Archive for September, 2016

$BLRX #Inlicensing of #Novel Treatment for #LiverFailure

Therapeutic compound is second project in-licensed under strategic collaboration with Novartis for screening and development of novel drug candidates

TEL AVIV, Israel, September 23, 2016  —

BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has signed an exclusive, worldwide agreement with BGN Technologies, the Technology Transfer Company of Ben-Gurion University, and Hadasit, the Technology Transfer Company of Hadassah Medical Organization, for the in-licensing of a novel treatment for various liver failure conditions such as end-stage liver disease (ESLD) and for conditions potentially leading to liver failure such as non-alcoholic steatohepatitis (NASH). This novel treatment, to be named BL-1220, is the second project in-licensed under the framework of the Company’s strategic collaboration with Novartis Pharma AG for the screening and development of novel drug candidates.

BL-1220 is an orally administered, novel composition of sodium alginate, developed by Professor Smadar Cohen from the Department of Biotechnology Engineering, Ben-Gurion University of the Negev, Israel, and Professor Yaron Ilan, Head of Internal Medicine Department A, Hadassah Medical Center, Jerusalem, Israel. Pre-clinical results obtained in animal models of liver impairment suggest that BL-1220 has strong hepato-protective effects. Collectively, the data demonstrate that BL-1220 is able to restore liver function. This technology could be directed toward rapid regeneration of normal liver in both acute and chronic conditions of liver injury.

Philip Serlin, Chief Financial and Operating Officer of BioLineRx, said, “In August this year, we in-licensed the first compound under our multi-year strategic partnership with Novartis, a novel drug candidate for controlling liver fibrosis through modulation of the immune system. Today, we are pleased to announce the second compound under the Novartis collaboration, also for the treatment of liver pathologies. Both of these projects fit our strategic focus on the immunology space. We continue to work closely with Novartis to identify cutting-edge, novel therapies and we expect to bring additional promising projects to the collaboration by the end of the year.”

In December 2014, BioLineRx and Novartis Pharma AG entered into a multi-year strategic collaboration to facilitate development and commercialization of Israeli-sourced drug candidates. Leveraging BioLineRx’s close and long-lasting ties with academic institutions, hospitals and biomedical companies in Israel, as well as its proven project screening process and development expertise, Novartis will evaluate projects identified and presented by BioLineRx for co-development and potential future licensing under the collaboration. The companies intend to co-develop a number of pre-clinical and early clinical therapeutic projects through clinical proof-of-concept. As part of the agreement, Novartis made an equity investment in BioLineRx of $10 million.

About Non-Alcoholic Steatohepatitis and End-Stage Liver Disease

Non-alcoholic steatohepatitis (NASH) is the progressive form of non-alcoholic fatty liver disease (NAFLD), and in many cases the resulting liver scarring is associated with liver cirrhosis. It is estimated that NASH affects 2% to 5% of the global population, and according to the US Association of Liver Disease, of those who will develop NASH, 15%-25% will progress to end stage liver disease (ESLD) and hepatocellular carcinoma (HCC) over 10-20 years. To date, a third of liver transplants and HCC cases are caused by NASH and it is expected to be the principal cause for transplantation by 2020. Currently there are no FDA-approved treatments for NAFLD or NASH, thus new potent therapeutics are an unmet medical need.

About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds, primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx’s leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML, is in the midst of a Phase 2b study as an AML consolidation treatment, and has recently initiated a Phase 2 study in stem cell mobilization for allogeneic transplantation; and BL-7010 for celiac disease and gluten sensitivity, which has successfully completed a Phase 1/2 study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD (known as Merck in the US and Canada) to run a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck’s KEYTRUDA®; and has recently signed a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech’s Atezolizumab in several Phase 1b studies for multiple solid tumor indications and AML.

For additional information on BioLineRx, please visit the Company’s website at http://www.biolinerx.com, where you can review the Company’s SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.

About Hadasit

Hadasit is the Technology Transfer company of the Hadassah Medical Organization in Jerusalem, Israel. The Hadassah Medical Center, established 100 years ago and regarded as one of Israel’s primary hospitals, has accumulated a vast amount of knowledge, medical research, dedication and innovation. The combination of practical experience, ability to pinpoint medical needs and cutting-edge research has yielded a huge potential of ideas, innovation and developments in all aspects of medicine, including therapeutics, diagnostics and medical devices.

In order to realize this potential, Hadassah established Hadasit – the business arm which was founded in 1986 as its vehicle for commercialization of medical technologies developed at the hospitals – and has been investing in turning ideas into viable products and services for the benefit of humanity. Hadasit collaborates with leading international companies and research facilities as well as incubators and venture capital groups.

About BGN Technologies

BGN Technologies is the technology transfer and commercialization company of Ben-Gurion University (BGU) and serves as the link between industry and academic research. BGN assists the university and its faculty to translate their inventions and academic achievements into commercially valuable products by collaborating with established Israeli and global companies as well as with new start-ups established for the development of specific BGU inventions. BGN innovations and commercialization cover diverse fields such as pharmaceuticals, drug delivery, biotechnology, medical devices, information technology, security, electro-optics, nanotechnologies, chemical processes, agro-technology, environment and energy big-data and e-health. For more information, please visit http://www.bgu.ac.il/bgn.

Various statements in this release concerning BioLineRx’s future expectations constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as “may,” “expects,” “anticipates,” “believes,” and “intends,” and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the “Risk Factors” section of BioLineRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2016. In addition, any forward-looking statements represent BioLineRx’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contacts:
PCG Advisory
Vivian Cervantes
Investor Relations
+1-212-554-5482
vivian@pcgadvisory.com

or

Tsipi Haitovsky
Public Relations
+972-52-989892
tsipihai5@gmail.com

Friday, September 23rd, 2016 Uncategorized Comments Off on $BLRX #Inlicensing of #Novel Treatment for #LiverFailure

$EXPI Appoints Industry Veteran #RussCofano as Its New #President

Russ Cofano to Lead Day to Day Operations of Rapidly Growing Real Estate Company

BELLINGHAM, WA–(September 23, 2016) – eXp World Holdings, Inc. (OTCQB: EXPI), owner of eXp Realty, the Agent-Owned Cloud Brokerage®, today announced the appointment of Russ Cofano as its President and General Counsel, effective immediately. Prior to being appointed President and General Counsel of eXp World Holdings, Inc., Cofano was the Company’s Chief Strategy Officer and General Counsel dating back to July 29, 2016. Jason Gesing, who previously served in the role of President of eXp World Holdings, Inc., will continue to serve as Chief Executive Officer of eXp Realty.

“Speaking on behalf of myself, the Board of Directors and the rest of the Executive Team we are very excited about yet another great beginning to a new chapter in the growth of the eXp World Holdings family of companies,” stated Glenn Sanford, CEO and Chairman of eXp World Holdings, Inc. Glenn Sanford continued, “Russ Cofano with his deep understanding of organized real estate is such a welcome addition to all of us. Russ will be providing industry leadership to the continuation of the vision that has been championed by so many here in the company including our wonderful Jason Gesing, CEO of eXp Realty. I am further amazed at the thoughtful, selfless leadership that Jason and the rest of the team have enthusiastically demonstrated in welcoming Russ to the team. Our collaborative mindset of putting the agent and broker owners first is what drives all of us and this move continues to reinforce that vision.”

Prior to joining eXp, Cofano was Senior Vice President of Industry Relations for Move, Inc., operator of realtor.com from June 2014 through September 2015. At Move, Cofano was instrumental in reinvigorating realtor.com’s relationship with MLSs and associations and was a key influencer in realtor.com product improvements. Prior to Move, Cofano served as Chief Executive Officer for the Missouri REALTORS from June 2011 through June 2014. In just three short years, Cofano super-charged the association with a re-energized staff, new strategic plan, innovative member focused governance structure, private member-only social network, and implementation of a new governmental affairs program for local markets. Prior to his stint in Missouri, Cofano was Vice President and General Counsel to Seattle-based John L. Scott Real Estate, consistently ranked as one of the largest real estate brokerage companies in the nation, and helped JLS weather the great recession.

About eXp World Holdings, Inc.

eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty, the Agent-Owned Cloud Brokerage® as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.

eXp World Holdings, Inc. also owns 89.4% of First Cloud Mortgage, Inc. a Delaware corporation launched in 2015 and now licensed to originate mortgages in Arizona, California, Virginia and New Mexico. First Cloud Mortgage has positioned itself as a Planet Friendly Mortgage Company via the purchase of carbon offsets for homeowners offsetting the first year of the Carbon Footprint of the typical home on each mortgage originated through First Cloud Mortgage, Inc.

As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.

For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit eXpWorldHoldings.com. For eXp Realty please visit: eXpRealty.com and for First Cloud Mortgage, Inc. check out FirstCloudMortgage.com.

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.

Investor Relations Contact Information:
Glenn Sanford
Chairman & CEO
eXp World Holdings, Inc.
glenn@expworldholdings.com
360-389-2426

Trade and Media Contact Information:
Jason Gesing
CEO
eXp Realty
jason@exprealty.com
617-970-8518

Friday, September 23rd, 2016 Uncategorized Comments Off on $EXPI Appoints Industry Veteran #RussCofano as Its New #President

$TTOO Announces $40 Million Equity Investment by Partner $CAJ

Canon U.S.A. takes 19.9 percent stake in the company; Seymour Liebman joins board of directors

LEXINGTON, Mass., Sept. 22, 2016  — T2 Biosystems, Inc. (NASDAQ:TTOO), a company developing innovative diagnostic products to improve patient health, today announced the purchase by Canon U.S.A., of approximately $40 million of the company’s stock in a private placement. The shares were purchased at $6.56, the closing market price of Tuesday, September 20, 2016. With this investment, Canon owns 19.9 percent of T2 Biosystems and Canon’s chief administrative officer and general counsel, Seymour Liebman has joined the company’s board of directors. This private placement closed on September 21, 2016.

“We are pleased to have the strong backing of our committed partner Canon – with whom we have been collaborating on Lyme disease product development since February of 2015,” said John McDonough, chief executive officer of T2 Biosystems. “Importantly, this financing puts us in a solid position to continue to grow the business, including furthering our launch of the T2Bacteria™ Panel into the market in 2017 and beyond. We expect the T2Bacteria Panel to be a critical catalyst for our overall sepsis commercial efforts, and we remain on track to submit our application for marketing clearance to the FDA by mid-2017.”

“Working closely with T2 Biosystems in the development of the Lyme disease diagnostic panel, we have come to appreciate the capabilities of its innovative diagnostic solutions,” said Joe Adachi, chairman and CEO, Canon U.S.A. “We are pleased to extend our relationship with T2 Biosystems and look forward to working together in the future.”

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

These securities are being sold in a private placement that have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities Exchange Commission (SEC) or an applicable exemption from such registration requirements.

About T2 Biosystems
T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance platform, or T2MR®, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, eliminating the time-consuming sample prep required in current methods. For more information, please visit www.t2biosystems.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the performance of the Company’s diagnostic products and the ability to bring such products to market. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. For more information on risk factors for T2 Biosystems, Inc.’s business, please refer to the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 9, 2016, under the heading “Risk Factors,” and other filings the Company makes with the Securities and Exchange Commission from time to time. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Media Contact:
Susan Heins, Pure Communications
susan@purecommunicationsinc.com 
864.286.9597

Investor Contact:
Matt Clawson, Pure Communications
matt@purecommunicationsinc.com 
949-370-8500
Thursday, September 22nd, 2016 Uncategorized Comments Off on $TTOO Announces $40 Million Equity Investment by Partner $CAJ

$GLMD & @UCSanDiego #ClinicalTrial Agreement to Assess #Aramchol

TEL AVIV, Israel, Sept. 22, 2016  — Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of a once-daily, oral therapy for the treatment of liver diseases, today announced that it has signed an Investigator-Initiated Clinical Trial Agreement with the University of California, San Diego, School of Medicine (the “University”).  The proposed study is a Phase I/IIa trial to assess safety, tolerability, efficacy, and pharmacokinetics of AramcholTM in a juvenile population with nonalcoholic fatty liver disease (NAFLD) (the “ARTISAN Study”).  The ARTISAN Study (ARamcholTM Trial to Improve Steatosis in Adolescent NAFLD) is to be led by Dr. Jeffrey Schwimmer, Professor of Clinical Pediatrics at the University.

Fatty liver disease in children has been increasingly recognized as an important pediatric health problem.  Pediatric NAFLD has some features that are similar to adults and several features that are unique to children.  In the United States, there are an estimated 5 to 8 million children with NAFLD.  The prevalence of NAFLD in children across the developed world is 5 to 10%.  From a liver standpoint, the major concern is that NAFLD is a risk factor for cirrhosis and liver cancer.  Beyond the risk for serious liver problems, children with NAFLD are also at increased risk for other important health problems including type 2 diabetes and atherosclerotic heart disease.

“NAFLD is the leading cause of chronic liver disease, yet there is no approved therapy in children or adults.  Based upon promising data in adults, the University is developing a proof-of-concept trial for AramcholTM in adolescents with NAFLD,” said Jeffrey Schwimmer, MD, professor of pediatrics, University of California, San Diego, School of Medicine and Director, Fatty Liver Clinic, Rady Children’s Hospital, San Diego.

The ARTISAN Study is subject to receipt of regulatory approvals and is currently expected to be initiated in the first half of 2017.

Galmed’s President and Chief Executive Officer, Mr. Allen Baharaff, stated “The ARTISAN Study marks the third investigator-initiated clinical trial and continues our strategy of collaborating with leading investigators to evaluate AramcholTM‘s efficacy across different populations and indications. We believe addressing the unmet need for treatment of juvenile population with NAFLD should not await the clinical development for adults.  Based on AramcholTM‘s safety profile and mechanism-of-action, we decided to approach this important indication in parallel with our ongoing adult studies.”

About Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis:
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the United States and it affects almost 30% of adults in Western countries. With climbing obesity rates and more sedentary patient populations, the prevalence of NAFLD is increasing worldwide and is becoming the predominant cause of chronic liver disease in parts of the world. NAFLD represents a spectrum of diseases ranging from simple excess liver fat, or steatosis, to nonalcoholic steatohepatitis (NASH). NASH is the progressive form of fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality in persons who drink little or no alcohol. NASH represents the more severe end of this spectrum and is characterized by steatosis, ballooning degeneration and lobular inflammation with or without fibrosis. Long-term risks of NASH include cardiovascular disease, cirrhosis, hepatocellular carcinoma and end stage liver disease requiring liver transplantation.

About Galmed Pharmaceuticals Ltd.:
Galmed is a clinical-stage biopharmaceutical company focused on the development of a novel, once-daily, oral therapy for the treatment of liver diseases utilizing its proprietary first-in-class family of synthetic fatty-acid/bile-acid conjugates, or FABACs. Galmed believes that its product candidate, Aramchol™, has the potential to be a disease modifying treatment for fatty liver disorders, including NASH, which is a chronic disease that Galmed believes constitutes a large unmet medical need. Galmed is currently conducting the ARREST Study, a multicenter, randomized, double blind, placebo-controlled Phase IIb clinical study designed to evaluate the efficacy and safety of Aramchol™ in subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic. More information about the ARREST Study may be found on ClinicalTrials.gov identifier: NCT02279524.

Forward-Looking Statements:
This press release may include forward-looking statements.  Forward-looking statements may include, but are not limited to, statements relating to Galmed’s objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Galmed intends, expects, projects, believes or anticipates will or may occur in the future.  These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate.  Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements.  Applicable risks and uncertainties include risks and uncertainties associated with the initiation, timing, progress and results of the Company’s research, preclinical studies and clinical trials as well as risks and uncertainties identified under the heading “Risk Factors” included in Galmed’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission, or the SEC, on March 22, 2016, and in other filings that Galmed has made and may make with the SEC in the future.  The forward-looking statements contained in this press release are made as of the date of this press release and reflect Galmed’s current views with respect to future events, and Galmed does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. 

Thursday, September 22nd, 2016 Uncategorized Comments Off on $GLMD & @UCSanDiego #ClinicalTrial Agreement to Assess #Aramchol

$ARDM Last Patient Dosed, #ORBIT #Phase3 in #NCFB

Aradigm Corporation (NASDAQ:ARDM) (the “Company”) today announced that the last patient has completed the final dosing visit in the ORBIT-3 and ORBIT-4 Phase 3 clinical studies of Pulmaquin®, Aradigm’s proprietary inhaled ciprofloxacin, an investigational new medication being studied for the treatment of patients with non-cystic fibrosis bronchiectasis (non-CF BE) who have chronic lung infections with Pseudomonas aeruginosa.

The Phase 3 clinical program for Pulmaquin in non-CF BE consisted of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that were identical in design except for a pharmacokinetics sub-study that was conducted in one of the trials only. Each trial enrolled patients (278 in ORBIT-3 and 304 in ORBIT-4) into a 48-week double-blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28 day open label extension in which all participants received Pulmaquin (total treatment duration, including the double-blind period, of approximately one year). The superiority of Pulmaquin vs. placebo during the double-blind period is being evaluated in terms of the time to first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. Lung function is being monitored as a safety indicator.

“We would like to sincerely thank our investigators from many countries and their patients with non-CF BE and chronic lung infections with Pseudomonas aeruginosa for their dedication and successful participation in both clinical trials. We are now focusing on expeditiously closing out both trials with data from a total of 582 enrolled subjects. We anticipate that the top line data will be available in the fourth quarter of this year. Both trials were designed to confirm the encouraging clinical data from the earlier Phase 2b ORBIT-2 clinical trial that demonstrated a substantial antimicrobial effect combined with an extension of the exacerbation free interval in subjects treated with Pulmaquin as compared to placebo,” said Juergen Froehlich, MD, Chief Medical Officer, Aradigm Corporation.

Pulmaquin is a dual release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin, available in oral and intravenous formulations, is a widely prescribed antibiotic. It is used to treat acute lung infections and is often preferred because of its broad-spectrum antibacterial activity against various bacteria, such as P. aeruginosa.

Following Phase 2a development of the liposomal portion of Pulmaquin (Lipoquin®) and Phase 1 development of Pulmaquin, the Phase 2b study ORBIT-2 with Pulmaquin was a 24-week multicenter, randomized, double-blind, placebo-controlled trial in 42 adult non-CF BE subjects. This study demonstrated a significant reduction in P.aeruginosa sputum activity (p=0.002) and a decrease in time to first exacerbation in the per protocol population (p=0.046) and the mITT (p=0.057) populations in the Pulmaquin treated subjects compared to placebo. Overall, the incidence of all treatment emergent adverse events was similar between groups. The most frequently reported treatment related adverse events (reported by ≥ 3 patients in either treatment group) included product taste abnormal and nausea in the Pulmaquin group and wheezing in the placebo group. No serious adverse events were considered treatment related. There were no deaths reported during ORBIT-2.

