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(WGBS) Launches the ICELL8(TM) Single-Cell System at ASHG

Company Presents Data Further Demonstrating Significant Benefits of ICELL8 Single-Cell System to Single-Cell Researchers

FREMONT, Calif., Oct. 6, 2015  — WaferGen Bio-systems (Nasdaq:WGBS) announced today the commercial launch and presentation of data from the ICELL8™ Single-Cell System at the American Society of Human Genetics (ASHG) annual meeting in Baltimore, MD.

In the hands of world-class early access partners globally, WaferGen’s ICELL8 Single-Cell system has consistently demonstrated the power to isolate thousands of single-cells, the control to identify and process individual cells using CellSelect™ automated imaging and software and the ability to provide critical insight derived from running multiple samples or experiments on a single chip. These revolutionary technology advancements in single-cell analysis have the potential to not only accelerate the drug discovery and development process, but also expand fundamental biological discovery and understanding. WaferGen will present a poster at ASHG highlighting data generated by the Company demonstrating the ICELL8 Single-Cell System’s ability to identify rare cells from a cell population at a sensitivity of <1%. The poster, number 1906W, will be presented at the conference on Wednesday, October 7, from 6-7pm. Additional details will also available at WaferGen’s ASHG booth (number 1027).

Early access partners and collaborators for the ICELL8 Single-Cell System included Genentech, Karolinska Institutet, The University of Texas MD Anderson Cancer Center, National Jewish Health, and The Broad Institute.  Data from a multitude of early access experiments demonstrated that single cells from solid tumors, brains cells, pulmonary airway cells, multiple cell lines, and nuclei, ranging from 5 to 100 µm in size, can be isolated and dispensed into a single chip without pre-selection or filtering.

“We are extremely pleased with the results being generated by our ICELL8 Single-Cell System, including those presented here at ASHG, at recent conferences in Europe and those presented by our early access partners.  As we enter the commercial single-cell market, we are excited by the potential of our technology to enable breakthrough scientific discoveries,” said Rollie Carlson, President and CEO of WaferGen.

About WaferGen

WaferGen Biosystems, Inc. is a biotechnology company that offers innovative genomic technology solutions for single-cell analysis and clinical research. The single cell analysis platform is a revolutionary system which can isolate thousands of single cells and processes specific cells for analysis, including Next Generation Sequencing. The system can also enable processing of up to eight samples by partitioning the chip into 8 sections. The SmartChip platform can be used for profiling and validating molecular biomarkers, and can perform massively-parallel single-plex PCR for one-step target enrichment and library preparation for clinical NGS. These technologies offer a powerful set of tools for biological analysis at the molecular and single-cell level in the life sciences, pharmaceutical, and clinical laboratory industries.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expected operating losses, expected revenues, expected expenses, expected cash usage, our expectations regarding our development of future products including single cell analysis technologies and our expectations concerning our competitive position and business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

CONTACT: INVESTOR CONTACTS:
         LifeSci Advisors, LLC
         Brian Ritchie
         BRitchie@LifeSciAdvisors.com

         WaferGen Bio-systems, Inc.
         Rollie Carlson
         Rollie.Carlson@wafergen.com
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(GTXI) Phase 2 Clinical Trial of Enobosarm in Breast Cancer Enrollment Begins

— Trial evaluating enobosarm in patients with advanced androgen receptor positive triple negative breast cancer —

— Data from patient-derived and cell line-derived xenografts of androgen receptor positive TNBC support clinical investigation with enobosarm —

GTx, Inc. (Nasdaq: GTXI) today announced the enrollment of the first patient into its Phase 2 clinical trial of enobosarm (GTx-024) to treat women with advanced, androgen receptor positive (AR+), triple negative breast cancer (TNBC). Enobosarm is the Company’s lead product candidate and is also being evaluated in a separate Phase 2 clinical trial to treat estrogen receptor positive (ER+), AR+ breast cancer, which the Company recently announced had also enrolled its first patient.

“Most women with triple negative breast cancer have extremely limited treatment options and poor prognoses,” said Robert J. Wills, Ph.D., Executive Chairman of GTx. “Based on our preclinical research and positive data from patient-derived and cell line-derived xenografts of TNBC, we are hopeful that enobosarm, by targeting the androgen receptor, may offer another treatment option to women with this disease.”

The open-label, multi-center, multinational Phase 2 clinical trial (NCT02368691) will evaluate the efficacy and safety of orally administered enobosarm in up to 55 women with advanced, AR+ TNBC. Patients will receive 18 mg of enobosarm once daily for up to 12 months. The initial stage will be assessed among the first 21 evaluable patients. If at least 2 of 21 patients achieve clinical benefit at week 16, then the trial will proceed to the second stage of enrollment of up to a total of 41 evaluable patients. Clinical benefit is defined as a complete response, partial response, or stable disease, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 16 weeks. The trial, which is being conducted under the leadership of Dr. Hope Rugo from the University of California at San Francisco, will include investigators from more than 40 clinical trial sites in the U.S. and abroad.

About enobosarm

Enobosarm, a selective androgen receptor modulator (SARM), has been evaluated in multiple completed or ongoing clinical trials enrolling over 1,500 subjects at doses ranging from 0.1 mg to 100 mg. At all evaluated dose levels, enobosarm was observed to be generally safe and well tolerated.

Most recently, enobosarm 9 mg has been tested in a Phase 2, proof of concept clinical trial of 22 postmenopausal women with ER+ metastatic breast cancer who have previously responded to endocrine therapy. Seventeen of the 22 patients were confirmed to be AR+. Six of these 17 patients demonstrated clinical benefit at six months. Seven patients in total (one patient with indeterminate AR status) achieved clinical benefit at six months. The results also demonstrated that, after a median duration on study of 81 days, 41 percent of all patients (9/22) achieved clinical benefit as best response and also had increased serum PSA levels which may be an indicator of AR activity. Enobosarm was well tolerated. The most common adverse events reported were pain, fatigue, nausea, hot flash/night sweats, and arthralgia.

About Triple Negative Breast Cancer

Breast cancer is the most commonly diagnosed cancer in women and one in eight women will develop invasive breast cancer in their lifetime. In 2012, 1.7 million women were diagnosed with breast cancer, and there were 6.3 million women alive who had been diagnosed with breast cancer in the previous five years. Clinical assessment of breast cancer includes routine characterization of receptor status including the presence or absence of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) in the tumor tissue. Receptor status is used to assess metastatic potential as well as to guide treatment decisions. Although the majority of breast cancers are considered hormone receptor positive, expressing ER and/or PR, 15–20 percent of women diagnosed with breast cancer will have triple negative breast cancer (TNBC), which is characterized by a lack of expression of ER, PR, and HER2. TNBC occurs more frequently in younger patients (< 50 years of age) and generally shows a more aggressive behavior. For those patients with advanced TNBC, standard palliative treatment options are limited to cytotoxic chemotherapy. However, even after initial response to chemotherapy, the duration of the response may be short, and there is a higher likelihood of visceral metastases, rapidly progressing disease, and inferior survival compared to hormone positive breast cancer. Therefore, research is focused on identifying therapeutic targets in TNBC.

Studies have demonstrated that up to 50 percent of TNBC will express the androgen receptor. Both preclinical and patient-derived and cell line-derived AR+ TNBC xenografts support the clinical approach of targeting the androgen receptor with enobosarm.

About GTx

GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development and commercialization of small molecules for the treatment of cancer, including treatments for breast and prostate cancer, and other serious medical conditions.

Forward-Looking Information is Subject to Risk and Uncertainty

This press release contains forward-looking statements based upon GTx’s current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements relating to GTx’s clinical trials for enobosarm (GTx-024) to treat patients with advanced breast cancer. GTx’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks (i) that clinical trials being conducted by GTx may not be initiated or completed on schedule, or at all, or may otherwise be suspended or terminated; (ii) that any additional clinical development of GTx’s product candidate, enobosarm, beyond the two Phase 2 clinical trials of enobosarm in patients with AR positive advanced breast cancer is contingent on GTx entering into new collaborative arrangements with third parties for such development or otherwise obtaining sufficient additional capital to permit such development, which it may be unable to do; or (iii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all. In addition, GTx will continue to need additional funding and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product candidate development programs and potentially cease operations. GTx’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx’s quarterly report on Form 10-Q for the quarter ended June 30, 2015, filed August 10, 2015, contains under the heading, “Risk Factors”, a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

GTx, Inc.
Investors:
Lauren Crosby, 901-271-8622
lcrosby@gtxinc.com
or
Media:
Red House Consulting
Denise Powell, 510-703-9491
denise@redhousecomms.com

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(OPCO) Unveils New Communications Plan to Better Utilize Corporate Resources

FAIRPORT HARBOR, OH–(October 06, 2015) – As part of ongoing efforts to more efficiently utilize corporate resources, The OurPet’s Company (OTCQX: OPCO) today announces it will no longer conduct quarterly earnings teleconferences. In support of this decision, OurPet’s is ramping up its online communications and social media strategies to ensure that shareholders have ongoing access to the company’s most recent news, financial reports and progress.

“We have hosted consistent quarterly earnings calls for the 18 months, and have not seen participation meet our targets. In light of this, we feel that we can allocate our funds toward more worthy causes, and have identified more far-reaching and cost-effect routes to disseminate company news and financial reports,” says Scott Mendes, CFO of OurPet’s Company. “This decision further emphasizes our commitment to increasing shareholder value, transparency and communication. We look forward to providing our shareholders and potential investors with more readily available, up-to-date corporate information.”

To demonstrate its new communications strategy, OurPet’s recently engaged DreamTeamNetwork, through which OurPet’s will fully utilize social media, news releases, targeted marketing and a mobile version of the OurPet’s website.

About The OurPet’s Company
The OurPet’s Company designs, produces and markets a broad line of innovative, trend-setting pet products and accessories sold under the OurPets and Pet Zone brands in the United States and overseas. OurPets and Pet Zone products are sold through leading pet specialty retailers, food, drug and mass merchandisers, direct-mail catalog and internet retailers. The OurPet’s Company has an extensive intellectual property portfolio with more than 160 patents in either issued or pending status. The company was named a Weatherhead Top 100 Fastest Growing Company in Northeast Ohio in 2013 and has been a Lake-Geauga County Fast Track 50 Hall of Fame local business success winner for the last eight consecutive years. In addition, The OurPet’s Company was named 2015 Business of the Year by the Painesville Area Chamber of Commerce. Investors and customers may visit www.ourpets.com and www.petzonebrand.com for more information about the Company, its products and brands.

Contact:

Media
Peter Ostapowicz
Marketing Coordinator
440-354-6500 x141
postapowicz@ourpets.com

Investor Relations
DreamTeamNetwork
Austin, Texas
www.DreamTeamNetwork.com
512.758.8877 Office
Editor@DreamTeamNetwork.com

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(FTEK) Awarded Air Pollution Control Orders Totaling $11 Million

Fuel Tech, Inc. (NASDAQ: FTEK), a world leader in advanced engineering solutions for the optimization of combustion systems and emissions control in utility and industrial applications, today announced the receipt of multiple air pollution control (APC) contracts from customers in the US and China. These awards have an aggregate value of approximately $11.0 million.

The first US order is for an Electrostatic Precipitator (ESP) upgrade to reduce particulate emissions from a large coal-fired utility boiler in the Midwest. This order represents the equipment and installation phase of a project for which engineering was released earlier this year. The scope includes the supply and installation of internal components, electrical power supplies and integrated plant controls for the ESP. Installation and startup are scheduled for completion in the second quarter of 2016. The second order is for an ESP retrofit on a coal-fired unit in the Midwest in which the scope includes engineering and equipment to improve the performance and reliability of the unit. Delivery of the equipment is scheduled for the first quarter of 2016. Both projects are designed to improve plant performance to meet the Environmental Protection Agency’s upcoming Mercury and Air Toxics Standards (MATS) for particulate emissions.

In China, two orders were received for ULTRA™ systems that will be installed on utility coal-fired units being retrofitted with NOx reduction technology. Fuel Tech’s ULTRA process provides for the safe and cost-effective on-site conversion of urea to ammonia for use as a reagent in the selective catalytic reduction (SCR) of NOx, eliminating the hazards associated with the transport, storage and handling of anhydrous or aqueous ammonia. Equipment deliveries are expected to occur in the fourth quarter of 2015. An additional award in China was received for Fuel Tech’s HERT™ High Energy Reagent Technology™ and NOxOUT® Selective Non-Catalytic Reduction (SNCR) systems for a coal-fired boiler at a power generation facility. Equipment delivery is expected to occur in the first quarter of 2016.

Vincent J. Arnone, President and Chief Executive Officer, commented, “These orders reflect the breadth of Fuel Tech’s cost-effective technology solutions portfolio on a global basis. Our ULTRA technology simplifies on-site ammonia generation for SCR applications of all types. We continue to see opportunities in China for this technology as that government addresses increasing public pressure to reduce harmful air pollutants by implementing more stringent emissions requirements. Our SNCR technology continues to provide a low-cost capital solution for NOx reduction to customers worldwide as they comply with ever tightening regulations. Our ESP particulate control solutions allow plant operators to meet the regulations under the utility MATS Rule and the Boiler Maximum Achievable Control Technology (MACT) Rule for industrial boilers.”

About Fuel Tech

Fuel Tech is a leading technology company engaged in the worldwide development, commercialization and application of state-of-the-art proprietary technologies for air pollution control, process optimization, and advanced engineering services. These technologies enable customers to produce both energy and processed materials in a cost-effective and environmentally sustainable manner.

The Company’s nitrogen oxide (NOx) reduction technologies include advanced combustion modification techniques and post-combustion NOx control approaches, including NOxOUT®, HERT™, and Advanced SNCR systems, ASCR™ Advanced Selective Catalytic Reduction systems, and I-NOx™ Integrated NOx Reduction Systems, which utilize various combinations of these systems, along with the ULTRA™ process for safe ammonia generation. These technologies have established Fuel Tech as a leader in NOx reduction, with installations on over 900 units worldwide.

Fuel Tech’s technologies for particulate control include Electrostatic Precipitator (ESP) products and services including complete turnkey capability for ESP retrofits, with experience on units up to 700 MW. Flue gas conditioning (FGC) systems include treatment using sulfur trioxide (SO3) and ammonia (NH3) based conditioning to improve the performance of ESPs by modifying the properties of the fly ash particle. Fuel Tech’s particulate control technologies have been installed on more than 125 units worldwide.

The Company’s FUEL CHEM® technology revolves around the unique application of chemicals to improve the efficiency, reliability, fuel flexibility, boiler heat rate, and environmental status of combustion units by controlling slagging, fouling, corrosion, opacity and improving boiler operations. The Company has experience with this technology, in the form of a customizable FUEL CHEM program, on over 110 units.

Fuel Tech also provides a range of services, including boiler tuning and selective catalytic reduction (SCR) optimization services. In addition, flow corrective devices and physical and computational modeling services are available to optimize flue gas distribution and mixing in both power plant and industrial applications.

