Archive for July, 2015
(XGTI) Implements Reverse Stock Split, Effective Friday, July 17, 2015
SARASOTA, Fla., July 20, 2015 — xG Technology, Inc. (“xG” or the “Company”) (Nasdaq: XGTI, XGTIW), a developer of patented wireless communications and spectrum sharing technologies, announced that its 1-for-10 reverse split (the “Reverse Stock Split”) of its common stock (the “Common Stock”) became effective at 5:00 p.m. Eastern Time on Friday, July 17, 2015, and the Common Stock will open for trading on July 20, 2015 on a post-split basis.
In connection with the Reverse Stock Split, the CUSIP number for the Common Stock has been changed to 98372A 507.
Information to Stockholders
Continental Stock Transfer & Trust Company is acting as exchange agent for the Reverse Stock Split and will send instructions to stockholders of record who hold stock certificates regarding the exchange of certificates for Common Stock. Stockholders who hold their shares of Common Stock in brokerage accounts or “street name” are not required to take any action to effect the exchange of their shares following the Reverse Stock Split. Continental Stock Transfer & Trust Company may be reached for questions at (212) 509-4000.
More information on the Reverse Stock Split can be found in xG’s Form 8-K, which will be filed with the Securities and Exchange Commission on July 20, 2015. Additional information on xG’s Reverse Stock Split will be available beginning on or about July 20, 2015 in “Frequently Asked Questions” on the Company’s website at www.xgtechnology.com.
About xG Technology
xG Technology has created a broad portfolio of intellectual property that makes wireless networks more intelligent, accessible, affordable and reliable. The company has created xMax, a patented all-IP cognitive radio technology that enables robust mobile broadband communications for private, consumer and government networks. xMax can solve the crisis facing the wireless industry caused by data-hungry devices and applications that are straining network capacity. It eliminates the need to acquire scarce and expensive licensed spectrum, thus lowering the total cost of ownership for wireless broadband access. xG’s goal is to help wireless broadband networks deliver voice, video and data services to fixed and mobile users. The xMax cognitive radio system incorporates advanced optimizing technologies that include spectrum sharing, interference mitigation, multiple-input multiple-output (MIMO) and software defined radio (SDR). These and other technologies make xMax ideal for wide area, as well as rapid emergency communication deployment. xG offers solutions for numerous industries worldwide, including urban and rural wireless broadband, utilities, defense, emergency response and public safety.
Based in Sarasota, Florida, xG has 60 U.S. and over 130 international patents and pending patent applications. xG is a publicly traded company listed on the NASDAQ Capital Market where xG common stock is traded under the symbol XGTI and xG warrants are traded under the symbol XGTIW. For more information, please visit www.xgtechnology.com.
Cautionary Statement Regarding Forward Looking Statements
Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements reflect the Company’s expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to xG Technology, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company’s actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.
For More Information:
Media Relations
Daniel Carpini
xG Technology, Inc.
daniel.carpini@xgtechnology.com
(941) 953-9035
Investor and Analyst Relations
James Woodyatt
xG Technology, Inc.
james.woodyatt@xgtechnology.com
(954) 572-0395
Jody Burfening/Carolyn Capaccio
LHA
ccapaccio@lhai.com
(212) 838-3777
(REPH) Positive Top-Line Results for Phase II Clinical Trial of Dex-IN
Company Plans to Meet With FDA to Discuss Phase III Clinical Program
MALVERN, Pa., July 17, 2015 — Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company developing multiple non-opioid therapeutics for the treatment of acute post operative pain, today announced positive efficacy results in the Phase II clinical trial for Dex-IN, a proprietary intranasal formulation of dexmedetomidine, for the treatment of acute pain in adult patients undergoing bunionectomy surgery. Dex-IN met the primary endpoint of the clinical trial in demonstrating significant pain relief compared with placebo over 48 hours. The Company plans to meet with the FDA to discuss the Company’s Phase III plans and determine what, if any, additional information will be required in association with the Phase III clinical program for Dex-IN.
“The positive top line results support the potential of Dex-IN, a non-opioid alternative, to treat acute post operative pain,” said Gerri Henwood, Recro Pharma’s President and Chief Executive Officer. “We look forward to discussing these Phase II results with the FDA and progressing into pivotal Phase III clinical trials.”
The Phase II trial was a randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of Recro Pharma’s proprietary intranasal formulation of dexmedetomidine, Dex-IN, in adult patients undergoing bunionectomy surgery, initiating dosing of study medication on Post Op Day 1. Patients who met the eligibility criteria were randomized to either a 50µg dose of Dex-IN or a placebo intranasal dose given every 6 hours. Following the beginning of treatment, patients remained under observation for 48 hours at study centers. Patients were followed for 7 days after the initial dose of study medication. There was an oral opioid rescue treatment available to patients in either treatment group, if required, to provide adequate pain relief. A total of 168 patients were randomized and received study medication in the clinical trial, 84 patients in each treatment group. Seven patients discontinued the study early, six for lack of efficacy (three in each treatment group) and one for a serious adverse event of hypotension.
The primary efficacy endpoint of the trial was the summed pain intensity difference over 48 hours, SPID48, starting on Post Op Day 1. Additional efficacy endpoints included use of opioid rescue medication, SPIDs over various time intervals, as well as other standard efficacy analyses. The most common adverse events observed in the study were blood pressure decrease / hypotension, nausea (similar incidences to placebo), nasal discomfort and headache. An adverse event of bradycardia was reported in 3 subjects in the Dex-IN treatment group.
Bunionectomy surgery generally involves an incision in the top or side of the big toe joint and the removal or realignment of soft tissue and bone. This is done to relieve pain and restore normal alignment to the joint. Bunionectomy surgery typically results in intense post operative pain. In the past, drugs that have demonstrated analgesic effectiveness following bunionectomy surgery have frequently translated that analgesic success into other post operative procedures that result in moderate to severe, acute pain.
About Recro Pharma, Inc.
Recro Pharma is a revenue generating specialty pharmaceutical company developing multiple non-opioid therapeutics for the treatment of acute post operative pain. Recro Pharma is currently developing IV/IM meloxicam, a proprietary, Phase III-ready, long-acting preferential COX-2 inhibitor, and Dex-IN, a proprietary intranasal formulation of dexmedetomidine currently being tested in Phase II, for the treatment of acute post operative pain. As Recro Pharma’s product candidates are not in the opioid class of drugs, the Company believes its candidates would avoid many of the side effects associated with commonly prescribed opioid therapeutics, such as addiction, constipation and respiratory distress, while maintaining analgesic effect.
Recro Pharma also owns and operates an 87,000 square foot, DEA-licensed facility that manufactures five commercial products and receives royalties associated with the sales of these products.
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Recro Pharma’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to Recro Pharma or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Recro Pharma as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Recro Pharma’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. Recro Pharma assumes no obligation to update any such forward-looking statements. Factors that could cause Recro Pharma’s actual performance to materially differ from those expressed in the forward-looking statements set forth in this press release include, without limitation: results and timing of the clinical trials of IV/IM meloxicam and Dex-IN; the ability to obtain and maintain regulatory approval of IV/IM meloxicam and Dex-IN, and the labeling under any such approval; regulatory developments in the United States and foreign countries; the Company’s ability to raise future financing for continued development; the performance of third-party suppliers and manufacturers; the Company’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection; the successful commercialization of IV/IM meloxicam and Dex-IN; In addition, the forward-looking statements in this press release should be considered together with the risks and uncertainties that may affect Recro Pharma’s business and future results included in Recro Pharma’s filings with the Securities and Exchange Commission at www.sec.gov. Recro Pharma assumes no obligation to update any such forward looking statements.
CONTACT: Recro Pharma, Inc. Charles T. Garner Chief Financial Officer (484) 395-2425 Media and Investors: Argot Partners Susan Kim (212) 600-1902 susan@argotpartners.com
(VRML) Announces Closing of $18.8 Million Public Offering of Common Stock
AUSTIN, Texas, July 17, 2015 — Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, today announced the closing of an underwritten public offering of 9,602,500 shares of its common stock, including 1,252,500 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares at a price to the public of $1.96 per share.
Canaccord Genuity acted as sole book-running manager and Roth Capital Partners acted as lead manager for the offering.
The net proceeds from the sale of the shares of common stock, after deducting the underwriting discount and the other offering expenses, are expected to be approximately $17.5 million. Vermillion intends to use the net proceeds from the offering to fund domestic and international commercialization, bioinformatics platform enhancements, portfolio expansion and general corporate purposes.
The offering was made pursuant to a shelf registration statement (File No. 333-198734) previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). This offering was made only by means of a prospectus supplement and accompanying base prospectus. A final prospectus supplement and the accompanying prospectus describing the terms of the offering were filed with the SEC on June 14, 2015 and are available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting the Syndicate Department of Canaccord Genuity Inc., Attention: Syndicate Department, 99 High Street, 12th Floor, Boston, Massachusetts 02110, or by telephone/email at (800) 225-6201/prospectus@canaccordgenuity.com.
This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
About Vermillion, Inc. – Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, have diagnostic programs in gynecologic disease. Vermillion’s lead diagnostic, OVA1®, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach. As the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, OVA1 represents a new class of software-based diagnostics.
Vermillion and VRML are trademarks of Vermillion, Inc.
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. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding Vermillion’s anticipated use of proceeds from the public offering. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including risks and uncertainties inherent in Vermillion’s business, including those described in the section entitled “Risk Factors” in Vermillion’s Annual Report on Form 10-K for the year ended December 31, 2014 and in Vermillion’s other periodic filings with the SEC. The events and circumstances reflected in Vermillion’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Vermillion does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor Relations Contact:
Michael Wood
LifeSci Advisors LLC
Tel 1-646-597-6983
mwood@lifesciadvisors.com
(FBIO) Subsidiary, Altamira Bio, Acquires ManNAc NIH License and CRADAs
ManNAc to be Studied as Potential Treatment of Hereditary Inclusion Body Myopathy (HIBM) and Various Nephropathies Associated With Hyposialylation
NEW YORK, July 17, 2015 — Fortress Biotech, Inc. (NASDAQ:FBIO) announced that its subsidiary, Altamira Bio, acquired from New Zealand Pharmaceuticals Ltd (NZP), a license from the National Institutes of Health (NIH) and Cooperative Research and Development Agreements (CRADAs) for the development of oral N-acetyl-D-mannosamine (ManNAc), a key compound in the sialic biosynthetic pathway, for the treatment of hyposialylation disorders. Hyposialylation disorders are a group of pathologies associated with abnormal sialylation of tissues, characteristic of Hereditary Inclusion Body Myopathy (HIBM), also known as GNE myopathy – a rare genetic disorder which causes progressive muscle-wasting and weakness.
New Zealand Pharmaceuticals Ltd (NZP) manufactures ManNAc (DEX-M74) and will remain the exclusive global supplier of ManNAc to Altamira Bio.
“HIBM, a severe debilitating muscle-wasting disease with unmet medical need, has a clearly established genetic link,” said Dr. Lindsay A. Rosenwald, Chairman, President and CEO of Fortress Biotech. “Thanks to the work conducted by NIH scientists to date, we have very compelling data on how ManNAc administration could supplement the genetic insufficiency to help these patients to normalize protein sialylation and retain their muscle strength. We are pleased to be working with NIH scientists in the NHGRI division who are leaders in this field in bringing this potential therapy to patients. We are also encouraged by recent discoveries on the possible involvement of hyposialylation in kidney diseases and testing ManNAc in patients with nephropathies for improving their kidney function.”
About GNE Myopathy
HIBM (GNE Myopathy) is a rare genetic disease inflicting approximately 2000 people worldwide. Disease symptoms emerge in adulthood and slowly lead to progressive muscle weakness. Most patients develop symptoms in their early 20s and eventually require a wheelchair as their arm, hand and leg muscles weaken. The disease is caused by mutations in GNE gene, which codes for a rate-limiting enzyme in the sialic acid synthesis pathway. Dysfunction in GNE in HIBM leads to impaired sialylation of certain glycoproteins and glycolipids believed to be responsible for the gradual muscle deterioration.
About ManNAc
N-acetyl-D-mannosamine (ManNAc) is an intermediate in sialic acid biosynthesis generated by functional GNE protein. Supplementation of ManNAc to the cells with dysfunctional GNE protein bypasses the need for GNE function and enables protein sialylation. ManNAc has been demonstrated in human studies to significantly increase circulating levels of sialic acid and is shown to treat disease in mouse models of both HIBM and kidney diseases. The FDA has provided orphan designation for ManNAc in HIBM. ManNAc is currently under investigation in an open label Phase I/II study for the treatment of the rare muscle-wasting disease Hereditary Inclusion Body Myopathy (HIBM), also known as GNE Myopathy. A protocol for a Phase I study to further investigate ManNAc safety and tolerability in various kidney diseases (nephropathies) associated with hyposialylation is under IRB review.
About Altamira Bio
Altamira Bio is a development stage company focused on the clinical development and commercialization of N-acetyl-D-mannosamine (ManNAc) and other therapies for orphan/rare disorders.
About Fortress Biotech
Fortress Biotech, Inc. (“Fortress” or “the Company”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress plans to develop and commercialize products that it acquires both directly as well as indirectly by establishing subsidiary companies, also known as Fortress Companies. The Company intends to leverage its biopharmaceutical business expertise and drug development capabilities to help the Fortress Companies achieve their goals. Additionally, the Company intends to provide funding and management services to each of the Fortress Companies and from time to time the Company and the Fortress Companies will seek licensing, partnerships, joint ventures, and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.com.
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
CONTACT: Lucy Lu, MD, Executive Vice President & Chief Financial Officer Fortress Biotech, Inc. 781-652-4525; ir@fortressbiotech.com
(TOR) Built New Organizational Structure to Offer Diversified Services
CHANGSHU, China, July 17, 2015 — Sutor Technology Group Limited (the “Company” or “Sutor”) (Nasdaq: TOR), one of the leading China-based manufacturers and service providers for fine finished steel products used by a variety of downstream applications, today announced that Company adjusted its organizational structure recently to provide customers with diversified services and consolidate the Company’s business transformation achievements.
To provide diversified services and realize “asset-light” operation, the Company built a new organizational structure. This new structure can help us integrate our internal and external resources in order to achieve our goal of becoming “one of the best service platforms in the industrial ecological chain”. The principle of such new organizational structure is “simple and effective flat management”. Under the new structure, there are three major parallel divisions compromising business, technical and operational divisions. Business division is composed of supply chain development department, logistic department, international e-business department, product innovation department and IE (integrate, industrial and internet education) department. Technical division is composed of factory services department and IT department. Operational division is composed of financing services department, public relations services department, customer services department and investment development services department.
Ms. Lifang Chen, Chairwoman and CEO of Sutor commented, “We are glad to see that, through all of our employees’ efforts, the Company completed the business transformation from a fine finished steel manufacturer into a fine finished steel supply chain service provider. To better fulfill our responsibilities of providing comprehensive one-stop services in processing, logistics, e-commerce and R&D to our end customers, we adjusted the organizational structure.”
About Sutor Technology Group Ltd
Sutor is one of the leading China-based manufacturers and service providers for high-end fine finished steel products and welded steel pipes used by a variety of downstream applications. The Company utilizes a variety of in-house developed processes and technologies to convert steel manufactured by third parties into fine finished steel products, including hot-dip galvanized steel, pre-painted galvanized steel, acid-pickled steel, cold-rolled steel and welded steel pipe products. The Company also provides fee-based steel processing services to customers, including industrial peers. To learn more about the Company, please visit http://www.sutorcn.com/en/index.php.