Aradigm has been granted orphan drug designations for liposomal ciprofloxacin as well as for ciprofloxacin for inhalation for non-CF BE in the U.S. In addition, the U.S. Food and Drug Administration (FDA) has designated Pulmaquin as a Qualified Infectious Disease Product (QIDP). The QIDP designation is granted for treatment of non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa. The QIDP designation made Pulmaquin eligible for Fast Track designation which was granted by the FDA in September 2014.

In 2013, Aradigm granted an exclusive, world-wide license for the Company’s inhaled liposomal ciprofloxacin product candidates for the indication of non-CF BE and other indications to Grifols S.A. More information on the terms of this license may be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 13, 2014.

About Non-Cystic Fibrosis Bronchiectasis

Non-CF BE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE represents an unmet medical need with high morbidity and mortality that affects more than 110,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm is currently in Phase 3 development of Pulmaquin (an investigational proprietary formulation of ciprofloxacin for inhalation) for the treatment of non-cystic fibrosis bronchiectasis. Aradigm’s inhaled ciprofloxacin formulations are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax. In addition, Aradigm has a pipeline composed of programs to prevent diseases in tobacco smokers through smoking cessation and a diagnostic program to detect aspirations of gastrointestinal fluid into the respiratory tract.

More information about Aradigm can be found at www.aradigm.com.

Forward-Looking Statements

Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including those related to the ORBIT-3 and ORBIT-4 clinical trials and the ability to continue successful product development of our potential product candidates, including Pulmaquin, as well as the other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC on March 30, 2016, and the Company’s Quarterly Reports on Form 10-Q.

Aradigm, Pulmaquin, Lipoquin and the Aradigm Logo are registered trademarks of Aradigm Corporation.

Aradigm Corporation
Nancy Pecota, 510-265-8800
Chief Financial Officer

Thursday, September 22nd, 2016 Uncategorized Comments Off on $ARDM Last Patient Dosed, #ORBIT #Phase3 in #NCFB

$AVXL @MichaelJFoxOrg Funded #ANAVEX273 Shows Efficacy

Michael J. Fox Foundation funded ANAVEX 2-73 drug candidate study presented at World Parkinson Congress 2016

NEW YORK, Sept. 22, 2016  — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL) today presented preclinical data demonstrating that ANAVEX 2-73, a sigma-1 receptor agonist, restores function in a classic animal model of Parkinson’s disease. Significant improvements were seen on all measures: behavioral, histopathological, and neuroinflammatory endpoints.

Veronica Francardo, PhD, and Angela Cenci, PhD, main authors of the study at Lund University, Sweden, commented: “We are in the fortunate situation that safety and tolerability of this compound have already been proven in human subjects, and that preliminary indications of a cognitive benefit have been obtained in a Phase 2a clinical trial for Alzheimer’s disease.”

Dosing of ANAVEX 2-73 daily for five weeks in a 6-hydroxydopamine lesions mouse model of Parkinson’s disease was followed by a battery of standardized tests that are linked to parkinsonian motor symptoms. The data indicates that ANAVEX 2-73 is well tolerated, induces significant motor recovery (p<0.05), induces neurohistological restoration (p<0.05) and reduces microglial activation (p<0.05), a potential biomarker of Parkinson’s disease. Behavioral patterns were completely normal, meaning no signs of either dystonia or stereotypic behaviors were detected in animals receiving the treatment. Further analyses are ongoing to confirm the neuroprotective effects of the compound and possibly elucidate some of the underlying mechanisms that contribute to the disease-modifying properties of ANAVEX 2-73. The study is funded by The Michael J. Fox Foundation for Parkinson’s Research.

Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, stated, “This initial data is encouraging, and together with already available clinical safety and tolerability data on ANAVEX 2-73, might accelerate the exploration of ANAVEX 2-73 as a potential therapeutic intervention in Parkinson’s disease.”

The data is presented at the World Parkinson Congress 2016 in Portland, Oregon by Veronica Francardo, PhD, from Lund University, Sweden, titled “Investigating the potential neurorestorative effects of a clinical Sigma-1 receptor agonist in a mouse model of Parkinson’s disease”. The poster presentation is available on the publications page of Anavex’s website.

Parkinson’s disease is a progressive disease of the nervous system marked by tremors, muscular rigidity, and slow, imprecise movement. It is associated with degeneration of the basal ganglia of the brain and a deficiency of the neurotransmitter dopamine. Parkinson’s disease afflicts more than 10 million people worldwide, typically middle-aged and elderly people.

About The Michael J. Fox Foundation for Parkinson’s Research
As the world’s largest nonprofit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $600 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges ground breaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.

About The World Parkinson Congress 2016
The World Parkinson Congress (WPC) is a triennial event with the 2016 edition marking the 4th such meeting since its inception in 2006. As in years past the mission of the WPC is to provide an international forum to disseminate the latest scientific discoveries, medical practices, caregiver initiatives and advocacy work relevant to Parkinson’s disease.  In doing so each Congress facilitates a worldwide dialogue to expedite the discovery of best treatment practices for this devastating condition. This year’s meeting takes place on September 20-23, 2016 at the Oregon Convention Center in Portland, Oregon and includes sessions on fundamental science as well as translational and clinical research.

About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:

Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com

Investors:
Matthew Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com

Media:
Dennis Dobson, Jr.
Dobson Media Group
(203) 258-0159
dennisdobsonjr@dobsonmediagroup.com
Thursday, September 22nd, 2016 Uncategorized Comments Off on $AVXL @MichaelJFoxOrg Funded #ANAVEX273 Shows Efficacy

$MIFI to Sell #Mobile #Broadband Business for $50 Million

SAN DIEGO, Sept. 22, 2016  — Novatel Wireless (NASDAQ:MIFI), a leading global provider of software-as-a-service (SaaS) and solutions for the Internet of Things (IoT), today announced that it has entered into an agreement with T.C.L. Industries Holdings, a Hong Kong company (“TCL”), whereby Novatel Wireless will sell to TCL its mobile broadband business (including its MiFi® branded hotspots and USB modem product lines) for a cash payment of US $50,000,000 payable at closing.  The closing of the transaction is subject to the receipt of various regulatory authority approvals, as well as the approval of Novatel Wireless’s stockholders and convertible noteholders.  The closing of the transaction is expected to occur in the first quarter of 2017.

“The sale of Novatel Wireless’s mobile broadband business to TCL is the most transformative event in Novatel Wireless’s history, and punctuates our period of metamorphosis,” said Sue Swenson, Chair of the Board and Chief Executive Officer of Novatel Wireless.  Ms. Swenson added, “Upon the closing of the transaction with TCL, Novatel Wireless will no longer sell any products it sold at the beginning of 2015.  We will have transitioned the company from a hardware-only business with approximately 80% of revenues tied to one customer into a predominantly SaaS, services and solutions business with thousands of customers generating recurring revenues. Going forward, we will deepen our focus on our recurring revenue IoT solutions such as our Ctrack telematics solutions, including fleet management and asset tracking & monitoring, and our Feeney Wireless (“FW”) business connectivity solutions, such as our recently launched Ignite offering.”

As of June 30, 2016, Novatel Wireless had 557,000 subscribers for its Ctrack and FW SaaS and services solutions, including 389,000 subscribers to its Ctrack telematics products.  After the closing of the transaction, Ctrack is expected to account for approximately 70% of total corporate revenue.  Since acquiring Ctrack in October of 2015, the company’s subscriber growth has increased in each successive quarter, highlighted with a 24% annualized growth rate for its Ctrack fleet management subscribers in the second quarter of 2016. In connection with the sale of Novatel Wireless’s mobile broadband business to TCL, Novatel Wireless plans to create a new public holding company (“Newco”) and a new operating structure.  The management of Novatel Wireless is currently considering several names and logos to be adopted by Newco going forward.

“The restructuring of the company’s various business units into a new public holding company with a new operating structure will enable us to streamline the infrastructure of the ongoing organization, make more efficient use of our existing management talent, and allow us to more closely track the performance of our various business units and support our business initiatives,” said Michael Newman, Chief Financial Officer of Novatel Wireless. “Commencing in the first quarter after the closing of the transaction with TCL, we estimate that Newco will be generating approximately $90 million in annualized revenues, with non-GAAP gross margin of more than 60% and adjusted EBITDA margin of approximately 10%,” added Mr. Newman.

Restructuring into New Public Holding Company

Novatel Wireless intends to undertake a holding company restructuring (the “Restructuring”), which will result in Newco, a newly-formed wholly-owned subsidiary of Novatel Wireless, owning all of the capital stock of Novatel Wireless.  Pursuant to the proposed Restructuring, a newly-formed, direct, wholly-owned subsidiary of Newco and an indirect wholly-owned subsidiary of Novatel Wireless (“Merger Sub”) will be merged with and into Novatel Wireless, with Novatel Wireless surviving as a direct wholly-owned subsidiary of Newco.  Each share of the common stock of Novatel Wireless issued and outstanding immediately prior to the merger of Novatel Wireless with Merger Sub will automatically convert into an equivalent corresponding share of the common stock of Newco, having the same designations, rights, privileges, qualifications and limitations as the corresponding share of Novatel Wireless common stock being converted.   Accordingly, upon consummation of the Restructuring, Novatel Wireless’s current stockholders will become stockholders of Newco, and the current directors and senior executive management team of Novatel Wireless will be the directors and senior executive management team of Newco.

The stockholders of Novatel Wireless will not recognize any gain or loss for U.S. federal income tax purposes upon conversion of their shares of Novatel Wireless common stock into Newco common stock in the proposed Restructuring.  Following the proposed Restructuring, the former shares of common stock of Novatel Wireless will continue to trade on the NASDAQ Stock Market as shares of common stock of Newco.

Houlihan Lokey Capital, Inc. served as financial advisor and Paul Hastings LLP served as outside legal counsel to Novatel Wireless for this transaction with TCL.

Conference Call Information
Novatel Wireless will host a conference call for analysts and investors today at 5:00 p.m. ET.

To access the conference call:

  • In the United States, call 1-844-881-0135
  • International parties can access the call at 1-412-317-6727

An audio replay of the conference call will also be available beginning one hour after the call, through October 6, 2016. To hear the replay, parties in the United States may call 1-877-344-7529 and enter access code 10093090. International parties may call 1-412-317-0088 and enter the same code.

About Novatel Wireless
Novatel Wireless, Inc. (Nasdaq:MIFI) is a leading global provider of software-as-a-service (SaaS) and solutions for the Internet of Things (IoT). Novatel Wireless sells its telematics solutions under the Ctrack brand, including its fleet management, asset tracking & monitoring, stolen vehicle recovery, and usage-based insurance platforms. The Company also sells business connectivity solutions and device management services through Feeney Wireless (“FW”).  Novatel Wireless has over 30 years of experience providing customers with secure and insightful solutions and analytics, with approximately 557,000 global subscribers, including 172,000 fleet management subscribers. Novatel Wireless, Inc. is headquartered in San Diego, California. www.novatelwireless.com.

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to a variety of matters, including, without limitation, statements regarding the timing and likelihood of Novatel Wireless’s planned sale of the mobile broadband business to TCL, the benefits and financial performance expected to be realized by the on-going business following the planned sale, certain terms and steps of the proposed Restructuring, conditions precedent to consummating the proposed sale of the mobile broadband business and the proposed Restructuring, and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Novatel Wireless and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Novatel Wireless undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For example, the consummation of the proposed sale of the mobile broadband business to TCL is subject to a number of closing conditions and the failure to satisfy any one of these conditions could result in the transaction not closing, in which case none of the expected future benefits of the transaction would occur. Other risks and uncertainties that could affect the forward-looking statements set forth in this press release include: following the Restructuring, the failure of the stockholders of Newco to approve the proposed sale of the mobile broadband business; failure to obtain approval of the holders of Novatel Wireless’s convertible notes; failure to obtain required regulatory approvals, including clearance from the Committee on Foreign Investment in the United States (CFIUS); the challenges and costs of closing, integrating, restructuring, and achieving any anticipated synergies or benefits from the proposed sale of the mobile broadband business and the Restructuring, the distraction of management or other diversion of valuable resources within each company caused by the proposed transactions; the ability to retain key employees, customers, and suppliers during the pendency of the proposed transactions and afterwards; and factors generally affecting the business, operations, and financial condition of Novatel Wireless and its various subsidiaries.  Certain of these and other risks and uncertainties are described more fully in Novatel Wireless’s most recently filed SEC documents, including Novatel Wireless’s Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent Quarterly Reports on Form 10-Q, under the heading “Risk Factors.”

Additional Information and Where to Find It

Following the proposed Restructuring, the stockholders of Newco will be asked to approve the sale of the mobile broadband business to TCL. In order to solicit this approval, Newco will file documents with the SEC, including a definitive proxy statement relating to the proposed sale. The definitive proxy statement will also be mailed to Newco’s stockholders in connection with the proposed sale. Investors and security holders are urged to read these documents when they become available because they will contain important information about Newco, the mobile broadband business and the proposed sale. Investors and security holders may obtain free copies of these documents and other related documents when they are filed with the SEC at the SEC’s web site at http://www.sec.gov or by directing a request to Newco, c/o Novatel Wireless, 9645 Scranton Road, Suite 205, San Diego, California 92121, Attention: Stockholder Services.

Newco and its directors and executive officers may be deemed participants in the solicitation of proxies from the stockholders of Newco in connection with the proposed sale. Information regarding the interests of these directors and executive officers in the proposed transaction will be included in the definitive proxy statement when it is filed with the SEC. Additional information regarding the directors and executive officers of Newco is also included in Novatel Wireless’s Annual Report on Form 10-K for the year ended December 31, 2015, which was filed with the SEC on March 15, 2016 and the definitive proxy statement relating to Novatel Wireless’s 2016 Annual Meeting of Stockholders, which was filed with the SEC on April 29, 2016. These documents are available free of charge at the SEC’s web site at www.sec.gov and from Stockholder Services at Novatel Wireless, as described above.

 

Investor Relations Contact:

Michael Sklansky
(858) 431-0792
msklansky@nvtl.com

Media Relations Contact:

Anette Gaven
619.993.3058 
agaven@nvtl.com
Thursday, September 22nd, 2016 Uncategorized Comments Off on $MIFI to Sell #Mobile #Broadband Business for $50 Million

$HTCH Announces Early Termination of Hart-Scott-Rodino Waiting Period

HUTCHINSON, Minn., Sept. 22, 2016  — Hutchinson Technology Incorporated (NASDAQ:HTCH) (“HTI”) today announced that the U.S. Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), with respect to the proposed merger of HTI with and into a wholly owned subsidiary of TDK Corporation (“TDK”).  The early termination of the waiting period under the HSR Act satisfies one of the remaining conditions to the closing of the pending merger.

As of August 21, 2016 (the “measurement date”), HTI’s level of cash (subject to certain adjustments) less any outstanding borrowings on its revolving line of credit (the “net cash”), as further defined in the merger agreement with affiliates of TDK, was approximately $47.1 million.  Based on HTI’s net cash position as of the measurement date, TDK would acquire all of the outstanding shares of common stock of HTI for total consideration of $4.00 per share.

The merger is currently expected to close no later than October 5, 2016, and remains subject to other customary closing conditions set forth in the merger agreement.

About Hutchinson Technology Incorporated

HTI is a global supplier of critical precision component technologies. As a key supplier of suspension assemblies for disk drives, HTI helps customers improve overall disk drive performance and meet the demands of an ever-expanding digital universe. Through its new business development initiatives, HTI focuses on leveraging its unique precision manufacturing capabilities in new markets to improve product performance, reduce size, lower cost, and reduce time to market.

Cautionary Note Regarding Forward-Looking Statements

This announcement contains forward-looking statements regarding the completion of the transactions contemplated by the merger agreement. HTI does not undertake to update its forward-looking statements. These statements involve risks and uncertainties. HTI’s actual results could differ materially from those anticipated in these forward-looking statements as a result of changes in HTI’s inability to consummate the transactions contemplated by the merger agreement due to the failure to satisfy conditions to its completion and other risks to consummation of the transaction and other factors described from time to time in HTI’s reports filed with the Securities and Exchange Commission.

INVESTOR CONTACT:
Chuck Ives
Hutchinson Technology Incorporated
320-587-1605

MEDIA CONTACT:
Connie Pautz
Hutchinson Technology Incorporated
320-587-1823
Thursday, September 22nd, 2016 Uncategorized Comments Off on $HTCH Announces Early Termination of Hart-Scott-Rodino Waiting Period

$BVXV #Phase2b #European Trial: Last Patient Out

Top line results expected in the coming months

NESS ZIONA, Israel, September 21, 2016  —

BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) announced today that the last participant in a European Phase 2b clinical trial of M-001, its universal flu vaccine candidate, has completed their final visit. Conducted in collaboration with the EU-sponsored UNISEC consortium, the trial is designed to evaluate the safety and immunogenicity of M-001 when used ahead of a pandemic influenza vaccine.

“This important milestone marks the conclusion of the patient facing part of our European trial. Laboratory analysis is now underway, and we look forward to the results in the coming months.  The conclusion of this trial, along with the upcoming start of our NIH-sponsored Phase 2 trial in the USA, means we are on track to be Phase 3 ready in the 2017/18 timeframe. We are excited to be one step closer to bringing our multi-strain and multi-season vaccine against seasonal and pandemic flu to the market,” explained BiondVax’s Chief Scientist, Dr. Tamar Ben-Yedidia.

In 2009, following the official World Health Organization (WHO) declaration of a H1N1 swine flu pandemic, it took about 6 months until vaccines against the new strain could be administered. During those 6 months the pandemic proliferated, ultimately killing up to 575,000 people globally[1].  The long delay is attributable to current egg-based manufacturing processes and the need for the new vaccine to be highly specific to the new pandemic flu strain.

To mitigate against the 6-month delay some authorities currently stockpile pandemic flu vaccines. For example, under the U.S. Department of Health and Human Services (HHS) Pandemic Influenza Plan, one of the key goals for vaccine preparedness is to “stockpile vaccines against influenza viruses with pandemic potential to cover 20 million persons.”[2]

However, given current flu vaccine technology, each different flu strain requires its own specific vaccine. As well, there is an unlimited number of potential future flu strains. BiondVax’s flu vaccine, M-001, is advantageous in that it is designed to provide protection against a broad range of current and future potential flu strains.

The current trial in Europe is designed to compare humoral and cellular immune response between two groups. These are (1) a control group receiving the standard avian pandemic vaccine alone, and (2) a group receiving BiondVax’s M-001 as a primer prior to receiving the pandemic vaccine.

The goal following its approval for use as a pandemic primer would be to administer stockpiled M-001 immediately upon declaration of any new pandemic, thereby providing broad flu protection until a virus-specific vaccine is produced a few months later. BiondVax’s long-term intent is to license M-001 as a standalone universal flu vaccine, replacing both the current seasonal and pandemic vaccine technology.