Many of Fuel Tech’s products and services rely heavily on the Company’s exceptional Computational Fluid Dynamics modeling capabilities, which are enhanced by internally developed, high-end visualization software. These capabilities, coupled with the Company’s innovative technologies and multi-disciplined team approach, enable Fuel Tech to provide practical solutions to some of our customers’ most challenging problems. For more information, visit Fuel Tech’s web site at www.ftek.com.

This press release may contain statements of a forward-looking nature regarding future events. These statements are only predictions and actual events may differ materially. Please refer to documents that Fuel Tech files from time to time with the Securities and Exchange Commission for a discussion of certain factors that could cause actual results to differ materially from those contained in the forward-looking statements.

Fuel Tech, Inc.
David S. Collins, 630-845-4500
Chief Financial Officer
or
The Equity Group Inc.
Devin Sullivan, 212-836-9608
Senior Vice President

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(ARNA) Announces Retirement of President and CEO

SAN DIEGO, Oct. 5, 2015  — Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that, at the request of the Board of Directors, Jack Lief, Arena’s President and Chief Executive Officer, has retired from the company, including its Board of Directors. Dr. Harry F. Hixson, a director of Arena since 2004, has been appointed to serve as interim Chief Executive Officer and interim principal financial officer. Arena will immediately initiate a search for a new chief executive officer.

“I leave Arena proud of the accomplishments made by our employees in advancing healthcare and science,” said Mr. Lief. “I look forward to watching the company transition through its next phase of development.”

“Jack has contributed in many ways since co-founding Arena in 1997, including overseeing the approval and commercial launch of the company’s internally discovered and developed drug BELVIQ, and the development of a robust clinical stage pipeline and productive research platform,” said Dr. Hixson. “We thank Jack and wish him great success in his future endeavors.”

Arena also reported that it is conducting an ongoing evaluation of its programs and operations, and intends to provide details regarding its 2016 financial plan later this year.

Dr. Hixson served as the Chairman of the board of directors of Sequenom, Inc., a genomics company, from January 2003 to March 2015, and as its Chief Executive Officer from September 2009 to June 2014. He previously served as Chief Executive Officer of BrainCells Inc., a drug discovery and development company, from 2004 to 2005, as Chief Executive Officer of Elitra Pharmaceuticals Inc., a biopharmaceutical company, from 1998 to 2003, and in various management positions with Amgen Inc., a biopharmaceutical company, from 1985 to 1991, most recently as President and Chief Operating Officer. Dr. Hixson holds a B.S. in Chemical Engineering from Purdue University, an M.B.A. from the University of Chicago and a Ph.D. in Physical Biochemistry from Purdue University.

About Arena Pharmaceuticals

Arena embraces the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena’s focus is discovering, developing and commercializing drugs to address unmet medical needs, and BELVIQ® (lorcaserin HCl) is Arena’s first internally discovered drug approved for marketing. Arena’s US operations are located in San Diego, California, and its operations outside of the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arena’s website at www.arenapharm.com.

Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about searching for a new chief executive officer; Arena’s evaluating its programs and operations; Arena’s financial plan; embracing the challenge of improving health; seeking to bring innovative medicines to patients; and Arena’s focus, plans, goals, strategy, expectations, research and development programs, and ability to discover and develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena’s expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: the timing and decisions relating to identifying a new chief executive officer, the ongoing evaluation of Arena’s programs and operations, and Arena’s 2016 financial plan, are uncertain; risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and the availability and use of BELVIQ or lorcaserin; cash and revenues generated from BELVIQ, including the impact of competition; the risk that Arena’s revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena’s guidance or previously reported results; the timing and outcome of regulatory review is uncertain, and lorcaserin may not be approved for marketing in combination with another drug, for another indication or using a different formulation or in any other territory for any indication; regulatory decisions in one territory may impact other regulatory decisions and Arena’s business prospects; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative arrangements; the timing and receipt of payments and fees, if any, from collaborators; the entry into or modification or termination of collaborative arrangements; unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of Arena’s research and development may not meet regulatory requirements or otherwise be sufficient for (or Arena or a collaborator may not pursue) further research and development, regulatory review or approval or continued marketing; Arena’s and third parties’ intellectual property rights; the timing, success and cost of Arena’s research and development and related strategy and decisions; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; having adequate funds; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena’s forward-looking statements are disclosed in Arena’s filings with the Securities and Exchange Commission. These forward-looking statements represent Arena’s judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Contact: Arena Pharmaceuticals, Inc.

Craig M. Audet, Ph.D., Senior Vice President,
Operations & Head of Global Regulatory Affairs
caudet@arenapharm.com
858.453.7200, ext. 1612
www.arenapharm.com

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(CPHR) Announces Settlement In Patent Litigation For Absorica®

MISSISSAUGA, ON, Oct. 5, 2015  – Cipher Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) (“Cipher” or “the Company”) today announced that the Company, along with its partners, Ranbaxy Pharmaceuticals, Inc. (“Ranbaxy”), a Sun Pharma Company, and Galephar Pharmaceutical Research, Inc. (“Galephar”), have entered into a Settlement Agreement with Actavis Laboratories F1, Inc., Andrx Corp., Actavis, Inc. and Actavis Pharma, Inc. (“Actavis”) that dismisses the patent litigation suit relating to Actavis’ Abbreviated New Drug Application (ANDA) for a generic version of Absorica® (isotretinoin capsules).

As part of the Settlement Agreement, Cipher, Ranbaxy and Galephar have entered into a non-exclusive license agreement with Actavis under which Actavis may begin selling its generic version of Absorica® in the U.S. on December 27, 2020 (approximately nine months prior to the expiration of the patents in September 2021) or earlier under certain circumstances.

The Settlement Agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.

About Cipher Pharmaceuticals Inc.

Cipher Pharmaceuticals (NASDAQ:CPHR; TSX:CPH) is a rapidly growing specialty pharmaceutical dermatology company with a diversified portfolio of commercial-stage products with the goal of becoming the most customer-centric dermatology company in North America.

Cipher has completed seven transactions in 2015, including the acquisition of Innocutis and its nine branded dermatology products, to build its U.S. commercial presence, expand its Canadian dermatology franchise and broaden its pipeline. Cipher is well-capitalized to drive long-term, sustained earnings growth by leveraging its proven clinical development capabilities and efficient commercial execution. For more information, visit www.cipherpharma.com.

Forward-Looking Statements

Statements made in this news release may be forward-looking and therefore subject to various risks and uncertainties. The words “may”, “will”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “plan”, “anticipate”, “estimate”, “expect”, “intend”, “forecast”, “objective”, “hope” and “continue” (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements.  Factors that could cause results to vary include those identified in the Company’s Annual Information Form, Form 40-F and other filings with Canadian and U.S. securities regulatory authorities. These factors include, but are not limited to our ability to enter into in-licensing, development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our  dependency on three products;  integration difficulties and other risks if we acquire or in-license technologies or product candidates;  reliance on third parties for the marketing of our products; the product approval process is highly unpredictable;  the timing of completion of clinical trials; reliance on third parties to manufacture our products; we may be subject to product liability claims; unexpected product safety or efficacy concerns may arise; generate revenue from a limited number of distribution and supply agreements; the pharmaceutical industry is highly competitive; requirements for additional capital to fund future operations; dependence on key managerial personnel and external collaborators;  no assurance that we will receive regulatory approvals in the U.S., Canada or any other jurisdictions;  limitations on reimbursement in the healthcare industry; limited reimbursement for products by government authorities and third-party payor policies;  various laws pertaining to health care fraud and abuse; reliance on the success of strategic investments and partnerships; the publication of negative results of clinical trials; unpredictable development goals and projected time frames; rising insurance costs; ability to enforce covenants not to compete; risks associated with the industry in which it operates; foreign currency risk; the potential violation of intellectual property rights of third parties; our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our products; changes in U.S., Canadian or foreign patent law; litigation in the pharmaceutical industry concerning the manufacture and supply of novel versions of existing drugs that are the subject of conflicting patent rights; inability to protect our trademarks from infringement; shareholders may be further diluted; volatility of our share price; a significant shareholder; we do not currently intend to pay dividends; our operating results may fluctuate significantly; we may be unsuccessful in evaluating material risks involved in complete and future acquisitions; we may be unable to identify, acquire or integrate acquisition targets successfully; operations in the U.S.; and inability to meet covenants on our credit facilities. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian or U.S. securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.

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(ONCE) Positive Top-line Results From Pivotal Phase 3 Trial of SPK-RPE65

Meets Primary and First Two Secondary Endpoints with High Statistical Significance and No Serious Adverse Events Related to SPK-RPE65

Demonstrates Restoration of Functional Vision and Improvement in Light Sensitivity in Subjects Previously Progressing toward Complete Blindness

First Randomized, Controlled Phase 3 Trial of a Gene Therapy for a Genetic Disease

PHILADELPHIA, Oct. 05, 2015  — Spark Therapeutics (NASDAQ:ONCE) today announced positive top-line results from the Phase 3 pivotal trial of its lead gene therapy product candidate, SPK-RPE65, for the treatment of RPE65-mediated inherited retinal dystrophies (IRDs).

The pivotal trial met its primary endpoint (p = 0.001), demonstrating improvement of functional vision in the intervention group compared to the control group, as measured by the change in bilateral mobility testing between baseline and one year.

There were no serious adverse events related to SPK-RPE65 or deleterious immune responses observed in the trial. Overall, adverse events related to the administration procedure were consistent with observations in earlier studies of SPK-RPE65.

In addition, subjects who received SPK-RPE65 outperformed control subjects across the first two secondary endpoints: full-field light sensitivity threshold testing (p < 0.001) and the mobility test change score for the first injected eye (p = 0.001). The third secondary endpoint, visual acuity, did not show statistically significant evidence of benefit (p = 0.17). All reported p-values reflect results from the intent-to-treat (ITT) population, the most stringent efficacy analysis population described in the statistical analysis plan (SAP).

“We saw substantial restoration of vision in patients who were progressing toward complete blindness,” said Albert M. Maguire, MD, principal investigator in the trial and professor of ophthalmology at the Perelman School of Medicine of the University of Pennsylvania. “The majority of the subjects given SPK-RPE65 derived the maximum possible benefit that we could measure on the primary visual function test, and this impressive effect was confirmed by a parallel improvement in retinal sensitivity.  If approved, SPK-RPE65 should have a positive, meaningful impact on the lives of patients with this debilitating condition.”

Based on these results, Spark intends to file a Biologics License Application with the U.S. Food and Drug Administration in 2016 as the first step in executing its global regulatory and commercialization strategy.

“These results are the culmination of more than a decade of work of many dedicated individuals to correct the underlying cause of RPE65-mediated blindness through the one-time administration of a gene therapy,” said Jean Bennett, MD, PhD, professor of ophthalmology and director of the Center for Advanced Retinal and Ocular Therapeutics at the Perelman School of Medicine of the University of Pennsylvania. “We are excited about the potential impact that the results will have on the treatment of this and other blinding conditions.”

Today’s results represent the first successful randomized, controlled Phase 3 trial ever completed in gene therapy for a genetic disease. It reflects more than a decade of innovation across all aspects of the program, including vector design, manufacturing and formulation, the surgical delivery procedure and clinical trial design, as well as the development and validation of a novel endpoint.

“This is an important moment for the field of gene therapy, and demonstrates Spark’s ability to carefully and precisely integrate technologies and approaches across a range of disciplines to move the concept of gene therapy toward a therapeutic reality for patients,” said Kathy High, MD, co-founder, president and chief scientific officer of Spark. “We wish to thank the trial participants and families as well as the investigators and all who contributed to this groundbreaking trial and successful result.”

“These data further validate Spark’s platform which is being applied across a growing pipeline of clinical and preclinical programs in gene therapy,” said Jeffrey D. Marrazzo, co-founder and chief executive officer of Spark. “The impact of these results provides the strongest indication yet of the role that Spark is uniquely poised to play across a wide range of inherited diseases.”

Trial Detail

The multicenter, pivotal Phase 3 trial randomized 31 subjects with confirmed RPE65 gene mutations. The ITT population included 21 subjects in the intervention group and 10 in the control group.

For the primary endpoint, subjects were evaluated at multiple time points over the course of one year for their performance in navigating a mobility course under a variety of light levels ranging from one lux (equivalent to a moonless summer night) to 400 lux (a brightly lit office) using the bilateral testing condition. Each attempt was recorded, and the videos were sent to independent, centralized, masked graders to assign a pass/fail score based on speed and accuracy with which the subjects navigated the course.

In addition to the primary endpoint, the SAP included three secondary endpoints tested statistically in the following hierarchical order:

  • Full-field light sensitivity threshold testing (FST), which reflects underlying physiological function by measuring light sensitivity of the entire visual field.
  • Change in mobility test score for the first eye injected, which compares the mobility test performance between baseline and year one for the first eye injected for the intervention group and, for the control group during the control year, the first eye injected after they crossed over.
  • Visual acuity testing, which measures changes in central vision by assessing the ability of the subject to read a standard eye chart.

A summary of top-line efficacy results follows:

Primary outcome (ITT)
Mobility test (MT) change score, bilateral p = 0.001
Secondary outcomes (ITT)
FST, averaged over both eyes p < 0.001
MT change score, first injected eye p = 0.001
Visual acuity, averaged over both eyes p = 0.17

“This is a watershed moment in the long-time pursuit of innovative gene therapy solutions for a range of blinding retinal degenerative diseases,” said Gordon Gund, chairman of the Foundation Fighting Blindness. “Spark, The Children’s Hospital of Philadelphia, the Foundation Fighting Blindness and a long list of collaborators in the non-profit, academic and government sectors are to be commended for diligently persevering over many years in their aim to realize the potential of gene therapy in the fight against blindness.”

Additional data from this clinical trial will be presented in a series of scientific meetings in the coming months, beginning with a presentation at the Retina Society Annual Scientific Meeting on October 10th in Paris by Principal Investigator Stephen R. Russell, MD, of the Stephen A. Wynn Institute for Vision Research at the University of Iowa.

Conference Call Details

Spark management will provide an overview of the top-line results for the Phase 3 trial of SPK-RPE65 during a conference call scheduled for today at 8:30 am ET. The conference call can be accessed by dialing (855) 851-4526 (domestic) or +1 (720) 634-2910 (international) and entering passcode 54830608. To access a live audio webcast, please visit the “Investors” section at www.sparktx.com.

A replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 (domestic) or +1 (404) 537-3406 (international) and entering passcode 54830608 or by visiting our website.

About Spark Therapeutics

Spark is a gene therapy leader seeking to transform the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. Spark’s initial focus is on treating rare diseases where no, or only palliative, therapies exist. Spark’s most advanced product candidate, SPK-RPE65, which has received both breakthrough therapy and orphan product designation, recently reported positive top-line results from a pivotal Phase 3 clinical trial for the treatment of rare blinding conditions. Spark’s validated gene therapy platform is being applied to a range of clinical and preclinical programs addressing serious genetic diseases, including inherited retinal dystrophies, hematologic disorders and neurodegenerative diseases. Spark builds on two decades of research, development and manufacturing at The Children’s Hospital of Philadelphia, including human trials conducted across diverse therapeutic areas and routes of administration. To learn more, please visit www.sparktx.com.

