Edge Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results
March 02 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 fourth
quarter and full-year ended December 31, 2016.
“Edge achieved several key clinical, regulatory and corporate
milestones in 2016, including commencing the Phase 3 trial for
EG-1962, receiving FDA Fast Track designation for EG-1962 and
making key additions to our leadership team,” said Brian A.
Leuthner, Edge’s President and Chief Executive Officer. “Looking
ahead, we are operationally and financially well-positioned to
execute our corporate growth strategy, in particular, continuing to
advance EG-1962 through achievement of key additional clinical
milestones including the anticipated completion of our Phase 3
NEWTON 2 study, while conducting additional research in order to
select the next PRECISATM-based development candidate from our
pipeline of potentially life-saving therapies.”
2016 and Recent Key Achievements
- Reported additional positive clinical data from Phase 1/2
NEWTON study of EG-1962, supporting its potential pharmacoeconomic
impact in the treatment of aneurysmal subarachnoid hemorrhage
(aSAH), including reductions in ICU and hospital length of stay
versus standard of care.
- Reported additional positive pharmacokinetic data from Phase
1/2 NEWTON North American study.
- Initiated pivotal Phase 3 NEWTON 2 study of EG-1962 in
aSAH.
- Publication of Phase 1/2 NEWTON study data in peer-reviewed
medical journal, Stroke.
- Granted Fast Track designation from the U.S. Food and Drug
Administration for EG-1962 for the treatment of subarachnoid
hemorrhage.
- Continued to expand and strengthen the organizational
infrastructure and leadership team with key executive appointments
in operations, clinical development and regulatory affairs.
- Ended 2016 with a strong balance sheet including $106.4 million
in cash and cash equivalents as of December 31, 2016.
Financial Results
Cash Position: Cash, cash equivalents and
marketable securities as of December 31, 2016 were $106.4 million,
compared with $130.2 million as of December 31, 2015.
Research & Development (R&D)
Expenses: R&D expenses were $6.8 million in the
fourth quarter of 2016 and $24.8 million in the year ended December
31, 2016, compared to $5.3 million and $17.8 million in the
comparable periods in 2015. 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 in the fourth
quarter of 2016 and $14.7 million in the year ended December 31,
2016, compared to $3.6 million and $8.7 million in the comparable
periods in 2015. The increase in G&A expense was largely due to
increases in personnel-related costs, stock-based compensation
expenses, facilities expense, and professional fees.
Net Loss: Net loss was $9.5 million for the
fourth quarter and $38.8 million for the year ended December 31,
2016, compared to net loss of $8.0 million and $28.1 million for
the comparable periods of 2015.
Conference Call Details
Edge will host a conference call and webcast today, Thursday,
March 2, 2017 at 8:30 a.m. Eastern time. Please dial (877)
388-5691, or (562) 350-0788 for international callers, and
reference participant code 65067360 approximately 15 minutes prior
to the call. A replay of the call may be accessed through March 16,
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 65067360. 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: 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 Edge’s being
operationally and financially positioned to execute its corporate
growth strategy, continuing to advance EG-1962 through achievement
of key additional clinical milestones including the anticipated
completion of the Phase 3 NEWTON 2 study, while conducting
additional research in order to select the next development
candidate from its pipeline of potentially life-saving therapies
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.