  1. http://www.cdc.gov/flu/spotlights/pandemic-global-estimates.htm, retrieved 19 Sept 2016.
  2. https://www.medicalcountermeasures.gov/barda/pandemic-influenza.aspx, retrieved 19 Sept 2016.

 

About BiondVax Pharmaceuticals Ltd

BiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit http://www.biondvax.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the current Phase 2 & contemplated phase 3 trials, the adequacy of available cash resources to fund product development and commercialization and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
For further information, please contact:

Joshua E Phillipson
Business Development
+972-8-930-2529 x5105
j.phillipson@biondvax.com

Kenny Green
Investor Relations
+1-646-201-9246
kenny@biondvax.com

Wednesday, September 21st, 2016 Uncategorized Comments Off on $BVXV #Phase2b #European Trial: Last Patient Out

$URRE #Acquires Second #Lithium Brine Project in #Utah

CENTENNIAL, Colo., Sept. 21, 2016  — Uranium Resources, Inc. (URI) (Nasdaq:URRE) (ASX:URI), announced today that it has entered into an agreement to acquire certain placer mining claims comprising the Sal Rica lithium brine project from Mesa Exploration Corporation (Mesa Exploration) (TSX-V:MSA) (OTCPK:MSAJF). The project is comprised of approximately 9,800 acres (3,960 hectares) of placer mining claims covering a highly prospective target for lithium-enriched brines in the Pilot Valley region of northwestern Utah. The target area is situated within a region of known brine-hosted lithium mineralization and is approximately 25 miles (40 kilometers) north of the town of Wendover, Utah in Box Elder County.

Under the terms of the agreement between URI and Mesa Exploration, URI will acquire an undivided 100 percent interest in the Sal Rica project, subject to a 2 percent net smelter return royalty (NSR), for the following consideration:

  • $50,000 cash paid to Mesa at closing;
  • 100,000 URI restricted shares at closing, with a registration statement to be filed with the SEC within 28 days of issue;
  • And 100,000 restricted shares at the first anniversary date of closing, with a registration statement to be filed with the SEC within 28 days of issue;
  • Closing is expected on or before October 21, 2016, subject to customary closing conditions.

Results from a shallow drilling program carried out by Quintana Petroleum in 1966 on the Sal Rica Project demonstrated the widespread presence of significant levels of lithium in brines associated with near surface aquifers. Geophysical studies by the University of Utah between 1957 and 1961 indicate that in the project area basin-fill sediments, which are potential host rocks for lithium enriched brines, have a depth range of up to 5,300 feet (1,615 meters). With lithium assay values ranging from 22 to 81 parts per million (ppm), as sampled by Quintana Petroleum over 13 drill holes, the data clearly demonstrates the high technical merit of the Sal Rica target area. Confirmation brine samples recently collected by Mesa Exploration personnel returned lithium grades averaging 66 ppm lithium, with values as high as 80 ppm, consistent with the results Quintana obtained from their previous drilling. Initial sampling of sediments in the project area by URI personnel also yielded lithium values ranging from 82 ppm to 213 ppm Li. All of the samples collected from the programs of Mesa Exploration and Uranium Resources were analyzed by ALS Minerals, Reno, Nevada USA.

The acquisition of the Sal Rica Project along with the recently acquired Nina claims in Nevada enhances URI’s intent to expand and broaden its corporate efforts to develop energy metal commodities, complimentary to the Company’s existing business operations and extensive technical expertise, in order to create increased shareholder value through exposure to rapidly expanding global energy demand. URI has rapidly advanced its internal program of lithium brine target identification, exploration and evaluation, and is now actively acquiring additional lithium prospects to build a robust and prospective lithium project portfolio.

About the Sal Rica Project:

The Sal Rica Project is located approximately 25 miles (40 kilometers) north of Wendover, Utah and 100 miles (160 kilometers) west-northwest of Salt Lake City. URI staff initially identified the Sal Rica Project target area through literature reviews of historical geological and geochemical data from the US Geological Survey as well as other public and private information sources, followed by field reconnaissance of the target area. As such, the Sal Rica Project area fulfills many of the technical criteria of the Company’s geological model for lithium-enriched brine deposits. The Pilot Valley, site of the Sal Rica project, is a closed drainage basin covering an area of approximately 130 square miles (337 square kilometers) and whose geology is dominated by lake and evaporite sediments that have been sources of potash and salt. In 1966 Quintana Petroleum carried out a shallow auger drilling program to evaluate the potential for shallow potash-enriched brines in the target area. During the course of their drilling program all of the brine samples collected from the drill holes were analyzed for a range of elements, including lithium. An analysis of the geochemical results from this “historical” drilling program indicated the wide-spread presence of lithium-enriched brines, ranging from 22 to 81 parts per million lithium in 13 drill holes. Recent “offset sampling” of the historic Quintana drill holes by Mesa Exploration confirmed the range of Quintana’s assay results. Mesa Exploration’s samples were analyzed by ALS Minerals at their analytic facility located in Reno, Nevada.

Sediment samples collected by URI personnel from the target area ranged from 82 to 213 ppm lithium as determined through geochemical analyses carried out by ALS Minerals. These recently completed assay results also confirm the range and magnitude of results obtained by the US Geological Survey, and Quintana, indicating the high quality and technical merits of the Sal Rica project. These results warrant future investigation to further characterize the potential for lithium-enriched brines in the subsurface environment. Near term exploration by URI at the Sal Rica Project will focus on the chemical characterization of the lithium bearing brine aquifers, as well as the vertical and lateral extent of lithium-bearing brines. The Sal Rica project is geologically similar to Nevada’s Clayton Valley, the site of Albemarle Corporation’s Silver Peak lithium-brine mine; the only lithium brine production facility in the United States. This acquisition provides URI with a second cornerstone project, with its previously announced Nina Project in Nevada, from which a complete lithium resource portfolio can be built.

About the Lithium Market

Lithium is a critical component for the manufacture of batteries for electrical storage and used in a wide range of devices ranging from cell phones to automobiles. The battery market is expected to grow 500% over the next 10 years, with lithium batteries accounting for 35% of this growth. At the same time, the transportation sub-market alone is expected to experience a 23% compounded annual growth rate during this same period, according to Bloomberg.

With large battery plants such as Tesla’s “Gigafactory” near Reno, Nevada and Faraday Motor Works’ proposed facility near Las Vegas, Nevada – URI’s Sal Rica Project is well placed within the evolving lithium brine production and consumption industry in the United States.

Lithium enriched brines are proven to be less expensive to explore for, develop and operate than other sources of lithium, such as lithium rich pegmatites and hectorite clays. This advantage of brines is coupled with a small environmental footprint and minimal carbon emissions, which makes ISR mining of brines an attractive method for producing lithium.

For more on the Lithium Market please go to our Company’s website located at www.uraniumresources.com.

Taking advantage of URI’s Expertise

With nearly forty years of corporate experience in the exploration, development, operation and restoration of ISR uranium recovery operations, URI is uniquely qualified to expand its business ventures into the lithium brine business. URI is positioned to take advantage of its extensive expertise in:

  • Design, construction, and operation of well fields;
  • The extraction and recovery (hydrometallurgy) of metals from groundwater;
  • Exploration of mineral properties; and
  • Permitting of new projects on privately-owned properties and lands administered by the US Bureau of Land Management and the US Forest Service.

The URI team has successfully explored for a wide range of mineral commodities, from industrial and agricultural minerals, precious metals, uranium and, now, lithium, in the United States and throughout the world. Using a disciplined approach, URI has centered its geological focus to locales, like those found in Utah and Nevada, that fit a preferred geologic criteria and have the potential to host economic resources of lithium. Furthermore, the Company’s decades of wellfield design, management, and hydrometallurgical operations experience is directly transferrable to lithium brine extraction and processing. In addition, the Company’s existing facilities also present value in a diversification into lithium, as demonstrated in the use of the existing in-house analytical laboratory at the Kingsville Dome Mine to provide rapid analysis of brine screening samples collected as part of ongoing exploration and evaluation activities.

Christopher M. Jones, President and Chief Executive Officer, said “Continuing our expansion into the lithium brine exploration business strengthens our portfolio of high-value projects. Diversifying our mineral project pipeline while maintaining our uranium business portfolio in readiness for the predicted price rise allows investors increased exposure to the energy industry. We remain optimistic about this new chapter in our development of URI.”

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

About Uranium Resources (URI)

URI is focused on developing energy-related metals. In addition to both the Sal Rica and the previously announced Nina Project, URI remains focused on advancing the Temrezli in-situ recovery (ISR) uranium project in Central Turkey. URI controls extensive exploration properties under nine exploration and operating licenses covering approximately 32,000 acres (over 13,000 ha) with numerous exploration targets, including the potential satellite Sefaatli Project, which is 30 miles (48 km) southwest of the Temrezli Project. In Texas, the Company has two licensed and currently idled processing facilities and approximately 11,000 acres (4,400 ha) of prospective ISR uranium projects. In New Mexico, the Company controls mineral rights encompassing approximately 190,000 acres (76,900 ha) in the prolific Grants Mineral Belt, which is one of the largest concentrations of sandstone-hosted uranium deposits in the world. Incorporated in 1977, URI also owns an extensive uranium information database of historic drill hole logs, assay certificates, maps and technical reports for the Western United States.

Cautionary Statement

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “estimates,” “projects,” “anticipates,” “believes,” “could,” and other similar words. All statements addressing events or developments that the Company expects or anticipates will occur in the future, including but not limited to statements relating to the future financing of the Company, the Company’s expected burn rate, and developments at the Company’s projects are forward-looking statements. Because they are forward-looking, they should be evaluated in light of important risk factors and uncertainties. These risk factors and uncertainties include, but are not limited to, (a) the Company’s ability to raise additional capital in the future; (b) spot price and long-term contract price of lithium and uranium; (c) risks associated with our foreign operations, (d) operating conditions at the Company’s projects; (e) government and tribal regulation of the uranium industry, the lithium industry, and the power industry; (f) world-wide uranium and lithium supply and demand, including the supply and demand for lithium based batteries; (g) maintaining sufficient financial assurance in the form of sufficiently collateralized surety instruments; (h) unanticipated geological, processing, regulatory and legal or other problems the Company may encounter, including in Utah and Turkey; (i) the ability of the Company to enter into and successfully close acquisitions or other material transactions, including the proposed transactions with Laramide; (j) the ability of the company to successfully close the transaction with Mesa; (k) and other factors which are more fully described in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of the Company’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on the Company’s forward-looking statements. Except as required by law, the Company disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this news release.

Competent Person’s Statement

Technical information in this press release is based on data reviewed by Dean T. Wilton, who is Chief Geologist and Vice President of Uranium Resources, Inc. Mr. Wilton is a “Qualified Person” as defined by Canadian National Instrument 43-101, and a “Competent Person” as defined in the 2012 Edition of the “Australasian Code for Reporting of Exploration Results, Mineral Resources and Ore Reserves” (JORC Code). He is a Certified Professional Geologist (CPG-7659), as designated by the American Institute of Professional Geologists, and is a Member of the Australian Institute of Geoscientists (MAIG #6384). Mr. Wilton has appropriate experience that is relevant to the evaluation of the style of mineral deposits relating to this document. Mr. Wilton consents to the inclusion in this release of the matters based on their information in the form and context in which they appear.

The photo is also available at Newscom, www.newscom.com, and via AP PhotoExpress.

Uranium Resources Contact:
Christopher M. Jones, President and CEO
303.531.0472	

info@uraniumresources.com
www.uraniumresources.com 

Jeff Vigil, CFO and VP Finance
303.531.0473
Wednesday, September 21st, 2016 Uncategorized Comments Off on $URRE #Acquires Second #Lithium Brine Project in #Utah

$ABEO Announces #Licensing of #AIM #AAV #GeneTherapy Vector Platform

NEW YORK, NY, and CLEVELAND, OH–(September 21, 2016) –

  • AIM vector system is a novel AAV-based vector technology platform that may target CNS and other tissues with increased efficiency and tissue specificity
  • Exclusive worldwide license adds ABO-202, an AAV gene therapy product, for the treatment of CLN1 patients with infantile neuronal ceroid lipofuscinosis (INCL, infantile Batten disease) to Abeona’s Batten pipeline; clinical trials anticipated 2017

Abeona Therapeutics Inc. (NASDAQ: ABEO), a clinical-stage biopharmaceutical company focused on developing therapies for life-threatening rare genetic diseases, announced today the exclusive worldwide license of a next generation gene therapy AAV capsid portfolio from University of North Carolina at Chapel Hill. The AIM vector system is a next generation platform of AAV capsids capable of widespread central nervous system gene transfer and can be used to confer high transduction efficiency for various therapeutic indications. Studies indicate that AIM vectors can efficiently and broadly target CNS tissue, and may provide a treatment for patients that have inhibitory antibodies to natural AAV serotypes. Importantly, the AIM vector system may provide second-generation treatment approaches for patients that have received a previous AAV injection.

“As we continue to build out our orphan and rare disease drug portfolio and move additional programs into the clinic, this agreement with UNC continues the execution of our strategy to combine our expertise in advancing gene therapy programs with the development of a next-generation proprietary AAV vector platform,” stated Steven H. Rouhandeh, Executive Chairman. “We look forward to harnessing the clinical utility and therapeutic potential of the AIM vector system technology platform to address a broad range of rare genetic diseases.”

In addition to the AAV capsid library, the license also adds ABO-202, an AAV-based CLN1 program, to Abeona’s Batten pipeline. ABO-202, developed at UNC by Steven Gray, Ph.D. with the support of The Saoirse Foundation, Taylor’s Tale, Hayden’s Batten Disease Foundation, and the Batten Disease Support and Research Association, is anticipated to enter clinical trials in 2017 for patients with infantile neuronal ceroid lipofuscinosis (INCL, infantile Batten disease), an inherited fatal genetic disease that primarily affects the nervous system.

“ABO-202 has shown promising preclinical efficacy in INCL mice after delivery of a functioning copy of the CLN1 gene to cells of the central nervous system, by extending survival and preserving strength when administered early in the disease course,” noted Steven J. Gray, Ph.D, Assistant Professor, Department of Ophthalmology, Gene Therapy Center, University of North Carolina at Chapel Hill. “Our work in developing these novel, next generation AAV gene therapy vectors has the potential to further advance the field of AAV-based technologies by efficiently and specifically targeting the CNS, with a likelihood of avoiding antibodies endogenously generated by natural AAV serotypes.”

“The AIM vector system is a next generation AAV-based gene therapy technology platform that represents a transformational opportunity for Abeona. The AIM platform will allow us to leverage our current pipeline into second generation products for CNS and other tissue-specific delivery, and help provide an answer for patients that have existing inhibitory antibodies,” stated Timothy J. Miller, Ph.D., President & CEO. “In addition, we add another AAV-based product ABO-202 (AAV-CLN1) for treatment of patients with infantile neuronal ceroid lipofuscinosis (INCL), which builds on our expertise in developing treatments for patients with forms of Batten disease.”

About Abeona: Abeona Therapeutics, Inc. is a clinical stage company developing gene and plasma-based therapies for life-threatening rare genetic diseases. Abeona’s lead programs are ABO-102 (AAV-SGSH) and ABO-101 (AAV-NAGLU), adeno-associated virus (AAV) based gene therapies for Sanfilippo syndrome (MPS IIIA and IIIB), respectively. Abeona is also developing EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-201 (AAV-CLN3) gene therapy for juvenile Batten disease (JNCL); ABO-202 (AAV-CLN1) gene therapy for treatment of infantile Batten disease (INCL), and ABO-301 (AAV-FANCC) for Fanconi anemia (FA) disorder using a novel CRISPR/Cas9-based gene editing approach to gene therapy for rare blood diseases. In addition, Abeona has a plasma-based protein therapy pipeline, including SDF Alpha™ (alpha-1 protease inhibitor) for inherited COPD, using our proprietary SDF™ (Salt Diafiltration) ethanol-free process. For more information, visit www.abeonatherapeutics.com.

About Infantile neuronal ceroid lipofuscinosis (INCL): CLN1, also known as PPT1, encodes an enzyme called palmitoyl-protein thioesterase 1 that is insufficiently active in Infantile NCL. Infantile NCL (INCL or Santavuori-Haltia disease) begins between about ages 6 months and 2 years and progresses rapidly. Affected children fail to thrive and have microcephaly. Also typical are short, sharp muscle contractions called myoclonic jerks. These children usually do not reach age 5.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include, without limitation, our plans for continued development and internationalization of our clinical programs, that the AIM vector system is a next generation AAV-based vector technology platform that may target CNS and other tissues, with increased efficiency and tissue specificity, that studies indicate that AIM vectors can efficiently and broadly target CNS tissue, and may provide a treatment for patients that have inhibitory antibodies to natural AAV serotypes, that the AIM vector system may provide second-generation treatment approaches for patients that have received a previous AAV injection, that is anticipated to enter clinical trials in 2017 for patients with infantile neuronal ceroid lipofuscinosis.

These statements are subject to numerous risks and uncertainties, including but not limited to continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the impact of competition; the ability to develop our products and technologies; the ability to achieve or obtain necessary regulatory approvals; the impact of changes in the financial markets and global economic conditions; and other risks as may be detailed from time to time in the Company’s Annual Reports on Form 10-K and other reports filed by the Company with the Securities and Exchange Commission. The Company undertakes no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Investor Contact:
Christine Silverstein
Vice President, Investor Relations
Abeona Therapeutics Inc.
+1 (212)-786-6212
csilverstein@abeonatherapeutics.com

Media Contact:
Andre’a Lucca
Vice President, Communications & Operations
Abeona Therapeutics Inc.
+1 (212)-786-6208
alucca@abeonatherapeutics.com

Wednesday, September 21st, 2016 Uncategorized Comments Off on $ABEO Announces #Licensing of #AIM #AAV #GeneTherapy Vector Platform

$OCRX Enrollment Done, #Phase2a #NIH Sponsored, #OCR002 Study In #AcuteLiverFailure

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., Sept. 21, 2016  — Ocera Therapeutics, Inc. (NASDAQ:OCRX), today announced completion of enrollment in STOP-ALF,  a Phase 2a clinical trial to evaluate the Safety and Tolerability of Ornithine Phenylacetate in patients with Acute Liver Failure. The study was conducted by the Acute Liver Failure Study Group, an NIH-sponsored network of university tertiary care liver transplant sites, with support and supply of study medication from Ocera.

“We are excited to announce the completion of STOP-ALF and to report there were no serious safety issues attributable to study medication observed at any dose level,” said William M. Lee, M.D., principal investigator of the study. “We are currently examining additional safety and tolerability parameters, and pharmacokinetic findings for OCR-002 in these acutely ill patients. A late-breaker abstract of top-line findings has been submitted to the American Association for the Study of Liver Diseases (AASLD) for presentation at “The Liver Meeting®” being held in mid-November.

