SUMMARY
This summary highlights selected information from this prospectus and the documents incorporated herein
by reference and does not contain all of the information that you need to consider in making your investment
decision. You should carefully read the entire prospectus, including the risks of investing in our securities
discussed under Risk Factors beginning on page 5 of this prospectus, the information incorporated herein by
reference, including our financial statements, and the exhibits to the registration statement of which this
prospectus is a part. All references in this prospectus to we, us, our, Edge, the Company and similar
designations refer to Edge Therapeutics, Inc. and its consolidated subsidiaries, unless otherwise indicated or as
the context otherwise requires.
Our Business
We are 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 critical care conditions. Our initial product candidates target rare, acute, life-threatening conditions for which we believe the approved existing therapies, if any, are inadequate.
We believe EG-1962, our lead product candidate, can 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
TM
development platform, through a novel delivery mechanism that enables targeted and sustained drug exposure while potentially avoiding dose-limiting systemic side effects associated with currently available formulations of nimodipine. EG-1962 has been granted orphan drug designation and Fast Track designation by the U.S. Food and Drug Administration (the FDA) for the treatment of patients with subarachnoid hemorrhage, and the European Commission granted orphan drug designation of EG-1962 for the treatment of patients with aneurysmal subarachnoid hemorrhage.
In July 2015, the 90-day outcome data were available for analysis for our Phase 1/2 clinical study of EG-1962 in North America, which we refer to as our NEWTON North America study. The NEWTON North America study met its primary and secondary endpoints of safety, tolerability, maximum tolerated dose (MTD) and pharmacokinetics. The results of the principal exploratory endpoint from the 90-day follow-up available for patients in the NEWTON North America study cohorts demonstrated that 60% (27 of 45) of patients treated with EG-1962 experienced a favorable clinical outcome (a score of 6 − 8 on the extended Glasgow Outcome Scale, or GOSE) versus only 28% (5 of 18) of patients treated with the standard of care, oral nimodipine. At final assessment, of the 45 patients treated with EG-1962 in NEWTON North America, 29% (13 of 45) of patients across 17 sites achieved the highest clinical outcome score (GOSE = 8, Upper Good Recovery) versus only 6% (1 of 18) of patients treated with the standard of care, oral nimodipine.
In July 2016 we commenced the Phase 3 NEWTON 2 study for EG-1962. NEWTON 2 is a Phase 3, multi-center, multi-national, randomized, double-blind, placebo-controlled, parallel-group study comparing the efficacy and safety of EG-1962 to standard of care oral nimodipine in adults with an aSAH. The primary endpoint of the NEWTON 2 study is the proportion of subjects with a favorable clinical outcome (a score of 6 – 8 on the GOSE) at day 90. The key secondary endpoint is the subjects score on the Montreal Cognitive Assessment scale, or MoCA. We expect the results of an interim analysis to be completed in early 2018 with the results of the full study to be available in late 2018.
We have also initiated a study of the safety, pharmacokinetics and clinical outcomes of EG-1962 administered directly into the basal cisterns of the brain in patients with aSAH who do not receive an external-ventricular drain (EVD) but remain at risk for delayed neurological complications following surgical repair of a ruptured aneurysm. This study is a US multicenter, randomized, controlled, open-label study in which 9 patients are expected to receive EG-1962 via intracisternal administration and 3 patients are expected to receive standard of care oral nimodipine. We expect data to be available from this study during 2017.
In addition to EG-1962, we are using our Precisa development platform to develop additional product candidates targeting other acute, serious conditions where limited or no effective therapies currently exist. We are developing our second product candidate, EG-1964, as a potential prophylactic treatment in the management of chronic subdural hematoma, or cSDH, to prevent recurrent bleeding on the surface of the brain. A cSDH is a