Archive for August, 2015
(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
(FNJN) Ruling in Favor of Finjan for Nearly $40 Million as Blue Coat Trial Concludes
Jury Finds Five of Six Finjan’s Patents Infringed by Blue Coat Systems
EAST PALO ALTO, CA–(Aug 5, 2015) – Finjan Holdings, Inc. (NASDAQ: FNJN), a cybersecurity company, announced today that the jury in Finjan, Inc. v. Blue Coat Systems Inc. (5:13-cv-03999-BLF) returned a unanimous verdict that Finjan’s U.S. Patent Nos. 6,154,844 (the “‘844 Patent”), 6,804,780 (the “‘780 Patent”), 6,965,968 (the “‘968 Patent”), and the 7,418,731 (the “‘731 Patent”) were literally infringed by Blue Coat. Further, the jury found that U.S. Patent No. 7,647,633 (the “‘633 Patent”) was infringed by Blue Coat under the Doctrine of Equivalents. Moreover, the jury found each of Finjan’s asserted patents valid. The verdict, reached on August 04, 2015, followed a two-week trial before the Honorable Beth Labson Freeman of the U.S. District Court for the Northern District of California.
Finjan alleged that Blue Coat’s products or combination of products, namely, WebPulse, ProxySG, CAS (or Content Analysis System), MAA (or Malware Analysis Appliance), and ProxyAG infringed one or more of the asserted claims of the asserted patents.
The jury also decided that Finjan was entitled to $39,528,487.00 damages as reasonable royalties for Blue Coat’s infringement.
“We are both grateful and gratified with the jury’s verdict,” said Julie Mar-Spinola, Finjan’s Chief Intellectual Property Officer and VP, Legal. “As we have stated in our earlier Litigation Updates, we are committed to our licensing best practices and will present our patent infringement claims credibly and convincingly to establish the merits of our case, in and outside of the courtroom. Additionally, we were confident in the merits of our patent claims against Blue Coat. It is significant that the jury unanimously agreed with us on all but one.”
Finjan is well-represented by Paul Andre, Lisa Kobialka, James Hannah, Hannah Lee, and Kris Kastens, and many other significant contributors from the law offices of Kramer Levin Naftalis & Frankel in Menlo Park, CA.
Finjan has also filed a second patent infringement lawsuit against Blue Coat Systems, Inc. (Blue Coat), alleging infringement of seven Finjan patents relating to new infringing Blue Coat products and services. The Complaint (5:15-cv-03295, Docket No. 1), filed July 15, 2015, in the U.S. District Court for the Northern District of California, alleges that Blue Coat’s new products and services infringe seven Finjan patents. In particular, Finjan is asserting infringement of U.S. Patent Nos. 6,154,844; 6,965,968; 7,418,731; 8,079,086; 8,225,408; 8,566,580; 8,677,494; four of which are being asserted against Blue Coat for the first time. This matter has also been assigned to Judge Freeman.
Finjan has filed patent infringement lawsuits against FireEye, Proofpoint, Sophos, Symantec, and Palo Alto Networks relating to, collectively, more than 20 patents in the Finjan portfolio. The court dockets for the foregoing cases are publicly available on the Public Access to Court Electronic Records (PACER) website, www.pacer.gov, which is operated by the Administrative Office of the U.S. Courts.
ABOUT FINJAN
Established nearly 20 years ago, Finjan is a globally recognized leader in cybersecurity. Finjan’s inventions are embedded within a strong portfolio of patents focusing on software and hardware technologies capable of proactively detecting previously unknown and emerging threats on a real-time, behavior-based basis. Finjan continues to grow through investments in innovation, strategic acquisitions, and partnerships promoting economic advancement and job creation. For more information, please visit www.finjan.com.