Cautionary Note on Forward-looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the company’s lead product candidate, SPK-RPE65. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that: (i) the data from our Phase 3 clinical trial of SPK-RPE65 may not support a label for the treatment of RPE65-mediated IRDs other than Leber congenital amaurosis (LCA); (ii) the improvements in functional vision demonstrated by SPK- RPE65 in our clinical trials may not be sustained over extended periods of time; and (iii) we could experience delays in submitting our regulatory filings, including our Biologics Licensing Application with FDA and, once submitted, such regulatory filings may not be approved. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in our Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and other filings we make with the Securities and Exchange Commission. All information in the press release is as of the date of the release, and Spark undertakes no duty to update this information unless required by law.

Contacts

Investor Relations
Spark Therapeutics, Inc.
Stephen W. Webster
Chief Financial Officer
(855) SPARKTX (1-855-772-7589)

Media 
Ten Bridge Communications
Dan Quinn
(781) 475-7974
dan@tenbridgecommunications.com

Financial Media
Teneo Strategy
Andy Maas
(212) 886-9321
andy.maas@teneostrategy.com
Monday, October 5th, 2015 Uncategorized Comments Off on (ONCE) Positive Top-line Results From Pivotal Phase 3 Trial of SPK-RPE65

(CTRV) Reports New Data demonstrating CMX157 to be 60-Fold More Potent

EDISON, N.J., Oct. 5, 2015  — ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, today announced preliminary data dramatizing  the unique properties of CMX157, the Company’s highly potent lipid prodrug of the successful antiviral drug tenofovir (TFV). CMX157 was shown to be 60-fold more active than tenofovir against the hepatitis B virus (HBV) based on in vitro studies. This significant potency difference has considerable potential in increasing the safety profile and reducing the side effects compared to tenofovir DF (Viread®).

The Company believes CMX157’s lipid-conjugate design clearly differentiates it from tenofovir DF.  ContraVir plans to file an investigational new drug (IND) application for CMX157 to treat HBV before year-end 2015. CMX157 benefits from earlier human studies in volunteers under an IND for HIV.  ContraVir is focused on a quick evaluation of CMX157 in a Phase 2 clinical study in patients with hepatitis B which it plans to begin in 2016.

CMX157’s enhanced absorption technology which utilizes the natural lipid uptake pathway to target the liver has the potential to lower systemic exposure compared to tenofovir, resulting in reduced off-target toxicity. Other studies with CMX157 are examining the efficiency of CMX157 prodrug conversion to the active antiviral, tenofovir diphosphate, within targeted hepatocytes, and further assessing the in vitro safety profile of CMX157, including a comprehensive evaluation of the likelihood of drug-drug interactions.

The United States is expected to see more than a 15% rise in hepatitis B patients through 2033 and there are about 350 million chronic HBV patients worldwide. ContraVir is committed to meeting its timelines so that the Company is positioned to treat these patients and capture this attractive and growing market.

About CMX157

CMX157 is a novel lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the active antiviral agent tenofovir diphosphate. Compared to tenofovir, CMX157 is up to 60-fold more active against HBV and more than 200-fold more active against all major HIV subtypes in vitro. CMX157’s novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal and bone side effects. It has completed a Phase 1 clinical trial in healthy volunteers, demonstrating a favorable safety, tolerability and drug distribution profile.

About ContraVir Pharmaceuticals

ContraVir is a biopharmaceutical company focused on the discovery and development of targeted antiviral therapies with two candidates in mid-to-late stage clinical development. ContraVir’s lead clinical drug, FV-100, is an orally available nucleoside analogue prodrug that is being developed for the treatment of herpes zoster, or shingles, which is currently in Phase 3 clinical development.  In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN) in a Phase 2 clinical study. ContraVir is also developing CMX157, a highly potent analog of the successful antiviral drug tenofovir, for the Hepatitis B virus (HBV). CMX157’s novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on ContraVir’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. ContraVir does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in ContraVir’s Form 10-K for the year ended June 30, 2015, and other periodic reports filed with the Securities and Exchange Commission.

For further information, please contact:

Tiberend Strategic Advisors, Inc.

Tirth Patel (investors)
tpatel@tiberend.com; (212) 375-2681

Claire Sojda (media)
csojda@tiberend.com; (212) 375-2686

Monday, October 5th, 2015 Uncategorized Comments Off on (CTRV) Reports New Data demonstrating CMX157 to be 60-Fold More Potent

(OPCO) Reaches Settlement With Competitor Over DuraPet(R) Patent

FAIRPORT HARBOR, OH–(October 05, 2015) – OurPet’s Company (OTCQX: OPCO), a leading proprietary pet supply company, today announced a patent infringement settlement with Loving Pets Corporation (“Loving Pets”).

The lawsuit alleged that Loving Pets’ Ruff-N-Tuff® Pet Feeding Dish infringed OurPet’s ‘529 utility patent, which is for a feeding dish with rubber on the bottom that does not extend up the sidewall. The matter was settled confidentially.

Dr. Steve Tsengas, President & CEO, commented, “We are pleased with the outcome of this patent infringement case. In the future, OurPet’s will continue to protect the value of our innovative product lines, and specifically our intellectual property portfolio, which currently includes 139 patents issued or pending.”

OurPet’s Company

OurPet’s Company designs, produces and markets a broad line of innovative, high-quality accessory and consumable pet products in the U.S. and overseas. Investor and customers may visit www.ourpets.com for more information about our company and its products. OurPet’s websites include www.petzonebrand.com and www.ourpets.com.

Certain of the matters set forth in this press release are forward-looking and involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially are the following: business conditions; growth in the industry; general economic conditions; addition or loss of significant customers; the loss of key personnel; product development; competition; risks of doing business abroad; foreign government regulations; fluctuations in foreign currency rates; rising costs for raw materials and sources of supply that may be limited or unavailable from time to time; the timing of orders booked; and the other risks that are described from time to time in OurPet’s Company SEC reports.

OurPet’s Company
Dr. Steven Tsengas
(440) 354-6500 (Ext. 111)

Monday, October 5th, 2015 Uncategorized Comments Off on (OPCO) Reaches Settlement With Competitor Over DuraPet(R) Patent

(TBPH) Announces New Employment Inducement Awards

DUBLIN, IRELAND–(Oct 2, 2015) –  Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma” or the “Company”) announced today that stock options to purchase an aggregate of 68,300 of the Company’s ordinary shares were granted to nine new non-executive officer employees on October 1, 2015. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4) under the Theravance Biopharma, Inc. 2014 New Employee Equity Incentive Plan (the “Inducement Plan”), which the Board of Directors of Theravance Biopharma adopted in October 2014 to facilitate the granting of equity awards to new employees. Each option has an exercise price per share equal to $11.13, which was the closing price of one Theravance Biopharma ordinary share on the Nasdaq Global Market on the date of grant. The options vest over four years, with 25% of the option shares vesting on the first anniversary of the date of grant and the remaining 75% of the option shares vesting in monthly installments over the three years thereafter. The options have a ten year term, and are subject to the terms and conditions of the Inducement Plan and applicable stock option agreement.

About Theravance Biopharma

The mission of Theravance Biopharma (NASDAQ: TBPH) is to create value from a unique and diverse set of assets: an approved product; a development pipeline of late-stage assets; and a productive research platform designed for long-term growth.

Our pipeline of internally discovered product candidates includes potential best-in-class opportunities in underserved markets in the acute care setting, representing multiple opportunities for value creation. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revenfenacin (TD-4208) is an investigational long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for COPD. Axelopran (TD-1211) is an investigational potential once-daily, oral treatment for opioid-induced constipation (OIC). Our earlier-stage clinical assets represent novel approaches for potentially treating diseases of the lung and gastrointestinal tract and infectious disease. In addition, we have an economic interest in future payments that may be made by GlaxoSmithKline plc pursuant to its agreements with Theravance, Inc. relating to certain drug development programs, including the combination of fluticasone furoate, umeclidinium, and vilanterol (the “Closed Triple”).

With our successful drug discovery and development track record, commercial infrastructure, experienced management team and efficient corporate structure, we believe that we are well positioned to create value for our shareholders and make a difference in the lives of patients.

For more information, please visit www.theravance.com.

THERAVANCE®, the Cross/Star logo, MEDICINES THAT MAKE A DIFFERENCE® and VIBATIV ® are registered trademarks of the Theravance Biopharma group of companies.

Contact Information:

Renee Gala
Chief Financial Officer
650-808-4045
investor.relations@theravance.com

Friday, October 2nd, 2015 Uncategorized Comments Off on (TBPH) Announces New Employment Inducement Awards

(CSIQ) Closes Purchase of Ontario Assets from KKR

GUELPH, Ontario, Oct. 2, 2015  — Canadian Solar Inc. (the “Company”, or “Canadian Solar”) (NASDAQ: CSIQ), one of the world’s largest solar power companies, today announced it has closed on the purchase of three operating solar projects totaling 59.8 MW AC from KKR. The total approximate enterprise value of this transaction is C$270 Million (USD$203.7 Million). In conjunction with this acquisition, Canadian Solar also closed a USD$50 Million loan with Credit Suisse, who also acted as sole financial advisor on the transaction.

The projects are located in Sault Ste. Marie, Ontario and hold long-term fixed-price contracts established pursuant to Renewable Energy Standard Offer Program. Canadian Solar plans to assume the roles of both the owner and operator of the projects, which have been connected to the grid from October 2010 to November 2011. In addition, term financing will be provided by Norddeutsche Landesbank Girozentrale, New York Branch and KfW-IPEX Bank, assumed as part of the acquisition.

Dr. Shawn Qu, Chairman and Chief Executive Officer of Canadian Solar, commented, “These projects will help round out our Canadian portfolio and are part of our strategy to own and operate projects. This acquisition demonstrates Canadian Solar’s ongoing investment and dedication to solar, as well as staying true to our strategy. We look forward to future transactions with KKR in North America.”

About Canadian Solar Inc.

Founded in 2001 in Canada, Canadian Solar is one of the world’s largest and foremost solar power companies. As a leading manufacturer of solar photovoltaic modules and a provider of solar energy solutions, Canadian Solar has a geographically diversified pipeline of utility-scale power projects. In the past 14 years, Canadian Solar has successfully deployed over 11 GW of premium quality modules in over 70 countries around the world. Furthermore, Canadian Solar is one of the most bankable companies in the world, having been publically listed on NASDAQ since 2006. For additional information about the company, visit the website or follow Canadian Solar on LinkedIn.

Safe Harbor/Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially. These statements are made under the “Safe Harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by such terms as “believes,” “expects,” “anticipates,” “intends,” “estimates,” the negative of these terms, or other comparable terminology. Factors that could cause actual results to differ include the risks regarding general business and economic conditions and the state of the solar industry; governmental support for the deployment of solar power; future available supplies of solar grade silicon; demand for solar products by consumers and inventory levels of such products in the supply chain; changes in demand from significant customers; changes in demand in our project markets, including Canada, the U.S., Japan and China; changes in customer order patterns; capacity utilization; level of competition; pricing pressure and declines in average selling price; delays in new product introduction; continued success in technological innovations and delivery of products with the features customers demand; utility-scale project approval process delays; utility-scale project construction delays; utility-scale project cancelation due to failure to obtain all the necessary permits; shortage in supply of materials or capacity requirements; availability of financing; exchange rate fluctuations; trade protectionism in Europe, the U.S. and India; litigation and other risks as described in the Company’s SEC filings, including its annual report on Form 20-F filed on April 23, 2015. Although the Company believes that the expectations reflected in its forward looking statements are reasonable, it cannot guarantee future results, level of activity, performance, or achievements. Investors should not place undue reliance on these forward-looking statements. All information provided in this press release is as of today’s date, unless otherwise stated, and Canadian Solar undertakes no duty to update such information, except as required under applicable law.

Friday, October 2nd, 2015 Uncategorized Comments Off on (CSIQ) Closes Purchase of Ontario Assets from KKR

(EOX) Completes Transaction With Koch Exploration

DENVER, CO–(October 02, 2015) – Emerald Oil, Inc. (NYSE MKT: EOX) (“Emerald” or the “Company”) today announced that it has closed the previously announced transaction with Koch Exploration Company, LLC for total consideration of approximately $17.4 million, including normal and customary closing adjustments. Koch Exploration also reimbursed Emerald for their proportionate share of existing AFEs, bringing the total transaction size to $22.8 million. The proceeds from the sale will be used to pay down a portion of the outstanding borrowings under the Company’s revolving credit facility.

About Emerald

Emerald is an independent exploration and production operator that is focused on acquiring acreage and developing wells in the Williston Basin of North Dakota and Montana, targeting the Bakken and Three Forks shale oil formations and Pronghorn sand oil formation. Emerald is based in Denver, Colorado. More information about Emerald can be found at www.emeraldoil.com.

Forward-Looking Statements

This press release may include “forward-looking statements” within the meaning of the securities laws. All statements other than statements of historical facts included herein may constitute forward-looking statements. Forward-looking statements in this document may include statements regarding the Company’s expectations regarding the Company’s operational, exploration and development plans; expectations regarding the nature and amount of the Company’s reserves; and expectations regarding production, revenues, cash flows and recoveries. When used in this press release, the words “will,” “potential,” “believe,” “estimate,” “intend,” “expect,” “may,” “should,” “anticipate,” “could,” “plan,” “predict,” “project,” “profile,” “model,” or their negatives, other similar expressions or the statements that include those words, are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of the Company, which may cause actual results to differ materially from those implied or expressed by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, fluctuations in oil and natural gas prices, uncertainties inherent in estimating quantities of oil and natural gas reserves and projecting future rates of production and timing of development activities, competition, operating risks, acquisition risks, liquidity and capital requirements, the effects of governmental regulation, adverse changes in the market for the Company’s oil and natural gas production, dependence upon third-party vendors, and other risks detailed in the Company’s periodic report filings with the Securities and Exchange Commission.

Corporate Contact:

Emerald Oil, Inc.
Mitch Ayer
Vice President – Finance & Investor Relations
(303) 595-5600
info@emeraldoil.com
www.emeraldoil.com

Friday, October 2nd, 2015 Uncategorized Comments Off on (EOX) Completes Transaction With Koch Exploration

(CDOR) Acquires Three Premium-Branded Hotels

NORFOLK, NE–(October 02, 2015) – Condor Hospitality Trust, Inc. (NASDAQ: CDOR), a hotel-focused real estate investment trust (REIT), announced today that it has completed the previously announced acquisition of three premium-branded hotels for $42.5 million. The three properties are comprised of the following:

  • 116-room SpringHill Suites Downtown, San Antonio, Texas
  • 142-room Hotel Indigo Atlanta Airport, College Park, Georgia
  • 120-room Courtyard Jacksonville Flagler Center, Jacksonville, Florida

“The acquisition of these three relatively new, high-quality hotels provides a vision of the company’s portfolio of the future and aligns perfectly with the new investment strategy underway,” said Bill Blackham, Condor Hospitality’s CEO. “These hotels are located in vibrant markets with solid growth potential and enjoy the benefit of premier brands.”

