Full Press Release Details
Edge Therapeutics Reports Third Quarter
2015 Financial Results
Successfully Completed Initial Public
BERKELEY HEIGHTS, N.J. - November
6, 2015 - Edge Therapeutics, Inc. (Nasdaq: EDGE), a clinical stage biotechnology company developing novel hospital-based
therapies in the management of acute, life threatening conditions, today announced financial results and highlights for the three
months ended September 30, 2015.
has been a remarkable year so far, during which Edge has achieved several significant regulatory and corporate milestones,"
said Brian A. Leuthner, Edge's President and Chief Executive Officer. "We continue
to make tremendous progress with EG-1962, our lead product, including reporting positive results from our Phase 1/2 NEWTON study;
establishing a clear path forward for our Phase 3 pivotal study; and being awarded orphan drug status by both the FDA and European
Commission." Mr. Leuthner continued, "In addition, we recently completed a successful IPO, which further strengthens
our cash position and enables us to conduct the pivotal Phase 3 study for EG-1962 and advance our other pipeline products and development
Quarter Highlights and Recent Events
Cash, cash equivalents and marketable securities as of September
30, 2015, were $52.9 million compared to $13.7 million at December 31, 2014. The increase was due to proceeds from the issuance
of preferred stock of $52.4 million and debt of $3.0 million earlier in 2015. Cash and cash equivalents would have been approximately
$136.1 million on a pro-forma basis after taking into account proceeds from the company's IPO, which closed October 6, 2015.
Research and development (R&D) expenses were $6.5 million
for the three months ended September 30, 2015 compared to $2.4 million for the same period in 2014. The increase was primarily
due to expenses related to the Phase 1/2 NEWTON study.
General and administrative (G&A) expenses were $2.0 million
at for the three months ended September 30, 2015 compared to $1.1 million in the same period in 2014. The increase was due to increased
personnel costs, stock-based compensation, and professional fees over the prior period.
Net loss for the three months ended September 30, 2015 was $10.1
million compared to a net loss of $3.5 million for the same period in 2014.
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 in the management of acute, life-threatening neurological conditions. EG-1962, Edge's 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, Edge's 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.
EG-1962 is a novel polymeric nimodipine
microparticle containing nimodipine suspended in a diluent of hyaluronic acid that utilizes the Company's proprietary PrecisaTM
development platform designed to improve patient outcomes following aSAH. EG-1962 has been granted orphan drug designation
by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of patients with aSAH.
An aneurysmal subarachnoid hemorrhage,
or aSAH, is a brain hemorrhage after which blood from a ruptured aneurysm enters the subarachnoid space, the area between the middle
and deepest protective layers of the brain. Approximately 600,000 individuals worldwide suffer an aSAH annually. In the US, approximately
35,000 aSAH patients, with an average age of 52, arrive alive at the hospital each year, and approximately 75% of these patients
die or suffer permanent brain damage.
About the NEWTON Trial
The NEWTON trial is a multicenter,
randomized, controlled, open-label Phase 1/2 trial evaluating the safety, tolerability and pharmacokinetics of escalating doses
of EG-1962 compared to the current standard of care, oral nimodipine, in subjects with aSAH. Of the total of 72 patients enrolled,
54 patients were randomized to receive EG-1962 and 18 patients were randomized to receive oral nimodipine. Pooled efficacy results
of the NEWTON trial showed that 60% of patients treated with EG-1962 achieved a favorable outcome (scores of 6-8 as measured by
the Extended Glasgow Outcome Score (GOSE)) at 90 days compared to 28% of patients in the active control standard of care oral nimodipine
arm who achieved a favorable outcome.
For additional information about Edge
Therapeutics, please visit www.edgetherapeutics.com.
Forward-Looking Statements
This press release and any statements
of representatives and partners of Edge Therapeutics, Inc. (the "Company") related thereto that are not historical
in nature (including but not limited to upcoming milestones) contain, or may contain, among other things, certain "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act of 1995.. These forward-looking 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 risk factors (many of which are beyond the Company's
control) as described under the heading "Risk Factors" in the Company's filings with the United States Securities
and Exchange Commission. The Company assumes no obligation to update or revise any forward-looking-statements contained in this
press release whether as a result of new information or future events, except as may be required by law.
Edge Therapeutics, Inc.
Tel: 1-800-208-EDGE (3343)
Email: awey@edgetherapeutics.com