About STOP-ALF

The Phase 2a study was a multi-center, open-label study, conducted in two cohorts of patients diagnosed with acute liver failure. Patients were treated pursuant to one of four escalating dosing regimens of intravenously-administered OCR-002, an ammonia scavenger, which were advanced only after safety and certain pharmacokinetic data were reviewed. Cohort 1 was comprised of affected patients with minimal renal dysfunction (defined as serum creatinine ≤ 1.5 mg/dL and mean arterial pressure of > 65 mm Hg). Cohort 2 included affected patients with compromised renal function (defined as serum creatinine > 1.5 mg/dL and < 10 mg/dL with mean arterial pressure of > 65 mm Hg). Dose levels within the four regimens ranged from approximately 3.33 g/24h to 20 g/24h for up to 5 treatment days. 36 of 47 patients enrolled are considered evaluable having completed at least 72 hours of treatment.

About Acute Liver Failure (ALF)

Acute liver failure is a rare syndrome with a significant mortality rate affecting an estimated 2,000 previously healthy individuals annually in the U.S. ALF is a rapid deterioration of liver function, often due to acetaminophen and idiosyncratic drug reactions, resulting in the liver’s inability to clear the circulating toxin Ammonia, which can lead to cerebral edema, intracranial hypertension, brainstem herniation and death.

About Ocera

Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate) in both intravenous and oral formulations. OCR-002 is an ammonia scavenger and has been granted orphan drug designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant hepatic encephalopathy (HE) in patients with acute liver failure and acute-on-chronic liver disease.

Ocera’s HE clinical development efforts include an ongoing Phase 2b clinical trial, STOP-HE, which is evaluating the safety and efficacy of intravenously-administered OCR-002 in resolving neurocognitive symptoms of acute HE in hospitalized patients with elevated ammonia. The Company expects to complete enrollment in the STOP-HE trial in the fourth quarter of 2016 with top-line data to be published soon thereafter.

Concurrent with STOP-HE, Ocera is evaluating orally-available OCR-002 in a Phase 1 study in patients with cirrhosis as a chronic use option to maintain remission of HE. Results of part one of this study are expected to be published by the end of 2016 with part two expected to commence in the first half of 2017. For additional information, please see www.ocerainc.com.

Forward-Looking Statements

This press release contains “forward-looking” statements, including, without limitation, all statements related to the clinical development of OCR-002, including but not limited to the potential benefits of OCR-002 to help patients with acute liver failure or hepatic encephalopathy, the timing of clinical and enrollment milestones, and the timing of study data. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “expected,” “hope,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Ocera’s current expectations. Forward-looking statements involve risks and uncertainties and Ocera’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including those risks and uncertainties discussed under the heading “Risk Factors” in Ocera’s Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent filings with the SEC. All information in this press release is as of the date of the release, and Ocera undertakes no duty to update this information unless required by law.

The content of this announcement is the sole responsibility of the authors and does not necessarily represent the official views or imply endorsement of the NIH.

OCRX-G

Susan Sharpe
Ocera Therapeutics, Inc.
contact@ocerainc.com
919-328-1109

Wednesday, September 21st, 2016 Uncategorized Comments Off on $OCRX Enrollment Done, #Phase2a #NIH Sponsored, #OCR002 Study In #AcuteLiverFailure

$CZR & Sponsors to Increase Contributions to #CEOC’s Restructuring

LAS VEGAS, Sept. 21, 2016  — Caesars Entertainment Corporation (NASDAQ: CZR) (“Caesars Entertainment”) today announced that it, along with affiliates of Apollo Global Management, LLC and TPG Capital, L.P. (together, the “Sponsors”), have proposed an enhancement to their contributions to Caesars Entertainment Operating Company, Inc.’s current restructuring plan. The proposed increase follows discussions with major creditor constituencies of CEOC and its Chapter 11 debtor subsidiaries (collectively, the “Debtors”) in an effort to reach a consensual debt restructuring agreement with all creditor groups in CEOC’s restructuring. Caesars Entertainment believes this proposal meets the requirements of the holders of CEOC’s second lien notes and is optimistic that such proposal will be acceptable.

The revised proposal contemplates additional contributions from Caesars Entertainment and the Sponsors that will result in approximately $1.6 billion of additional value being distributed to the second lien noteholders. These additional contributions, which will enhance the recovery to the second lien noteholders and unsecured creditors, have been proposed by Caesars Entertainment and the Sponsors who are engaged in negotiations with the first lien bondholders and bank lenders on these points. This additional value consists of:

  • An estimated $954 million of Caesars Entertainment equity contributed by the Sponsors and an estimated $92 million of Caesars Entertainment equity contributed by Caesars Entertainment on behalf of non-sponsor only shareholders. The Sponsors’ contribution represents more than a 10 to 1 disproportionate incremental contribution as compared to non-sponsor only shareholders. Taken together, this would result in the depletion of all of the sponsor-held equity in Caesars Entertainment. Additionally, assuming the previously announced merger of Caesars Entertainment and Caesars Acquisition Company (“Caesars Acquisition”) (NASDAQ: CACQ) is completed, the Sponsors’ only continuing ownership in Caesars Entertainment would be as a result of their ownership in Caesars Acquisition and CEOC creditors would control more than 62% of the equity of the combined entity.
  • A significant cash contribution in excess of $100 million by individual directors and officers through funding by D&O insurance; and
  • A small reduction in recovery for the first lien banks and bondholders valued in the hundreds of millions of dollars. Caesars Entertainment has asked holders of CEOC’s first lien notes to forgo the excess cash sweep and for the holders of CEOC’s prepetition credit agreement claims to forgo 2.7% of the reorganized company’s equity, both of which are provided for in the Debtors’ current Chapter 11 plan.

The revised proposal expires on Friday, September 23, 2016 at 11:59 p.m. (New York time). In the event the proposal is not accepted by the deadline, CEOC has indicated that Caesars Entertainment and the Sponsors’ support for the plan is superceded and unnecessary.

About Caesars Entertainment Corporation
Caesars Entertainment Corporation (CEC) is the world’s most diversified casino-entertainment provider and the most geographically diverse U.S. casino-entertainment company. CEC is mainly comprised of the following three entities: the majority owned operating subsidiary Caesars Entertainment Operating Company, wholly owned Caesars Entertainment Resort Properties and Caesars Growth Properties, in which we hold a variable economic interest. Since its beginning in Reno, Nevada, 75 years ago, CEC has grown through development of new resorts, expansions and acquisitions and its portfolio of subsidiaries now operate 47 casinos in 13 U.S. states and five countries. The Company’s resorts operate primarily under the Caesars®, Harrah’s® and Horseshoe® brand names. CEC’s portfolio also includes the London Clubs International family of casinos. CEC is focused on building loyalty and value with its guests through a unique combination of great service, excellent products, unsurpassed distribution, operational excellence and technology leadership. The Company is committed to environmental sustainability and energy conservation and recognizes the importance of being a responsible steward of the environment. For more information, please visit www.caesars.com.

Forward Looking Statement
This release includes “forward-looking statements” intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. You can identify these statements by the fact that they do not relate strictly to historical or current facts. These statements contain words such as, “will”, “estimate”, “likely”, and “forecast” or the negative or other variations thereof or comparable terminology. In particular, they include statements relating to, among other things, future actions that may be taken by CEC and the sufficiency of CEC’s cash balances for the remainder of 2016.  These forward-looking statements are based on current expectations and projections about future events.

You are cautioned that forward-looking statements are not guarantees of future performance or results and involve risks and uncertainties that cannot be predicted or quantified and, consequently, the actual performance of CEC may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the following factors, as well as other factors described from time to time in our reports filed with the Securities and Exchange: CEC’s ability (or inability) to secure additional liquidity to meet its ongoing obligations and its commitments to support the CEOC restructuring as necessary, CEC’s financial obligations exceeding or becoming due earlier than what is currently forecast and risk associated with the CEOC restructuring and related litigation, including if the Debtors pursue a plan without CEC’s support.

Wednesday, September 21st, 2016 Uncategorized Comments Off on $CZR & Sponsors to Increase Contributions to #CEOC’s Restructuring

$CASC to Present at the #LadenburgThalmann 2016 #Healthcare #Conference

SEATTLE, Sept. 20, 2016  — Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today announced that Julie Eastland, Chief Financial Officer, will present a corporate overview at the Ladenburg Thalmann 2016 Healthcare Conference. The presentation will take place at 8:30am EDT on Tuesday, September 27, 2016 in New York City.

A live and archived webcast of the presentation will be accessible on the “Events & Presentations” page of the “News & Events” section of Cascadian Therapeutics’ website at www.cascadianrx.com.

About Cascadian Therapeutics
Cascadian Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative product candidates for the treatment of cancer. Our lead product candidate, tucatinib, also known as ONT-380, is an orally active and selective small molecule HER2 inhibitor, which has been studied in approximately 200 patients to date. Preliminary results from two ongoing Phase 1b studies of tucatinib in combination showed promising systemic activity, a favorable safety profile and encouraging activity against brain metastases. Cascadian Therapeutics is also conducting a randomized, double-blind, placebo-controlled Phase 2 study called HER2CLIMB. The study is evaluating tucatinib versus placebo in combination with capecitabine and trastuzumab in late stage HER2+ breast cancer patients, with and without brain metastases, who have previously been treated with a taxane, trastuzumab, pertuzumab and T-DM1. This study is expected to enroll 180 patients across approximately 100 clinical sites in the U.S., Canada, and Western Europe. The Company is also developing a cell cycle inhibitor, Chk1, and plans to move the program forward through IND-enabling studies in 2017. For more information, visit www.cascadianrx.com.

 

Investor Contact:
Julie Rathbun
Rathbun Communications
206-769-9219
ir@cascadianrx.com

Tricia Truehart
The Trout Group
646-378-2953
ttruehart@troutgroup.com

Media Contact:
Amy Bonanno
BMC Communications
646-513-3117
abonanno@bmccommunications.com
Tuesday, September 20th, 2016 Uncategorized Comments Off on $CASC to Present at the #LadenburgThalmann 2016 #Healthcare #Conference

$PLUG #CEO #AndyMarsh Featured Speaker at #WuhanInnovationSummit

LATHAM, N.Y., Sept. 20, 2016  — Plug Power Inc. (NASDAQ:PLUG), a leader in providing energy solutions that change the way the world moves, announces that CEO Andy Marsh will take center stage today as a featured speaker at the Wuhan HOME Innovation Summit. The summit is held in Wuhan, China, the capital city of Hebei province and home to China’s 2nd largest auto maker Dongfeng Motor Corporation.

Mr. Marsh’s talk will be given during the conference session “Hydrogen Powered Vehicles: Hydrogen Energy Changes Life and Future.” During this presentation, titled “Clean, Commercial Energy Solutions for Mobility,” Mr. Marsh will highlight how Plug Power’s GenKey hydrogen and fuel cell solutions are currently powering more than 13,000 electric vehicles today in the industrial mobility market, and have powered industrial vehicles for more than 120 million hours in real-world applications.

Plug Power’s success in today’s hydrogen and fuel cell market sets the stage for the industry’s direction over the next quarter century, not just in North America, but globally, as the world becomes more innovative, efficient and environmentally-conscious. Plug Power’s advanced and proven technology is primed to make inroads into other electric vehicle applications, like buses, taxis, fleet cars and utility vehicles.  These captive and tethered vehicle fleets have the ability to make use of centralized hydrogen solutions similar to those delivered by Plug Power to its current industrial vehicle customers.

“Plug Power has proven the only viable, commercial application for widespread adoption of hydrogen engines today, a model that can translate into adoption in the Chinese market to meet internationally-set sustainable development goals,” said Andy Marsh, CEO for Plug Power.  “Plug Power’s hydrogen fuel cell solutions offer an environmentally-friendly option to power motive applications, producing only heat and water as byproducts of energy creation.”

During the Summit, Mr. Marsh will meet with Mr. Wan, Mayor of Wuhan, in a closed-door session to discuss Plug Power’s existing and planned collaborations with several local business partners. Mr. Wan is expected to give Mr. Marsh an overview of the Wuhan Hydrogen Working Group and the 500 million Chinese Yuan Wuhan Hydrogen Fund, set up to support local hydrogen initiatives, including fuel cell vehicles, hydrogen generation and storage, and hydrogen infrastructures.

The Summit is sponsored by the Chinese Association of Science & Technology (CAST) and Hubei provincial government, and organized by Global Talents and Entrepreneurship Center (Wuhan) and the municipal government of Wuhan. Mr. Shenglian Guo, Lieutenant Governor of Hubei Province, will open the summit, followed by a keynote speech from Mr. Yong Shang, CAST Vice President.

About Plug Power Inc.
The architects of modern hydrogen and fuel cell technology, Plug Power has revolutionized the industry with its simple GenKey solution, elements of which are designed to increase productivity, lower operating costs and reduce carbon footprints in a reliable, cost-effective way. Plug Power’s GenKey solution couples together all the necessary elements to power, fuel and service a customer. Plug Power is the partner that customers trust to take their businesses into the future. For more information about Plug Power, visit www.plugpower.com.

Safe Harbor Statement
This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties about Plug Power Inc. (“PLUG”), including but not limited to statements about PLUG’s 2016 objectives, including goals relating to revenue, sales, booking, gross and GenFuel installations, and the GenFund Power-Purchase Agreement program. You are cautioned that such statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by which, such performance or results will have been achieved. Such statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in these statements. In particular, the risks and uncertainties include, among other things, the risk that we continue to incur losses and might never achieve or maintain profitability; the risk that we will need to raise additional capital to fund our operations and such capital may not be available to us; the risk that our lack of extensive experience in manufacturing and marketing products may impact our ability to manufacture and market products on a profitable and large-scale commercial basis; the risk that unit orders will not ship, be installed and/or converted to revenue, in whole or in part; the risk that pending orders may not convert to purchase orders, in whole or in part; the risk that a loss of one or more of our major customers could result in a material adverse effect on our financial condition; the risk that a sale of a significant number of shares of stock could depress the market price of our common stock; the risk that negative publicity related to our business or stock could result in a negative impact on our stock value and profitability; the risk of potential losses related to any product liability claims or contract disputes; the risk of loss related to an inability to maintain an effective system of internal controls or key personnel; the risks related to use of flammable fuels in our products; the cost and timing of developing, marketing and selling our products and our ability to raise the necessary capital to fund such costs; the ability to achieve the forecasted gross margin on the sale of our products; the risk that our actual net cash used for operating expenses may exceed the projected net cash for operating expenses; the cost and availability of fuel and fueling infrastructures for our products; market acceptance of our products, including GenDrive, GenSure and GenKey systems; the volatility of our stock price; our ability to establish and maintain relationships with third parties with respect to product development, manufacturing, distribution and servicing and the supply of key product components; the cost and availability of components and parts for our products; our ability to develop commercially viable products; our ability to reduce product and manufacturing costs; our ability to successfully expand our product lines; our ability to successfully expand internationally; our ability to improve system reliability for our GenDrive, GenSure and GenKey systems; competitive factors, such as price competition and competition from other traditional and alternative energy companies; our ability to protect our intellectual property; the cost of complying with current and future federal, state and international governmental regulations; risks associated with potential future acquisitions; and other risks and uncertainties referenced in our public filings with the Securities and Exchange Commission. For additional disclosure regarding these and other risks faced by PLUG, see disclosures contained in PLUG’s public filings with the Securities and Exchange Commission (the “SEC”) including, the “Risk Factors” section of PLUG’s Annual Report on Form 10-K for the year ended December 31, 2015. You should consider these factors in evaluating the forward-looking statements included in this presentation and not place undue reliance on such statements. The forward-looking statements are made as of the date hereof, and PLUG undertakes no obligation to update such statements as a result of new information.

Media and Investor Relations Contact: 
Teal Vivacqua
Plug Power Inc.
Phone: 518.738.0269
Tuesday, September 20th, 2016 Uncategorized Comments Off on $PLUG #CEO #AndyMarsh Featured Speaker at #WuhanInnovationSummit

$DTSI to be #Acquired by $TSRA

Combined company creates a global innovator in premium audio and imaging solutions

Projected 2016 pro forma revenue of approximately $450 million

Immediately accretive to EPS and cash flow

Transaction value represents 28% premium to DTS’s 30-day VWAP as of September 19, 2016

Combined company to be renamed at the closing of the transaction

Tessera Technologies, Inc. (NASDAQ: TSRA) (“Tessera” or the “company”), a leader in developing innovative imaging and semiconductor packaging and bonding technologies and DTS, Inc., (NASDAQ: DTSI) (“DTS”) a premier audio solutions provider for mobile, home, and automotive markets, today announced that they have entered into a definitive agreement under which Tessera will acquire DTS for $42.50 per share, representing a 28% premium to DTS’s 30-day volume weighted average price as of September 19, 2016. The all-cash transaction is valued at approximately $850 million.

The transaction will combine market leading audio and imaging innovators with complementary products, technologies, customer channels and intellectual property assets to enable the creation of an expanded, integrated platform to invent the future of smart sight and sound. Upon completion of the acquisition, the combined company will be one of the world’s leading product and technology licensing companies, with over 450 engineers focused on developing next-generation imaging, audio and semiconductor packaging technologies. In addition, the acquisition adds significant scale and diversifies revenue across end markets and customers. The combined company is forecasted to achieve pro forma 2016 revenue of approximately $450 million, nearly half of which will come from product licensing.

The transaction will be immediately accretive to Tessera’s earnings per share and free cash flow. The combined company is expected to realize $15 million in annualized cost synergies within the first 12-18 months following the closing of the transaction and anticipates revenue synergies from the expansion of addressable markets and leveraging of complementary customer channels and technologies. Tessera intends to fund the acquisition with a combination of available cash on hand and approximately $600 million of committed debt financing from RBC Capital Markets. The combined company will maintain a strong balance sheet with pro forma cash and investments of approximately $100 million. The combined company is expected to generate significant free cash flow that will provide flexibility to retire debt, fund quarterly dividends, explore M&A opportunities, and continue investments into its business units. In order to better reflect the combined company’s capabilities and technologies, a new corporate name and stock symbol will be adopted in connection with the closing of the transaction.

“Our acquisition of DTS’s talented team and industry-leading products will represent a transformational step in the execution of Tessera’s strategic vision, with exciting new product development and marketing opportunities. We expect this acquisition to be immediately accretive to Tessera’s earnings and accelerate growth. Our complementary technology portfolios are ideally suited to deliver the next generation of audio and imaging solutions to mobile, consumer electronics, and automotive markets while expanding our ability to address incredible new opportunities in IoT and AR/VR,” said Tom Lacey, Tessera CEO. “I am particularly excited that Jon Kirchner and the exceptional DTS team will join the Tessera family as we continue to grow and expand the DTS brand.”