Follow Finjan Holdings, Inc.:
Twitter: @FinjanHoldings
LinkedIn: linkedin.com/company/finjan
Facebook: facebook.com/FinjanHoldings
Finjan Mobile Defense Challenge 2015: contest.finjan.com
Cautionary Note Regarding Forward-Looking Statements
Except for historical information, the matters set forth herein that are forward-looking statements involve certain risks and uncertainties that could cause actual results to differ. Potential risks and uncertainties include, but are not limited to, the outcome of pending or future enforcement actions, our ability to expand our technology portfolio, the enforceability of our patents, the continued use of our technologies in the market, our stock price, changes in the trading market for our securities, regulatory developments, general economic and market conditions, the market acceptance and successful business, technical and economic implementation of Finjan Holdings’ intended plan; and the other risk factors set forth from time to time in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2014, and the Company’s periodic filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from Finjan Holdings, Inc. All forward-looking statements herein reflect our opinions only as of the date of this release, and Finjan Holdings undertakes no obligation, and expressly disclaims any obligation, to update forward-looking statements herein in light of new information or future events.
(CDRB) CEO Talks Growth in BYOD Enterprises, Rising Adoption of iRAPP
NEW YORK, NY–(Aug 5, 2015) – Code Rebel Corp. (NASDAQ: CDRB), an enterprise software development firm that licenses its proprietary software solution to enable simplified secure access and communications between PC and Mac environments on virtually any computer, tablet, or smartphone, today is pleased to announce the release of an exclusive BizTechReports webcast featuring Code Rebel founder and CEO Arben Kryeziu, along with its newly appointed Director, renowned futurist and former Apple executive, Dr. James Canton, discussing the growing prevalence of Bring-Your-Own-Device (BYOD) Enterprises, and rising adoption of its iRAPP Solution by major Fortune 500 companies such as AT&T, Microsoft, Cisco, IBM, Bloomberg, and J.P. Morgan Chase. The webcast can be found here: http://biztechreports.com/blog/2015/06/15/byod-and-cloud-create-demand-for-enterprises-to-leverage-both-mac-and-windows-platforms/
BizTechReports is an independent reporting agency that analyzes user trends in business technology. They explore the role that technology products and services play in the overall economy and/or in specific vertical industries. With offices in Washington, DC and Toronto, Canada, BizTechReports’ mission is to put enterprise technologies into a context that business decision-makers can understand and appreciate.
“BYOD has impacted the enterprise. Every enterprise needs to have a BYOD strategy that enables flexibility, high performance and agility. Code Rebel’s iRAPP solution enables enterprise customers exactly that and it’s truly platform agnostic. They can access information anywhere and anytime from multiple screens regardless of platform — from Mac to PC,” says Arben Kryeziu, CEO of Code Rebel. “With iRAPP enterprise features such as an access platform for simultaneous users, Microsoft Remote Desktop Protocol and Data Safety, customers can address many BYOD benefits.”
Leading Code Rebel customers, such as Wells Fargo, are using iRAPP to enhance enterprise collaboration, employee productivity and service. Customers include Fortune 500 companies such as AT&T, Microsoft, Cisco, IBM, Bloomberg, J.P. Morgan Chase, Lloyds Bank, Merck, Panasonic and IKEA, as well as organizations such as the University of California, University of Texas and University of Missouri.
For more information on Code Rebel products and current uses, please visit: http://www.coderebel.com/products/ and http://www.coderebel.com/about/news/casestudies/
About Code Rebel
Code Rebel is an enterprise software company that develops, licenses, and supports software designed for cross-platform enterprise security and productivity. The proprietary Code Rebel iRAPP software addresses the growing requirement of corporate IT departments for secure access from diverse enterprise devices. Code Rebel software was developed by its in-house engineering team to address the demand for secure interoperability between mobile, desktop, and server environments and interaction between Apple and Microsoft devices and software. Code Rebel software facilitates mobile, desktop, and server environment interoperability seamlessly across Apple and Microsoft devices and software. The company provides enterprise client support for its software to a diverse range of industries. For more information visit: http://www.coderebel.com, Facebook and Twitter
Forward-Looking Statements
This press release contains information about Code Rebel’s view of its future expectations, plans and prospects that constitute forward-looking statements. Actual results may differ materially from historical results or those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets into its portfolio of software and services, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the technical skills and experience necessary to meet the requirements of its clients, and its ability to protect its intellectual property. Code Rebel encourages you to review other factors that may affect its future results in Code Rebel’s registration statement and in its other filings with the Securities and Exchange Commission.
