June 30, 2013 was $20,546, or $0.01 per share compared to a net loss from discontinued operations of $1,527,325, or $0.55 per share for the six months ended June 30, 2012.
Total net loss for the six months ended June 30, 2013 increased $1,414,858 to $2,895,861, or $1.07 per share compared to a net loss of $1,481,003, or $0.53 for the six months ended June 30, 2012.
Salvatore Emma, Jr., the Company’s President and CEO, commented, “Micron’s custom molding and orthopedic implant sales increased by 48.8% for the three months ended June 30, 2013 compared to the same period in 2012 and 41.0% for the six months ended June 30, 2013 as compared to the same period in 2012. The increases in custom molding and orthopedic implant sales are due to increased orders in medical, defense, and automotive markets. Additionally, the Company continues to realize increased order volumes for machined orthopedic implant components which continued into the second quarter of 2013. Shipments of machined orthopedic implant components are expected to continue to increase for the remainder of 2013.
These increases were partially offset by decreases in sensor sales of $827,036 and $1,872,762 for the three and six months ended June 30, 2013, respectively, as compared to the same periods in 2012. The decrease in sensor sales is due to several factors: (1) several customers moved to thinner silver products; (2) sensor volume decreased 10.3% and 13.3%, respectively; and (3) the market price of silver decreased approximately 30% in the second quarter.
The move to thinner silver products has resulted in the Company experiencing a decrease in selling price and silver surcharge billed. Sales volumes for sensor decreased due in part to one of the Company’s largest customers adding a secondary supplier along with fluctuations in ordering patterns. The unusually high volatility of the silver prices resulted in the decrease of total silver surcharge billed.
Total silver surcharge billed decreased by $493,930 and $966,735, respectively, for the three and six months ended 2013, due to the items mentioned above.
In the second quarter, management performed a lengthy and thorough evaluation of the Company’s deferred tax assets. Management’s evaluation resulted in uncertainty relating to the Company’s ability to fully utilize the deferred tax assets. While management has a positive outlook on the future and its ability to generate taxable income, management could not overcome the more-likely-than-not threshold to fully utilize the deferred tax asset within the next few years. Accordingly, the Company has established a full valuation allowance of $2,267,969 on its remaining deferred tax assets, which is reflected in the second quarter results. Future evaluations will be performed as the financial condition of the Company warrants.”
About Arrhythmia Research Technology, Inc.
The Company through its wholly-owned subsidiary, Micron Products, Inc. manufactures components, devices and equipment primarily for the medical and defense industries. Micron is engaged in the production and sale of silver/silver chloride coated and conductive resin sensors used as component parts in the manufacture of integrated disposable electrophysiological sensors. These disposable medical devices are used worldwide in the monitoring of electrical signals in various medical applications. The Company has expanded into custom thermoplastic injection molded products with a full array of design, engineering and production services and management. The addition of an orthopedic implant machining operation produces quick-turn, high volume and patient-specific, finished orthopedic implants. The Company also has developed and distributes customizable proprietary signal-averaging electrocardiography (SAECG) software used in the detection of certain heart arrhythmias and that is reconfigurable for a variety of hardware platforms.
For more information please check our websites:
http://www.arthrt.com
http://www.micronproducts.com
Forward-looking statements made herein are based on current expectations of the Company that involve a number of risks and uncertainties and should not be considered as guarantees of future performance. The factors that could cause actual results to differ materially include our ability to retain customers who represent significant proportions of revenue; our ability to maintain our pricing model and/or decrease our cost of sales; our ability to increase sales of higher margin products and services; our ability to manage our level of debt and provisions in the debt agreements which could limit our ability to react to changes in the economy or our industry; failure to comply with financial and other covenants in our credit facility; volatility in commodity and energy prices and our ability to offset higher costs with price increases; continued availability of supplies or materials used in manufacturing at competitive prices; variability of customer delivery requirements; variations in the mix of products sold; a stable interest rate market and/or a stable currency rate environment in the world, and specifically the countries where we are doing business; amount and timing of investments in capital equipment, sales and marketing, engineering and information technology resources and our ability to offset higher costs with price increases. More information about factors that potentially could affect the Company’s financial results is included in the Company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2012.
Contact:
Investor Relations
(978) 602-1436
Website: http://www.arthrt.com
(ARWR) Completes Enrollment Phase 1 Study of ARC-520 in Chronic Hep-B
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it completed enrollment in a Phase 1 clinical trial of ARC-520, its RNAi-based candidate against chronic hepatitis B virus infection. Initial data indicate that ARC-520 is generally safe and well tolerated at all six dose levels studied, enabling the company to proceed with plans to initiate a Phase 2a pilot efficacy study in chronic HBV patients.
“We are very pleased with these results and the pace at which we were able to complete the Phase 1 study. This positive readout on safety and tolerability of ARC-520 and the Dynamic Polyconjugate (DPC) delivery platform has broad implications for Arrowhead. It gives us additional confidence as we move into an upcoming Phase 2a study and we believe it represents a key de-risking event for expanding our pipeline of RNAi therapeutics based on the DPC platform,” said Christopher Anzalone, Ph.D., President and Chief Executive Officer.
The Phase 1 trial was designed to characterize the safety profile of ARC-520 across a range of doses and evaluate pharmacokinetics. It is a single-center, randomized, double-blind, placebo-controlled, single dose-escalation, first-in-human study of ARC-520 administered intravenously to healthy adult volunteers. All subjects have been dosed and received either placebo or ARC-520 in doses ranging from 0.01 mg/kg to 2 mg/kg.
The study was planned to enroll 36 subjects in six cohorts of six subjects each, with 2 subjects receiving placebo and 4 receiving ARC-520. The study successfully enrolled all 36 subjects (24 received ARC-520, 12 placebo) at a single center in Melbourne, Australia. All subjects received their full, assigned dose and there were no discontinuations for adverse events or otherwise.
Based on pre-clinical studies, including GLP toxicology, it is expected that if any clinically significant or dose-limiting toxicities were to occur, they would be observed within the first 24-48 hours after administration, and would be apparent in elevations in blood chemistries. The anticipated organs of interest for potential toxicity and the resultant chemistries are liver (ALT), kidney (creatinine, urea), and muscle (CK, AST, LDH, Troponin I). In this Phase 1 study, laboratory results have not indicated any organ toxicity involving the liver, kidney, or muscle in any subject.
There have been no serious or severe adverse events reported in any subject. Overall, adverse events have been consistent with those typically seen in normal volunteer studies, including in placebo subjects. The most common events reported were upper respiratory infection (7), which were not unexpected as the trial was enrolled during the Australian winter, and headache (7). The only other events reported in more than one subject were mild lightheadedness (2), which were not accompanied by any changes in vital signs, laboratories or physical examinations. One subject developed an urticarial rash with no other physical findings, and was treated successfully with anti-histamine. Adverse events appear to have been randomly scattered across all six dosing groups with no apparent dose-related increases in occurrence rate or severity with the possible exception of mild lightheadedness. Both subjects with mild lightheadedness were in the 2 mg/kg group. Laboratory abnormalities have occurred sporadically across groups and time points pre- and post-dosing. None of these indicate any organ toxicity and the frequency and severity do not appear to be dose-related.