Forward-Looking Statements
This press release includes certain statements that are not descriptions of historical facts, but are “forward-looking statements” in nature within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, among others, those concerning our expected financial performance, liquidity and strategic and operational plans, our future operating results, our expectations regarding the market for our products, our expectations regarding the steel market, as well as all assumptions, expectations, predictions, intentions or beliefs about future events. You are cautioned that any such forward-looking statements are not guarantees of future performance and that a number of risks and uncertainties could cause our actual results to differ materially from those anticipated, expressed or implied in the forward-looking statements. These risks and uncertainties include, but not limited to, the factors mentioned in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended June 30, 2014, and other risks mentioned in our other reports filed with the Securities Exchange Commission (“SEC”). Copies of filings made with the SEC are available through the SEC’s electronic data gathering analysis retrieval system (EDGAR) at http://www.sec.gov. The words “believe,” “expect,” “anticipate,” “project,” “targets,” “optimistic,” “intend,” “aim,” “will” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company assumes no obligation and does not intend to update any forward-looking statements, except as required by law.
For more information, please contact:
Investor Relations
Sutor Technology Group Limited
Tel: +86-512-5268-0988
Email: investor_relations@sutorcn.com
(TNXP) Closes $20.1 Million Public Offering of Common Stock
NEW YORK, July 17, 2015 — Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (“Tonix”) today announced the closing of its previously announced underwritten public offering of 2,325,000 shares of its common stock, as well as the sale of 348,750 additional shares pursuant to the full exercise of the over-allotment option granted to the underwriters. The shares were sold in the offering at a public offering price of $7.50 per share, resulting in gross proceeds to Tonix of approximately $20.1 million, before deducting the underwriting discount and other offering expenses payable by Tonix.
Roth Capital Partners and Oppenheimer & Co. acted as joint book-running managers for the offering. Janney Montgomery Scott acted as co-manager in this offering.
The shares described above were offered by Tonix pursuant to a registration statement previously filed with, and subsequently declared effective by, the Securities and Exchange Commission (“SEC”). A prospectus supplement relating to the offering has also been filed with the SEC and is available, along with the accompanying base prospectus, on the SEC’s website at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Tonix Pharmaceuticals Holding Corp.
Tonix is dedicated to the development of next-generation medicines for common yet challenging disorders of the central nervous system, characterized by chronic disability, inadequate treatment options, high utilization of healthcare services, and significant economic burden. Tonix’s TonmyaTM is currently being evaluated in the Phase 3 AFFIRM study in fibromyalgia. TNX-102 SL, the same proprietary product candidate as Tonmya, is currently being evaluated in the Phase 2 AtEase study in post-traumatic stress disorder. A Phase 2 proof-of-concept study of TNX-201 in episodic tension-type headache is ongoing. This press release and further information about Tonix can be found at www.tonixpharma.com.
CONTACT: Tonix Pharmaceuticals Holding Corp. Leland Gershell Chief Financial Officer (212) 980-9155 x104 leland.gershell@tonixpharma.com Investor Relations Martini Communications Amy Martini amartini@martinicommunications.com Public Relations Dian Griesel Int'l. Susan Forman / Laura Radocaj (212) 825-3210 sforman@dgicomm.com lradocaj@dgicomm.com
(ICLD) New Contracts for Next-Generation WiFi/DAS Business of Over $2.3 Million
SHREWSBURY, N.J., July 17, 2015 — InterCloud Systems, Inc. (Nasdaq:ICLD), a leading provider of cloud networking orchestration and automation solutions and services, announced today that it was recently awarded over $2.3 million in next-generation WiFi and DAS networks from existing and new clients. The work on these projects is expected to be completed between Q-3 and Q-4 of 2015.
Mark Munro, CEO of InterCloud Systems stated: “The new contracts from existing customers support that InterCloud continues to deliver industry leading solutions to our demanding customers. The addition of new customers also validates our company’s broad platform of services. Our management team remains focused on continuing to build a portfolio of next-generation IT services that will keep InterCloud competitive over the next several years as the IT industry continues to build momentum in cloud and managed services. Customers are in need of companies like InterCloud that can deliver leading edge solutions in cloud today and also assist them in navigating through this disruption and confusion in the marketplace.”
About InterCloud Systems, Inc.
InterCloud Systems, Inc. is a single-source provider of end-to-end information technology (IT) and next-generation network solutions including Software Defined Networking (SDN) and Network Function Virtualization (NFV) to the service provider (carrier) and corporate enterprise markets through cloud solutions and professional services. InterCloud offers cloud and managed services, professional services, and infrastructure and applications, to assist its customers in meeting their changing technology demands. InterCloud’s cloud solutions offer enterprise and service-provider customers the opportunity to adopt an operational expense model by outsourcing to InterCloud, rather than the capital expense model that has dominated in recent decades. Additional information regarding InterCloud may be found on InterCloud’s website at www.intercloudsys.com.
Forward-looking statements:
The above news release contains forward-looking statements. The statements contained in this document that are not statements of historical fact, including but not limited to, statements identified by the use of terms such as “anticipate,” “appear,” “believe,” “could,” “estimate,” “expect,” “hope,” “indicate,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “project,” “seek,” “should,” “will,” “would,” and other variations or negative expressions of these terms, including statements related to expected market trends and the Company’s performance, are all “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and involve a number of risks and uncertainties. These statements are based on assumptions that management believes are reasonable based on currently available information, and include statements regarding the intent, belief or current expectations of the Company and its management. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performances, and are subject to a wide range of external factors, uncertainties, business risks, and other risks identified in filings made by the company with the Securities and Exchange Commission. Actual results may differ materially from those indicated by such forward-looking statements. The Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based except as required by applicable law and regulations.
CONTACT: Investor Relations InterCloud Systems, Inc. Telephone 561-988-1988 Website www.intercloudsys.com
(GLUU) Launches Mission: Impossible Mobile Game Ahead of the Worldwide Theatrical Release
Players accept dangerous missions and eliminate high-profile enemies across the globe
Glu Mobile Inc. (NASDAQ: GLUU), a leading global developer and publisher of free-to-play games for smartphone and tablet devices, today announced the availability of the Mission: Impossible – Rogue Nation mobile game on the App Store and Google Play. Under license from Paramount Pictures and in creative collaboration with Skydance, Glu has developed the official mobile game in conjunction with the highly anticipated feature film Mission: Impossible – Rogue Nation, which is scheduled for U.S. theatrical release on July 31, 2015.
“We are excited to deliver the first ever free-to-play Mission: Impossible mobile game as part of Glu’s ongoing partnerships with Paramount Pictures and Skydance,” said Niccolo de Masi, Glu Chairman and CEO. “Mission: Impossible – Rogue Nation’s intense action gameplay introduces players to exotic locations from the upcoming film while incorporating engaging social components such as PvP, co-op agencies, and in-game chat.”
“We are thrilled to provide a new way for our global audience to interact with the Mission Impossible franchise,” said LeeAnne Stables, President of Consumer Products for Paramount Pictures. “This action-packed mobile game from Glu brings the excitement of the new movie right into the hands of fans.”
“The Mission: Impossible – Rogue Nation film takes the action, adventure and stakes to a new level and the team at Glu did a fantastic job of incorporating these elements in new and innovative ways through the mobile game,” added Jesse Sisgold, Chief Operating Officer of Skydance.
About the Mission: Impossible – Rogue Nation Mobile Game
Your mission, should you choose to accept it… Join the Impossible Mission Force (IMF) to infiltrate secure locations and eliminate high-profile targets, perform lethal strikes and confront the Syndicate. Travel across the globe to exotic locations like Morocco, London, and Vienna to collect intelligence and take on enemy threats. Choose among story, heavy gun, gauss rifle, repeatable, and stealth missions to accomplish your goal of eliminating the Syndicate once and for all. Join other players to build an agency, complete missions and earn team rewards. Communicate with fellow IMF agents through chat to share tips and tricks. This message will self-destruct…
Features of the Mission: Impossible – Rogue Nation Mobile Game
- Track the Syndicate Across the Globe – Travel to exotic locations as you take out enemy agents, destroy rogue bases, and eliminate the boss in each region!
- Complete Impossible Missions – Complete each mission’s objective as you stop the Syndicate and assist the IMF. Stake out targets from long range, take them down with well-placed shots, assault enemy bases head-on, or infiltrate enemy lines without compromising your identity.
- Equip Advanced Weaponry and Gear – Load up on weapons such as sniper rifles, assault rifles, heavy guns and gauss rifles, and then upgrade them. Don’t forget to grab the latest gear: rocket launchers, throwing knives, med kits, armor and more!
- Destroy Enemy Bases and Build Your Defenses – Build your IMF headquarters defenses to protect your resources and assault and steal other players’ headquarters! Fortify your defenses with upgrades such as turrets to repel even the most stubborn attackers.
- Join and Form Agencies – Create an IMF agency with other players and work together to win agency events.
Paramount Pictures and Skydance present a Tom Cruise / Bad Robot Production, “MISSION: IMPOSSIBLE – ROGUE NATION.” With the IMF disbanded and Ethan (Tom Cruise) out in the cold, the team now faces off against a network of highly skilled special agents, the Syndicate. These highly trained operatives are hellbent on creating a new world order through an escalating series of terrorist attacks. Ethan gathers his team and joins forces with disavowed British agent Ilsa Faust (Rebecca Ferguson), who may or may not be a member of this rogue nation, as the group faces its most impossible mission yet. Starring Tom Cruise, Jeremy Renner, Simon Pegg, Rebecca Ferguson, Ving Rhames, Sean Harris and Alec Baldwin.
The film is directed by Christopher McQuarrie, with a screenplay by Christopher McQuarrie and story by Christopher McQuarrie and Drew Pearce. Based on the television series created by Bruce Geller. Produced by Tom Cruise, J.J. Abrams, Bryan Burk, David Ellison, Dana Goldberg and Don Granger. Jake Myers is an executive producer.
Paramount Pictures will distribute “MISSION: IMPOSSIBLE – ROGUE NATION” on July 31, 2015.
The Mission: Impossible – Rogue Nation game is available for free from the App Store on iPhone, iPad, or iPod touch at http://bit.ly/1fH0SpT, on Google Play at http://bit.ly/1K6uYNd, and the Amazon Appstore at http://amzn.to/1OdGo36.
For updates and information about the game, visit: http://www.glu.com/missionimpossible5game
About Glu Mobile
Glu Mobile (NASDAQ:GLUU) is a leading global developer and publisher of free-to-play games for smartphone and tablet devices. Glu is focused on creating compelling original IP games such as CONTRACT KILLER, COOKING DASH, DEER HUNTER, DINER DASH, DINO HUNTER: DEADLY SHORES, ETERNITY WARRIORS, FRONTLINE COMMANDO, RACING RIVALS, and TAP SPORTS BASEBALL, and branded IP games including KIM KARDASHIAN: HOLLYWOOD, ROBOCOP: THE OFFICIAL GAME, and TERMINATOR GENYSIS: REVOLUTION on the App Store, Google Play, Amazon Appstore, Facebook, Mac App Store, and Windows Phone. Glu’s unique technology platform enables its titles to be accessible to a broad audience of consumers globally. Founded in 2001, Glu is headquartered in San Francisco with major U.S. offices outside Seattle and in Long Beach, and international locations in Canada, China, India, Japan, Korea, and Russia. Consumers can find high-quality entertainment wherever they see the ‘g’ character logo or at www.glu.com. For live updates, please follow Glu via Twitter at www.twitter.com/glumobile or become a Glu fan at www.facebook.com/glumobile.
CONTRACT KILLER, COOKING DASH, DEER HUNTER, DINER DASH, DINO HUNTER: DEADLY SHORES, ETERNITY WARRIORS, FRONTLINE COMMANDO, RACING RIVALS, TAP SPORTS BASEBALL, GLU, GLU MOBILE and the ‘g’ character logo are trademarks of Glu Mobile Inc. or its subsidiaries.
About Paramount Pictures Corporation
Paramount Pictures Corporation (PPC), a global producer and distributor of filmed entertainment, is a unit of Viacom (NASDAQ: VIAB, VIA), a leading content company with prominent and respected film, television and digital entertainment brands. Paramount controls a collection of some of the most powerful brands in filmed entertainment, including Paramount Pictures, Paramount Animation, Paramount Television, Paramount Vantage, Paramount Classics, Insurge Pictures, MTV Films, and Nickelodeon Movies. PPC operations also include Paramount Home Media Distribution, Paramount Pictures International, Paramount Licensing Inc., and Paramount Studio Group.
About Skydance
Skydance is a diversified media company founded by David Ellison in 2010 to create elevated, event-level entertainment for global audiences. The Company brings to life stories of immersive worlds across platforms, including feature film, television, gaming and digital. Among Skydance’s blockbuster and award-winning feature film successes are True Grit, Star Trek Into Darkness, Mission: Impossible – Ghost Protocol, GI JOE – Retaliation, Jack Reacher, World War Z and Terminator Genisys. Skydance’s upcoming film slate features Mission: Impossible – Rogue Nation in 2015 and Geostorm, Star Trek 3 and Jack Reacher 2 in 2016. Skydance Television’s original scripted series include the critically acclaimed Manhattan on WGN and Grace and Frankie on Netflix.
Media Contacts:
Jason Enriquez
Glu Mobile Inc.
PR@glu.com
(415) 800-6263
(ALNY) to Reschedule First RNAi Roundtable Webcast
– ALN-CC5 for the Treatment of Complement-Mediated Diseases Rescheduled for Thursday, July 23, 9:00 – 10:00 a.m. ET –
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that due to an unforeseen scheduling issue with its guest speaker, the first program in the company’s series of RNAi Roundtable webcasts has been rescheduled. “ALN-CC5 for the Treatment of Complement-Mediated Diseases,” which was originally scheduled for Friday, July 17, 8:00 – 9:00 a.m. ET will now take place Thursday, July 23, 9:00 – 10:00 a.m. ET. Revised details of the program are listed below. There are no additional changes at this time to any of the other Roundtable webcasts which were previously announced.
ALN-CC5 for the treatment of Complement-Mediated Diseases
Thursday, July 23, 9:00 – 10:00 a.m. ET
- Pushkal Garg, M.D., Senior Vice President, Clinical Development
- Moderator: John Maraganore, Ph.D., Chief Executive Officer
- Guest Speaker: Regis Peffault de Latour, M.D., Ph.D., Professor, Hematology and Transplantation, Saint-Louis Hospital, Paris
About RNAi
RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.
About Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is leading the translation of RNAi as a new class of innovative medicines. Alnylam’s pipeline of investigational RNAi therapeutics is focused in 3 Strategic Therapeutic Areas (STArs): Genetic Medicines, with a broad pipeline of RNAi therapeutics for the treatment of rare diseases; Cardio-Metabolic Disease, with a pipeline of RNAi therapeutics toward genetically validated, liver-expressed disease targets for unmet needs in cardiovascular and metabolic diseases; and Hepatic Infectious Disease, with a pipeline of RNAi therapeutics that address the major global health challenges of hepatic infectious diseases. In early 2015, Alnylam launched its “Alnylam 2020” guidance for the advancement and commercialization of RNAi therapeutics as a whole new class of innovative medicines. Specifically, by the end of 2020, Alnylam expects to achieve a company profile with 3 marketed products, 10 RNAi therapeutic clinical programs – including 4 in late stages of development – across its 3 STArs. The company’s demonstrated commitment to RNAi therapeutics has enabled it to form major alliances with leading companies including Merck, Medtronic, Novartis, Biogen, Roche, Takeda, Kyowa Hakko Kirin, Cubist, GlaxoSmithKline, Ascletis, Monsanto, The Medicines Company, and Genzyme, a Sanofi company. In addition, Alnylam holds an equity position in Regulus Therapeutics Inc., a company focused on discovery, development, and commercialization of microRNA therapeutics. Alnylam scientists and collaborators have published their research on RNAi therapeutics in over 200 peer-reviewed papers, including many in the world’s top scientific journals such as Nature, Nature Medicine, Nature Biotechnology, Cell, New England Journal of Medicine, and The Lancet. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information about Alnylam’s pipeline of investigational RNAi therapeutics, please visit www.alnylam.com.
Alnylam Forward Looking Statements
Various statements in this release concerning Alnylam’s future expectations, plans and prospects, including without limitation, Alnylam’s views with respect to the potential for RNAi therapeutics, expectations regarding its STAr pipeline growth strategy, and its plans regarding commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Alnylam’s ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its drug candidates, the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting intellectual property, Alnylam’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, obtaining regulatory approval for products, competition from others using technology similar to Alnylam’s and others developing products for similar uses, Alnylam’s ability to manage operating expenses, Alnylam’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Alnylam’s dependence on third parties for development, manufacture, marketing, sales and distribution of products, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation to update any forward-looking statements.
Alnylam Pharmaceuticals, Inc.
Michael Mason, 617-551-8327
Vice President, Finance and Treasurer
or
Spectrum
Liz Bryan (Media), 202-955-6222 x2526
(CETX) Announces New Orders Totaling Over $4.2M
FARMINGDALE, N.Y., July 16, 2014 — Cemtrex Inc., (CETX) today announced that the company has received new orders in excess of $4,200,000 across its two business groups: Environmental Products & Systems and Electronics Manufacturing Services.
The company received approximately $2.5M in new environmental products sales with deliveries expected over the next twelve months for new projects located in Southeast Asia. The company also received approximately $1.7M in new electronics products orders for a diverse set of existing European customers in medical, industrial, and automation industries with deliveries expected over the next twelve months.
Cemtrex’s CEO, Saagar Govil, commented, “We are continuing to see demand in both of our important markets where there are overall economic concerns, Europe and Asia. We are confident that with our product portfolio, niche industry segments, and continued demand from our customers we can continue to grow our business despite outside market concerns.”
About Cemtrex, Inc.
Cemtrex, Inc. (NASDAQ:CETX) is a world leading diversified industrial and manufacturing company that provides a wide array of solutions to meet today’s technology challenges. Cemtrex provides electronic manufacturing services of custom engineered printed circuit board assemblies, emission monitors & instruments for industrial processes, and environmental control & air filtration systems for industries & utilities.
www.cemtrex.com
Safe Harbor Statement
This press release contains forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date.
For further information, please contact:
Cemtrex Inc.
Saagar Govil
Phone: 631-756-9116
Email
(UUUU) Receives Mine Permit from State of Wyoming for Its Sheep Mountain Uranium Project
LAKEWOOD, COLORADO–(July 16, 2015) – Energy Fuels Inc. (NYSE MKT:UUUU)(TSX:EFR) (“Energy Fuels” or the “Company”) is pleased to announce that the State of Wyoming has granted the Company approval for a major revision to the existing mining permit for its 100%-owned Sheep Mountain Project, including expansion of surface and underground mining. This is considered a major milestone in the permitting process for this facility. The Sheep Mountain Project is a conventional uranium project located in the Crooks Gap Mining District of central Wyoming, and one of the largest uranium development projects in the U.S. today. The project was formerly operated by Western Nuclear from the 1950’s to the 1980s, at which time the mine was shut down due to low uranium prices.
In order to place the Sheep Mountain Project into production, the Company also requires a final environmental impact statement (“EIS”) from the U.S. Bureau of Land Management (“BLM”) and a facility to process the ore from this property. In January 2015, the BLM issued a draft EIS, and the Company expects the BLM to issue a final EIS and approve the Plan of Operations by mid-2016. The Company is continuing to evaluate processing options for the Sheep Mountain Project, including the permitting and construction of a new onsite heap leach facility or the use of an existing third party milling facility in the region.
According to an April 2012 preliminary feasibility study (“PFS”), the Sheep Mountain Project contains 30.3 million pounds of uranium contained in 12.9 million tons of Indicated Mineral Resources with an average grade of 0.117% eU3O8. In addition, the Sheep Mountain Project is one of the only uranium projects in the U.S. with reserves. Included in the Indicated Mineral Resources, the project contains 18.4 million pounds of uranium contained in 7.5 million tons of Probable Mineral Reserves with an average grade of 0.123% eU3O8. The PFS also estimates that the project can produce up to 1.5 million pounds of U3O8 per year over a 15-year mine life.
Stephen P. Antony, President and CEO of Energy Fuels stated: “With over 30 million pounds of uranium resources, the Sheep Mountain Project is one of the largest and most important uranium projects in the U.S. Receipt of the mining permit is a key achievement for Energy Fuels, as we work to ready this project for mining.”
“In 2014, Energy Fuels was the second largest producer of uranium in the U.S. with nearly 1 million pounds of production. Our goal is to become the leading uranium producer in the U.S., which could be achieved through our project pipeline that we believe is unmatched in the industry today. We recently added existing ISR production to our portfolio, through the acquisition of Uranerz and its Nichols Ranch ISR Mine and Plant in Wyoming. In addition, large-scale conventional uranium projects, such as our Sheep Mountain, Roca Honda, and Henry Mountains Projects, are critical components of Energy Fuels’ production growth strategy, as we seek to significantly scale-up our production capability to capture expected uranium market improvements.”
Stephen P. Antony, P.E., President & CEO of Energy Fuels, is a Qualified Person as defined by National Instrument 43-101 and has reviewed and approved the technical disclosure contained in this news release.
About Energy Fuels
Energy Fuels is a leading integrated US-based uranium mining company, supplying U3O8 to major nuclear utilities. Energy Fuels operates two of America’s key uranium production centers, the White Mesa Mill in Utah and the Nichols Ranch Processing Facility in Wyoming. The White Mesa Mill is the only conventional uranium mill operating in the U.S. today and has a licensed capacity of over 8 million pounds of U3O8 per year. The Nichols Ranch Processing Facility, acquired in the Company’s acquisition of Uranerz Energy Corporation, is an in situ recovery (“ISR”) production center with a licensed capacity of 2 million pounds of U3O8 per year. Energy Fuels also has the largest NI 43-101 compliant uranium resource portfolio in the U.S. among producers, and uranium mining projects located in a number of Western U.S. states, including two producing mines, mines on standby, and mineral properties in various stages of permitting and development. The Company’s common shares are listed on the NYSE MKT under the trading symbol “UUUU”, and on the Toronto Stock Exchange under the trading symbol “EFR”.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain information contained in this news release, including any information relating to the Sheep Mountain Projects’ resources, reserves and economics, expectations regarding the timing and receipt of future government approvals, the evaluation and availability of processing options, bringing the Sheep Mountain Project back into production, the Sheep Mountain Project being one of the largest and most important uranium projects in the U.S., the Company becoming the leading uranium producer in the U.S., the Company’s project pipeline being unmatched in the industry today, the Company’s ability to increase uranium production in the future, and any other statements regarding Energy Fuels’ future expectations, beliefs, goals or prospects constitute forward-looking information within the meaning of applicable securities legislation (collectively, “forward-looking statements”). All statements in this news release that are not statements of historical fact (including statements containing the words “expects”, “does not expect”, “plans”, “anticipates”, “does not anticipate”, “believes”, “intends”, “estimates”, “projects”, “potential”, “scheduled”, “forecast”, “budget” and similar expressions) should be considered forward-looking statements. All such forward-looking statements are subject to important risk factors and uncertainties, many of which are beyond Energy Fuels’ ability to control or predict. A number of important factors could cause actual results or events to differ materially from those indicated or implied by such forward-looking statements, including without limitation: the Sheep Mountain Projects’ resources, reserves and economics, expectations regarding the timing and receipt of future government approvals, the evaluation and availability of processing options, bringing the Sheep Mountain Project back into production, the Sheep Mountain Project being one of the largest and most important uranium projects in the U.S., the Company becoming the leading uranium producer in the U.S., the Company’s project pipeline being unmatched in the industry today, the Company’s ability to increase uranium production in the future; and other risk factors as described in Energy Fuels’ most recent annual information form and annual and quarterly financial reports.
Energy Fuels assumes no obligation to update the information in this communication, except as otherwise required by law. Additional information identifying risks and uncertainties is contained in Energy Fuels’ filings with the various securities commissions which are available online at www.sec.gov and www.sedar.com. Forward-looking statements are provided for the purpose of providing information about the current expectations, beliefs and plans of the management of Energy Fuels relating to the future. Readers are cautioned that such statements may not be appropriate for other purposes. Readers are also cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.
Energy Fuels Inc. – Investor Inquiries:
Curtis Moore
VP – Marketing and Corporate Development
(303) 974-2140 or Toll free: (888) 864-2125
investorinfo@energyfuels.com
www.energyfuels.com
(ISR) Cesium-131 Cancer Fighting Portfolio on Display at AAPM Convention
RICHLAND, WA–(Jul 16, 2015) – IsoRay Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced it participated at the American Association of Physicists in Medicine by hosting a private dinner and booth display. The annual AAPM meeting took place July 12-16, 2015 at the Anaheim Convention Center in Anaheim, California.
IsoRay CEO Dwight Babcock commented, “IsoRay is pleased to once again participate at the AAPM annual meeting. At this venue, we have a great opportunity to meet physicists from major institutions who are instrumental in the dosimetry planning for the use of Cesium-131 for a specific patient’s treatment. With peer reviewed publications continuing to show the positive results patients are achieving with the use of Cesium-131, physicists are increasingly becoming interested in the innovative alternative our Cesium-131 products offer the patient.”
IsoRay’s various products, including Cesium-131 seeds, sutured seeds, stranded mesh and the GliaSite® radiation therapy system, give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after completion of a tumor removal or by placing seeds within the prostate. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy surrounding tissue compared to other alternative treatments. IsoRay’s cancer fighting products diminish the ability of the tumor to recur, resulting in important benefits for patients in longevity as well as quality of life. Cesium-131 is now being used for the treatment of a wide array of cancers throughout the body including brain, lung, head and neck, chest wall, prostate and gynecologic cancers.
About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of GliaSite® and Cesium-131 by visiting www.isoray.com. Join us on Facebook/Isoray. Follow us on Twitter @Isoray.
Safe Harbor Statement
Statements in this news release about IsoRay’s future expectations, including: the advantages of our products and their delivery systems, whether interest in and use of our products will increase or continue, whether awareness and adoption of our products in the medical community will continue or increase, whether peer-reviewed publications of treatment results using our products will report favorable results, and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of past studies, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases beyond prostate, successful completion of future research and development activities, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay’s reports filed with the SEC. Unless required to do so by law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
IsoRay Medical
Info@Isoray.com
(509) 375-1202
(AMRS) Multi-Year, Multi-Million-Dollar Agreement With Global Food Ingredients Supplier
Marks Amyris’s First Collaboration Agreement in Food Sector
EMERYVILLE, Calif., July 16, 2015 — Amyris, Inc. (Nasdaq:AMRS), the industrial bioscience company, today announced a multi-year, multi-million-dollar collaboration agreement with a global food ingredients supplier. This agreement marks Amyris’s first collaboration in the growing food ingredients sector. The partner will provide funding for the development program, which Amyris will be responsible for executing, and the agreement includes a long-term value share provision in regard to future end-market product sales by the partner. Under the terms of the agreement, the company is unable to disclose details of the collaboration.
“We’re excited with the continued momentum in executing our plan with growing our collaboration partnerships,” said John Melo, President & CEO of Amyris. “This collaboration adds to our current portfolio of collaboration partners and our growing portfolio of over 20 products under agreement with more than 10 partners. We are on track to introduce three new commercial products this year for our partners as a result of our earlier collaborations. Collaborations continue to fund our direct R&D costs and provide strong product revenue growth.”
About Amyris
Amyris is the integrated renewable products company that is enabling the world’s leading brands to achieve sustainable growth. Amyris applies its innovative bioscience solutions to convert plant sugars into hydrocarbon molecules, specialty ingredients and consumer products. The company is delivering its No Compromise® products in focused markets, including specialty and performance chemicals, fragrance ingredients, and cosmetic emollients. More information about the company is available at www.amyris.com.
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 growing collaboration partnerships and product offerings, introduction of three new commercial products in 2015, and funding and prospects for a new collaboration) 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 risks related to manufacturing capacity at Amyris’s Brotas facility, delays or failures in development, production and 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 quarterly report on Form 10-Q filed on May 5, 2015. 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 is a registered trademark of Amyris, Inc.
CONTACT: Peter DeNardo Director, Investor Relations and Corporate Communications Amyris, Inc. +1 (510) 740-7481 investor@amyris.com
(NVIV) Significant Improvement of 2nd & 3rd Patients Implanted with Neuro-Spinal Scaffold
– Third Patient Improves from Complete to Incomplete Spinal Cord Injury –
InVivo Therapeutics Holdings Corp. (NVIV) today announced a one-month post-implant update for the third study patient and a six-month post-implant update for the second study patient in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with complete acute spinal cord injury.
In the time between implantation and the one-month post-injury assessment of the third study patient, the patient improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. The patient has regained sacral sensation with improved bladder function. Historically, fewer than 4% of patients with a high thoracic neurologic level of injury convert from AIS A to AIS B in the first month after injury. There were no reported serious adverse events associated with the Neuro-Spinal Scaffold.
The second patient demonstrated marked improvement in sensory function with partial sensation present five dermatome levels lower on the right side compared to the three-month assessment. This translates to regaining partial sensation from the lower ribs to the hip on the right. The patient continues to make meaningful progress in activities of daily living.
The Neuro-Spinal Scaffold was implanted in both patients by Dr. Dom Coric of Carolina Neurosurgery and Spine Associates, Chief of Neurosurgery at the Carolinas Medical Center (CMC) in Charlotte, NC. The study is being led at CMC by Dr. Coric and Dr. William Bockenek, Chief Medical Officer of Carolinas Rehabilitation and Chairman of the Department of Physical Medicine and Rehabilitation at CMC.
Dr. Coric said, “I am very encouraged with the third patient’s neurologic recovery following successful implantation of the investigational Neuro-Spinal Scaffold.” Dr. Bockenek further stated, “It is exciting and promising when a patient who is classified as a complete spinal cord injury becomes classified as incomplete. This is a relatively unusual occurrence and gives much more potential for further recovery.”