Code Rebel Investor Relations Contact:
Christopher R. Sawicki II
President
Code Rebel Corporation
Phone (cell): (480) 338-9330
Phone (work): (808) 871-6496
Email: chris@coderebel.com
http://www.coderebel.com
Howard Gostfrand
President
American Capital Ventures
Phone (work): (305) 918-7000
Email: info@amcapventures.com
www.amcapventures.com
(VSAR) to Present at the Canaccord Genuity 35th Annual Growth Conferenc
MENLO PARK, Calif., Aug. 4, 2015 — Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that Mr. Jay Shepard, President and Chief Executive Officer, is scheduled to present at the Canaccord Genuity 35th Annual Growth Conference on Wednesday, August 12, 2015 at the InterContinental in Boston, Massachusetts.
Event: | Canaccord Genuity 35th Annual Growth Conference |
Date: | Wednesday, August 12, 2015 |
Time: | 11:30 a.m. ET / 8:30 a.m. PT |
An audio webcast of the Company’s presentation will be available on the investor relations section of Versartis’ website at www.versartis.com. A replay of the presentation will be available for 90 days.
About Versartis, Inc.
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone for the treatment of growth hormone deficiency (GHD). Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. The Company completed the Phase 2a stage of a Phase 1b/2a trial evaluating weekly, twice-monthly and monthly dosing regimens of somavaratan in children with GHD in June 2014 and initiated a global Phase 3 registration trial, VELOCITY, in GHD children in January 2015. In addition, the Company initiated a Phase 2/3 trial in Japan for children with GHD in April 2015. Additional information on Versartis clinical trials can be found at www.versartistrials.com. Further information on Versartis can be found at www.versartis.com.
Cautionary Note on Forward Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, plans and timing of our clinical trials and the potential for eventual regulatory approval of somavaratan. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our success being heavily dependent on somavaratan; somavaratan being a new chemical entity; the risk that somavaratan may not have favorable results in clinical trials or receive regulatory approval; potential delays in our clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that somavaratan may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that we may encounter difficulties in manufacturing somavaratan; if somavaratan is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing our intellectual property rights; our reliance on our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We discuss many of these risks in greater detail under the heading “Risk Factors” contained in our Annual Report on Form 10-K for the year ended December 31, 2014, which is on file with the Securities and Exchange Commission (SEC), and in our Quarterly Report on Form 10-Q for the three months ended June 30, 2015, which we expect to file with the SEC on or before August 5, 2015. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. 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: Corporate & Investors: Joshua Brumm Chief Financial Officer (650) 963-8582 IR@versartis.com Investors: Nick Laudico The Ruth Group (646) 536-7030 nlaudico@theruthgroup.com Media: Debra Bannister Corporate Communications (530) 676-7373 media@versartis.com
(PEIX) to Present at the Jefferies 2015 Industrials Conference
SACRAMENTO, Calif., Aug. 4, 2015 — Pacific Ethanol, Inc. (NASDAQ:PEIX), a leading producer and marketer of low-carbon renewable fuels in the United States, announced it will present at the Jefferies 2015 Industrials Conference on August 10th. The event will take place in New York City.
Bryon McGregor, Chief Financial Officer, is scheduled to present at 10:00 a.m. ET on Monday, August 10th and will host one-on-one meetings throughout the day. Investors may access a webcast of the presentation by visiting Pacific Ethanol’s website at www.pacificethanol.com.
