Edge Therapeutics Announces Multi-Year Research Collaboration with Leading Academic Medical Center

November 18, 2014

Discovery agreement with St. Michael’s Hospital focuses on new therapies for acute neurological conditions

BERKELEY HEIGHTS, N.J., November 18, 2014 – Edge Therapeutics, a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming the treatment of acute, life-threatening neurological conditions, today announced a multi-year research and discovery collaboration with St. Michael’s Hospital, which is affiliated with the University of Toronto. The collaboration will focus on new therapeutic approaches for the treatment of various acute neurological conditions resulting from neurovascular instability.

This discovery collaboration brings together Edge’s scientific expertise in neurovascular disease with the research and high-throughput drug screening resources of St. Michael’s Hospital. Initially the collaboration will focus on using validated models of intracerebral hemorrhage, cavernous malformations, and traumatic brain injury developed by St. Michael’s to rapidly screen libraries of compounds for therapeutic activity, and to identify and optimize lead candidates for Edge’s early stage pipeline.

“Cerebrovascular diseases such as intracerebral hemorrhage are devastating and life threatening conditions for patients and families, the successful treatment of which represents an area of high unmet need in the acute care setting. This collaboration enhances Edge’s discovery capabilities in line with our vision to build a fully integrated biotechnology company focused on lifesaving therapies that can be administered in the hospital,” said Brian Leuthner, President and Chief Executive Officer of Edge Therapeutics, Inc. “St. Michael’s Hospital is at the forefront of brain-related research and its high-throughput Zebrafish screening program is one of the most advanced screening facilities in the world. We are confident that combining our expertise with the discovery capabilities of this world class research and academic center will help identify novel therapeutic candidates for clinical development.”

“We are excited to collaborate with Edge to develop therapeutic approaches for cerebrovascular instability,” said Xiao-Yan Wen, MD, PhD, Director and Scientist, Zebrafish Centre for Advanced Drug Discovery at St. Michael’s Hospital. “We hope the combination of resources provided by Edge along with our high-throughput screening technology will address the dearth of innovation in these grievous conditions that are characterized by high morbidity and mortality.”

As previously announced, Edge Therapeutics has initiated patient enrollment in the third cohort of its NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study, a multicenter, randomized, controlled, open-label, Phase 1/2 clinical trial of its lead product candidate EG-1962. The NEWTON study is evaluating the safety, tolerability and pharmacokinetics of EG-1962 compared to the current standard of care, oral nimodipine, in patients with aneurysmal subarachnoid hemorrhage (aSAH). Edge is also investigating a second compound, EG-1964, for prevention of recurrence of chronic subdural hematoma. The company plans to submit an IND for that treatment in 2015.

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. EG-1964, our second product candidate, is being evaluated as a potential prophylactic treatment in the management of chronic subdural hematoma, to prevent recurrent bleeding on the surface of the brain.

For additional information about Edge Therapeutics, please visit www.edgetherapeutics.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).

For more information, contact:

Gene Mack
Edge Therapeutics, Inc.
Tel: +1 800 208-3343
Email:gmack@edgetherapeutics.com