The study remains blinded and follow-up is ongoing. Arrowhead intends to report additional data including pharmacokinetics and relative occurrence rates for adverse events in placebo and ARC-520 treatment groups at an appropriate venue when those data become available. The company plans to use the blinded analysis available now to move forward with a filing seeking approval to proceed with a Phase 2a trial in Hong Kong.
About ARC-520
Approximately 350 million people worldwide are chronically infected with the hepatitis B virus. Chronic HBV infection can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally. Arrowhead’s RNAi-based candidate ARC-520 is designed to treat chronic HBV infection by reducing the expression and release of new viral particles and key viral proteins. The goal is to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. The siRNAs in ARC-520 intervene at the point of DNA transcription, upstream of where nucleotide and nucleoside analogues act. In transient and transgenic mouse models of HBV infection, a single co-injection of Arrowhead’s DPC delivery vehicle with cholesterol-conjugated siRNA targeting HBV sequences resulted in multi-log knockdown of HBV RNA, proteins and viral DNA with long duration of effect. In a chimpanzee chronically infected with HBV and high viremia and antigenemia, ARC-520 induced rapid reductions of 90-95% in HBV DNA, e-antigen, and s-antigen. Arrowhead has completed enrollment in a phase 1 single ascending dose study in normal volunteers, which the company expects to follow with a phase 2a study in chronic HBV patients.
About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary drug delivery technologies to develop targeted drugs based on the RNA interference mechanism that efficiently silence disease-causing genes. Arrowhead technologies also enable partners to create peptide-drug conjugates that specifically home to cell types of interest while sparing off-target tissues. Arrowhead’s pipeline includes clinical programs in chronic hepatitis B virus and obesity and partner-based programs in oncology.
For more information please visit http://www.arrowheadresearch.com, or follow us on Twitter @ArrowRes. To be added to the Company’s email list to receive news directly, please send an email to ir@arrowres.com
Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Arrowhead Research Corporation’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.
(JMSN) Closes Series A Bridge Financing
LAS VEGAS, NV–(Oct 8, 2013) – Jameson Stanford Resources Corp. (OTCQB: JMSN) (the “Company”), an emerging metals and minerals exploration and development company, announced that it has closed $500,000 of Series A Convertible Promissory Notes, due September 15, 2015.
The notes are secured by the Company’s mining claims and mineral leases related to the Chopar Mining Property, Star Mountain Mining District, located in Beaver County, Utah. The proceeds of this financing will be used primarily to fund the Company’s ongoing mineral exploration activities and for general working capital purposes. Jameson Stanford may also issue up to an additional $1,000,000 of Series B Convertible Promissory Notes on similar terms.
“This funding provides the Company with immediate capital to advance exploration efforts at our Star Mountain project as well as for general working capital,” said Michael Stanford, president and chief executive officer of Jameson Stanford Resources. “We are confident that our minerals exploration activities on our Chopar Mine claims will allow us to begin operations in late 2013. We are continuing to ramp up our exploration activities as we secure financing.”
About Jameson Stanford Resources Corp.
Jameson Stanford Resources is focused on developing significant mining claims, mineral leases and excavation rights for projects located in historic mining districts and other sites in central and southwestern Utah. The Company is presently engaged in exploration activities in connection with copper, gold, silver and base metals properties located in historic mining districts in Beaver County and Juab County, Utah. In addition, Jameson Stanford Resources has acquired excavation rights and special permitting related to deposits of alluvial minerals and silica sand located in Weber County, Utah.
Safe Harbor Forward-Looking Statements
In connection with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Jameson Stanford Resources Corporation, is hereby providing cautionary statements identifying important factors that could cause our actual results to differ materially from those projected in forward-looking statements (as defined in such act). Any statements that are not historical facts and that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, indicated through the use of words or phrases such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “intends,” “plans,” “believes” and “projects”) may be forward-looking and may involve estimates and uncertainties which could cause actual results to differ materially from those expressed in the forward-looking statements. These statements include, but are not limited to, our expectations concerning the presence of minerals and our ability to mine and process minerals commercially at a profit.
We caution that the factors described herein could cause actual results to differ materially from those expressed in any forward-looking statements we make and that investors should not place undue reliance on any such forward-looking statements. Further, any forward-looking statement speaks only as of the date on which such statement is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of anticipated or unanticipated events or circumstances. New factors emerge from time to time, and it is not possible for us to predict all of such factors. Further, we cannot assess the impact of each such factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Contact:
Jameson Stanford Resources Corp.
Las Vegas, NV
www.JamesonStanford.com
702-933-0808
IR@JamesonStanford.com
Mission Investor Relations
Atlanta, GA
www.MissionIR.com
404-941-8975
Investors@MissionIR.com
(CYTR) New Aldoxorubicin Data Demonstrates Significant Advantages over Doxorubicin
CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced compelling preliminary data from its global Phase 2b soft tissue sarcoma trial indicating that patients treated with aldoxorubicin had a significantly higher OVERALL RESPONSE RATE (ORR) of 22% as compared to those administered the widely used chemotherapeutic agent doxorubicin with an ORR of 0%.
Additionally, aldoxorubicin compared with doxorubicin produced statistically significant improvement in survival rates in animals with a human model of glioblastoma (brain tumor), and showed an improved and narrow distribution of aldoxorubicin within the human body in a pharmacokinetics trial. Results from the glioblastoma trial and pharmacokinetics trial were discussed in poster presentations at the 2013 European Cancer Congress (ECCO/ESMO/ESTRO) being held in Amsterdam, Netherlands.
“We are compiling an ever-increasing portfolio of impressive human and pre-clinical data that aldoxorubicin could have an essential role in the treatment of patients with a wide range of cancers,” said CytRx President and CEO Steven A. Kriegsman. “This collective body of data gives us tremendous hope that we will be able to make an important difference in the lives of cancer patients worldwide. This data also supports our belief in the potential benefit of our linker technology platform to one day form the basis of a multi-billion dollar revenue oncology franchise with drugs to treat a wide range of cancers.
“Given the promising prospects for aldoxorubicin, we are aggressively moving forward with its clinical development,” he added. “We recently received acceptance from the U.S. Food and Drug Administration (FDA) for a protocol to conduct a Phase 2 clinical trial with aldoxorubicin in glioblastoma, a very difficult-to-treat and deadly cancer, and also plan to conduct a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma.”
