Edge Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results
March 01 2018 - 6:30AM
Interim Analysis from EG-1962 Phase 3 NEWTON 2
Study in Aneurysmal Subarachnoid Hemorrhage Expected by the End of
April 2018
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, 2017.
“In 2017, Edge Therapeutics achieved meaningful progress as we
continued to develop and seek to commercialize EG-1962 to address
the unmet need of patients with aneurysmal subarachnoid hemorrhage
(aSAH),” said Brian A. Leuthner, Edge’s President and Chief
Executive Officer. “Our Phase 3 NEWTON 2 study of EG-1962 is
proceeding on track to the interim analysis after completion in
December 2017 of the pre-planned futility analysis. In preparation
for potential commercialization of EG-1962, we secured a commercial
supply agreement with an external manufacturer for EG-1962. In
addition, as part of our pre-commercial planning, we continue to
gain a better understanding regarding health economic outcomes and
the tremendous economic burden of aSAH.”
Leuthner continued, “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
NEWTON 2 interim analysis by the end of April, and if the study
continues to full enrollment as planned, top-line results from the
full NEWTON 2 study in late 2018. In 2018, we are also focused on
expanding our pipeline by conducting additional preclinical
development in order to select the next PRECISATM-based development
candidate, as well as pursuing external business development
opportunities to acquire additional products for our development
portfolio.”
2017 Key Achievements
- Completed the EG-1962 Phase 3 NEWTON 2 Futility
Analysis; Study Continues as Planned. In December 2017,
Edge announced that an independent Data Monitoring Committee (DMC)
recommended that the Phase 3 NEWTON 2 study of EG-1962 continue as
planned based on the completion of a pre-planned futility analysis.
The DMC made this recommendation after evaluating data from the Day
90 follow-up visit of the first 150 patients randomized and
treated, as well as the available safety data in the study.
- Presented Health Economic Data at the Neurocritical
Care Society (NCS) 15th Annual Meeting. Edge presented new
retrospective, claims-based health economic data showing aSAH per
patient hospital charges represent a high economic burden for U.S.
hospitals, and ultimately to government and commercial insurers.
The analysis also showed that the aSAH patient population currently
being studied in the NEWTON 2 study had the highest per patient
hospital charges and experienced the longest hospitalizations among
all aSAH patients. Specifically, these are patients who require an
external ventricular drain (EVD), and undergo either neurosurgical
clipping or endovascular coiling for repair of their aneurysm.
- Received Pediatric Investigation Plan Waiver from the
European Medicines Agency. Edge 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.
- Secured a Commercial Supply Manufacturer for
EG-1962. Edge signed a supply agreement with Oakwood
Laboratories for the commercial manufacture of EG-1962 for initial
product launch and thereafter.
- Continued to expand and strengthen the organizational
infrastructure and leadership team. Edge appointed
experienced executives in regulatory affairs and finance, and added
to its Board of Directors.
Financial Results
Cash Position: Cash, cash equivalents and
marketable securities as of December 31, 2017 were $88.1 million,
compared with $106.4 million as of December 31, 2016. Net cash used
in operating activities was $40.7 million for the year.
Research & Development (R&D)
Expenses: R&D expenses were $10.8 million in the
fourth quarter of 2017 and $34.3 million in the year ended December
31, 2017, compared to $6.8 million and $24.8 million in the
comparable periods in 2016. The increase in R&D expense was
primarily due to an increase in external expenses related to
EG-1962 clinical development, EG-1964 formulation development, and
personnel-related costs for the NEWTON 2 study.
General & Administrative (G&A)
Expenses: G&A expenses were $5.3 million in the fourth
quarter of 2017 and $17.7 million in the year ended December 31,
2017, compared to $4.2 million and $14.7 million in the comparable
periods in 2016. The increase in G&A expense was largely due to
increases in personnel-related costs, investor relations costs,
stock-based compensation expenses, and legal and professional
fees.
Net Loss: Net loss was $13.9 million for the
fourth quarter and $50.9 million for the year ended December 31,
2017, compared to net loss of $9.5 million and $38.8 million for
the comparable periods of 2016.
