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
September 30, 2017, and recent corporate progress.
Third Quarter and Recent Corporate Progress
- In September, the 150th patient was randomized into Edge’s
EG-1962 Phase 3 NEWTON 2 study in aneurysmal subarachnoid
hemorrhage (aSAH). The achievement of this milestone triggered
preparation for a pre-specified futility analysis by the study’s
external independent Data Monitoring Committee (DMC). Once the
first 150 patients in the NEWTON 2 study complete their Day 90
follow-up assessments, the clinical data package will be compiled
and submitted to the study’s DMC to perform the futility
analysis.
- Edge presented new retrospective, claims-based health economic
data showing aSAH per patient hospital charges represent a high
economic burden for U.S. hospitals. 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. The analysis was presented at the
Neurocritical Care Society (NCS) 15th Annual Meeting.
- Edge was announced as one of three finalists for the “Innovator
of the Year” award for EG-1962 during the 2017 Congress of
Neurological Surgeons (CNS) Annual Meeting. The finalists for the
award, honoring the most innovative approaches considered to have
the greatest impact on neurological surgery, were evaluated and
selected by CNS’s membership of neurosurgeons.
- Pharmaceutical industry leader Rosemary A. (Rose) Crane was
appointed to Edge’s Board of Directors. The former executive at
Johnson & Johnson and Bristol-Myers Squibb brings over 30 years
of commercial and operations experience to the Board of
Directors.
“We continued to achieve meaningful progress in the third
quarter, highlighted by the randomization of the 150th patient in
our Phase 3 NEWTON 2 study of EG-1962, and the presentation of new
health economic data that quantify the tremendous health economic
burden of aSAH,” said Brian A. Leuthner, Edge’s President and Chief
Executive Officer. “The health economic analysis reinforces our
commitment to evaluating EG-1962 as a potential treatment option
for patients with aSAH. Our top priority is executing on the
ongoing Phase 3 study and we remain on track for conducting the
pre-specified futility analysis by the end of 2017. We anticipate
reporting top-line efficacy results from the formal interim
analysis in early 2018. If the study continues to full enrollment
as planned, we anticipate providing top-line results from the full
study in late 2018.”
Financial Results
Cash Position: Cash, cash equivalents and
marketable securities as of September 30, 2017 were $97.3 million,
compared with $106.4 million as of December 31, 2016.
Research & Development (R&D)
Expenses: R&D expenses were $6.9 million in the
third quarter of 2017, compared to $6.7 million in the third
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 $4.0 million for the three
months ended September 30, 2017, compared to $3.6 million in the
comparable period in 2016. The increase in G&A expense was
largely due to increases in personnel-related costs, legal and
professional fees.
Net Loss: Net loss was $11.3 million for the
third quarter ended September 30, 2017, compared to net loss of
$10.8 million for the comparable period in 2016.
Appoints Andrew Saik as Chief Financial Officer and
Makes Inducement Grant under NASDAQ Rule 5635(c)(4)
Additionally, Edge announced the appointment of Andrew Saik as
the company’s Chief Financial Officer, effective immediately. Mr.
Saik will be responsible for leading financial strategy and
operations for Edge, and will report to Mr. Leuthner. Mr. Saik was
most recently Chief Financial Officer at Vertice Pharma, LLC, where
he secured a $300 million commitment to fund acquisitions from a
prominent private equity firm. Previously, he was Chief Financial
Officer at Auxilium Pharmaceuticals, Inc., where he helped lead the
execution of Auxilium's growth strategy and successful sale to Endo
International plc for $2.3 billion. He succeeds Albert N. Marchio
II, Edge’s Chief Accounting and Administrative Officer, who became
Edge’s CFO on an interim basis when the company’s previous CFO left
in March 2017. Mr. Marchio will help with the transition of the new
CFO and will continue to serve as Edge’s Chief Accounting and
Administrative Officer.
Mr. Saik was previously Senior Vice President, Finance and
Treasurer at Endo Health Solutions, Inc., where he was responsible
for internal and external reporting, global consolidations of
M&A transactions, cash management, debt financing and risk
management. During his tenure at Endo, he helped complete the $1.6
billion acquisition of Paladin Labs and refinance $3 billion in
debt in a new corporate structure. Prior to Endo, Mr. Saik served
in senior financial management roles with increasing responsibility
at Valeant Pharmaceuticals International, including Senior Vice
President, Finance. In this post, he served as the overall finance
lead for the acquisition and integration of the Johnson &
Johnson and Sanofi-Aventis dermatology business units in the U.S.
and Canada, enabling Valeant to build the largest dermatology
business in North America. Previously at Valeant, Mr. Saik was
Chief Financial Officer of the $1.5 billion Specialty
Pharmaceuticals Division. He holds a Master of Business
Administration from the University of Southern California and a
Bachelor of Arts from the University of California, Los
Angeles.
“After an extensive search, we've selected a proven finance
executive in the pharmaceutical industry with a track record of
success in multiple areas including shaping financial strategy,
leading successful M&A transactions, integrating global company
and product acquisitions and cash management that have helped add
significantly to shareholder value,” said Mr. Leuthner. “We believe
Andrew further strengthens Edge's management team as the company
moves toward potential commercialization of EG-1962. I also want to
acknowledge Bert Marchio, who has done an exceptional job since
stepping in to fill the CFO role in March.”
“This is an exciting time to join the Edge team, which has
achieved impressive progress so far with its EG-1962 development
program and expects to reach key milestones during the balance of
2017 and in 2018,” said Mr. Saik. "As the company continues
clinical development of EG-1962 for patients with aSAH, I look
forward to contributing to the company's future success and helping
Edge to maintain a strong financial position so that we are ready
for potential commercialization.”
