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(EBIO) First Patients Dosed with EBI-005 in Phase 3 Allergic Conjunctivitis Study
– Top-line Data Expected in First Quarter 2016 –
Eleven Biotherapeutics, Inc. (Nasdaq: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced dose administration for the first patients in a Phase 3 study of EBI-005 for the treatment of moderate to severe allergic conjunctivitis. This Phase 3 study was designed and initiated following the completion in October 2014 of a Phase 2 study in which EBI-005 exhibited biological activity in improving the symptoms of late-phase allergic responses in patients with moderate to severe allergic conjunctivitis. This included statistically significant improvements in mean change from baseline in patient reported ocular itching, tearing and associated nasal symptoms compared to vehicle-control at the second to last and final assessment time points following allergen exposure in a modified direct conjunctival allergen provocation test (CAPT) model.
“Patient dosing in this Phase 3 study represents a significant step forward in the clinical development of EBI-005, a drug candidate with potential for the treatment of moderate to severe allergic conjunctivitis patients who are refractory to standard of care treatments for ocular allergy,” said Abbie Celniker, PhD, Chief Executive Officer of Eleven Biotherapeutics. “We look forward to reporting top line data from this Phase 3 study in the first quarter of 2016.”
“Many allergic conjunctivitis patients develop a late-phase severe allergic response which is not treated with antihistamines or mast cell stabilizers, the current standard of care. The ocular itching, tearing, redness and other symptoms, which if left untreated can become severe, resulting in chronic ocular pain, corneal scarring and distortion of vision. Currently, many of these patients are treated with topical steroids, which have a number of adverse side effects, including increased intraocular pressure and cataract formation,” said Dr. Victor Perez, Professor of Ophthalmology at Bascom Palmer Eye Institute. “EBI-005 offers the potential to mediate this late-phase allergic response by blocking the interleukin-1 (IL-1) receptor, believed to be responsible for the symptoms of ocular surface inflammation in diseases like allergic conjunctivitis, with an acceptable, long-term safety and tolerability profile.”
This multi-center, double-masked, randomized, vehicle controlled Phase 3 pivotal trial is designed to evaluate the safety and efficacy of EBI-005 for up to four weeks in patients with moderate to severe allergic conjunctivitis in an environmental setting. Approximately 250 patients will be randomized 1:1 to receive treatment with EBI-005 or with vehicle. If the results of this first Phase 3 trial are favorable, Eleven intends to initiate a second Phase 3 trial in the second half of 2016.
About EBI-005
Eleven Biotherapeutics’ most advanced product candidate is EBI-005, a novel, topically-administered interleukin-1 (IL-1) receptor blocker in development as a protein therapeutic for inflammatory diseases at the surface of the eye. The EBI-005 program is based on the role that elevated levels of the inflammatory cytokine IL-1 play in the initiation and maintenance of the inflammation, pain, redness, itching and other symptoms associated with ocular surface diseases. EBI-005 is currently in Phase 3 clinical development for the treatment of moderate to severe allergic conjunctivitis. In a completed Phase 2 clinical trial, EBI-005 exhibited biological activity in improving the symptoms of late-phase allergic responses in patients with moderate to severe allergic conjunctivitis in a (CAPT) model.
About Allergic Conjunctivitis
Allergic conjunctivitis (AC) affects the ocular surface and is characterized by symptoms of ocular itching, ocular tearing, ocular redness and associated nasal symptoms. If allergic conjunctivitis is left untreated or becomes severe, patients may suffer chronic ocular pain and distortion of vision that can significantly reduce their quality of life. Allergic conjunctivitis is a common cause of patient visits to eye care professionals in the United State. Allergic conjunctivitis affects 15% to 40% of the U.S. population. According to Eleven’s primary market research, in the United States 11 million patients seek medical treatment for allergic conjunctivitis annually. Of these patients, approximately 4 million have moderate allergic conjunctivitis and approximately 1.8 million have severe allergic conjunctivitis.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company with a proprietary protein engineering platform, called AMP-Rx, that it applies to the discovery and development of protein therapeutics to treat diseases of the eye. The Company’s therapeutic approach is based on the role of cytokines in diseases of the eye, the Company’s understanding of the structural biology of cytokines and the Company’s ability to rationally design and engineer proteins to modulate the effects of cytokines. Cytokines are cell signaling molecules found in the body that can have important inflammatory effects. For more information please refer to the Company’s website www.elevenbio.com.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, advancement or maturation of its product candidates and product pipeline, clinical development of the Company’s therapeutic candidates, including expectations regarding timing of initiation of clinical trials, patient enrollment and availability of results, regulatory requirements for initiation of clinical trials and registration of product candidates, sufficiency of cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from ongoing clinical trials; whether results of early clinical trials will be indicative of the results of future trials; adequacy of any clinical models; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals and other factors discussed in the “Risk Factors” section of the Company’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission on April 30, 2015 and other reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.
Eleven Biotherapeutics, Inc.
Leah Monteiro, 617-714-0619
Leah.Monteiro@elevenbio.com
(CERE) Awarded Patent for iCODE™ Trait Development System
– Company is deploying the innovative trait technology for corn, soybean, sorghum and other crops – Announcement follows recent patent award for an innovation in soybean related to plant processes that are the target of a class of commercial herbicides
THOUSAND OAKS, Calif., Aug. 12, 2015 — Ceres, Inc. (Nasdaq: CERE), an agricultural biotechnology company, has been awarded a U.S. patent for its iCODE multi-gene trait development system. The company indicated that the patent award is a key milestone in its plan to further develop and license this technology to other crop companies and organizations.
iCODE was developed to rapidly create, evaluate and select optimal combinations of genes and their control components for next-generation biotechnology traits in crops such as corn and soybean. The system is significantly more powerful than current practices. iCODE, which is an acronym for Intelligent Combinatorial Optimization and Directed Evolution, utilizes a plant cell’s own gene-shuffling system to create thousands of test plants with various novel combinations of pre-selected genes and promoters, which are the on-off switches for genes. Due to the efficiency of the system, Ceres says that iCODE can enable new kinds of discoveries and allow even smaller research programs to better compete against much larger competitors.
Ceres President and CEO Richard Hamilton noted that iCODE has the potential to revolutionize how traits are developed for many crops and can create new opportunities for intellectual property around proprietary combinations of genes and promoters. “Seed and trait companies rely on intellectual property protection, and iCODE could play a key role for companies attempting to access this new IP landscape. The first to unlock the potential will have a significant advantage in this area,” he suggested.
In practice, iCODE allows researchers to empirically test thousands of gene and promoter combinations in a single acre. Unlike first-generation traits, which usually consist of a single gene per trait, today’s biotech traits under development often pair multiple genes with multiple promoters to produce favorable characteristics. However, creating the thousands of combinations of genes and promoters that are required to identify the optimal candidates is time-consuming and costly, and has often eluded even the most robust trait development pipelines. iCODE helps solve this issue by providing an efficient, high-throughput approach.
The iCODE system is the latest in a line of innovations from Ceres. The company pioneered gene discovery and genome annotation through the use of high-throughput DNA sequencing systems in plants and was the first to utilize a two-species development system to identify plant genes that offer agronomic improvements— a system that was later followed by other plant science companies. Ceres is deploying the multi-gene trait development system internally and believes there are opportunities to out-license the system to other crop biotechnology companies. The company is currently in discussions with institutions and companies to establish best practices for evaluating the technology for larger scale deployment.
Today’s announcement follows a recent patent awarded to Ceres for a genetic sequence derived from soybean, covering uses of the gene in areas such as research, product development and plant transformation. The company believes that its gene is useful in regulating key biosynthetic processes that are the target of a class of commercial herbicides. Ceres plans to offer other seed companies a commercial license to the innovation, including an opportunity for exclusivity in certain crops.
The new patent announced today was issued by the U.S. Patent and Trademark Office as U.S. Patent No. 9,101,100 and is titled Methods and Materials for High Throughput Testing of Transgene Combinations. Ceres owns or maintains exclusive licensed rights to approximately 95 issued patents and numerous pending patent applications in the United States and in various foreign jurisdictions. A patent is an intellectual property right granted by a government to an inventor to exclude others from making, using, offering for sale, or selling the invention for a limited time in exchange for public disclosure of the invention when the patent is granted.
About Ceres
Ceres, Inc. is an agricultural biotechnology company that develops and markets seeds and traits to produce crops for animal feed, sugar and other markets. The company’s advanced plant breeding and biotechnology technology platforms, which can increase crop productivity, improve quality, reduce crop inputs and improve cultivation on marginal land, have broad application across multiple crops, including food, feed, fiber and fuel crops. Ceres markets its seed products under its Blade brand. The company also licenses its biotech traits and technology, including its Persephone genome visualization software, to other life science companies and organizations. iCODE is a trademark of Ceres.
Ceres Forward-Looking Statements
This press release may contain forward-looking statements. All statements, other than statements of historical facts, including statements regarding Ceres’ efforts to develop and commercialize its products and technologies, anticipated yields and product performance, status of crop plantings, short-term and long-term business strategies, market and industry expectations, future operating metrics, and future results of operations and financial position, including anticipated cost savings from the company’s restructuring plan and projected cash expenditures, are forward-looking statements. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Ceres’ control. Factors that could materially affect actual results can be found in Ceres’ filings with the U.S. Securities and Exchange Commission. Ceres undertakes no obligation to update publicly, except to the extent required by law, any forward-looking statements for any reason after the date the company issues this press release to conform these statements to actual results or to changes in the company’s expectations.
(AMRS) Biossance™ Brand Announces The Launch Of The Embodied Project
Beauty, Fitness, and Wellness Experts Candice Kumai, Vicky Vlachonis and Nitika Chopra will provide Tips and Information Throughout the Personal Journey to Self-betterment
EMERYVILLE, Calif., Aug. 11, 2015 — Today, Biossance™, the first consumer beauty brand from parent company Amyris, Inc. (NASDAQ: AMRS), is announcing their launch of The Embodied Project to support its first product Biossance™ The Revitalizer, a breakthrough facial moisturizer that replenishes the skin by using one of the emollients already found naturally within your body. The Embodied Project is a 30-day complimentary consultation program to encourage women to live life to the fullest and nurture their health in mind, body and spirit while elevating the beauty of their skin.
To take part in The Embodied Project, women are invited to take a two-minute survey to answer questions about their lifestyle and daily habits. Following the survey, each participant will receive a sample of The Revitalizer and will begin the four-week personal challenge consisting of curated content tailored just for them from beauty, wellness, and health experts Candice Kumai, Vicky Vlachonis and Nitika Chopra. During this time, the experts will share daily tips, recipes, facts, and helpful content to guide the women as they work on becoming the best version of themselves.
The Revitalizer, which is the featured product in The Embodied Project, is a facial moisturizer made of 100% plant-derived squalane. Squalane is a natural moisturizer found within our skin that can diminish in some as early as their 20’s. The Revitalizer is a weightless moisturizer that instantly hydrates skin with a silky glow, is suitable for all skin types, and replenishes skin with what was once already there.
“I’m excited to be a part of the Biossance team and the rollout of the inspiring Embodied Project,” said Candice Kumai, wellness journalist, 5x bestselling author and chef. “As a chef and wellness journalist, it is essential to fuel your beautiful body with nutrients, and it’s just as important to be mindful of what you are putting on your body as well. The Revitalizer is the perfect beauty product for women to nurture their gorgeous bodies and glow from the inside-out!”
“Being a part of this program and having the opportunity to help women look and feel their best every day is a privilege and a passion of mine,” said Vicky Vlachonis, an osteopath and wellness expert. “It is so important to be mindful of yourself and your body, and with The Revitalizer, women can experience real results by restoring what already exists naturally in their bodies.”
“My love for inspirational beauty products fits in perfectly with the Biossance brand and it is exciting to watch the skincare line break through the beauty world,” said Nitika Chopra, certified life coach and wellness entrepreneur. “Sometimes all you need is a little push and motivation to truly feel empowered and that’s exactly what The Embodied Project is intended to do.”
The Revitalizer is currently offered in a 50ML bottle and available exclusively at Biossance.com. An expanded line of several other Biossance products will be available in 2016.
About Biossance
The Biossance brand, at its core, is dedicated to using science to make the scarce abundant, the rarified accessible, and the natural sustainable. The beauty of your skin relies on vital moisturizers found in your body, one of which is squalane. The Biossance brand’s patented, plant-derived emollient, Neossance® Squalane replenishes your skin by using a moisturizer found naturally in your body. This rich ingredient instantly hydrates while locking in essential moisture, leaving your skin feeling nourished and noticeably revitalized. The Biossance skincare line is designed with your own biological fingerprint in mind. We make what is already yours accessible again, turning the finite into the infinite. Sometimes all you need is a catalyst to nurture what’s within. Restore your own biological beauty. More information about Biossance is available at www.Biossance.com.
About Amyris
Amyris is the integrated renewable products company that is enabling the world’s leading brands to achieve sustainable growth. Amyris applies its innovative bioscience solutions to convert plant sugars into hydrocarbon molecules, specialty ingredients and consumer products. The company is delivering its No Compromise® products in focused markets, including specialty and performance chemicals, fragrance ingredients, and cosmetic emollients. More information about the company is available at www.amyris.com.
Amyris, the Amyris logo, Neossance and Biossance are trademarks or registered trademarks of Amyris, Inc.
Media Contacts
Christine Coppinger
Sunshine Sachs
212.691.2800 | Amyris@sunshinesachs.com
Peter DeNardo
Director, Investor Relations and Corporate Communications
Amyris, Inc.
510.740.7481 | pr@amyris.com
(ABMD) Outlines Long-Term Growth Strategy, Unveils Future Products
DANVERS, Mass., Aug. 11, 2015 — Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, will present the Company’s long-term growth strategy and five- year vision for Impella® revenues during its annual investor conference today in Boston. The meeting will also include projected patient figures for the high-risk percutaneous coronary intervention (PCI) market, describe a new patient population of interest, and introduce future Impella products in the pipeline for heart failure, along with scientific and case presentations from leading physicians.
During the conference, Michael R. Minogue, Abiomed president, chairman and chief executive officer, and members of Abiomed’s management team will present the company’s long-range business plan with details on future product approvals, the size of relevant patient populations and the estimated Impella adoption rates for each patient group, and discuss marketing goals and objectives following the Protected PCI launch.
Among the specific topics to be presented at today’s event include:
- Treating Higher Risk Patients: Leading physicians will present their experiences with Impella in both the surgical and catheterization lab settings, including a review of the recent TCTMD educational video on Protected PCI. Presentations will be given by: Mark Anderson, M.D., John Lasala, M.D., Jeffrey Moses, M.D., and George Vetrovec, M.D.
- Impella in the Post-PMA Era: Management will present an in-depth look at the patient populations, market, and potential opportunity for Impella. Some of those markets include:
- Protected PCI patients – Abiomed estimates the urgent and elective high risk PCI patient population as a 121,000 annual patient opportunity. With future PMA approvals, the emergent patient population remains at 100,000 patients. During this presentation, Abiomed management will elaborate on several of the new marketing efforts used to drive elective and urgent Protected PCI utilization.
- Chronic care patients — Abiomed is expanding its development focus to chronic care patients, centering on patient ambulation and mobilization, as well as new technologies. Abiomed continues to focus its efforts on native heart recovery and remodeling with intent to explant as a cost-effective strategy that promotes quality of life.
- Impella New Product Pipeline and Opportunity: Management will review the pipeline and next-generation devices, including:
- Impella Expandable Cardiac Power or “ECP”: The ECP pump is designed for blood flow of >3 liters/minute. It is intended to be delivered on the standard Impella 9 Fr catheter and will include an 18 Fr expandable inflow in the left ventricle only with a smooth, clear, polyurethane membrane crossing the left ventricle.
- Next Generation Impella CP: The enhanced Impella CP pump is designed to have an increased flow of 4.5 liters/minute with improved inflow design and smart sensor technology. It will be delivered on the standard Impella 9 Fr catheter and 14 Fr pump and is designed to provide support for up to 10 days.
- Next Generation Impella 5.0: The “Impella 5.5”: The pump is designed for flow of 5.5 liters per minute. It will be delivered on the standard 9 Fr catheter and includes a 19 Fr pump that is 45% shorter than the current Impella 5.0. This pump is designed for duration of weeks to months.
- Impella Bridge to Recovery or “BTR”: The Impella BTR is designed with similar specifications to the Impella 5.5 and is being developed with the intention of permitting patients to be discharged from the hospital with a wearable driver. It is designed to provide support for months to years.
- The Five Year Vision for Growth and Financial Revenue Outlook: Management will review the potential opportunities for the new and existing Impella products and will also present a model of its vision for Impella revenues in the five-year time frame. This model will reflect assumptions about the size of the accessible markets, average selling price (ASP) of Impella, and the financial impact of unlocking new patient opportunities. These models indicate a potential of up to $1.2 to $1.8 billion in Impella revenues, and possibly larger with the receipt of future regulatory approvals for treatment of heart failure patients. This revenue potential, in conjunction with operating leverage, will create a vision for a fast growing, 30%+ operating margin, business.