“This is an exciting transaction that provides substantial and immediate value to our shareholders. We look forward to working closely with Tom and the Tessera team to achieve a smooth integration and pursuing the attractive opportunities ahead,” said Jon Kirchner, chairman and CEO of DTS. “We believe that as part of Tessera we will be in a unique position to deliver the world’s leading audio and imaging solutions to all of our key markets and drive meaningful value for our combined customers, partners and employees.”

Combined company profile:

  • DTS’s innovative audio solutions include, among others, DTS-HD® and DTS:X™ audio codecs, DTS Headphone:X® and DTS Sound™ pre-and post processing solutions , DTS Play-Fi® wireless audio, and HD Radio™
  • Tessera’s world-class FotoNation®, Invensas and intellectual property businesses, which have developed and licensed technologies that ship globally in billions of devices
  • A major technology presence in the consumer electronics, mobile, automotive and semiconductor markets
  • A superior R&D team made up of over 450 imaging, audio and semiconductor packaging engineers
  • Significant sales channel leverage with immediate mobile and automotive customer cross-selling opportunities
  • At the closing of the transaction, Lacey will continue to serve as CEO and Kirchner is expected to join as President of the combined company.

Transaction Structure and Terms

Under the terms of the definitive agreement, Tessera will acquire DTS in an all cash transaction valued at approximately $850 million. DTS equity awards will be assumed or exchanged for cash upon closing of the transaction, in accordance with the terms of the definitive agreement. DTS stockholders will become entitled to receive $42.50 per share in cash at the time of the closing. Additionally, all of DTS’s outstanding debt will be retired at the closing of the transaction.

The transaction has been unanimously approved by both companies’ respective Boards of Directors. Closing of the transaction is expected by late fourth quarter of 2016 or early first quarter of 2017, and is subject to regulatory approval as well as the approval of DTS’s stockholders and other customary closing conditions.

Advisors

GCA acted as financial advisor and Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor to Tessera; Centerview acted as financial advisor and DLA Piper LLP acted as legal advisor to DTS.

Conference Call

Tessera’s management will discuss the proposed transaction with analysts and investors on a conference call today at 8:30 a.m. Eastern (5:30 a.m. Pacific).

To access the conference call:

Participant Toll-Free Dial-In Number: 888.723.9308
Participant International Dial-In Number: +1.615.489.8916
Conference ID: 83665062

All participants should dial in approximately 10 minutes prior to the start of the conference call. A live webcast will be available on the company’s website at www.tessera.com. Here is the link for today’s webcast: Tessera webcast.

Upon publication and filing of the conference call transcript, a replay of the call will be available via telephone for two days by dialing (855) 859-2056 or (404) 537-3406, and using the conference ID referenced above. At the same time a replay of the webcast will be available for 90 days on the Investors section of the company’s website at www.tessera.com.

About Tessera Technologies, Inc.

Tessera Technologies, Inc., including its Invensas and FotoNation subsidiaries, licenses technologies and intellectual property to customers for use in areas such as mobile computing and communications, memory and data storage, and 3D-IC technologies, among others. Our technologies include semiconductor packaging and interconnect solutions, and imaging products and solutions for mobile and other vision systems. For more information call +1.408.321.6000 or visit www.tessera.com

Tessera, the Tessera logo, Invensas, the Invensas logo, FotoNation, the FotoNation logo are trademarks or registered trademarks of affiliated companies of Tessera Technologies, Inc. in the United States and other countries. All other company, brand and product names may be trademarks or registered trademarks of their respective companies.

About DTS, Inc.

Since 1993, DTS, Inc. (Nasdaq: DTSI) has been dedicated to making the world sound better. Through its pioneering audio solutions for mobile devices, home theater systems, cinema, automotive and beyond, DTS provides incredibly high-quality, immersive and engaging audio experiences to listeners everywhere. DTS technology is integrated in more than two billion devices globally, and the world’s leading video and music streaming services are increasingly choosing DTS to deliver premium sound to their listeners’ network-connected devices. For more information, please visit www.dts.com.

Forward-Looking Statements

This press release or any statements incorporated by reference herein, including, for example, the expected date of closing of the transaction and the potential benefits of the transaction, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based on Tessera’s current expectations, estimates and projections about its business and industry, management’s beliefs and certain assumptions made by Tessera and DTS, all of which are subject to change. In addition, forward-looking statements also consist of statements involving trend analyses and statements including such words as “will,” “may,” “anticipate,” “believe,” “could,” “would,” “might,” “potentially,” “estimate,” “continue,” “plan,” “expect,” “intend,” and similar expressions or the negative of these terms or other comparable terminology that convey uncertainty of future events or outcomes are intended to identify forward-looking statements. All forward-looking statements address matters that involve risks and uncertainties, many of which are beyond our control, and are not guarantees of future results. Accordingly, there are or will be important factors that could cause actual results to differ materially from those indicated in such statements and, therefore, you should not place undue reliance on any such statements and caution must be exercised in relying on forward-looking statements. We believe that these factors include, but are not limited to, the following: 1) uncertainty as to whether Tessera will be able to enter into or consummate the proposed transaction; 2) failure to realize the anticipated benefits of the proposed transaction, including as a result of delay in completing the transaction or integrating the businesses of Tessera and DTS; 3) uncertainty as to the long-term value of DTS; 4) unpredictability and severity of natural disasters; 5) the resolution of intellectual property claims; 6) pricing trends, including Tessera’s and DTS’s ability to achieve economies of scale; 7) Tessera’s ability to implement its business strategy; 8) retention of key executives; 9) intense competition from a number of sources; 10) future regulations and policies affecting Tessera’s and DTS’s businesses; 11) general economic and market conditions; 12) the integration of businesses Tessera may acquire or new business ventures Tessera may start; 13) the evolving legal, regulatory and tax regimes under which we operate; 14) the expected amount and timing of cost savings and operating synergies; 15) failure to receive the approval of the stockholders of DTS; 16) recent and proposed changes to U.S. patent laws, rules, and regulations; 17) continued involvement in material legal proceedings; 18) issues with Tessera’s ability to integrate acquired technologies and 19) other developments in the markets Tessera and DTS operate, as well as management’s response to any of the aforementioned factors.

The foregoing review of important factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included herein and elsewhere, including the Risk Factors included in our most recent reports on Form 10-K and Form 10-Q and other documents of Tessera and DTS on file with the Securities and Exchange Commission (the “SEC”). Tessera’s and DTS’s respective SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statements made or incorporated by reference in this press release are qualified in their entirety by these cautionary statements, and there can be no assurance that the actual results or developments anticipated by Tessera or DTS will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Tessera or DTS or their respective businesses or operations. Except to the extent required by applicable law, Tessera and DTS undertake no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Additional Information About the Transaction and Where to Find It

In connection with the proposed transaction, DTS will file a proxy statement with the SEC. Additionally, DTS will file other relevant materials with the SEC in connection with the proposed acquisition of DTS by Tessera pursuant to the terms of an Agreement and Plan of Merger by and among Tessera, DTS and the other parties thereto. The materials to be filed by DTS with the SEC may be obtained free of charge at the SEC’s web site at www.sec.gov. Investors and security holders of DTS are urged to read DTS’s proxy statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction because they will contain important information about the transaction and the parties to the transaction.

DTS, Tessera and their respective directors, executive officers and other members of their management and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of DTS stockholders in connection with the proposed transaction. Investors and security holders may obtain more detailed information regarding the names, affiliations and interests of certain of DTS’s executive officers and directors in the solicitation by reading DTS’s proxy statement for its 2016 annual meeting of stockholders and the proxy statement and other relevant materials filed with the SEC in connection with the transaction when they become available. Investors and security holders may obtain more detailed information regarding the names, affiliations and interests of certain of Tessera’s executive officers and directors in the solicitation by reading Tessera’s proxy statement for its 2016 annual meeting of stockholders. Information concerning the interests of DTS’s participants in the solicitation, which may, in some cases, be different than those of DTS’s stockholders generally, will be set forth in the proxy statement relating to the transaction when it becomes available. Additional information regarding DTS directors and executive officers is also included in DTS’s proxy statement for its 2016 annual meeting of stockholders.

TSRA-G

Tessera General Media Contact:
Adolph Hunter, +1 408-321-6710
Director, Corporate Communications
ahunter@tessera.com
or
Tessera Investor Contact:
The Piacente Group | Investor Relations
Matt Steinberg, +1-212-481-2050
Tessera@tpg-ir.com
or
DTS Investor Contact:
DTS, Inc.
Geri Weinfeld, +1-818-436-1231
Senior Director, Investor Relations
geri.weinfeld@dts.com

Tuesday, September 20th, 2016 Uncategorized Comments Off on $DTSI to be #Acquired by $TSRA

$AEGR Appoints #RemiMenes as #CCO

CAMBRIDGE, Mass., Sept. 20, 2016  — Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR), a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, today announced the appointment of Remi A. Menes as chief commercial officer, effective immediately.

Mary Szela, Chief Executive Officer of Aegerion said, “Remi brings extensive pre-launch and launch expertise and a proven ability to develop and lead commercial efforts globally. Commercialization of rare disease therapies takes a targeted approach and requires strong patient focus. Remi’s broad experience implementing holistic, patient-centered programs that demonstrate the value proposition of therapies make him ideally suited to lead our commercial operations globally, including our sales, marketing and market access efforts. We look forward to his contributions as we continue to drive and evolve our global commercial operations, and particularly as we prepare to submit a marketing authorization application for MYALEPT® in the EU by year-end and, upon anticipated marketing approval, launch JUXTAPID® in Japan.”

Remi Menes most recently served as the General Manager of AbbVie Finland, where he was responsible for the Affiliate’s operations and P&L and its flagship product Humira. He also served as Board Member of Pharma Industry Finland. Before joining AbbVie Finland in 2013, Mr. Menes served as Area Commercial Director, Virology & Neonatal Care, Western Europe & Canada at AbbVie Europe. From 2008-2010, he was the Commercial Director, Specialty Products Division and a Member of the Affiliate Leadership Team at Abbott Canada. Between 1990 and 2008, Mr. Menes held a series of roles of increasing responsibility at Merck Frosst Canada Ltd., including Director, Sales & Marketing, in which he led the Canadian launch of SINGULAIR® for Allergic Rhinitis, and Product Manager for SINGULAIR and PROPECIA®/PROSCAR®. He holds an Executive M.B.A. and a B.Sc. in Organic Chemistry with a minor in Business Studies from Concordia University.

About Aegerion Pharmaceuticals, Inc.
Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases.  For more information about the company, please visit www.aegerion.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding: the anticipated submission of a marketing authorization application for MYALEPT in the EU and the anticipated approval and launch of JUXTAPID in Japan. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among others: the risk that regulatory authorities in regions or countries where either of our products is not yet approved may refuse to approve such products, such approvals are not made on a timely basis or such approvals impose significant restrictions or require additional development; and the other risks inherent in the commercialization, drug development and regulatory approval process. For additional disclosure regarding these and other risks we face, see the disclosure contained in the “Risk Factors” section of Aegerion’s Quarterly Report on Form 10-Q filed on August 9, 2016, and our other public filings with the Securities and Exchange Commission, available on the SEC’s website at http://www.sec.gov. We undertake 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.

Investors and others should note that we communicate with our investors and the public using our company website (www.aegerion.com) and our investor relations website (http://ir.aegerion.com), including but not limited to company disclosures; investor presentations and FAQs; Securities and Exchange Commission filings; press releases; public conference calls and webcasts. The information that we post on these websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

CONTACT:
Aegerion Pharmaceuticals, Inc.                                                        
Amanda Murphy, Associate Director, Investor & Public Relations                                 
857-242-5024  
Amanda.murphy@aegerion.com
Tuesday, September 20th, 2016 Uncategorized Comments Off on $AEGR Appoints #RemiMenes as #CCO

$TBRA to be #Acquired by $AGN, Global GI R&D Pipeline, #NASH Mainlined

– Acquisition Adds Global Rights to Highly Differentiated Compounds to Treat Multi-Factorial Elements of NASH – – Cenicriviroc (CVC) First-in-Class Oral CCR2/5 Inhibitor Impacting Inflammation, Fibrosis – – Evogliptin, Oral DPP-4 Inhibitor, in Phase 1 Study as a Potential Treatment for NASH in Combination with CVC Impacting Metabolic Element of Disease – – NASH Expected to Become Leading Cause of Liver Transplants by 2020i – – Allergan to Host Conference Call Wednesday, September 21, 2016 at 8:30 a.m. ET to Discuss Recent R&D Acquisitions –

DUBLIN and SAN FRANCISCO, Sept. 20, 2016  Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Tobira Therapeutics, Inc. (NASDAQ: TBRA), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases, today announced that they have entered into a definitive agreement under which Allergan will acquire Tobira for an upfront payment of $28.35 per share, in cash, and up to $49.84 per share in Contingent Value Rights (CVRs) that may be payable based on the successful completion of certain development, regulatory and commercial milestones, for a total potential consideration of up to $1.695 billion. The Boards of Directors of both companies have unanimously approved the transaction.

NASH is a severe type of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes.ii NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage.ii The inflammation can lead to fibrosis (scarring) of the liver and eventually progress to cirrhosis, portal hypertension, liver cancer and eventual liver failure.ii

The acquisition adds Cenicriviroc (CVC) and Evogliptin, two differentiated, complementary development programs for the treatment of the multi-factorial elements of NASH, including inflammation, metabolic syndromes and fibrosis, to Allergan’s global Gastroenterology R&D pipeline.

“The acquisition of Tobira is a strategic R&D investment within a white space area of our global Gastroenterology franchise and an opportunity to advance the development of novel treatments for NASH,” said Brent Saunders, CEO and President of Allergan. “With the increasing rates of diabetes, obesity and other metabolic conditions in the U.S. and in developed nations globally, NASH is set to become one of the next epidemic-level chronic diseases we face as a society. It is important that we invest in new treatments today so that healthcare systems, providers and patients have treatment options to face this challenge in the coming years.”

“With this acquisition, Allergan will now have one of the strongest portfolios of development stage programs for the treatment of NASH, with Cenicriviroc as the cornerstone. We will continue to look for differentiated development-stage assets that can bolster this position and enhance our commitment to innovation in this disease,” added Saunders.

Cenicriviroc (CVC) is a first-in-class, once-daily, oral Phase 3 ready potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in the inflammatory and fibrogenic pathways in NASH that cause liver damage and often lead to cirrhosis, liver cancer or liver failure. In the Phase 2b CENTAUR study, CVC demonstrated a clinically and statistically significant improvement in fibrosis of at least one stage without worsening of NASH, one of two key secondary endpoints, after one year of treatment.

The acquisition also adds Evogliptin, an oral DPP-4 (Dipeptidyl peptidase-4) inhibitor for the potential treatment of NASH. Evogliptin is being studied in a Phase 1 trial assessing the safety, tolerability and steady-state pharmacokinetic parameters of the compound when administered with and without CVC. In NASH, increased DPP-4 serum levels and hepatic DPP-4 expression is correlated with disease severity.

“Both the CVC and Evogliptin programs provide highly differentiated compounds that can make a significant impact in the treatment of NASH, where today there are no approved therapies available for patients,” said David Nicholson, Chief Research & Development Officer, Allergan.  “Importantly, NASH treatment may well require a multi-therapeutic approach to address the multiple factors of the disease. CVC has been shown in clinical trials to provide significant improvement in liver fibrosis, the hallmark of NASH. Liver fibrosis is associated with key long-term outcomes, including overall mortality, liver transplantation and liver-related events.  Evogliptin, in preclinical models, has been shown to decrease hepatic glucose production, improve hepatic triglyceride content and steatosis, and reduce histologic markers of inflammation of the liver. Together, these programs provide a highly complementary potential therapeutic approach to address the inflammatory, metabolic and fibrotic elements of NASH that the medical community will need to treat this condition.”

“I am extremely excited to see Tobira and Allergan come together,” said Laurent Fischer, M.D., Chief Executive Officer, Tobira Therapeutics. “The combination of our team’s innovation in the NASH space and the infrastructure, development expertise and world-class ability of Allergan to market medicines will enable us to more rapidly develop and commercialize needed medications for patients suffering from NASH and other serious fibrotic diseases around the world.”

“We are delighted that cenicriviroc will be rapidly advancing into Phase 3 studies under the stewardship of Allergan, an industry leader with world class capabilities in advancing novel treatment options to patients across the globe, and I look forward to the future success of this partnership,” added Dennis Podlesak, Chairman of the Board of Tobira.

Under the terms of the merger agreement, a subsidiary of Allergan will commence a cash tender offer to purchase all of the outstanding shares of Tobira common stock for $28.35 per share, plus one Contingent Value Right to receive up to $49.84 per share in future payments based on the successful completion of certain development, regulatory and commercial milestones. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Tobira common stock. Holders of approximately 36 percent of the outstanding shares of Tobira common stock have entered into an agreement to tender their shares into the tender offer. The merger agreement contemplates that Allergan will acquire any shares of Tobira that are not tendered into the offer through a second-step merger, which will be completed as soon as practicable following the closing of the tender offer. Pending approvals, Allergan anticipates closing the transaction by the end of 2016.

Covington & Burling LLP is serving as Allergan’s lead legal counsel. Centerview Partners and Citi are serving as financial advisors to Tobira and Skadden, Arps, Slate, Meagher & Flom LLP and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP are serving as Tobira’s legal counsel.

Conference Call
Allergan management will host a conference call to discuss the Tobira Therapeutics acquisition, and other recent R&D acquisitions, Wednesday, September 21, 2016 at 8:30 AM EST. The number to call from within the United States is (877) 251-7980, conference ID 85674735.  From international locations, the conference call can be accessed at (706) 643-1573 using the same conference ID.  The call will also be webcast and can be accessed through the companies’ websites at www.allergan.com. To access the slides go to Allergan’s Investor Relations Web site at http://ir.allergan.com. A replay of the conference call will also be available by calling (855) 859-2056 in the U.S. or (404) 537-3406 outside of the U.S., conference ID 85674735.

About Non-Alcoholic Steatohepatitis (NASH)
NASH is a severe type of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes.ii NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage.ii The inflammation can lead to fibrosis (scarring) of the liver and eventually progress to cirrhosis, portal hypertension, liver cancer, and eventual liver failure.ii

NAFLD and NASH affect approximately 30% and 5%, respectively, of the US population[iii] and NAFLD affects more than 20% of the population worldwide.[iv] NASH is the fastest growing cause of liver cancer and liver transplant in the U.S.[v] The increasing prevalence of NASH is attributed to the growing obesity epidemic and the disease is often diagnosed in patients who have diabetes, high cholesterol or high triglycerides.iii There is currently no approved treatment for NASH.

About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, the Company’s R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs in development.

Our Company’s success is powered by our more than 15,000 global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live healthier lives everyday.

For more information, visit Allergan’s website at www.Allergan.com.