About Pacific Ethanol, Inc.
Pacific Ethanol, Inc. (PEIX) is the leading producer and marketer of low-carbon renewable fuels in the Western United States. With the addition of four Midwestern ethanol plants in July 2015, Pacific Ethanol more than doubled the scale of its operations, entered new markets, and expanded its mission to be the industry leader in the production and marketing of low carbon renewable fuels. Pacific Ethanol owns and operates eight ethanol production facilities, four in the Western states of California, Oregon and Idaho, and four in the Midwestern states of Illinois and Nebraska. The plants have a combined production capacity of 515 million gallons per year, produce over one million tons per year of ethanol co-products such as wet and dry distillers grains, wet and dry corn gluten feed, condensed distillers solubles, corn gluten meal, corn germ, corn oil, distillers yeast and CO2. Pacific Ethanol markets and distributes ethanol and co-products domestically and internationally. Pacific Ethanol’s subsidiary, Kinergy Marketing LLC, markets all ethanol for the Pacific Ethanol plants as well as for third parties, with over 800 million gallons of ethanol marketed annually based on historical volumes. Pacific Ethanol’s subsidiary, Pacific Ag. Products LLC, markets wet and dry distillers grains. For more information please visit www.pacificethanol.com.
CONTACT: Company IR Contact: Pacific Ethanol, Inc. 916-403-2755 866-508-4969 Investorrelations@pacificethanol.com IR Agency Contact: Becky Herrick LHA 415-433-3777 Media Contact: Paul Koehler Pacific Ethanol, Inc. 916-403-2790 paulk@pacificethanol.com
(ACTA) Adds Executive Vice-President of Sales and Chief Financial Officer
New Executives Bring High-Growth Credentials in Public Sector Sales and Finance
SAINT PAUL, Minn., Aug. 4, 2015 — GovDelivery, the leading cloud-based digital communication solution for government, announced today that the company has bolstered its leadership team with the appointments of Mike Coughlin as chief financial officer and Howard Langsam as executive vice president in charge of sales. These additions to the GovDelivery leadership team follow a period of rapid growth. GovDelivery has closed three acquisitions in the past nine months and has grown its team by 59% since January 2014. Both the St. Paul and Washington D.C. offices have recently been recognized as top workplaces by local media.
“We’re thrilled to have attracted such incredible talent in both Mike and Howard. They are exceptional executives who have the skills and experience to help us execute against our vision of empowering government to make better lives for more people,” said Scott Burns, CEO and co-founder of GovDelivery. “In the past year, GovDelivery has grown and expanded on almost every front and we expect these great additions to our team to take our growth to the next level.”
Langsam will be responsible for driving continued growth at GovDelivery, leading the teams that grow the company’s client base and expand GovDelivery’s work with existing clients. Coughlin will oversee the finance and contracting functions with a focus on building the scalable systems necessary for continued rapid growth.
Langsam’s experience ranges from technology startups to major services firms serving the public sector. He joins GovDelivery from NTT DATA, one of the 10 largest IT services companies in the world. At NTT DATA, Langsam’s most recent role was as a senior vice president in the public sector business unit with general management responsibility for a 9-figure revenue portfolio with a team of more than 700. He joined NTT DATA in late 2008 as vice president of state and local sales where sales nearly tripled in five years. Langsam will be based in GovDelivery’s East coast office in Washington, D.C.
“I have seen firsthand the need for government organizations to improve program results by better connecting with the public,” said Langsam. “GovDelivery is positioned well to address this need, and I’m thrilled to join the team.”