Members of the Abiomed management team scheduled to speak at today’s event include:
- Michael Minogue, Chief Executive Officer, President & Chairman
- Andrew Greenfield, Vice President & General Manager of Global Marketing
- Dr. Thorsten Siess, Chief Technology Officer
- Dr. David Weber, Chief Operating Officer
Abiomed invites its investors and potential investors to listen to the presentations via a live webcast that can be accessed under the Investor section of the company’s website at www.abiomed.com. The presentations are scheduled to begin at approximately 9:00 a.m. EST. A replay of the webcast will be available on the Abiomed website for a brief period after the event.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com
FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including statements regarding development of Abiomed’s existing and new products, the Company’s progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company’s actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company’s filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.
For further information please contact: Ingrid Goldberg Director, Investor Relations 978-646-1590 ir@abiomed.com
(ABTL) to Present at the 35th Annual Canaccord Genuity Growth Conference
IRVINE, Calif., Aug. 11, 2015 — Autobytel Inc. (NASDAQ:ABTL), a leading provider of online automotive services dedicated to connecting consumers with dealers, has been invited to present at the 35th Annual Canaccord Genuity Growth Conference being held August 12-13, 2015 at the InterContinental Boston Hotel.
Autobytel President and CEO Jeff Coats is scheduled to present on Thursday, August 13 at 2:30 p.m. Eastern time, with one-on-one meetings held throughout the day.
The presentation will be webcast live and available for replay at http://wsw.com/webcast/canaccord18/abtl and via the investor relations section of the company’s website at www.autobytel.com.
For more information about the conference or to schedule a one-on-one meeting with Autobytel management, please contact your Canaccord Genuity representative.
Tax Benefit Preservation Plan
At December 31, 2014, the company had approximately $94.5 million in available net operating loss carryforwards (“NOLs”) for U.S. federal income tax purposes. The company’s Tax Benefit Preservation Plan (“Plan”) was adopted by the company’s Board of Directors to preserve the company’s NOLs and other tax attributes and thus reduce the risk of a possible change of ownership under Section 382 of the Internal Revenue Code. Any such change of ownership under Section 382 would limit or eliminate the ability of the company to use its existing NOLs for federal income tax purposes. Rights issued under the Plan could be triggered upon the acquisition by any person or group of 4.9% or more of the company’s outstanding common stock and could result in substantial dilution of the acquirer’s percentage ownership in the company. As of August 4, 2015, there were 10,419,719 shares of the Company’s common stock outstanding. There is no guaranty that the Plan will achieve the objective of preserving the value of the company’s NOLs. For more information, please visit http://investor.autobytel.com/tax.cfm.
About Autobytel Inc.
Autobytel Inc. provides high quality consumer leads and associated marketing services to automotive dealers and manufacturers throughout the United States. The company also provides consumers with robust and original online automotive content to help them make informed car-buying decisions. The company pioneered the automotive Internet in 1995 with its flagship website www.autobytel.com and has since helped tens of millions of automotive consumers research vehicles; connected thousands of dealers nationwide with motivated car buyers; and has helped every major automaker market its brand online.
Investors and other interested parties can receive Autobytel news alerts and special event invitations by accessing the online registration form at investor.autobytel.com/alerts.cfm.
CONTACT: Company Contact:
Kim Boren
Chief Financial Officer
949-437-4694
kimb@autobytel.com
Investor Relations
Liolios Group, Inc.
Cody Slach or Sean Mansouri
949-574-3860
ABTL@liolios.com
(CLIR) Announces Installation and Operation of Duplex™ Technology at California Refinery
SEATTLE, Aug. 11, 2015 — ClearSign Combustion Corporation (NASDAQ: CLIR) announced today that it has successfully completed the initial installation of its Duplex™ technology in a multiple-burner, vertical-cylindrical production process heater at a California refinery. As previously announced, successful demonstration of Duplex at this facility will allow the refinery to meet strict environmental regulations for emissions of nitrogen oxides (NOx) and carbon monoxide (CO) in a cost-effective manner.
ClearSign and the customer are encouraged by the preliminary results achieved to date, which have shown a significant reduction in NOx emissions without the use of flue gas recirculation (FGR) or selective catalytic reduction (SCR). Additional testing leading to optimization of the technology will continue in order to reach the stated objectives of 6 ppm NOx, corrected to 3% O2.
The installation was completed within the customer’s allotted downtime period and was promptly returned to full production while testing continues.
About ClearSign Combustion Corporation
ClearSign Combustion Corporation designs, develops and markets technologies that drive to improve key performance characteristics of combustion systems, including emissions and operational performance, energy efficiency and overall cost-effectiveness. Our patent-pending Duplex™ and Electrodynamic Combustion Control™ platform technologies enhance the performance of combustion systems in a broad range of markets, including the chemical, petrochemical, refinery, power and commercial boiler industries. For more information, please visit www.clearsign.com
Cautionary note on forward-looking statements
This press release includes forward-looking information and statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding our assumptions, projections, expectations, targets, intentions or beliefs about future events that are based on management’s belief, as well as assumptions made by, and information currently available to, management. While we believe that our expectations are based upon reasonable assumptions, there can be no assurances that our goals and strategy will be realized. Numerous factors may affect our actual results and may cause results to differ materially from those expressed in forward-looking statements made by us or on our behalf. Some of these factors include the acceptance of existing and future products, the impact of competitive products and pricing, general business and economic conditions, and other factors detailed in our Annual Report on Form 10-K and other periodic reports filed with the SEC. We specifically disclaim any obligation to update or revise any forward-looking statement whether as a result of new information, future developments or otherwise.
(CFRXW) Provides Update on CF-301 Phase 1 Trial
Study Continues as Planned for CF-301, Under Development for Staph Bloodstream Infections, Including MRSA
YONKERS, NY–(Aug 11, 2015) – ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) (NASDAQ: CFRXZ), a clinical-stage biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, today announced that an independent Data and Safety Monitoring Board (DSMB) recommended the continuation of the CF-301 Phase 1 study. Thus far, the study has successfully completed two dose levels out of the currently planned four, and ContraFect expects to complete the study by year-end. If the results of the Phase 1 study in healthy volunteers are favorable, ContraFect plans to advance CF-301 into Phase 2 study next year in patients with staph bloodstream infections, including MRSA.
“ContraFect is pleased to have made progress in this important initial stage of development for CF-301, the first lysin allowed by the FDA to enter human clinical trials, targeting drug-resistant Staph infections, including MRSA,” said Julia P. Gregory, ContraFect’s Chief Executive Officer. “Novel approaches, like CF-301, with activity against drug-resistant bacteria and biofilms offer great potential to successfully treat these current life-threatening infections.”
ContraFect is conducting a single Phase 1 randomized, double-blind, placebo-controlled, dose-ranging trial in healthy volunteers in the United States to evaluate the safety, tolerability and pharmacokinetics of CF-301 alone. An independent DSMB reviews the safety and pharmacokinetic data for each dose level in order to recommend proceeding to the next higher dose. Additional information on the trial can be found at https://www.clinicaltrials.gov/ct2/show/NCT02439359
About CF-301
CF-301 is a bacteriophage lysin with potent activity against Staph aureus infections. CF-301 has the potential to be a first-in-class treatment for Staph bacteremia as it has a new mechanism of action for eliminating bacteria. It has specific and rapid bactericidal activity against Staph aureus and does not impact the body’s good bacteria. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. In vitro and in vivo experiments have shown that CF-301 clears biofilm. Combinations of CF-301 with standard of care antibiotics increased survival significantly in animal models of disease when compared to treatment with antibiotics or CF-301 alone. CF-301 was licensed from The Rockefeller University and developed at ContraFect.
About Staph Bacteremia
Staphylococcus aureus (“S. aureus”) is a major cause of bacteremia, and Staph aureus bacteremia is associated with higher morbidity and mortality, compared with bacteremia caused by other pathogens. The burden of Staph aureus bacteremia, particularly methicillin-resistant Staph aureus bacteremia, in terms of cost and resource use is high. The risk of infective endocarditis and of seeding to other metastatic foci increases the risk of mortality and raises the stakes for early, appropriate treatment.
Staphylococcus (“Staph”) infections occur in both hospital and community settings, and in the United States there are approximately 120,000 cases annually of Staph bacteremia (a bloodstream infection), which causes approximately 30,000 deaths annually. Of further concern, drug-resistant strains of Staph are now evolving and developing additional resistance against standard-of-care antibiotics, which may ultimately result in increased number of cases and mortality from Staph bacteremia. A recent study commissioned by U.K. Prime Minister David Cameron found that without action, drug-resistant infections that already kill hundreds of thousands a year globally could exceed 10 million by 2050.
About ContraFect
ContraFect is a clinical-stage biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. Due to drug-resistant and newly emerging pathogens, hospital acquired infections are currently the fourth leading cause of death in the United States, following heart disease, cancer and stroke. We intend to address drug-resistant infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect’s initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (methicillin-resistant staphylococcus bacteria) and influenza.
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intend,” “plans,” “potential,” “transform,” “look forward to,” “novel,” “if” or similar references to future periods. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect’s current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control, including those detailed in ContraFect’s filings with the Securities and Exchange Commission. Specific forward-looking statements in this release include, without limitation, statements regarding anticipated screening and enrollment of healthy volunteers in our Phase 1 clinical trial of CF-301, the data obtained throughout the trial regarding the safety, tolerability and pharmacokinetics of CF-301, the DSMB’s review of the trial data, our dosing plans for Phase 1, our ability to advance CF-301 into Phase 2, our ability to develop therapies to combat life-threatening infections, and CF-301’s activity against drug-resistant bacteria and biofilms. Actual results may differ from those set forth in the forward-looking statements. Any forward looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Relations Contact
Barbara Ryan
Clermont Partners
Tel: 203-274-2825
Email: Email Contact
Avonelle McLean
ContraFect Corporation
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(NXTD) Issues Update; Major Progress Now On Sale
BOSTON, Aug. 11, 2015 — SoundView Technology Group (http://soundview.co) releases the following market and company update for NXT-ID, Inc. (NASDAQ: NXTD).
Market & Company Update
Summary
This season is famously bad in terms of liquidity in the stock market and especially for smaller, already thinly-traded issues. Since successfully launching their secure digital Wocket and raising capital to fund marketing and production expansion for the upcoming holiday season shares of NXTD have been cut in half since our last published update in June.
Part of the reason for the recent decline appears to be a direct result of a “sell” rating put on the shares by Zacks. It’s important to realize that the Zacks system is driven by a set of quantitative and backward-looking metrics. Their ratings are not based on what we would call traditional research into what future business trends will be. Methods like the one Zacks uses can be useful for well established companies like GE or Oracle but are worse than useless for emerging growth companies.
The situation is especially compelling given that NXT-ID remains precisely on the plan we dialed into to our estimates this year and next which feed directly into our Intrinsic Valuation (IV) value of $7.47/share. There are certainly some potential near-term events like distribution partnerships that we have not factored into our numbers as of yet.
What follows is a more detailed account of company progress in Q2, the plans and outlook for Q3 and Q4, the terms of the capital raise and adjustments to our IV model based on them.
Recent Results
The most significant accomplishment in Q2 was shipping the first batch of pre-orders. The company will recognize some revenue ($110K) for the quarter with the rest falling into Q3 due to the 2 week return period. Production level Wockets are in the field and being used. Initial indications are for an 80% success rate which is very good given the incredible diversity of POS devices and terminals. The company expects to get this up closer to 90% with some tweaks and software updates.
The second major hurdle cleared recently was obtaining the financing needed to fund the marketing and increased production required to be ready for the upcoming holiday shopping season. NXT-ID completed a $3 million equity capital raise that provides sufficient funding to ramp up production and marketing of the Wocket. The capital raise included 1,72 million shares of common stock at $1.75 per share as well a private placement of 860,716 warrants to purchase shares of common stock at an exercise price of $2.35 per share. If exercised NXT-ID would receive another $2M in funding,
Although nothing has been announced the management team has been working through a number of potential distribution arrangements and becoming operationally ready to be able to run at a 10,000 unit per month delivery rate.
One stealthy but potentially important note on recent results was the filing for a patent covering “Crypto-Currency Management” which isn’t a near-term driver but as the momentum behind blockchain-based technology keeps expanding the ability to address non-traditional digital currency will be important. (see further blockchain-related comments in the market section below.)
Market Update
The digital payments space has remained a hotbed of activity with PayPal now a separate public company (NASDAQ:PYPL) and Visa (NYSE:V) teaming up and funding Stripe. The proliferation of devices that can tie into future payment systems (like the Apple Watch and Moto 360) helps justify infrastructure updates that will make payments easier across a broad array of types – from cards to Wockets to phones to watches.
EMV has been in the news and NXT-ID has been planning for it for a long time. In order to fully support EMV the Wocket will be upgraded to include EMV and NFC technologies. It will take EMV quite some to roll out to the masses of terminals out there so an upgraded Wocket later this year will enable consumers to use these terminals when they begin to encounter them.
We’ve seen an explosion of activity around generalizing the blockchain technology underlying Bitcoin for all sorts of transactional applications. It may help legitimize usage. Although the Wocket isn’t about Bitcoin per se it’s in a good position to help consumers who want to use Bitcoin or other digital currencies.
Anecdotally we noted more “Bitcoin accepted here” signs on Cape Cod this summer. We made some inquiries and although usage is not commonplace in general more travelers are using Bitcoin as a kind of standard currency when they can. Rather than convert Euros to dollars they have brought Bitcoin. Maybe this is just due to the recent weakness in the Euro, or maybe it’s a trend. In any case this is the first time we’ve come into contact with Bitcoin run-of-the-mill consumer locations like restaurants, amusement parks and gift shops.
The events and players are distinct but in general the market is “more of the same” which is a concerted movement toward more digital, more secure and more mobile payments which is exactly where the Wocket fits. It remains to be seen how consumers sift through the myriad offerings and settle into what works for them. As we’ve stated before the Wocket is unique as an actual wallet replacement rather than something that is an extension of your smartphone.
Stock Conclusion
In the few years we’ve been working with and following NXT-ID the current moment offers the best risk/reward we’ve seen so far. The company has come a very long way since their IPO at $1 and seen share prices as high as $5.60 with a substantial period trading between $4-5/share.
There are a few reasons we can point to in the short term – limited liquidity, a spurious and backward-looking downgrade from Zacks in the headlines and general “risk off” mentality as the world grapples with slowing growth and rising (at least in the US) interest rates.
We remain comfortable with our 40,000 unit assumption for 2015 based on the planned marketing campaign in Q3, a monthly production goal of 10,000 units and the upcoming holiday buying season. Market data suggests there is already demand for 100,000 to 200,000 units if it can be reached and serviced so at this point demand isn’t a limiting factor. Looking further out into 2016 our 120,000 unit number isn’t aggressive either.
We’re tweaking our model to account for some more shares outstanding and also took the opportunity to add expenses for SG&A to support increased marketing and operational readiness. It has had only a minor impact on the IV estimate – taking it from $8.28 to $7.47.
As we mentioned at the start of the note the risk/return from the current stock level is very attractive. Longer-term investors will also note that our the IV for 2016 doubles so if NXT-ID exits 2015 with good momentum there is quite a bit of additional upside
The NXT research update (PDF) is also published and available here:
http://s3.amazonaws.com/Published_Research/NXT-ID_NXTD_SV_NOTE_AUGUST_2015.pdf
Past reports and related research can be found on our website at http://soundview.co/infosec.
Editor’s Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.
Glossary of Terms
IV or Intrinsic Value is our method of evaluating growth stocks. Over the last twenty years we’ve found that most traditional measures like P/E, PEG, and even DCF models are not effective at arriving at a single price point that represents the true value of the future prospects of a company. It has some things in common with a DCF approach but deviates by focusing instead on long-term market value since it’s more akin to what a growth stock delivers than stable cash flows.
POS is an abbreviation for “Point of Sale” systems which include terminals which handle your credit cards to back office computers that interface with the large payment processors and gateways.
Disclosures
SoundView serves as a strategic advisor to NXT-ID and provides this research note for informational purposes only. SoundView does not have “ratings” and is not an investment bank, broker/dealer or registered investment advisor. We’ve undertaken to research all facts presented here but can make no promises that they are correct or that our reasoning and supporting intrinsic valuation model is an accurate depiction of the future. SoundView employees may have positions in stocks they work on however at the time of this writing we are not aware of any outstanding positions in the shares of NXT-ID.
About NXT- ID Inc. – Mobile Security for a Mobile World: (NXTD) (NXTDW):
NXT-ID, Inc.’s innovative MobileBio® solution mitigates consumer risks associated with mobile computing, m-commerce and smart OS-enabled devices. The company is focused on the growing m-commerce market, launching its innovative MobileBio® suite of biometric solutions that secure consumers’ mobile platforms led by Wocket® ; a next generation smart wallet designed to replace all the cards in your wallet, no smart phone required. Wocket was recognized as one of the top technology products at CES 2015 by multiple media outlets including Wired.com. The Wocket works most anywhere credit cards are accepted and only works with your biometric stamp of approval or passcode.
NXT-ID’s wholly owned subsidiary, 3D-ID LLC, is engaged in biometric identification and has 22 licensed patents in the field of 3D facial recognition http://www.nxt-id.com/, http://3d-id.net/
Contact:
Kris Tuttle
SoundView Technology Group
kris@soundview.co
+1-617-828-6462
(NNVC) Dramatic Effects of Topical Anti-Herpes Treatment Reproduced
SHELTON, Conn., Aug. 10, 2015 — NanoViricides, Inc., (NYSE MKT: NNVC) (the “Company”), a nanomedicine company developing anti-viral drugs, reports that the dramatic improvements in clinical symptoms associated with herpes simplex virus infection were reproduced in an animal model in a different laboratory. These studies were performed by TransPharm Preclinical Solutions (“TransPharm”), a pre-clinical services company in Jackson, MI.