About Tobira Therapeutics

Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases. The company’s lead product candidate, cenicriviroc (CVC), is a first-in-class immunomodulator and dual inhibitor of CCR2 and CCR5 in late-stage development for the treatment of NASH, a serious liver disease that can progress to cirrhosis, liver cancer and liver failure. CVC is also being investigated to address primary sclerosing cholangitis (PSC), a disease which causes inflammation and scarring of the bile ducts, eventually leading to serious liver damage. Tobira’s pipeline also includes evogliptin, a selective DPP-4 inhibitor, which it plans to develop for NASH in combination with CVC. Learn more about Tobira at www.tobiratx.com.

Tobira® is a registered trademark owned by Tobira Therapeutics, Inc.

Allergan Cautionary Statement Regarding Forward-Looking Statements

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (such periodic public filings having been filed under the “Actavis plc” name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

Tobira Cautionary Statement Regarding Forward-Looking Statements

All of the statements in this press release, other than historical facts, are forward-looking statements, including, without limitation, the statements made concerning Allergan’s pending acquisition of Tobira. As a general matter, forward-looking statements are those focused upon anticipated events or trends, expectations, and beliefs relating to matters that are not historical in nature. Such forward-looking statements are subject to uncertainties and factors relating to Tobira’s operations and business environment, all of which are difficult to predict and many of which are beyond the control of Tobira. Among others, the following factors could cause actual results to differ materially from those set forth in the forward-looking statements: (i) uncertainties as to how many Tobira stockholders will tender their shares of Tobira common stock in the tender offer; (ii) the possibility that competing offers will be made; (iii) the possibility that various closing conditions for the transaction may not be satisfied or waived; (iv) the risk that the merger agreement with Allergan may be terminated in circumstances requiring Tobira to pay Allergan a termination fee; (v) risks related to obtaining the requisite consents to the transaction, including, without limitation, the timing (including possible delays) and receipt of regulatory approvals from various governmental entities (including any conditions, limitations or restrictions placed on these approvals and the risk that one or more governmental entities may deny approval); (vi) the possibility that the transaction may not be timely completed, if at all; and (vii) that, prior to the completion of the transaction, if at all, Tobira’s business may experience significant disruptions due to transaction-related uncertainty. Other factors that could cause actual results to differ materially include those set forth in Tobira’s SEC reports, including, without limitation, the risks described in the Tobira’s Annual Report on Form 10-K for its fiscal year ended December 31, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2016. Tobira assumes no obligation and does not intend to update these forward-looking statements, except as expressly required by law.

Notice to Investors

The tender offer for the outstanding shares of common stock of Tobira referred to in this press release has not yet commenced. The description contained in this press release is neither an offer to purchase nor a solicitation of an offer to sell any securities. The solicitation and the offer to buy shares of Tobira common stock will be made pursuant to an offer to purchase and related materials that Allergan intends to file with the Securities and Exchange Commission. At the time the offer is commenced, Allergan will file a tender offer statement on Schedule TO with the Securities and Exchange Commission, and thereafter Tobira will file a solicitation/ recommendation statement on Schedule 14D-9 with respect to the offer. The tender offer statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the solicitation/recommendation statement will contain important information that should be read carefully and considered before any decision is made with respect to the tender offer. These materials will be sent free of charge to all stockholders of Tobira when available. Additionally, Tobira and Allergan will file other relevant materials in connection with the proposed acquisition of Tobira by Allergan pursuant to the terms of the merger agreement. All of these materials (and all other materials filed by Tobira with the Securities and Exchange Commission) will be available at no charge from the Securities and Exchange Commission through its website at www.sec.gov. Free copies of the offer to purchase, the related letter of transmittal and certain other offering documents will be made available by Allergan and when available may be obtained by directing a request to Allergan’s Investor Relations Department at  (862) 261-7488. Investors and security holders may also obtain free copies of the documents filed with the Securities and Exchange Commission by Tobira by contacting Tobira Investor Relations at (650) 351-5013.

INVESTORS AND STOCKHOLDERS OF TOBIRA ARE ADVISED TO READ THE SCHEDULE TO AND THE SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION WHEN THEY BECOME AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER OFFER OR MERGER, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO.

iFrom NAFLD to NASH to cirrhosis-new insights into disease mechanisms. Wree, A. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):627-36
ii The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Fatty Liver Disease (Nonalcoholic Steatohepatitis). https://www.niddk.nih.gov/health-information/health-topics/liver-disease/nonalcoholic-steatohepatitis/Pages/facts.aspx
iiiNonalcoholic fatty liver disease: A systematic review. ME, Rinella. Journal of the American Medical Association, 2015, Vol. 313, pp. 2263-2273.
ivSattar N, et al. Non-alcoholic fatty liver disease. Available from: http://www.bmj.com/content/349/bmj.g4596.
vAnderson, C.D. Curr Surg Rep (2015) 3: 24. doi:10.1007/s40137-015-0101-6.

 

CONTACTS:        ALLERGAN:
Investors:
Lisa DeFrancesco
(862) 261-7152

                           Media:
                           Mark Marmur
(862) 261-7558

TOBIRA:
Investors:
Ian Clements, Ph.D.
(650) 351-5013

Media:
                           Brewlife
                           Kelly Boothe, Ph.D.
(415) 946-1076

Tuesday, September 20th, 2016 Uncategorized Comments Off on $TBRA to be #Acquired by $AGN, Global GI R&D Pipeline, #NASH Mainlined

$EXPI @eXpRealty Sells Out 2016 San Antonio Conference

Agenda Includes Keynote Addresses by Both Rick Miller and Stefan Swanepoel

BELLINGHAM, WA–(September 20, 2016) – eXp Realty, the Agent-Owned Cloud Brokerage® (eXp World Holdings, Inc.) (OTCQB: EXPI) today announced that both Rick Miller and Stefan Swanepoel will deliver keynote addresses at next month’s sold out conference of Company agents and brokers.

eXp Realty’s third annual eXpCon, scheduled for October 5-7 in San Antonio, Texas, will be attended by approximately 600 eXp agents and brokers, representing more than a 3-fold increase from last year’s gathering and the first time that the Company has sold out one of its major annual events. eXp World Holdings, Inc. also hosts its annual meeting each April, attended by the Company’s shareholders who are predominantly also eXp Realty agents and brokers.

Miller, who has held CEO or President roles in companies ranging from a Fortune 10 and Fortune 30 to a startup and nonprofit, will deliver the conference’s opening keynote address on the evening of October 5th. Miller’s professional experiences, including as President of the $13B Global Services Unit of AT&T, and his unconventional approach to management have been highlighted in Harvard Business Review, Selling Power, USA Today, and MSN Business. He presently is CEO at Being Chief, LLC (www.beingchief.com) where he serves as an advisor to a broad range of Chiefs, across a diverse number of industries. Miller was elected to the Company’s Board as an independent director in July of this year.

Swanepoel, widely regarded as the foremost authority on trends within the real estate industry, will address conference attendees on the morning of October 6th. Swanepoel ‘s T3 Sixty Group, in addition to providing consulting services, also produces many of the real estate industry’s most authoritative publications and reports including the Swanepoel TRENDS Report, the Swanepoel Power 200, the T3 Tech Guide, the T3 Risk Guide and The Real Estate Confronts series. Swanepoel has authored and/or co-authored more than 30 books and reports analyzing the strategies, shifts and changes impacting the residential real estate brokerage business. His books have been featured on over 18 bestseller lists including the New York Times, Wall Street Journal, USA Today, Huffington Post, CEO Read and Amazon.com. Swanepoel has given over 1,000 talks to more than one million people, serves as Editor-in-Chief of the SP200 (ranking of the most powerful people in real estate) and is also the Host of the T3 Summit (the leading real estate leadership summit). He has served as CEO of nine companies and two non-profit organizations.

The record attendance for eXpCon in part reflects what has been a banner year for the Agent-Owned Cloud Brokerage®. eXp Realty has more than 1,700 real estate professionals in more than 40 different US states, the District of Columbia, and Alberta, Canada. eXp Realty began 2016 with 862 real estate agents and brokers. In August, the Company reported year over year revenue growth of 137% and an agent count total of 1,400 as of June 30, 2016.

“The attendance at this year’s conference is indicative of the strength of the Company’s value proposition for agents with its emphasis on agent-ownership and agent support, as well as the strength of the relationships that are formed and which develop on a daily basis on our Cloud Campus,” said Founder and CEO, Glenn Sanford. “We’re honored and humbled to have both Rick Miller and Stefan Swanepoel headline this year’s event and believe that we will be able to deliver a conference that rivals that of any real estate brokerage in the industry.”

Sponsors for eXpCon 2016 include First American Title; First Cloud Mortgage; HMS Home Warranty, IMMOVIEWER, Oakley Signs and the RedX.

About eXp World Holdings, Inc.

eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage® as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.

eXp World Holdings, Inc. also owns 89.4% of First Cloud Mortgage, Inc. a Delaware corporation launched in 2015 and now licensed to originate mortgages in Arizona, California, Virginia and New Mexico. First Cloud Mortgage has positioned itself as a Planet Friendly Mortgage Company via the purchase of carbon offsets for homeowners offsetting the first year of the Carbon Footprint of the typical home on each mortgage originated through First Cloud Mortgage, Inc.

As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.

For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit eXpWorldHoldings.com. For eXp Realty please visit: eXpRealty.com and for First Cloud Mortgage, Inc. check out FirstCloudMortgage.com.

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.

Investor Relations Contact Information:
Glenn Sanford
Chairman & CEO
eXp World Holdings, Inc.
glenn@expworldholdings.com
360-389-2426

Trade and Media Contact Information:
Jason Gesing
CEO
eXp Realty
jason@exprealty.com
617-970-8518

Tuesday, September 20th, 2016 Uncategorized Comments Off on $EXPI @eXpRealty Sells Out 2016 San Antonio Conference

$GLBL Initiates Process to Explore #StrategicAlternatives

Company Working Collaboratively With SunEdison
Seeks to Resolve Intercompany Claims Consensually

BETHESDA, Md., Sept. 19, 2016  — TerraForm Power, Inc. (Nasdaq:TERP) (“TerraForm Power” or the “Company”), an owner and operator of clean energy power plants, today announced that, at the recommendation of its Corporate Governance and Conflicts Committee, its Board of Directors has initiated a process to explore and evaluate potential strategic alternatives to maximize stockholder value, including a merger or sale of its entire business.

“Our Board and management team have been working to preserve and protect stockholder value and, after careful review, we have decided that exploring all possible alternatives to maximize that value is in the best interests of all our stockholders,” said Peter Blackmore, Interim Chief Executive Officer. “With a diverse portfolio of assets and record of strong operating performance, TerraForm Power offers a unique opportunity for a broad range of potential acquirers and investors.”

“We are actively exploring the potential sale of all of TerraForm Power’s equity interests, as well as alternative structures,” continued Blackmore. “We are open to considering a transaction involving a new sponsor that would contribute to the stabilization and future growth of the Company’s very attractive platform of generation assets in a way that benefits TerraForm Power stockholders, including through negotiation of new sponsorship arrangements or through assumption of SunEdison’s existing sponsorship agreements. TerraForm Power also is taking appropriate steps to operate as an independent company without a new sponsor, if that should become necessary in the short or long term. Our benchmark for decisions will be the best interests of TerraForm Power stockholders.”

TerraForm Power has entered into confidentiality arrangements with SunEdison, Inc. and representatives for certain of its stakeholders to allow TerraForm Power to share confidential information about strategic alternatives and other matters. Certain strategic alternatives for TerraForm Power may require stockholder approval. Since SunEdison is operating under Chapter 11 bankruptcy protection, many decisions made by SunEdison – such as how to vote its shares in TerraForm Power to approve a merger or sale of substantially all of TerraForm Power’s assets – may require the approval of the U.S. Bankruptcy Court for the Southern District of New York. According to Blackmore, “We have been working closely with SunEdison on disposition alternatives so far and regard a collaborative exploration of strategic alternatives to be in the best interests of TerraForm Power, its public stockholders and SunEdison given the collective alignment of interests in maximizing stockholder value.”

TerraForm Power also has notified SunEdison that its Corporate Governance and Conflicts Committee is prepared to enter into discussions with SunEdison and/or its stakeholders to settle intercompany claims and defenses between TerraForm Power and SunEdison on a schedule that is consistent with the pursuit of strategic alternatives by TerraForm Power.

“We believe it is in the best interests of TerraForm Power and SunEdison for there to be a prompt settlement of all intercompany claims and defenses to facilitate the strategic review process,” said Jack Stark, Chairman of the Corporate Governance and Conflicts Committee. “We are committed to negotiate actively with SunEdison to resolve intercompany matters consensually on arm’s-length terms as soon as possible, although we stand ready to enforce our rights in litigation if necessary.”

TerraForm Power noted that its publicly traded sister company, TerraForm Global, Inc. (Nasdaq:GLBL), has announced that it is undertaking a similar review of strategic alternatives.

TerraForm Power has engaged Centerview Partners, Morgan Stanley and AlixPartners as financial advisors and Sullivan & Cromwell LLP as its legal advisor.

About TerraForm Power

TerraForm Power is a renewable energy company that is changing how energy is generated, distributed and owned. TerraForm Power creates value for its investors by owning and operating clean energy power plants. For more information about TerraForm Power, please visit: www.terraformpower.com.

Cautionary Note Regarding Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. These statements involve estimates, expectations, projections, goals, assumptions, known and unknown risks, and uncertainties and typically include words or variations of words such as “expect,” “anticipate,” “believe,” “intend,” “plan,” “seek,” “estimate,” “predict,” “project,” “goal,” “guidance,” “outlook,” “objective,” “forecast,” “target,” “potential,” “continue,” “would,” “will,” “should,” “could,” or “may” or other comparable terms and phrases.

They include, without limitation, statements relating to the potential sale of all of the Company’s equity interests; the possibility of a transaction involving a new sponsor, new sponsorship arrangements or the assumption of SunEdison’s existing sponsorship arrangements; the stabilization and future growth of the Company; the operation of TerraForm Power as an independent company; approval of any transaction by the Company’s stockholders, SunEdison or the U.S. Bankruptcy Court for the Southern District of New York; and the settlement of intercompany claims and defenses. These forward-looking statements are based on current expectations as of the date of this press release and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements, including but not limited to: whether the sale of the Company’s equity interests or an alternative transaction occurs; the ability to identify a suitable counterparty for a transaction; the terms of any such transaction, including whether any such transaction involves a new sponsorship arrangement or the assumption of SunEdison’s existing sponsorship arrangement; the amount of time a transaction may take; the approval of a transaction by any necessary parties; whether the Company and SunEdison and/or its stakeholders are able to reach an acceptable settlement of any intercompany claims and defenses and the terms of any such settlement;  as well as additional factors we have described in other filings with the Securities and Exchange Commission.

The risks included above are not exhaustive. Other factors that could adversely affect our business and prospects are described in the filings made by us with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.

Contacts:

Investors:

Brett Prior
TerraForm Power
bprior@terraform.com
(650) 889-8628

Media:

Meaghan Repko / Michael Freitag / Nicholas Leasure
Joele Frank, Wilkinson Brimmer Katcher
media@terraform.com
(212) 355-4449
Monday, September 19th, 2016 Uncategorized Comments Off on $GLBL Initiates Process to Explore #StrategicAlternatives

$VRAY Receives #CEMark for its #MRIdian #Linac System

510(k) Application Submitted to the FDA

CLEVELAND, Sept. 19, 2016  — ViewRay, Inc. (Nasdaq: VRAY) announced today that the company has received CE Mark approval for its next generation linear accelerator-based MRI-guided radiation therapy system, the MRIdian Linac. The MRIdian Linac builds on the first generation MRIdian system, but replaces cobalt with linear accelerator technology.

The MRIdian is the world’s first and only clinical MRI-guided radiation therapy system.

In addition to receiving CE Mark approval for the MRIdian Linac in Europe, the company has also submitted its 510(k) application for the MRIdian Linac technology in the United States.

“We are excited to have CE Mark approval and to begin selling MRIdian Linac within Europe,” said Chris A. Raanes, president and chief executive officer of ViewRay. “We believe the radiation oncology community has been eagerly awaiting the availability of a clinical MRI-guided Linac system, and we’re pleased to bring them ViewRay’s well-established MRI-guidance capabilities with the familiar functionality of a linac-based platform. We now look forward to progress on our 510(k) filing with the FDA.”

With receipt of its CE Mark, MRIdian Linac is available for sale and clinical use in Europe. In the United States, the MRIdian Linac technology is available for non-clinical research use only at this time.

About ViewRay

ViewRay®, Inc. (Nasdaq: VRAY), designs, manufactures and markets the MRIdian® radiation therapy system. MRIdian integrates MRI technology, radiation delivery and proprietary software to locate, target and track the position and shape of soft-tissue tumors during radiation. ViewRay believes this combination of enhanced visualization and accuracy will significantly improve outcomes for patients.

The MRIdian Linac is a technology under development in the United States and not available for sale or distribution in the United States. ViewRay and MRIdian are registered trademarks of ViewRay, Inc.

Forward Looking Statements:

This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the benefits of MRIdian Linac for physicians and patients and the expected reception of the MRIdian System in Europe. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue ViewRay’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, competition in the industry in which ViewRay operates and overall market conditions. These forward-looking statements are made as of the date of this press release, and ViewRay assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents ViewRay files with the SEC available at www.sec.gov.

SOURCE ViewRay, Inc.

Monday, September 19th, 2016 Uncategorized Comments Off on $VRAY Receives #CEMark for its #MRIdian #Linac System

$TECD to #Acquire Technology Solutions Unit from $AVT for $2.6B

Transaction Creates Premier Global IT Distributor with the Most Diverse End-to-End Solutions from the Data Center to the Living Room

Significantly Broadens Value-Added Distribution Business

Establishes Presence in Asia-Pacific while Enhancing Customer and Product Portfolios in the Americas and Europe

Transaction Expected to Be Significantly Accretive to Tech Data non-GAAP Earnings Per Share in First Year After Closing

Tech Data to Host Conference Call and Webcast at 8:30 a.m. ET Today

CLEARWATER, Fla., Sept. 19, 2016  — Tech Data Corporation (NASDAQ:TECD) today announced that it has entered into a definitive agreement to acquire the Technology Solutions business from Avnet, Inc. (NYSE:AVT) for $2.4 billion in cash and 2.785 million shares of Tech Data common stock, in a transaction valued at approximately $2.6 billion, based on a 15-day weighted average closing stock price. Tech Data also expects to realize approximately $200 million in present value of tax benefits.

The combination provides increased capabilities and expanded reach across technologies and geographies to establish Tech Data as one of the world’s most diverse end-to-end global IT distributors with operations in 35 countries.

The transaction is expected to be significantly accretive to Tech Data’s non-GAAP earnings per share in the first year after closing. Tech Data expects to achieve annual cost savings of approximately $100 million within two years after closing, primarily from efficiencies related to technology platforms, as well as duplicative functions and corporate expenses.