Increased Responses Show OVERALL RESPONSE RATE of 22% in Global Phase 2b Trial in Advanced Soft Tissue Sarcoma
Preliminary data from the Phase 2b clinical trial directly comparing aldoxorubicin with doxorubicin as a first-line treatment for patients with metastatic, locally advanced or unresectable soft tissue sarcomas showed that aldoxorubicin-treated patients demonstrated a significantly greater percentage of overall responses compared with those treated with doxorubicin, the current standard-of-care for advanced, metastatic soft tissue sarcoma. This was based on a blinded reading of tumor scans by an independent radiology review. In this trial, aldoxorubicin was safely delivered at 3.5 times the dose level of doxorubicin in the comparator arm. The overall response data, which were reviewed on a blinded basis by independent radiologists, are as follows:
82 Evaluated Patients | ||||||||||||||||||||||
58 aldoxorubicin-treated | 24 doxorubicin-treated | |||||||||||||||||||||
Number | Percentage | Number | Percentage | |||||||||||||||||||
Partial response | 13 | 22% | 0 | 0% | ||||||||||||||||||
Stable disease | 27 | 46% | 11 | 46% | ||||||||||||||||||
Responses were evaluated using the RECIST 1.1 criteria. Partial responses are defined as at least a 30% shrinkage in the sum of the longest diameters of target tumors with no increase in non-target tumors or development of new tumors. Stable disease is defined as less than a 20% increase in the longest diameter of target tumors with no increase in non-target tumors or development of new tumors.
“The magnitude of the clinical response difference supports our belief that aldoxorubicin could fill an important medical need in patients with advanced soft tissue sarcoma,” said Executive Vice President and Chief Medical Officer Daniel Levitt, M.D., Ph.D. “Although preliminary, we are certainly optimistic about aldoxorubicin’s prospects in soft tissue sarcoma based on the favorable results from our earlier second-line Phase 1b/2 clinical trial in patients who had failed other therapies and these preliminary overall response results as a first-line treatment announced today. The study is ongoing and many of the patients with tumor responses and stable disease are still receiving treatment.” The Company expects to report top-line data for the global Phase 2b clinical trial in December 2013.
Significantly Increased Survival with Excellent Safety Profile in Glioblastoma Model
CytRx announced additional data from a trial in immunodeficient mice transplanted with human glioblastoma cells in their brain that showed those animals treated with aldoxorubicin had a median survival rate of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline.
“We saw clear evidence of drug concentration inside tumors growing in the brain and significant tumor regression in aldoxorubicin-treated animals, where doxorubicin did not appear to enter the tumor to any significant degree and showed virtually no efficacy in the treatment of these brain tumors,” said Om Prakash, Ph.D., the study’s principal investigator and poster presenter at ESMO. “Aldoxorubicin significantly reduced the number of dividing cells within the brain tumors in this trial and showed a statistically relevant increased expression of apoptosis or cell death markers. The combined results of this trial are significant as glioblastoma is the most common and aggressive of the adult brain tumors with a median survival of 12-14 months despite aggressive treatment.” Dr. Prakash is Research Professor of Medicine, Stanley S. Scott Cancer Center, Louisiana State University (LSU) Health Sciences Center, New Orleans.
FDA Agreement for Phase 2 Clinical Trial in Glioblastoma
“We have reached an agreement with the FDA to enroll up to 28 patients in a Phase 2 clinical trial to evaluate the preliminary efficacy and safety of aldoxorubicin in patients with unresectable glioblastoma whose tumors have progressed following prior treatment with surgery, radiation and with the drug temozolomide. I am pleased to announce that the John Wayne Cancer Center in Santa Monica, Calif.; City of Hope in Duarte, Calif.; and the LSU Cancer Center in New Orleans have agreed to participate in this trial,” stated Dr. Levitt. The trial is set to commence this year with preliminary results expected in the third quarter of 2014. “The strong survival, tumor regression and safety evidence from this study provides more than sufficient rationale to move into clinical development of aldoxorubicin for the treatment of patients suffering from this devastating cancer,” Dr. Levitt added.
Phase 2 Clinical Trial in AIDS-related Kaposi’s Sarcoma
CytRx announced plans to initiate a Phase 2 clinical trial in 2013 evaluating the preliminary efficacy of aldoxorubicin in patients with AIDS-related Kaposi’s sarcoma, a common HIV-associated tumor. The current standard-of-care for severe dermatological and systemic Kaposi’s sarcoma is liposomal doxorubicin (Doxil®); however, a significant proportion of patients exhibit minimal to no clinical response to this agent and the drug’s toxicity often prevents continued therapy. The Phase 2 trial will enroll up to 30 patients and will be conducted at the LSU Health Science Center in New Orleans.
“The key to this trial is that Kaposi’s sarcoma usually manifests as skin lesions. We have the opportunity to biopsy these lesions as the trial progresses and to collect important information about the accumulation of aldoxorubicin at the tumor site,” said Dr. Levitt.
Better, Safer Distribution of Aldoxorubicin in Cancer Patients
CytRx announced in its poster presentation at ESMO that additional data from a Phase 1b clinical trial at the Cedars Sinai Medical Center in Beverly Hills, Calif., evaluating the pharmacokinetics and safety of aldoxorubicin in patients with metastatic solid tumors who have either relapsed or not responded to treatment with standard therapies clearly demonstrate that aldoxorubicin has circulating half-life of approximately 20-24 hours with narrow volume of distribution to healthy tissue and slow clearance from the circulation. Doxorubicin has a significantly shorter half-life and a much wider distribution in normal, healthy tissues in cancer patients than aldoxorubicin. In this study, treatment with aldoxorubicin has extended past 13 cycles (a cycle is 21 days).
“We found that only trace amounts of either free doxorubicin or its major metabolite, doxorubicinol, were detectable in the blood stream even over multiple cycles of administration,” said Dr. Levitt. “The long circulating half-life, slow clearance and narrower volume of distribution of aldoxorubicin provide insights into its ability to safely deliver higher levels of agent to tumors and not normal, healthy tissues compared with doxorubicin.”
About Aldoxorubicin
The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. It is associated with many side effects–especially the potential for damage to the heart muscle at cumulative doses greater than 500 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on the heart muscle, even at cumulative doses of drug well over 2 grams/m2.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline 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. The Company plans to initiate a Phase 3 global pivotal trial under a special protocol assessment (SPA) 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 Kaposi’s sarcoma. CytRx is expanding its pipeline of oncology candidates based on a novel linker platform technology that can be utilized with multiple chemotherapeutic agents and could allow for greater concentration of drug at tumor sites. The Company 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), plans to seek a partner for further development of bafetinib, and is evaluating further development of tamibarotene. For more information about CytRx Corporation, visit www.cytrx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx’s clinical trials, the risk that any future human testing of aldoxorubicin, including the conclusion of the Phase 2b clinical testing of aldoxorubicin as a first-line treatment in patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy, might not produce objective response results similar to the preliminary data described in this press release, or might not correlate with the trial’s primary endpoint of progression-free survival, risks related to CytRx’s ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
(CTIC) FDA Grants Special Protocol Assessment of Pacritinib in Myelofibrosis
– PERSIST-2 trial expected to initiate in fourth quarter of 2013 –
SEATTLE, Oct. 7, 2013 — Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that the company reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the planned pivotal Phase 3 clinical trial, known as the PERSIST-2 trial, evaluating pacritinib compared to best available therapy, including approved JAK2 inhibitors such as ruxolitinib, in patients with myelofibrosis whose platelet counts are <100,000/uL. The SPA is a written agreement between CTI and the FDA regarding the design, endpoints and planned statistical analysis approach of the trial to be used in support of a potential New Drug Application (NDA) submission. The PERSIST-2 trial is the second of two planned Phase 3 clinical trials in patients with myelofibrosis. CTI expects to initiate the PERSIST-2 clinical trial in the fourth quarter of 2013.