All of the nanoviricides® tested improved clinical scores dramatically, with clinical presentation being arrested at redness or simply raised local lesions, and a complete absence of zosteriform spreading. All of the nanoviricides treated animals survived the lethal HSV-1 infection challenge for the duration of the study while untreated animals died towards the end of the study. These nanoviricides are designed as topical treatment for the breakout of herpes sores.
Some of the nanoviricides found effective in the previous study were tested in this study for the confirmation of efficacy in a dermal animal model in Balb-c mice using the same highly aggressive and neurotropic HSV-1 strain H129c, which was used previously.
The earlier studies were performed in the laboratory of Dr. Ken S. Rosenthal at Northeast Ohio Medical University where Dr. Rosenthal continued as a Professor Emeritus. He is a leading researcher in herpes virus anti-viral agents and vaccines.
In the previous study, two of the anti-Herpes nanoviricides® reduced the extent of disease (morbidity) and mortality of the HSV-1 infected animals that were treated. These nanoviricides also reduced virus production in cell culture. Importantly, topical dermal treatment with these nanoviricides led to almost complete (>85%) survival of the infected mice in this animal model whereas all untreated animals died of the disease. Further, these nanoviricides were superior to topical treatment with an acyclovir formulation employed as a positive control. The Company reported on these studies in April, 2015.
Professor Rosenthal consulted with NanoViricides and TransPharm for the establishment of the animal model for dermal HSV-1 infection using the HSV-1 strain H129c at the TransPharm laboratories.
Existing therapies against HSV include acyclovir and drugs chemically related to it. These drugs must be taken orally or by injection and are not very effective as topical agents. Other drugs are largely ineffective. Currently, there is no cure for any of the herpesvirus infections.
About Dr. Rosenthal
Dr. Rosenthal is now Professor at the Roseman University of Health Sciences College of Medicine, NV. He continues as Professor Emeritus at Northeast Ohio Medical University (NEOMED), after retiring in December 2014. He is a leading researcher in the field of herpes viruses, antiviral drugs and vaccines. His research interests encompass several aspects of how herpes simplex virus (HSV) interacts with the host to cause disease. His research has addressed how HSV infects skin cells and examined viral properties that facilitate its virulence and ability to cause encephalitis. He is also researching how the human host immune response works against HSV for the development of protective and therapeutic vaccines.
About TransPharm
Transpharm Preclinical Solutions offer numerous types of studies for testing antimicrobials, antivirals, antifungals, antiparasitics, along with newer therapies using antibodies. TransPharm’s scientists’ skill set covers a broad range of Research and Development. This allows us to offer numerous services upon request. We have many strategic alliances along the Biotechnology Corridor which allows us to offer a wide variety of services.
About NanoViricides:
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. 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. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
(ESPR) Braunstein Joins Aisling Capital as Operating Partner
NEW YORK, Aug. 10, 2015 — Aisling Capital, a leading investment firm that invests in companies developing and commercializing important and innovative healthcare products, services and technologies, announced that Scott Braunstein, MD has joined the firm as an Operating Partner. Dr. Braunstein will assist in evaluating potential future investments for the firm, as well as working broadly with Aisling portfolio companies.
“Scott has over 25 years of experience in the healthcare industry in a variety of clinical, business, strategy, product and technology leadership roles. We are delighted to welcome him to Aisling Capital,” said Drew Schiff, MD, Managing Partner at Aisling Capital. “In his new role, Scott will contribute his unique insights and perspectives to our late-stage private equity investment strategies.”
Dr. Braunstein serves as Senior Vice President, Strategy and Corporate Development at Pacira Pharmaceuticals. He spent 12 years as a Healthcare Analyst and Portfolio Manager at J.P. Morgan Asset Management, where he invested in and conducted diligence on a wide variety of pharmaceutical products and product candidates. He reviewed pharmaceutical company strategies, business models and management teams, and provided stock recommendations for the J.P. Morgan Asset Equity Group.
“I am very excited to join Aisling Capital and its talented team,” said Dr. Braunstein. “I am looking forward to working across the firm’s impressive portfolio of healthcare companies to help them better meet their business objectives, as well as identifying new investment opportunities.”
Dr. Braunstein serves as a director of Esperion Therapeutics (Nasdaq: ESPR), STAT Medical and the Cornell Alumni Association for the College of Agriculture and Life Sciences. Dr. Braunstein received his M.D. from the Albert Einstein College of Medicine and completed his residency in internal medicine at Cornell University-New York Hospital. He received his B.S. from Cornell University.
(IMDZ) & (MRK) to Collaborate on Combination Trials of Two Immune Design Immunotherapies
Phase 1 Trials to Evaluate Investigational Agents G100 or LV305 Combined With Merck’s KEYTRUDA(R) (pembrolizumab)
SEATTLE, SOUTH SAN FRANCISCO, Calif. and KENILWORTH, N.J., Aug. 10, 2015 — Immune Design (Nasdaq:IMDZ) today announced it has entered into clinical collaboration agreements through subsidiaries of Merck (NYSE:MRK), known as MSD outside of the United States and Canada, to evaluate the safety and efficacy of two Immune Design immuno-oncology investigative agents, G100 and LV305, separately combined with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in Phase 1 trials in patients with non-Hodgkin’s lymphoma (NHL) and melanoma, respectively.
The first clinical trial will examine intratumoral administration of G100 with intravenous administration of KEYTRUDA in patients with follicular NHL receiving local radiation. In addition to an evaluation of the safety of the combination, the study will assess the response in both injected and non-injected lesions. The second clinical trial in melanoma will evaluate safety and response to the combination of LV305 and KEYTRUDA in patients who have not yet responded to treatment with KEYTRUDA alone after three months of treatment.
Immune Design’s G100 and LV305 investigational agents are designed to work in vivo and activate the immune system via the induction and/or expansion of anti-tumor CD8 T cells. They are intended to be “off-the-shelf” therapies, in contrast to other T-cell approaches that require individualized ex vivo manipulation. G100 is a potent toll-like receptor-4 (TLR4) agonist designed to generate a robust anti-tumor immune response when administered directly to the tumor micro-environment. LV305, in contrast, is designed to activate the immune system through the in vivo generation of cytotoxic T cells (CTLs), initially against a specific tumor-associated antigen, NY-ESO-1. Immune Design is studying LV305 primarily as part of CMB305, a prime boost approach currently in a Phase 1 expansion trial.
“There is great potential to expand the potential of immunotherapy through combination approaches that will stimulate and enhance the immune system in order to mount the strongest response against cancer,” said Carlos Paya, M.D., Ph.D, President and Chief Executive Officer of Immune Design. “Immune Design has two distinct approaches in oncology, and we look forward to collaborating with Merck to evaluate the potential of combining each of G100 and LV305 with KEYTRUDA in these areas of medical need.”
“Our understanding of the immune system’s role and its impact in the treatment of cancer continues to grow,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “This collaboration with Immune Design adds to a broad clinical program designed to explore the role of KEYTRUDA in innovative immuno-oncology combinations – and underscores our commitment to advance the care of patients with cancer.”
About G100
G100 is a product candidate generated from the company’s GLAASTM discovery platform, and includes a specific formulation of Glucopyranosyl Lipid A (GLA), a synthetic, toll-like Receptor-4 (TLR-4) agonist. G100 is part of Immune Design’s intratumoral immune activation, or ‘Endogenous Antigen’ approach to treating cancer, which leverages the activation of dendritic cells, T cells and other immune cells in the tumor microenvironment to potentially create a robust immune response against the tumor’s preexisting diverse set of antigens. Preclinical and clinical data have demonstrated the ability of G100 to activate dendritic cells in tumors and to increase antigen-dependent systemic humoral and cellular Th1 immune responses. In addition to the study planned under this collaboration, a Phase 1 study of G100 in patients with Merkel cell carcinoma (MCC) recently completed enrollment, and Immune Design presented data at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, the poster for which can be accessed on the company’s website. In the first eight patients in MCC study, G100 has an acceptable safety profile and a fifty percent (50%) objective response rate per protocol.
About LV305
LV305, generated from Immune Design’s ZVexTM platform, is designed to activate the immune system through the in vivo generation of cytotoxic T cells (CTLs) initially against a specific tumor-associated antigen, NY-ESO-1. LV305 is part of Immune Design’s ‘Specific Antigen’ approach, which drives the in vivo generation of a strong, antigen-specific CTL response against selected antigens present in a tumor. Preclinical tests have demonstrated the ability of LV305 to reduce tumor growth of NY-ESO-1-expressing tumors, increase production of antigen-specific CD8 cells, and significantly improve the survival of tumor-bearing animals. LV305 is the first step in Immune Design’s novel prime-boost approach to immuno-oncology, which includes combination with G305, generated from the GLAAS platform, to expand CTLs and potentially generate a potent, durable immune response. Immune Design announced positive data from a Phase 1 study of LV305 at the 2015 ASCO Annual Meeting, the poster for which can be accessed on the company’s website. In that study, LV305 caused either a de novo or statistically-significant increase in antigen-specific CD8 T cells in 80% of the six evaluable mid- and high-dose patients. Immune Design is primarily studying LV305 as part of CMB305, a prime boost approach.
About KEYTRUDA® (pembrolizumab)
KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merck is advancing a broad and fast-growing clinical development program for KEYTRUDA with more than 100 clinical trials – across more than 30 tumor types and over 16,000 patients – both as a monotherapy and in combination with other therapies.
Selected Important Safety Information for KEYTRUDA
Pneumonitis occurred in 12 (2.9%) of 411 patients with advanced melanoma receiving KEYTRUDA (the approved indication in the United States), including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 pneumonitis.
Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients respectively, receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.
Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients, including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.
Hypophysitis occurred in 2 (0.5%) of 411 patients, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving KEYTRUDA. Monitor for signs and symptoms of hypophysitis (including hypopituitarism and renal insufficiency). Administer corticosteroids for Grade 2 or greater hypophysitis. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3; and permanently discontinue KEYTRUDA for Grade 4 hypophysitis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients, including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer corticosteroids for Grade 3 or greater hyperthyroidism. Withhold KEYTRUDA for Grade 3; permanently discontinue KEYTRUDA for Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.
Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred in patients receiving KEYTRUDA. Monitor patients for hyperglycemia and other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA in cases of severe hyperglycemia until metabolic control is achieved.
Nephritis occurred in 3 (0.7%) patients receiving KEYTRUDA, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.
Other clinically important immune-mediated adverse reactions can occur. The following clinically significant, immune-mediated adverse reactions occurred in patients treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial seizures arising in a patient with inflammatory foci in brain parenchyma, severe dermatitis including bullous pemphigoid, myasthenic syndrome, optic neuritis, and rhabdomyolysis.
For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Restart KEYTRUDA if the adverse reaction remains at Grade 1 or less. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.
Infusion-related reactions, including severe and life-threatening reactions, have occurred in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritis, flushing, rash, hypotension, hypoxemia, and fever. For severe or life-threatening reactions, stop infusion and permanently discontinue KEYTRUDA.
Based on its mechanism of action, KEYTRUDA may cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.
For the treatment of advanced melanoma, KEYTRUDA was discontinued for adverse reactions in 9% of 411 patients across all doses studied. Serious adverse reactions occurred in 36% of patients receiving KEYTRUDA. The most frequent serious adverse drug reactions reported in 2% or more of patients were renal failure, dyspnea, pneumonia, and cellulitis.
The most common adverse reactions (reported in at least 20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).
The recommended dose of KEYTRUDA is 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity. No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA. It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA. Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.
About Immune Design
Immune Design is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body’s immune system to fight disease. The company’s technologies are engineered to activate the immune system’s natural ability to generate and/or expand antigen-specific cytotoxic T cells, while also enhancing other immune effectors, to fight cancer and other chronic diseases. CMB305 and G100, the primary focus of Immune Design’s ongoing immuno-oncology clinical programs, are products of its two synergistic discovery platforms, ZVexTM and GLAASTM, the fundamental technologies of which were licensed from the California Institute of Technology and the Infectious Disease Research Institute (IDRI), respectively. Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com.
Forward-Looking Statement of Immune Design
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Immune Design’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the timing of initiation, progress, scope and outcome of clinical trials for Immune Design’s product candidates and the reporting of clinical data regarding Immune Design’s product candidates. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Immune Design’s collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Immune Design’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Immune Design’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, Immune Design assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck
Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and the Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
CONTACT: Immune Design
Media Contact
Julie Rathbun
Rathbun Communications
julie@rathbuncomm.com
206-769-9219
Investor Contact
Shari Annes
Annes Associates
sannes@annesassociates.com
650-888-0902
Merck
Media Contact
Pamela Eisele
(267) 305-3558
Investor Contact
Justin Holko
(908) 740-1879
(INO) Strategic Cancer Vaccine Collaboration With MedImmune
Agreement Includes Clinical-Stage INO-3112 HPV Cancer Vaccine and Preclinical Collaboration to Develop Additional Cancer Vaccine Candidates
Inovio Schedules Conference Call for 8:30am ET Today; Go to inovio.com and Click on “Webcast” Tab
PLYMOUTH MEETING, Pa., Aug. 10, 2015 — Inovio Pharmaceuticals (Nasdaq:INO) today announced that it has entered into a license agreement and collaboration with MedImmune, the global biologics research and development arm of AstraZeneca.
Under the agreement, MedImmune will acquire exclusive rights to Inovio’s INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18. INO-3112, which is in phase I/II clinical trials for cervical and head and neck cancers, works by generating killer T-cell responses that are able to destroy HPV 16- and 18-driven tumors. These HPV types are responsible for more than 70 percent of cervical pre-cancers and cancers.
MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline in HPV-driven cancers. Emerging evidence suggests that the benefits from immuno-oncology molecules, such as those in MedImmune’s portfolio, can be enhanced when they are used in combination with cancer vaccines that generate tumor-specific T-cells.
Under the terms of the agreement, MedImmune will make an upfront payment of $27.5 million to Inovio as well as potential future payments upon reaching development and commercial milestones totaling up to $700 million. MedImmune will fund all development costs. Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales.
Within the broader collaboration, MedImmune and Inovio will develop up to two additional DNA-based cancer vaccine products not included in Inovio’s current product pipeline, which MedImmune will have the exclusive rights to develop and commercialize. Inovio will receive development, regulatory and commercialization milestone payments and will be eligible to receive royalties on worldwide net sales for these additional cancer vaccine products.
Dr. David Berman, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune, said: “Today’s collaboration with Inovio leverages our deep internal expertise in the use of vaccines to drive antigen-specific T-cell responses. The unique combination of our broad immuno-oncology portfolio with Inovio’s T-cell-activating INO-3112, which enhances cancer specific killer T-cells, has the potential to deliver real clinical benefits for patients.”
Dr. J. Joseph Kim, President and CEO, Inovio, said: “Our licensing partnership with MedImmune represents an important step in executing our immuno-oncology combination strategy and advancing Inovio’s cancer vaccine R&D pipeline with a leading cancer immunotherapy company. INO-3112 is progressing, with positive interim data generated in an Inovio-initiated phase I study. We appreciate MedImmune’s recognition of our ability to activate best-in-class killer T-cells in vivo and look forward to working with them on this collaboration.”
Today’s agreement builds on the existing partnership between Inovio and MedImmune on two research and development collaborations in the infectious disease area. Both efforts are funded by the Defense Advanced Research Projects Agency (DARPA) and support R&D focused on Ebola, influenza, and bacterial infections. MedImmune has a strong heritage in infectious disease and vaccine innovation, having developed the first monoclonal antibody approved by the US Food & Drug Administration for the prevention of an infectious disease and the technology that led to the creation of an HPV vaccine.
About INO-3112
Inovio’s SynCon® DNA-based immunotherapies help the immune system activate disease-specific killer T cells to fight a targeted disease. HPV, the most pervasive sexually transmitted virus, causes numerous pre-cancers and cancers. Inovio’s HPV immunotherapy called INO-3112 targets disease associated with the high-risk HPV types 16 and 18, which are responsible for over 70% of cervical pre-cancers and cancers. INO-3112 combines Inovio’s VGX-3100, its immunotherapy targeting HPV-caused diseases, with its DNA-based immune activator encoded for IL-12. INO-3112 is in three clinical studies for cervical and head and neck cancers.
Earlier this year, Inovio reported preliminary data showing that INO-3112 generated significant antigen-specific CD8+ T cell responses in 3 of 4 patients with head and neck cancer associated with human papillomavirus (HPV) types 16 and 18. These positive results represent the first study and first report of antigen-specific T cell immune responses generated in cancer patients after treatment with a DNA immunotherapy.
Previously in a phase II efficacy trial, treatment with VGX-3100 resulted in histopathological regression of late-stage cervical dysplasia to early stage or no disease, meeting the study’s primary endpoint. In addition, the trial demonstrated clearance of the HPV virus in conjunction with regression of cervical lesions, meeting the secondary endpoint. Robust T-cell activity was observed in subjects who received VGX-3100 compared to those who received placebo.
About MedImmune
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers. For more information, please visit www.medimmune.com.
About AstraZeneca in Oncology
Oncology is a therapeutic area in which AstraZeneca has a deep-rooted heritage. It will be potentially transformational for the company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one day eliminate cancer as a cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.