“We are excited to announce this transformative transaction, which creates a premier global IT distributor with the most diverse end-to-end solutions from the data center to the living room,” said Bob Dutkowsky, chief executive officer of Tech Data. “This combination complements our value-added distribution capabilities in Europe and the Americas, while establishing Tech Data’s presence in Asia-Pacific, which will be a new market for us. As a result of the enhanced value proposition created through this transaction, Tech Data will be even better positioned to capture opportunities in next-generation technologies, deliver differentiated value to our customers and vendor partners, support career development for our employees, and generate strong returns for our shareholders.  We believe the strategic and financial benefits resulting from this transformative combination are compelling for both our company and our stakeholders. We look forward to welcoming the Technology Solutions team to the Tech Data family and are excited about the future opportunities ahead.”

Patrick Zammit, president of the Technology Solutions business, said, “Industry standardization, innovation and converging technologies have transformed our industry. The broader portfolio created through this combination will enable both businesses to better capitalize on these trends, while also providing new opportunities for Technology Solutions to optimize and expand its offering, as well as unlock value in ways we could not historically. Given the strength of our customer and vendor relationships, our common cultures and values, as well as the skilled and engaged teams at both businesses, I am confident that this is a winning combination.”

Tech Data + Technology Solutions: Strong Platform for Growth and Value Creation

Significantly broadens value-added distribution business: Technology Solutions is an established leader in value-added distribution, delivering superior technology solutions, services, software, and hardware across the data center, which is complementary to Tech Data’s diversified portfolio of offerings and strategic areas targeted for growth. On a pro forma basis, Tech Data’s revenues for the 12 months ended July 31, 2016 would have increased from $26 billion to approximately $35 billion, with revenue attributable to complex, higher-margin data center offerings increasing from approximately 29 percent to 45 percent. Pro-forma non-GAAP operating income for the 12 months ended July 31, 2016 would have more than doubled, after expected cost savings.

Increases Tech Data’s ability to capitalize on key next-generation technologies: Next-generation technologies, including converged and hyper-converged infrastructure, security, analytics and the cloud, represent a more than $450 billion market opportunity, which is expected to grow at a 13 percent compounded annual growth rate through 20191. The combination of Tech Data and Technology Solutions will create a premier IT distributor with unmatched skills, consultative expertise, and strong partner relationships to help its customers capture these next-generation technology opportunities.

Extends reach in new and existing regions, creating a more balanced geographic footprint: Tech Data’s data center business is well-established in Europe and has a growing presence in North America.  Overall, these regions represented approximately 61 percent and 39 percent of Tech Data’s fiscal year 2016 revenues, respectively. With Technology Solutions, Tech Data will enhance its customer and product portfolios in the Americas and Europe, and establish an immediate presence in the fast-growing Asia-Pacific region, which will be a new market for Tech Data. Following the close of the transaction, Tech Data will expand its operations from 21 to 35 countries worldwide, with Europe comprising 53 percent of the Company’s $35 billion pro forma revenues, the Americas 44 percent and Asia-Pacific 3 percent.

Expands go-to-market capabilities by adding complementary skills, vendor relationships and new customers: Technology Solutions partners with more than 40 of the world’s top IT vendors to address the IT business needs of 20,000 customers in more than 80 countries. Tech Data has similarly strong and diversified relationships with more than 600 vendors and 105,000 customers. As a combined company, the Tech Data and Technology Solutions businesses can offer a broader and differentiated set of solutions to a larger and more diversified customer base, while enhancing relationships with channel partners.

Brings together teams with similar values and cultures:  Both Tech Data and Technology Solutions share a corporate culture centered on providing a world-class customer experience through teamwork, integrity, a passion for winning, and innovation. Tech Data expects that these shared values, as well as the expertise and talent from both organizations, will support a smooth integration following the close of the transaction.

Terms and Financing
Under the terms of the agreement, which was approved by the boards of directors of both companies, Avnet will receive at closing $2.4 billion in cash and approximately 2.785 million shares of Tech Data common stock, representing an approximate 7 percent ownership position in Tech Data.

Tech Data intends to finance the cash portion of the consideration through a combination of cash on hand, drawings under its existing revolver, and proceeds from a new term loan facility and senior notes, which are backstopped by fully-committed debt financing from BofA Merrill Lynch.

Following the close of the transaction, Tech Data will continue to benefit from strong cash flows to support debt reduction and organic growth initiatives. Tech Data expects to maintain an investment-grade profile and to reach a target leverage ratio of approximately 2.5x total debt-to-adjusted EBITDA within 18 to 24 months.

Approvals
The transaction is expected to close in the first half of calendar 2017, subject to customary closing conditions and regulatory approvals.

Advisors
BofA Merrill Lynch is serving as lead financial advisor and Raymond James and Associates is also serving as financial advisor to Tech Data. Cleary Gottlieb Steen & Hamilton LLP is serving as Tech Data’s legal counsel.

Tech Data to Host Investor/Analyst Conference Call and Webcast
Tech Data will host a conference call and webcast today, September 19, 2016, at 8:30 a.m. ET to discuss the transaction.

The live conference call is available by dialing (866) 610-1072 from the U.S. or (973) 935-2840 from outside the U.S. and entering conference code 84578145. Supporting materials, as well as a link to an audio webcast of the conference call, will be available at www.techdata.com/investor.

A replay of the conference call will be available approximately one hour after completion of the conference call through October 3, 2016 and can be accessed by dialing (800) 585-8367 from the U.S. or (404) 537-3406 from outside the U.S.  The replay confirmation code is 84578145. The webcast will be archived on the Tech Data website at www.techdata.com/investor.

(1) IDC – Digital Transformation: Challenges and Opportunities in 2016, June 2016.

About Tech Data
Tech Data Corporation is one of the world’s largest wholesale distributors of technology products, services and solutions. Its advanced logistics capabilities and value added services enable 105,000 resellers to efficiently and cost effectively support the diverse technology needs of end users in more than 100 countries. Tech Data generated $26.4 billion in net sales for the fiscal year ended January 31, 2016. It is ranked No. 108 on the Fortune 500® and one of Fortune’s “World’s Most Admired Companies.”  To learn more, visit www.techdata.com, or follow us on Facebook and Twitter.

Forward-Looking Statements
Certain statements in this communication may contain “forward‑looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements, including statements regarding Tech Data’s plans, objectives, expectations and intentions relating to the proposed acquisition of Avnet’s technology solutions business (“Acquisition”), the proposed Acquisition’s expected contribution to Tech Data’s results, financing and closing of the proposed Acquisition, the expected timing and benefits of the proposed Acquisition, Tech Data’s, Avnet’s and the Acquired Business’ financial results and estimates and/or business prospects involve a number of risks and uncertainties and actual results could differ materially from those projected.  These forward‑looking statements are based on current expectations, estimates, forecasts, and projections about the proposed Acquisition and the operating environment, economies and markets in which Tech Data and the Acquired Business operate and the beliefs and assumptions of our management. Words such as “expects,” “anticipates,” “targets,” “goals,” “projects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words, and similar expressions are intended to identify such forward‑looking statements. In addition, any statements that refer to projections of Tech Data or the Acquired Business’ future financial performance, our anticipated growth and trends in our businesses, and other characterizations of future events or circumstances, are forward‑looking statements.  These forward‑looking statements are only predictions and are subject to risks, uncertainties, and assumptions.  Therefore, actual results may differ materially and adversely from those expressed in any forward‑looking statements.

For additional information with respect to risks and other factors which could occur, see Tech Data’s Annual Report on Form 10-K filed on January 31, 2016, including Part I, Item 1A, “Risk Factors” therein, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other securities filings with the Securities and Exchange Commission (the “SEC”) that are available at the SEC’s website at www.sec.gov and other securities regulators. Readers are cautioned not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Many of these factors are beyond Tech Data’s control. Unless otherwise required by applicable securities laws, Tech Data disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Tech Data undertakes no duty to update any forward‑looking statements contained herein to reflect actual results or changes in Tech Data’s expectations.

Tech Data Contacts
Investors/Analysts:
Charles V. Dannewitz
Executive Vice President and Chief Financial Officer
(727) 532-8028
chuck.dannewitz@techdata.com

Arleen Quinones
Vice President, Investor Relations & Corporate Communications
(727) 532-8866
arleen.quinones@techdata.com

Media:
Brian Kosoy
Director, Corporate Communications
(727) 299-8865
brian.kosoy@techdata.com
Monday, September 19th, 2016 Uncategorized Comments Off on $TECD to #Acquire Technology Solutions Unit from $AVT for $2.6B

$NSAT Announces Receipt of Indications of Interest

VANCOUVER, Sept. 19, 2016  – Norsat International Inc. (“Norsat” or the “Company”) (TSX: NII and NYSE MKT: NSAT), a provider of unique and customized communication solutions for remote and challenging applications, today announced that it has recently received indications of interest from multiple parties with respect to a strategic transaction.  Privet Fund Management LLP (“Privet”) is one such party that has offered to acquire the Company for cash consideration of US$8.00 per share subject to due diligence, financing and other conditions.

Norsat has retained Raymond James Ltd. as its financial advisor and McMillan LLP as its legal advisor to assist the Company’s Board of Directors (the “Board”) in reviewing and evaluating the proposals and comparing such proposals to Norsat’s standalone strategic plan, consistent with the Board’s fiduciary duties. The review process initiated by the Board could result in bids with consideration higher than US$8.00 per share and the Company will work with its advisors to consider the proposals as well as other potential opportunities in comparison to the Company’s long-term strategic plan.

The Company has not established a definitive timeline to complete this review and no decision has been reached at this time. There can be no assurance that the review being undertaken will result in a business combination or a path different from the Company’s current strategic plan. The Company does not intend to make any further announcements regarding the review unless and until the Board has approved a specific transaction or other course of action requiring disclosure.

About Norsat International Inc.
Founded in 1977, Norsat International Inc. is a leading provider of innovative communication solutions that enable the transmission of data, audio and video for remote and challenging applications. Norsat’s products and services include leading-edge product design and development, production, distribution and infield support and service of fly-away satellite terminals, microwave components, antennas, Radio Frequency (RF) conditioning products, maritime based satellite terminals and remote network connectivity solutions. More information is available at www.norsat.com, via email at investor@norsat.com or by phone at 1-604-821-2800.

Forward Looking Statements
The discussion and analysis of this news release contains forward-looking statements concerning anticipated developments in Norsat’s operations in future periods, the adequacy of its financial resources and other events or conditions that may occur in the future. Forward-looking statements are frequently, but not always, identified by words such as “expects,” “anticipates,” “believes,” “intends,” “estimates,”, “predicts,” “potential,” “targeted,” “plans,” “possible” and similar expressions, or statements that events, conditions or results “will,” “may,” “could” or “should” occur or be achieved. These forward-looking statements include, without limitation, statements about Norsat’s market opportunities, strategies, competition, expected activities and expenditures as it pursues its business plan, the adequacy of available cash resources and other statements about future events or results. Forward-looking statements are statements about the future and are inherently uncertain, and actual achievements of the Company or other future events or conditions may differ materially from those reflected in the forward-looking statements due to a variety of risks, uncertainties and other factors, such as business and economic risks and uncertainties. The forward-looking statements are based on the beliefs, expectations and opinions of management on the date the statements are made. Consequently, all forward-looking statements made in this news release are qualified by this cautionary statement and there can be no assurance that actual results or anticipated developments will be realized. For the reasons set forth above, investors should not place undue reliance on forward-looking statements. These forward-looking statements are made as of the date of this news release and Norsat assumes no obligation to update or revise them to reflect new events or circumstances, other than as required by law.

SOURCE Norsat International Inc.

Dr. Amiee Chan, President & CEO, Tel: 604 821-2800, Email: achan@norsat.com; Mr. Arthur Chin, Chief Financial Officer, Tel: 604 821-2800, Email: achin@norsat.comCopyright CNW Group 2016

Monday, September 19th, 2016 Uncategorized Comments Off on $NSAT Announces Receipt of Indications of Interest

$WINT Announces #FDA #FastTrack Designation for #AEROSURF®

WARRINGTON, Pa., Sept. 19, 2016  — Windtree Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AEROSURF® (lucinactant for inhalation) for the treatment of premature infants with respiratory distress syndrome (RDS). AEROSURF is a novel, investigational combination drug/device product that is being developed to deliver aerosolized KL4 surfactant to premature infants with RDS, potentially reducing the need for invasive endotracheal intubation and mechanical ventilation to administer surfactant therapy.

“This Fast Track designation for AEROSURF underscores the significant need to reduce the use of invasive intubation and mechanical ventilation, which are required to administer surfactant therapy, but may result in serious complications and increase the risk for other respiratory conditions,” commented Craig Fraser, President and Chief Executive Officer. “By enabling non-invasive delivery of our aerosolized KL4 surfactant, we believe that AEROSURF will address a serious unmet medical need and potentially provide transformative clinical and pharmacoeconomic benefits. We look forward to continuing our work with the FDA to advance AEROSURF through the clinical development and regulatory approval process, with the goal of bringing a transformative therapy to treat premature infants in an expedited time frame.”

The Fast Track program was created by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Drugs that receive this designation benefit from more frequent communications and meetings with FDA to review the drug’s development plan including the design of the proposed clinical trials, use of biomarkers and the extent of data needed for approval. Drugs with Fast Track Designation may qualify for priority review to expedite the FDA review process, if relevant criteria are met.

AEROSURF is currently being studied in a phase 2b clinical trial in premature infants 26 to 32-week gestational age receiving nasal continuous positive airway pressure (nCPAP) for RDS. The phase 2b trial includes clinical sites in North America, Europe and South America.

About Windtree Therapeutics
Windtree Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel surfactant therapies for respiratory diseases and other potential applications. Windtree’s proprietary technology platform includes a synthetic, peptide-containing surfactant (KL4 surfactant) that is structurally similar to endogenous pulmonary surfactant and novel drug-delivery technologies being developed to enable noninvasive administration of aerosolized KL4 surfactant. Windtree is focused initially on improving the management of respiratory distress syndrome (RDS) in premature infants and believes that its proprietary technology may make it possible, over time, to develop a pipeline of KL4 surfactant product candidates to address a variety of respiratory diseases for which there are few or no approved therapies.

For more information, please visit the Company’s website at www.windtreetx.com.

Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.  Examples of such risks and uncertainties include those risks related to Windtree’s aerosolized KL4 surfactant development programs, including for AEROSURF, which may involve time-consuming and expensive clinical trials, which may be subject to potentially significant delays or regulatory holds, or fail; risks related to the development of aerosol delivery systems (ADS) and related components, manufacture by contract manufacturers or suppliers of drug products, drug substances, ADS and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including those of the U.S. Food and Drug Administration or other regulatory authorities that may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of Windtree’s products; and other risks and uncertainties described in Windtree’s filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.

SOURCE Windtree Therapeutics, Inc.

Monday, September 19th, 2016 Uncategorized Comments Off on $WINT Announces #FDA #FastTrack Designation for #AEROSURF®

$SRPT Announces #FDA Accelerated Approval of #EXONDYS51 in #MuscularDystrophy

— EXONDYS 51™ the first DMD treatment approved in the US, targets dystrophin deficiency, the underlying cause of Duchenne —

–U.S. Commercial Launch planned to commence immediately–

–Conference call Scheduled for September 19, 2016, 4:00 p.m. EST–

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for EXONDYS 51™ (eteplirsen) as a once weekly intravenous infusion of 30 milligrams per kilogram for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping. This indication is based on an increase in dystrophin in skeletal muscles observed in some patients treated with EXONDYS 51. A clinical benefit of EXONDYS 51 has not been established. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. The most common adverse reactions compared to a placebo group were vomiting (38%) and balance disorder (38%) with contusion, excoriation, arthralgia, rash, catheter site pain, and upper respiratory tract infection also reported more frequently than placebo (≥ 10%).

“Today’s accelerated approval of EXONDYS 51 represents a major milestone in the treatment of Duchenne Muscular Dystrophy for patients amenable to skipping exon 51 by targeting the underlying genetic cause of the disease – the lack of the dystrophin protein,” said Edward Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. “We are grateful to the many patients and investigators who participated in EXONDYS 51’s clinical studies. EXONDYS 51 represents the culmination of many years of work across our entire organization and the Duchenne community to address a critical unmet need by bringing this novel medicine to patients. We will continue to leverage what we have learned from EXONDYS 51 to facilitate future development of potential new treatments targeting additional exons with the goal of one day treating all DMD patients amenable to exon skipping.”

The underlying cause of Duchenne muscular dystrophy is a mutation or error in the gene for dystrophin, an essential protein involved in muscle fiber function. Certain genetic mutations in DMD involve the deletion of exons, which interrupt proper translation of the genetic code into protein.

Duchenne muscular dystrophy is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 – 5,000 males born worldwide. It is estimated that up to thirteen percent of people with DMD have mutations addressable by EXONDYS 51.

Patients and physicians can access information by visiting www.SareptAssist.com or calling 1-888-727-3782.

Conference Call

The Company will be hosting a conference call at 4:00 p.m. EST. The conference call may be accessed by dialing (844) 534-7313 for domestic callers and (574) 990-1451 international callers. The passcode for the call is 85217990. Please specify to the operator that you would like to join the “Sarepta Corporate Update.” The conference call will be webcast live under the investor relations section of Sarepta’s website at www.sarepta.com and will be archived there following the call for 90 days. Please connect to Sarepta’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

About Duchenne Muscular Dystrophy (DMD)

DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. DMD is estimated to affect approximately one in every 3,500-5000 males born worldwide. A devastating and incurable muscle-wasting disease, DMD is associated with specific errors in the gene that codes for dystrophin, a protein that plays a key structural role in muscle fiber function. Progressive muscle weakness in the lower limbs spreads to the arms, neck and other areas. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. The condition is universally fatal, and death usually occurs before the age of 30.

About EXONDYS 51™

EXONDYS 51 uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 51 of the dystrophin gene. EXONDYS 51 is designed to bind to exon 51 of dystrophin pre-mRNA, resulting in exclusion of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 51 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein. Data from clinical studies of EXONDYS 51 in a small number of DMD patients have demonstrated a consistent safety and tolerability profile. The pivotal trials were not designed to evaluate long-term safety and a clinical benefit of EXONDYS 51 has not been established.

Important Safety Information

  • Adverse reactions observed in patients (N=8) treated with 30 or 50 mg/kg/wk of EXONDYS 51 with incidence ≥ 25% and higher than in the placebo group (N=4) (Study 1) were: balance disorder (38%), vomiting (38%) and contact dermatitis (25%). The most common adverse reactions were balance disorder and vomiting.
  • The following events were reported in ≥ 10% of patients treated with EXONDYS 51 for up to 208 weeks (N=88) and occurred more frequently than placebo in a controlled trial for 24 weeks (Study 1): vomiting, contusion, excoriation, arthralgia, rash, catheter site pain, and upper respiratory tract infection.
  • There have been reports of transient erythema, facial flushing, and elevated temperature occurring on the day of EXONDYS 51 infusion.