Mark Perrin, InVivo’s CEO, said, “We are excited about the neurologic progress that each of our three study patients has made to date. It is particularly noteworthy that two of the patients improved rapidly within the first month post-injury from a complete to incomplete spinal cord injury. Patient number one improved from AIS A to AIS C in one month which occurs in fewer than 5% of AIS A patients with T10-T12 injury, and patient number three exhibited improvement AIS A to AIS B which historically is observed in fewer than 4% of patients with a T4 injury. To date, the Neuro-Spinal Scaffold has been successfully implanted in three consecutive patients with no serious adverse events associated with either the scaffold or the surgical procedure. We look forward to continuing to follow these patients and expect to complete enrollment of the remaining two patients in our pilot trial within the coming months.”
About the Neuro-Spinal Scaffold
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding continued enrollment in our pilot trial and the expected benefits, efficacy and future clinical outcomes of the company’s Neuro-Spinal Scaffold. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to obtain FDA approval to modify its pilot trial protocol or to conduct a future study; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2014, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.
InVivo Therapeutics Holdings Corp.
Investor Relations
Brian Luque, 617-863-5535
bluque@invivotherapeutics.com
(MARA) Subsidiary Enters Into Settlement and License Agreement With Ricoh
LOS ANGELES, CA–(Jul 15, 2015) – Marathon Patent Group, Inc. (NASDAQ: MARA) (“Marathon”), a patent licensing company, announced today that its wholly-owned subsidiary, CyberFone Systems, LLC (“CyberFone”), has entered into a settlement and license agreement with Ricoh Company, LTD (“Ricoh”). The consideration to be paid by Ricoh to CyberFone and all other terms of the license agreement are confidential.
CyberFone previously asserted infringement relating to U.S. Patent 6,044,382. The portfolio, which has a large and established licensing base, consists of ten United States patents and 27 foreign patents and one patent pending. The patent rights that cover digital communications and data transaction processing are foundational to certain applications in the wireless, telecommunications, financial and other industries. The portfolio cites and has been cited in patents owned by IBM, Cisco, Hitachi, Siemens, NEC and in at least 437 other patents issued or pending in the United States.
Dr. Rocco Martino, inventor and President of CyberFone Systems, is today responsible for more than 42 patented inventions, many in the data processing and computer transaction fields. On behalf of Dr. Martino, Marathon’s CyberFone Systems has executed over 40 settlement and license agreements protecting his patented inventions.
Doug Croxall, Chief Executive Officer of Marathon, stated, “We’re pleased with the continued success of our licensing campaign with Dr. Martino. In an age when individual inventors are seeing their constitutionally protected rights eroded by larger companies utilizing their disparate financial resources to twist the patent system and choosing to pursue the unauthorized use of the patents, as opposed to paying a reasonable royalty, we will continue to stand up with and for them.”
“Dr. Martino, and those like him are incredibly valuable to inventors, innovators and the American economy,” said Mr. Croxall. “It is important to recognize him, especially in light of the continuing anti-patent assertion/New Economic Policy rhetoric coming from the Executive and Legislative branches of our government.”
Mishcon de Reya New York LLP acts as litigation counsel for CyberFone.
About Marathon Patent Group
Marathon is a patent acquisition and monetization company. The Company acquires patents from a wide-range of patent holders from individual inventors to Fortune 500 companies. Marathon’s strategy of acquiring patents that cover a wide-range of subject matter allows the Company to achieve diversity within its patent asset portfolio. Marathon generates revenue with its diversified portfolio through actively managed concurrent patent rights enforcement campaigns. This approach is expected to result in a long-term, diversified revenue stream. To learn more about Marathon Patent Group, visit www.marathonpg.com.
About Mishcon de Reya New York LLP
Mishcon de Reya New York LLP commenced operations in 2010 and has subsequently grown to over 25 attorneys with capabilities across ten different practice areas: Complex Civil Litigation, IP and Patent Litigation, Family, International Arbitration, Internal Investigations, White Collar Criminal and Regulatory Defense, Fraud and Asset Recovery, Hedge and Mutual Funds, and Employment Litigation. We fiercely guard our clients’ interests, offer flexibility in what can be an overly rigid profession and avoid traditional models. The firm acts for plaintiffs and defendants, institutions and individuals, with very low levels of conflict. We are trial lawyers, experienced advocates at both the trial and appellate levels.
Many of these influences stem from Mishcon de Reya London, which in 2012 celebrated the 75th anniversary of its founding, the same year in which it was recognized by its peers as U.K. Law Firm of the Year not once, but twice. Both offices have a strong litigation heritage, with more than 200 litigators representing a diverse portfolio of clients in more than 60 countries.
Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
CONTACT INFORMATION
Marathon Patent Group
Jason Assad
678-570-6791
Jason@marathonpg.com
(SPPR) Signs Agreement to Acquire Three Premium-Branded Hotels
Changes Name Effective July 15 to Condor Hospitality Trust Reflecting New Direction
NORFOLK, NE–(July 15, 2015) – Supertel Hospitality, Inc. (NASDAQ: SPPR), a real estate investment trust (REIT), announced today that it has signed agreements to acquire three, premium-branded hotels in an off-market transaction for $42.5 million. The properties are the 116-room SpringHill Suites by Marriott, San Antonio, Texas, the 142-room Hotel Indigo adjacent to the Hartsfield-Jackson Atlanta International Airport in Atlanta, Georgia, and the 120-room Courtyard by Marriott in Jacksonville, Florida.
The acquisitions are subject to completion of satisfactory due diligence and financing. The transactions are expected to close in 2015 during the third quarter and are projected to be accretive to 2015 fourth quarter results.
Changes Name to Condor Hospitality
The company has changed its name from Supertel Hospitality, Inc. to Condor Hospitality Trust, Inc. Upon the completion of Nasdaq procedures, the company’s common stock trading symbol will change from SPPR to CDOR. The trading symbol for the company’s Series A preferred stock will change from SPPRP to CDORP and the trading symbol for the company’s Series B preferred stock will change from SPPRO to CDORO.
“The acquisition of these three hotels aligns perfectly with the new strategy underway at the company and creates a great opportunity for us to announce the renaming of the company to Condor Hospitality,” said Bill Blackham, Condor Hospitality’s CEO. “The name Supertel connotes economy and midscale hotels, segments that are no longer part of our future plans, which was an important part of the consideration behind renaming the company. The recently announced prospective acquisitions and the new name are consistent with the dynamic new direction for the company.
“The Condor is a highly respected bird known for its considerable strength, tenacity and long life, traits that exemplify what we strive to be as a company — a respected industry leader in the premium, select-service, extended-stay and limited service hotel segments operated under high quality, contemporary brands.”
“As previously announced, we have accelerated capital recycling through disposition of much of our economy and economy extended-stay hotel portfolio which has an average age of 30 years and in many cases is located in tertiary markets,” he noted. “We intend to reinvest the capital from those dispositions into a higher quality, significantly newer, upscale portfolio of hotels in order to drive increased shareholder value.”
Blackham said that the hotels under contract are a window into the company’s portfolio of the future. Condor’s acquisition profile will be hotels located primarily in the 20th through 50th MSAs. The hotels under contract are located in Atlanta, the country’s 8th largest MSA; San Antonio, the 25th; and Jacksonville, the 40th. Targeted hotels are expected to have an average investment in the $15 to $20 million range with an average age of 10 years or less. He also pointed out that this off market acquisition is the result of one of several evolving strategic alliances with highly competent management companies, in this case Peachtree Hotel Group and its affiliate Peachtree Hospitality Management (“PHM”). PHM is a Georgia based hotel property management company currently operating 27 hotel properties with more than 3,000 hotel rooms. It is an approved operator of the major, premium hotel brands including Marriott, Starwood, InterContinental, Hilton, Hyatt, Choice and Wyndham.
“Condor is in a state of transition, divesting older properties in the economy segment and investing in newer, contemporary hotels to create a significantly larger hospitality REIT comprised of a higher quality portfolio with greater margins and located in markets with better fundamentals,” he said. “We will remain highly disciplined in our acquisition investment strategy, continuously review our portfolio and, when appropriate, upgrade into properties that we believe will generate more attractive returns. Brand considerations will be important in our portfolio because brand relevancy is critical to meeting evolving guest preferences, particularly the increasingly important Millennial generation.
About the Hotels
The Hotel Indigo Hartsfield Atlanta International Airport was built in 2012 on a 1.76 acre parcel near the world’s busiest airport and is located at 1776 Harvard Ave., in College Park, Ga. The 142-key boutique hotel offers 2,100 square feet of meeting space, a high energy entrance and lobby area, the Harvard & Main Restaurant and bar, fitness room, business center and 93 parking spaces.
The SpringHill Suites Downtown/Riverwalk, San Antonio, Texas, is located on 1.1 acres at 524 S. St. Mary’s Street in the heart of the popular Riverwalk tourist/business district in San Antonio. The property opened in December 2014 following extensive renovations during an upbranding conversion. The city’s convention center, only two blocks away, is expanding to 1.65 million square feet, which will make it the ninth largest in the country. No Property Improvement Plan (PIP) is anticipated due to the recent conversion. The 116-key, all-suite, four-story hotel features 2,100 square feet of meeting space, lobby and breakfast area, business center, swimming pool, fitness center and 34 parking spaces.
The Courtyard by Marriott Jacksonville, Flagler Center is located adjacent to the 1.4 million square foot Flagler Center business park, the Baptist Medical Center South and the Citi Card credit card processing center. Situated on 3.0 acres at 14402 Old St. Augustine Road, the 120-room hotel features 565 square feet of meeting space, lobby and cafe restaurant/lounge, business center, fitness center, swimming pool and 139 parking spaces. Opened in 2007, the property was significantly updated and renovated in 2014, including upgrading to Courtyard’s new Bistro concept. No PIP requirement is anticipated.
“These hotels are in ‘like-new’ condition in very attractive markets and have brand affiliation conducive to future RevPAR expansion, particularly given the recent completion of extensive renovations,” Blackham said.
“Upon completion of the acquisitions, Condor will additionally own premium-branded properties in the Marriott and InterContinental brand families. We have an active pipeline within these brands, as well as with other premium-branded hotel companies such as Hilton and Hyatt.”
ABOUT CONDOR HOSPITALITY
Condor Hospitality Trust is a self-administered real estate investment trust that specializes in the investment and ownership of upper midscale and upscale, premium branded select-service, extended stay and limited service hotels. The company currently owns 48 hotels in 19 states. Condor’s hotels are franchised by a number of the industry’s most well-regarded brand families including Hilton, Choice and Wyndham. For more information or to make a hotel reservation, visit www.condorhospitality.com.
Certain matters within this press release are discussed using forward-looking language as specified in the Private Securities Litigation Reform Act of 1995, and, as such, may involve known and unknown risks, uncertainties and other factors that may cause the actual results or performance to differ from those projected in the forward-looking statement. These risks are discussed in the company’s filings with the Securities and Exchange Commission.
Contact:
Ms. Krista Arkfeld
Director of Corporate Communications
karkfeld@supertelinc.com
(402) 371-2520
(MDGN) First Patient Enrolled in U.S.-Based Phase 2 Clinical Trial of TARGT-EPO
PHILADELPHIA, July 15, 2015 — Medgenics, Inc. (NYSE:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that the first patient has been enrolled in its U.S.-based Phase 2 clinical trial of MDGN-201 (TARGTEPOTM), an investigational gene therapy for the treatment of anemia in end stage renal disease (ESRD) patients undergoing peritoneal dialysis.
“Enrolling our first patient in the U.S. represents a significant achievement for the Company,” commented Garry Neil, MD, Chief Scientific Officer of Medgenics. “We look forward to progressing the study and continuing the advancement of this unique gene therapy platform.”
About the Trial (MG-EP-RF-04)
The objective of this Phase 2, open-label study is to evaluate the safety and biologic activity of MDGN-201 TARGTEPO treatment when maintaining hemoglobin levels within the targeted range of 9-12 g/dl. Biological activity assessments will include duration of TARGTEPO secretion as measured by serum EPO levels above baseline. Each patient will be administered with a targeted dose of EPO delivered via TARGTEPO. The targeted doses will be determined according to two cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day). Additional details may be found on www.clinicaltrials.gov using identifier NCT02468414.
About Medgenics, Inc.
Medgenics is developing the TARGT™ (Transduced Autologous Restorative Gene Therapy) system, a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides using ex vivo gene therapy and the patient’s own tissue for the treatment of orphan and rare diseases. For more information, visit the Company’s website at www.medgenics.com.
Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company’s financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
CONTACT: Medgenics, Inc. John Leaman john.leaman@medgenics.com Brian Piper Brian.piper@medgenics.com Stern Investor Relations Beth DelGiacco 212-362-1200 Beth@sternir.com
(ITUS) Settlement and License Agreement With eBay, Vendio, & Auctiva
LOS ANGELES, CA–(July 15, 2015) – ITUS Corporation (“ITUS“) (NASDAQ: ITUS), today announced that its wholly owned subsidiary, Auction Acceleration Corporation (“AAC”), has entered into a Settlement and License Agreement with eBay, Inc., Auctiva, LLC, and Vendio Services, LLC.
The Settlement and License Agreement resolves a lawsuit between the parties that was filed on September 8, 2014 in The United States District Court for the Northern District of California, which will be dismissed. AAC owns the rights to patents that cover presentation and cross selling technologies enabling auction sellers to cross-sell and upsell additional items to interested buyers, resulting in incremental sales and higher yields per transaction.
About ITUS Corporation
ITUS funds, develops, acquires, and licenses emerging technologies such as High-Tech, Biotechnology, Life Sciences, and Informatics. The company’s wholly owned subsidiary, Anixa Diagnostics, is developing non-invasive, cancer screening tests, and the company and its other subsidiaries have ongoing development and licensing programs involving encrypted communications, advanced materials, and thin-film, flat panel displays. Additional information is available at www.ITUScorp.com.
Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect ITUS Corporation’s current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections of our Annual Report on Form 10-K for the fiscal year ended October 31, 2014 as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
ITUS Corporation: FOCUSED ON INNOVATION™
Contact:
Dean Krouch
310-484-5184
dkrouch@ITUScorp.com
(BGMD) Announces Payoff of Secured Term Loan
WALTHAM, Mass., July 15, 2015 — BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, announced today that it has paid off its secured term loan facility with General Electric Capital Corporation and Comerica Bank.
The secured term loan in the aggregate principal amount of $10 million was funded to BG Medicine in February 2012. BG Medicine has been making monthly principal and interest payments on this loan since August 2013. With today’s payoff, all security interests that had been granted to the secured lenders are now released and discharged.
“The payoff of the secured term loan facility and elimination of the associated cash burn was an important milestone for BG Medicine and will allow us to invest additional operating cash to grow our business,” said Paul R. Sohmer, M.D., President and Chief Executive Officer of BG Medicine. “Fulfilling this key objective was an essential step in our plan to redirect critical resources to support our role in the U.S. market introduction of automated galectin-3 testing, which became available in the U.S. earlier this month.”
About BG Medicine, Inc.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders. For additional information about BG Medicine, heart failure and galectin-3 testing, please visit www.BG-Medicine.com.
The BG Medicine Inc. logo is available for download here.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated benefits of the payoff of the secured term loan facility on our ability to grow our business. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond the Company’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. These risks and uncertainties include, among other things, the factors discussed under the heading “Risk Factors” contained in BG Medicine’s annual report and quarterly reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and BG Medicine disclaims any obligation to update the information contained in this press release as new information becomes available.