Our broad pipeline of next-generation medicines is focused on four main disease areas – ovarian, lung, breast and hematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Roche, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, including safety and efficacy for VGX-3100 and INO-3112, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immune therapy and vaccine products, our ability to advance our portfolio of immune-oncology products independently, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, our ability to enter into partnerships in conjunction with our research and development programs, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company’s technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2014, our Form 10-Q for the quarter ended June 30, 2015, and other regulatory filings from time to time. There can be no assurance that any product in Inovio’s pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.
CONTACT: Investors: Bernie Hertel,
Inovio Pharmaceuticals,
858-410-3101,
bhertel@inovio.com
Media: Jeff Richardson,
Inovio Pharmaceuticals,
267-440-4211,
jrichardson@inovio.com
(ZYNE) IPO Closing Exercise in Full of Option to Purchase Additional Shares
DEVON, Pa., Aug. 10, 2015 — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), announced today the closing of its initial public offering of 3,450,000 shares of common stock at a public offering price of $14.00 per share, before underwriting discounts, which includes the exercise in full by the underwriters of their option to purchase up to 450,000 additional shares of common stock at the public offering price, resulting in gross proceeds of $48.3 million. All of the shares in the offering were sold by Zynerba.
Jefferies LLC and Piper Jaffray & Co. acted as joint book-running managers for the offering, and Canaccord Genuity Inc. and Oppenheimer & Co. Inc. acted as co-managers for the offering.
A registration statement on Form S-1 relating to these securities was declared effective by the Securities and Exchange Commission on August 4, 2015. Copies of the final prospectus may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-821-7388, or by email at Prospectus_Department@Jefferies.com, or by accessing the SEC’s website at www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a specialty pharmaceutical company focused on developing and commercializing proprietary next-generation synthetic cannabinoid therapeutics formulated for transdermal delivery. Zynerba is evaluating two product candidates, ZYN002 and ZYN001, in five indications. ZYN002, the company’s CBD Gel, is the first and only synthetic CBD formulated as a patent protected permeation-enhanced gel and is being studied in refractory epilepsy, Fragile X syndrome and osteoarthritis. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC in a transdermal patch to deliver THC through the skin and into the bloodstream. ZYN001 will be studied in fibromyalgia and peripheral neuropathic pain. Learn more at www.zynerba.com and follow the company on Twitter at @ZynerbaPharma.
CONTACT: Investor Contacts
Armando Anido, Chairman and CEO
Richard Baron, CFO
Zynerba Pharmaceuticals
484.581.7505
Media Contact
Jennifer Guinan
Sage Strategic Marketing
610.410.8111
Jennifer@sagestrat.com
(AQXP) Aquinox Should be on Every Investor’s Radar
Canadian biotech Aquinox Pharmaceuticals (NASDAQ: AQXP) created quite the industry buzz last week when the company reported positive mid-stage trial results for its bladder pain drug, AQX-1125.
In addition to meeting secondary endpoints, the LEADERSHIP trial also demonstrated that a high proportion of patients (49%) achieved a clinically meaningful improvement in pain (2 points or greater on an 11-point NRS scale) as compared to placebo (39%).
“Consistently positive results from multiple secondary endpoints have strengthened our confidence in further development of AQX-1125 for BPS/IC,” David Main, president and CEO of Aquinox stated in the news release. “The encouraging effect of AQX-1125 observed on the primary endpoint of reduction in pain together with several statistically significant secondary endpoints, underscore the potential of AQX-1125 as a once daily, oral therapy for this debilitating disease.”
Aquinox also provided a general business update, recapping news from July when the company reported negative FLAGSHIP trial results for AQX-1125 as treatment for chronic pulmonary disease (COPD). As such, the company said it is not planning further development of AQX-1125 as a potential treatment for COPD.
Aquinox instead is reallocating resources to the prioritization of its activities to support possible future registration and planned pivotal clinical trials with AQX-1125 for bladder pain syndrome/interstitial cystitis (BPS/IC) and is deferring the initiation of its phase 2 trial in chronic rhinosinusitis with nasal polyps.
Also on deck is approaching top line data in KINSHIP, a phase 2 clinical trial to evaluate the safety and efficacy of AQX-1125 in atopic dermatitis. Target enrollment in the KINSHIP trial was achieved in early May 2015, and the company anticipates top line data from the trial in Q4 2015.
With Aquinox successfully advancing AQX-1125 for the treatment of a disease affecting between 5 and 12 million Americans each year, the company is aptly positioned to drive shareholder value – warranting a second glance at the small company making big waves in the biotech market.
(TREE) Americans Don’t Understand What’s in Their Wallet
1 in 5 Americans pay credit card interest without even knowing their interest rate
CHARLOTTE, N.C., Aug. 7, 2015 — LendingTree®, the nation’s leading online loan marketplace, recently conducted a survey among a nationally representative sample of 3,170 Americans to gain insight into credit card behaviors, sentiments and knowledge. Of the 2,462 Americans who stated they owned at least one credit card, many don’t know where they financially stand with their credit accounts. Forty-two percent of Americans did not know the combined total credit limit of their credit cards and 58 percent did not know the highest annual percentage rate (APR) of their credit cards.
While many respondents pay off their entire credit card balance each month (almost 52 percent) and therefore pay little attention to APRs, not everyone is as diligent. Of the 58 percent of people who did not know the APRs of their credit cards, nearly 40 percent (38.06%) carried a credit card balance to the next month, incurring interest fees. This translates to a little over one-fifth of card-carrying Americans paying credit card interest without even knowing what the interest payments are.
“Credit cards can be a very convenient and beneficial form of payment when managed responsibly,” stated Doug Lebda, CEO of LendingTree. “But when you make purchases using a credit card and carry the balance from month to month, you incur interest – effectively increasing the price of your purchases by fifteen to twenty-five percent, depending on your interest rate. Miscalculating a budget or not understanding how interest rates can affect your bottom line can lead to consumers being in unexpected credit card debt.”
The survey also found 40 percent of Americans did not know their credit utilization ratio, or the amount of debt one owes in comparison to their maximum credit debt allowance. Without knowing your total credit limit, you cannot calculate your credit utilization.
A previous study done by LendingTree showed that less than a quarter knew that credit utilization accounts for approximately 30 percent of one’s credit score. In this latest survey only 14 percent of Americans did not know which credit score band they fell into. But in the previous study, data showed that when asked in an open-ended question to provide their credit score, nearly 60 percent of Americans didn’t know their exact credit score or provided an implausible value.
“Credit bands only represent a general view of where one stands financially and the bands can be pretty broad. Two individuals both with “very good” credit scores can still get very different rates and offers. A person with a 750 score is likely to get a much better deal than someone with a 720,” said Lebda. “To get the best financial rates and offers, it’s best to keep track of your credit score and know what could affect it. Having a solid grasp of your credit situation can save you significant money, but it’s also just simply good practice to make sure your finances are correct and you’re not victim to a reporting error or credit fraud.”
There are a number of financial tools available online that can help track your credit score. LendingTree’s My LendingTree platform is a free service that provides monthly credit score updates and insights on how one can improve that score. LendingTree has recently upgraded its platform to also provide savings alerts and recommendations for an individual’s financial accounts including mortgages, auto loans, personal loans, and more.
To view the original press release version in the LendingTree Press Room, please visit:
https://www.lendingtree.com/press-release/americans-dont-understand-their-wallet
Methodology
The 2015 U.S. Credit Card Survey was conducted online within the United States by SurveyMonkey® on behalf of LendingTree between July 16 and July 21, 2015 among a nationally representative sample of 3,170 Americans ages 18 and up.
About LendingTree
LendingTree (NASDAQ: TREE) is the nation’s leading online loan marketplace, empowering consumers as they comparison-shop across a full suite of loan and credit-based offerings. LendingTree provides an online marketplace which connects consumers with multiple lenders that compete for their business, as well as an array of online tools and information to help consumers find the best loan. Since inception, LendingTree has facilitated more than 55 million loan requests. LendingTree provides free monthly credit scores through My LendingTree and access to its network of over 350 lenders offering home loans, personal loans, credit cards, student loans, personal loans, business loans, home equity loans/lines of credit, auto loans and more. LendingTree, LLC is a subsidiary of LendingTree, Inc. For more information go to www.lendingtree.com, dial 800-555-TREE, like our Facebook page and/or follow us on Twitter @LendingTree.
MEDIA CONTACT:
Megan Greuling
704-943-8208
megan.greuling@lendingtree.com
(DEPO) Sends Letter to Horizon Pharma
Highlights Horizon’s Failure to Make Compelling Proposal Despite Horizon’s Stated Willingness to Increase Price and Include Cash Component Depomed Files Investor Presentation
NEWARK, Calif., Aug. 7, 2015 — Depomed, Inc. (NASDAQ: DEPO) (“Depomed” or the “Company”) today announced that it has sent the following letter to Horizon Pharma plc (NASDAQ: HZNP) (“Horizon”):
August 7, 2015
Timothy P. Walbert
Chairman of the Board, President and Chief Executive Officer
Horizon Pharma plc
Connaught House, 1st Floor, 1 Burlington Road
Dublin 4, Ireland
Dear Tim,
In our conversation late last week, you stated that Horizon was prepared to increase its proposal and to include a cash component of up to 25%. This was confirmed in an email late Friday night from one of your Board members to our Board Chairman. Yet you still have not made a new proposal. Instead, you have insisted that we need to first make a counter-offer. It does not make any sense to engage with Horizon unless you make a sufficiently compelling and detailed proposal.
As we have previously told you, in order to be compelling, a proposal must reflect what Depomed would contribute to the combined company, as well as the value of synergies from the transaction. Surely your bankers and internal staff have this information as confirmed by the reference from one of your bankers last week.
You continue to be wrongly focused on a “premium to unaffected price”, when you know that our so-called “unaffected price” did not take account of our recent strong results, the additional insights we provided about NUCYNTA and the confirmation this week that all Depomed products remain covered by the major PBMs. What matters is the intrinsic value of Depomed and the contribution Depomed would make to the combined company. The inclusion of 25% cash does not change this from being mostly a stock-for-stock transaction.
We are making available an investor presentation today which shows the continued period of accelerated growth we have experienced and Depomed’s promising outlook. It also includes an equity contribution analysis which shows Depomed’s equity contribution to the combined company– for example, based on revenues in 2016 and 2017, Depomed’s equity contribution would 33% and 35%, respectively.1 The Depomed shareholders are entitled to an ownership interest that is commensurate with what Depomed would contribute to the combined company as well as a share of the synergies.
Your willingness to increase your proposal is an obvious recognition that the vast majority of our shareholders do not support what you have proposed. Our Board takes its fiduciary duties seriously and will always be open to any compelling proposal that creates value for its shareholders, but we are prepared and committed to take actions that we deem appropriate to protect our shareholders’ interests, even if it involves protracted litigation and a proxy fight.
Best regards, Jim
Depomed also made available an investor presentation under the webcast and presentation section of the company’s investor relations page at investor.depomedinc.com.
Morgan Stanley & Co. LLC and Leerink Partners LLC are serving as financial advisors to Depomed and Baker Botts L.L.P. and Gibson, Dunn & Crutcher LLP are serving as legal counsel.
About Depomed
Depomed is a specialty pharmaceutical company that commercializes products for pain and neurology related disorders. Our NUCYNTA® franchise includes NUCYNTA® ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment, and NUCYNTA® (tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia. CAMBIA® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug indicated for acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults. Lazanda® (fentanyl) Nasal Spray is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Gralise, Nucynta ER and various partner product candidates are formulated with Depomed’s proven, proprietary Acuform® drug delivery technology. Additional information about Depomed may be found at www.depomed.com.
Forward-Looking Statements
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to Depomed’s prospects as a standalone business, Depomed’s business strategy, expectations regarding Depomed’s future financial results and the ability to create shareholder value, expectations regarding anticipated growth and the future contributions and potential of NUCYNTA, and other risks detailed in the company’s Securities and Exchange Commission filings, including the company’s Annual Report on Form 10-K for the year ended December 31, 2014 and its most recent Quarterly Report on Form 10-Q. The inclusion of forward-looking statements should not be regarded as a representation that any of the company’s plans, objectives or expectations will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Important Additional Information
Depomed intends to file a revocation statement and revocation card with the U.S. Securities and Exchange Commission (the “SEC”) in connection with a proposed solicitation by Horizon Pharma, plc to be able to call a special meeting of Depomed shareholders (the “Horizon Special Meeting Solicitation”). INVESTORS AND SHAREHOLDERS ARE STRONGLY ENCOURAGED TO READ THE REVOCATION STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS) AND OTHER DOCUMENTS FILED WITH THE SEC IF AND WHEN THEY BECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION.
These documents, including any solicitation statement (and amendments or supplements thereto) and other documents filed by Depomed with the SEC, will be available for no charge at the SEC’s website at http://www.sec.gov and at the investor relations section of Depomed’s website at http://www.depomed.com. Copies may also be obtained by contacting Depomed’s Investor Relations by mail at 7999 Gateway Blvd., Suite 300, Newark, CA 94560 or by telephone at 510-744-8000.
Certain Information Regarding Participants
Depomed, its directors and certain of its executive officers may be deemed to be participants in the solicitation of revocations in connection with the Horizon Special Meeting Solicitation. Information regarding the names of Depomed’s directors and executive officers and their respective interests in Depomed by security holdings or otherwise is set forth in Depomed’s proxy statement for the 2015 Annual Meeting of Shareholders, filed with the SEC on April 6, 2015. To the extent holdings of such participants in Depomed’s securities have changed since the amounts described in the 2015 proxy statement, such changes have been reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC. Additional information can also be found in Depomed’s Annual Report on Form 10-K for the year ended December 31, 2014, filed with the SEC on February 26, 2015 and in Depomed’s latest Quarterly Report on Form 10-Q.
Investor Contact:
Depomed, Inc.
August J. Moretti
Chief Financial Officer
510-744-8000
amoretti@depomed.com
or
Christopher Keenan
VP, Investor Relations and Corporate Communication
510-744-8000
ckeenan@depomed.com
Innisfree M&A Incorporated
Larry Miller / Jonathan Salzberger / Scott Winter
(212) 750-5833
Media Contact:
Joele Frank, Wilkinson Brimmer Katcher
Eric Brielmann
415-869-3950
Andy Brimmer and Averell Withers
212-355-4449
(CLIR) Signs Agreement with Tesoro Refining & Marketing Company LLC
SEATTLE, Aug. 7, 2015 — ClearSign Combustion Corporation (NASDAQ: CLIR) announced today that it has entered into an agreement with Tesoro Refining & Marketing Company LLC to evaluate the performance of ClearSign’s low emissions Duplex™ technology in Tesoro’s refinery heaters.
In the initial stage of the agreement, ClearSign will retrofit Duplex technology within a selected multiple-burner process heater at Tesoro’s Los Angeles refinery. Several performance criteria will be evaluated, including NOx emissions that meet or exceed the California South Coast Air Quality Management District’s (SCAQMD) ambitious NOx Reclaim Program’s goal of reducing refinery NOx emissions to half of their current level of (tons NOx or PPM) by 2020.
About Tesoro Refining & Marketing Company LLC
Tesoro Refining & Marketing Company LLC is a subsidiary of Tesoro Corporation. Tesoro Corporation, a Fortune 100 company, is an independent refiner and marketer of petroleum products. Tesoro, through its subsidiaries, operates six refineries in the western United States with a combined capacity of over 850,000 barrels per day and ownership in a logistics business which includes a 35% interest in Tesoro Logistics LP and ownership of its general partner. Tesoro’s retail-marketing system includes over 2,200 retail stations under the ARCO®, Shell®, Exxon®, Mobil®, USA Gasoline™ and Tesoro® brands.
About ClearSign Combustion Corporation
ClearSign Combustion Corporation designs, develops and markets technologies that drive to improve key performance characteristics of combustion systems, including emissions and operational performance, energy efficiency and overall cost-effectiveness. Our patent-pending Duplex™ and Electrodynamic Combustion Control™ platform technologies enhance the performance of combustion systems in a broad range of markets, including the chemical, petrochemical, refinery, power and commercial boiler industries. For more information, please visit www.clearsign.com.
Cautionary note on forward-looking statements
This press release includes forward-looking information and statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding our assumptions, projections, expectations, targets, intentions or beliefs about future events that are based on management’s belief, as well as assumptions made by, and information currently available to, management. While we believe that our expectations are based upon reasonable assumptions, there can be no assurances that our goals and strategy will be realized. Numerous factors may affect our actual results and may cause results to differ materially from those expressed in forward-looking statements made by us or on our behalf. Some of these factors include the acceptance of existing and future products, the impact of competitive products and pricing, general business and economic conditions, and other factors detailed in our Annual Report on Form 10-K and other periodic reports filed with the SEC. We specifically disclaim any obligation to update or revise any forward-looking statement whether as a result of new information, future developments or otherwise.
(NVDA) Tech Licensed By Pixar for Accelerating Feature Film Production
SANTA CLARA, CA–(Aug 7, 2015) – To accelerate production of its computer-animated feature films and short film content, Pixar Animation Studios is licensing a suite of NVIDIA (NASDAQ: NVDA) technologies related to image rendering, the companies announced today.
The multi-year strategic licensing agreement gives Pixar access to NVIDIA’s quasi-Monte Carlo (QMC) rendering methods. These methods can make rendering more efficient, especially when powered by GPUs and other massively parallel computing architectures.