Coughlin started his career in public accounting with E&Y before taking a series of finance leadership positions in growth technology companies over the last 18 years. His compelling success record includes VUE, Inc, now PearsonVUE, the leading certification testing company. Mike acted as CFO in the early stages with the company reaching $100 million in revenue resulting in the sale of VUE. In addition, Mike was the CFO of Paisley Consulting, the leading Governance Risk and Compliance solution provider until its sale to Thomson Reuters. Coughlin has extensive experience in global expansion, scaling cloud-based businesses, SEC compliance, and mergers and acquisitions. He will be based in GovDelivery’s Central office in St. Paul, Minn.
“GovDelivery has a strong position in the market and a lot of upside,” said Coughlin. “I joined the team because of the company’s visionary leadership, the extraordinary role it plays in helping government reach more than 90 million people, and the promise of even faster growth in the future.”
About GovDelivery
GovDelivery empowers government to create better lives for more people. More than 1,000 organizations worldwide use the GovDelivery platform and network to inform and engage over 90 million people. GovDelivery is the only digital marketing platform built exclusively for public sector organizations in order to promote usage of services, enhance public awareness, and increase the contributions and involvement of citizen communities. Visit www.govdelivery.com.
CONTACT: Media contact: Kelsey Lund Kelsey.Lund@govdelivery.com 651-925-5766
(PCLN) Named Preferred Menu Provider for OpenTable
SinglePlatform customer menus will update across all OpenTable platforms
Connecting with hungry diners just got a lot easier for restaurants. SinglePlatform from Constant Contact®, Inc. (NASDAQ:CTCT) today announced that OpenTable, Inc., the world’s leading provider of online restaurant reservations, has named SinglePlatform as its new preferred provider of restaurant menus in North America. With this partnership, restaurants that use OpenTable can take advantage of unlimited updates for up to five menus, and SinglePlatform will provide a dedicated support team, ensuring accurate menus that will aid the decision-making of the millions of diners OpenTable seats per month.
“Diners rely on OpenTable to provide all the information they need to discover and book the perfect restaurant, and menus are a key element of the discovery and decision-making experience,” said Scott Jampol, Senior Vice President of Marketing at OpenTable. “By partnering with SinglePlatform, we’re working together to make it easy and seamless for our restaurant customers to update and showcase their latest menus and seasonal fare.”
Via the partnership with SinglePlatform, OpenTable restaurant customers can update their menus from OpenTable’s Restaurant Center and have those updates reflected on the OpenTable site and mobile apps.
“It’s an understatement to say that online search is essential to a local restaurant’s success,” said Pete Chen, vice president and general manager of SinglePlatform from Constant Contact. “Restaurants need to have accurate menu information readily available online, as well as a way for consumers to take action on their restaurant selection.”
About SinglePlatform from Constant Contact
SinglePlatform from Constant Contact gives small businesses a single place to update their critical business information and delivers that information across its publishing partner network, including the top business directory sites, the top ratings and reviews sites, and dozens of other sites and apps, as well as the businesses’ social media profiles, website, and mobile site. It makes a business listing more than an address and phone number by adding the rich content that consumers want when they are searching for information – such as digital menus, products, pricing, and services. In 2014, SinglePlatform’s publishing partner network generated nearly 400 million views for small business locations.
About OpenTable
OpenTable, Inc., part of The Priceline Group (NASDAQ:PCLN), is the world’s leading provider of online restaurant reservations, seating more than 16 million diners per month via online bookings across more than 32,000 restaurants. The OpenTable network connects restaurants and diners, helping diners discover and book the perfect table and helping restaurants deliver personalized hospitality to keep guests coming back. The OpenTable service enables diners to see which restaurants have available tables, select a restaurant based on verified diner reviews, menus, and other helpful information, and easily book a reservation. In addition to the company’s website and mobile apps, OpenTable powers online reservations for nearly 600 partners, including many of the Internet’s most popular global and local brands. For restaurants, the OpenTable hospitality solutions enable them to manage their reservation book, streamline their operations, and enhance their service levels. Since its inception in 1998, OpenTable has seated more than 830 million diners around the world. The Company is headquartered in San Francisco, California, and the OpenTable service is available throughout the United States, as well as in Canada, Germany, Japan, Mexico, and the UK.
