Edge Therapeutics Reports First Quarter 2017 Financial Results and Continued Operational Progress
May 03 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 results and corporate highlights for the
quarter ended March 31, 2017, and recent highlights.
“We began 2017 by successfully building upon the positive
momentum of last year,” said Brian A. Leuthner, Edge’s President
and Chief Executive Officer. “Our EG-1962 Phase 3 NEWTON 2 study
continues to progress in the clinic and we have activated our first
site in Europe. We remain on track with our previously stated
anticipated timelines for NEWTON 2 top-line efficacy data from the
pre-specified interim analysis and from the full study. In
addition, we initiated our study assessing EG-1962 administered
directly into the basal cisterns of the brain for aneurysmal
subarachnoid hemorrhage (aSAH). We also received notification that
the Pediatric Committee (PDCO) of the European Medicines Agency
(EMA) has recommended granting a pediatric waiver for EG-1962. On
the financial front, we recently added to our strong cash position,
which enables us to accelerate timelines for pre-commercial
activities for EG-1962 and execute strategies to expand our product
portfolio.”
First Quarter and Recent Key Achievements
- Activated the first clinical site in Europe for the Phase 3
NEWTON 2 study.
- Initiated Edge’s multi-center, controlled, open-label study of
intracisternal administration of EG-1962 in adults with aSAH.
- The PDCO of the EMA recommended granting a product-specific
waiver for EG-1962 across all subsets of the pediatric
population.
- Reported additional data on EG-1962 at the International Stroke
Conference 2017 in February.
- Appointed Alyssa Wyant as Senior Vice President, Regulatory
Affairs, further strengthening Edge’s organizational infrastructure
and leadership team.
- Secured $18 million in gross proceeds from an above market
registered direct offering of common stock at a purchase price of
$10.00 per share.
Financial Results
Cash Position: Cash, cash equivalents and
marketable securities as of March 31, 2017 were $95.6 million,
compared with $106.4 million as of December 31, 2016. On April 21,
2017, Edge closed the sale of shares of its common stock in a
registered direct offering of $18 million in gross proceeds from
Satter Medical Technology Partners, L.P., an investment firm with
significant investments in several life sciences and medical
technology companies.
Research & Development (R&D)
Expenses: R&D expenses were $7.6 million in the
first quarter of 2017, compared to $5.3 million in the first
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 March 31, 2017, compared to $3.7 million in the
comparable period in 2016. The increase in G&A expense was
largely due to increases in personnel-related costs, non-recurring
executive separation costs, stock-based compensation expenses,
facilities expense, and professional fees.
Net Loss: Net loss was $12.2 million for the
first quarter ended March 31, 2017, compared to net loss of $9.2
million for the comparable period in 2016.
Conference Call Details
Edge will host a conference call and webcast today, Wednesday,
May 3, 2017 at 8:30 a.m. EDT. Please dial (877) 388-5691, or (562)
350-0788 for international callers, and reference participant code
7855024 approximately 15 minutes prior to the call. A replay of the
call may be accessed through May 17, 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
7855024. 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, Edge remaining on track with its
previously stated anticipated timelines for NEWTON 2 top-line
efficacy data from the pre-specified interim analysis and from the
full study and the recent financing extending Edge’s cash runway
while enabling it to accelerate timelines for pre-commercial
activities for EG-1962 and execute strategies to expand its product
portfolio. 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 March 31, |
|
|
2017 |
|
2016 |
Operating
expenses: |
|
|
|
|
Research
and development expenses |
|
$ |
7,589,496 |
|
$ |
5,346,763 |
General
and administrative expenses |
|
|
4,201,842 |
|
|
3,685,597 |
|
|
|
|
|
|
|
Total operating
expenses |
|
|
11,791,338 |
|
|
9,032,360 |
|
|
|
|
|
|
|
Loss from
operations |
|
|
(11,791,338) |
|
|
(9,032,360) |
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
Interest
income |
|
|
96,259 |
|
|
42,814 |
Interest
expense |
|
|
(475,141) |
|
|
(180,864) |
|
|
|
|
|
|
|
Net loss and
comprehensive loss |
|
$ |
(12,170,220) |
|
$ |
(9,170,410) |
|
|
|
|
|
|
|
Loss per share basic
and diluted |
|
$ |
(0.42) |
|
$ |
(0.32) |
|
|
|
|
|
|
|
Weighted average common
shares outstanding basic and diluted |
|
|
28,998,616 |
|
|
28,812,907 |
EDGE THERAPEUTICS, INC. |
Balance Sheets |
|
|
March 31, 2017 |
|
December 31, 2016 |
ASSETS |
(unaudited) |
|
|
Current
assets: |
|
|
|
Cash and
cash equivalents |
$ |
95,590,661 |
|
$ |
106,398,919 |
Prepaid
expenses and other current assets |
|
699,525 |
|
|
954,581 |
Total
current assets |
|
96,290,186 |
|
|
107,353,500 |
Property
and equipment, net |
|
3,465,055 |
|
|
3,418,077 |
Other
assets |
|
142,870 |
|
|
142,870 |
Total assets |
$ |
99,898,111 |
|
$ |
110,914,447 |
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
$ |
2,527,616 |
|
$ |
3,471,032 |
Accrued
expenses |
|
3,638,589 |
|
|
3,213,715 |
Short
term debt |
|
579,554 |
|
|
- |
Total
current liabilities |
|
6,745,759 |
|
|
6,684,747 |
Noncurrent liability: |
|
|
|
|
|
Long term
debt |
|
14,505,605 |
|
|
14,953,143 |
STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Preferred
stock, 5,000,000 shares authorized at March 31, 2017 and
December 31, 2016, 0 outstanding |
|
- |
|
|
- |
Common
stock, $0.00033 par value, 75,000,000 shares authorized at March
31, 2017 and December 31, 2016, 29,011,436 shares
and 28,918,516 shares issued and outstanding at March
31, 2017 and December 31, 2016, respectively |
|
9,786 |
|
|
9,756 |
Additional paid-in capital |
|
191,895,736 |
|
|
190,341,769 |
Accumulated deficit |
|
(113,258,775) |
|
|
(101,074,968) |
Total
stockholders' equity |
|
78,646,747 |
|
|
89,276,557 |
Total
liabilities and stockholders' equity |
$ |
99,898,111 |
|
$ |
110,914,447 |
Investor Contact:
Gregory Gin
Edge Therapeutics, Inc.
Tel: 1-800-208-EDGE (3343)
Email: ir@edgetherapeutics.com
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