For the full prescribing information please refer to U.S. Full Prescribing Information at www.EXONDYS51.com

About Sarepta Therapeutics

Sarepta Therapeutics is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including EXONDYS 51, designed to skip exon 51 and approved under the accelerated approval pathway. For more information, please visit us at www.sarepta.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding EXONDYS 51‘s continued approval for its indication potentially being contingent upon verification of a clinical benefit in confirmatory trials; the potential benefits and risks of EXONDYS 51; the accelerated approval of EXONDYS 51 representing a major milestone in the treatment of DMD for patients amenable to skipping exon 51 by targeting the underlying genetic cause of the disease; EXONDYS 51’s potential to address an unmet need and being a novel medicine; Sarepta’s plans to continue to leverage what it has learned from EXONDYS 51 to facilitate future development of potential new treatments targeting additional exons with the goal of someday treating all DMD patients amenable to exon skipping; the estimated number of patients worldwide of patients with DMD and the estimated percentage of people with DMD that have mutations addressable by EXONDYS 51 and Sarepta’s plans for a US Commercial launch to commence immediately.

These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control or unknown. Known risk factors include, among others: the planned commercial launch in the US for EXONDYS 51 may not be successful in part or at all for various reasons including the actual market size and drug supply needed may not be consistent with the company’s expectations and its executed commercial readiness plans, the degree to which EXONDYS 51 is accepted by patients and prescribed by physicians, the efficiency of our manufacturing, sales, distribution and specialty pharmacy network in getting Exondys51 to the market and future economic, competitive, reimbursement and regulatory conditions that could negatively impact the commercial launch of EXONDYS 51; the confirmatory and other studies for Exondys51 may not yield data consistent with prior results or demonstrate a benefit that supports continued or full regulatory approval; we may not be able to complete clinical trials required by the FDA or other regulatory authorities for approval of our pipeline of exon-skipping products; the results of our ongoing research and development efforts and clinical trials for our product candidates and our technologies may not be positive or consistent with prior results or demonstrate a safe treatment benefit or support an NDA filing, positive advisory committee recommendation or marketing approval by the FDA or other regulatory authority; we may not be able to execute on our business plans including meeting our expected or planned regulatory milestones and timelines, clinical development plans and bringing our product candidates to market, including the commercialization of EXONDYS 51, for various reasons, including factors outside of the Company’s control, such as possible limitations of Company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner or at all, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading “Risk Factors” in Sarepta’s most recent Annual Report on Form 10-K for the year ended December 31, 2015 or Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta which you are encouraged to review.

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

Internet Posting of Information

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

 

Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
iestepan@sarepta.com
or
W2O Group
Brian Reid, 212-257-6725
breid@w2ogroup.com

Monday, September 19th, 2016 Uncategorized Comments Off on $SRPT Announces #FDA Accelerated Approval of #EXONDYS51 in #MuscularDystrophy

$CRIS Reports #Inducement #Grants

LEXINGTON, Mass., Sept. 16, 2016  — Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, today announced that on September 12, 2016, the independent Compensation Committee of the Board of Directors of Curis approved the grant of inducement stock options to purchase a total of 521,000 shares of Curis common stock to six new employees, with a grant date of September 12, 2016 (the “Q3 2016 Inducement Grants”).

Each of the Q3 2016 Inducement Grants has an exercise price per share equal to the closing price of the Company’s common stock on September 12, 2016, the date of grant.  Each stock option has a 10 year term and vests over four years, with 25% of the original number of shares underlying the award vesting on the first anniversary of the employee’s date of hire and an additional 6.25% of the original number of shares underlying the award vesting on each successive three-month period thereafter, subject to the new employee’s continued service with the Company through the respective vesting dates.  Each stock option was granted as an inducement equity award outside of the Company’s Amended and Restated 2010 Stock Incentive Plan, as amended, and was made as an inducement material to such employee’s acceptance of employment with the Company.

About Curis, Inc.

Curis is a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers. The company’s clinical drug candidates include CUDC-907, which is being investigated in a Phase 2 trial in patients with Diffuse Large B Cell Lymphoma, or DLBCL, and in a separate Phase 1 trial in patients with solid tumors. As part of a broad collaboration with Aurigene, Curis has exclusive licenses to oral small molecule antagonists of the PD-1 and VISTA pathways, including the PD-L1/VISTA antagonist, CA-170 that is currently being investigated in a Phase 1 trial in patients with solid tumors or lymphoma. Curis also has an exclusive license to molecules designed to inhibit IRAK4, including CA-4948, currently in the pre-IND stage of development. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma, and are further developing Erivedge in other diseases including idiopathic pulmonary fibrosis and myelofibrosis. For more information, visit Curis’s website at www.curis.com.

Cautionary Note Regarding Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: Curis’ goals relating to advancing its drug candidates into later stages of development, with the objective of bringing its drugs to cancer patients and creating long-term shareholder value. Forward-looking statements used in this press release may contain the words “believes,” “expects,” “anticipates,” “plans,” “seeks,” “estimates,” “assumes,” “will,” “may,” “could” or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. For example, Curis faces a number of risks inherent in the research and development of novel drugs to treat cancer and may not be able to successfully advance the development of any of its programs in the time frames it projects, if at all. Curis and its collaborators may experience adverse results, delays and/or failures in their drug development programs. Curis’ drug candidates are unproven and may cause unexpected toxicities and/or fail to demonstrate sufficient safety and efficacy in clinical trials and may never achieve the requisite regulatory approval needed for commercialization. The FDA could impose restrictions on clinical trials of Curis’ drug candidates, which could delay, make more costly or otherwise adversely impact Curis’ future development plans. Curis will require substantial additional capital to fund its research and development programs, and such capital may not be available on reasonable terms, or at all. Curis may not obtain or maintain necessary patent protection for its programs and could become involved in expensive and time consuming patent litigation and interference proceedings. Curis faces substantial competition from other companies developing cancer therapeutics. Curis is dependent upon third party collaborations such as Genentech and Aurigene, and may not be able to maintain these arrangements on acceptable terms, or at all. Unstable market and economic conditions may adversely affect Curis’ financial condition and its ability to access capital to fund the growth of its business. Curis also faces risks relating to: potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies; competition; its ability to obtain or maintain necessary patent protection; unstable market and economic conditions; unplanned expenses; and other important risks relating to its business, operations, financial condition and future prospects that are discussed in its most recent Form 10-K and Form 10-Q and other filings that it periodically makes with the Securities and Exchange Commission.

In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis’s views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law.

 

For More Information:
James E. Dentzer
Chief Financial Officer & Chief Administrative Officer
Curis, Inc.
617-503-6500
jdentzer@curis.com

Media Contact:
David Schull
Russo Partners
212-845-4271
david.schull@russopartnersllc.com
Friday, September 16th, 2016 Uncategorized Comments Off on $CRIS Reports #Inducement #Grants

$NAUH to Ring #Nasdaq #ClosingBell Sept. 19

ADVISORY, Sept. 16, 2016  —

What:
National American University Holdings, Inc. (Nasdaq:NAUH), through its wholly owned subsidiary, operates National American University (“NAU”), a regionally accredited, proprietary, multi-campus institution of higher learning offering associate, bachelor’s, master’s, and doctoral degree programs in technical and professional disciplines, will visit the Nasdaq MarketSite in Times Square.

In honor of the occasion, Dr. Ron Shape, Chief Executive Officer, will ring the Closing Bell.

Where:
Nasdaq MarketSite – 4 Times Square – 43rd & Broadway – Broadcast Studio

When:
Monday, September 19, 2016 – 3:45 p.m. to 4:00 p.m. ET

National American University Contact:
Adam Prior
The Equity Group Inc.
aprior@equityny.com
(212) 836-9606

Nasdaq MarketSite:
Emily Pan
(646) 441-5120
emily.pan@nasdaq.com

Feed Information:
Fiber Line (Encompass Waterfront): 4463

Gal 3C/06C 95.05 degrees West
18 mhz Lower
DL 3811 Vertical
FEC 3/4
SR 13.235
DR 18.295411
MOD 4:2:0
DVBS QPSK

Social Media:
For multimedia features such as exclusive content, photo postings, status updates and video of bell ceremonies, please visit our Facebook page:
http://www.facebook.com/NASDAQ.

For photos from ceremonies and events, please visit our Instagram page:
http://instagram.com/nasdaq

For livestream of ceremonies and events, please visit our YouTube page:
http://www.youtube.com/nasdaq/live

For news tweets, please visit our Twitter page:
http://twitter.com/nasdaq

For exciting viral content and ceremony photos, please visit our Tumblr page:
http://nasdaq.tumblr.com/

Webcast:
A live stream of the Nasdaq Closing Bell will be available at:
https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx

Photos:
To obtain a hi-resolution photograph of the Market Close, please go to http://business.nasdaq.com/discover/market-bell-ceremonies and click on the market close of your choice.

About National American University Holdings, Inc.
National American University Holdings, Inc., through its wholly owned subsidiary, operates National American University (“NAU”), a regionally accredited, proprietary, multi-campus institution of higher learning offering associate, bachelor’s, master’s, and doctoral degree programs in technical and professional disciplines. Accredited by the Higher Learning Commission, NAU has been providing technical and professional career education since 1941. NAU opened its first campus in Rapid City, South Dakota, and has since grown to multiple locations throughout the United States. In 1998, NAU began offering online courses. Today, NAU offers degree programs in traditional, online, and hybrid formats, which provide students increased flexibility to take courses at times and places convenient to their busy lifestyles.

About Nasdaq
Nasdaq (Nasdaq:NDAQ) is a leading provider of trading, clearing, exchange technology, listing, information and public company services across six continents. Through its diverse portfolio of solutions, Nasdaq enables customers to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today’s global capital markets. As the creator of the world’s first electronic stock market, its technology powers more than 70 marketplaces in 50 countries, and 1 in 10 of the world’s securities transactions. Nasdaq is home to more than 3,700 listed companies with a market value of approximately $9.3 trillion and nearly 18,000 corporate clients. To learn more, visit: nasdaq.com/ambition or business.nasdaq.com.

Friday, September 16th, 2016 Uncategorized Comments Off on $NAUH to Ring #Nasdaq #ClosingBell Sept. 19

$CDOR Increases Common Stock #Dividend to an Annualized $0.12 per Share

BETHESDA, Md., Sept. 16, 2016  — Condor Hospitality Trust, Inc. (NASDAQ:CDOR), a hotel-focused real estate investment trust (REIT) headquartered and incorporated in the state of Maryland, today announced that its board of directors has declared a common stock dividend of $0.03 per share for the third quarter, or $0.12 per share on an annualized basis.  The dividend will be payable on October 12, 2016 to shareholders of record as of September 29, 2016.

“We are pleased to declare and pay a third quarter dividend to the holders of our common stock of $0.03 per share, a quarterly $0.02 per share increase from the $0.01 per share dividend paid on the common stock in the prior quarter,” said Bill Blackham, Condor’s Chief Executive Officer.  “We have also declared the third quarter dividend payable on September 30, 2016 to our Series D preferred stock shareholders. The board of directors intends to continue to review all circumstances in the future and consider the payment of common stock dividends, if permitted and in amounts it deems appropriate,” Mr. Blackham continued.

About Condor Hospitality Trust, Inc.

Condor Hospitality Trust, Inc. (NASDAQ:CDOR), is a self-administered real estate investment trust incorporated in the state of Maryland that specializes in the investment and ownership of upper midscale and upscale, premium-branded select-service, extended stay and limited-service hotels.  The company currently owns 30 hotels in 15 states.  Condor’s hotels are franchised by a number of the industry’s most well-regarded brand families including Hilton, Marriott, Starwood, InterContinental Hotels Group, Choice, and Wyndham.  For more information or to make a hotel reservation, visit www.condorhospitality.com.

Certain matters within this press release are discussed using forward-looking language as specified in the Private Securities Litigation Reform Act of 1995, and, as such, may involve known and unknown risks, uncertainties and other factors that may cause the actual results or performance to differ from those projected in the forward-looking statement. These risks are discussed in the company’s filings with the Securities and Exchange Commission.

 

Contact:
Jonathan J. Gantt
Chief Financial Officer & Senior Vice President
jgantt@trustcondor.com
402-371-2520
Friday, September 16th, 2016 Uncategorized Comments Off on $CDOR Increases Common Stock #Dividend to an Annualized $0.12 per Share

$AERI Raises $125 Million in #PublicOffering

Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, today announced the pricing of a registered underwritten public offering of $75 million of shares of its common stock at a price to the public of $29.50 per share, before deducting underwriting discounts and commissions and other estimated offering expenses. The offering was upsized by $25 million over the offering amount anticipated to be sold as previously announced. This is in addition to $50 million raised separately through the completion and full utilization of an at-the-market (ATM) program with Cantor Fitzgerald & Co. filed prior to market open on September 15, 2016. Total gross proceeds raised through these offerings were $125 million. The shares sold through the $50 million ATM program will be issued on or about September 20, 2016, and the $75 million public offering is expected to close on or about September 21, 2016, subject to the satisfaction of customary closing conditions.

Cantor Fitzgerald & Co. is acting as sole bookrunner for the $75 million public offering and sole manager for the $50 million ATM program.

Aerie intends to use the net proceeds of the offerings for general corporate purposes, including the complete funding of RhopressaTM commercialization costs, execution of clinical trials in Japan, commencement of construction of a manufacturing plant in Ireland and continuation of preclinical activity in support of its product pipeline, along with ongoing working capital requirements.

Shelf registration statements relating to the shares are effective with the Securities and Exchange Commission. The shares in each offering may be offered only by means of a prospectus, including a prospectus supplement, forming a part of each effective registration statement. A prospectus supplement relating to the $50 million ATM program and a preliminary prospectus supplement relating to the $75 million public offering were filed with the Securities and Exchange Commission on September 15, 2016. Electronic copies of the preliminary prospectus supplement, the prospectus supplement and the accompanying prospectuses relating to the offerings are available on the website of the Securities and Exchange Commission at www.sec.gov. Copies of the prospectus supplement relating to the $50 million ATM program and of the preliminary prospectus supplement and the final prospectus supplement relating to the $75 million public offering, when available, and the accompanying prospectuses relating to the offerings may be obtained by contacting Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 5th Floor, New York, New York 10022, or by telephone at 212-829-7122, or by e-mail at prospectus@cantor.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of Aerie, and shall not constitute an offer, solicitation or sale of any security 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 Aerie Pharmaceuticals, Inc.

Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. Aerie’s two lead product candidates are once-daiIy IOP-lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA filing for RhopressaTM (netarsudil ophthalmic solution) 0.02% was submitted in the third quarter of 2016. The second product candidate, RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of RhopressaTM and widely prescribed PGA latanoprost, currently has two Phase 3 registration trials underway, named Mercury 1 and Mercury 2. If these trials are successful, a RoclatanTM NDA filing is expected to take place near year-end 2017. Aerie is also focused on the development of additional product candidates and technologies in ophthalmology.

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. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “exploring,” “pursuing” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the timing of and our ability to request, obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; our expectations regarding the commercialization of our product candidates; our expectations related to the offerings discussed in this press release, including the completion, timing and size of the offerings and the use of proceeds therefrom; the potential advantages of our product candidates; and our plans to pursue development of our product candidates for additional indications and other therapeutic opportunities. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on regulatory approvals and economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading “Risk Factors” in the quarterly and annual reports that we file with the Securities and Exchange Commission (SEC). 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.

 

 

Aerie Pharmaceuticals
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Burns McClellan, Inc., on behalf of Aerie Pharmaceuticals
Investors
Ami Bavishi, 212-213-0006
abavishi@burnsmc.com
or
Media
Justin Jackson, 212-213-0006
jjackson@burnsmc.com

Friday, September 16th, 2016 Uncategorized Comments Off on $AERI Raises $125 Million in #PublicOffering

$FNCX Announces #ReverseStockSplit

1-for-20 Reverse Stock Split and Adjustment of Authorized Shares Effective September 16, 2016

Function(x) Inc. (Nasdaq:FNCX) (the “Company”) today announced a reverse stock split of its shares of common stock at a ratio of 1-for-20 shares effective when the market opens on September 16, 2016. At the market open on Friday, September 16, 2016, the Company’s common stock will begin trading on a split-adjusted basis, under the same trading symbol, FNCX.

As a result of the reverse split, each 20 pre-split shares of common stock outstanding will automatically combine into one new share of common stock without any action on the part of the holders. The reverse split will also apply to common stock issuable upon the exercise of the Company’s outstanding warrants and stock options.

As a result of the reverse stock split, the Company’s issued and outstanding shares of common stock will decrease to approximately 3,023,753 shares, post-split, from approximately 60,475,058 shares, pre-split. No fractional shares will be issued as a result of the reverse split. Owners of fractional shares outstanding after the reverse stock split will be paid cash for such fractional interests.

The reverse split was approved by the Company’s Board of Directors on September 9, 2016, in part, to enable the Company to regain and maintain compliance with the minimum closing bid price of $1.00 per share for continued listing on The Nasdaq Capital Market.

Robert F.X. Sillerman, Executive Chairman and Chief Executive Officer, said, “With this reverse stock split, we expect to satisfy Nasdaq’s minimum bid price requirement and to maintain compliance with that requirement as we move forward with the development of our business. We are highly confident about the long-term prospects of our Company as we continue to make Function(x) a premier destination for digital content consumption.”

Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on September 16, 2016, a copy of which is available at www.sec.gov.

About Function(x) Inc.

Function(x) operates Wetpaint.com, the leading online destination for entertainment news for millennial women, covering the latest in television, music, and pop culture, and Rant, a leading digital publisher with original content in 13 different verticals, most notably in sports, entertainment, pets, cars and food. Function(x) Inc. is also the largest shareholder of DraftDay Gaming Group, which is well-positioned to become a significant participant in the expanding fantasy sports market, offering a high-quality daily fantasy sports experience both directly to consumers and to businesses desiring turnkey solutions to new revenue streams. Function(x) Inc. also owns Choose Digital, a digital marketplace platform that allows companies to incorporate digital content into existing rewards and loyalty programs in support of marketing and sales initiatives. For more information, visit www.functionxinc.com.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. All information provided in this press release is as of the date of this release. Except as required by law, Function(x), Inc. undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.

 

Investors:
Function(x)
Birame Sock, 212-231-0092
President & Chief Operating Officer
bsock@functionxinc.com
or
Media Relations:
IRTH Communications
Robert Haag, 866-976-4784
Managing Partner

Friday, September 16th, 2016 Uncategorized Comments Off on $FNCX Announces #ReverseStockSplit