OpenTable, OpenTable.com, OpenTable logos, and other service names are the trademarks of OpenTable, Inc. and/or its affiliates.
About Constant Contact®, Inc.
Constant Contact introduced the first email marketing tool for small businesses, nonprofits, and associations in 1998. Today, the company helps more than 650,000 customers worldwide find marketing success through the only all-in-one online marketing platform for small organizations. Anchored by our world-class email marketing tool, Constant Contact helps small businesses drive repeat business and find new customers. It features multi-channel marketing campaigns (newsletters/announcements, offers/promotions, online listings, events/registration, and feedback) combined with shared content, contacts, and reporting; free award-winning coaching and product support; and integrations with critical business tools – all from a single login. The company’s extensive network of educators, consultants/resellers, technology providers, franchises, and national associations offer further support to help small organizations succeed and grow. Through its Innovation Loft, Constant Contact is fueling the next generation of small business technology.
Constant Contact and the Constant Contact Logo are registered trademarks of Constant Contact, Inc. All Constant Contact product names and other brand names mentioned herein are trademarks or registered trademarks of Constant Contact, Inc. All other company and product names may be trademarks or service marks of their respective owners.
Cautionary Language Concerning Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements regarding Constant Contact’s relationship with OpenTable, including SinglePlatform by Constant Contact’s status as OpenTable’s preferred provider of restaurant menus in North America. These forward-looking statements are made as of the date they were first issued and were based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management. Words such as “expect,” “anticipate,” “should,” “believe,” “hope,” “target,” “project,” “goals,” “estimate,” “potential,” “predict,” “may,” “will,” “suggest,” “might,” “could,” “intend,” variations of these terms or the negative of these terms and similar expressions that are not statements of historical fact are intended to identify these forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Constant Contact’s control. Constant Contact’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, the success of SinglePlatform by Constant Contact’s relationship with OpenTable, adverse economic conditions in general and adverse economic conditions specifically affecting the markets in which Constant Contact operates, Constant Contact’s ability to successfully develop and introduce new offerings or enhancements to existing products, adverse regulatory or legal developments, litigation risk and expense, Constant Contact’s ability to continue to promote and maintain its brands in a cost-effective manner, changes in the competitive environment, the company’s ability to compete effectively, and other risks detailed in Constant Contact’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission as well as other documents that may be filed by the it from time to time with the Securities and Exchange Commission. Past performance is not necessarily indicative of future results. The forward-looking statements included in this press release represent Constant Contact’s views as of the date of this press release. Constant Contact anticipates that subsequent events and developments will cause its views to change. Constant Contact undertakes no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Constant Contact’s views as of any date subsequent to the date of this press release.
(CTCT-F)
OpenTable
Media Contact:
Tiffany Fox, 415-344-4275
tfox@opentable.com
or
Constant Contact
Media Contact:
Erika Tower, 781-482-7039
pr@constantcontact.com
or
Investor Contact:
Jeremiah Sisitsky, 339-222-5740
ir@constantcontact.com
(CATB) to Present at the Wedbush PacGrow Healthcare Conference
Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage drug development company built on a pathway pharmacology technology platform, today announced that Catabasis will present a company overview at the Wedbush PacGrow Healthcare Conference. The Wedbush PacGrow Healthcare Conference will be held August 11 – 12, 2015, in New York, NY at Le Parker Meridien Hotel.
- Jill C. Milne, Ph.D., chief executive officer, will present Catabasis corporate and pipeline updates on August 11, 2015, at 10:20am local time at Le Parker Meridien.
A webcast of the presentation will be available in the Investors section of the Company’s website, www.catabasis.com, and will be archived for 30 days following the presentation.