“The FDA worked closely with us to achieve SPA agreement during first cycle review of the PERSIST-2 trial protocol for pacritinib,” stated James A. Bianco, M.D., CTI’s President and CEO. “As a result of the SPA, which established agreement on trial design to support regulatory approval, we expect that we will be able to initiate this pivotal Phase 3 clinical trial of pacritinib by the end of the year. Myelofibrosis is a chronic disease and JAK inhibitors have had a dramatic impact on the lives of people living with myelofibrosis. Data from earlier studies of pacritinib showed a clinically meaningful improvement in symptoms with minimal suppression of platelets or red blood cells. We believe patients with myelofibrosis, particularly those with low platelet counts, could benefit from new treatment options.”
PERSIST-2 is a 300 patient randomized, open-label, multi-center pivotal trial in patients with myelofibrosis whose platelet counts are <100,000/uL. The trial will evaluate pacritinib as compared to best available therapy, including approved JAK2 inhibitors that are dosed according to the product label for myelofibrosis patients with thrombocytopenia. Patients will be randomized (1:1:1) to receive 200 mg pacritinib twice daily, 400 mg pacritinib once daily or best available therapy. The agreed upon co-primary endpoints are the percentage of patients achieving a 35 percent or greater reduction in spleen volume measured by MRI or CT at 24 weeks of treatment and the percentage of patients achieving a Total Symptom Score (TSS) reduction of 50 percent or greater using six key symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MF-SAF) diary. The trial is expected to enroll patients at clinical sites in the United States, Europe and Australia.
Pacritinib Development Strategy
Based on pacritinib’s efficacy and tolerability profile demonstrated to date, CTI is pursuing a broad approach to advancing this therapy for myelofibrosis patients by conducting two Phase 3 clinical trials: one in a broad set of patients without limitations on blood platelet counts, the PERSIST-1 trial, and the other in patients with low platelet counts, the PERSIST-2 trial, as described above, which is expected to begin in the fourth quarter of 2013.
In January 2013, CTI initiated PERSIST-1, which is a 270 patient randomized, open-label, multicenter Phase 3 trial comparing the efficacy and safety of pacritinib with that of best available therapy in patients with myelofibrosis. Best available therapy includes any physician-selected treatment other than JAK inhibitors and there is no exclusion by patient platelet count. The trial is currently enrolling patients at clinical sites in Europe, Australia, Russia and the United States. More details on the PERSIST-1 study can be found at www.clinicaltrials.gov.
About Pacritinib
Pacritinib is an oral tyrosine kinase inhibitor (TKI) with dual activity against JAK2 and FLT3. The JAK family of enzymes are a central component in signal transduction pathways, which are critical to normal blood cell growth and development as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood related cancers including myeloproliferative neoplasms, leukemia and lymphoma. Pacritinib may offer an advantage over other JAK inhibitors through effective treatment of symptoms while having less treatment-emergent thrombocytopenia and anemia than has been seen in currently approved and in-development JAK inhibitors.
About Myelofibrosis
Myelofibrosis is classified as a myeloproliferative neoplasm and is a chronic bone marrow disorder. Myelofibrosis is caused by the accumulation of malignant bone marrow cells that triggers an inflammatory response, scarring the bone marrow and limiting its ability to produce red blood cells prompting the spleen and liver to take over this function. Symptoms that arise from this disease include enlargement of the spleen, anemia, extreme fatigue and pain.
About Cell Therapeutics, Inc.
CTI (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable. CTI is headquartered in Seattle, WA. For additional information and to sign up for email alerts and get RSS feeds, please visit www.CellTherapeutics.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI’s securities. Such statements include, but are not limited to, statements regarding CTI’s expectations with respect to the development of CTI and its product and product candidate portfolio, the expected commencement of the PERSIST-2 clinical trial in the fourth quarter of 2013, the expected efficacy and potential benefits of pacritinib and the expectations concerning enrollment locations for the PERSIST-2 clinical trial. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI and its product and product candidate portfolio in particular including, among others, risks associated with the following: that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that CTI cannot predict or guarantee the outcome of preclinical and clinical studies, that CTI may not obtain reimbursement for PIXUVRI in certain markets in the European Union as planned, that the conditional marketing authorization for PIXUVRI may not be renewed, that the second Phase 3 clinical trial of pacritinib will not occur as planned, that CTI may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities, that CTI may experience delays in the commencement of preclinical and clinical studies, risks related to the costs of developing, producing and selling PIXUVRI, pacritinib, and CTI’s other product candidates, and other risks, including, without limitation, competitive factors, technological developments, that CTI’s operating expenses continue to exceed its net revenues, that CTI may not be able to sustain its current cost controls or further reduce its operating expenses, that CTI may not achieve previously announced goals and objectives as or when projected, that CTI’s average net operating burn rate may increase, that CTI will continue to need to raise capital to fund its operating expenses, but may not be able to raise sufficient amounts to fund its continued operation as well as other risks listed or described from time to time in CTI’s most recent filings with the Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI does not intend to update any of the statements in this press release upon further developments.
Contacts:
Monique Greer
+1 206-272-4343
mgreer@ctiseattle.com
Ed Bell
+1 206-282-7100
ebell@ctiseattle.com
In Europe:
CTI Life Sciences Limited, Milan Branch
Laura Villa
+39 02 89659706
lvilla@cti-lifesciences.com
CTI_EUInvestors@CTI-Lifesciences.com
(CRME) Publication of Positive Data of Study On BRINAVESS
VANCOUVER, Oct. 7, 2013 – Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced publication of positive data from an observational, retrospective study performed at the Skåne University Hospital in Malmö, Sweden. The study included 251 recent-onset atrial fibrillation (AF) patients who received 355 BRINAVESS™ treatments during the period between January 15, 2011 and April 15, 2013. During the observation period, 70% of the AF patients treated with BRINAVESS converted with a median time of 11 minutes. Conversion efficacy was 76% in patients with AF duration <10 hours. The median time spent in the ER for patients who converted on BRINAVESS was 6.5 hours. These results are published in the October 2013 issue of The European Journal of Cardiovascular Medicine.
“It is exciting to see that patients treated in the clinically critical first 48 hours after AF onset appear to continue to derive better-than-expected benefit from BRINAVESS and that they also prefer this therapy over DC cardioversion,” stated William Hunter, M.D., Chief Executive Officer of Cardiome Pharma Corp. “The high conversion efficacy coupled with short hospital stay we believe makes BRINAVESS a practical option for physicians and patients who value rapid relief from AF.”
“Skåne University Hospital developed a “fast-track” AF program in the emergency room where patients with short duration AF were promptly treated with BRINAVESS, which likely contributed to the higher efficacy seen in this setting compared to the ACT and AVRO clinical trials,” stated Dr. Steen Juul-Möller, the study’s Principal Investigator and Cardiome’s Medical Director. “The finding that 75% of successfully treated BRINAVESS patients remained in normal sinus rhythm after a one year follow-up period – was an extremely interesting and important finding that requires further investigation,” added Dr. Juul-Möller.
