Edge Therapeutics

Edge Therapeutics was a clinical-stage biotechnology firm established in 2009 by co-founders Brian A. Leuthner, who served as President and CEO, and R. Loch Macdonald, who acted as Chief Scientific Officer. Leuthner brought over two decades of experience in the hospital acute care market to the venture. The company focused on discovering and developing hospital-based therapies for acute, life-threatening neurological conditions. Its business model centered on reformulating proven, FDA-approved drugs into targeted, locally delivered treatments to minimize systemic side effects. This was achieved through its proprietary Precisa™ development platform, which created polymer-based microparticles for targeted and sustained drug release directly at the site of injury.

The company's lead product candidate was EG-1962, a polymeric microparticle formulation of nimodipine designed for direct administration to the brain to treat aneurysmal subarachnoid hemorrhage (aSAH), a type of brain bleed from a ruptured aneurysm. The goal was for a single dose to provide sustained drug exposure over 21 days, improving patient outcomes and offering a more convenient and effective option than the standard oral nimodipine. After showing promise in early trials and raising significant funding, including an IPO in 2015, the company advanced EG-1962 into a pivotal Phase III trial.

In March 2018, the trajectory of Edge Therapeutics changed dramatically when an Independent Data Monitoring Committee recommended halting the Phase III trial for EG-1962, citing a low probability of meeting its primary endpoint. This event led to a collapse in the company's stock price and a significant operational scale-back, as EG-1962 was its only clinical-stage asset. Following this setback, Edge explored strategic alternatives and in November 2018, announced a definitive merger agreement with PDS Biotechnology Corporation. The merger was completed in March 2019, with the combined entity operating under the PDS Biotechnology name (NASDAQ: PDSB) and shifting focus to PDS's pipeline of cancer immunotherapies. Pre-merger Edge security holders retained approximately 30% of the new company.

Keywords: neurological therapies, biotechnology, drug delivery, aneurysmal subarachnoid hemorrhage, EG-1962, Precisa platform, nimodipine microparticle, Brian Leuthner, R. Loch Macdonald, clinical-stage, hospital-based therapies, PDS Biotechnology merger, aSAH treatment, brain injury, targeted drug delivery, polymeric microparticles, biopharmaceutical, venture capital, stock market, pharmaceutical development