Proceeds to Advance Development of EG-1962 and Earlier Stage Pipeline BERKELEY HEIGHTS, N.J., April 9, 2015 – Edge Therapeutics, a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies for acute, life-threatening neurological conditions, today announced that it has raised approximately $72.5 million in gross proceeds from two recently completed private financing rounds.
The most recent round, a $56 million Series C-2 financing, was completed in April 2015 and was led by Venrock with participation of Sofinnova Ventures, Janus Capital Management LLC, funds managed by Franklin Advisors, Inc., New Leaf Venture Partners and BioMed Ventures. The earlier round, a $16.5 million Series C-1 financing, was completed in December 2014 and included investments by a number of high net worth individuals, family offices and private foundations. In connection with the C-2 offering, Anders Hove, M.D., Partner at Venrock and James Healy, M.D., Ph.D., Managing Partner of Sofinnova Ventures, have joined the Edge Therapeutics Board of Directors.
"This significant financing from a sophisticated syndicate of leading life sciences investors is a transformative event for Edge," said Sol J. Barer, Ph.D., Chairman of the Board of Directors of Edge Therapeutics. "We welcome the new members of our Board of Directors, whose deep experience in both venture capital and specifically in biotechnology will be invaluable as Edge continues to grow into a fully integrated biotechnology company." "Edge remains committed to helping vulnerable patients who have suffered brain hemorrhages," said Brian Leuthner, President and CEO of Edge Therapeutics. "We greatly appreciate the financial investment from our shareholders which provides resources for EG-1962, earlier stage product candidates and discovery opportunities."
Edge expects to use part of the proceeds from these financings to complete its Phase 1/2 NEWTON study and prepare for a Phase 3 pivotal study for its lead product candidate, EG-1962, which is designed to improve patient outcome following an aneurysmal subarachnoid hemorrhage (aSAH), also known as a ruptured brain aneurysm. As previously announced in February 2015, preliminary data from two of six patient cohorts of the NEWTON study showed that 61% (N = 11) of the 18 patients who received EG-1962, experienced a favorable outcome on the extended Glasgow Outcome Scale (eGOS). The eGOS is a validated 8 point scale (1 = death, 8 = good recovery) used to assess recovery for patients who have suffered a ruptured brain aneurysm. A favorable outcome in the NEWTON study protocol is defined as an eGOS score between 6 and 8 as measured 90 days after treatment.
By contrast, only 17% (N = 1) of the six patients treated with oral nimodipine in the first two cohorts of the NEWTON study had a favorable outcome on the eGOS. Edge expects to complete enrollment of additional patient cohorts and announce top-line data from the NEWTON study in mid-2015. Credit Suisse and Leerink Partners served as placement agents for the Series C-2 Financing, and Maxim Group, LLP served as placement agent for the Series C-1 Financing.
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. About EG-1962 and EG-1964 EG-1962 is a novel polymeric nimodipine microparticle that utilizes Edge's proprietary PrecisaTM development platform. EG-1962 is designed to avoid the dose-limiting side effects associated with oral nimodipine, including hypotension, by administering treatment directly to the site of the injury. Edge is also investigating a second compound, EG-1964, for prevention of recurrence of chronic subdural hematoma.
About The NEWTON Study
The NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study is a multicenter, randomized, controlled, open label clinical trial evaluating the safety, tolerability and pharmacokinetics of escalating doses of EG-1962 compared to the current standard of care, oral nimodipine, in patients with aSAH. About Precisa™ EG-1962 and EG-1964 both utilize Edge's proprietary, programmable, biodegradable polymer-based development platform, known as Precisa™. The Precisa™ platform allows Edge to create therapeutics capable of delivering medicines directly to the site of injury, providing a novel delivery mechanism that enables targeted and sustained drug exposure while potentially avoiding the systemic, dose-limiting side effects often associated with current standards of care. For additional information about Edge Therapeutics, please visit www.edgetherapeutics.com.
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). This press release does not constitute an offer to sell or the solicitation of an offer to buy the company's securities, nor shall there be any sale of the company's securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification for an exemption under the securities law of any such jurisdiction, including the registration requirements under U.S. securities laws. Investor Contact: Gene Mack Edge Therapeutics, Inc. Tel: +1 800 208-3343 Email: [email protected]