Patients with recent-onset AF and whom cardioversion was considered were evaluated for BRINAVESS treatment. Over the period of the study, 251 patients received 355 treatments. In all patients, 70% of BRINAVESS treatments were successful and 70% of the patients responded at least once with conversion to sinus rhythm. The conversion rate was higher at 76% among patients with AF duration <10 hours compared to 66% in those with AF >10 hours (P<0.05). Transient bradycardia and hypotension were seen in 5 patients (1.4%) occurring within minutes after conversion and were judged as a response to the change in heart rhythm. No ventricular tachyarrhythmias, including Torsade-des-Pointes were seen.1
Those patients who did not respond to BRINAVESS treatment were subsequently treated with DC cardioversion. All patients who had experienced both BRINAVESS and DC cardioversion were given a questionnaire to assess cardioversion preference and were followed up for a maximum period of 27 months (BRINAVESS [n = 156]; DC cardioversion [n=91]). Among those who converted with BRINAVESS, 72% would prefer this treatment, in patients who did not convert with BRINAVESS, 61% said they would prefer DC cardioversion if they experienced a relapse (P<0.001). Furthermore, among BRINAVESS responders, 78% were satisfied or very satisfied with the treatment. In the follow up portion of the study, after 12 months, 75% of BRINAVESS responders were still in sinus rhythm, compared to 45% of patients that required DC cardioversion (P<0.001).
References:
- Juul-Möller, S. Vernakalant in recently developed Atrial Fibrillation: How to translate pharmacological trials into clinical practice. European Journal of Cardiovascular Medicine. Vol. 2, Issue 4. Published online October 4, 2013.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a biopharmaceutical company dedicated to the discovery, development and commercialization of new therapies that will improve the health of patients around the world. Cardiome has one marketed product, BRINAVESSTM (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Forward- looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for the remainder of 2013 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and development and product and drug development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many such known risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions in the United States, Canada, Europe, and the other regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to expand commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this presentation to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in our business strategy or development plans; intellectual property matters, including the unenforceability or loss of patent protection resulting from third-party challenges to our patents; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the availability of capital to finance our activities; and any other factors described in detail in our filings with the Securities and Exchange Commission available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
(ANV) Record Gold Production and Sales in the Third Quarter of 2013
Commissioning New 21,500 Gallons per Minute Capacity Merrill-Crowe Plant
RENO, NEVADA–(Oct. 7, 2013) – Allied Nevada Gold Corp. (“Allied Nevada”, “we”, “us”, “our” or the “Company”) (TSX:ANV) (NYSE MKT:ANV) is pleased to announce that it has achieved its metal production and sales expectations in the third quarter of 2013. The Hycroft mine (“Hycroft”) produced a record 52,198 ounces of gold and 184,070 ounces of silver in the third quarter of 2013 and we sold a record 52,713 ounces of gold and 184,082 ounces of silver. We believe that we are on track to achieve full year production and sales guidance of 175,000 – 200,000 ounces of gold and 0.9 million – 1.1 million ounces of silver in 2013.
“I am very pleased with the progress being made at site by the new operating team. While I fully expected them to turn the operation around, I am impressed with the speed and efficiency with which they have been able to improve production,” commented Randy Buffington, President and CEO of Allied Nevada. “This is a first-rate team with the systems, discipline and determination that give us the confidence that we can continue to move forward with building a world-class operation.”
Processing operations at Hycroft have improved significantly in the third quarter. Pumping capacity and fresh water availability have increased to meet processing requirements and total solution flows to the leach pads are now averaging 22,000 gallons per minute (“gpm”), an increase of 36% from the beginning of the third quarter. The new 21,500 gpm Merrill-Crowe plant began commissioning at the end of the third quarter. Initially, about 7,000 gpm will be processed through the plant with staged increases planned each week until the plant is fully commissioned and capable of processing 21,500 gpm, which is expected by the end of October. Once fully commissioned, we will discontinue use of the old Merrill-Crowe plant and carbon columns. The silver sales ratio is expected to increase with the exclusive use of the new Merrill-Crowe plant from current levels of approximately 3.5 ounces of silver for each ounce of gold produced to in excess of 6:1.
Lewis leach pad remediation is ongoing with all permits in place to begin introducing solution into wells drilled into dry areas of the pad. Testing has begun which will determine the rate and speed of recovery and solution penetration to better predict the timing of metal production from the pad. No production from these areas is factored into our 2013 or 2014 projections.
Loading of the North leach pad began on May 7, 2013, with the first solution being introduced to the pad ahead of schedule on May 15, 2013. In the five months of operation, the North leach pad has performed as predicted based on our recovery curves. Construction of the gyratory crusher has progressed well and we expect the crusher to be commissioned in the fourth quarter, as planned.
Positive initial results from the ongoing oxidation test program of Hycroft sulfide concentrate were announced in August 2013. These results indicate that viable solutions exist for oxidizing and processing concentrate onsite. We have begun the second phase of testing, led by M3 Engineering and Technology (“M3”), based in Tucson, Arizona, who were selected based on their past successes and familiarity with our milling flow sheet and the oxidation techniques being assessed. We believe that M3 will complete a prefeasibility study for the oxidation circuit by the end of 2013. The plan is for M3 to then immediately move into completing a feasibility study incorporating the oxidation work with all engineering completed to date on the milling circuit. The feasibility is expected to be completed by the end of the third quarter of 2014.
We expect to provide third quarter financial results during the week of November 4, 2013. A conference call and Q&A session will follow the release, details and timing of which will be announced shortly.
Cautionary Statement Regarding Forward Looking Information
This press release contains forward-looking statements within the meaning of the U.S. Securities Act of 1933, the U.S. Securities Exchange Act of 1934 (and the equivalent under Canadian securities laws) and the Private Securities Litigation Reform Act, that are intended to be covered by the safe harbor created by such sections. Statements that are not historical fact are forward-looking statements. Forward-looking statements can be identified by, among other things, the use of forward-looking language, such as the words “plan,” “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project,” “may,” “will,” “would,” “could,” “should,” “seeks,” or “scheduled to,” or other similar words, or the negative of these terms or other variations of these terms or comparable language, or by discussion of strategy or intentions. Such forward-looking statements include, without limitation, statements regarding expectations regarding gold and silver recovery; delays in processing gold and silver; anticipated sales, costs and project economics; the results and timing of metallurgical test work, prefeasibility and feasibility studies; the realization, scope, size and capital requirements of expansion and construction activities and the timing thereof; reserve estimates; future business strategy, plans and goals and other statements that are not historical facts.