“NVIDIA and Pixar have worked together for years to improve workflows in content creation,” said Steven Parker, vice president of engineering and CTO of rendering technology at NVIDIA. “With NVIDIA’s QMC sampling technology, Pixar can accelerate its creative process while continuing to produce visual imagery and animation of the very highest standard.”
“Pixar has long used NVIDIA GPU technology to push the limits of what is possible in animation and the filmmaking process,” said Steve May, vice president and CTO at Pixar. “NVIDIA’s particular QMC implementation has the potential to enhance rendering functionality and significantly reduce our rendering times.”
As part of the agreement, NVIDIA will also contribute ray-tracing technology to Pixar’s OpenSubdiv Project, an open-source initiative to promote high-performance subdivision surface evaluation on massively parallel CPU and GPU architectures. This will enable rendering of complex Catmull-Clark subdivision surfaces in animation with unprecedented precision.
To Keep Current on NVIDIA:
- Keep up with the NVIDIA Blog, and follow us on Facebook, Google+, Twitter, LinkedIn and Instagram.
- View NVIDIA videos on YouTube and images on Flickr.
- Use the Pulse news reader to subscribe to the NVIDIA Daily News feed.
About Pixar Animation Studios
Pixar Animation Studios, a wholly owned subsidiary of The Walt Disney Company, is an Academy Award®-winning film studio with world-renowned technical, creative and production capabilities in the art of computer animation. The Northern California studio has created some of the most successful and beloved animated films of all time, including “Toy Story,” “Monsters, Inc.,” “Cars,” “The Incredibles,” “Ratatouille,” “WALL-E,” “Up,” “Toy Story 3” and “Brave.” Its movies have won 30 Academy Awards® and have grossed more than $8.7 billion at the worldwide box office to date. “Inside Out,” Pixar’s fifteenth feature, is currently in theaters worldwide.
About NVIDIA
Since 1993, NVIDIA (NASDAQ: NVDA) has pioneered the art and science of visual computing. The company’s technologies are transforming a world of displays into a world of interactive discovery — for everyone from gamers to scientists, and consumers to enterprise customers. More information at http://nvidianews.nvidia.com/ and http://blogs.nvidia.com/.
Certain statements in this press release including, but not limited to, statements as to: the impact of the licensing of NVIDIA’s image rendering technologies to Pixar; and the benefits and impact of NVIDIA’s quasi-Monte Carlo rendering methods and ray-tracing technology are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: global economic conditions; our reliance on third parties to manufacture, assemble, package and test our products; the impact of technological development and competition; development of new products and technologies or enhancements to our existing product and technologies; market acceptance of our products or our partners’ products; design, manufacturing or software defects; changes in consumer preferences or demands; changes in industry standards and interfaces; unexpected loss of performance of our products or technologies when integrated into systems; as well as other factors detailed from time to time in the reports NVIDIA files with the Securities and Exchange Commission, or SEC, including its Form 10-Q for the quarterly period ended April 26, 2015. Copies of reports filed with the SEC are posted on the company’s website and are available from NVIDIA without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, NVIDIA disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
© 2015 NVIDIA Corporation. All rights reserved. NVIDIA and the NVIDIA logo are trademarks and/or registered trademarks of NVIDIA Corporation in the U.S. and other countries. Other company and product names may be trademarks of the respective companies with which they are associated. Features, pricing, availability and specifications are subject to change without notice.
For further information, contact:
Gail Laguna
Senior PR Manager
NVIDIA Professional Visualization
(408) 386-2435
glaguna@nvidia.com
(AMRN) First Amendment Decision a Win for Amarin and Physician Plaintiffs
Federal Court Rules Promotion of ANCHOR Clinical Data of Vascepa(R) and Research on the Potential Connection Between Vascepa and Cardiovascular Risk Reduction Is Constitutionally Protected Speech
BEDMINSTER, NJ and DUBLIN, IRELAND–(August 07, 2015) – Amarin Corporation plc (NASDAQ: AMRN) today announced a United States District Court has ruled that Amarin may promote to healthcare professionals certain uses of Amarin’s lead product, Vascepa®(icosapent ethyl) capsules, that are not covered by current FDA-approved labeling for the drug so long as the promotion is truthful and non-misleading. The Court declaration covers promotion of the FDA-reviewed and agreed effects of Vascepa demonstrated in the ANCHOR clinical trial of patients with persistently high triglycerides after statin therapy and use of peer-reviewed scientific publications that present the current state of scientific research related to the potential of Vascepa to reduce the risk of cardiovascular disease. Based on today’s ruling Amarin plans to begin promotional activities consistent with the opinion as soon as possible.
Decision is a victory aimed at improved patient care
The decision opens more direct and effective paths to communicate truthful and non-misleading information about Vascepa clinical trial results and the state of science relevant to the potential of Vascepa to reduce the risk of cardiovascular disease. With accurate information readily available, healthcare professionals will be better able to assess for themselves how best to choose among available treatment options for their patients. With healthcare professionals better informed, this decision is a victory that Amarin believes will lead to improved patient care.
Cardiovascular disease is the leading cause of death for men and women in the United States. Significant risk from cardiovascular disease remains for tens of millions of Americans after statin therapy and recommended changes in diet and exercise. Given the significant need to reduce the risk of cardiovascular disease, numerous independent national and international treatment guidelines and position statements recommend drug therapy as an adjunct to healthy diet, lifestyle change and statin therapy for at-risk patients with persistently high triglyceride levels in their blood to lower those patients’ triglycerides and/or non-high-density lipoprotein cholesterol. The use of Vascepa in this patient population, as studied in the ANCHOR trial, is contemplated by guidelines, is medically accepted and commonly prescribed by physicians. This is the practical reality despite the fact that FDA did not approve Vascepa for this use and even though a link between such treatment and reduced cardiovascular risk has not been determined. Use of Vascepa within these guidelines is also listed on independent drug compendia on which reimbursement from Medicare, Medicaid and private payor plans is based. Amarin’s REDUCE-IT cardiovascular outcomes study of Vascepa, which is designed to evaluate the efficacy of Vascepa in reducing cardiovascular mortality and morbidity in a high-risk patient population on statin therapy, is over 95% enrolled.
“This lawsuit is based on the principle that better informed physicians will make better treatment decisions for their patients,” said John F. Thero, President and Chief Executive Officer. “Many physicians are aware of the efficacy data included in FDA-approved labeling for Vascepa but are not aware of efficacy data from the ANCHOR study of Vascepa. FDA has already included the safety data from both the MARINE and ANCHOR studies in approved Vascepa labeling. Amarin will now be able to communicate efficacy data from ANCHOR and other relevant study results to these physicians and to others in the medical community in the context of appropriate disclaimers.”
The truthful and non-misleading information about Vascepa protected by the Court order
The Court determined that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides, and specifically make to healthcare professionals the following truthful and non-misleading statements:
- Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. Vascepa should not be taken in place of a healthy diet and lifestyle or statin therapy.
- Vascepa is not FDA-approved for the treatment of statin-treated patients with mixed dyslipidemia and high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels due to current uncertainty regarding the benefit, if any, of drug-induced changes in lipid/lipoprotein parameters beyond statin-lowered low-density lipoprotein cholesterol on cardiovascular risk among statin-treated patients with residually high triglycerides. No prospective study has been conducted to test and support what, if any, benefit exists.
- Recent cardiovascular outcomes trials (ACCORD-Lipid, AIM-HIGH, and HPS2-THRIVE), while not designed to test the effect of lowering triglyceride levels in patients with high triglyceride levels after statin therapy, each failed to demonstrate incremental cardiovascular benefit of adding a second lipid-altering drug (fenofibrate or formulations of niacin), despite raising high-density lipoprotein cholesterol and reducing triglyceride levels, among statin-treated patients with well-controlled low-density lipoprotein cholesterol.
- The ANCHOR trial demonstrates that Vascepa lowers triglyceride levels in patients with high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels not controlled by diet and statin therapy.
- In the ANCHOR trial, Vascepa 4g/day significantly reduced TG [triglycerides], non- HDL-C [non-high-density lipoprotein cholesterol or non-“good cholesterol,”] Apo B [Apolipoprotein B], VLDL-C [very-low-density lipoprotein cholesterol], TC [total cholesterol] and HDL-C [high-density lipoprotein cholesterol or “good cholesterol”] levels from baseline relative to placebo in patients with high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels not controlled by diet and statin therapy. The reduction in TG [triglycerides] observed with Vascepa was not associated with elevations in LDL-C [low-density lipoprotein cholesterol or “bad cholesterol] relative to placebo.
The Court’s ruling also permits communication to healthcare professionals of the following information:
- peer-reviewed scientific publications relevant to the potential effect of EPA on the reduction of the risk of coronary heart disease, such as the JELIS cardiovascular outcomes trial of a pure-EPA product in Japanese patients and other publications on omega-3 acid studies; and
- more complete efficacy data from the ANCHOR trial.
To ensure that this speech is non-misleading, Amarin would also disclose the following:
- FDA has not approved to Vascepa reduce the risk of coronary heart disease;
- The effect of Vascepa on the risk of cardiovascular mortality and morbidity has not been determined;
- A cardiovascular outcomes study of Vascepa designed to evaluate the efficacy of Vascepa in reducing cardiovascular mortality and morbidity in a high-risk patient population on statin therapy is currently underway;
- Vascepa may not be eligible for reimbursement under government healthcare programs, such as Medicare or Medicaid, for treatment of statin-treated patients with mixed dyslipidemia and high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels or to reduce the risk of coronary heart disease. We encourage you to check that for yourself; and
- Any potential financial or affiliation biases between the firm and those who conducted the ANCHOR study.
About prohibitions on communication of off-label drug information
Once a drug is approved by FDA for a specific use in a specific patient population, physicians may exercise their medical judgment to prescribe the drug for any use in any patient population. It is estimated that approximately 20% of all prescriptions in the United States are used by physicians for such “off-label” indications. FDA has taken the position, however, that federal law prohibits pharmaceutical companies from proactively promoting data to the medical community regarding off-label uses — even when such information is accurate, not misleading and reflective of accepted medical treatment.
FDA has acknowledged the importance of the off-label use of many pharmaceutical products. Federal, state and private health plans routinely pay for many off-label drug uses, including certain off-label uses of Vascepa. FDA permits limited communications on off-label uses, such as in response to unsolicited requests for information, under FDA’s publication reprint guidance and in connection with scientific exchanges. Prior to this judgment, these restrictions significantly limited the flow of information about the specified off-label uses of Vascepa.
About the ruling and potential future proceedings
The ruling today by the Honorable Judge Paul Engelmayer of the United States District Court for the Southern District of New York granted Amarin and the physician plaintiffs relief in the form of a declaratory judgment. The ruling declared as unconstitutional, in this case with the specified disclosures, FDA off-label promotion restrictions.
An appeal of the Court’s ruling can be filed within 60 days. The ruling will remain in effect until the Court makes a final decision in the case unless the ruling is appealed and overturned. The underlying litigation may proceed until the Court enters a final order in the case. The lawsuit did not seek and the ruling did not grant approval of the indication contemplated by the ANCHOR study.
About the REDUCE-IT cardiovascular outcomes study
The REDUCE-IT cardiovascular outcomes study is the first prospective double-blinded cardiovascular outcomes study of any drug in a population of patients who, despite stable statin therapy, have elevated triglyceride levels. The REDUCE-IT study is also the first cardiovascular outcomes study to test a high, 4-gram dose of a pure-EPA only omega-3 prescription product. In the REDUCE-IT study, pure-EPA Vascepa is being studied as an adjunct to, and not as a replacement for, statin therapy. If successful, Amarin plans to seek additional indicated uses for Vascepa that extend beyond the populations studied in the successful MARINE and ANCHOR trials of Vascepa. These additional indications would potentially address tens of millions of patients in the United States and worldwide with elevated triglyceride levels despite stable statin therapy.
Amarin is blinded to the results of the REDUCE-IT study. The pooled, blinded event rate in the REDUCE-IT study is tracking to expectations for the study to continue until 2017 with results anticipated to be published in 2018. An interim review by the independent data monitoring committee of the efficacy and safety results of the trial is expected to occur during 2016 upon reaching 60% of the target aggregate number of cardiovascular events.
About VASCEPA® (icosapent ethyl) capsules
VASCEPA® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly pure-EPA omega-3 prescription product in a 1 gram capsule.
FDA-approved Indications and Usage
- VASCEPA (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of VASCEPA on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for VASCEPA
- VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
- Use with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo.
- Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
- Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the FDA as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.
About Amarin
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Amarin’s clinical program includes commitment to the ongoing REDUCE-IT cardiovascular outcomes study. Vascepa® (icosapent ethyl), Amarin’s first FDA-approved product, is a highly-pure, EPA-only, omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
Forward-looking statements
This press release contains forward-looking statements, including interpretations of the Court ruling and statements about the merits of legal arguments, whether the REDUCE-IT trial will continue as contemplated, whether the demonstrated clinical effects of Vascepa will result in cardiovascular risk reduction benefit in the REDUCE-IT trial and whether the results described herein will result in improved patient care. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. There can be no guarantee that Amarin will continue to be successful in this lawsuit. The litigation process could involve appeals and take a significant amount of time to reach final conclusion. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: the risk that Amarin’s interpretation of the legal opinion and applicable legal standards may not be determinative or adjudicated definitively in Amarin’s favor; the risk that the stated preliminary relief will not be permitted on a permanent basis and uncertainties associated generally with litigation, research and development, clinical trials and related regulatory approvals. There can be no assurance that promotion of the information allowed by the Court ruling will have a material impact on Amarin’s operating results. While Amarin plans to increase certain sales and marketing costs to promote the newly allowed information to healthcare professionals, the extent to which revenues may change as a result of such promotion cannot at this time be predicted. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Availability of other information about Amarin
Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Amarin contact information:
Investor Relations:
Michael Farrell
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Graham Morrell
Trout Group
In U.S.: +1 (646) 378-2954
gmorrell@troutgroup.com
Source: Amarin Corp. Plc
Media Inquiries:
Lee Davies
Makovsky
In U.S.: +1 (212) 508-9651
ldavies@makovsky.com
(TWOU) CFO Cathy Graham to Speak at Upcoming Investor Conferences
LANDOVER, Md., Aug. 7, 2015 — 2U, Inc. (NASDAQ:TWOU), today announced that Chief Financial Officer Cathy Graham will speak at two technology-focused investor conferences next week. 2U is a leading provider of cloud-based software-as-a-service technology fused with technology-enabled services that enables leading nonprofit colleges and universities to deliver high-quality degree programs online.
On Monday, August 10, Graham will speak at the 17th Annual Pacific Crest Global Technology Leadership Forum held at the Sonnenalp Hotel in Vail, Colorado at 10 a.m. MDT (12 p.m. EDT).
On Wednesday, August 12, Graham will speak at the Oppenheimer 18th Annual Technology, Internet & Communications Conference held at the Four Seasons Hotel in Boston, Massachusetts at 9:45 a.m. EDT.
Live webcasts of the presentations will be available at investor.2u.com. An archive of the webcasts also will be available for 90 days following the live presentation.
About 2U, Inc. (NASDAQ:TWOU)
2U partners with leading colleges and universities to deliver the world’s best online degree programs so students everywhere can reach their full potential. Our Platform, a fusion of cloud-based software-as-a-service technology and technology-enabled services, provides schools with the comprehensive operating infrastructure they need to attract, enroll, educate, support and graduate students globally. Blending live face-to-face classes, dynamic course content and real-world learning experiences, 2U’s No Back Row® approach ensures that every qualified student can experience the highest quality university education for the most successful outcome.
To learn more, go to 2U.com. Be sure to follow us on LinkedIn (http://www.linkedin.com/company/2u), Twitter (http://twitter.com/2Uinc) and Facebook (http://www.facebook.com/2u).
CONTACT: Investor Contact:
Ed Goodwin, 301-892-4239, egoodwin@2U.com
Media Contact:
Shirley Chow, 646-597-5850, schow@2U.com
(VPCOU) Update on Retail Store Expansion; Acquisition Strategy Post $41.4M Raise
DANIA BEACH, Fla., Aug. 6, 2015 — Vapor Corp. (NASDAQ CM: VPCO, VPCOU) (“the Company”), a leading U.S.-based distributor and retailer of vaporizers, e-liquids, e-cigarettes and e-hookahs, today issued comments on its recent capital raise and the intention to expand its network of retail locations.
“Following the completion of our recent public offering, we are extraordinarily well funded and well-positioned to execute against our business plan swiftly and judiciously,” said Jeff Holman, CEO of Vapor Corp. “I am happy to report that Vapor Corp. now has a financially clean slate and will use this significant war chest to fund our expansion efforts. Our 10 existing ‘Vape Store’ locations are performing well and are profitable at the individual store level. This significant infusion of capital will allow us to accelerate our retail expansion through a combination of new store launches and a roll up, in the form of purchasing existing, profitable vape store locations. The current retail environment is highly fragmented and ripe for consolidation.”
On July 30, 2015, Vapor Corp. closed an offering of 3,761,657 preferred stock units at $11 per unit for gross proceeds of approximately $41.4 million and net proceeds to Vapor Corp. of approximately $38.7 million. Each unit consists of one-fourth of a share of Series A preferred stock (convertible into 10 shares of common stock) and 20 Series A warrants. Each Series A warrant is exercisable into one share of common stock at an exercise price of $1.24 per share. The units began trading on The NASDAQ Capital Market under the ticker symbol “VPCOU” immediately following the closing on July 30, 2015.
