Archive for October, 2015
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders including multiple sclerosis (MS) and neuromyelitis optica (NMO), today announced the issuance of four additional key patents covering its broad T-cell immunotherapy platform. The recent allowances bring the number of granted U.S. and international patents in Opexa’s patent portfolio to 160, including in-licensed patents. The expansion of Opexa’s intellectual property portfolio further strengthens the patent estate surrounding Tcelna®, Opexa’s personalized T-cell immunotherapy in development for the treatment of secondary progressive multiple sclerosis.
Recently-granted European Patent Nos. 1546719, 2016414 and 2420833 are directed to Opexa’s proprietary methods for preparing individualized T-cell vaccines, while European Patent No. 2363710 is directed to the autologous T-cell vaccine compositions themselves. The claims cover the use of particular immunodominant epitopes found in myelin basic protein, proteolipid protein and myelin oligodendrocyte protein in the preparation of such T-cell vaccines, as well as the identification and use of specific antigenic epitopes that are disease-relevant for individual patients from these and other polypeptide antigens.
“We are very pleased with the issuance of the new European patents and the continued growth of our intellectual property portfolio,” stated Neil K. Warma, President and Chief Executive Officer of Opexa. “This family of patents is key to protecting and strengthening our intellectual property position surrounding our personalized T-cell immunotherapy for the treatment of autoimmune diseases. We continue to be aggressive in the strengthening of our patent estate and have also recently submitted new patent applications related to our proprietary epitope screening assay and potency assay.”
About Opexa
Opexa is a biopharmaceutical company developing a personalized immunotherapy with the potential to treat major illnesses, including multiple sclerosis (MS) as well as other autoimmune diseases such as neuromyelitis optica (NMO). These therapies are based on Opexa’s proprietary T-cell technology. The Company’s leading therapy candidate, Tcelna®, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of secondary progressive MS. Tcelna consists of myelin-reactive T-cells, which are expanded ex vivo from the patient’s peripheral blood and reintroduced into the patient in an attenuated form via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin for each individual patient.
For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com or follow company news on Twitter via @OpexaCEO.
Cautionary Statement Relating to Forward-Looking Information for the Purpose of “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995
Statements contained in this release, other than statements of historical fact, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “expects,” “believes,” “may,” “intends,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the safety, efficacy and projected development timeline of drug candidates such as Tcelna® and OPX-212 constitute forward-looking statements. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation our ability to raise additional capital to continue our development programs, our ability to successfully develop potential products such as Tcelna and OPX-212, our ability to obtain, maintain and protect intellectual property rights (including for Tcelna and OPX-212), as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks are described in detail in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2014 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2015. All forward-looking statements contained in this release speak only as of the date on which they were first made by us, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after such date.

Opexa Therapeutics, Inc.
Karthik Radhakrishnan, 281-775-0600
Chief Financial Officer
HOUSTON, Oct. 06, 2015 — LINN Energy, LLC (Nasdaq:LINE) (“LINN” or the “Company”) and LinnCo, LLC (Nasdaq:LNCO) (“LinnCo”) announced today that the Board of Directors has approved management’s recommendation to suspend LINN’s distribution and LinnCo’s dividend effective September 30, 2015. LINN’s Board of Directors will evaluate the Company’s ability to reinstate the distribution and dividend on an ongoing basis.
POTENTIAL TAX LIABILITIES
LINN continues to evaluate opportunities to improve its balance sheet. Potential future repurchases or cancellations of outstanding senior notes at a discount and/or asset sales could result in a tax liability for LINN’s unitholders. The effect to each unitholder would depend on the unitholder’s individual tax position with respect to the units. If available, prior year passive losses from a unitholder’s interest in the Company may serve to reduce or eliminate a unitholder’s current and future year taxable income and related income tax liability.
ABOUT LINN ENERGY
LINN Energy’s mission is to acquire, develop and maximize cash flow from a growing portfolio of long-life oil and natural gas assets. LINN Energy is a top-20 U.S. independent oil and natural gas development company, with approximately 7.3 Tcfe of proved reserves in producing U.S. basins as of December 31, 2014. More information about LINN Energy is available at www.linnenergy.com.
ABOUT LINNCO
LinnCo was created to enhance LINN Energy’s ability to raise additional equity capital to execute on its acquisition and growth strategy. LinnCo is a Delaware limited liability company that has elected to be taxed as a corporation for United States federal income tax purposes, and accordingly its shareholders will receive a Form 1099 in respect of any dividends paid by LinnCo. More information about LinnCo is available at www.linnco.com.
SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS
This press release includes “forward-looking statements.” All statements, other than statements of historical facts, included in this press release that address activities, events or developments that the Company expects, believes, targets or anticipates will or may occur in the future are forward-looking statements. These statements include, but are not limited to forward-looking statements about acquisitions, divestitures and trades, potential strategic alliances, timing and payment of distributions, and the expectations of plans, strategies, objectives and anticipated financial and operating results of the Company, including the Company’s drilling program, production, hedging activities, capital expenditure levels and other guidance included in this press release. These statements are based on certain assumptions made by the Company based on management’s experience and perception of historical trends, current conditions, anticipated future developments and other factors believed to be appropriate. 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. These include risks relating to the Company’s financial performance and results, availability of sufficient cash flow to pay distributions and execute its business plan, prices and demand for oil, natural gas and natural gas liquids, the ability to replace reserves and efficiently develop current reserves and other important factors that could cause actual results to differ materially from those projected as described in the Company’s reports filed with the Securities and Exchange Commission. See “Risk Factors” in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other public filings and press releases.
Any forward-looking statement speaks only as of the date on which such statement is made and the Company undertakes no obligation to correct or update any forward-looking statement, whether as a result of new information, future events or otherwise.

LINN ENERGY, LLC
Investors & Media:
Clay Jeansonne - Vice President - Investor Relations
281-840-4193
Sarah Nordin - Public Relations & Media
713-904-6605
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
— 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.
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.
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
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
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.
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
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
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)
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.
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.
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.
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
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 Twitter, LinkedIn, Facebook, YouTube, 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
- 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
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.
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.
— 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.
- $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
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