CONTACT: Stephen Hall, EVP & Chief Financial Officer (781) 890-1199
(ONCS) to Participate in Webcast on Advances in Cancer Immunotherapy
SAN DIEGO, July 14, 2015 — OncoSec Medical Inc. (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, announced today that Robert H. Pierce, MD, Chief Scientific Officer, will participate in a BioPharma Dealmakers webcast featuring four companies developing cancer immunotherapies. The webcast is scheduled for 11:00 am ET on July 21, 2015. To register for the webcast, please click here.
The webcast will explore some of the challenges and opportunities of technologies at the cutting edge of cancer immunotherapy. Participants will learn about new approaches that have been developed to:
- Harness the full potential of our immune system
- Screen for novel target and antibody combinations
- Enlist our own immune system to attack cancer cells
- Improve the delivery of cancer-specific therapeutics to tumors
The webcast will include a round table discussion and a Q&A session to enable participants to contribute their own thoughts on this highly innovative area of cancer research. The webcast is sponsored in part by OncoSec. In addition to Dr. Pierce, other webcast participants include:
- Jeremy Graff, PhD, Senior Vice President, Pharmaceutical Research for Biothera. Dr. Graff joined Biothera from Eli Lilly and Company where he was Research Fellow and Group Leader, Oncology Patient Tailoring.
- Björn Frendéus, PhD, Chief Scientific Officer, BioInvent. Dr. Frendéus is an immunologist and graduate of the Swedish Foundation for Strategic Research.
- Harlan Robins, PhD, Adaptive Biotechnologies. Dr. Robins is the Chief Scientific Officer and Co-Founder of Adaptive Biotechnologies.
- Moderator: Gaspar Taroncher-Oldenburg, PhD. Dr. Taroncher-Oldenburg is an independent consultant and former managing editor of SciBX: Science-Business eXchange for Nature Publishing Group and the former scientific editor at Nature Biotechnology.
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing its investigational ImmunoPulse™ intratumoral cancer immunotherapy. OncoSec’s core technology is designed to enhance the local delivery and uptake of DNA IL-12 and other DNA-based immune-targeting agents. Clinical studies of ImmunoPulse™ IL-12 have demonstrated an acceptable safety profile and evidence of anti-tumor activity in the treatment of various skin cancers as well as the potential to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse™ IL-12, is currently in Phase II development for several indications, including metastatic melanoma and squamous cell carcinoma of the head and neck. In addition to ImmunoPulse™ IL-12, the company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse™ platform. For more information, please visit www.oncosec.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management’s current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition, and market conditions. These and additional risks and uncertainties are more fully described in OncoSec Medical’s filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec Medical disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
About the Webcast
Biopharma Dealmakers webcasts are dedicated to small and large companies looking for commercial partnerships. Read the quarterly Biopharma Dealmakers supplement in Nature Biotechnology and Nature Reviews Drug Discovery.
CONTACT:
Investor Relations:
Jordyn Kopin
OncoSec Medical Inc.
855-662-6732
investors@oncosec.com
Media Relations:
Mary Marolla
OncoSec Medical Inc.
855-662-6732
media@oncosec.com
(CRNT) Accelerating 4G Service Launch for Large Mobile Operators Across Asia Pacific
IP-20 platform enables simple, quick network upgrades and expansions
PARAMUS, New Jersey, July 14, 2015 —
Ceragon Networks Ltd., (NASDAQ: CRNT), the #1 wireless backhaul specialist, today announced that three leading mobile operators in the Asia Pacific region, including one in India, are deploying its IP-20 platform as means to accelerate 4G services availability. The total value of the three projects is over $43 million.
All three mobile operators are long-standing Ceragon customers and share a common challenge: to quickly and efficiently upgrade and expand their networks to 4G/LTE. In order to provide the most extensive suite of 4G services to their subscribers, they require a wireless backhaul solution that will allow for simple and quick network upgrade, with no service interruption, and rapid network expansion for support of mobile, enterprise and residential subscribers, as well as school districts for bridging the digital divide. The IP-20 platform is uniquely designed to support business objectives such as accelerating transformation to digital services, increasing operational efficiency and enhancing customer experience. With the IP-20 platform, Ceragon’s customers enjoy a simple upgrade of existing wireless backhaul links with new radio technologies, without replacing radios nor antennas on towers and rooftops, such as ultra-high 4G backhaul capacity using the highest modulations, capacity boosting and IP traffic management techniques, better spectrum utilization and management, and state of the art quality of service enforcement & management. The capability to perform a simple upgrade proves to be a major contribution to meeting the operators’ business objectives.
With network expansions required in all three operators’ regions, Ceragon provides the IP-20 platform’s unique wireless backhaul 4×4 MIMO technology for quadrupling capacity over a single narrowband channel over long distances, avoiding the need to opt for wideband short range spectrum. Moreover, in order to meet stringent network availability requirements, Ceragon offers an extensive suite of equipment redundancy capabilities, unique to the IP-20 platform, in order to ensure consistent and reliable network performance.
The IP-20 platform provides all three operators with a unified, simple to deploy & operate solution that fits all network segments, from wireless backhaul for the Radio Access Network, all the way to the backbone.
“We are delighted to continue these key customer relationships by providing value via our advanced turnkey solutions,” said Ira Palti, president and CEO of Ceragon. “Having all three operators choose Ceragon for their individual 4G network expansion and upgrade illustrates the immense benefits our IP-20 platform provides for solving a wide variety of wireless backhaul needs.”
About Ceragon Networks Ltd.
Ceragon Networks Ltd. (NASDAQ: CRNT) is the #1 wireless backhaul specialist. We provide innovative, flexible and cost-effective wireless backhaul and fronthaul solutions that enable mobile operators and other wired/wireless service providers to deliver 2G/3G, 4G/LTE and other broadband services to their subscribers. Ceragon’s high-capacity solutions use microwave technology to transfer voice and data traffic while maximizing bandwidth efficiency, to deliver more capacity over longer distances under any deployment scenario. Based on our extensive global experience, Ceragon delivers turnkey solutions that support service provider profitability at every stage of the network lifecycle enabling faster time to revenue, cost-effective operation and simple migration to all-IP networks. As the demand for data pushes the need for ever-increasing capacity, Ceragon is committed to serve the market with unmatched technology and innovation, ensuring effective solutions for the evolving needs of the marketplace. Our solutions are deployed by more than 430 service providers in over 130 countries.
Join the discussion:
LinkedIn:http://www.linkedin.com/company/14470
Facebook:https://www.facebook.com/ceragonnetworks
Twitter:https://twitter.com/Ceragon
YouTube:http://www.youtube.com/user/CeragonNetworks?featur
Backhaul Forum:http://www.backhaulforum.com/
Ceragon Networks® and FibeAir® are registered trademarks of Ceragon Networks Ltd. in the United States and other countries. CERAGON ® is a trademark of Ceragon Networks Ltd., registered in various countries. Other names mentioned are owned by their respective holders.
This press release contains statements concerning Ceragon‘s future prospects that are “forward-looking statements“ under the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include: projections of capital expenditures and liquidity, competitive pressures, revenues, growth prospects, product development, financial resources, restructuring costs, cost savings and other financial matters. You can identify these and other forward-looking statements by the use of words such as “may,“ “plans,“ “anticipates,“ “believes,“ “estimates,“ “predicts,“ “expects,“ “intends,“ “potential“ or the negative of such terms, or other comparable terminology. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including risks associated with increased working capital needs; risks associated with the ability of Ceragon to meet its liquidity needs; the risk that Ceragon will not achieve the benefits it expects from its expense reduction and profit enhancement programs; the risk that Ceragon will not comply with the financial or other covenants in its agreements with its lenders; the risk that sales of Ceragon‘s new IP-20 products will not meet expectations; risks associated with doing business in Latin America, including currency export controls and recent economic concerns; risks relating to the concentration of our business in the Asia Pacific region and in developing nations; the risk of significant expenses in connection with potential contingent tax liability associated with Nera‘s prior operations or facilities; and other risks and uncertainties detailed from time to time in Ceragon‘s Annual Report on Form 20-F and Ceragon‘s other filings with the Securities and Exchange Commission, and represent our views only as of the date they are made and should not be relied upon as representing our views as of any subsequent date. We do not assume any obligation to update any forward-looking statements.
Media Contact:
Matthew Krieger
GK Public Relations
Tel: + 914-768-4219
matthew@gkpr.com
Company Contact:
Tanya Solomon
Ceragon Networks
Tel: +972-3-543-1163
tanyas@ceragon.com
Investor Contact:
Claudia Gatlin
Tel. +1-(212)-830-9080
claudiag@ceragon.com
(EPRS) and Polpharma Group Enter Into a Multi-Product, Multi-Region, Profit-Sharing Collaboration
- Profit-sharing collaboration focused on the commercialization of EPIRUS’ biosimilars pipeline in EU, Middle East, Turkey, Russia and CIS territories (“Territories”)
- EPIRUS retains commercial rights to Switzerland, Norway, Austria, Belgium, Denmark, Finland, Luxembourg, the Netherlands and Sweden
- Call to be hosted today at 9 a.m. ET
BOSTON, July 14, 2015 — EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS) and Polpharma Group today announced the signing of a multi-product, multi-region profit-sharing collaboration for select EPIRUS biosimilars, including BOW015(infliximab, reference biologic Remicade®), BOW050 (adalimumab, reference biologic Humira®) and BOW070 (tocilizumab, reference biologic Actemra®), representing $6 billion in innovator sales in the specified territoriesi. Polpharma Group is a leading generics company based in Poland with annual sales of approximately $1 billion and a strong commercial infrastructure, including a salesforce of over 1,700 employees globally.
With EPIRUS leading the global product development and clinical programs, both parties will jointly fund clinical development and collaborate on regulatory filings in the specified territories. EPIRUS will also be responsible for process development, scale-up and manufacturing, with Polpharma Group overseeing commercialization across the territories. Clinical development costs and eventual operating profit will be split 51 percent Polpharma Group and 49 percent EPIRUS. Polpharma Group will contribute approximately $30 million towards clinical development costs, as well as cover product launch costs across all three programs.
“This profit-sharing collaboration with Polpharma Group enables us to better direct our business and retain future value,” said Amit Munshi, president and chief executive officer, EPIRUS Biopharmaceuticals. “We have an aggressive plan to bring our products to markets globally and to build a pure-play, sustainable and profitable biosimilar business. To achieve this goal, we need an equally aggressive partner with aligned objectives. Polpharma Group is rooted in over 80 years of experience in highly competitive global markets with complex generics. They have already made a substantial commitment to the biosimilar space with a vision to expand.”
EPIRUS retains the commercial rights to Switzerland and Norway along with select EU countries including Austria, Belgium, Denmark, Finland, Luxembourg, the Netherlands and Sweden, allowing the Company to build its direct commercial footprint. EPIRUS also retains rights to North America and other global markets not addressed in this agreement. A joint management board will oversee the collaboration.
“Partnering with EPIRUS allows us to combine their technical expertise with our commercial strength,” said Jerzy Starak, chairman of the supervisory board, Polpharma Group. “We are pleased to join the experience of both teams and the potential of these markets to provide patients with more affordable access to modern treatment.”
Conference Call and Webcast Information:
The EPIRUS leadership team will host a conference call and webcast today, July 14, 2015 at 9 a.m. Eastern Time. To access the conference call, please dial 1-855-638-3957 (United States) or 1-224-633-1318 (International).The conference ID is 81626670. The webcast can be accessed on EPIRUS’ website at www.epirusbiopharma.com. Please connect to either the conference call or webcast at least 10 minutes early to ensure adequate time to register. The webcast will be archived on EPIRUS’ website for a period of three months.
About EPIRUS Biopharmaceuticals
EPIRUS Biopharmaceuticals (Nasdaq:EPRS) is a biopharmaceutical company focused on building a pure-play, sustainable, profitable biosimilar business. As such, EPIRUS will be able to improve patient access to important, cost-effective medicines worldwide. EPIRUS’ current pipeline of biosimilar product candidates includes BOW015 (infliximab, reference biologic Remicade®), BOW050(adalimumab, reference biologic Humira®) and BOW070 (tocilizumab, reference biologic Actemra®). The reference products for these candidates together generated $23 billion in global sales for 2014, according to EvaluatePharma®. EPIRUS has developed distinct strategies to penetrate the global market, leveraging partnerships to optimize value retention over the long-term. For more information visit EPIRUS’ website at www.epirusbiopharma.com.
About Polpharma Group
Polpharma Group is a leading generics player based in Poland, operating across Europe, the Caucasus and Central Asia, with manufacturing subsidiaries in Russia and Kazakhstan. Polpharma Group is among the top 20 generic drug manufacturers in the world with annual sales of approximately $1 billion. Polpharma Group’s portfolio includes about 600 products with another 200 in pipeline. It is also one of the leading European API producer delivering products for pharmaceutical companies worldwide. In order to provide patients with more affordable access to modern biologic drugs, Polpharma Group has decided to focus on biosimilar products. It has created a state-of-the-art R&D and production center, and established strategic partnerships in addition to expanding its capabilities in the development and commercialization of biosimilars. For more information visit Polpharma Group’s website atwww.polpharma.pl/en.
Forward-Looking Statements
Various statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this document, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to EPIRUS or its management may identify forward-looking statements. EPIRUS cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by EPIRUS to secure and maintain relationships with collaborators and single-source contract manufacturers; risks relating to clinical trials; risks relating to the commercialization, if any, of EPIRUS’ proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property; risks related to the loss of any of EPIRUS’ key management personnel; risks that EPIRUS may lack the financial resources and access to capital to fund proposed operations and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of EPIRUS’ annual report on Form 10-K for the fiscal year ended December 31, 2014 which is on file with the SEC and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in EPIRUS’ annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect EPIRUS’ results. There can be no assurance that the actual results or developments anticipated by EPIRUS will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, EPIRUS. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to EPIRUS or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. EPIRUS cautions investors not to rely too heavily on the forward-looking statements EPIRUS makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and EPIRUS undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
i As reported by EvaluatePharma® for 2014 innovator sales; Remicade is a registered trademark of J&J; Humira is a registered trademark of AbbVie; ACTEMRA is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
Contact Information:
Jennifer Almond, EPIRUS Biopharmaceuticals, Inc.
+1-617-606-3288
ir@epirusbiopharma.com
Magdalena Rzeszotalska, Polpharma Group
+48 607 696 473
magdalena.rzeszotalska@polpharma.com
(TBIO) Launches Most Comprehensive Genetic Test for Diagnosis of Leukodystrophy
New Test is Most Comprehensive for Definitive Diagnosis of These Devastating Genetic Disorders
Transgenomic, Inc. (NASDAQ: TBIO), a global biotechnology company advancing precision medicine through advanced diagnostic tests and clinical and research services, today announced the launch of the Transgenomic Leukodystrophy NGS Panel for the diagnosis of leukodystrophy, a group of rare progressive genetic disorders that affect the central nervous system by disrupting the growth or maintenance of the myelin sheath insulating nerve cells.
Leukodystrophies have typically been difficult to diagnose, with definitive diagnoses taking years of testing. Previously, brain MRI scans were commonly used, but often provided non-specific results. With the advent of improved genetic testing methods, the Global Leukodystrophy Initiative (GLIA) Consortium has issued diagnostic guidelines that recommend use of a broad spectrum next-generation sequencing (NGS) panel, whole exome sequencing, or whole genome sequencing as the preferred first-line diagnostic tool. The new Transgenomic Leukodystrophy NGS Panel includes 137 genes and incorporates all of the genes GLIA recommends for testing. As the most comprehensive test on the market, it can potentially make definitive diagnoses accessible to patients and their families much earlier in the disease process.