Forward-looking statements address activities, events or developments that Allied Nevada expects or anticipates will or may occur in the future, and are based on current expectations and assumptions. Although Allied Nevada management believes that its expectations are based on reasonable assumptions, it can give no assurance that these expectations will prove correct. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, among others, risks that Allied Nevada’s exploration and property advancement efforts will not be successful; risks and uncertainties inherent to its Hycroft project expansion, risks relating to fluctuations in the price of gold and silver; the inherently hazardous nature of mining-related activities; uncertainties concerning reserve and resource estimates; uncertainties relating to obtaining approvals and permits from governmental regulatory authorities; and availability and timing of capital for financing the Company’s exploration and development activities, including the uncertainty of being able to raise capital on favorable terms or at all; as well as those factors discussed in Allied Nevada’s filings with the U.S. Securities and Exchange Commission (the “SEC”) including Allied Nevada’s latest Annual Report on Form 10-K and its other SEC filings (and Canadian filings) including, without limitation, its latest Quarterly Report on Form 10-Q (which may be secured from us, either directly at the SEC website at www.sec.gov). The Company does not intend to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws.
Allied Nevada Gold Corp.
Randy Buffington
President & CEO
(775) 358-4455
Allied Nevada Gold Corp.
Tracey Thom
Vice President, Investor Relations
(775) 789-0119
(GALE) To Present at American College of Surgeons Clinical Congress 2013
- NeuVax induces a full immune response in treated patients and creates an immune memory to target residual cancer cells
- Phase 3 PRESENT HER2 1+/2+ patients confirmed as optimal treatment population
PORTLAND, Ore., Oct. 7, 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 an oral presentation given today at the American College of Surgeons Clinical Congress 2013 taking place October 6-10, 2013 in Washington D.C.
The oral presentation, entitled “Predicting Clinical Benefit After Completion of Treatment with the Adjuvant Breast Cancer Vaccine, NeuVax™ (nelipepimut-S or E75),” analyzed biomarker data and clinical outcomes from the NeuVax phase 2 trial. A number of variables were analyzed, including HER2 levels, effect of boosters, induction, and amplification of the NeuVax T-cell response. The data demonstrates that induction, rather than amplification, of an anti-HER2 immune response confers optimal clinical benefit and may partially explain why NeuVax works in HER2 IHC 1+/2+ patients with low-to-intermediate HER2 antigen exposure. This data is consistent with previously published biomarker data indicating a correlation between increasing NeuVax specific T-cells following vaccination and reductions in breast cancer recurrence rates.
“The presentation by Dr. Berry reinforces two key aspects of the NeuVax Phase 3 PRESENT trial. First, the data supports the correlation of the mechanism of action of NeuVax during the induction dosing. Second, immune T-cell response targeting HER2 expressing cancer cells correlates with reduction in recurrences in the target patient population, and that PRESENT is targeting the patient population with women who have a low-to-intermediate expression of HER2 with an unmet medical need,” said Mark J. Ahn, President and Chief Executive Officer of Galena Biopharma.
NeuVax is a cancer immunotherapy that harnesses the power of the immune system to seek out and destroy HER2 presenting cancer cells. NeuVax is the most immunogenic peptide of the HER2 protein which is injected into the body to allow the immune system to develop a robust HER2-directed T-cell response, creating immune memory, and priming the immune system against tumor cells. This active immunotherapy can not only kill tumor cells present at the time of therapy, but with the additional advantage of immune memory, the boosted immune system is primed to eradicate any remaining or recurrent tumor cells in a patient.
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 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 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 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 for our commercial success, 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 June 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
(CXM) Provides Update On Exchange Listing
SAN DIEGO, Oct. 7, 2013 — Cardium Therapeutics (NYSE MKT: CXM) today provided an update on its exchange listing. As previously reported, a communication from the staff of the Company’s current listing exchange, NYSE MKT, indicated that the Company was considered to be noncompliant with certain listing requirements based on its quarterly report for the period ended September 30, 2012, and provided that the company should submit a plan to staff of the exchange that would reestablish compliance with the NYSE MKT listing requirement by March 31, 2013. On December 6, 2012, the company reported that it had submitted a plan designed to reestablish compliance with the exchange’s requirement in advance of the March 31, 2013 time frame, and on January 6, 2013, announced that the plan had been accepted by the listing exchange. On April 5, 2013, the Company reported that the NYSE MKT had granted an additional quarterly extension of the listing exchange compliance plan from March 31 to June 30, 2013. On July 2, 2013, the Company reported that its exchange had granted an additional quarterly extension of the listing exchange compliance plan from June 30, 2013 to September 30, 2013. The Company today reports that the NYSE MKT has granted an additional quarterly extension of the listing exchange compliance plan from September 30, 2013 to December 31, 2013.
The notification received from the listing exchange had no current effect on the listing of the company’s shares on the exchange. Rather the Company has now been afforded the opportunity to regain compliance with the requirements of Section 1003(a)(iv) of the exchange’s company guide by the end of the revised plan period of December 31, 2013, although as is normal course the Company’s exchange compliance would continue to be evaluated on an ongoing basis. Additional information and provisions regarding the NYSE MKT requirements are found in Part 10 of its company guide. The Company will be subject to periodic review by the exchange staff during the period covered by the plan. Failure to make progress consistent with the plan or to regain compliance with the continued listing standards by the end of the applicable extension periods could result in the Company’s shares being delisted from the exchange. If the Company’s common stock was not traded on the NYSE MKT, it would be expected to trade on the OTC exchange, an alternative regulated quotation service that provides quotes, sale prices and volume information in over-the-counter equity securities. The Company’s common stock was traded on the OTC until July 2007, when the company elected to instead list its shares on the NYSE MKT (formerly the American Stock Exchange).
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 building the Company’s medical data analytics platform technology and selling term life insurance. LifeAgain recently announced its first 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 expectations. For example, there is no assurance that the Company will satisfy the requirements of its compliance plan and will otherwise continue to satisfy the listing requirements of its exchange or that its shares can continue to be listed on a national exchange; that planned product development efforts and clinical studies can be performed in an efficient and effective manner; that regulatory approvals can be obtained in a timely manner or at all; that partnering, distribution or other commercialization efforts can be achieved; that our products or proposed products will prove to be sufficiently safe and effective; that our products 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; that third parties on whom we depend will behave as anticipated; or that necessary regulatory approvals will be obtained. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development, testing and marketing of biologics, medical devices and other products, and the conduct of human clinical trials, including the timing, costs and outcomes of such trials, whether our efforts to launch new products and expand our markets will be successful or completed within the time frames contemplated, our dependence upon proprietary technology, our ability to obtain necessary funding, regulatory approvals and qualifications, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make 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.
For Terms of Use Privacy Policy, please visit www.cardiumthx.com.
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.
(TKMR) Presents TKM-PLK1 Data at 6th Annual North American Neuroendocrine Tumor Society
New Data Shows Positive Chromogranin-A Biomarker Results in GI-NET Patient
Phase I/II Clinical Trial with TKM-PLK1 Ongoing in Patients with Advanced Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC)
VANCOUVER, British Columbia, Oct. 4, 2013 — Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced that it presented additional TKM-PLK1 data at the 6th Annual NET Conference hosted by the North American Neuroendocrine Tumor Society (NA-NETS) to be held in Charleston, South Carolina from October 4-5, 2013.
