November 22, 2014 11:29 AM ET

Pharmaceuticals

Company Overview of Edge Therapeutics, Inc.

Company Overview

Edge Therapeutics, Inc., a hospital-focused biopharmaceutical company, designs and develops implantable technology for direct delivery of therapeutic compounds to the site of brain injury. Its drugs cover therapeutic areas, such as spontaneous brain hemorrhage, traumatic brain injuries, and brain surgeries. The company develops NimoGel and NimoVent to prevent delayed cerebral ischemia, a catastrophic delayed complication after subarachnoid hemorrhage. Its therapeutics are delivered to patients in the United States and internationally. The company was founded in 2009 and is based in New Providence, New Jersey.

139 South Street

Suite 102

New Providence, NJ 07974

United States

Founded in 2009

Phone:

800-208-3343

Fax:

800-208-3433

Key Executives for Edge Therapeutics, Inc.

Co-Founder
Chief Financial Officer
Age: 54
Chief Accounting and Operations Officer
Compensation as of Fiscal Year 2014.

Edge Therapeutics, Inc. Key Developments

Edge Therapeutics Announces Multi-Year Research and Discovery Collaboration with St. Michael's Hospital

Edge Therapeutics announced a multi-year research and discovery collaboration with St. Michael's Hospital. 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. 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.

Edge Therapeutics, Inc. Initiates Enrollment of Third Cohort in Phase 1/2 Newton Study of EG-1962

Edge Therapeutics, Inc. announced that it has initiated patient enrollment in the third cohort of the NEWTON study, a multicenter, randomized, controlled, open-label, Phase 1/2 clinical trial of the company's lead product candidate, EG-1962. EG-1962 is a novel polymeric nimodipine microparticle that utilizes Edge's proprietary Precisa(TM) development platform and has the potential to improve patient outcome following aneurysmal subarachnoid hemorrhage (aSAH). It is designed to avoid the dose-limiting side effects associated with standard of care oral nimodipine, including hypotension, by administering treatment directly to the site of the injury. The announcement follows the protocol-specified review by the NEWTON Data Safety Monitoring Committee (DSMC) of the safety and pharmacokinetic data from the first two cohorts (n=24) of the trial, as well as of other exploratory clinical outcomes. Based upon its review, the DSMC unanimously recommended increasing the dose of EG-1962 to 400 mg for the third cohort of the trial, as there were no unexpected drug-related serious adverse events, including hypotension, observed with either the 200 mg dose of EG-1962 in the second cohort or the 100 mg dosage in the first cohort. In contrast, 3 of 6 (50%) patients randomized to standard of care oral nimodipine experienced hypotension. The NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study is evaluating the safety, tolerability and pharmacokinetics of EG-1962 compared to the current standard of care, oral nimodipine, in patients with aSAH. The Company is also assessing patient functional outcomes at 30 and 90 days, which it believes will be indicative of the potential efficacy of EG-1962.

Edge Therapeutics, Inc. Obtains $10 Million Venture Loan Facility with Hercules Technology Growth Capital, Inc

Edge Therapeutics, Inc. announced that it has obtained up to $10 million in venture debt financing from Hercules Technology Growth Capital, Inc. to support the continued development of EG-1962, the company's lead product candidate. Edge is developing EG-1962 to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage. The company believes that EG-1962 can become the new standard of care for patients suffering from a ruptured brain aneurysm who receive an intraventricular catheter. The $10 million in funding from Hercules is in the form of secured indebtedness. Payments under the loan agreement are interest only for 12 months, followed by 30 equal monthly payments of principal and interest through the scheduled maturity date on March 1, 2018.

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