“Leukodystrophy comprises a group of devastating genetic diseases that have been difficult to diagnose and almost impossible to treat,” said Paul Kinnon, President and Chief Executive Officer of Transgenomic. “We accordingly are very pleased to launch our Leukodystrophy NGS Panel, the most comprehensive genetic test for these conditions available today. By enabling clinicians to pinpoint the genetic source of the disorder earlier in the disease, we hope the Leukodystrophy NGS Panel will enable better disease management and facilitate the development of more effective therapies using new technologies, such as stem cells or gene editing techniques. This new test is another example of our commitment to harnessing advanced genetic tools to improve the lives of patients and families.”
The leukodystrophies are a group of about 40 inherited conditions in which the white matter of the brain is abnormal as a result of altered development or degeneration of the myelin sheath, the fatty covering that protects neurons. The condition results in progressive loss of neurologic function. Leukodystrophies often appear during infancy or early childhood, although the disease occasionally first manifests in adults. Diagnosis has typically been made by brain MRI, but many of the findings are non-specific. Most leukodystrophies result in progressive disability and death, often in childhood. Bone marrow transplantation is being performed for a few leukodystrophies, but current treatment is primarily supportive.
Robert Rauner, President of the United Leukodystrophy Foundation, commented, “On average it can take up to a decade to arrive at a definitive diagnosis for a leukodystrophy. Transgenomic’s genetic testing panel may help affected individuals arrive at a definitive diagnosis earlier to guide patient management decisions. This is very positive for those affected by leukodystrophy.”
For more information on the Transgenomic Leukodystrophy NGS Panel, visit http://www.transgenomic.com/product/leukodystrophy-ngs-panel-2/
Transgenomic, Inc. is a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through advanced diagnostic technologies, such as its revolutionary ICE COLD-PCR™ and its unique genetic tests provided through its Patient Testing business. Transgenomic also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies and sells equipment, reagents and other consumables for applications in molecular testing and cytogenetics. Transgenomic’s diagnostic technologies are designed to improve medical diagnoses and patient outcomes.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to the expected timing for the availability of additional mutations with the ICEme kits, the potential uses for the ICEme kits, the effectiveness of the ICEme kits and Multiplexed ICE COLD-PCR technology, the availability of the ICEme kits for diagnostic use and expectations regarding the ICEme kits’ and Multiplexed ICE COLD-PCR’s ability to facilitate the development of Transgenomic’s pipeline. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic’s filings with the Securities and Exchange Commission, including in Transgenomic’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on April 15, 2015. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
For Transgenomic, Inc.
Media Contact
BLL Partners LLC
Barbara Lindheim, 212-584-2276
blindheim@bllbiopartners.com
or
Investor Contact
Argot Partners
Susan Kim, 212-600-1902
susan@argotpartners.com
(OPGN) to Acquire AdvanDx, Closes $6 Million Financing With Merck GHI
Gains Rapid Molecular Diagnostic Tests and Additional Sales Channels
Conference Call to Begin at 10:00 a.m. Eastern Time Today
GAITHERSBURG, Md., July 14, 2015 — OpGen, Inc. (Nasdaq:OPGN), has agreed to acquire AdvanDx, Inc., a Woburn, Mass. developer of advanced molecular diagnostic products. The acquisition will be accounted for as a merger combination. The consummation of the merger provides OpGen with a family of FDA approved and CE marked rapid molecular tests for use with the company’s Acuitas® MDRO Gene tests and bioinformatics for multi-drug resistant organisms.
AdvanDx is a market leader in molecular testing of blood cultures. Its QuickFISH™ products are FDA approved and provide 20 minute identification and differentiation of Gram-negative species and other blood pathogens. AdvanDx had gross revenue of approximately $4.8 million in 2014 (based on unaudited financial statements) and has approximately 20 employees. Its facilities are located in Woburn, Mass. and Vedbaek, Denmark.
“The acquisition of AdvanDx strengthens OpGen’s portfolio of rapid molecular tests for combating drug resistant infections, while providing additional avenues to sell our Acuitas tests,” said Evan Jones, Chairman & CEO. “Combination of the two companies will expand our revenue and customer base and provide rapid testing capabilities to complement our MDRO gene tests. Together we will be able to combine rapid organism ID capabilities with best in class drug resistance testing.”
OpGen issued 681,818 shares of OpGen common stock in the merger transaction. Majority stockholders in AdvanDx include SLS Ventures AB, Merck Global Health Innovation Fund (Merck GHI) and LD Pensions.
David M. Rubin, Ph.D., Managing Director, Merck Global Health Innovation Fund, to Join OpGen Board of Directors
GAITHERSBURG, Md., July 14, 2015 — OpGen, Inc. (NASDAQ:OPGN) today announced the closing of a $6 million financing by the Merck Global Health Innovation Fund (Merck GHI). In connection with this financing, David M. Rubin, Ph.D., Managing Director of Merck GHI, has been appointed to OpGen’s board of directors, effective immediately.
Evan Jones, chairman and chief executive officer of OpGen, said, “Merck is a world leader in antibiotics and infectious disease therapeutics and vaccines. With its strong capabilities and global reach, we see opportunities to accelerate the growth of our business and to improve patient care worldwide. The investment by Merck GHI will help us further develop OpGen’s molecular information business and rapid diagnostics to guide antibiotic therapy. We welcome David Rubin to the OpGen board and look forward to formalizing our collaboration in a number of areas in the coming months.”
Under the agreement Merck GHI will purchase 1,136,364 shares of OpGen common stock at a price of $4.40 per share for an aggregate purchase price of $5 million, and a $1 million senior secured promissory note with 8% interest maturing in July 2017. OpGen has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock sold in the private placement.
Dr. Rubin is managing director at Merck Global Health Innovation LLC., where he is responsible for identifying investment opportunities in emerging healthcare solutions and services, with a particular emphasis on solutions for precision medicine. Dr. Rubin joined Merck from Cognia Corporation, a bioinformatics company, where he most recently served as President and CEO. Previously he was at The Wilkerson Group/IBM Global Services. Dr. Rubin was a National Institutes of Health and American Cancer Society post-doctoral fellow at Harvard Medical School, where he worked on the ubiquitin-proteasome pathway. He serves as a director of several companies including Electrocore LLC, Daktari Diagnostics and Prophecy Inc., and as a board observer for several others. He received post-graduate business training at Harvard University, a Ph.D. in molecular biology from Temple University and a B.A. in biology from SUNY Binghamton.
Dr. Rubin’s appointment to the OpGen board of directors brings the total to seven directors.
About AdvanDx
AdvanDx develops advanced molecular diagnostic products for the diagnosis and treatment of life-threatening infections. The company has three product families: PNA FISH, 90-minute pathogen ID; QuickFISH, 20 minute pathogen ID; and XpressFISH, 70 minute mecA resistance ID. For more information visit www.AdvanDx.com.
About OpGen
OpGen, Inc. is an early commercial-stage company using molecular testing and bioinformatics to assist healthcare providers in combating multi-drug resistant bacterial infections. The company’s products and services are designed to enable the rapid identification of hospital patients who are colonized or infected with life-threatening MDROs. The company’s products include the Acuitas MDRO Gene Test, CR Elite Test, Resistome Test, Whole Genome Sequence Analysis and the Acuitas Lighthouse MDRO Management System. In addition, the company has more than 10 years of experience mapping microbial, plant and human genomes. Learn more at www.opgen.com.
Conference Call and Webcast
Management will hold a conference call today at 10:00 a.m. Eastern time to discuss recent developments. The call may be accessed by dialing (888) 883-4599 (domestic) or (484) 653-6821 (international) five minutes prior to the start of the call and providing passcode 85034204. The live, listen-only webcast of the conference call may be accessed by visiting the investors section of the company’s website at http://ir.opgen.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.
A telephone replay also will be available from 1:00 p.m. Eastern time through July 20, 2015 and may be accessed by dialing (855) 859-2056 from within the U.S. or (404) 537-3406 from outside the U.S. All listeners should provide passcode 85034204.
Forward-Looking Statements
This press release includes statements relating to the company’s Acuitas MDRO Gene Test and Acuitas Lighthouse MDRO Management System and commercialization plans for these products and services. These statements and other statements regarding our future plans and goals constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, the successful integration of AdvanDx, the rate of adoption of our products and services by hospitals, the success of our commercialization efforts, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen’s business, please review our filings with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
CONTACT: OpGen Michael Farmer Director, Marketing (240) 813-1284 mfarmer@opgen.com InvestorRelations@opgen.com Investors LHA Kim Sutton Golodetz (212) 838-3777 kgolodetz@lhai.com or Bruce Voss (310) 691-7100 bvoss@lhai.com Media Lisa Guiterman (301) 217-9353 lisa.guiterman@gmail.com
(AXPW) Announces 1-for-35 Reverse Stock Split
Company’s Common Stock to Begin Trading on Split Adjusted Basis at Open of Market on July 14, 2015
NEW CASTLE, Pa., July 14, 2015 — Axion Power International, Inc. (Nasdaq: AXPW) (“AXION “), a developer of advanced lead-carbon PbC® batteries, energy storage systems and frequency regulation systems, today announced that it has effected a 1-for-35 reverse stock split previously approved by the Company’s stockholders at a special meeting held on June 17, 2015. The 1-for-35 reverse stock split was effective as of the close of business on July 13, 2015 and the Company’s common stock will begin trading on a split-adjusted basis on Tuesday, July 14, 2015.
The reverse stock split will reduce the number of shares of the Company’s common stock currently outstanding from approximately 93.9 million shares to approximately 2.7 million shares. Proportional adjustments will be made to the conversion and exercise prices of the Company’s outstanding warrants, convertible notes and stock options, and to the number of shares issued and issuable under the Company’s equity compensation plans.
The number of authorized shares of the Company’s common stock will remain 100 million shares. The reverse stock split is intended to increase the market price per share of the Company’s common stock to allow the Company to maintain the listing of its common stock on The NASDAQ Capital Market. The Company’s common stock will continue to trade on The NASDAQ Capital Market under the symbol “AXPW.”
The new CUSIP number for the common stock following the reverse stock split will be 05460X208. Information for Stockholders: Upon the effectiveness of the reverse stock split, each thirty-five shares of the Company’s issued and outstanding common stock will be automatically combined and converted into one issued and outstanding share of common stock, par value $0.005 per share. The Company will not issue any fractional shares in connection with the reverse stock split. Instead, fractional share interests will be rounded up to the next largest whole number. The reverse stock split will not modify the rights or preferences of the common stock. As a result of the reverse stock split, the Company will today recommence honoring requests for exercise of its derivative securities.
The Company’s transfer agent, Continental Stock Transfer & Trust Company, will act as its exchange agent for the reverse stock split. Continental Stock Transfer & Trust Company will provide stockholders of record holding certificates representing pre-split shares of the Company’s common stock as of the effective date a letter of transmittal providing instructions for the exchange of shares. Registered stockholders holding pre-split shares of the Company’s common stock electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares via a broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to brokers’ particular processes, and will not be required to take any action in connect with the reverse stock split. Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on May 28, 2015, a copy of which is available at www.sec.gov or at www.axionpower.com under the SEC Filings tab located on the Investors page.
About Axion Power International, Inc.
Axion Power is an industry leader in lead-carbon energy storage. Its PbC battery technology utilizing proprietary activated carbon electrodes is the only advanced battery that can be assembled on existing lead-acid production lines throughout the world. Axion Power’s primary goal is to become the leading supplier of carbon electrode assemblies for lead-acid battery companies around the world.
For more information, visit www.axionpower.com
Forward-looking Statements
Certain statements in this Press Release are “forward-looking statements” within the meaning of the Private Securities Litigation Act of 1995. These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risk factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include the risk for the Company to complete its development work, as well as the risks inherent in commercializing a new product (including technology risks, market risks, financial risks and implementation risks, and other risks and uncertainties affecting the Company), as well as other risks that have been included in filings with the Securities and Exchange Commission, all of which are available at www.sec.gov. We disclaim any intention or obligation to revise any forward-looking statements, including, without limitation, financial estimates, whether as a result of new information, future events, or otherwise.
Contacts
Axion Power International, Inc.
Charles Trego, CFO
info@axionpower.com
DresnerAllenCaron
Rudy Barrio (Investors)
r.barrio@allencaron.com
(212) 691-8087
(NVGN) Pre-clinical Studies Suggest Anisina May Improve Chemotherapy Effectiveness
– Potential to improve effectiveness of chemotherapy – May reduce the risk of life-long side-effects associated with childhood chemotherapy
NEW YORK, July 13, 2015 — US-Australian drug discovery company, Novogen Limited (NRT: ASX; NVGN: NASDAQ), today announced details of an in vivo proof of concept study that demonstrates their lead anti-tropomyosin drug candidate, Anisina, has the potential to improve the effectiveness of chemotherapy in children and reduce life-long side-effects.
The study results were presented by Dr Timothy Cripe from the Nationwide Children’s Hospital Research Institute, at the Eighth Annual Cancer Molecular Therapeutics Research Association (CMTRA) meeting in Boston, USA. The results demonstrated that Anisina significantly improved the efficacy of standard of care microtubule targeting compound, vincristine, in an animal model of neuroblastoma.
Neuroblastoma is a cancer that is most frequently observed in the young with more than 90% of diagnoses occurring in children under 5 years of age. It is considered to be the most common solid tumour in children outside the brain. Although childhood cancers such as neuroblastoma are relatively rare compared to adult cancers, the potential years of life lost are substantial making it imperative that new clinical strategies are developed to treat this disease.
The importance of this study, from a clinical perspective, is that it shows we can dose animals with a proprietary formulation of Anisina in combination with the standard of care and recapitulate in an animal model of neuroblastoma the same effect as observed in the test tube.
According to Dr Justine Stehn, Novogen Anti-Tropomyosin Program Director, this represents an important milestone in the development of Anisina as a combination therapy for the treatment of neuroblastoma.
The study was done as part of the Children’s Oncology Drug Alliance (CODA) involving Australian charity, The Kids’ Cancer Project (Sydney), The University of New South Wales (Sydney), The Nationwide Children’s Hospital (Columbus, Ohio), and Novogen. The objective of this study was to evaluate the effectiveness of Anisina either alone or in combination with vincristine, in a mouse model of human neuroblastoma (CHLA20).
Animals with tumors were treated with i) no drug (control), ii) Anisina alone (150mg/kg), iii) vincristine alone (0.5mg/kg) or iv) Anisina (150mg/kg) + vincristine (0.5mg/kg). Consistent with existing data, Novogen was able to show that Anisina on its own was effective in reducing tumor growth by about 35%.
Dr Timothy Cripe, principal investigator, Nationwide Children’s Hospital said more importantly, when used in combination, the Anisina/vincristine treatment not only reduced tumor growth but also made tumors “regress”.
“Of the five animals in the combinatorial Anisina/vincristine treatment group, three (60%) reached a complete response – meaning that their tumors were deemed to be too small to be measured, with one animal showing a ‘maintained complete response’ meaning that the tumor had disappeared for more than 60 days after treatment had stopped,” Dr Cripe said.