About Catabasis
Catabasis Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics using its proprietary Safely Metabolized And Rationally Targeted, or SMART, linker technology platform. The Company’s SMART linker technology platform is based on the concept of treating diseases by simultaneously modulating multiple targets in one or more related disease pathways. The Company engineers bi-functional product candidates that are conjugates of two molecules, or bioactives, each with known pharmacological activity, joined by one of its proprietary SMART linkers. The SMART linker conjugates are designed for enhanced efficacy and improved safety and tolerability. The Company’s focus is on treatments for rare diseases. The Company is also developing other product candidates for the treatment of serious lipid disorders. For more information on the Company’s technology and pipeline of drug candidates, please visit www.catabasis.com.
About CAT-1004
CAT-1004 is an oral small molecule that inhibits activated NF-kB, a protein that coordinates cellular response to muscular damage, stress and inflammation and plays an important role in muscle health. In skeletal muscle, activated NF-kB drives muscle degeneration and suppresses muscle regeneration. In animal models of DMD, CAT-1004 inhibited activated NF-kB, reduced muscle inflammation and degeneration and increased muscle regeneration. In Phase 1 clinical trials, CAT-1004 inhibited activated NF-kB and was well-tolerated with no observed safety concerns. The FDA has granted CAT-1004 orphan drug and fast track designations for the treatment of DMD.
About CAT-2054
CAT-2054 is an investigational oral drug initially being developed for the treatment of hypercholesterolemia in patients for whom existing therapies are insufficient. By modulating the SREBP pathway, CAT-2054 may inhibit production of important cholesterol metabolism proteins such as PCSK9, HMG-CoA reductase, ATP citrate lyase and NPC1L1. If approved, CAT-2054, may have the potential to be the first therapy to simultaneously modulate cholesterol synthesis, clearance and absorption.
Corporate and Media Contact
Catabasis Pharmaceuticals, Inc.
Andrea Matthews, 617-349-1971
amatthews@catabasis.com
(FTEK) Awarded Air Pollution Control Orders Totaling $4.7 Million
Fuel Tech, Inc. (NASDAQ:FTEK), a world leader in advanced engineering solutions for the optimization of combustion systems and emissions control in utility and industrial applications, today announced the receipt of multiple air pollution control (APC) contracts from customers in the US, Europe and China. These awards have an aggregate value of approximately $4.7 million.
The first US order is for engineering and long-lead equipment for an Electrostatic Precipitator (ESP) retrofit on a Midwestern coal-fired unit. Preliminary engineering is scheduled to complete in the third quarter of 2015. The project is designed to improve the performance of the plant to meet the Environmental Protection Agency’s upcoming Mercury and Air Toxics Standards (MATS) for particulate emissions. The plant will utilize dry sorbent injection and activated carbon injection to control acid gas and mercury emissions. The ESP upgrades are scheduled to complete in the second quarter of 2016 and, when implemented, will capture the fly ash and sorbents.
Two additional US contracts were received for ESP equipment and optimization services for utility boilers in the Midwest, with deliveries scheduled for the third quarter of 2015. In addition, a US order for upgrades to an existing Selective Catalytic Reduction (SCR) system was received for an industrial gas-fired boiler. These upgrades are designed to optimize performance and reliability for SCR performance, with delivery scheduled for the third quarter of 2015.
In the UK, a contract was received for Fuel Tech’s NOxOUT® Selective Non-Catalytic Reduction (SNCR) technology for a unit burning biomass. Delivery for the system is scheduled for the fourth quarter of 2015. This is the second recent order for SNCR technology in the UK, and follows the order announced in May for Fuel Tech’s Advanced NOxOUT® Selective Non-Catalytic Reduction (ASNCR) technology at the Drax Power Station for four boilers burning both coal and biomass.
Fuel Tech is working with Doosan Babcock to provide an emissions control solution to meet the requirements of the European Union’s Industrial Emissions Directive. Through the utilization of advanced control and injection systems in conjunction with more accurate boiler data, ASNCR optimizes urea injection to improve NOx reduction performance and minimize reagent costs.