“As the vaporizer and e-liquid market continues to mature, there is a tremendous opportunity for Vapor Corp. to capitalize on its industry knowledge and proven track record of launching and supporting a successful retail store concept,” continued Mr. Holman. “We are confident that consumers will react favorably to our expanded retail and branded presence. We are currently on track to fulfill our goal of increasing our company owned retail store footprint by 20 to 30 branded retail locations before the end of the calendar year. In addition, based upon “The Vape Store’s” proven track record, we also expect the coming launch of our franchise model to be exceptionally well received.”
These ramp-up efforts come amid considerations by the Food and Drug Administration (FDA) to implement its new regulations, further evidencing the constantly evolving e-cigarette and vaporizer market.
“We predict that the pending FDA regulations will improve safety and the responsible use of vaping products in what is currently a largely unregulated space. However, these regulations will likely make it more difficult for smaller, local vape shops to remain in business. As a result we expect to see the elimination or consolidation of much of the current vape store landscape. Vapor Corp. is cognizant of the opportunity that this presents for the company to make reasonably priced acquisitions during its consolidation efforts, and at the same time offer smaller businesses a reasonable liquidity event under the circumstances. Vapor Corp. is committed to the responsible use of vaporizers and accompanying substances, and is excited to be so strategically positioned to benefit from this changing regulatory landscape,” concluded Mr. Holman.
Forward-Looking Statements
This press release includes forward-looking statements including statements regarding growth, aggressive expansion, launch of our franchise model, and predictions regarding FDA regulations. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. The results anticipated by any or all of these forward-looking statements might not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include the impact of competitive products or pricing, technological changes, the effect of economic conditions, and unexpected federal and/or state regulation regarding vaporizers. Further information on our risk factors is contained in our filings with the SEC, including the Prospectus dated July 23, 2015. We undertake no obligation to publicly update or revise any forward-looking statements, whether as the result of new information, future events or otherwise.
About Vapor Corp.
Vapor Corp., a NASDAQ company, is a U.S. based distributor and retailer of vaporizers, e-liquids and electronic cigarettes. It recently acquired the retail store chain “The Vape Store” as part of a merger with Vaporin, Inc. The Company’s innovative technology enables users to inhale nicotine vapor without smoke, tar, ash or carbon monoxide. Vapor Corp. has a streamlined supply chain, marketing strategies and wide distribution capabilities to deliver its products. The Company’s brands include VaporX®, Krave®, Hookah Stix® and Vaporin™ and are distributed to retail stores throughout the U.S. and Canada. The Company sells direct to consumer via e-commerce and Company-owned brick-and-mortar retail locations operating under “The Vape Store” brand.
(NXTM) 10th Anniversary ofSystem One; Unveil of Robust Pipeline & Launch Plans
Company continues decade-long commitment to innovation with breakthrough technologies
LAWRENCE, Mass., Aug. 6, 2015 — This summer, NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of dialysis products, is celebrating the 10th year anniversary of the Food and Drug Administration’s (FDA) clearance of the first and only portable home hemodialysis (HHD) system, the NxStage® System One™. In connection with the anniversary, NxStage unveiled details of new innovations from its robust pipeline including its next generation hemodialysis system, peritoneal dialysis (PD) system and next generation critical care system during its second quarter of 2015 financial results conference call this morning. In addition, NxStage announced that it expects to begin by launching its next generation hemodialysis system later next year.
“Over the last decade, NxStage’s model of innovation has yielded transformational technologies, including the System One, our dialysate preparation system, and a rich portfolio of integrated offerings and capabilities,” stated Jeffrey H. Burbank, Founder and Chief Executive Officer of NxStage. “We’re proud to have a portfolio that includes many of the industry’s ‘firsts’ in terms of technology and clearances that are having a wonderful impact on patient lives and advancing the standard of renal care.”
“As a clinician, I’ve seen that the life-changing benefits of HHD with the System One are truly remarkable,” said Renal Nurse Practitioner Lisa Koester of Barnes Jewish Dialysis Center in St. Louis, Missouri. “Because of this breakthrough technology, patients are able to get back to work, family and a more normal life.”
Burbank continued, “Our established track record of innovation is enabling strong growth, market expansion, customer diversification, and solid operating performance across our business, in addition to laying the groundwork for much more. I’m excited to deliver new breakthrough technologies for HHD, PD, critical care, as well as traditional three times weekly in-center therapy. These innovations are designed to give patients even more flexibility in meeting their clinical and lifestyle needs, as well as provide economic advantages to our customers. We expect these innovations to significantly expand our addressable market, from an estimated $1 billion to $5 billion in total, and fuel our long-term growth.”
To learn more about NxStage’s history of innovation, visit Our History of Innovation for a graphic timeline highlighting the Company’s milestone clearances.
NxStage will also host a conference call today at 9:00 a.m. Eastern Time to discuss its second quarter financial results and its technology pipeline. To listen to the conference call, please dial 877-392-9886 (domestic) or 707-287-9329 (international). The call will also be webcast LIVE and can be accessed via the investor relations section of the Company’s website at http://ir.nxstage.com. A replay of the conference call will be available through August 14, 2015 by dialing 855-859-2056 (domestic) or 404-537-3406 (international) and referencing conference ID 77465339. An online archive of the conference call can be accessed via the investor relations section of the Company’s website at http://ir.nxstage.com.
For more information about the System One, home hemodialysis or home nocturnal hemodialysis, please visit www.nxstage.com.
Despite the health benefits that home hemodialysis may provide to those with chronic kidney disease, this form of therapy is not for everyone. The reported benefits of home hemodialysis may not be experienced by all patients. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream and blood loss due to clotting or accidental disconnection of the blood tubing set. Certain risks are unique to the home. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed.
About the NxStage System One
The NxStage System One is the first and only portable hemodialysis machine cleared specifically by the U.S. Food & Drug Administration (FDA) for home hemodialysis and home nocturnal hemodialysis. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients’ homes and give patients the freedom to travel with their therapy. When combined with the NxStage Pureflow SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, including while they are sleeping – at home or on vacation and at a medically appropriate treatment frequency. The System One is also used to provide a range of flexible therapy options in more traditional care settings such as hospitals and dialysis centers. Its safety and efficacy have been demonstrated by experience with more than 10 million treatments with thousands of patients around the world. www.nxstage.com.
About NxStage Medical
NxStage Medical Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the Company’s website at www.nxstage.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,” “expect,” “estimate,” “plan,” and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those that are discussed in NxStage’s filings with the Securities and Exchange Commission, including its most recent quarterly or annual report.
NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Media contact:
Kristen K. Sheppard, Esq.
ksheppard@nxstage.commailto:ksheppard@nxstage.com
Tel: (978) 332-5923
(ZYNE) Builds Out Board of Directors
High-Caliber Appointees Offer Track Record of Success in Building Innovative Pharmaceutical Companies as Company Closes IPO
DEVON, Pa., Aug. 6, 2015 — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), announced today that it has appointed six new members of its board of directors. The appointees offer extensive scientific, regulatory commercial and financial experience and successful track records in development- and commercial-stage pharmaceutical companies. With these new appointments, Philip Wagenheim and Steve Gailar have resigned as members of the Zynerba board of directors.
The new Zynerba board appointments are as follows. Full biographies are available at zynerba.com.
| Warren D. Cooper, MB, BS, BSc, MPFM | Former CEO, Prism Pharmaceuticals; Merck, Sharp, Dohme |
| William J. Federici, MBA, CPA | Vice President and Chief Financial Officer of West Pharmaceutical Services |
| Thomas L. Harrison, LH.D | Chairman Emeritus of Diversified Agency Services, a division of Omnicom Group |
| Daniel L. Kisner, MD | Former venture partner/partner, Aberdare Ventures; President and CEO, Caliper Technologies |
| Kenneth I. Moch | President, Euclidean Life Science Advisors; Former President and CEO, Chimerix, BioMedical Enterprises, Alteon, and Biocyte Corporation |
| Cynthia Rask, MD | Board certified in Clinical Neurophysiology; Former Acting Director, Office of Cellular, Tissue and Gene Therapies US Food and Drug Administration (FDA); Abbott Laboratories, Genentech |
“These high-caliber board appointments well-position Zynerba, the first and only transdermal cannabinoid company, for its continued development,” said Armando Anido, Chief Executive Officer (CEO) and Chairman of Zynerba Pharmaceuticals. “With such a broad range of expertise, we are confident that the board will strategically guide the company as we rapidly approach clinical development in the coming months and ultimately pursue regulatory approval and commercialization of our novel transdermal cannabinoid treatments for patients in need. We thank Phil and Steve for their support and guidance and for successfully positioning Zynerba for its introduction to the public market.”
About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a specialty pharmaceutical company focused on developing and commercializing proprietary next-generation synthetic cannabinoid therapeutics formulated for transdermal delivery. Zynerba is evaluating two product candidates, ZYN002 and ZYN001, in five indications. ZYN002, the company’s CBD Gel, is the first and only synthetic CBD formulated as a patent protected permeation-enhanced gel and is being studied in refractory epilepsy, Fragile X syndrome and osteoarthritis. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC in a transdermal patch to deliver THC through the skin and into the bloodstream. ZYN001 will be studied in fibromyalgia and peripheral neuropathic pain. Learn more at www.zynerba.com and follow the company on Twitter at @ZynerbaPharma.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that we will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration (“FDA”) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, we may not be able to obtain the label claims that we are seeking from the FDA. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: our ability to commercialize our product candidates; the size and growth potential of the markets for our product candidates, and our ability to service those markets; our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of our product candidates; the success, cost and timing of our product development activities, studies and clinical trials; the success of competing products that are or become available; and our expectations regarding our ability to obtain and adequately maintain sufficient intellectual property protection for our product candidates. These and other risks are described under the heading “Risk Factors” the registration statement on Form S-1 (commission file number 333-205355), which was declared effective by the Securities and Exchange Commission on August 4, 2015. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
CONTACT: Investor Contacts
Armando Anido, Chairman and CEO
Richard Baron, CFO
Zynerba Pharmaceuticals
484.581.7505
Media Contact
Jennifer Guinan
Sage Strategic Marketing
610.410.8111
Jennifer@sagestrat.com
(MRGE) (IBM) Watson to Gain Ability to “See” w/ Planned $1B Acquisition of Merge Healthcare
Deal Brings Watson Technology Together with Leader in Medical Images
ARMONK, N.Y. and CHICAGO, Aug. 6, 2015 — IBM (NYSE: IBM) today announced that Watson will gain the ability to “see” by bringing together Watson’s advanced image analytics and cognitive capabilities with data and images obtained from Merge Healthcare Incorporated’s (NASDAQ: MRGE) medical imaging management platform. IBM plans to acquire Merge, a leading provider of medical image handling and processing, interoperability and clinical systems designed to advance healthcare quality and efficiency, in an effort to unlock the value of medical images to help physicians make better patient care decisions.
Merge’s technology platforms are used at more than 7,500 U.S. healthcare sites, as well as most of the world’s leading clinical research institutes and pharmaceutical firms to manage a growing body of medical images. The vision is that these organizations could use the Watson Health Cloud to surface new insights from a consolidated, patient-centric view of current and historical images, electronic health records, data from wearable devices and other related medical data, in a HIPAA-enabled environment.
Under terms of the transaction, Merge shareholders would receive $7.13 per share in cash, for a total transaction value of $1 billion. The closing of the transaction is subject to regulatory review, Merge shareholder approval, and other customary closing conditions, and is anticipated to occur later this year. It is IBM’s third major health-related acquisition – and the largest – since launching its Watson Health unit in April, following Phytel (population health) and Explorys (cloud based healthcare intelligence).
“As a proven leader in delivering healthcare solutions for over 20 years, Merge is a tremendous addition to the Watson Health platform. Healthcare will be one of IBM’s biggest growth areas over the next 10 years, which is why we are making a major investment to drive industry transformation and to facilitate a higher quality of care,” said John Kelly, senior vice president, IBM Research and Solutions Portfolio. “Watson’s powerful cognitive and analytic capabilities, coupled with those from Merge and our other major strategic acquisitions, position IBM to partner with healthcare providers, research institutions, biomedical companies, insurers and other organizations committed to changing the very nature of health and healthcare in the 21st century. Giving Watson ‘eyes’ on medical images unlocks entirely new possibilities for the industry.”
Teaching Watson to “See” Medical Images
The planned acquisition bolsters IBM’s strategy to add rich image analytics with deep learning to the Watson Health platform – in effect, advancing Watson beyond natural language and giving it the ability to “see.” Medical images are by far the largest and fastest-growing data source in the healthcare industry and perhaps the world – IBM researchers estimate that they account for at least 90% of all medical data today – but they also present challenges that need to be addressed:
- The volume of medical images can be overwhelming to even the most sophisticated specialists – radiologists in some hospital emergency rooms are presented with as many as 100,000 images a day1.
- Tools to help clinicians extract insights from medical images remain very limited, requiring most analysis to be done manually.
- At a time when the most powerful insights come at the intersection of diverse data sets (medical records, lab tests, genomics, etc.), medical images remain largely disconnected from mainstream health information.
IBM plans to leverage the Watson Health Cloud to analyze and cross-reference medical images against a deep trove of lab results, electronic health records, genomic tests, clinical studies and other health-related data sources, already representing 315 billion data points and 90 million unique records. Merge’s clients could compare new medical images with a patient’s image history as well as populations of similar patients to detect changes and anomalies. Insights generated by Watson could then help healthcare providers in fields including radiology, cardiology, orthopedics and ophthalmology to pursue more personalized approaches to diagnosis, treatment and monitoring of patients.
Cutting-edge image analytics projects underway in IBM Research’s global labs suggest additional areas where progress can be made. They include teaching Watson to filter clinical and diagnostic imaging information to help clinicians identify anomalies and form recommendations, which could help reduce physician viewing loads and increase physician effectiveness.
“As Watson evolves, we are tackling more complex and meaningful problems by constantly evaluating bigger and more challenging data sets,” Kelly said. “Medical images are some of the most complicated data sets imaginable, and there is perhaps no more important area in which researchers can apply machine learning and cognitive computing. That’s the real promise of cognitive computing and its artificial intelligence components – helping to make us healthier and to improve the quality of our lives.”
Watson Health and Merge Capabilities
Will Benefit Researchers, Clinicians and Individuals
IBM’s Watson Health unit plans to bring together Merge’s product and solution offerings with existing expertise in cognitive computing, population health, and cloud-based healthcare intelligence offerings to:
- Offer researchers insights to aid clinical trial design, monitoring and evaluation;
- Help clinicians to efficiently identify options for the diagnosis, treatment and monitoring a broad array of health conditions such as cancer, stroke and heart disease;
- Enable providers and payers to integrate and optimize patient engagement in alignment with meaningful use and value-based care guidelines; and
- Support researchers and healthcare professionals as they advance the emerging discipline of population health, which aims to optimize an individual’s care by identifying trends in large numbers of people with similar health status.
“Merge is widely recognized for delivering market leading imaging workflow and electronic data capture solutions,” said Justin Dearborn, chief executive officer, Merge. “Today’s announcement is an exciting step forward for our employees and clients. Becoming a part of IBM will allow us to expand our global scale and deliver added value and insight to our clients through Watson’s advanced analytic and cognitive computing capabilities.”
“Combining Merge’s leading medical imaging solutions with the world-class machine learning and analytics capabilities of IBM’s Watson Health is the future of healthcare technology,” said Michael W. Ferro, Jr., Merge’s chairman. “Merge’s leading technology and proven expertise represent a unique combination of assets that will deliver unparalleled value to Watson Health clients. Together, we will unlock unprecedented new opportunities to improve patient diagnostics and deliver enhanced care.”
About Merge
Merge is a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare. Merge’s enterprise and cloud-based technologies for image intensive specialties provide access to any image, anywhere, any time. Merge also provides clinical trials software with end-to-end study support in a single platform and other intelligent health data and analytics solutions. With solutions that have been used by providers for more than 25 years, Merge is helping to reduce costs, improve efficiencies and enhance the quality of healthcare worldwide. For more information, visit merge.com and follow us @MergeHealthcare.
IBM Watson: Pioneering a New Era of Computing
Watson is the first commercially available cognitive computing capability representing a new era in computing. The system, delivered through the cloud, analyzes high volumes of data, understands complex questions posed in natural language, and proposes evidence-based answers. Watson continuously learns, gaining in value and knowledge over time, from previous interactions.
In January 2014, IBM launched the IBM Watson unit, a business dedicated to developing and commercializing cloud-delivered cognitive computing technologies. The move signified a strategic shift by IBM to deliver a new class of software, services and apps that improves by learning, and discovers insights from massive amounts of Big Data. As part of the unit, the company has increased the number and diversity of cognitive computing services delivered to its partners, adding new beta Watson services in February 2015, and scalable deep learning APIs with the acquisition of AlchemyAPI in March 2015.
In April 2015, the company continued to build on its strengths in cognitive computing, analytics, security and cloud with the launch of IBM Watson Health and the Watson Health Cloud platform. The new unit will help improve the ability of doctors, researchers and insurers to innovate by surfacing new insights from the massive amount of personal health data being created daily. The Watson Health Cloud allows this information to be anonymized, shared and combined with a dynamic and constantly growing aggregated view of clinical, research and social health data.