“Condor has accelerated the disposition of legacy hotels in order to recycle capital from older properties in the economy segment and reinvest in newer, higher quality assets transitioning the company into a hospitality real estate investment trust owning a portfolio in the premium, select-service, extended stay and limited-service hotel segments with the goal of delivering more attractive returns to our shareholders,” said Blackham. “The hotels were introduced to Condor by Peachtree Hospitality Management under our initiative of aligning with hotel management companies to identify prospective hotel acquisitions meeting our investment criteria and build long term relationships. Peachtree Hospitality Management will manage all three hotels and we anticipate that all of our existing and new hotel management relationships will grow as the transition of the company evolves.”

The company funded the acquisitions with cash on hand, primarily from prior legacy hotel dispositions, and with debt financing including the assumption of an existing loan and a newly originated loan with GE Capital Franchise Finance Corporation. The acquisitions are projected to be accretive to 2015 fourth quarter results.

About Condor Hospitality Trust, Inc.

Condor Hospitality Trust, Inc. (NASDAQ: CDOR), formerly known as Supertel Hospitality, Inc., 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 20 states including the three newly acquired hotels. Condor’s hotels are franchised by a number of the industry’s most well-regarded brand families including Hilton, Marriott, InterContinental Hotels Group, 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:
Krista Arkfeld
Director of Corporate Communications
karkfeld@trustcondor.com
402-371-2520

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(BTX) Agrees to Sell $5.1 Million of Equity

BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, today announced that it has agreed to sell 1,600,000 of its common shares, no par value, at an offering price of $3.19 per share to its largest shareholder, Broadwood Partners, L.P. (“Broadwood”). Neal Bradsher, a BioTime director, is the President of the investment manager of Broadwood. BioTime expects to receive gross proceeds of approximately $5.1 million from the sale. The price per share was the closing price of BioTime common shares on the NYSE MKT on October 1, 2015, the last trading day before BioTime and the investor agreed upon the purchase price. BioTime will pay no fees or commissions to broker-dealers or any finder’s fees, nor will the Company issue any stock purchase warrants, in connection with the offer and sale of the shares. The sale is expected to close on October 7, 2015.

The common shares offered by BioTime in the registered direct offering are being offered and sold pursuant to a prospectus supplement dated as of October 2, 2015, which has been filed with the Securities and Exchange Commission (“SEC”) in connection with a takedown from the Company’s shelf registration statement on Form S-3 (File No. 333-201824), which became effective on February 12, 2015, and the base prospectus dated February 12, 2015. Copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at 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 above, nor shall there be any sale of any such securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

About BioTime

BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage biotechnology company. BioTime and its subsidiaries are leveraging their industry-leading experience in pluripotent stem cell technology and a broad intellectual property portfolio to facilitate the development and use of cell-based therapies and gene marker-based molecular diagnostics for major diseases and degenerative conditions for which there presently are no cures. The lead clinical programs of BioTime and its subsidiaries include OpRegen®, currently in a Phase I/IIa trial for the treatment of the dry form of age-related macular degeneration; AST-OPC1, currently in a Phase I/IIa trial for spinal cord injuries; Renevia™, currently in a pivotal trial in Europe as an injectable matrix for the engraftment of transplanted cells to treat HIV-related lipoatrophy; and cancer diagnostics, nearing the completion of initial clinical studies for the detection of lung, bladder, and breast cancers. AST-VAC2, a cancer vaccine, is in the pre-clinical trial stage.

BioTime’s subsidiaries include the publicly traded Asterias Biotherapeutics, Inc., developing pluripotent stem cell-based therapies in neurology and oncology, including AST-OPC1 and AST-VAC2; Cell Cure Neurosciences Ltd., developing stem cell-based therapies for retinal and neurological disorders, including OpRegen®; OncoCyte Corporation, developing cancer diagnostics; LifeMap Sciences, Inc., developing and marketing an integrated online database resource for biomedical and stem cell research; LifeMap Solutions, Inc., a subsidiary of LifeMap Sciences, developing mobile health (mHealth) products; ES Cell International Pte Ltd, which has developed cGMP-compliant human embryonic stem cell lines that are being marketed by BioTime for research purposes under the ESI BIO branding program; OrthoCyte Corporation, developing therapies to treat orthopedic disorders, diseases, and injuries; and ReCyte Therapeutics, Inc., developing therapies to treat a variety of cardiovascular and related ischemic disorders.

BioTime common stock is traded on the NYSE MKT and the TASE under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on TwitterLinkedInFacebookYouTube, and Google+.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime’s Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://news.biotimeinc.com

 

BioTime, Inc.
Dan L. Lawrence, 510-775-0510
dlawrence@biotimemail.com
or
Investor Contact:
EVC Group, Inc.
Michael Polyviou, 646-445-4800
mpolyviou@evcgroup.com
or
Media Contact:
Gotham Communications, LLC
Bill Douglass, 646-504-0890
bill@gothamcomm.com
or
Israel Contact:
Gelbart-Kahana Investor Relations
Zeev Gelbart, +972-3-6074717
zeevg@gk-biz.com

Friday, October 2nd, 2015 Uncategorized Comments Off on (BTX) Agrees to Sell $5.1 Million of Equity

(EDGE) Congratulated By (HTGC) Over IPO

  • Twelve (12) Hercules Portfolio Companies Completed or Announced IPO and M&A Liquidity Events Year-to-Date 2015
  • Hercules Currently Has Six (6) Portfolio Companies in IPO Registration
  • Hercules Holds Warrant Positions in 131 Pre-IPO or M&A Portfolio Companies, as of June 30, 2015, Representing Potential Future Additional Returns to Investors*
  • Hercules Holds Equity Positions in 47 Pre-IPO or M&A Portfolio Companies, as of June 30, 2015, Representing Potential Future Additional Returns to Investors*

Hercules Technology Growth Capital, Inc. (NYSE:HTGC) (“Hercules” or the “Company”), the leading specialty finance company to innovative, high-growth venture capital-backed companies, today noted that its portfolio company, Edge Therapeutics, Inc., completed its initial public offering (“IPO”) on October 1, 2015. Edge Therapeutics, a clinical-stage biotechnology company developing therapies capable of transforming treatment paradigms in the management of acute, life-threatening neurological conditions, included approximately 7.3 million shares of its common stock at $11.00 per share in the offering, raising approximately $80 million. Shares of the company are trading on the NASDAQ Global Market under the symbol “EDGE.”

Hercules initially committed $10 million in venture debt financing to Edge Therapeutics in August 2014.

As of October 1, 2015, Hercules currently has six (6) additional portfolio companies who have either publicly or confidentially filed Form S-1 Registration Statements with the SEC in contemplation of a potential IPO. However, there can be no assurances that these companies will complete their IPOs in a timely manner or at all.

  • Gelesis, Inc.
  • Cerecor Inc.
  • Four (4) companies filed confidentially under the JOBS Act

*Not all companies will go public or complete an M&A event.

About Hercules Technology Growth Capital, Inc.

Hercules Technology Growth Capital, Inc. (NYSE:HTGC) (“Hercules”) is the leading specialty finance company focused on providing senior secured venture growth loans to high-growth, innovative venture capital-backed companies in the technology, biotechnology, life sciences, healthcare, and energy & renewable technology industries. Since inception (December 2003), Hercules has committed more than $5.5 billion to over 325 companies and is the lender of choice for entrepreneurs and venture capital firms seeking growth capital financing. Companies interested in learning more about financing opportunities should contact info@htgc.com, or call 650.289.3060.

Hercules’ common stock trades on the New York Stock Exchange (NYSE) under the ticker symbol “HTGC.”

In addition, Hercules has three outstanding bond issuances of 7.00% Notes due April 2019, 7.00% Notes due September 2019, and 6.25% Notes due July 2024, which trade on the NYSE under the symbols “HTGZ,” “HTGY,” and “HTGX,” respectively.

Forward-Looking Statements:

The information disclosed in this release is made as of the date hereof and reflects Hercules most current assessment of its historical financial performance. Actual financial results filed with the Securities and Exchange Commission may differ from those contained herein due to timing delays between the date of this release and confirmation of final audit results. These forward-looking statements are not guarantees of future performance and are subject to uncertainties and other factors that could cause actual results to differ materially from those expressed in the forward-looking statements including, without limitation, the risks, uncertainties, including the uncertainties surrounding the current market volatility, and other factors we identify from time to time in our filings with the Securities and Exchange Commission. Although we believe that the assumptions on which these forward-looking statements are based are reasonable, any of those assumptions could prove to be inaccurate and, as a result, the forward-looking statements based on those assumptions also could be incorrect. You should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this release are made as of the date hereof, and Hercules assumes no obligation to update the forward-looking statements for subsequent events.

 

Hercules Technology Growth Capital, Inc.
Michael Hara, 650-433-5578 HT-HN
Investor Relations and Corporate Communications
mhara@htgc.com

Friday, October 2nd, 2015 Uncategorized Comments Off on (EDGE) Congratulated By (HTGC) Over IPO

(BWEN) Announces $6 Million in New Gearing Orders

CICERO, Ill., Oct. 01, 2015  — Broadwind Energy, Inc. (NASDAQ:BWEN) today announced $6 million in new gearing orders to be produced by its Brad Foote Gear Works, Inc. subsidiary.

Broadwind President and CEO Peter Duprey stated, “As the fleet of more than 48,000 wind turbines installed in the U.S. starts to age, we are seeing growing opportunities for replacement wind gearing which is helping to offset weak oil and gas and mining orders.”

About Broadwind Energy, Inc.
Broadwind Energy (NASDAQ:BWEN) applies decades of deep industrial expertise to innovate integrated solutions for customers in the energy and infrastructure markets. From gears and gearing systems for wind, oil and gas and mining applications, to wind towers and specialty weldments, to comprehensive remanufacturing of gearboxes and blades, to operations and maintenance services, we have solutions for the energy needs of the future. With facilities throughout the U.S., Broadwind Energy’s talented team of nearly 800 employees is committed to helping customers maximize performance of their investments—quicker, easier and smarter. Find out more at www.bwen.com

Forward-Looking Statements
This release includes various forward-looking statements related to future, not past, events. Statements in this release that are not historical are forward-looking statements. These statements are based on current expectations, and we undertake no obligation to update these statements to reflect events or circumstances occurring after this release. Such statements are subject to various risks and uncertainties that could cause actual results to vary materially from those stated. Such risks and uncertainties include, but are not limited to: expectations regarding our business, end-markets, relationships with customers and our ability to diversify our customer base; the impact of competition and economic volatility on the industries in which we compete; our ability to realize revenue from customer orders and backlog; the impact of regulation on our end-markets, including the wind energy industry in particular; the sufficiency of our liquidity and working capital; our restructuring plans and the associated cost savings; our ability to preserve and utilize our tax net operating loss carry-forwards; and other risks and uncertainties described in our filings with the Securities and Exchange Commission, including those contained in Part I, Item 1A “Risk Factors” of our Annual Reports on Form 10-K.

Thursday, October 1st, 2015 Uncategorized Comments Off on (BWEN) Announces $6 Million in New Gearing Orders

(MYOS) (CYRX) Cryoport Appoints Robert Hariri, MD, PhD to its Board of Directors

Conference call scheduled for 4:30 p.m. ET on Monday, October 5th to introduce Dr. Hariri

LAKE FOREST, Calif., Oct. 1, 2015  — Cryoport, Inc. (NASDAQ: CYRX) (“Company”) today announced the appointment of Robert Hariri, MD, PhD to its Board of Directors.

Dr. Hariri is the Chairman, Founder and Chief Scientific Officer of Celgene Cellular Therapeutics, one of the world’s largest human cellular therapeutics companies and wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG).  He has pioneered the use of stem cells and biomaterials to treat a range of life threatening diseases and has made transformative contributions in the field of tissue engineering.

Dr. Hariri is a visionary scientist, surgeon, aviator and entrepreneur. He has over 100 issued and pending patents; authored over 100 published chapters, articles and abstracts; and is most recognized for his discovery of pluripotent stem cells from the placenta and as a member of the team which discovered the physiological activities of TNF (tumor necrosis factor).

Along with J. Craig Venter, PhD, Dr. Hariri, is Co-Founder & President of Human Longevity Cellular Therapeutics, Inc. located in San Diego, CA, a leader in genomics and cellular technology. He is Founder and Chairman of Myos Corporation located in Cedar Knolls, NJ (NASDAQ: MYOS), an emerging bio-therapeutics and bio-nutrition company focused on the discovery, development and commercialization of products that improve muscle health and function essential to the management of sarcopenia, cachexia and chronic and acute muscle diseases.

Dr. Hariri also serves on numerous Boards of Directors, including Myos Corporation, Bionik Laboratories and Provista Diagnostics. Dr. Hariri is a member of the scientific advisory board for the Archon X PRIZE for Genomics, which is awarded by the X PRIZE Foundation.  He is also a member of the Board of Trustees of the J. Craig Venter Institute, a Trustee of the Liberty Science Center and has been appointed Commissioner of the New Jersey Commission on Cancer Research.

Dr. Hariri was recipient of the Thomas Alva Edison Award in 2007 and 2011, The Fred J. Epstein Lifetime Achievement Award and has received numerous other honors for his many contributions to biomedicine and aviation. He is an Adjunct Associate Professor of Pathology at the Mount Sinai School of Medicine and served as a member of the Board of Visitors of his alma mater, Columbia University School of Engineering & Applied Sciences and the Science & Technology Council of the College of Physicians and Surgeons. Dr. Hariri was awarded his M.D. and Ph.D. degrees from Cornell University Medical College and received his surgical training at The New York Hospital-Cornell Medical Center.  He also directed the Aitken Neurosurgery Laboratory and the Center for Trauma Research.

Dr. Hariri has also produced several feature films and documentaries, which can be reviewed at www.imdb.com.

Dr. Hariri stated, “As an established investor in Cryoport’s common stock, I have a great deal of confidence in the need and demand for Cryoport’s cold chain and logistical solutions in the life sciences market, which is expected to increase substantially as cellular therapies such as stem cells, immunotherapies and, especially, CAR-T cell therapies come to commercialization. These advanced therapies require rigid and well-designed enhanced cold chain management solutions to ensure effective patient treatment, as temperature excursion will affect efficacy. To effectively bring these therapies through clinical trials and commercialization, after receiving FDA approval, the use of advanced cold-chain solutions, such as Cryoport’s, is crucial. The cellular therapies market, on a broad scale, is greatly enhanced by the presence and use of Cryoport’s technologies.”

He continued, “My extensive involvement with cellular and regenerative medicines throughout my career brought Cryoport to my attention long before being invited to join the Company’s Board of Directors. As indicated by my previous actions, I believe the Company is an incredible investment opportunity as the services Cryoport provide are crucial to the development of the next stage of the life sciences industry and cellular therapies, in particular.”