“What is exciting about this novel drug technology is that Anisina has the potential to improve the effectiveness of the current standard of care chemotherapeutic, vincristine. What this means from a clinical perspective is that chemotherapy may be more effective in treating patients. In some cases doses of vincristine used in the clinic could be lowered thereby minimizing the risk of leaving children with side-effects that have life-long consequences.”
Dr Stehn said the outcome of this study was encouraging.
“Studies are now underway to validate the combinatorial effect of Anisina with a microtubule targeting compound in an animal model of adult cancer with the objective still being to have first-in-man studies commencing by mid-2016 once we have completed the standard battery of toxicology studies that are requisite for any experimental drug prior to entering the clinic,” Dr Stehn said.
About Anisina
Anisina is a small molecule which belongs to a family of compounds termed the anti-tropomyosins or ATMs. Anisina has been designed to inhibit a protein known as Tpm3.1. Tpm3.1 is a structural protein and is a core component of the skeleton, or cytoskeleton of a cancer cell. By binding to Tpm3.1, Anisina impacts the function of this structural protein causing the collapse of the cytoskeleton which results in the death of the cancer cell. Anisina has been shown to be effective against a broad range of cancer types. At Novogen we are focused on the clinical development of Anisina for the treatment of both adult (melanoma and prostate) and pediatric (neuroblastoma) cancers.
About CODA
CODA’s mission is to accelerate development of innovative new therapeutic approaches to the treatment of childhood cancers and to take account of the fact that childhood cancers are different to adult cancers and that the lifelong consequences of cancer drug side-effects can be far more devastating in a child than in an adult.
CODA unites the research and resources of five organizations in Australia and the US.
The Australian members are:
- The charity, The Kids’ Cancer Project
- The originator of the anti-tropomyosin technology, the University of New South Wales and its commercial arm, New South Innovations
- Biotechnology company, Novogen Limited
The US member is:
- Nationwide Children’s Hospital, Columbus, Ohio
Novogen is providing access to both its anti-tropomyosin and super-benzopyran drug technologies. Anisina is being evaluated for its ability to complement the action of standard chemotherapies in childhood cancers. TRXE-009 is being evaluated for its ability to treat brain cancers in children.
Further information on CODA is available at www.childrensoncologydrugalliance.org
About Novogen
Novogen is a public, Australian-US drug development company whose shares trade on both The Australian Securities Exchange (NRT) and NASDAQ (NVGN). The Novogen group includes US-based, CanTx Inc, a joint venture company with Yale University. Novogen has two drug technology platforms (the super-benzopyrans (SBPs) and anti-tropomyosins (ATMs)) yielding drug candidates that are first-in-class with potential application across a range of degenerative diseases. Given the encouraging data from in vitro and in vivo pre-clinical Proof-of-Concept studies in the field of Oncology, our immediate focus is to bring our lead Oncology drug candidates Cantrixil, Anisina and Trilexium into the clinic in 2016 pending successful completion of their respective toxicology programs. Ovarian cancer, colorectal cancer, malignant ascites, prostate cancer, neural cancers (glioblastoma, neuroblastoma in children) and melanoma are the potential clinical indications being pursued, with the ultimate objective of employing both technologies as a unified approach to therapy.
About The Kids’ Cancer Project
The Kids’ Cancer Project is an Australian charity dedicated to funding medical research to find a cure for childhood cancer. Thanks to community support the charity has invested more than $24 million into research and is currently supporting 13 research projects. The independent charity is the largest not-for-profit funder of childhood cancer in Australia. The Kids’ Cancer Project was inspired by one man who promised to find the cure for childhood cancer and make a difference. The Kids’ Cancer Project supports research that will increase a child’s chance of survival and that will eradicate or minimise the toxicity of current treatments children endure. The Kids’ Cancer project supports collaborative research that has the greatest chance of clinical success and is excited about the potential that Anisina presents as a potential improvement in chemotherapy treatment. Visit www.thekidscancerproject.org.au for further information or to donate.
For more information, please visit www.novogen.com
Forward Looking Statement
This press release contains “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as “expects,” “appear,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “should,” “would,” “may,” “target,” “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to any statements relating to the Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s drug development program, including, but not limited to, Anisina, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to Anisina, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to, Anisina, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, including, but not limited to, the intellectual property relating to Anisina, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on management’s current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.
(HEAR) Partners With Audiology For Groundbreaking HyperSound Clear™
SAN DIEGO, July 13, 2015 — Turtle Beach Corporation (NASDAQ: HEAR), the leading-edge audio technology company, today announced a new partnership with Audiology Management Group, Inc. (AMG) for HyperSound Clear™, the Company’s groundbreaking hearing healthcare product planned to launch later this year. HyperSound® technology is a fundamentally new approach to sound delivery that generates a highly directional, narrow beam of audio in the air, much like the way a flashlight directs a beam of light. When an individual enters the audio beam created by HyperSound Clear, they hear immersive 3D audio, and as a first-of-its-kind product for the hearing healthcare market, HyperSound Clear has been shown to improve sound clarity and speech intelligibility for people with hearing loss for a crisp, clear home entertainment listening experience. With this new partnership, AMG – a leading audiology services company that provides an extensive range of products and services proven to drive sales for the country’s most elite Ear, Nose & Throat, Retail, Hospital and University Hospital practices – will offer HyperSound Clear as an all-new, entry level hearing healthcare solution to hearing centers and their patients as soon as it becomes available.
“We’re thrilled to partner with AMG to offer HyperSound Clear as a gateway hearing solution product, and a device that we believe will spark broader awareness in hearing healthcare,” said Rodney Schutt, Senior Vice President and General Manager for the HyperSound business at Turtle Beach Corporation. “Researchers estimate that over 48 million Americans suffer from hearing loss. Additionally, approximately 80% of people who go see a hearing healthcare specialist for the first time do so because they’re having trouble hearing and understanding the television, and we think HyperSound Clear will be a great entry-level hearing healthcare device that directly addresses that issue with hearing and enjoying home entertainment.”
Schutt continued, “Currently, the amount of time between a patient’s first visit with their hearing healthcare specialist and when they actually get their first hearing aid is five to six years. Typically, these first-time patients simply don’t want to get a hearing aid, and instead turn to other means to address hearing and understanding the television; whether that means turning-up the volume or turning on closed captioning. What happens from there is that this behavior creates a divide in the household where family members and friends no longer want to sit in the room and watch television with somebody with hearing loss because the volume is too loud. With HyperSound Clear connected to your TV or home theater system, we create an environment where everyone can once again return to the family room and enjoy the latest home entertainment together.”
“HyperSound Clear is a unique and innovative device for hearing healthcare. Why? Because, most importantly, HyperSound Clear has the potential to motivate people with hearing loss to address their hearing issues earlier in life,” said Michael Tease, President, Audiology Management Group. “Addressing hearing loss earlier is not only better for enjoying home entertainment again, but is also important for overall health as well.”
Researchers estimate that one in five Americans, and one in three people over age 65, suffer from hearing loss, and an estimated 360 million people worldwide suffer from some form of hearing loss. Further, hearing loss is the third most common chronic physical condition in the United States after heart disease and arthritis. A nationwide survey1 of nearly 4,000 adults and their significant others show a considerably higher rate of depression, anxiety, and other psychosocial disorders in adults with untreated hearing loss.
To learn more about HyperSound technology and HyperSound Clear, please visit the official website at http://hypersoundhearing.com.
About Audiology Management Group, Inc.
Audiology Management Group, Inc. (AMG) is a leading innovative audiology services company dedicated to improving the business performance of its members and equity partners. AMG’s goal is to support its members and partners in achieving high performance hearing health clinics (HPCs) through a patient centric growth model that creates the possibility for above average ROI. More information on AMG can be found on the company’s website at http://audiologymanagementgroup.com.
About Turtle Beach Corporation
Turtle Beach Corporation (www.turtlebeachcorp.com) designs leading-edge audio products for the consumer, commercial and healthcare markets. Under the Turtle Beach brand (www.turtlebeach.com), the Company markets a wide selection of quality gaming headsets catering to a variety of gamers’ needs and budgets, for use with video game consoles, including officially-licensed headsets for the Xbox One and PlayStation®4, as well as for personal computers and mobile/tablet devices. Under the HyperSound brand (www.hypersound.com), the Company markets pioneering directed audio solutions that have applications in digital signage and kiosks, consumer electronics and healthcare. The company’s shares are traded on the NASDAQ Exchange under the symbol: HEAR.
Forward-Looking Statements
This press release includes forward-looking information and statements within the meaning of the federal securities laws. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding assumptions, projections, expectations, targets, intentions or beliefs about future events. Forward looking statements are based on management’s statements containing the words “may”, “could”, “would”, “should”, “believe”, “expect”, “anticipate”, “plan”, “estimate”, “target”, “project”, “intend” and similar expressions constitute forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which could cause actual results to differ materially from those contained in any forward-looking statement. Forward-looking statements are based on management’s current belief, as well as assumptions made by, and information currently available to, management.
While the Company believes that its expectations are based upon reasonable assumptions, there can be no assurances that its goals and strategy will be realized. Numerous factors, including risks and uncertainties, may affect actual results and may cause results to differ materially from those expressed in forward-looking statements made by the Company or on its behalf. Some of these factors include, but are not limited to, the substantial uncertainties inherent in acceptance of existing and future products, the difficulty of commercializing and protecting new technology, the impact of competitive products and pricing, general business and economic conditions, risks associated with the expansion of our business including the implementation of any businesses we acquire, our indebtedness, and other factors discussed in our public filings, including the risk factors included in the Company’s most recent Annual Report on Form 10-K and the Company’s other periodic reports. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the Securities and Exchange Commission, the Company any is under no obligation to publicly update or revise any forward-looking statement after the date of this release whether as a result of new information, future developments or otherwise.
Untreated Hearing Loss in Adults- A Growing National Epidemic, American Speech-Language Hearing Association
(PSDV) Positive Top Line Results From Phase II Study of Medidur™ for Uveitis
Statistically Significant Reduction in Recurrence of Disease and Statistically Significant Improvement in Visual Acuity
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced positive top line results from a Phase II investigator-sponsored study of pSivida’s Medidur for uveitis affecting the posterior of the eye (posterior, intermediate and pan-uveitis). Dr. Glenn J. Jaffe, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine in Durham, NC, presented the top line results during an oral abstract session at the American Society of Retina Specialists in Vienna, Austria, reporting a statistically significant reduction in recurrence of uveitis and a statistically significant improvement in visual acuity in eyes treated with Medidur.
In the three-year, ongoing study, 11 participants with recurrent non-infectious intermediate, posterior or pan uveitis were randomized to receive a masked low or a high dose of Medidur. (pSivida is studying only the low dose of Medidur in its Phase III clinical trials.) Fellow eyes with uveitis were treated with standard of care, which included steroid eye drops. At the most recent follow-up visit reported, participants have been followed for between 12 and 24 months.
Through the last follow-up visit reported, none of the eyes treated with Medidur had any recurrence of uveitis, while fellow eyes treated with standard of care averaged 2.33 recurrences. The difference between treatment with Medidur and standard of care was statistically significant (p=0.014).
Eyes treated with Medidur experienced a significant improvement in visual acuity, gaining an average of 17 letters from baseline letters at 12 months on the Snellen eye chart (p=0.014 at 12 months). At the last follow-up visit reported, the average gain from baseline in Medidur-treated eyes was over 20 letters, while eyes treated with standard of care declined an average of 10 letters.
The most common adverse event in study eyes was elevated intraocular pressure (IOP). Through the last follow-up visit reported, three study eyes developed elevated IOP and were treated with eye drops, with filtering procedures subsequently performed in two of these eyes. However, those two eyes still gained an average of over 25 letters from baseline at the last observation. The study remains masked as to the dosage so results cannot yet be separated for the low and high doses of Medidur.
pSivida recently announced that at three months in its first Phase III trial, which is testing only the low dose of Medidur, only 4% more study eyes (2/3 of which received Medidur) experienced elevated IOP than the fellow non-study eyes (none of which received Medidur). Initial IOP elevation is an indication of the likelihood of subsequent clinically significant IOP increases. The minimal difference observed in elevated IOP in the assessment suggests highly favorable results for a key safety measure of the trial, the number of eyes that develop clinically significant increases in IOP within 12 months of receiving Medidur relative to control eyes.
“The results in Dr. Jaffe’s study are very dramatic. The efficacy of Medidur in controlling uveitis and restoring visual acuity was spectacular. At the extreme, in addition to completely arresting any recurrence of uveitis, Medidur restored vision to two eyes that were legally blind at baseline, improving from 20:400 to 20:25 and from 20:500 to 20:40 at the last follow-up visit. We look forward to the unmasking of the data to view the results for the low dose of Medidur we are studying,” said Dr. Paul Ashton, President and Chief Executive Officer of pSivida Corp.
About the Phase II Trial. The investigator-sponsored Phase II study is evaluating the tolerability, safety and benefits of high and low dose Medidur in recurrent non-infectious posterior, intermediate or pan-uveitis. Eleven enrolled participants were randomized to receive a masked low or a high dose of Medidur in the worse eye. (Only the low dose is being studied in pSivida’s Phase III trials.) Fellow eyes with uveitis are treated with standard of care. Eyes are observed on the day of injection, on days 1, 7, 14, 28, then monthly for up to six months, then every three months for 18 additional months. For purposes of these results, all participants were followed for a minimum of one year, with a mean follow-up duration of 20.5 months. Because the study is ongoing, the dose remained masked, and the results present aggregate data for the low and high dose. Full top-line results of this Phase II study have been submitted for publication.
About Medidur. Medidur is an injectable micro-insert designed to treat posterior uveitis that provides sustained release of flucinolone acetonide (a corticosteroid) for three years. Medidur comprises the same micro-insert (same design, same polymers, same drug, same dose) as ILUVIEN® for DME. ILUVIEN has been approved in the U.S. and 17 EU countries and is sold in the U.S., the U.K., Germany and Portugal.
About Posterior Uveitis. Posterior uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is a leading cause of blindness in the developed and developing countries. It afflicts people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S. posterior uveitis affects approximately 175,000 people, resulting in approximately 30,000 cases of blindness and making it the third leading cause of blindness in the U.S.
Patients with posterior uveitis are typically treated with systemic steroids but over time frequently develop serious side effects that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer. Medidur is designed to provide improved outcomes compared to standard of care but with a significant reduction in side effects.
About the Phase III Trials. pSivida’s two Phase III trials for Medidur are double-blind studies comparing injections of Medidur to sham injections on a two-to-one basis. The first trial is fully enrolled with 129 patients in 16 centers in the U.S. and 17 centers outside the U.S. The primary end point of the first trial is recurrence of posterior uveitis within one year. The last scheduled visit for the last patient in this trial is in March 2016, and top-line data is expected in the second quarter of 2016. The second trial will enroll up to 150 patients in approximately 15 centers in India. The primary endpoint of the second trial is recurrence of posterior uveitis within six months. Patients in both trials will be followed for three years. pSivida plans to seek approval for Medidur for posterior uveitis based on 12-month data from the first Phase III trial, six-month data from the second Phase III trial and data from a utilization study of pSivida’s redesigned proprietary inserter together with data referenced from the Phase III trials of ILUVIEN for DME. With favorable results, pSivida expects to file a New Drug Application in the first half of 2017.
