Edge Therapeutics Reports Third Quarter Financial Results
November 01 2016 - 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 for the three months ended September
30, 2016 and recent highlights.
“Our operations are progressing according to plan and we now
have multiple sites actively screening patients for our Phase 3
NEWTON 2 study of EG-1962, including many leading academic centers
that are high-volume treatment centers for aneurysmal subarachnoid
hemorrhage (aSAH),” said Brian A. Leuthner, Edge’s President and
Chief Executive Officer. “During the quarter, we held investigator
meetings for North American and Israeli sites participating in
NEWTON 2, and received positive feedback and strong enthusiasm for
the potential clinical benefit of EG-1962 over the current standard
of care. In addition, we have commenced patient screening in our
cisternal EG-1962 study and are on track for initiating patient
enrollment in the fourth quarter of 2016. At the same time, we
continue to bolster our management team by adding the necessary
leadership and experience that complements the existing Edge team,
and strengthens our position to advance our promising portfolio of
life-saving therapies toward commercialization.”
Third Quarter and Recent Highlights
- In July, Edge initiated the pivotal Phase 3 NEWTON 2
(Nimodipine microparticles to
Enhance recovery While reducing
TOxicity after subarachNoid
hemorrhage) study of EG-1962 administered through an existing
external ventricular drain (EVD) in adults who suffer an aSAH
resulting from a ruptured brain aneurysm. For information on NEWTON
2, including a list of study sites, please visit clinicaltrials.gov
and enter the identifier NCT02790632.
- In August, Edge closed a $20 million dual-tranche term loan
with Hercules Capital, Inc. At closing, $15 million was drawn down
with an additional $5 million available to be drawn down at Edge's
option until June 2017. Proceeds from the term loan refinanced
existing debt and will be used for general corporate purposes.
- In September, Edge announced additional positive
pharmacokinetic data from the Phase 1/2 NEWTON North American study
of EG-1962 that supports the potential clinical and health economic
impact of EG-1962 in aSAH.
- In October, Edge appointed Dan Brennan, a proven and respected
commercial leader in the biopharmaceutical industry, to the newly
created position of Chief Operating Officer.
- In the third quarter, Edge began screening patients in a
multi-center, randomized, controlled, open-label study of
intracisternal administration of EG-1962 in adults with aSAH. This
study will investigate the safety and pharmacokinetic profile of
EG-1962 administered directly into the basal cisterns of the brain
compared to standard of care oral nimodipine in a group of 12
patients with aSAH. Clinical outcomes will be assessed, as
well.
Financial Results
Cash Position: Cash, cash equivalents and
marketable securities as of September 30, 2016 were $112.8 million,
compared with $130.2 million as of December 31, 2015.
Research & Development (R&D)
Expenses: R&D expenses were $6.7 million for the
three months ended September 30, 2016, compared to $6.5 million for
the same period in 2015. The increase in R&D expense was
primarily due to increased personnel-related costs related to the
NEWTON 2 study and other R&D expenses.
General & Administrative (G&A)
Expenses: General and administrative expenses were $3.6
million for the three months ended September 30, 2016, compared to
$2.0 million for the same period in 2015. The increase in G&A
expense was largely due to stock-based compensation expenses,
personnel-related costs, facilities expense, professional fees and
additional expenses to support public company operations.
Net Loss: Net loss was $10.8 million for the
three months ended September 30, 2016, compared to net loss of
$10.1 million for the same period in 2015.