About IBM
For more information on IBM Watson, visit: ibm.com/watson. For more information on IBM Watson Health, visit: ibm.com/watsonhealth
Check out the IBM Watson press kit at: http://www-03.ibm.com/press/us/en/presskit/27297.wss
Join the conversation at #ibmwatson and #watsonhealth. Follow Watson on Facebook and see Watson on YouTube and Flickr.
Learn more about this story at: http://asmarterplanet.com/blog/2015/08/seeing-believing-bringing-cognitive-image-analytics-healthcare.html
Footnote: 1 – IBM Research estimate
Cautionary Statement Regarding Forward-Looking Statements
Certain statements in this communication regarding the proposed transaction between IBM and Merge, the expected timetable for completing the transaction, benefits and synergies of the transaction, future opportunities for the combined company and products and any other statements regarding IBM and Merge’s future expectations, beliefs, goals, or prospects constitute forward-looking statements made within the meaning of Section 21E of the Securities Exchange Act of 1934 and (collectively, forward-looking statements). Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered forward-looking statements. A number of important factors could cause actual results or events to differ materially from those indicated by such forward-looking statements, including the parties’ ability to consummate the transaction; the conditions to the completion of the transaction, including the receipt of stockholder approval, court approval or the regulatory approvals required for the transaction may not be obtained on the terms expected or on the anticipated schedule; the parties’ ability to meet expectations regarding the timing, completion and accounting and tax treatments of the transaction; the possibility that the parties may be unable to achieve expected synergies and operating efficiencies in the arrangement within the expected time-frames or at all and to successfully integrate Merge’s operations into those of IBM; such integration may be more difficult, time-consuming or costly than expected; operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) may be greater than expected following the transaction; the retention of certain key employees of Merge may be difficult; IBM and Merge are subject to intense competition and increased competition is expected in the future; fluctuations in foreign currencies could result in transaction losses and increased expenses; the volatility of the international marketplace; and the other factors described in IBM’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and in its most recent quarterly report filed with the SEC, and Merge’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and in its most recent quarterly report filed with the SEC. IBM and Merge assume no obligation to update the information in this communication, except as otherwise required by law. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof.
Additional Information and Where to Find It
This communication may be deemed to be solicitation material in respect of the proposed acquisition of Merge by IBM. In connection with the proposed acquisition, Merge intends to file relevant materials with the SEC, including Merge’s proxy statement in preliminary and definitive form. STOCKHOLDERS OF MERGE ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING MERGE’S DEFINITIVE PROXY STATEMENT, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain the documents free of charge at the SEC’s web site, http://www.sec.gov. Documents will also be available for free at Merge’s Investor Relations web site, http://www.merge.com/Company/Investors.aspx. Such documents are not currently available.
Participants in Solicitation
IBM and its directors and executive officers, and Merge and its directors and executive officers, may be deemed to be participants in the solicitation of proxies from the holders of Merge common shares in respect of the proposed transaction. Information about the directors and executive officers of IBM is set forth in the proxy statement for IBM’s 2015 Annual Meeting of Stockholders, which was filed with the SEC on March 9, 2015. Information about the directors and executive officers of Merge is set forth in the proxy statement for Merge’s 2015 Annual Meeting of Stockholders, which was filed with the SEC on May 8, 2015. Investors may obtain additional information regarding the interest of such participants by reading the definitive proxy statement regarding the acquisition when it becomes available.
Media Contacts
For IBM Watson Health
Christine Douglass
IBM Media Relations
415-535-4479 (mobile)
cgdouglass@us.ibm.com
For Merge Healthcare
Michael R. Klozotsky
Merge Healthcare Corporate Marketing
312.946.2535
312.895.4700
michael.klozotsky@merge.com
(IKAN) To Be Acquired By (QCOM)
–Qualcomm Atheros Augments its Networking Portfolio with End-to-End Fixed Access Broadband Capabilities–
SAN DIEGO, Aug. 6, 2015 — Qualcomm Incorporated (NASDAQ: QCOM) today announced that its subsidiary, Qualcomm Atheros, Inc., has entered into a definitive merger agreement to acquire Ikanos Communications, Inc. (NASDAQ: IKAN), a high performance broadband networking semiconductor and software provider enabling both central office and home gateway solutions. Pursuant to the agreement, Qualcomm Atheros, through a wholly-owned subsidiary, will commence a tender offer to acquire all of the issued and outstanding shares of common stock of Ikanos for $2.75 per share in cash, and assume all outstanding indebtedness at the closing of the transaction.
The acquisition is intended to expand Qualcomm Atheros’ footprint in the carrier fixed line segment with the addition of high performance broadband access and modem technologies critical to enhancing users’ connected experiences in the home. The home gateway extends Qualcomm Atheros’ leadership in carrier Wi-Fi and wired connectivity, while providing a central hub for Internet of Everything (IoE) enabled devices, services and 3G/LTE small cells.
Ikanos’ board of directors has unanimously approved the transaction and recommends the offer to Ikanos stockholders. The transaction is expected to close before the end of this year and is subject to customary closing conditions, including a minimum tender of a majority of outstanding shares of Ikanos and regulatory clearances in certain non-US jurisdictions.
“Qualcomm Atheros has always viewed the home gateway as the enabler for consumers to not only access the Internet for browsing and downloading content and video streaming, but also as the hub of the Internet in the home for a variety of reliable and high quality services,” said Rahul Patel, senior vice president and general manager, connectivity, Qualcomm Technologies, Inc. “The combination of Qualcomm Atheros’ broad home gateway IP portfolio, including Wi-Fi, powerline, small cell, and Ethernet switch technologies, and Ikanos’ advanced wired modem technology, is designed to create a complete solution for a wide range of home gateway products to better serve the carrier segment.”
The acquisition of Ikanos provides Qualcomm Atheros access to a wide array of leading technologies, including A/VDSL2 and G.fast modem technology and chipsets for consumer premises equipment (CPE) and central office (CO) infrastructure. Ikanos also offers multi-mode gateway processor and accelerator technology for fiber, LTE, Ethernet and hybrid-copper applications. In addition, Ikanos inSIGHT software allows remote diagnosis, management and optimization of the broadband connection and quality-of-service, and voice over IP (VoIP) integrated access devices and bridges. Ikanos’ strong central office product portfolio, as well as its technology collaboration with Alcatel-Lucent in the area of fixed access communications, enables Qualcomm Atheros to offer a strong product portfolio in the ultra-broadband access space, including G.fast.
“Qualcomm Atheros and Ikanos have a long history of collaboration in the carrier space and share a common vision for the connected home. Bringing the two companies together enables Qualcomm Atheros to accelerate implementation of its strategy for the connected home, and to move the home gateway forward as a key enabler for new carrier applications and services,” said Omid Tahernia, president and chief executive officer, Ikanos.
About Qualcomm Incorporated
Qualcomm Incorporated (NASDAQ: QCOM) is a world leader in 3G, 4G and next-generation wireless technologies. Qualcomm Incorporated includes Qualcomm’s licensing business, QTL, and the vast majority of its patent portfolio. Qualcomm Technologies, Inc., a wholly-owned subsidiary of Qualcomm Incorporated, operates, along with its subsidiaries, substantially all of Qualcomm’s engineering, research and development functions, and substantially all of its products and services businesses, including its semiconductor business, QCT. For more than 30 years, Qualcomm ideas and inventions have driven the evolution of digital communications, linking people everywhere more closely to information, entertainment and each other. For more information, visit Qualcomm’s website, OnQ blog, Twitter and Facebook pages.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding: the proposed transaction between Qualcomm Atheros and Ikanos; the expected timetable for completing the transaction; strategic and other potential benefits of the transaction; and any other statements about Qualcomm managements’ future expectations, beliefs, goals, plans, or prospects, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include: the possibility that certain closing conditions to the transaction will not be satisfied; that required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the ability to timely consummate the transaction and possibility that the transaction will not be completed; the ability of Qualcomm Atheros to successfully integrate Ikanos’ operations and employees; the anticipated benefits of the transaction may not be realized; and those additional factors discussed in Qualcomm’s most recent Quarterly and Annual Reports on Forms 10-Q and 10-K filed with the Securities and Exchange Commission. Investors are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Qualcomm undertakes no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this press release.
About the Tender Offer
THE PRESS RELEASE IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT AN OFFER TO BUY OR THE SOLICITATION OF AN OFFER TO SELL ANY SHARES OF IKANOS COMMON STOCK. THE TENDER OFFER DESCRIBED IN THIS DOCUMENT HAS NOT YET COMMENCED.
At the time the offer is commenced, a subsidiary of Qualcomm Atheros will file a Tender Offer Statement on Schedule TO with the United States Securities and Exchange Commission (“SEC”), and Ikanos will file a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer.
The Offer to Purchase, the related Letter of Transmittal and certain other offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all stockholders of Ikanos at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will be available without charge at the SEC’s web site, at http://www.sec.gov. Free copies of these materials and certain other offering documents will be sent to Ikanos’ stockholders by the information agent for the offer.
IKANOS STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING THE OFFER TO PURCHASE, RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT, INCLUDING ALL AMENDMENTS TO THOSE MATERIALS. SUCH DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION, WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER.
Additional Information and Where to Find It
In addition to the Solicitation/Recommendation Statement, Ikanos files annual, quarterly and current reports, proxy statements and other information with the SEC. You may read and copy any reports, statements or other information filed by Ikanos at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549.
Qualcomm is a trademark of Qualcomm Incorporated, registered in the United States and other countries.
Qualcomm Contacts:
Laurie Falconer, Qualcomm Atheros
Phone: 1-408-652-0632
Email: laurief@qti.qualcomm.com
Emily Kilpatrick, Corporate Communications
Phone: 1-858-845-5959
Email: corpcomm@qualcomm.com
Warren Kneeshaw, Investor Relations
Phone: 1-858-658-4813
Email: ir@qualcomm.com
(ENG) Reports Q2 2015 Results, Sixth Consecutive Profitable Quarter
HOUSTON, Aug. 6, 2015 — ENGlobal (Nasdaq:ENG), a leading provider of engineering and automation services, today announced its financial results for the second quarter ended June 27, 2015.
HIGHLIGHTS OF CONTINUING OPERATIONS:
- Revenue of $21.1 million,
- Gross profit margin of 21.9%
- Net income of $0.03 per diluted share
Revenues in the second quarter of 2015 were $21.1 million, a decrease of 22.5% from $27.2 million in the prior year period. ENGlobal reported net income of $1 million, or $0.03 per diluted share, for the quarter ended June 27, 2015, compared to net income of $1.6 million, or $0.06 per diluted share, for the quarter ended June 28, 2014. During the quarter ended June 27, 2015, the Company incurred non-cash expenses for depreciation, amortization and stock compensation of $0.5 million as compared to $0.7 million for the same period in 2014.
Management’s Assessment
Mark Hess, ENGlobal’s Chief Financial Officer, said: “We are pleased to report today’s profitable results—which I’m proud to say represents six consecutive profitable quarters. ENGlobal’s profit margins remain respectable given the current environment, and our available capital has improved over the last year. The Company continues to maintain a healthy cash balance and working capital of $25.4 million, and we have no borrowings under our current credit facility.”
“ENGlobal’s response to the current energy marketplace has been to increase our efforts in developing new business,” said William Coskey, P.E., Chairman and Chief Executive Officer of ENGlobal. “While we are excited about several new opportunities and client relationships that this internal process has produced, it also appears to be a great time to consider strategic acquisitions.”
The following table illustrates the composition of the Company’s revenue and profitability for its operations for the three months ended June 27, 2015 and June 28, 2014:
| Quarter Ended | Quarter Ended | |||||||
| (in thousands) | June 27, 2015 | June 28, 2014 | ||||||
| % of | Gross | Operating | % of | Gross | Operating | |||
| Segment | Total | Total | Profit | Profit | Total | Total | Profit | Profit |
| Revenue | Revenue | Margin | Margin | Revenue | Revenue | Margin | Margin | |
| Engineering & Construction | $ 12,931 | 61.4% | 16.0% | 10.3% | $ 12,629 | 46.5% | 18.5% | 10.9% |
| Automation | 8,122 | 38.6% | 31.2% | 24.1% | 14,541 | 53.5% | 23.8% | 18.8% |
| Consolidated | $ 21,053 | 100.0% | 21.9% | 5.0% | $ 27,170 | 100.0% | 21.3% | 5.7% |
The following table presents certain balance sheet items as of June 27, 2015 and June 28, 2014:
| (in thousands) | As of June 27, 2015 | As of June 28, 2014 |
| Cash | $ 9,315 | $ 4,060 |
| Working capital | 25,446 | 17,981 |
| Credit facility balance | — | — |
The Company’s Quarterly Report on Form 10-Q for the quarter ended June 27, 2015 will be filed with the Securities and Exchange Commission today reflecting these results.
About ENGlobal
ENGlobal (Nasdaq:ENG) is a provider of engineering and automation services primarily to the energy sector throughout the United States and internationally. ENGlobal operates through two business segments: Automation and Engineering. ENGlobal’s Automation segment provides services related to the design, fabrication and implementation of distributed control, instrumentation and process analytical systems. The Engineering segment provides consulting services for the development, management and execution of projects requiring professional engineering, construction management, and related support services. Within the Engineering segment, ENGlobal’s Government Services group provides engineering, design, installation and operation and maintenance of various government, public sector and international facilities, and specializes in the turnkey installation and maintenance of automation and instrumentation systems for the U.S. Defense industry worldwide. Further information about the Company and its businesses is available at www.ENGlobal.com.
Safe Harbor for Forward-Looking Statements
The statements above regarding the Company’s expectations regarding its operations and certain other matters discussed in this press release may constitute forward-looking statements within the meaning of the federal securities laws and are subject to risks and uncertainties including, but not limited to: (1) the effect of economic downturns and the volatility of oil and natural gas prices and significantly depressed oil prices since the end of 2014; (2) our ability to execute to our internal performance plans such as our post-divestiture outlook, productivity improvement and cost containment initiatives; (3) our ability to attract and retain key professional personnel; (4) our ability to retain existing customers and attract new customers; (5) our ability to realize revenue projected in our backlog and our ability to collect accounts receivable and process accounts payable in a timely manner; (6) our ability to identify, consummate and integrate potential acquisitions; (7) our reliance on third-party subcontractors and equipment manufacturers; (8) our ability to sustain profitability and positive cash flow from operations; (9) our ability to comply with the terms of our new credit facility; (10) operational and political risks in Russia and Kazakhstan along the Caspian Sea; (11) the effect of changes in laws and regulations with which the Company must comply and the associated costs of compliance with such laws and regulations; and (12) the effect of changes in accounting policies and practices as may be adopted by regulatory agencies. Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in ENGlobal’s filings with the Securities and Exchange Commission. In addition, reference is hereby made to cautionary statements set forth in the Company’s most recent reports on Form 10-K and 10-Q, and other SEC filings.
Click here to join our email list: http://www.b2i.us/irpass.asp?BzID=702&to=ea&s=0.
CONTACT: Mark A. Hess
(281) 878-1040
ir@ENGlobal.com
(RVLT) Acquires Energy Source, Rapidly Growing LED Technology Platform
Energy Source’s unique market position increases RVLT’s growing customer base and enhances revenue acceleration
Revolution Lighting Technologies, Inc. (NASDAQ:RVLT) (“Revolution Lighting”), a global provider of advanced LED lighting solutions, today announced it has acquired Energy Source, LLC, a turnkey provider of LED lighting based energy savings projects within the commercial, industrial, hospitality, retail, education and municipal sectors.
The acquisition brings together RVLT’s innovative portfolio of LED products and control systems with Energy Source’s expertise in providing LED focused energy savings projects, its strong customer base and preferred partnership status with utility companies across the Northeast, including National Grid and Eversource (formerly NStar). These partnerships, along with its customer base – including Citizens Bank, CVS Caremark and International Packaging – that covers facilities throughout the United States has enabled Energy Source to grow its revenues at a CAGR of over 45% since 2011.
Energy Source’s revenue and EBITDA are expected to be $30 million and $4.5 million, respectively, for the 2015 full year. In addition to the accretive effect of Energy Source’s existing business, RVLT is expected to provide Energy Source with a significant portion of its LED requirements in order to meet its customers’ demand for high quality LED products and solutions.
Under the terms of the agreement, RVLT paid a total purchase price of $30 million for 100 percent of the outstanding ownership interests of Energy Source: comprised of $10 million in cash, $10 million in RVLT common stock (approximately 8.8 million shares), and $10 million in the form of a promissory note (due on the one year anniversary of the acquisition with an annual interest rate of 5%) together with a 3 year earnout based on Adjusted EBITDA of Energy Source. The $10 million upfront cash portion has been financed through the issuance of RVLT common shares (approximately 8.7 million shares) to a non-affiliated investor.
The transaction has been structured so that the entire purchase price will be tax deductible for federal and state income tax purposes. RVLT expects the transaction to be accretive to earnings per share in the second half of 2015.
“We are excited to welcome Energy Source, as this strategic acquisition strengthens our existing relationships in key markets. With an ongoing need for energy efficiency and compelling savings, not only do we expect to see significant product pull-through from their existing and future projects, but a valuable resource as part of our growing management team,” said Robert V. LaPenta, Chairman, Chief Executive Officer and President of Revolution Lighting.