In connection with Mr. Saik’s new employment, the Compensation
Committee of Edge’s Board of Directors has approved the grant of
non-qualified stock options to Mr. Saik, who will receive options
to purchase 200,000 shares of Edge’s common stock. The
effective date of the grant is November 1, 2017 and the exercise
price for such stock options will be equal to the closing price of
Edge’s common stock on such date, as reported by NASDAQ. The grant
was made as an inducement material to Mr. Saik’s acceptance of
employment with Edge, in accordance with NASDAQ Listing Rule
5635(c)(4).
The options have a 10-year term and will vest over a period of
four years, with 25 percent vesting on October 31, 2018, which is
one year following Mr. Saik’s date of hire, and the remaining 75
percent vesting in approximately equal monthly increments over the
succeeding thirty-six months, subject to Mr. Saik’s continuous
employment with Edge through each applicable vesting date. In
addition, the options are subject to acceleration or forfeiture
upon the occurrence of certain events as set forth in Mr. Saik’s
option and employment agreements.
Conference Call Details
Edge will host a conference call and webcast today, Wednesday,
November 1, 2017 at 8:30 a.m. EDT. Please dial (877) 388-5691, or
(562) 350-0788 for international callers, and reference participant
code 95430949 approximately 15 minutes prior to the call. A replay
of the call may be accessed through November 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 95430949. 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 results 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 early 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 EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development expenses |
$ |
6,913,171 |
|
|
$ |
6,724,503 |
|
|
$ |
23,477,971 |
|
|
$ |
18,046,572 |
|
General
and administrative expenses |
|
3,990,283 |
|
|
|
3,552,289 |
|
|
|
12,365,509 |
|
|
|
10,526,775 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
10,903,454 |
|
|
|
10,276,792 |
|
|
|
35,843,480 |
|
|
|
28,573,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(10,903,454 |
) |
|
|
(10,276,792 |
) |
|
|
(35,843,480 |
) |
|
|
(28,573,347 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
Other
expense |
|
- |
|
|
|
(163,463 |
) |
|
|
- |
|
|
|
(163,463 |
) |
Interest
income |
|
214,064 |
|
|
|
56,082 |
|
|
|
479,297 |
|
|
|
148,272 |
|
Interest
expense |
|
(592,089 |
) |
|
|
(375,089 |
) |
|
|
(1,591,998 |
) |
|
|
(717,263 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss |
|
(11,281,479 |
) |
|
|
(10,759,262 |
) |
|
|
(36,956,181 |
) |
|
|
(29,305,801 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share basic
and diluted |
$ |
(0.37 |
) |
|
$ |
(0.37 |
) |
|
$ |
(1.23 |
) |
|
$ |
(1.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding basic and diluted |
|
30,852,514 |
|
|
|
28,896,941 |
|
|
|
30,091,640 |
|
|
|
28,848,842 |
|
EDGE THERAPEUTICS, INC.Balance
Sheets |
|
|
September 30, 2017 |
|
December 31, 2016 |
ASSETS |
(unaudited) |
|
|
Current
assets: |
|
|
|
Cash and
cash equivalents |
$ |
97,307,258 |
|
|
$ |
106,398,919 |
|
Prepaid
expenses and other current assets |
|
326,733 |
|
|
|
954,581 |
|
Total current assets |
|
97,633,991 |
|
|
|
107,353,500 |
|
|
|
|
|
|
|
Property
and equipment, net |
|
3,462,343 |
|
|
|
3,418,077 |
|
Other
assets |
|
142,870 |
|
|
|
142,870 |
|
|
|
|
|
|
|
Total assets |
$ |
101,239,204 |
|
|
$ |
110,914,447 |
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
$ |
2,964,971 |
|
|
$ |
3,471,032 |
|
Accrued
expenses |
|
3,282,398 |
|
|
|
3,213,715 |
|
Short
term debt |
|
5,454,610 |
|
|
|
- |
|
Total current liabilities |
|
11,701,979 |
|
|
|
6,684,747 |
|
|
|
|
|
|
|
Noncurrent liability: |
|
|
|
|
|
Long term
debt |
|
14,883,240 |
|
|
|
14,953,143 |
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY |
|
|
|
|
|
Preferred
stock, 5,000,000 shares authorized at September 30, 2017 and
December 31, 2016, 0 outstanding |
|
- |
|
|
|
- |
|
Common
stock, $0.00033 par value, 75,000,000 shares authorized at
September 30, 2017 and December 31, 2016, 30,859,200
shares and 28,918,516 shares issued and outstanding at
September 30, 2017 and December 31, 2016, respectively |
|
10,397 |
|
|
|
9,756 |
|
Additional paid-in capital |
|
212,688,325 |
|
|
|
190,341,769 |
|
Accumulated deficit |
|
(138,044,737 |
) |
|
|
(101,074,968 |
) |
Total
stockholders' equity |
|
74,653,985 |
|
|
|
89,276,557 |
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity |
$ |
101,239,204 |
|
|
$ |
110,914,447 |
|
Investor and Media Contact:
Gregory Gin
Edge Therapeutics, Inc.
Tel: 1-800-208-EDGE (3343)
Email: ir@edgetherapeutics.com
EDGE THERAPEUTICS, INC. (NASDAQ:EDGE)
Historical Stock Chart
From Jun 2024 to Jul 2024
EDGE THERAPEUTICS, INC. (NASDAQ:EDGE)
Historical Stock Chart
From Jul 2023 to Jul 2024