Edge Therapeutics Expands Senior Management Team and Opens New Headquarters to Support Continued Growth
April 8, 2014
BERKELEY HEIGHTS, N.J. – April 08, 2014 – Edge Therapeutics, a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, life-threatening neurological conditions, today announced the appointment and promotion of key executives to its senior management team to strengthen the Company’s leadership.
Herbert J. Faleck, D.O. has joined Edge as Chief Medical Officer; Andrew J. Einhorn as Chief Financial Officer; Alpaslan Yaman, Ph.D. as Vice President, Operations and Manufacturing, Gene Mack as Senior Director, Investor Relations, and William Shatynski as Senior Director, Financial Reporting and Controller. Additionally, Albert Marchio has been appointed to the expanded role of Chief Accounting and Operations Officer for the Company.
“Edge is expanding its leadership team to support the company’s continued growth and the development of EG-1962, our lead compound being studied in the Phase 1/2 NEWTON trial for the treatment of subarachnoid hemorrhage,” said Brian Leuthner, President and Chief Executive Officer of Edge Therapeutics. “Our ability to attract these talented and accomplished professionals speaks to the potential clinical and commercial value of our product candidates, EG-1962 and EG-1964.”
Separately, Edge announced that the Company has opened its new corporate headquarters at 200 Connell Drive, Suite 1600, Berkeley Heights, New Jersey.
Herbert J. Faleck, D.O., Chief Medical Officer
Dr. Faleck, a pediatric neurologist, has more than 25 years of experience in clinical research. Prior to joining Edge, he was the Chief Medical Officer of Celgene Cellular Therapeutics where he led the clinical, medical, regulatory and organizational development for a key division of Celgene Corporation. Dr. Faleck joined Celgene in 2000 as Vice President of Clinical Research and Development and was responsible for several therapeutic areas including hematology/oncology and inflammation as well as the clinical programs that resulted in the approval of several of Celgene’s key products. Previously, Dr. Faleck held positions of increasing responsibility at Novartis Pharmaceuticals.
Andrew J. Einhorn, Chief Financial Officer
Mr. Einhorn has more than 10 years of experience in the pharmaceutical industry in the development and execution of corporate strategy. Prior to joining Edge, he served as co-founder and Chief Financial Officer for three specialty pharmaceutical and therapeutics companies: Oceana Therapeutics, Inc., Esprit Pharma, and ESP Pharma, where he was involved in numerous financing, acquisition and licensing transactions across a variety of therapeutic areas and geographies, and played a key role in the ultimate sale of those companies to larger pharmaceutical companies. Previously, Mr. Einhorn spent more than 20 years as an investment banker and has extensive experience in corporate finance, capital markets and financial analysis.
Alpaslan Yaman, Ph.D., Vice President, Operations and Manufacturing
Dr. Yaman has more than 28 years of biotech, pharmaceutical and medical device industry experience in sterile and non-sterile formulation development, process development and scale-up, validation, technology transfer and technical services with specific experience in sterile microparticle process design and scale-up. He has been recognized as a Subject Matter Expert and certified in process excellence as a Six Sigma Black Belt professional. Prior to joining Edge, Dr. Yaman worked for Johnson & Johnson in Product Support/Technical Services and Schering Plough as Director, Pharmaceutical Technology Transfer and Global Technical Services. Dr. Yaman has also performed similar roles at Purdue Pharma, Novartis and Hoffmann-LaRoche.
Gene Mack, Senior Director, Investor Relations
Mr. Mack has more than 14 years of experience as a senior sell-side equity analyst covering the biotechnology, life science and specialty pharmaceutical sectors for a number of investment banking firms. His experience includes evaluation and numerous in-licensing, strategic and corporate financing transactions and the consistent publication of research for institutional investors in biotechnology and pharmaceutical sectors. Prior to Edge, Mr. Mack was a Senior Biotechnology Analyst at Brean Capital and spent the majority of his career at Lazard Capital Markets. Previously, Mr. Mack completed research in biochemistry at Cornell University Medical College and clinical neurology at Columbia University College of Physicians and Surgeons where he was part of a team investigating less invasive treatments for malignant gliomas and cerebrovascular disease including aneurysms, arteriovenous malformations and stroke.
William Shatynski, Senior Director, Financial Reporting and Controller
Mr. Shatynski has over 25 years of senior financial and accounting experience in both the public and private sectors. Prior to joining Edge, Mr. Shatynski was Senior Director and Controller at Insmed Inc. where he was responsible for internal and external financial reporting, Sarbanes-Oxley 404 compliance and SEC filings. Mr. Shatynski’s previous experience includes a number of roles of increasing responsibility in accounting, tax and auditing across a variety of industries. Mr. Shatynski is a licensed certified public accountant in New Jersey.
About Edge Therapeutics, Inc.
Edge Therapeutics is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, life-threatening neurological conditions. EG-1962, our lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, or aSAH, which is bleeding around the brain due to a ruptured brain aneurysm. A single dose of EG-1962 delivers a high concentration of nimodipine, the current standard of care, directly to the brain with sustained drug exposure over 21 days. EG-1962 utilizes our proprietary, programmable, biodegradable polymer-based development platform, or our Precisa™ development platform, a novel delivery mechanism that enables targeted and sustained drug exposure while potentially avoiding the dose-limiting side effects associated with currently available formulations of nimodipine. EG-1962 is currently in a Phase 1/2 safety and dose-escalation clinical trial called The NEWTON trial. Our second product candidate, EG-1964, is being evaluated as a potential prophylactic treatment in the management of chronic subdural hematoma, or cSDH, to prevent recurrent bleeding on the surface of the brain.
For more information on Edge Therapeutics, Inc., please visit: www.pdsbiotech.com.
Forward Looking Statements
This press release and any statements of representatives and partners of Edge Therapeutics, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” as defined in the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
For more information contact:
Edge Therapeutics, Inc.
Senior Director, Investor Relations
973-442-1555 ext. 112