Jerrell Shelton, CEO of Cryoport, said, “The appointment of such a notable cellular therapy industry participant as Dr. Robert Hariri speaks volumes about Cryoport’s positioning within the advancing life sciences markets, including stem cells; immunotherapies, especially CAR-T cell therapies; animal husbandry; and human reproductive medicine.  Dr. Hariri will be an enormous asset to our company and its Board of Directors, as he brings wide ranging and extensive experience within cellular and regenerative therapies.”

“Cryoport’s services as applied in cellular and regenerative medicines achieve the highest possible standards in cold chain logistics, especially as related to standardizing cell cryopreservation during shipment packaging, shipping, information, and, sometimes, short duration storage. Dr. Hariri’s recognition of Cryoport as the most advanced cryogenic logistics solution in the world is a tribute to the Cryoport team and the services provided by the company,” concluded Shelton.

Conference Call
Cryoport will host a conference call at 4:30 p.m. ET on Monday, October 5, 2015 to introduce Dr. Robert Hariri.  Participants should dial 1-888-504-7963 (United States) or 1-719-325-2432 (International) and request the “Cryoport call.” A live audio webcast of the call will also be available on the Investor Relations section of the Company’s website at www.cryoport.com. Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the webcast will be available approximately two hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.cryoport.com for a limited time.  A dial-in replay of the call will also be available to those interested until October 12, 2015.  To access the replay, dial 1-877-870-5176 (United States) or 1-858-384-5517 (International) and enter replay pin number: 373591.

About Cryoport, Inc.
Cryoport is the premier provider of cryogenic logistics solutions to the life sciences industry through its purpose-built proprietary packaging, information technology and specialized cold chain logistics expertise. The Company provides leading edge logistics solutions for biologic materials, such as immunotherapies, stem cells, CAR-T cells and reproductive cells for clients worldwide. Leading global companies, such as FedEx, UPS and DHL have each separately selected Cryoport as the preferred cryogenic logistics provider for time- and temperature-sensitive biological material. Cryoport actively supports points-of-care, CRO’s, central laboratories, pharmaceutical companies, contract manufacturers and university researchers. For more information, visit www.cryoport.com.

To download Cryoport’s investor relations app, which offers access to SEC documents, press releases, videos, audiocasts and more, please click to download from your iPhone and iPad or  Android mobile device.

Forward Looking Statements
Statements in this news release which are not purely historical, including statements regarding Cryoport, Inc.’s intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. It is important to note that the company’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties associated with the effect of changing economic conditions, trends in the products markets, variations in the company’s cash flow, market acceptance risks, and technical development risks. The company’s business could be affected by a number of other factors, including the risk factors listed from time to time in the company’s SEC reports including, but not limited to, the annual report on Form 10-K for the year ended March 31, 2015. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Cryoport, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

Thursday, October 1st, 2015 Uncategorized Comments Off on (MYOS) (CYRX) Cryoport Appoints Robert Hariri, MD, PhD to its Board of Directors

(SRPT) Pivotal Phase IIb Eteplirsen Additional Long-Term Efficacy and Safety Data

— Eteplirsen provided a statistically significant 6 minute walk test advantage of 151 meters at three years compared to an external control —

— Fourth muscle biopsy results confirm increased dystrophin production in nearly all eteplirsen-treated patients and exon skipping in 100 percent of patients —

— Eteplirsen safety profile remains consistent with prior results —

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced additional clinical efficacy and safety data from the Company’s Phase IIb program of eteplirsen in patients with Duchenne muscular dystrophy (DMD). The data demonstrated that eteplirsen provided a statistically significant advantage of 151 meters in the ability of study participants to walk at three years, compared with external controls. Further, the fourth biopsy data confirmed the mechanism of action of eteplirsen, demonstrating exon skipping in all patients and dystrophin production in nearly all patients. Safety data remained consistent with prior results.

Eteplirsen, Sarepta’s lead drug candidate, is designed to target the underlying cause of DMD by enabling the production of a functional dystrophin protein in patients with mutations amenable to exon 51 skipping. Approximately 13 percent of people with DMD are estimated to have a mutation targeted by eteplirsen/exon 51 skipping.

“We are encouraged by the positive clinical outcomes, such as the statistically significant difference in the 6MWT in eteplirsen-treated patients compared to a control, especially since we see them accompanied by data that continues to demonstrate exon skipping and dystrophin production in most patients,” said Edward Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. “We are committed to bringing eteplirsen and our other investigational exon skipping therapies to patients with DMD and will continue to work with all stakeholders to advance these programs as quickly as possible so we can better address the unmet need for treatments in the DMD community.”

Results of Sarepta’s Phase IIb program were included in the New Drug Application (NDA) that Sarepta submitted to the U.S. Food and Drug Administration (FDA) for eteplirsen for the treatment of DMD amenable to exon 51 skipping. The primary clinical endpoint in the NDA was the comparison of the 6MWT ITT analysis of the eteplirsen-treated group compared to an external control with similar inclusion criteria. The FDA granted eteplirsen Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) action date of February 26, 2016. Previously, the FDA granted Rare Pediatric Disease Designation to eteplirsen, as well Orphan Drug Designation and Fast Track Status.

New Long-Term Efficacy Data

  • Patients who were treated with eteplirsen experienced a statistically significant 151 meter difference in the 6-minute walk test (6MWT) at three years compared with external DMD controls. The 6MWT is a well-accepted measure of ambulation and clinical function in patients with DMD. (p<0.01).
  • Eteplirsen-treated patients had a lower rate of loss of ambulation than external DMD controls over three years.
  • Eteplirsen-treated patients experienced a slower rate of decline through Week 192 than external DMD controls.
  • Pulmonary function remained relatively stable through approximately four years in eteplirsen-treated patients.

New results from a fourth biopsy performed on 11 patients demonstrated that exon skipping occurred in 100 percent of patients after 180 weeks of treatment, confirming the mechanism of action of eteplirsen. In addition, biochemical evidence from three quantification methods, analysis of dystrophin positive fibers, dystrophin intensity and Western Blot testing, confirmed that dystrophin was present in most patients following eteplirsen treatment.

Fourth Biopsy Results

  • Confirmed exon skipping in 100% of patients
  • Percent dystrophin-positive fibers increased (p<0.001) in comparison to untreated controls
  • Dystrophin intensity increased (p<0.001) in comparison to untreated controls
  • Western Blot confirmed presence of dystrophin protein in 9 of 11 (82%) of eteplirsen-treated patients at Week 180 vs 1 of 9 (11%) in the DMD control biopsies

New Long-Term Safety Data

New results from Sarepta’s safety database, which includes approximately 100 patients exposed to eteplirsen, showed that the eteplirsen safety profile remained consistent with prior results. Common adverse drug reactions included flushing, erythema, and mild temperature elevation. No pulmonary embolisms, hospitalizations, injection site reactions or thrombocytopenia have been observed.

Webcast & Conference Call

Sarepta will provide a corporate update and report on recent data from the Phase IIb study of eteplirsen for Duchenne muscular dystrophy via a live webcast and conference call on October 1, 2015 at 7:00 AM EST. The update will be followed by a panel discussion with Duchenne muscular dystrophy experts Anne Connolly, MD; Eugenio Mercuri, MD, PhD; Jerry Mendell, MD; Perry Shieh, MD, PhD; and Steve Wilton, PhD, BSc.

The presentation will be webcast live under the investor relations section of Sarepta’s website at www.sarepta.com and will be archived there for 90 days. Please connect to Sarepta’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

The conference call may be accessed by dialing 877-727-3245 for US domestic callers and 530-379-4673 for international callers. The passcode for the call is 48471076. Please specify to the operator that you would like to join the “Sarepta Corporate Update and Report on Recent Data.”

About the 6-Minute Walk Test (6MWT)

The 6MWT was developed as an integrated assessment of cardiac, respiratory, circulatory, and muscular capacity for use in clinical trials of various cardiac and pulmonary conditions. In recent years, the 6MWT has been adapted to evaluate functional capacity in neuromuscular diseases and has served as the basis for regulatory approval of a number of drugs for rare diseases, with mean changes in the 6MWT ranging from 28 to 44 meters. Additionally, published data from longitudinal natural history studies assessing dystrophinopathy, a disease continuum comprised of DMD and Becker muscular dystrophy, support the utility of the 6MWT as a clinically meaningful endpoint in DMD. These data show that boys with DMD experience a significant decline in walking ability compared to healthy boys over one year, suggesting that slowing the loss of walking ability is a major treatment goal.

About Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. One of the most common fatal genetic disorders, DMD affects approximately one in every 3,500 boys born worldwide. A devastating and incurable muscle-wasting disease, DMD is associated with specific errors in the gene that codes for dystrophin, a protein that plays a key structural role in muscle fiber function. Progressive muscle weakness in the lower limbs spreads to the arms, neck and other areas. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. The condition is universally fatal, and death usually occurs before the age of 30.

About Eteplirsen

Eteplirsen is designed to address the underlying cause of DMD by enabling the production of a functional dystrophin protein. Eteplirsen uses Sarepta’s novel phosphorodiamidate morpholino oligomer (PMO)-based chemistry and proprietary exon-skipping technology to skip exon 51 of the dystrophin gene. This enables the repair of specific genetic mutations that affect approximately 13 percent of people with DMD. By skipping exon 51, eteplirsen may restore the gene’s ability to make a shorter, but still functional, form of dystrophin from messenger RNA (mRNA). Promoting the synthesis of a truncated dystrophin protein is intended to stabilize or significantly slow the disease process and prolong and improve the quality of life for patients with DMD. Eteplirsen has not been approved by the FDA or any regulatory authority for the treatment of DMD.

Data from clinical studies of eteplirsen in DMD patients have demonstrated a broadly favorable safety and tolerability profile and restoration of dystrophin protein expression.

About Sarepta Therapeutics

Sarepta Therapeutics is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and other diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including its lead DMD product candidate, eteplirsen, designed to skip exon 51. Sarepta is also developing therapeutics for the treatment of infectious diseases, such as drug-resistant bacteria and other rare human diseases. For more information, please visit us at www.sarepta.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the safety and efficacy of eteplirsen, analysis of eteplirsen and external control data and their implications, eteplirsen’s potential as a treatment for Duchenne Muscular Dystrophy and its potential market size and Sarepta’s commitment to bringing eteplirsen and its other exon skipping investigational therapies to patients with DMD and plans to continue working with all stakeholders to advance these programs as quickly as possible. Forward-looking statements also include those regarding Sarepta’s future business developments and actions and the timing of the same.

These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: the results of our ongoing research and development efforts and clinical trials for eteplirsen and our other product candidates may not be positive or consistent with prior results or demonstrate a safe treatment benefit there may be delays in Sarepta’s projected regulatory and development timelines relating to the eteplirsen NDA and plans for commercializing eteplirsen and developing Sarepta’s other product candidates for various reasons including possible limitations of Sarepta’s financial and other resources; Sarepta may not be able to successfully complete its planned commercialization of eteplirsen or continue developing its product candidates as planned for a variety of reasons including due to regulatory, court or agency decisions, such as decisions by the USPTO with respect to patents that cover Sarepta’s product candidates, scale-up of manufacturing may not be successful, and any or all of Sarepta’s product candidates may fail in development or may not receive required regulatory approvals for commercialization (including potentially under an accelerated pathway); and those risks identified under the heading “Risk Factors” in Sarepta’s 2014 Annual Report on Form 10-K or and most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect Sarepta’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the Company’s filings with the SEC. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Internet Posting of Information

We routinely post information that may be important to investors in the ‘For Investors’ section of our website at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

 

Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
iestepan@sarepta.com
or
W2O Group
Ryan Flinn, 415-946-1059
Mobile: 510-207-7616
rflinn@w2ogroup.com

Thursday, October 1st, 2015 Uncategorized Comments Off on (SRPT) Pivotal Phase IIb Eteplirsen Additional Long-Term Efficacy and Safety Data

(XOMA) Development & Commercialization First-in-Class Anti-TGF-beta Antibody

  • $37.0 million upfront payment
  • $13.5 million loan maturity date extended to September 2020
  • Potential milestone payments of up to $480.0 million
  • Royalties tiered from mid-single digits to low double digits

BERKELEY, Calif., Oct. 1, 2015  — XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today it has exclusively licensed the global development and commercialization rights to its anti-transforming growth factor-beta (TGFb) antibody program to Novartis. Under the terms of the agreement, XOMA will receive $37.0 million in the form of an upfront payment and is eligible to receive up to $480.0 million if all development, regulatory, and commercial milestones are met. In addition, XOMA is eligible to receive royalties on product sales that range from the mid-single digits to the low double digits. In connection with this license agreement, Novartis has agreed to extend the maturity date on the approximately $13.5 million of outstanding debt under the secured note agreement, which bears interest at the six-month LIBOR plus 2% (currently 2.53%), to September 30, 2020. XOMA has also agreed to reduce the royalty rate to XOMA associated with Novartis’ clinical stage anti-CD40 antibodies.

“XOMA and Novartis have worked closely together for several years to develop new product candidates. When they expressed interest in our anti-TGFb program, we knew Novartis was the best company to bring this exciting potential therapy to the patients whom it may help,” stated John Varian, Chief Executive Officer of XOMA. “Novartis is recognized as a leader in oncology, where an anti-TGFb molecule has real potential either as monotherapy or in combination with other therapeutic options.

“We had said we did not plan to raise equity capital at our recent stock price in order to fund the development of our very exciting endocrine portfolio. With this non-dilutive liquidity of essentially $50.5 million, we currently project this capital, in combination with our planned cost savings measures, will fund operations into 2017. We remain on track to begin our XOMA 358 Phase 2 clinical program this fall and fully anticipate we will have the data from these studies during that timeframe,” concluded Mr. Varian.

About TGF-beta

Transforming growth factor-beta (TGFb) is a potent immune suppressive cytokine that is involved in many cellular processes, including inhibition of cell growth and immune suppression. While TGFb is essential for normal tissue homeostasis, elevated levels of TGFb may drive the progression of numerous diseases, including advanced metastatic cancer and fibrosis.

Three isoforms of TGFb exist in humans: TGFb1, 2 and 3. TGFb1 is overexpressed in many cancers and is believed to increase the likelihood of metastasis. Inhibiting TGFb1 and 2 while sparing TGFb3 may reduce tumor-protecting regulatory T cells, while allowing for the development of cytotoxic immune responses enhanced by TGFb3, improving the therapeutic index of TGFb inhibitors. Given the role of the TGFb pathway in cancer, it has become an attractive target for cancer drug development.

About XOMA 089

Discovering the TGFb antibody program was made possible because of XOMA’s proprietary antibody discovery technology platform. XOMA 089 is a fully human, high-affinity, late preclinical monoclonal antibody that neutralizes TGFb1 and 2 while sparing TGFb3. Data have shown this compound to be both active against tumor growth in preclinical models of head and neck cancer as well as breast cancer and breast cancer metastasis. Preclinical data also suggest that it may be synergistic with PD1 inhibition and work highlighting these results was recently presented at the 2015 FASEB meeting on the TGFb Superfamily: Signaling in Development and Disease. XOMA has made significant progress regarding this lead compound on both the understanding of its activity, mechanism of action, as well as preclinical toxicology and manufacturing. Other antibodies included in this license agreement inhibit TGFb1, which may be a more appropriate approach to certain indications. These antibodies have potential in immuno-oncology either as a monotherapy and may be particularly amenable to combination therapies, especially with immune checkpoint inhibitors.

