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Edge Therapeutics Reports Second Quarter 2017 Financial Results And Continued Operational Progress



8/1/2017 1:09:40 PM

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BERKELEY HEIGHTS, N.J., Aug. 01, 2017 (GLOBE NEWSWIRE) -- Edge Therapeutics, Inc. (Nasdaq:EDGE), a clinical-stage biotechnology company developing novel hospital-based therapies for the management of acute, life-threatening conditions, today announced financial and operational results for the quarter ended June 30, 2017, and recent corporate progress.

“During the second quarter, we further advanced development of EG-1962 on multiple fronts and achieved important pre-commercial and regulatory progress for EG-1962,” said Brian A. Leuthner, Edge’s President and Chief Executive Officer. “NEWTON 2, our Phase 3 clinical study designed to support potential registrations throughout the world for EG-1962 as a treatment for aneurysmal subarachnoid hemorrhage (aSAH) delivered via external ventricular drain, is ongoing. We look forward to the study’s pre-planned futility analysis in late-2017, top-line efficacy results from the interim analysis in the first quarter of 2018 and, if needed, top-line results from the full study in late-2018. We are also evaluating alternative routes of administration to expand the population of aSAH patients who may benefit from EG-1962. This includes our ongoing controlled study of EG-1962 delivered directly into the basal cisterns of the brain in good-grade patients with ruptured brain aneurysms. In addition, during the quarter, we initiated development activities for lumbar administration of EG-1962. There remains a significant unmet need to improve outcomes in patients with aSAH, and we look forward to receiving EG-1962 data in the coming quarters.”

Second Quarter and Recent Key Achievements

  • Received from the European Medicines Agency a product-specific pediatric waiver for EG-1962 across all subsets of the pediatric population, which removes the requirement for pediatric clinical studies to support a marketing authorization application for EG-1962 in Europe.
  • Signed a supply agreement with Oakwood Laboratories for the commercial manufacturing of EG-1962 for initial product launch and thereafter.
  • Initiated a preclinical study of lumbar administration of EG-1962 in order to explore alternative routes of administration for aSAH patients, as well as to investigate EG-1962’s potential to address other serious conditions with high unmet need and few available treatment options.
  • Secured $18 million in gross proceeds from a registered direct offering of common stock at a purchase price of $10.00 per share, a price that exceeded the closing price of Edge common stock on the date of the purchase agreement.

Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2017 were $108.7 million, compared with $106.4 million as of December 31, 2016.

Research & Development (R&D) Expenses: R&D expenses were $9.0 million in the second quarter of 2017, compared to $6.0 million in the second quarter of 2016. The increase in R&D expense was primarily due to an increase in external expenses related to EG-1962 clinical development, personnel-related costs related to the NEWTON 2 study and other R&D expenses.

General & Administrative (G&A) Expenses: G&A expenses were $4.2 million for the three months ended June 30, 2017, compared to $3.3 million in the comparable period in 2016. The increase in G&A expense was largely due to increases in legal and professional fees, personnel-related costs, and other expenses.

Net Loss: Net loss was $13.5 million for the second quarter ended June 30, 2017, compared to net loss of $9.4 million for the comparable period in 2016.

Conference Call Details

Edge will host a conference call and webcast today, Tuesday, August 1, 2017 at 8:30 a.m. EDT. Please dial (877) 388-5691, or (562) 350-0788 for international callers, and reference participant code 53280120 approximately 15 minutes prior to the call. A replay of the call may be accessed through August 15, 2017 on the investor section of Edge’s website or by dialing (855) 859-2056, or (404) 537-3406 for international callers, and referencing participant code 53280120. A live webcast of the conference call will be available on the investor relations section of Edge’s website at www.edgetherapeutics.com.

About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms for the management of acute, life-threatening neurological and other conditions. EG-1962, Edge’s lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, which is bleeding around the brain due to a ruptured brain aneurysm.

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