“We are pleased to present data at this conference reaching researchers and physicians treating patients who have been diagnosed with neuroendocrine tumors. We have an ongoing Phase I/II clinical trial with TKM-PLK1, with current enrollment targeting patients with either advanced Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC), initiated following encouraging drug activity observed in these indications during Phase I,” said Dr. Mark J. Murray, Tekmira’s President and CEO.
Tekmira has enrolled a total of 36 patients in a population of advanced cancer patients with solid tumors. Doses ranged from 0.15 mg/kg to 0.90 mg/kg during the dose escalation portion of the trial, with the maximum tolerated dose (MTD) of 0.75 mg/kg administered to the expansion cohort. A total of 174 doses were administered with a mean number of 5.3 doses per patient (range of 1-31 doses). No dose dependent changes in liver function tests were observed.
Forty percent (6 out of 15) of patients evaluable for response, treated at a dose equal to or greater than 0.6 mg/kg, showed clinical benefit. Of the 36 patients enrolled, three out of the four ACC patients (75%) treated with TKM-PLK1 achieved stable disease, including one patient who saw a 19.3% reduction in tumor size and is still on study receiving TKM-PLK1. Of the two GI-NET patients enrolled, both experienced clinical benefit: one patient had a partial response based on RECIST criteria, and the other GI-NET patient achieved stable disease and showed a greater than 50% reduction in Chromogranin-A (CgA) levels, a key biomarker used to predict clinical outcome and tumor response.
“Lowered levels of Chromogranin-A (CgA) are linked to improved survival and favorable response to treatment in neuroendocrine patients. We are encouraged that a GI-NET patient who achieved stable disease showed a greater than 50% decline in CgA levels. We intend to collect CgA data in our ongoing TKM-PLK1 Phase I/II clinical trial and expect to have results from this completed trial by mid-2014. If supported by the data, we will commence a pivotal trial in GI-NET in 2014,” added Dr. Murray.
About Chromogranin-A (CgA)
There have been recent advances in neuroendocrine biomarkers, including research that demonstrates elevated CgA levels correlate with disease burden and poor outcomes, providing evidence that baseline and serial CgA levels may be used to monitor clinical outcome.
About the TKM-PLK1 Phase I/II Clinical Trial
The ongoing TKM-PLK1 Phase I/II clinical trial, which is currently targeting GI-NET and ACC patients for enrollment, is a multi-center, single arm, open label study designed to measure efficacy using RECIST and tumor biomarkers for GI-NET patients, as well as to evaluate TKM-PLK1’s safety, tolerability and pharmacokinetics. TKM-PLK1, which employs a unique lipid nanoparticle (LNP) formulation for oncology applications, will be administered weekly with each four-week cycle consisting of three once-weekly doses followed by a rest week. It is expected that approximately 20 patients with advanced GI-NET or ACC tumors will be enrolled in this trial, with a minimum of 10 GI-NET patients to be enrolled.
About TKM-PLK1
Tekmira’s lead oncology product candidate, TKM-PLK1, targets polo-like kinase 1 (PLK1), a protein involved in tumor cell proliferation and a validated oncology target. Inhibition of PLK1 expression prevents the tumor cell from completing cell division, resulting in cell cycle arrest and death of the cancer cell. PLK1 has been a target of interest for years, and evidence that patients with elevated levels of PLK1 in their tumors exhibit poorer prognosis and survival rates has been documented in the medical literature. By using an RNAi approach and exploiting its naturally occurring mechanism of action, Tekmira can potentially overcome the limitations of other approaches and effectively silence PLK1.
About Gastrointestinal Neuroendocrine Tumors (GI-NET)
Neuroendocrine tumors (NETs) refers to a group of unusual and complex cancers that affect neuroendocrine cells, with those arising in the gastrointestinal tract referred to as GI-NET. It is estimated that there has been a four-fold increase in the incidence of NETs between 1973 and 2004. Approximately 55,000 people are living with GI-NET in the United States. There is a poor prognosis for advanced metastatic NETs, with 25% of patients surviving less than one year. The treatment of patients with gastrointestinal neuroendocrine tumors remains a challenge, and currently there are no approved anti-cancer drugs or treatments indicated specifically for GI-NET.
About Adrenocortical Carcinoma (ACC)
Adrenocortical Carcinoma (ACC) is a rare cancer that forms in the outer layer of tissue of the adrenal gland (a small organ on top of each kidney that makes steroid hormones, adrenaline, and noradrenaline to control heart rate, blood pressure, and other body functions). Even with appropriated diagnosis and treatment, most patients will develop recurrence and succumb to ACC because of the underlying tumor biology, the difficulty of achieving a complete resection, and the lack of effective systemic therapies.
About RNAi and Tekmira’s LNP
RNAi therapeutics have the potential to treat a broad number of human diseases by “silencing” disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi therapeutics, such as “siRNAs,” require delivery technology to be effective systemically. Tekmira believes its LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira’s LNP platform is being utilized in multiple clinical trials by both Tekmira and its partners. Tekmira’s LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles that are effective in delivering RNAi therapeutics to disease sites in numerous preclinical models. Tekmira’s LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible, and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
Forward-Looking Statements and Information
This news release contains “forward-looking statements” or “forward-looking information” within the meaning of applicable securities laws (collectively, “forward-looking statements”). Forward-looking statements are generally identifiable by use of the words “believes,” “may,” “plans,” “will,” “anticipates,” “intends,” “budgets,” “could,” “estimates,” “expects,” “forecasts,” “projects” and similar expressions, and the negative of such expressions. Forward-looking statements in this news release include statements about Tekmira’s strategy, future operations, clinical trials, prospects and the plans of management; RNAi (ribonucleic acid interference) product development programs; the results of the Phase I clinical trial with TKM-PLK1; the effects of Tekmira’s products on the treatment of cancer, including gastrointestinal neuroendocrine tumors (GI-NET) and adrenocortical carcinoma (ACC); the expected completion and release of data from a Phase I/II clinical trial with TKM-PLK1, which will enroll patients with advanced GI-NET or ACC tumors; and, the expected timing of the commencement of a pivotal trial in GI-NET in 2014.
With respect to the forward-looking statements contained in this news release, Tekmira has made numerous assumptions regarding, among other things: LNP’s status as a leading RNAi delivery technology; the effectiveness of Tekmira’s products as a treatment for cancer, including gastrointestinal neuroendocrine tumors (GI-NET) and adrenocortical carcinoma (ACC); results in preclinical models are indicative of the potential effect in humans; Tekmira’s research and development capabilities and resources; FDA approval with respect to commencing clinical trials; the timing and obtaining of regulatory approvals for Tekmira’s products; the time required to complete research and product development activities; and Tekmira’s ability to protect its intellectual property rights and not to infringe on the intellectual property rights of others. While Tekmira considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Tekmira’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the completion of, and timing of the release of the data from, the Phase I/II clinical trial with TKM-PLK1 may not occur as anticipated, or at all; TKM-PLK1 may not enter a pivotal trial in GI-NET within the timeframe anticipated, or at all; Tekmira’s ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; Tekmira’s research and development capabilities and resources will not meet current or expected demand; Tekmira’s products may not prove to be effective in the treatment of cancer, including GI-NET or ACC; the possibility that other organizations have made advancements in RNAi delivery technology that Tekmira is not aware of; the FDA will not approve the commencement of Tekmira’s planned clinical trials or approve the use of Tekmira’s products and generally, difficulties or delays in the progress, timing and results of clinical trials; the FDA may determine that the design and planned analysis of Tekmira’s clinical trials do not adequately address the trial objectives in support of Tekmira’s regulatory submissions; pre-clinical and clinical trials may be more costly or take longer to complete than anticipated; pre-clinical or clinical trials may not generate results that warrant future development of the tested drug candidate; and the possibility that Tekmira has not sufficiently budgeted for expenditures necessary to carry out planned activities.