Conference Call Details
Edge will host a conference call and webcast today, Thursday,
March 1, 2018 at 8:30 a.m. Eastern time. Please dial (877)
388-5691, or (562) 350-0788 for international callers, and
reference conference ID 4891539 approximately 15 minutes prior to
the call. A replay of the call may be accessed through March 15,
2018 on the investor section of Edge’s website or by dialing (855)
859-2056, or (404) 537-3406 for international callers, and
referencing conference ID 4891539. 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 EVD, 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, the timing for results of
the NEWTON 2 interim analysis and top-line results from the full
NEWTON 2 study, expanding the pipeline by conducting additional
preclinical development in order to select the next PRECISATM-based
development candidate and pursuing external business development
opportunities to acquire additional products. 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 |
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development expenses |
|
$ |
10,833,679 |
|
|
$ |
6,778,806 |
|
|
$ |
34,311,650 |
|
|
$ |
24,825,379 |
|
General
and administrative expenses |
|
|
5,289,461 |
|
|
|
4,159,993 |
|
|
|
17,654,970 |
|
|
|
14,686,767 |
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
16,123,140 |
|
|
|
10,938,799 |
|
|
|
51,966,620 |
|
|
|
39,512,146 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(16,123,140 |
) |
|
|
(10,938,799 |
) |
|
|
(51,966,620 |
) |
|
|
(39,512,146 |
) |
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
Other
expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(163,463 |
) |
Interest
income |
|
|
221,606 |
|
|
|
64,027 |
|
|
|
700,903 |
|
|
|
212,299 |
|
Interest
expense |
|
|
(588,145 |
) |
|
|
(486,411 |
) |
|
|
(2,180,143 |
) |
|
|
(1,203,674 |
) |
|
|
|
|
|
|
|
|
|
Loss before income
taxes |
|
|
(16,489,679 |
) |
|
|
(11,361,183 |
) |
|
|
(53,445,860 |
) |
|
|
(40,666,984 |
) |
|
|
|
|
|
|
|
|
|
Benefit
for income taxes |
|
|
2,586,057 |
|
|
|
1,845,986 |
|
|
|
2,586,057 |
|
|
|
1,845,986 |
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss |
|
$ |
(13,903,622 |
) |
|
$ |
(9,515,197 |
) |
|
$ |
(50,859,803 |
) |
|
$ |
(38,820,998 |
) |
|
|
|
|
|
|
|
|
|
Loss per share basic
and diluted |
|
$ |
(0.45 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.67 |
) |
|
$ |
(1.34 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding basic and diluted |
|
|
30,863,864 |
|
|
|
28,896,941 |
|
|
|
30,393,952 |
|
|
|
28,864,216 |
|
|
|
|
|
|
|
|
|
|
EDGE THERAPEUTICS, INC.Balance
Sheets |
|
|
|
|
|
December 31, 2017 |
|
December 31, 2016 |
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and
cash equivalents |
$ |
88,067,647 |
|
|
$ |
106,398,919 |
|
Prepaid
expenses and other current assets |
|
986,680 |
|
|
|
954,581 |
|
Total
current assets |
|
89,054,327 |
|
|
|
107,353,500 |
|
Property
and equipment, net |
|
3,423,880 |
|
|
|
3,418,077 |
|
Other
assets |
|
142,870 |
|
|
|
142,870 |
|
Total assets |
$ |
92,621,077 |
|
|
$ |
110,914,447 |
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
$ |
4,369,133 |
|
|
$ |
3,471,032 |
|
Accrued
expenses |
|
5,422,205 |
|
|
|
3,213,715 |
|
Short
term debt |
|
3,075,421 |
|
|
|
- |
|
Total
current liabilities |
|
12,866,759 |
|
|
|
6,684,747 |
|
Noncurrent
liability: |
|
|
|
|
|
Long term
debt |
|
17,382,907 |
|
|
|
14,953,143 |
|
STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Preferred
stock, 5,000,000 shares authorized at December 31, 2017 and 2016,
zero outstanding |
|
- |
|
|
|
- |
|
Common
stock, $0.00033 par value, 75,000,000 shares authorized at December
31, 2017 and December 31, 2016, 30,869,205 shares and 28,918,516
shares issued and outstanding at December 31, 2017 and December 31,
2016, respectively |
|
10,400 |
|
|
|
9,756 |
|
Additional paid-in capital |
|
214,309,370 |
|
|
|
190,341,769 |
|
Accumulated deficit |
|
(151,948,359 |
) |
|
|
(101,074,968 |
) |
Total
stockholders' equity |
|
62,371,411 |
|
|
|
89,276,557 |
|
Total
liabilities and stockholders' equity |
$ |
92,621,077 |
|
|
$ |
110,914,447 |
|
Investor Contact:
Gregory Gin
Edge Therapeutics, Inc.
Tel: 1-800-208-EDGE (3343)
Email: ir@edgetherapeutics.com
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