In China, five orders were received for multiple ULTRA™ systems that will be installed on utility coal-fired units being retrofitted with NOx reduction technology. Fuel Tech’s ULTRA process provides for the safe and cost-effective on-site conversion of urea to ammonia for use as a reagent in the SCR process for NOx control, eliminating the hazards associated with the transport, storage and handling of anhydrous or aqueous ammonia. Equipment deliveries are expected to occur in the third quarter of 2015.
Vincent J. Arnone, President and Chief Executive Officer, commented, “We are excited about the ESP orders as utility plant operators continue to meet MATS emission requirements. The recent Supreme Court ruling raised questions about MATS compliance dates, and these contracts support predictions by many industry experts that compliance dates for 2016 will remain on schedule. The contracts in the UK demonstrate recent growth in the European market and we are pleased to work with Doosan Babcock as we see potential for other projects within the European Union.”
Mr. Arnone continued, “Our ULTRA technology simplifies on-site ammonia generation for SCR applications of all types. We are pleased to see that our air pollution control product line continues to play a role in assisting China in its endeavor to reduce harmful air pollutants.”
About Fuel Tech
Fuel Tech is a leading technology company engaged in the worldwide development, commercialization and application of state-of-the-art proprietary technologies for air pollution control, process optimization, and advanced engineering services. These technologies enable customers to produce energy and processed materials in a cost-effective and environmentally sustainable manner.
The Company’s nitrogen oxide (NOx) reduction technologies include advanced combustion modification techniques and post-combustion NOx control approaches, including NOxOUT®, HERT™, and Advanced SNCR systems, ASCR™ Advanced Selective Catalytic Reduction systems, and I-NOx™ Integrated NOx Reduction Systems, which utilize various combinations of these systems, along with the ULTRA™ process for safe ammonia generation. These technologies have established Fuel Tech as a leader in NOx reduction, with installations on over 900 units worldwide.
Fuel Tech’s technologies for particulate control include Electrostatic Precipitator (ESP) products and services including complete turnkey capability for ESP retrofits, with experience on units up to 700 MW. Flue gas conditioning (FGC) systems include treatment using sulfur trioxide (SO3) and ammonia (NH3) based conditioning to improve the performance of ESPs by modifying the properties of the fly ash particle. Fuel Tech’s particulate control technologies have been installed on more than 125 units worldwide.
The Company’s FUEL CHEM® technology revolves around the unique application of chemicals to improve the efficiency, reliability, fuel flexibility, boiler heat rate, and environmental status of combustion units by controlling slagging, fouling, corrosion, opacity and improving boiler operations. The Company has experience with this technology, in the form of a customizable FUEL CHEM program, on over 110 units.
Fuel Tech also provides a range of services, including boiler tuning and selective catalytic reduction (SCR) optimization services. In addition, flow corrective devices and physical and computational modeling services are available to optimize flue gas distribution and mixing in both utility and industrial applications.
Many of Fuel Tech’s products and services rely heavily on the Company’s exceptional Computational Fluid Dynamics modeling capabilities, which are enhanced by internally developed, high-end visualization software. These capabilities, coupled with innovative technologies and a multi-disciplined team approach, enable Fuel Tech to provide practical solutions to many of our customers’ most challenging problems. For more information, visit Fuel Tech’s web site at www.ftek.com.
This press release may contain statements of a forward-looking nature regarding future events. These statements are only predictions and actual events may differ materially. Please refer to documents that Fuel Tech files from time to time with the Securities and Exchange Commission for a discussion of certain factors that could cause actual results to differ materially from those contained in the forward-looking statements.
Fuel Tech, Inc.
David S. Collins, 630-845-4500
Chief Financial Officer
or
The Equity Group Inc.
Devin Sullivan, 212-836-9608
Senior Vice President
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