Conference Call Details
Edge will host a conference call and webcast today, Tuesday,
November 1, 2016 at 8:30 a.m. Eastern time. Please dial (877)
388-5691, or (562) 350-0788 for international callers, and
reference participant code 4072165 approximately 15 minutes prior
to the call. A replay of the call may be accessed through November
15, 2016 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 4072165. 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 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: the 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 clinical
progress of EG-1962, initiating enrollment in the fourth quarter of
2016 for intracisternal administration of EG-1962 and additional
and previously reported data reinforcing Edge’s belief in the
potential clinical and health economic impact of EG-1962 and its
potential to become a significant new treatment for aSAH. 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 September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development
expenses |
|
$ |
6,724,503 |
|
|
$ |
6,507,972 |
|
|
|
$ |
18,046,572 |
|
|
$ |
12,574,455 |
|
General and administrative
expenses |
|
|
3,552,289 |
|
|
|
1,976,888 |
|
|
|
|
10,526,775 |
|
|
|
5,052,983 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
10,276,792 |
|
|
|
8,484,860 |
|
|
|
|
28,573,347 |
|
|
|
17,627,438 |
|
Loss from
operations |
|
|
(10,276,792 |
) |
|
|
(8,484,860 |
) |
|
|
|
(28,573,347 |
) |
|
|
(17,627,438 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
Warrant remeasurement |
|
|
- |
|
|
|
(1,433,502 |
) |
|
|
|
- |
|
|
|
(1,879,823 |
) |
Other Expense |
|
|
(163,463 |
) |
|
|
- |
|
|
|
|
(163,463 |
) |
|
|
- |
|
Interest income |
|
|
56,082 |
|
|
|
1,333 |
|
|
|
|
148,272 |
|
|
|
2,810 |
|
Interest expense |
|
|
(375,089 |
) |
|
|
(213,021 |
) |
|
|
|
(717,263 |
) |
|
|
(615,047 |
) |
Net loss and
comprehensive loss |
|
|
(10,759,262 |
) |
|
|
(10,130,050 |
) |
|
|
|
(29,305,801 |
) |
|
|
(20,119,498 |
) |
Cumulative dividend on
Series C , C-1 and C-2 convertible preferred stock |
|
|
- |
|
|
|
(1,827,568 |
) |
|
|
|
- |
|
|
|
(4,257,083 |
) |
Net loss attributable
to common stockholders |
|
$ |
(10,759,262 |
) |
|
$ |
(11,957,618 |
) |
|
|
$ |
(29,305,801 |
) |
|
$ |
(24,376,581 |
) |
|
|
|
|
|
|
|
|
|
|
Loss per share
attributable to common stockholders |
|
|
|
|
|
|
|
|
|
basic and diluted |
|
$ |
(0.37 |
) |
|
$ |
(7.08 |
) |
|
|
$ |
(1.02 |
) |
|
$ |
(14.44 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding basic and diluted |
|
|
28,896,941 |
|
|
|
1,688,475 |
|
|
|
|
28,848,842 |
|
|
|
1,688,475 |
|
|
|
|
|
|
|
|
|
|
|
EDGE THERAPEUTICS,
INC.Balance Sheets
|
|
September 30, |
|
December 31, |
|
|
|
2016 |
|
|
|
2015 |
|
ASSETS |
|
(unaudited) |
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
112,784,622 |
|
|
$ |
130,189,421 |
|
Prepaid expenses and other current
assets |
|
|
359,863 |
|
|
|
1,081,084 |
|
Total current assets |
|
|
113,144,485 |
|
|
|
131,270,505 |
|
|
|
|
|
|
Property and equipment, net |
|
|
3,291,873 |
|
|
|
2,766,992 |
|
Other assets |
|
|
142,870 |
|
|
|
55,161 |
|
|
|
|
|
|
Total assets |
|
$ |
116,579,228 |
|
|
$ |
134,092,658 |
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
LIABILITIES |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
1,963,350 |
|
|
$ |
2,584,249 |
|
Accrued expenses |
|
|
2,290,249 |
|
|
|
3,734,348 |
|
Short term debt |
|
|
- |
|
|
|
2,271,111 |
|
Total current liabilities |
|
|
4,253,599 |
|
|
|
8,589,708 |
|
|
|
|
|
|
Noncurrent
liability: |
|
|
|
|
Long term debt |
|
|
14,817,482 |
|
|
|
3,025,423 |
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY |
|
|
|
|
Common stock, $0.00033 par value,
75,000,000 shares authorized at September 30, 2016 and December 31,
2015, 28,915,226 shares and 28,810,845 shares issued and
outstanding at September 30, 2016 and December 31, 2015,
respectively |
|
|
9,754 |
|
|
|
9,720 |
|
Additional paid-in capital |
|
|
189,058,164 |
|
|
|
184,721,777 |
|
Accumulated deficit |
|
|
(91,559,771 |
) |
|
|
(62,253,970 |
) |
Total stockholders' equity |
|
|
97,508,147 |
|
|
|
122,477,527 |
|
|
|
|
|
|
Total liabilities and stockholders'
equity |
|
$ |
116,579,228 |
|
|
$ |
134,092,658 |
|
|
|
|
|
|
Investor Contact:
Gregory Gin
Edge Therapeutics, Inc.
Tel: 1-800-208-EDGE (3343)
Email: ir@edgetherapeutics.com
Media Contact:
Laura Bagby
6 Degrees
Tel: 312-448-8098
Email: lbagby@6degreespr.com
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