About XOMA Corporation

XOMA Corporation is a leader in the discovery and development of therapeutic antibodies. The Company’s innovative product candidates result from the Company’s expertise in developing ground-breaking monoclonal antibodies, including allosteric antibodies, which have created new opportunities to potentially treat a wide range of human diseases. XOMA’s scientific research has produced a portfolio of six endocrine assets, each of which has the opportunity to address multiple indications. The Company’s lead product candidate, XOMA 358, is an allosteric monoclonal antibody that reduces both the binding of insulin to its receptor and down-regulates insulin signaling, which could have a major effect on the treatment of hyperinsulinism. For more information, visit www.xoma.com.

Forward-Looking Statements

Certain statements contained in this press release including, but not limited to, statements related to therapeutic potential of our product candidates, anticipated timing of clinical trials, anticipated timing of the release of clinical data, the anticipated process of clinical data analysis, the anticipated receipt by XOMA of royalty or milestone payments, cost savings and anticipated cost savings and capital reserves and cost saving activities or statements that otherwise relate to future periods are 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. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Potential risks to XOMA meeting these expectations are described in more detail in XOMA’s most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA’s prospects. Any forward-looking statement in this press release represents XOMA’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.

CONTACT: Investor Contacts:
         Ashleigh Barreto, XOMA Corporation
         510-204-7482
         barreto@xoma.com

         Juliane Snowden, The Oratorium Group, LLC
         jsnowden@oratoriumgroup.com

         Media Contact:
         Ryan Flinn, W2O Group
         415-946-1059
         rflinn@w2ogroup.com
Thursday, October 1st, 2015 Uncategorized Comments Off on (XOMA) Development & Commercialization First-in-Class Anti-TGF-beta Antibody

(NSPR) Announces One-for-Ten Reverse Stock Split

BOSTON, MA–(Oct 1, 2015) – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today a one-for-ten reverse split of its common stock, effective as of 12:00 am Eastern Time on October 1, 2015. Beginning with the opening of trading on October 1, 2015, the Company’s common stock will trade on the NYSE MKT on a split adjusted basis. In addition, the number of authorized shares of the Company’s common stock was decreased from 125 million to 50 million.

As previously disclosed, at InspireMD’s Annual Meeting on September 9, 2015, the Company’s stockholders authorized the Board of Directors to amend the Amended and Restated Certificate of Incorporation of the Company to effect a reverse stock split at a ratio of one-for-ten and to reduce the number of authorized shares of its common stock.

Upon the effectiveness of the reverse stock split, every ten (10) shares of InspireMD common stock outstanding automatically combine into one (1) new share of common stock with no change in par value per share. Proportionate adjustments will be made to (i) the per share exercise price and the number of shares of common stock that may be purchased upon exercise of outstanding stock options and warrants to purchase shares of the Company’s common stock and (ii) the number of authorized shares of common stock reserved for future issuance under the Company’s equity compensation plans.

The Company’s common stock will continue to trade on the NYSE MKT under the symbol “NSPR.” The new CUSIP number for the common stock following the reverse stock split is 45779A507. No fractional shares will be issued following the reverse stock split. Any fractional shares resulting from the reverse stock split will be rounded up to the next whole share.

Registered Stockholders holding their shares of common stock in book-entry or through a bank, broker or other nominee form do not need to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Action Stock Transfer Corp, will send instructions for exchanging those certificates for new certificates representing the post-split number of shares. Action Stock Transfer Corp can be reached at (801) 274-1088.

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 July 29, 2015, a copy of which is also available at www.sec.gov or at www.inspiremd.com under the SEC Filings tab located on the Investors page.

About InspireMD, Inc.
InspireMD (www.inspiremd.com) seeks to utilize its proprietary MGuard™ with MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

InspireMD intends to pursue applications of this MicroNet technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

About CGuard™ EPS
The proprietary CGuard™ Embolic Prevention System (EPS) uses the same MicroNet™ technology featured on the MGuard™ and MGuard Prime™ coronary Embolic Protection Systems. The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.

MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate.
CGuard™ EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:
InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804
Email: craigs@inspiremd.com

PCG Advisory
Vivian Cervantes
Investor Relations
Phone: (212) 554-5482

Thursday, October 1st, 2015 Uncategorized Comments Off on (NSPR) Announces One-for-Ten Reverse Stock Split

(EZCH) Mellanox Announces Definitive Agreement to Acquire EZchip

  • Combines highly successful teams, technologies, and products
  • Addresses large, growing markets, and expands opportunity within customer bases
  • Provides advanced, intelligent end-to-end interconnect solutions and processing capabilities that enable superior performance for data-intensive applications in Web 2.0, cloud, Big Data, telecom, secure data center, and storage
  • Expects accretive non-GAAP EPS impact from day one

Mellanox® Technologies, Ltd. (NASDAQ:MLNX), a leading supplier of end-to-end interconnect solutions for servers and storage systems, and EZchip (NASDAQ:EZCH) (TASE:EZCH), a leader in high-performance processing solutions for carrier and data center networks, announced today that they have entered into a definitive merger agreement under which Mellanox shall acquire 100 percent of EZchip’s outstanding ordinary shares for a cash purchase price of $25.5 per share implying a transaction value of approximately $811 million (approximately $620 million net of cash). The terms of the transaction have been unanimously approved by both the Mellanox and EZchip Boards of Directors.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20150930005470/en/

The EZchip acquisition is a step in Mellanox’s strategy to become the leading broad-line supplier of intelligent interconnect solutions for the software-defined data centers. The addition of EZchip’s products and expertise in security, deep packet inspection, video, and storage processing enhances Mellanox’s leadership position, and ability to deliver complete end-to-end, intelligent 10, 25, 40, 50, and 100Gb/s interconnect and processing solutions for advanced data center and edge platforms. The combined company will have diverse and robust solutions to enable customers to meet the growing demands of data-intensive applications used in high-performance computing, Web 2.0, cloud, secure data center, enterprise, telecom, database, financial services and storage environments.

“The synergies between EZchip and Mellanox create attractive opportunities. We expect our combined technologies, and product portfolios to deliver leading end-to-end intelligent interconnect and processing solutions to data centers and wide area networks,” said Eyal Waldman, president and CEO of Mellanox Technologies. “The new and emerging Web 2.0 and cloud applications that influence our day-to-day lives depend on fast data movement and processing. Mellanox’s interconnect provides the fastest and most-scalable solution for moving data within the data center, allowing the continuous development, use and expansion of these applications. EZchip’s processing solutions allow users to process and analyze, at wire speed, data both within and outside the data center. The solutions from the combined company will enable data center customers to meet the growing demands of data-intensive applications. We expect that the acquisition of EZchip’s technologies and team will better position us to offer further capabilities for smarter interconnect and processing solutions at 100Gb/s and beyond. As our second significant acquisition in Israel, we are confident in our ability to effectively integrate the talented teams from EZchip and Mellanox. We are looking forward to work together to build a successful company.”

“Joining forces with Mellanox represents numerous synergies that create a true powerhouse for connectivity and processing. With Mellanox’s leading layer 1 – 3 connectivity solutions for data centers and EZchip’s leading layer 3 – 7 processing solutions for carrier networks, the two companies complement each other in technology, products, markets served and customers. Together, we enable a multitude of layer 1 through 7 solutions for data centers and carriers,” said Eli Fruchter, CEO of EZchip. “I want to thank our shareholders and customers for their trust in us and our outstanding employees for building a winning company, a company that started fifteen years ago with many competitors and no customers, and became a market leader with leading-edge technology and products. We are delighted to join the Mellanox team and look forward to working together to drive the combined company’s further growth.”

Mellanox and EZchip each believe that employees represent one of their most important assets. Mellanox looks forward to combining employees from both organizations. Mellanox intends to retain both companies’ existing product lines, and will ensure continuity for customers and partners of both companies.

The combined businesses currently have approximately 2,400 employees, and have generated combined revenues of $668 million for the twelve months ended June 30, 2015.

The transaction is projected to close in the first quarter of 2016, subject to the completion of certain closing conditions. Mellanox expects the transaction to be non-GAAP accretive from day one.

Under the terms of the definitive agreement, EZchip shareholders will receive $25.5 for each ordinary share of EZchip that they hold at the closing of the transaction. Mellanox intends to fund the transaction with cash on hand from the combined companies and $300 million in fully-committed debt financing. The proposed acquisition is subject to customary closing conditions, including the receipt of applicable regulatory approvals and the approval of EZchip’s shareholders.

In connection with the transaction, J.P. Morgan acted as exclusive financial adviser and provided a financing commitment to Mellanox and Herzog Fox & Neeman and Latham & Watkins LLP acted as Mellanox’s legal counsel. Barclays acted as exclusive financial adviser to EZchip and Naschitz, Brandes, Amir & Co. and Carter Ledyard & Milburn LLP acted as EZchip’s legal counsel.

Conference Call

Mellanox and EZchip will jointly conduct a conference call to discuss Mellanox’s agreement to acquire EZchip at 5:30 a.m. Pacific Time, today, September 30, 2015. To listen to the call, dial +1-785-424-1666 approximately ten minutes prior to the start time. Presentation slides along with a webcast of the live and archived call will be available on the investor relations section of the Mellanox website at http://ir.mellanox.com.

Press Conference

Mellanox and EZchip will hold a press briefing in the Mellanox Tel Aviv office, Thursday, October 1, 10:00 a.m. Israel Time. In order to listen to the briefing, please use the following registration link: https://cc.readytalk.com/r/tr97vnkpv2kx&eom. On the confirmation mail, please click “Join Meeting.” Transcripts will be available as soon as practical on the investor relations section of the Mellanox website at http://ir.mellanox.com.

About EZchip

EZchip is a fabless semiconductor company that provides high-performance processing solutions for a wide range of applications for the carrier, cloud and data center networks. EZchip’s broad portfolio of solutions scales from a few to hundreds of Gigabits-per-second, and includes network processors, multi-core processors, intelligent network adapters, high-performance appliances and a comprehensive software ecosystem. EZchip’s processing solutions excel at providing great flexibility and high performance coupled with superior integration and power efficiency.

About Mellanox

Mellanox Technologies is a leading supplier of end-to-end InfiniBand and Ethernet interconnect solutions and services for servers and storage. Mellanox interconnect solutions increase data center efficiency by providing the highest throughput and lowest latency, delivering data faster to applications and unlocking system performance capability. Mellanox offers a choice of fast interconnect products: adapters, switches, software, cables and silicon that accelerate application runtime and maximize business results for a wide range of markets including high-performance computing, enterprise data centers, Web 2.0, cloud, storage and financial services. More information is available at www.mellanox.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements related to the acquisition of EZchip’s outstanding ordinary shares, the accretive non-GAAP earnings per share impact in fiscal 2016, the combined company’s technologies, product portfolios and markets, the synergies between Mellanox and EZchip, the growth of fast data movement and processing, the combined company’s capabilities for smarter interconnect and processing solutions at 100 Gb/s and beyond, the ability to effectively and efficiently integrate the team from EZchip, Mellanox’s intent to retain both companies’ existing product lines, the projected timing for closing of the acquisition and the intended source of funds for the acquisition. These forward-looking statements are based on Mellanox’s current expectations, estimates and projections about our industry and business, management’s beliefs and certain assumptions made by Mellanox, all of which are subject to change. Forward-looking statements can often be identified by words such as “projects,” “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” “ongoing,” similar expressions and variations or negatives of these words. These forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause our actual results to differ materially and adversely from those expressed in any forward-looking statement. More information about the risks, uncertainties and assumptions that may impact Mellanox, EZchip and the combined company’s business is set forth in Mellanox’s annual report on Form 10-K for the year ended December 31, 2014 filed with the Securities and Exchange Commission (SEC) on March 2, 2015 and in its quarterly report on Form 10-Q for the six months ended June 30, 2015, filed with the SEC on July 31, 2015, and in EZchip’s Annual Report on Form 20-F for the year ended December 31, 2014, filed with the Securities and Exchange Commission on March 31, 2015. Other risks, uncertainties and assumptions that could cause Mellanox, EZchip and the combined company’s actual results to differ materially from those projected may be described from time to time in reports Mellanox and EZchip file with the SEC, including reports Mellanox’s reports on Forms 10-Q and 8-K and EZchip’s reports on Form 6-K. Neither Mellanox nor EZchip undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Mellanox is a registered trademark of Mellanox Technologies, Ltd. All other trademarks are property of their respective owners.

Mellanox Press/Media Contact
McGrath/Power Public Relations and Communications
Allyson Scott, +1-408-727-0351
allysonscott@mcgrathpower.com
or
Mellanox Investor Contact
Mellanox Technologies
Gwyn Lauber, +1-408-916-0012
gwyn@mellanox.com
or
Mellanox Israel PR Contact
Gelbart Kahana Investor Relations
Sharon Levin, +972-3-6070567
sharonl@gk-biz.com
or
EZchip Investor Contact
EZchip
Jeffrey A Schreiner, +1-408-520-3676
jschreiner@ezchip.com
or
EZchip PR Contact
EZchip
Daureen Green, +972-4-959-6677
dgreen@ezchip.com

Wednesday, September 30th, 2015 Uncategorized Comments Off on (EZCH) Mellanox Announces Definitive Agreement to Acquire EZchip

(CLIR) Selected by Delek for Process Optimization

Company enters Texas market to support 75,000-barrel-per-day refinery operation

SEATTLE, Sept. 30, 2015  — ClearSign Combustion Corporation (NASDAQ: CLIR), an emerging leader in combustion and emissions control technology for industrial, commercial and utility markets, announced today it will install its Duplex™ technology at a Texas refinery owned by a subsidiary of Delek US Holdings, Inc. This agreement marks ClearSign’s entrance into the Texas market and the company’s fourth major refinery customer in recent months.

ClearSign will retrofit burners within a process heater at Delek’s 75,000-barrel-per-day refinery in Tyler, Texas. It is expected that ClearSign’s unique, patent-pending Duplex technology will eliminate potential flame impingement upon process tubes and reduce maintenance costs and downtime. Delek has expressed interest in retrofitting the Duplex technology into other process heaters if the initial installation proves the viability of ClearSign’s solution.

Lindale-based JLCC, Inc. will lead the contracting services for the project on behalf of ClearSign.

“The oil and gas industry has a need for practical, effective solutions that reduce impingement on process tubes which should improve utilization rates and operating conditions,” noted JLCC Founder Jerry Lang. “ClearSign’s Duplex technology offers the industry an economic, future-proof option to simultaneously remove operational bottlenecks while reducing NOx emissions.”

“We’ve gained considerable traction in recent months, and in two of the country’s leading oil and gas markets,” said Stephen Pirnat, CEO of ClearSign. “We look forward to demonstrating exceptional results in the field and further building on this momentum.”

