Edge Therapeutics Reports Second Quarter 2017 Financial Results and Continued Operational Progress
August 01 2017 - 6:30AM
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. Edge is evaluating EG-1962 in two
clinical studies: a pivotal Phase 3 NEWTON 2 study of EG-1962
delivered via external ventricular drain, and a study of direct
intracisternal administration of EG-1962. For additional
information about Edge, please visit www.edgetherapeutics.com.
Forward-Looking StatementsThis press release
and any statements of representatives of Edge Therapeutics, Inc.
related thereto that are not historical in nature 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 Edge’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," “seeks,” "intends," "plans," "potential" or similar
expressions, including statements with respect to the potential
effects of its products, the design of NEWTON 2 potentially
supporting registration for EG-1962 throughout the world, the
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. These
statements are based upon the current beliefs and expectations of
Edge’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
Edge's control) as described under the heading "Risk Factors" in
Edge’s filings with the United States Securities and Exchange
Commission.
EDGE THERAPEUTICS,
INC.Statements of Operations and Comprehensive
Loss(Unaudited) |
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development expenses |
$ |
8,975,304 |
|
|
$ |
5,975,306 |
|
|
$ |
16,564,800 |
|
|
$ |
11,322,069 |
|
General
and administrative expenses |
|
4,173,384 |
|
|
|
3,288,889 |
|
|
|
8,375,226 |
|
|
|
6,974,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
13,148,688 |
|
|
|
9,264,195 |
|
|
|
24,940,026 |
|
|
|
18,296,555 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(13,148,688 |
) |
|
|
(9,264,195 |
) |
|
|
(24,940,026 |
) |
|
|
(18,296,555 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
168,974 |
|
|
|
49,376 |
|
|
|
265,233 |
|
|
|
92,190 |
|
Interest
expense |
|
(524,768 |
) |
|
|
(161,310 |
) |
|
|
(999,909 |
) |
|
|
(342,174 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss |
|
(13,504,482 |
) |
|
|
(9,376,129 |
) |
|
|
(25,674,702 |
) |
|
|
(18,546,539 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share basic
and diluted |
$ |
(0.44 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.86 |
) |
|
$ |
(0.64 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding basic and diluted |
|
30,403,419 |
|
|
|
28,828,449 |
|
|
|
29,704,898 |
|
|
|
28,820,678 |
|
EDGE THERAPEUTICS, INC.Balance
Sheets |
|
|
|
|
|
June 30, 2017 |
|
December 31, 2016 |
ASSETS |
(unaudited) |
|
|
Current
assets: |
|
|
|
Cash and
cash equivalents |
$ |
108,714,544 |
|
|
$ |
106,398,919 |
|
Prepaid
expenses and other current assets |
|
636,939 |
|
|
|
954,581 |
|
Total
current assets |
|
109,351,483 |
|
|
|
107,353,500 |
|
Property
and equipment, net |
|
3,491,619 |
|
|
|
3,418,077 |
|
Other
assets |
|
142,870 |
|
|
|
142,870 |
|
Total assets |
$ |
112,985,972 |
|
|
$ |
110,914,447 |
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
$ |
4,350,153 |
|
|
$ |
3,471,032 |
|
Accrued
expenses |
|
4,154,019 |
|
|
|
3,213,715 |
|
Short
term debt |
|
3,086,296 |
|
|
|
- |
|
Total
current liabilities |
|
11,590,468 |
|
|
|
6,684,747 |
|
Noncurrent liability: |
|
|
|
|
|
Long term
debt |
|
17,127,131 |
|
|
|
14,953,143 |
|
STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Preferred
stock, 5,000,000 shares authorized at June 30, 2017 and
December 31, 2016, 0 outstanding |
|
- |
|
|
|
- |
|
Common
stock, $0.00033 par value, 75,000,000 shares authorized at June 30,
2017 and December 31, 2016, 30,829,264 shares and 28,918,516 shares
issued and outstanding at June 30, 2017 and December 31, 2016,
respectively |
|
10,386 |
|
|
|
9,756 |
|
Additional paid-in capital |
|
211,021,245 |
|
|
|
190,341,769 |
|
Accumulated deficit |
|
(126,763,258 |
) |
|
|
(101,074,968 |
) |
Total
stockholders' equity |
|
84,268,373 |
|
|
|
89,276,557 |
|
Total
liabilities and stockholders' equity |
$ |
112,985,972 |
|
|
$ |
110,914,447 |
|
Investor and Media Contact:
Gregory Gin
Edge Therapeutics, Inc.
Tel: 1-800-208-EDGE (3343)
Email: ir@edgetherapeutics.com
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