About pSivida Corp.
pSivida Corp. (www.psivida.com), headquartered in Watertown, MA, is a leader in the development of sustained release, drug delivery products for treating eye diseases. pSivida has developed three of only four FDA-approved treatments for back-of-the-eye diseases. The most recent, ILUVIEN®, a micro-insert for diabetic macular edema, is licensed to Alimera Sciences and sold in the U.S. and three EU countries. Retisert®, an implant for posterior uveitis, is licensed to and sold by Bausch & Lomb. pSivida’s lead product candidate, Medidur™, a micro-insert for posterior uveitis, is currently in pivotal phase III clinical trials with an NDA anticipated in the first half of 2017. pSivida’s preclinical development program is focused on using its core platform technologies, Durasert™ and/or Tethadur™, to deliver drugs and biologics to treat wet and dry age-related macular degeneration (AMD), glaucoma, osteoarthritis and other diseases.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: actual final IOP safety results for Medidur Phase III trials; ability to achieve profitable operations and access to capital; fluctuations in operating results; further impairment of intangible assets; decline in Retisert royalties; successful commercialization of, and receipt of revenues from, ILUVIEN for DME; effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; consequences of fluocinolone acetonide side effects; number and cost of clinical trials and data necessary to support an NDA for, approval by Indian regulators of the trial design for, timing of filing the NDA for, and regulatory approval and successful commercialization of, Medidur; delays in completion of clinical trials; increases in cost of clinical trials; changes in, or misunderstandings with respect to, FDA guidance on required clinical trials; development of the Latanoprost Product and any exercise by Pfizer of its option; ability of Tethadur to successfully deliver large biologic molecules and to develop products using it; ability to successfully develop product candidates, complete clinical trials and receive regulatory approvals; ability to market and sell products; success of current and future license agreements; termination of license agreements; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. You should read and interpret any forward-looking statements together with these risks. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Follow pSivida on social media:
Twitter: https://twitter.com/pSividaCorp
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For more information on pSivida, visit www.psivida.com
Martin E. Janis & Company, Inc.
Beverly Jedynak
President
T: 312-943-1123
M: 773-350-5793
bjedynak@janispr.com
(AXN) Positive Results of Registration Trial of Buprenorphine/Naloxone for Opioid Dependence
JERSEY CITY, NJ / July 13, 2015 / Aoxing Pharmaceutical Company, Inc. (NYSE MKT: AXN) (“Aoxing Pharma”), a specialty pharmaceutical company focusing on research, development, manufacturing, and distribution of narcotic, pain-management and addiction treatment pharmaceuticals, today announced positive results of its Buprenorphine/Naloxone sublingual tablets as a treatment for opioid dependence. This was a registration clinical study evaluating the safety and efficacy of the sublingual tablets in order to gain the final production and marketing clearance by the China Food and Drug Administration (CFDA).
In this multi-center, placebo-controlled, double-blinded, randomized, and paralleled study, 300 patients with opioid dependence were enrolled in 12-week therapy. The primary endpoints of this study were to evaluate the safety and effectiveness of the sublingual tablets for the opioid dependence patients, by measuring the rate of outpatient service. The secondary endpoints of the study included the negative rate of urine morphine test, and others. In the study, the drug demonstrated statistical significance in the measurements designed in the trial.
“We are very excited and encouraged by the progress of our Buprenorphine/Naloxone sublingual tablets program, which could be the first such therapy available in Chinese market for treating opioid dependence patients. We are working on the final preparation of the registration data package, and look forward to final clearance by the China CFDA,” said Mr. Zhenjiang Yue, the Chairman and CEO of Aoxing Pharma.
Drug abuse has become a profound social problem in China. In 2014 it was estimated that there were 14 million individuals, or 1% of the whole population, with drug abuse or opioid dependence problems. The annual economic loss was estimated at approximately $100 billion USD due to drug abuse problem in China. At present, Methadone is the principal method of treating opioid dependence in China. Industry research has indicated at Buprenorphine/Naloxone is more effective than Methadone and significantly less injurious to the patient’s overall health. For this reason, the Company believes that the product will find a large market when finally introduced in China.
About Aoxing Pharmaceutical Company, Inc.
Aoxing Pharmaceutical Company, Inc. is a US incorporated specialty pharmaceutical company with its operations in China, specializing in research, development, manufacturing and distribution of a variety of narcotics and pain-management products. Headquartered in Shijiazhuang City, outside Beijing, Aoxing has the largest and most advanced manufacturing facility in China for highly regulated narcotic medicines. Its facility is one of the few GMP facilities licensed for the manufacture of narcotic medicines by the China State Food and Drug Administration (CFDA). It has a joint venture collaboration with Johnson Matthey Plc to produce and market narcotics and neurological drugs in China. For more information, please visit: www.aoxingpharma.com.
Safe Harbor Statement from Aoxing Pharmaceutical Company, Inc.
Certain statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause actual results to differ materially from those set forth in these statements. All forward-looking statements included herein are based upon information available to the Company as of the date hereof and, except as is expressly required by the federal securities laws, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. To the extent that any statements made here are not historical, these statements are essentially forward-looking. Undue reliance should not be placed on forward-looking information. The economic, competitive, governmental, technological and other risk factors identified in the Company’s filings with the Securities and Exchange Commission, specifically, Item 1A, “Risk Factors,” in the Form 10-K for the year ended June 30, 2014, may cause actual results or events to differ materially from those described in the forward looking statements in this press release. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise.
CONTACT:
Aoxing Pharmaceutical Company:
646-367-1747
investor.relations@aoxingpharma.com
(ANAC) Positive Top-Line Results, Phase 3 Pivotal Studies of Crisaborole in Atopic Dermatitis
- Crisaborole, a novel non-steroidal topical anti-inflammatory PDE-4 inhibitor, achieved statistically significant results on all primary and secondary endpoints in both studies and demonstrated a safety profile consistent with previous studies
- Anacor expects to submit a New Drug Application for crisaborole to the U.S. Food and Drug Administration in the first half of 2016
Anacor to Host a Conference Call Today at 7:30 a.m. ET / 4:30 a.m. PT to Discuss Results
Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) today announced preliminary top-line results from its two Phase 3 pivotal studies of Crisaborole Topical Ointment, 2% (formerly AN2728), a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. In both studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies.
Summary of Primary and Secondary Phase 3 Pivotal Study Results | ||||
Study AD-301 | Study AD-302 | |||
(crisaborole / vehicle) N=503 / 256 |
(crisaborole / vehicle) N=513 / 250 |
|||
Primary Endpoint | ||||
% of patients who achieved success in the Investigator’s Static Global Assessment (ISGA), defined as a score of 0 (clear) or 1 (almost clear) with a minimum 2-grade improvement at day 29 | 32.8% / 25.4% (p=0.038) |
31.4% / 18.0% (p<0.001) |
||
Secondary Endpoints | ||||
% of patients who achieved an ISGA score of 0 (clear) or 1 (almost clear) at day 29 | 51.7% / 40.6% (p=0.005) |
48.5% / 29.7% (p<0.001) |
||
Time to Success in ISGA: Time course to success in ISGA between crisaborole and vehicle was statistically significantly different (p<0.001) in each study, with patients treated with crisaborole achieving success earlier than vehicle-treated patients. | ||||
“We are extremely pleased by the top-line results from our Phase 3 pivotal studies of crisaborole. We believe there is a significant unmet medical need for a novel non-steroidal topical anti-inflammatory treatment option for the patients who are affected by mild-to-moderate atopic dermatitis,” said Paul L. Berns, Chairman and Chief Executive Officer of Anacor. “We also want to extend a special thanks to the clinical investigators who conducted the studies and the patients and their families who volunteered to participate in our studies. We currently plan to file a New Drug Application for crisaborole in the first half of 2016 and, if approved, we believe crisaborole could offer an important treatment option for patients with mild-to-moderate atopic dermatitis.”
Atopic dermatitis is a chronic rash characterized by inflammation and itching. Lesions of atopic dermatitis are commonly red, elevated and oozing patches and are often accompanied by pruritus (itching). The lesions’ lichenification, a thickening of the skin with exaggerated skin lines, is considered to be a hypertrophic response to chronic rubbing. Based on available sources, we believe approximately 18 to 25 million people in the United States suffer from atopic dermatitis, and 80% to 90% have mild or moderate disease. Atopic dermatitis can persist into adulthood, but most commonly appears in childhood, with estimates that between 8% and 18% of all infants and children in the United States are affected by the disease.
Patients suffering with the condition often try multiple treatments to treat their atopic dermatitis, yet many are not satisfied with the effectiveness of their medications. Topical corticosteroids are broad anti-inflammatories, which if used inappropriately or for long periods of time may lead to local side effects including skin thinning, acne and stretch marks and systemic side effects, including HPA axis suppression. In addition, patients are often instructed to limit use on thin skin areas such as the face, neck and skin folds. The only non-steroidal topical pharmacologic therapies currently approved for prescription in the U.S. for the treatment of atopic dermatitis are topical calcineurin inhibitors, which have a “boxed warning” on their labels concerning potential cancer risk.
“Mild-to-moderate atopic dermatitis, or eczema, is a chronic, life-altering inflammatory skin disease that can be a constant challenge for patients and family members. Based on the safety and efficacy profile demonstrated by crisaborole in these Phase 3 pivotal studies, crisaborole, if approved, could become a significant first-in-class treatment option for patients suffering from mild-to-moderate atopic dermatitis and the physicians who treat them,” said Amy Paller, M.D., Walter J. Hamlin Professor and Chair of Dermatology, Professor of Pediatrics, Northwestern University Feinberg School of Medicine.
“I’m impressed with the performance of crisaborole on the primary and secondary endpoints in these Phase 3 pivotal studies. Crisaborole represents an innovative non-steroidal topical anti-inflammatory and, if approved, has the potential to offer physicians and patients a new, important therapeutic choice for treating mild-to-moderate atopic dermatitis,” said Lawrence Eichenfield, M.D., Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital, San Diego and a Professor of Dermatology and Pediatrics at the University of California, San Diego School of Medicine.
About our Phase 3 Pivotal Studies
Our Phase 3 pivotal studies of crisaborole consisted of two multi-center, double-blind, vehicle-controlled studies of over 750 patients each, aged 2 years and older with mild-to-moderate atopic dermatitis (defined as an ISGA score of 2 (mild) or 3 (moderate)). The ISGA is a 5-point scale ranging from 0 (clear) to 4 (severe). Patients were randomized in a 2:1 ratio (crisaborole:vehicle). Crisaborole or vehicle was applied twice daily for 28 days. The primary efficacy endpoint was success in ISGA at day 29 (defined as the proportion of patients achieving an ISGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline). Secondary endpoints included the proportion of patients achieving an ISGA score of 0 or 1, irrespective of a minimum 2-grade improvement, at day 29 and time to success in ISGA. Our safety evaluation included reported adverse events, safety laboratory tests and vital signs.
The safety results were consistent with previous studies. The majority of adverse events in crisaborole-treated patients were graded as mild in severity. The most common adverse events occurring on a pooled basis across both studies in ≥ 2% of patients were application site pain (4.4% and 1.2% for crisaborole and vehicle, respectively) and upper respiratory tract infections (3.0% and 3.0% for crisaborole and vehicle, respectively). There were no treatment-related serious adverse events among patients treated with crisaborole.
In addition to the Phase 3 pivotal studies, we are conducting an open-label long-term safety study to evaluate the safety of intermittent use of crisaborole for up to 12 months. Patients who completed either pivotal study had the option to enroll in the long-term safety trial. At completion, at least 100 patients will have been enrolled for 12 months and at least 300 patients will have been enrolled for 6 months, during which time patients will have been treated with crisaborole as needed under the direction of the investigator. We currently expect to announce the results of the long-term safety study by the end of 2015.
Conference Call and Webcast
Anacor will host a conference call today at 7:30 a.m. ET / 4:30 a.m. PT, during which management will discuss the top-line results of our Phase 3 pivotal studies. The call may be accessed by dialing (877) 291-1367 (domestic) and (914) 495-8534 (international) five minutes prior to the start of the call. The call will also be webcast live and can be accessed on the Events and Presentations page, under Investors, on Anacor’s website at www.anacor.com and will be available for three months following the call.
About Crisaborole Topical Ointment, 2%
Crisaborole Topical Ointment, 2%, is an investigational non-steroidal topical anti-inflammatory PDE-4 inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis. Crisaborole is a novel boron-containing small molecule and, although the specific mechanism of action is not yet completely defined, we believe that crisaborole inhibits PDE-4 in target cells, which reduces the production of pro-inflammatory cytokines thought to cause the signs and symptoms of atopic dermatitis.
About Anacor Pharmaceuticals
Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor’s first approved drug, KERYDIN® (tavaborole) topical solution, 5%, is an oxaborole antifungal approved by the U.S. Food and Drug Administration in July 2014 for the topical treatment of onychomycosis of the toenails. In July 2014, Anacor entered into an exclusive agreement with Sandoz Inc., a Novartis company, pursuant to which PharmaDerm, the branded dermatology division of Sandoz, distributes and commercializes KERYDIN in the United States. In September 2014, PharmaDerm launched KERYDIN in the United States. Anacor’s lead product development candidate is Crisaborole Topical Ointment, 2%, an investigational non-steroidal topical PDE-4 inhibitor for the potential treatment of mild-to-moderate atopic dermatitis and psoriasis. Beyond KERYDIN and crisaborole, Anacor has discovered three investigational compounds that it has out-licensed for further development. The first compound is licensed to Eli Lilly and Company for the potential treatment of an animal health indication. The second compound, AN5568, also referred to as SCYX-7158, is licensed to Drugs for Neglected Diseases initiative for the potential treatment of human African trypanosomiasis. The third compound is licensed to GlaxoSmithKline LLC for development in tuberculosis. Anacor also has a pipeline of other internally discovered topical and systemic boron-based compounds in early stages of research and development. These include AN3365, an investigational Gram-negative antibiotic, and certain other wholly-owned investigational product candidates. For more information, visit www.anacor.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the progress, timing and results of Anacor’s clinical trials, the safety and efficacy of Anacor’s approved product and product development candidates, the timing of Anacor’s potential regulatory filings and approval of Anacor’s product development candidates, the commercial success of KERYDIN and the timing and potential commercial success of Anacor’s product development candidates. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words “may,” “might,” “will,” “should,” “estimate,” “project,” “plan,” “anticipate,” “expect,” “intend,” “outlook,” “believe” and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Anacor undertakes no obligation to update any forward-looking statement except as required by law. These forward-looking statements are based on estimates and assumptions by Anacor’s management that, although believed to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by Anacor’s forward-looking statements: the successful commercialization of KERYDIN pursuant to Anacor’s distribution and commercialization agreement with Sandoz Inc.; any issues, delays or failures arising during the course, or as a result, of Anacor’s studies relating to crisaborole; any delay by Anacor in filing for regulatory approval or failure by the U.S. Food and Drug Administration to approve crisaborole; Anacor’s ability to timely and successfully launch, either alone or with a partner, crisaborole, if approved; the impact of general economic, industry, market or political conditions; and the other risks and uncertainties identified in Anacor’s periodic filings, including Anacor’s Annual Report on Form 10-K for the year ended December 31, 2014 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2015.
Anacor Pharmaceuticals, Inc.
DeDe Sheel, 650-543-7575
Senior Director, Investor Relations and Corporate Communications
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