About Delek US Holdings, Inc.

Delek US Holdings, Inc. is a diversified downstream energy company with assets in petroleum refining, logistics and convenience store retailing. The refining segment consists of refineries operated in Tyler, Texas and El Dorado, Arkansas with a combined nameplate production capacity of 155,000 barrels per day. Delek US Holdings, Inc. and its affiliates also own approximately 62 percent (including the 2 percent general partner interest) of Delek Logistics Partners, LP. Delek Logistics Partners, LP is a growth-oriented master limited partnership focused on owning and operating midstream energy infrastructure assets. The retail segment markets motor fuel and convenience merchandise through a network of approximately 360 company-operated convenience store locations operated under the MAPCO Express®, MAPCO Mart®, East Coast®, Fast Food and Fuel™, Favorite Markets®, Delta Express® and Discount Food Mart™ brand names. Delek US Holdings, Inc. also owns approximately 48 percent of the outstanding common stock of Alon USA Energy, Inc.

About ClearSign Combustion Corporation

ClearSign Combustion Corporation designs and develops technologies that aim to improve key performance characteristics of combustion systems including energy efficiency, emissions control, fuel flexibility and overall cost effectiveness. Our patent-pending Duplex™ and Electrodynamic Combustion Control™ platform technologies improve control of flame shape and heat transfer and optimize the complex chemical reactions that occur during combustion in order to minimize harmful emissions. For more information about the Company, please visit www.clearsign.com.

Cautionary note on forward-looking statements

This press release includes forward-looking information and statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding our assumptions, projections, expectations, targets, intentions or beliefs about future events that are based on management’s belief, as well as assumptions made by, and information currently available to, management. While we believe that our expectations are based upon reasonable assumptions, there can be no assurances that our goals and strategy will be realized. Numerous factors, including risks and uncertainties, may affect our actual results and may cause results to differ materially from those expressed in forward-looking statements made by us or on our behalf. Some of these factors include the acceptance of existing and future products, the impact of competitive products and pricing, general business and economic conditions, and other factors detailed in our Quarterly Report on Form 10-Q and other periodic reports filed with the SEC. We specifically disclaim any obligation to update or revise any forward-looking statement whether as a result of new information, future developments or otherwise.

Wednesday, September 30th, 2015 Uncategorized Comments Off on (CLIR) Selected by Delek for Process Optimization

(CXRX) Completes $520 Million Public Offering

OAKVILLE, ON, Sept. 30, 2015  – Concordia Healthcare Corp. (“Concordia” or the “Company”) (NASDAQ: CXRX) (TSX: CXR) today announced that, further to its September 24, 2015 press release, it has completed its underwritten public offering (the “Offering”) of 8,000,000 common shares of Concordia for aggregate gross proceeds of US$520 million.

The Offering was completed at a price per share of US$65.00 (the “Offering Price”) by a syndicate of underwriters led by Goldman, Sachs & Co. and RBC Capital Markets, as lead book running managers, and Credit Suisse Securities (USA) LLC and Jefferies LLC, as additional book running managers, together with the Canadian affiliates of certain of the book running managers (the “Underwriters”). The Company also has granted the Underwriters an option to purchase up to an additional 1,200,000 common shares of Concordia at the Offering Price, exercisable at any time, and from time to time, in whole or in part, up to 30 days after and including the closing date of the Offering.

The Company intends to use the net proceeds of the Offering to fund in part the purchase price and costs related to the acquisition of Amdipharm Mercury Limited (“AMCo”), which the Company expects to close during the fourth quarter of 2015. The Company expects to finance the balance of the purchase price through a combination of term loans and a private placement of non-convertible debt securities, and has committed financing from certain of the Underwriters to pay for the purchase price of AMCo, to refinance all outstanding term loans or indebtedness for borrowed money of AMCo, and to repay certain existing debt of Concordia.

As previously announced, the Company entered into an agreement to acquire London-based AMCo earlier this month. The purchase price for the acquisition will consist of cash consideration of approximately £800 million (approximately US$1.2 billion), a fixed amount of 8.49 million common shares of the Company, and the repayment of AMCo’s existing debt of approximately US$1.4 billion (senior secured facilities of £581 million and €440 million), plus accrued interest and related cross-currency swaps. In addition, Concordia will pay £272,801 (approximately US$414,000), and a maximum cash earn-out of £144 million (approximately US$220 million) based on AMCo’s future gross profit over a period of 12 months from October 1, 2015.

No securities regulatory authority has either approved or disapproved the contents of this press release. This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About Concordia

Concordia is a diverse healthcare company focused on legacy pharmaceutical products and orphan drugs. Concordia’s legacy pharmaceutical division, Concordia Pharmaceuticals Inc., consists of a portfolio of branded products and authorized generic contracts, including branded products such as Nilandron®, for the treatment of metastatic prostate cancer; Dibenzyline®, for the treatment of pheochromocytoma; Lanoxin®, for the treatment of mild-to-moderate heart failure and atrial fibrillation; Plaquenil®, for the treatment of lupus and rheumatoid arthritis, Donnatal® for the treatment of irritable bowel syndrome and Zonegran® (zonisamide) for treatment of partial seizures in adults with epilepsy. Concordia’s orphan drugs division owns Photofrin®. Photofrin® is marketed by Pinnacle Biologics, Inc. in the United States.

Concordia operates out of facilities in Oakville, Ontario; Bridgetown, Barbados; Roanoke, Virginia and has a specialty healthcare distribution (SHD) division that operates out of Kansas City, Missouri. Pinnacle Biologics, Inc. is located in Chicago, Illinois.

Notice regarding forward-looking statements:

This news release includes forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of Canadian securities laws, regarding Concordia and its business, which may include, but are not limited to the exercise of the Underwriters’ Option, the use of proceeds of the Offering, the completion of the term loans and the private placement of notes and the completion of the acquisition of AMCo. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of Concordia’s management, and are based on assumptions and subject to risks and uncertainties. Although Concordia’s management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks relating to Concordia’s securities, the Acquisition, the pharmaceutical industry and the regulation thereof, economic factors, the equity and debt markets generally, general economic and stock market conditions and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

Wednesday, September 30th, 2015 Uncategorized Comments Off on (CXRX) Completes $520 Million Public Offering

(MDWD) Awarded BARDA Contract Valued Up to $112 Million

Contract Highlights Product’s Merit and Therapeutic Impact, as well as Potential Role in Mass Casualty Preparedness

YAVNE, Israel, Sept. 30, 2015  — MediWound Ltd. (Nasdaq:MDWD), a fully integrated biopharmaceutical company specializing in innovative therapies to address unmet needs in severe burn and wound management, announces that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has awarded the Company a contract valued at up to $112 million. The contract is for the advancement of the development and manufacturing, as well as the procurement of NexoBrid®, the Company’s proprietary pharmaceutical product for enzymatic removal of eschar in adults with deep-partial and full-thickness thermal burns, as a medical countermeasure as part of BARDA preparedness for mass casualty events.

The five-year base contract includes $24 million of funding to support development activities to complete the U.S. Food and Drug Administration (FDA) approval process for NexoBrid for use in thermal burn injuries, as well as $16 million for procurement of NexoBrid, which is contingent upon FDA Emergency Use Authorization (EUA) and/or FDA marketing authorization for NexoBrid. In addition, the contract includes options for further funding of up to $22 million for expanding NexoBrid’s indications and of up to $50 million for additional procurement of NexoBrid.

“BARDA’s commitment underscores the important role NexoBrid might play in preparing for mass casualty events where subsequent surgical capacity is limited and rapid severity assessment and intervention are imperative,” stated Gal Cohen, President and Chief Executive Officer of MediWound. “This non-dilutive funding provides important recognition of the potential merits of NexoBrid and the therapeutic impact of our technology, as well as provides significant support for our ongoing clinical development and manufacturing programs. This contract frees up a portion of the Company’s proceeds raised during the IPO, which were initially intended for use in clinical development of NexoBrid and now can be used to further advance our pipeline.  We are very happy to join forces with the U.S. government in support of its preparedness programs for mass casualty events. We look forward to working with BARDA to have NexoBrid available for burn patients in the U.S.”

The challenges of providing definitive burn care are heightened when delivering treatment after a mass casualty event in a resource-strained environment. The Government Accountability Office reports that in a mass casualty event, more than 10,000 patients might require thermal burn care, which will create bottlenecks in the ability to provide quality treatment and care for victims. Effective and rapid non-surgical debridement would increase treatment capacity to provide definitive wound healing to burn injuries. The use of non-surgical means that are capable of providing fast debridement without harming healthy tissues, particularly during public health emergencies, could potentially reduce the time, labor and resource burdens associated with the current standard-of-care, thereby enabling the treatment of more patients.

NexoBrid represents a new paradigm in burn care management having demonstrated in clinical studies, with statistical significance, its ability to non-surgically and rapidly remove in a single, four-hour application the dead or the damaged tissue (eschar) earlier than other modalities, without harming viable tissue. In clinical studies NexoBrid has demonstrated a significant reduction in surgical burden with long-term outcomes that are comparable to the current surgical treatment. NexoBrid was granted marketing authorization from the European Medicines Agency and the Israeli Ministry of Health for the removal of eschar in adults with deep partial and full-thickness thermal burns, and has been launched in Europe and Israel. MediWound is currently conducting a Phase 3 clinical study with NexoBrid in the U.S. for the removal of eschar in adults with deep-partial and full-thickness thermal burns.

“In addition to the U.S. government’s interest in NexoBrid in preparing for burn mass casualty events, last fall the Disaster Committee of the International Society for Burn Injuries (ISBI) recommended inclusion of NexoBrid in their draft plan for mass casualty events, as they too see a role for NexoBrid in providing relief in the expected bottleneck in hospitals after such disasters. We look forward to working with various international agencies and with governments to advance the use of NexoBrid for mass casualty and disaster preparedness, as well as in military medicine,” added Mr. Cohen.

About BARDA

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies.

About Emergency Use Authorization (EUA)

The Emergency Use Authorization (EUA) allows FDA to help strengthen the U.S. public health protections against chemical, biological, radiological, and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. Under the Federal Food, Drug, and Cosmetic Act, the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

About MediWound Ltd.

MediWound is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, as well as chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency and from the Israeli Ministry of Health for removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns. NexoBrid represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier and, without harming viable tissues. For more information, please visit www.mediwound.com.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecast, commercial results, clinical trials and the regulatory authorizations. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on MediWound’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, unexpected results of clinical trials, delays or denial in the FDA or the EMA regulatory approval process, or additional competition in the market. In particular, you should consider the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2014 and information contained in other documents filed with or furnished to the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The forward-looking statements made herein speak only as of the date of this announcement and MediWound undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Contacts: Anne Marie Fields
Sharon Malka Senior Vice President
Chief Financial & Operation Officer LHA
MediWound Ltd. 212-838-3777
ir@mediwound.co.il afields@lhai.com
Wednesday, September 30th, 2015 Uncategorized Comments Off on (MDWD) Awarded BARDA Contract Valued Up to $112 Million

(BLPH) Announces Clinical Trial Functional Respiratory Imaging Data

HAMPTON, N.J., Sept. 30, 2015  — Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, announced that an oral presentation of late-breaking data from a clinical trial sponsored by the Company was presented today at the European Respiratory Society (ERS) International Congress 2015 in Amsterdam. The data showed that INOpulse®, an inhaled treatment of nitric oxide entering phase 3 testing for the treatment of pulmonary arterial hypertension, improved vasodilation in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (COPD). The abstract titled “Pulmonary vascular effects after pulsed inhaled NO evaluated by functional respiratory imaging (FRI)” was presented by W. De Backer, M.D., Director Department of Pulmonary Medicine, University Hospital and University of Antwerp. The presentation was in the session: “Pulmonary hypertension: new treatment insights” chaired by Professor Marc Humbert and Professor H. Areschir Ghofrani. The abstract presentation may be viewed at www.bellerophon.com, under the Investors Tab.

In the trial, 6 subjects (3 male and 3 female between the ages of 65-79) with pulmonary hypertension associated with COPD on long-term oxygen therapy were given an acute dose of INOpulse inhaled nitric oxide. Following treatment, the subjects underwent functional respiratory imaging to determine the geometry of their lungs, airway and pulmonary vascular structures.

In all of the subjects, administration of inhaled nitric oxide resulted in increased blood volume in the blood vessels in the lungs while also preserving oxygen saturation following treatment. Anecdotally, all patients in the trial reported having felt better following the treatment.

Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, stated, “We continue to be encouraged by the progress we are making in the development of INOpulse as a potential treatment for pulmonary hypertension. This late-breaker session at the ERS Congress builds on earlier studies indicating that INOpulse has the potential to reduce pulmonary hypertension in COPD patients. In the next several months, we plan to test the effect of reducing pulmonary hypertension on exercise capacity for these patients.”

About Pulmonary Hypertension

Pulmonary hypertension is a rare lung disorder in which the arteries that carry blood from the heart to the lungs become narrowed, making it difficult for blood to flow through the vessels. As a result, the blood pressure in these arteries — called pulmonary arteries — rises far above normal levels. This abnormally high pressure strains the right ventricle of the heart, causing it to expand in size. Overworked and enlarged, the right ventricle gradually becomes weaker and loses its ability to pump enough blood to the lungs. This could lead to the development of right heart failure.

About Bellerophon

Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary and cardiac diseases. The Company is currently developing two product candidates under its INOpulse® program, a proprietary pulsatile nitric oxide delivery device. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company intends to commence Phase 3 clinical trials in 2015, and the other for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), which is in Phase 2 development. The Company’s plans also call for the completion of further work on the use of INOpulse to treat pulmonary hypertension associated with COPD and idiopathic pulmonary fibrosis during 2016. Additionally, management is reviewing alternative paths forward for its Bioabsorbable Cardiac Matrix program. For more information, please visit www.bellerophon.com.

Forward-looking Statements

Any statements in this press release about Bellerophon’s future expectations, plans and prospects, including statements about the clinical development of its product candidates and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, and other factors discussed in the “Risk Factors” section of the Company’s most recent filings with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent Bellerophon’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

CONTACT: At Bellerophon:
         Amy Edmonds, Vice President
         Head of Clinical Operations &
         Administration
         (908) 574-4765

         At Rx Communications Group:
         Melody Carey
         (917) 322-2571
Wednesday, September 30th, 2015 Uncategorized Comments Off on (BLPH) Announces Clinical Trial Functional Respiratory Imaging Data

(ISCO) Develops Technology to Replace Cartilage

CARLSBAD, CA–(September 30, 2015) – International Stem Cell Corporation (OTCQB: ISCO)(www.internationalstemcell.com, ISCO or the Company), a California-based biotechnology company developing novel stem cell-based therapies, today announced that the Company’s scientific team has developed a robust innovative technology to generate functional articular cartilage from the patient’s own skin or adipose tissue to treat osteoarthritis. This breakthrough technology may allow ISCO to not only address the therapeutic needs of patients suffering from osteoarthritic knee joints, but to also treat those with shoulder joints and intervertebral spinal disk osteoarthritis.