A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira’s annual report on Form 20-F for the year ended December 31, 2012 (Annual Report), which is available at www.sedar.com or at www.sec.gov/edgar.shtml. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Tekmira disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
CONTACT: Investors Jodi Regts Director, Investor Relations Phone: 604-419-3234 Email: jregts@tekmirapharm.com Media David Ryan Longview Communications Inc. Phone: 416-669-7906 Email: dryan@longviewcomms.ca
(TXMD) to Present at 12th Annual Bio Investor Forum
TherapeuticsMD, Inc. (NYSE MKT: TXMD) announced today that the Company will present at the 12th Annual BIO Investor Forum. Hosted by the Biotechnology Industry Organization (BIO), the 12th Annual BIO Investor Forum features leading private and emerging public companies. The meeting will take place October 8-9, 2013 at the Palace Hotel in San Francisco, CA.
Robert Finizio, Co-Founder and Chief Executive Officer, will present on Wednesday, October 9, 2013 at 8:30 a.m. Pacific Time.
The presentation will also be available via a live audio webcast at the following link: http://www.veracast.com/webcasts/bio/investorforum2013/21201212401.cfm
Following the presentation, a replay will be available on TherapeuticsMD’s website at www.therapeuticsmd.com under the “Investor Relations” section and will remain available for 30 days after the actual presentation date.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD® and BocaGreenMD™ brands. We are currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. We are also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure.
vitaMedMD® and TherapeuticsMD® are registered trademarks of TherapeuticsMD, Inc. BocaGreenMD™ is a trademark of TherapeuticsMD, Inc.
About the BIO Investor Forum
The 12th Annual BIO Investor Forum is an international investor conference focused on private and emerging public biotech companies. Because its mission is to support industry-wide success, it presents a broad and unbiased view of investment opportunities. In addition, the BIO Investor Forum draws business development executives from leading global pharmaceutical and established biotechnology companies.
(LOJN) Law Enforcement Liaison Peter Perrien Next President of IAATI
CANTON, Mass., Oct. 4, 2013 — LoJack Corporation (NASDAQ: LOJN), a provider of vehicle theft recovery systems and advanced fleet management solutions, announced today that Peter Perrien was named the 62nd president of the International Association of Auto Theft Investigators (IAATI). Perrien’s election was announced at the Annual IAATI Training Seminar, which was held in Rimini, Italy.
The IAATI is an organization of nearly 4,000 members from around the world – all volunteers – who are focused on combining resources and training to improve communication and coordination between professional auto theft investigators across the globe. Perrien will head the group that includes experienced professionals from across the automotive industry including law enforcement agencies, insurance representatives, manufacturers and rental car companies as well as members of the National Insurance Crime Bureau.
“We are thrilled that Peter has been named IAATI’s next president,” said Patrick Clancy, Vice President of LoJack’s Law Enforcement Department. “Peter’s extensive career in law enforcement, specifically leading auto theft investigations, embodies everything that IAATI stands for. He is a tremendous selection to lead the organization for the foreseeable future.”
“We see millions of dollars in assets lost each year due to vehicle theft and the only way to combat it is through education, training and collaboration,” said Perrien. “My goal, and the goal for IAATI, is to keep training and educating to let the police know who we are and what we are about.” As president of IAATI, Perrien will focus on the organization’s primary message, which is to provide a global approach to vehicle theft deterrence, investigation, recovery and its kindred crimes. To do so, Perrien will be looking to expand training, networking and the recruitment of new members. He will also be looking to implement more localized trainings and seminars that target the education of law enforcement on critical topics including identification and insurance fraud, salvage thefts and emerging trends in the automotive theft market.
Perrien began his career with the New Orleans Police Department (NOPD) as a patrol officer in 1972. In the ensuing years, Perrien served as an intelligence detective for the white collar/organized crime unit and also as a technology detective for the FBI and NOPD Public Integrity Special Operations unit. In 2000, Perrien accepted a Law Enforcement Liaison position with LoJack and has served the Louisiana region for 13 years. Perrien has been a member of the IAATI board since 2006 and will continue to serve as a LoJack Law Enforcement Liaison in Louisiana.
“Peter is a dedicated member of IAATI and as such, a perfect choice for the next president,” said John O’Byrne, IAATI’s 61st president. “Peter and I have known each other for years and his track record in law enforcement and auto theft speaks for itself. I have no doubt that he will continue to serve the organization in an outstanding capacity, just as he has done in the past serving as vice president.”
For more information about LoJack’s team of Law Enforcement Liaisons, please visit http://www.lojack.com/For-Law-Enforcement.
About IAATI
The International Association of Auto Theft Investigators (IAATI) was formed in 1952 in order to improve communication and coordination among the growing family of professional auto theft investigators. It has grown to 3,604 members representing over 35 countries and includes representatives of law enforcement agencies, as well as many others with a legitimate interest in auto theft investigation, prevention and education. We recognize that, just as law enforcement agencies cannot successfully function independent of one another, auto theft investigation requires the active participation of the private sector; therefore, our membership also includes the insurance industry, automobile manufacturers, car rental companies and, of course, the National Insurance Crime Bureau and its sister agencies in Canada and Europe.
About LoJack Corporation
LoJack Corporation, the company that has helped more than nine million people protect their vehicles in the event of theft over the past 25+ years, today provides safety, security and protection for an ever-growing range of valuable assets and people. Leveraging its core strengths, including its well-known brand, direct integration with law enforcement and dealer distribution network, LoJack Corporation is expanding into new areas across the continuum from theft deterrence to recovery. The Company is focusing on creating a new level of value for its dealer, customer and investor communities by delivering innovative offerings and multiple technologies in expanding geographies. For more information, visit www.lojack.com, www.autotheftblog.com, www.youtube.com/lojack, www.twitter.com/LoJackCorp or www.Facebook.com/LoJackCorp.
© 2013 LoJack Corporation. All rights reserved. LoJack and the LoJack logo are trademarks or registered trademarks of LoJack Corporation in the United States and other countries.
CONTACT: | ||
Jeremy Warnick | Matt Landry | Maria Brown |
LoJack Corp. | Matter Communications | Matter Communications |
781-302-4251 | 978-499-9250, x 226 | 978-499-9250, x212 |
jwarnick@lojack.com | lojack@matternow.com | lojack@matternow.com |
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- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
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