Investor Contact:Gregory GinEdge Therapeutics,
Inc.Tel: 1-800-208-EDGE (3343)Email: ir@edgetherapeutics.com
Media Contact:Laura Bagby6 DegreesTel:
312-448-8098Email: lbagby@6degreespr.com
|
EDGE THERAPEUTICS, INC. |
Statements of Operations and Comprehensive
Loss |
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Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
|
2016 |
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|
2015 |
|
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|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development expenses |
|
$ |
6,778,807 |
|
|
$ |
5,265,496 |
|
|
$ |
24,825,379 |
|
|
$ |
17,839,951 |
|
General and
administrative expenses |
|
|
4,159,992 |
|
|
|
3,605,884 |
|
|
|
14,686,767 |
|
|
|
8,658,867 |
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
10,938,799 |
|
|
|
8,871,380 |
|
|
|
39,512,146 |
|
|
|
26,498,818 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(10,938,799 |
) |
|
|
(8,871,380 |
) |
|
|
(39,512,146 |
) |
|
|
(26,498,818 |
) |
|
|
|
|
|
|
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Other income
(expense): |
|
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|
|
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|
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Warrant
remeasurement |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,879,823 |
) |
Other expense |
|
|
- |
|
|
|
- |
|
|
|
(163,463 |
) |
|
|
- |
|
Interest income |
|
|
64,027 |
|
|
|
6,274 |
|
|
|
212,299 |
|
|
|
9,084 |
|
Interest expense |
|
|
(486,411 |
) |
|
|
(201,447 |
) |
|
|
(1,203,674 |
) |
|
|
(816,494 |
) |
|
|
|
|
|
|
|
|
|
Loss before income
taxes |
|
|
(11,361,183 |
) |
|
|
(9,066,553 |
) |
|
|
(40,666,984 |
) |
|
|
(29,186,051 |
) |
|
|
|
|
|
|
|
|
|
Benefit for income
taxes |
|
|
1,845,986 |
|
|
|
1,107,405 |
|
|
|
1,845,986 |
|
|
|
1,107,405 |
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss |
|
|
(9,515,197 |
) |
|
|
(7,959,148 |
) |
|
|
(38,820,998 |
) |
|
|
(28,078,646 |
) |
|
|
|
|
|
|
|
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Cumulative
dividend on Series C , C-1 and C-2 convertible preferred
stock |
|
- |
|
|
|
(99,325 |
) |
|
|
- |
|
|
|
(4,356,408 |
) |
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|
|
|
|
|
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Net loss attributable
to common stockholders |
|
$ |
(9,515,197 |
) |
|
$ |
(8,058,473 |
) |
|
$ |
(38,820,998 |
) |
|
$ |
(32,435,054 |
) |
|
|
|
|
|
|
|
|
|
Loss per share
attributable to common stockholders |
|
|
|
|
|
|
|
|
basic and
diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.30 |
) |
|
$ |
(1.34 |
) |
|
$ |
(4.01 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding basic and diluted |
|
|
28,917,648 |
|
|
|
27,286,273 |
|
|
|
28,864,216 |
|
|
|
8,087,924 |
|
|
|
|
|
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EDGE THERAPEUTICS, INC. |
Balance Sheets |
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December 31, |
December 31, |
|
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2016 |
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|
2015 |
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ASSETS |
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|
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Current assets: |
|
|
|
|
Cash and cash
equivalents |
|
$ |
106,398,919 |
|
|
$ |
130,189,421 |
|
Prepaid expenses and
other current assets |
|
|
954,581 |
|
|
|
1,081,084 |
|
Total current
assets |
|
|
107,353,500 |
|
|
|
131,270,505 |
|
|
|
|
|
|
Property and equipment,
net |
|
|
3,418,077 |
|
|
|
2,766,992 |
|
Other assets |
|
|
142,870 |
|
|
|
55,161 |
|
|
|
|
|
|
Total assets |
|
$ |
110,914,447 |
|
|
$ |
134,092,658 |
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
LIABILITIES |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
|
$ |
3,471,032 |
|
|
$ |
2,584,249 |
|
Accrued expenses |
|
|
3,213,715 |
|
|
|
3,734,348 |
|
Short term debt |
|
|
- |
|
|
|
2,271,111 |
|
Total current
liabilities |
|
|
6,684,747 |
|
|
|
8,589,708 |
|
|
|
|
|
|
Noncurrent
liability: |
|
|
|
|
Long term debt |
|
|
14,953,143 |
|
|
|
3,025,423 |
|
|
|
|
|
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STOCKHOLDERS'
EQUITY |
|
|
|
|
Preferred stock,
5,000,000 shares authorized at December 31, 2016 and 2015,
zero outstanding |
|
|
- |
|
|
|
- |
|
Common stock, $0.00033
par value, 75,000,000 shares authorized at December 31, 2016 |
|
|
|
|
and December 31, 2015,
28,918,516 shares and 28,810,845 shares issued and outstanding |
|
|
|
|
at December 31, 2016
and December 31, 2015, respectively |
|
|
9,756 |
|
|
|
9,720 |
|
Additional paid-in
capital |
|
|
190,341,769 |
|
|
|
184,721,777 |
|
Accumulated
deficit |
|
|
(101,074,968 |
) |
|
|
(62,253,970 |
) |
Total stockholders'
equity |
|
|
89,276,557 |
|
|
|
122,477,527 |
|
|
|
|
|
|
Total liabilities and
stockholders' equity |
|
$ |
110,914,447 |
|
|
$ |
134,092,658 |
|
|
|
|
|
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