“While we are working on obtaining regulatory approval for the Parkinson’s disease treatment in Australia, as well as in the US, we are also pursuing a number of other therapeutic indications including osteoarthritis, which can potentially be treated with the patient’s own cells,” commented ISCO’s chief scientific officer, Ruslan Semechkin, PhD.

Despite the high prevalence of osteoarthritis, currently there is a lack of an effective treatment for this disease. ISCO developed and successfully tested a scalable system that permits the generation of functional human cartilage tissue with superior mechanical properties and, more importantly, the capacity to provide greater stability than other tissue that is currently available for the treatment of osteoarthritis.

Osteoarthritis is a degenerative joint disease characterized by progressive erosion of the articular cartilage. Although osteoarthritis can damage any joint in the body, the disorder most commonly affects joints in the hands, knees, hips and spine. The erosion of articular cartilage leads to joint pain, stiffness, and impaired mobility. According to the Arthritis foundation osteoarthritis affects over 27 million Americans with an estimated medical costs of as much as $65 billion.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell.

Safe harbor statement

Statements pertaining to anticipated developments, expected clinical studies (including timing and results), progress of research and development, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Contact

International Stem Cell Corporation
Ruslan Semechkin, PhD
Phone: 760-940-6383
Email: ir@intlstemcell.com

Media:
Christopher R. Hippolyte
Phone: +1-646-942-5634
Email: chris.hippolyte@russopartnersllc.com

Tony Russo, Ph.D.
Phone: (212) 845-4251
Email: tony.russo@russopartnersllc.com

Wednesday, September 30th, 2015 Uncategorized Comments Off on (ISCO) Develops Technology to Replace Cartilage

(APPS) Announces Pricing of Public Offering of Common Stock

AUSTIN, Texas, Sept. 29, 2015  — Digital Turbine, Inc. (Nasdaq: APPS), the company empowering mobile operators and Original Equipment Manufacturers (“OEMs”) around the globe with end-to-end mobile solutions, today announced the pricing of its public offering of 7,600,000 shares of common stock at a price to the public of $1.57 per share.

The net proceeds to Digital Turbine from this offering are expected to be approximately $11.2 million, after deducting underwriting discounts. In addition, Digital Turbine has also granted the underwriter a 30-day option to purchase up to 1,140,000 additional shares of common stock.

The Company expects to use the net proceeds from the offering for organic business opportunities, product development, general corporate purposes, working capital and capital expenditures.

B. Riley & Co., LLC is acting as the underwriter for the offering. The offering is expected to close on or about October 2, 2015, subject to customary closing conditions.

The public offering will be made pursuant to a shelf registration statement on Form S-3 filed with the Securities Exchange Commission (“SEC”). A prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and when filed will be available on the SEC’s website located at http://www.sec.gov. The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained from B. Riley & Co., LLC, 11100 Santa Monica Blvd., Suite 800, Los Angeles, California 90025.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Digital Turbine
Digital Turbine works at the convergence of media and mobile communications, delivering end-to-end products and solutions for mobile operators, app advertisers, device OEMs and other third parties to enable them to effectively monetize mobile content and acquire higher value users. The company’s products include DT Ignite™, a mobile device management solution with targeted app distribution capabilities, DT IQ™, a customized user experience and app discovery tool, DT Marketplace™, an application and content store, and DT Pay™, a content management and mobile payment solution. Offerings also include DT Media, an advertiser solution for unique and exclusive carrier inventory, and Appia, a leading worldwide mobile user acquisition network. Digital Turbine has delivered more than 100 million app installs for hundreds of advertisers. In addition, more than 31 million customers use Digital Turbine’s solutions each month across more than 20 global operators. The company is headquartered in Austin, Texas with global offices in Durham, Berlin, Singapore, Sydney and Tel Aviv.

Forward-Looking Statements
This news release includes “forward-looking statements” within the meaning of the U.S. federal securities laws. Statements in this news release that are not statements of historical fact, including but not limited to statements regarding the proposed public offering, the anticipated closing date and use of proceeds of the offering and any other statement that may be construed as a prediction of future performance or events, speak only as of the date made and involve known and unknown risks, uncertainties and other factors which may, should one or more of these risks uncertainties or other factors materialize, cause actual results to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, among others, the risks identified in Digital Turbine’s filings with the SEC, including its most recent Form 10-K and Form 10-Q filings, the preliminary prospectus supplement related to the proposed public offering and subsequent filings with the SEC. You should not place undue reliance on these forward-looking statements. The company does not undertake to update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

For more information, contact:
Carolyn Capaccio/Sanjay M. Hurry
LHA
(212) 838-3777
digitalturbine@lhai.com

Tuesday, September 29th, 2015 Uncategorized Comments Off on (APPS) Announces Pricing of Public Offering of Common Stock

(XENT) FDA Submission to Seek Expanded Indication of PROPEL

Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced that the company has submitted a supplemental premarket approval (PMA-s) submission to the U.S. Food and Drug Administration (FDA) to seek approval to expand the indication of the PROPEL® mini steroid releasing sinus implant to the treatment of patients undergoing frontal sinus surgery.

An expanded indication would allow Intersect ENT to market placement of PROPEL mini in the frontal sinuses, which are located behind the eyebrows. PROPEL mini is currently indicated for placement in the ethmoid sinuses, located just behind the bridge of the nose.

At least one in four of the over 500,000 patients undergoing surgery for chronic sinusitis suffers from frontal sinus disease. The condition contributes greatly to the debilitating symptoms of chronic sinusitis, including severe headaches, and is known to be the most difficult sinus to manage.

“This is an exciting milestone for Intersect ENT,” said Lisa Earnhardt, president and CEO, Intersect ENT. “More than 75,000 patients have benefitted from PROPEL to date and we look forward to broadening access to sustained local steroid delivery to more patients suffering from chronic sinusitis.”

Last month, Intersect ENT announced preliminary results of PROGRESS, a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of PROPEL mini when used following frontal sinus surgery. The study met its primary efficacy endpoint, demonstrating a statistically significant 38% relative reduction in the need for post-operative interventions, such as the need for additional surgical procedures or need for oral steroid prescription, compared to surgery alone. The device placement success rate was 100% and there were no device-related adverse events.

About Intersect ENT

Intersect ENT, Inc. is dedicated to improving the quality of life for patients with ear, nose and throat conditions. The company markets two steroid releasing implants, PROPEL and PROPEL mini, clinically proven to improve surgical outcomes for patients with chronic sinusitis undergoing ethmoid sinus surgery. In addition, Intersect ENT is developing new steroid releasing implants designed to provide ENT physicians with even more customized options to treat patients with chronic sinusitis less invasively and more cost effectively. Chronic sinusitis is an inflammatory condition leading to debilitating symptoms and chronic infections, and is one of the most costly conditions to U.S. employers.

For additional information on the company or the products including risks and benefits please visit www.intersectENT.com.

Forward-Looking Statements

The statements in this press release regarding the potential expanded indication for PROPEL® mini and the ability for Intersect ENT to broaden access to its products by patients with chronic sinusitis are “forward-looking” statements. These forward-looking statements are based on Intersect ENT’s current expectations and inherently involve significant risks and uncertainties. These statements include those related to the review of data by and timing for approval by the FDA as well as the rate of patient adoption for Intersect ENT’s products, if approved. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, the performance of PROPEL and PROPEL mini, the development of competitive products, the uncertain timing of completion of and the success of clinical trials and market competition. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Intersect ENT’s filings on Form 10-K, Form 10-Q and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

XENT-G

 

for Intersect ENT, Inc.
Media Contact:
Nicole Osmer, 650-454-0504
nicole@nicoleosmer.com
Investor Contact:
Jeri Hilleman, 650-641-2105
ir@intersectent.com

Tuesday, September 29th, 2015 Uncategorized Comments Off on (XENT) FDA Submission to Seek Expanded Indication of PROPEL

(WGBS) to Commence Commercial Launch of ICELL8 Single-Cell System at ASHG 2015

System Isolates More Than 10,000 Single Cells Per Day and Automatically Selects Cells to Process

FREMONT, Calif., Sept. 29, 2015  — WaferGen Bio-systems (Nasdaq:WGBS) announced that the Company will commence the commercial launch of the ICELL8™ Single-Cell System at the American Society of Human Genetics (ASHG) Annual Meeting taking place October 6-8, 2015, in Baltimore, MD. The system will create a new standard for single-cell analysis, enabling unbiased isolation of up to 1,800 single cells on a single chip. The system includes an imaging station for rapid image capture and CellSelect™ software for automatic selection of cells of interest for further processing for RNA sequencing. The system also allows researchers to run multiple samples on a single chip, enabling applications that require investigation under uniform conditions.

“We are pleased that the ICELL8 Single-Cell System will now be available to deliver what the single-cell research community has requested: greater cell isolation capabilities, control over the selection of isolated cells and the ability to run multi-sample experiments,” said Rollie Carlson, CEO of WaferGen.

The ICELL8 Single-Cell System provides the following:

  • Power – Poisson distribution for isolation of up-to 1,800 single-cells on a single chip using multi-sample nano-liter dispense technology that accommodates cell sizes from 5-100um in a single sample. The rapid and simple cell isolation and imaging protocol ensures that multiple chips can be processed in a single 8-hour day.
  • Control – CellSelect software allows for complete user-guided selection, as well as automatic determination of wells having individual cells to select for down-stream applications.
  • Insight – By enabling the analysis of up-to 8 samples on a single chip, complex experimental designs can now be accomplished in single-cell research.

“In order to conduct as thorough an evaluation of the ICELL8 Single-Cell System as possible, we sought both world-class early access collaborators who were experienced single cell researchers, as well as those just embarking on this exciting new frontier. We invited these researchers to test the system using challenging cell types, including cells directly from human subjects, and we were quite pleased to see the robust performance of the system under these conditions,” said Dr. Maithreyan Srinivasan, WaferGen’s Chief Technology Officer.

Extensive results with early access partners and in-house WaferGen research and development initiatives presented at the Single Cell Genomics 2015 conference demonstrated the system’s performance and utility, successfully processing various cell types, including live single neurons, human tumor cells, mouse tumor cells and nuclei. Further, the system has been shown to detect rare cell types with minimal sequencing costs, allowing researchers to more accurately interrogate complex samples to find the genomic information critical to their research. The ICELL8 Single-Cell System is the first single-cell analysis system to offer the scale of isolation, the control of cell selection and the openness of study design to truly expand single-cell analysis.

Order information will be available at the ASHG conference.

About WaferGen

WaferGen Bio-systems, Inc. is a biotechnology company that offers innovative genomic technology solutions for single-cell analysis and clinical research. The single cell analysis platform is a revolutionary system which can isolate thousands of single cells and processes specific cells for analysis, including Next Generation Sequencing. The system can also enable processing of up to eight samples by partitioning the chip into 8 sections. The SmartChip platform can be used for profiling and validating molecular biomarkers, and can perform massively-parallel single-plex PCR for one-step target enrichment and library preparation for clinical NGS. These technologies offer a powerful set of tools for biological analysis at the molecular and single-cell level in the life sciences, pharmaceutical, and clinical laboratory industries.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expected operating losses, expected revenues, expected expenses, expected cash usage, our expectations regarding our development of future products including single cell analysis technologies and our expectations concerning our competitive position and business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

CONTACT: INVESTOR CONTACTS:
         LifeSci Advisors, LLC
         Brian Ritchie
         BRitchie@LifeSciAdvisors.com

         WaferGen Bio-systems, Inc.
         Rollie Carlson
         Rollie.Carlson@wafergen.com
Tuesday, September 29th, 2015 Uncategorized Comments Off on (WGBS) to Commence Commercial Launch of ICELL8 Single-Cell System at ASHG 2015

(ACLS) Multiple Orders For ‘Purion M’ Implanter

Company Reiterates Q3 Guidance and Remains Confident That Axcelis Will Exit 2015 With 17-20% Market Share

BEVERLY, Mass., Sept. 29, 2015  — Axcelis Technologies, Inc. (Nasdaq: ACLS), a leading supplier of enabling ion implantation solutions for the semiconductor industry,  announced today that it has received orders for the Company’s Purion M™ medium current implanter from three leading specialty device chipmakers. The systems, ranging in wafer sizes from 150-300mm, will be used in high volume production of image sensors, power devices and specialty logic chips supporting automotive, mobile and the Internet of Things market spaces. The first system has shipped, with revenue expected in the fourth quarter.  The other tools will ship in the second half of 2016, upon completion of a R&D program funded by two customers.

“These wins highlight the advantages the Purion M provides for specialty device manufacturing, especially in the areas of energetic metals contamination control and advanced process control,” said Bill Bintz, executive vice president, engineering and marketing. “The Purion M’s innovative hybrid filtering technique is the only technology available today specifically designed to utilize both magnetic and electrostatic filtration to enable unmatched metals filtration, subsequently delivering significantly higher device yield for our customers.” He continued, “New investments in R&D for advanced process control technologies, specifically designed to address emerging device types and substrates, will enable fabrication of these structures at the highest levels of productivity and yield.”

John Aldeborgh, executive vice president, customer operations, commented, “We’re excited about the adoption of the Purion M in the very active specialty device market. Our customers in this space have seen a strong resurgence in business, and they are actively upgrading for technology and productivity reasons. This market has accounted for nearly half of our sales in 2015, and we look forward to expanding our footprint with the full Purion Platform, including the Purion M, Purion H, and Purion XE.”

President and CEO Mary Puma said, “We reiterate Q3 guidance and remain confident that Axcelis will exit 2015 with 17-20% market share of the implant market. We also expect continued market share growth in 2016 as the Purion product family enters volume production at additional memory and non-leading edge logic and foundry fabs.”

Safe Harbor Statement
This press release contains forward-looking statements under the SEC safe harbor provisions. These statements, which include our guidance for future financial performance and market share, are based on management’s current expectations and should be viewed with caution. They are subject to various risks and uncertainties, many of which are outside the control of the Company, including the timing of orders and shipments, the conversion of orders to revenue in any particular quarter, or at all, the continuing demand for semiconductor equipment, relative market growth, continuity of business relationships with and purchases by major customers, competitive pressure on sales and pricing, increases in material and other production costs that cannot be recouped in product pricing and global economic, political and financial conditions. These risks and other risk factors relating to Axcelis are described more fully in the most recent Form 10-K filed by Axcelis and in other documents filed from time to time with the Securities and Exchange Commission.

About Axcelis:
Axcelis (Nasdaq: ACLS), headquartered in Beverly, Mass., has been providing innovative, high-productivity solutions for the semiconductor industry for over 35 years. Axcelis is dedicated to developing enabling process applications through the design, manufacture and complete life cycle support of ion implantation systems, one of the most critical and enabling steps in the IC manufacturing process. Learn more about Axcelis at www.axcelis.com.

CONTACTS:

Maureen Hart (editorial/media) 978.787.4266
Doug Lawson (investor relations) 978.787.9552

Tuesday, September 29th, 2015 Uncategorized Comments Off on (ACLS) Multiple Orders For ‘Purion M’ Implanter