LaPenta further noted, “Mike Lemoi, president, and Ron Sliney, vice president, have over 55 years of combined experience in the lighting and energy business and they have clearly demonstrated, through their ownership and leadership of Energy Source, their deep understanding of the lighting and energy markets and the lighting solutions and programs that best serve these customers. We are very fortunate to have both Mike and Ron continue in their leadership roles at Energy Source and take on an active role within RVLT as we collaborate together for many years to come.”
“We are very happy to officially join the Revolution Lighting team as we share a similar full service approach to develop and implement cost effective energy efficient solutions for our growing list of clients,” said Mike Lemoi, President of Energy Source. “Revolution Lighting’s extensive LED product line and significant network platform combined with our comprehensive offering of LED based energy programs will allow Energy Source the ability to offer turn-key installations with superior LED products.”
“RVLT distributor partners will now also have the opportunity to offer full turn-key energy services to their existing customer base,” said Ron Sliney, Vice President of Energy Source. “We see this as a real win for all parties. Energy source will have the ability to bring a turnkey service to RVLT distributors helping them to increase LED product sales within their markets. This also will allow Energy Source to drive core RVLT products and services throughout the country and into many different market segments.”
“Energy Source has a vast amount of experience in a multitude of market segments including municipal, hospitality, commercial, industrial, retail, and educational. We are excited for the opportunity to continue to grow our business nationally with RVLT LED lamps, fixtures and network partners,” says Lemoi. “This relationship will allow us to drive our high-impact sales and energy service organization locally as well as nationally.”
About Revolution Lighting Technologies Inc.
Revolution Lighting Technologies, Inc. (NASDAQ:RVLT) is a leading LED lighting solutions company. We design, manufacture, market and sell energy-efficient LED and conventional lighting solutions with a strong presence in the industrial, commercial and government markets in the United States, Canada, and around the world. Revolution Lighting has created an innovative, multi-brand, lighting company that offers a comprehensive product platform of high-quality interior and exterior LED lamps and fixtures with a focus on the developing market for LED lighting solutions.
Revolution Lighting markets and distributes its products through a network of independent sales representatives and distributors, as well as through energy savings companies, national accounts and its wholly owned subsidiary, Value Lighting, a leading supplier of lighting solutions to the multifamily residential housing sector and new construction marketplace across the U.S. Other brands within our RVLT family include Lumificient, which supplies LED illumination for the signage industry; and Sentinel, a revolutionary patented and licensed monitoring and smart grid control system for outdoor lighting applications. Revolution Lighting was recognized as a 2014 Deloitte technology fast 500 company. For additional information visit: www.rvlti.com.
About Energy Source
Energy Source is a turnkey implementer of comprehensive energy savings projects, which includes comprehensive energy audits, installation, and rebate incentives within the Commercial, Industrial, Hospitality, Retail, Education and Municipal sectors. Additionally, the company provides LED lighting and controls solutions. Energy Source works closely with its clients such as Citizens Bank, CVS Caremark and International Packaging to identify energy conservation opportunities from “broad stroke” identification through actual implementation of projects. For more than 20 years, they have helped clients realize their energy goals, reduce simple paybacks, and maximize return on investments by identifying energy conservation opportunities through actual implementation of projects. For additional information, visit: http://www.energysource.com
Cautionary Statement for Forward-Looking Statements
Certain of the above statements contained in this press release are forward-looking statements that involve a number of risks and uncertainties, including statements relating to our business pipeline and sales opportunities, our revenue, Adjusted EBITDA and cash flow outlook. Such forward-looking statements are within the meaning of that term in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Reference is made to Revolution Lighting’s filings under the Securities Exchange Act for additional factors that could cause actual results to differ materially, including our history of losses, customer concentration risks, the potential for future dilution to our existing common stockholders, our status as a controlled company, the risk that demand for our LED products fails to emerge as anticipated, the availability of financing for our customers, competition from larger companies, and risks relating to third party suppliers and manufacturers, as well as the other Risk Factors described in Item 1A of our Form 10-K for the fiscal year ended December 31, 2014. Revolution Lighting Technologies, Inc. undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those indicated in the forward-looking statements as a result of various factors. Readers are cautioned not to place undue reliance on these forward-looking statements.
For Revolution Lighting Technologies, Inc.
Amato and Partners, LLC
Investor Relations Counsel
Gerald Amato, 212.430.0361
admin@amatoandpartners.com
(ARWR) to Present at Jefferies 2015 Hepatitis B Summit
Arrowhead Research Corporation (NASDAQ: ARWR) today announced that chief operating officer and head of R&D Bruce Given, M.D., will present at the Jefferies 2015 Hepatitis B Summit in Boston on Thursday, August 6, 2015.
About ARC-520
Arrowhead’s RNAi-based candidate ARC-520 is being investigated in the treatment of chronic HBV infection. The small interfering RNAs (siRNAs) in ARC-520 intervene at the mRNA level, upstream of the reverse transcription process where current standard of care nucleotide and nucleoside analogues act. Arrowhead is investigating ARC-520 specifically, to determine if it can be used to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. Arrowhead has completed a Phase 1 single ascending dose study in normal volunteers and the company is conducting single dose Phase 2a studies and multiple dose Phase 2b studies in chronic HBV patients. Approximately 350-400 million people worldwide are chronically infected with the hepatitis B virus, which can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally.
About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary Dynamic Polyconjugate delivery platform to develop targeted drugs based on the RNA interference mechanism that efficiently silences disease-causing genes. Arrowhead’s pipeline includes ARC-520 for chronic hepatitis B virus and ARC-AAT for liver disease associated with Alpha-1 antitrypsin deficiency.
For more information please visit http://www.arrowheadresearch.com, or follow us on Twitter @ArrowRes. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadresearch.com/alerts.cfm.
Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Arrowhead Research Corporation’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.
DYNAMIC POLYCONJUGATES is a trademark of Arrowhead Research Corporation.
Source: Arrowhead Research Corporation
Arrowhead Research Corporation
Vince Anzalone, CFA
626-304-3400
ir@arrowres.com
or
Investor Relations:
The Trout Group
Todd James
646-378-2926
ir@arrowres.com
or
Media:
Russo Partners
Matt Middleman, M.D.
212-845-4272
matt.middleman@russopartnersllc.com
(ATVI) Ready, Set, Go — Skylanders® SuperChargers Delivers Racing and Online Multiplayer
Skylanders Charges into Gamescom with Exciting Announcements and Franchise Firsts
Activision Publishing, Inc., a wholly owned subsidiary of Activision Blizzard, Inc. (NASDAQ: ATVI), continues to blaze the toys-to-life trail with Skylanders franchise firsts, racing and online multiplayer gameplay on console in Skylanders® SuperChargers, developed by Vicarious Visions. Whether fans prefer co-operative play in Adventure Mode or competitive multiplayer with up to four players in Racing Mode, Skylanders SuperChargers’ online gaming is fueled with adrenaline-pumping action right out of the box.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20150805005409/en/
Skylanders’ all-new Racing Mode, playable in Land, Sea and Sky environments, features supercharged racing combat, layering in even more depth and excitement to the game’s online multiplayer component. The high-octane mode is further amplified with all-new time trials, which include three-lap races that take friendly competition up a notch as players battle for the best time score on the leaderboard. All Skylanders SuperChargers Starter Packs will come loaded with six dynamic race tracks – two each for Land, Sea and Sky. With hidden routes, power-ups, and diverse locations, Racing Mode offers completely new ways to enjoy the game. Whether played in offline split-screen or online multiplayer, gamers can choose the best route to finish a race, trying to avoid attacks along the way as they navigate through dynamic environments. Voice-chat is available with friends for an added layer of excitement.
Skylanders SuperChargers delivers more ways to play than ever before:
- Single-player Adventure Mode
- Online and local co-operative Adventure Mode
- Local 2-player head-to-head racing in split screen
- Online competitive racing with up to 4 players
“Skylanders fans told us they wanted to go head-to-head in online multiplayer with their friends and family, and we delivered. Skylanders SuperChargers enables gamers to race against friends all over the world and brings an exciting new expansion to the Skylanders gameplay experience,” said John Coyne, senior vice president of consumer marketing, Activision Publishing, Inc. “We continue to be firmly committed to driving Skylanders’ spirit for providing originality, innovation, creativity and fun with each game.”
Skylanders SuperChargers continues to rev its engine with the addition of Skylanders SuperChargers Racing Action Packs at launch and beyond. These optional expansion packs, one each for Land, Sea and Sky, unlock even more thrilling racing content for Portal Masters. Each pack comes loaded with three special toys, including a SuperCharger, its signature vehicle and a villain trophy. The villain trophy unlocks two new tracks and new modes, including SuperVillain Cup, Boss Pursuit and Mirror Cup. There are 12 boss villains across all three packs, with four in each pack, which players can defeat and play as. Fans can then store these boss villains on their villain trophy toy to play at a friend’s house.
Fans can augment their SuperCharger experience with a complementary, dedicated racing combat game — Skylanders SuperChargers Racing — for the Wii™ system and Nintendo 3DS™ hand-held system. All-new tracks, augmented with power-ups, boosts, hazards and more, offer up to 50 different and exciting gameplay experiences. On Nintendo 3DS, gamers can go head-to-head with competitive multiplayer via local play or online with up to four players. Iconic Nintendo character Bowser™ and his Sky vehicle, Clown Cruiser are available in the Skylanders SuperChargers Racing Starter Packs for Wii and Nintendo 3DS and can also be played on the Wii U™ system. The Supercharged character not only works in Skylanders SuperChargers Racing, but also as amiibo in compatible Nintendo games, so players can store their saved data in both modes with a simple twist of the figure’s base.
About Skylanders SuperChargers
Skylanders SuperChargers expands upon the franchise’s signature gameplay to introduce a brand-new play pattern to fans, vehicles-to-life. For the first time ever, kids can explore and navigate the mountainous terrains, deep sea environments and big blue skies of Skylands like never before by going behind the wheel of powerful, tricked-out land, sea and sky vehicles – bringing them from physical world into the digital world in a high octane action-adventure videogame. The game offers a diverse and dynamic story-driven gameplay experience, filled with vehicle-based and on-foot adventures featuring combat, puzzles, mini games, activities and platforming — all set within a variety of new compelling environments. Skylanders SuperChargers has 20 land, sea and sky vehicles that are fun to play in the game and in the real world. There is also a new class of heroes — 20 SuperCharger toys that feature all-new powerful attacks and moves, upgrades and personalities. The game supports all 300+ Skylander toys from previous games.
Skylanders SuperChargers will be available on September 25 in Europe and September 20 in North America on the Xbox One, Xbox 360, PlayStation® 4 system, PlayStation® 3 system and Nintendo’s Wii U™ system. Additionally, the complete Skylanders SuperChargers experience will be available on iPad® 1. Skylanders SuperChargers Racing will be available on September 25 in Europe and September 20 in North America for Wii™ and Nintendo 3DS.
About the Skylanders® Franchise
The award-winning, $3 billion Skylanders franchise has sold through more than 250 million action figures2 since pioneering the toys-to-life category in 2011 with the debut of Skylanders® Spyro’s Adventure. The game originated a play pattern that seamlessly bridged physical and virtual worlds across multiple platforms. In 2012, Skylanders® Giants further evolved the genre and added LightCore® characters to the collection of interaction figures. Skylanders® SWAP Force™, which launched in 2013, introduced an all new play pattern – swapability. In 2014, Skylanders® Trap Team reversed the magic of bringing toys to life by allowing players to pull characters out of the digital world into the physical world and became the number 1 kids’ console game globally2.
About Activision Publishing
Headquartered in Santa Monica, California, Activision Publishing, Inc. is a leading global producer and publisher of interactive entertainment. Activision maintains operations throughout the world. More information about Activision and its products can be found on the company’s website, www.activision.com or by following @Activision.
Cautionary Note Regarding Forward-looking Statements: Information in this press release that involves Activision Publishing’s expectations, plans, intentions or strategies regarding the future, including statements about the expected release dates of Skylanders SuperChargers and Skylanders SuperChargers Racing are forward-looking statements that are not facts and involve a number of risks and uncertainties. Factors that could cause Activision Publishing’s actual future results to differ materially from those expressed in the forward-looking statements set forth in this release include unanticipated product delays and other factors identified in the risk factors sections of Activision Blizzard’s most recent annual report on Form 10-K and any subsequent quarterly reports on Form 10-Q. The forward-looking statements in this release are based upon information available to Activision Publishing and Activision Blizzard as of the date of this release, and neither Activision Publishing nor Activision Blizzard assumes any obligation to update any such forward-looking statements. Forward-looking statements believed to be true when made may ultimately prove to be incorrect. These statements are not guarantees of the future performance of Activision Publishing or Activision Blizzard and are subject to risks, uncertainties and other factors, some of which are beyond its control and may cause actual results to differ materially from current expectations.
© 2015 Activision Publishing, Inc., SKYLANDERS, SKYLANDERS SUPERCHARGERS, SKYLANDERS SUPERCHARGERS RACING, SWAP FORCE, SKYLANDERS UNIVERSE, LIGHTCORE and ACTIVISION are trademarks of Activision Publishing, Inc.
¹Available on select tablet devices
² Based on revenue from January – June, 2015, according to the NPD Group, GfK Chart-track, and Activision Blizzard internal estimates, including toys and accessories.
PMK•BNC
Michele Wyman, 310.854.3264
michele.wyman@pmkbnc.com
or
Activision Publishing, Inc.
Bianca Blair, 310.633.3811
bianca.blair@activision.com
(SLTD) Secures $3.5 Million Contract With CA-Based Trading Company
Company to Install Approximately 1.5-Megawatt Solar Power System for Prominent Agricultural Organization
SANTA BARBARA, CA–(August 05, 2015) – Solar3D, Inc. (NASDAQ: SLTD), a leading provider of solar power solutions and the developer of a proprietary high efficiency solar cell, announced today that its operating division SUNworks has secured a $3.52 million contract to design and install a photovoltaic system for Rivermaid Trading Company.
For over 80 years, Lodi-based Rivermaid Trading Company has provided expertise in agriculture, operations, consumer marketing, logistics and more. Led by CEO Patrick Arichibeque, the organization is responsible for 50% of California’s pear volume alone, and is also a top five shipper in the California cherry industry. Rivermaid is committed to sustainability, with a long-term approach to caring for the land, environment resources and community within their region.
SUNworks will be tasked with the design and installation of a 1.477MW SunPower roof mount solar system. The system is designed to achieve cost savings of approximately $11,800,000 over the next 25 years.
“Our expertise and track record in the agriculture industry has continued to drive organic referrals our way,” said Abe Emard, CEO of SUNworks. “Rivermaid is an ideal customer in that their vision for a sustainable future aligns with our own. We are pleased to enter into an agreement with this prominent organization to implement a solar program that drives down cost while making the community a cleaner place.”
“We are thrilled to be working with Rivermaid, and with Patrick Arichibeque and his team,” said Jim Nelson, CEO of Solar3D. “As our leadership expands due to consolidation, so do the capabilities and services we are able to offer. Quality companies see this and we are creating great relationships. We believe this growth-by-acquisition strategy will continue to grow the size of the projects we work on, resulting in increased revenue and overall shareholder value.”
About Solar3D, Inc.
Solar3D, a leading provider of solar power solutions, is focused on the design, installation and management of solar power systems for commercial, agricultural and residential customers. Through its wholly owned subsidiaries, Solar3D is one of the fastest growing solar systems providers in California delivering 2.5 kilowatt to multi-megawatt commercial systems. Solar3D’s technology division is developing a patent-pending 3-dimensional solar cell technology to maximize the conversion of sunlight into electricity. The Solar3D Cell collects sunlight from a wide angle and lets light bounce around in 3-dimensional microstructures on the solar cell surface. The Company’s mission is to further the widespread adoption of solar power by deploying affordable, state-of-the-art systems and developing breakthrough new solar technologies.
To learn more about Solar3D, visit our website at http://www.Solar3D.com.
About SUNworks
SUNworks is a commercial and residential wholly owned subsidiary of Solar3D, Inc. (NASDAQ: SLTD), a leading solar power company and the developer of a proprietary, high efficiency solar cell. SUNworks is focused on the design, installation and management of solar systems for agricultural, commercial, and residential customers. The Company has delivered hundreds of 2.5 kilowatt to 1-megawatt commercial systems and has the capability to deliver systems as large as 25 megawatts. SUNworks serves commercial, agricultural and residential customers throughout California and Nevada.
Safe Harbor Statement
Matters discussed in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When used in this press release, the words “anticipate,” “believe,” “estimate,” “may,” “intend,” “expect” and similar expressions identify such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the expectations of the Company and are subject to a number of risks and uncertainties. These risks include, but are not limited to, risks and uncertainties associated with: the impact of economic, competitive and other factors affecting the Company and its operations, markets, products, and prospects for sales, failure to commercialize our technology, failure of technology to perform as expected, failure to earn profit or revenue, higher costs than expected, persistent operating losses, ownership dilution, inability to repay debt, failure of acquired businesses to perform as expected, the impact on the national and local economies resulting from terrorist actions, and U.S. actions subsequently; and other factors detailed in reports filed by the Company.
Investor Relations
Andrew Haag
Managing Partner
IRTH Communications
sltd@irthcommunications.com
Tel: (877) 368-3566
Media
Eric Fischgrund
FischTank Marketing and PR
eric@fischtankpr.com
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