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8-K - CURRENT REPORT - Acer Therapeutics Inc. | opxa_8k.htm |
Exhibit
99.1
Acer Therapeutics Reports Third Quarter 2017 Financial Results and
Provides Corporate Update
Closed Merger and Concurrent $15.7M Financing
Announced Positive Results from Pivotal Clinical Trial of
EDSIVO™ (celiprolol) for
Treatment of vEDS
CAMBRIDGE, MA – Nov. 13, 2017 – Acer Therapeutics
Inc. (Nasdaq: ACER), a pharmaceutical company focused on the
acquisition, development and commercialization of therapies for
serious rare and ultra-rare diseases with critical unmet medical
need, today reported financial results for the quarter ended
September 30, 2017 and provided an update on the
Company’s recent corporate developments.
“The third
quarter was transformative for Acer. We became a public
Nasdaq-listed company, closed a concurrent financing and announced
positive results from our pivotal clinical trial of EDSIVO™,
each a critical step in bringing us closer to our goal of becoming
a leading pharmaceutical company that acquires, develops and
commercializes therapies for the treatment of patients with serious
rare and ultra-rare diseases with critical unmet medical
need,” said Chris Schelling, CEO and Founder of Acer.
“We continue to successfully advance our lead product
candidate, EDSIVO™, a potential life-saving therapy for
patients with vEDS. We believe that our current cash position will
allow us to advance EDSIVO™ through NDA submission with the
FDA in the first half of 2018. As a public company, we look forward
to advancing and expanding our pipeline with the goal of bringing
multiple products to patients over the next several
years.”
Corporate
Activities
●
Closed merger with
Opexa Therapeutics, Inc. and $15.7 million concurrent financing,
and common stock commenced trading on Nasdaq Capital
Market.
●
Announced positive
results from the pivotal clinical trial of EDSIVO™
(celiprolol) for the treatment of vascular Ehlers-Danlos Syndrome
(vEDS). Acer’s retrospective source-verified analysis of the
trial data, including the primary and secondary endpoints,
confirmed the data from a previously published randomized
controlled clinical study of celiprolol(1). Acer plans to use such
pivotal clinical data to support a New Drug Application (NDA)
regulatory filing with the U.S. Food and Drug Administration (FDA)
in the first half of 2018.
1
Cash position. Cash and cash equivalents
were $8.4 million as of September 30, 2017, compared to $1.8
million as of December 31, 2016.
Research and Development Expenses.
Research and development expenses were $2.1 million for the three
months ended September 30, 2017, compared with $1.6 million for the
three months ended September 30, 2016. The increase in expenses is
primarily due to an increase in spending for clinical development
and manufacturing services related to EDSIVO™.
General and Administrative Expenses.
General and administrative expenses were $1.3 million for the three
months ended September 30, 2017, compared with $0.3 million for the
three months ended September 30, 2016. The increase in expenses is
primarily due to an increase in professional services and
pre-commercial launch costs related to
EDSIVO™.
Net Loss. Net loss for the three months
ended September 30, 2017 was $3.5 million, or $1.09 loss per share
(basic and diluted), compared with a net loss of $1.9 million, or
$0.77 loss per share (basic and diluted), for the three months
ended September 30, 2016.
For
additional information please see Acer’s Quarterly Report on
Form 10-Q filed today with the SEC.
About
Acer Therapeutics
Acer,
headquartered in Cambridge, MA, is a pharmaceutical company focused
on the acquisition, development and commercialization of therapies
for patients with serious rare and ultra-rare diseases with
critical unmet medical need. Acer’s late-stage clinical
pipeline includes two candidates for severe genetic disorders for
which there are few or no FDA-approved treatments: EDSIVO™
(celiprolol) for vEDS, and ACER-001 (a fully taste-masked,
immediate release formulation of sodium phenylbutyrate) for urea
cycle disorders (UCD) and Maple Syrup Urine Disease (MSUD). There
are no FDA-approved drugs for vEDS and MSUD and limited options for
UCD, which collectively impact more than 4,000 patients in the
United States. Acer’s product candidates have clinical
proof-of-concept and mechanistic differentiation, and Acer intends
to seek approval for them in the U.S. by using the regulatory
pathway established under section 505(b)(2) of the Federal Food,
Drug, and Cosmetic Act, or FFDCA, that allows an applicant to rely
for approval at least in part on third-party data, which is
expected to expedite the preparation, submission, and potential
approval of a marketing application.
For
more information, visit www.acertx.com.
2
References
(1) Ong
KT, et al. Effect of celiprolol on prevention of cardiovascular
events in vascular Ehlers-Danlos syndrome: a prospective
randomised, open, blinded-endpoints trial. Lancet. 2010; 376:
1476–84.
Forward-Looking
Statements
This
press release contains “forward-looking statements”
that involve substantial risks and uncertainties for purposes of
the safe harbor provided by the Private Securities Litigation
Reform Act of 1995. All statements, other than statements of
historical facts, included in this press release regarding
strategy, future operations, future financial position, future
revenue, projected expenses, prospects, plans and objectives of
management are forward-looking statements. Examples of such
statements include, but are not limited to, statements relating to
the potential for EDSIVO™ (celiprolol) and ACER-001 to safely
and effectively target diseases; the adequacy of the
company’s capital to support its future operations and its
ability to successfully initiate and complete clinical trials and
regulatory submissions and to obtain marketing approval for any of
its product candidates; the nature, strategy and focus of the
company; and the development, expected timeline and commercial
potential of any product candidates of the company. Acer may not
actually achieve the plans, carry out the intentions or meet the
expectations or projections disclosed in the forward-looking
statements and you should not place undue reliance on these
forward-looking statements. Such statements are based on
management’s current expectations and involve risks and
uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements
as a result of many factors, including, without limitation, risks
and uncertainties associated with the ability to project future
cash utilization and reserves needed for contingent future
liabilities and business operations, the availability of sufficient
resources of the company to meet its business objectives and
operational requirements, the fact that the results of earlier
studies and trials may not be predictive of future clinical trial
results, the protection and market exclusivity provided by
Acer’s intellectual property, risks related to the drug
development and the regulatory approval process and the impact of
competitive products and technological changes. Acer disclaims any
intent or obligation to update these forward-looking statements to
reflect events or circumstances that exist after the date on which
they were made. You should review additional disclosures we make in
our filings with the Securities and Exchange Commission, including
our Quarterly Reports on Form 10-Q and Annual Report on Form 10-K.
You may access these documents for no charge at
http://www.sec.gov.
ACER THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
|
Three
Months
Ended September
30,
|
Nine
Months Ended
September
30,
|
||
|
2017
|
2016
|
2017
|
2016
|
Operating
expenses
|
|
|
|
|
Research and
development
|
$2,057,421
|
$1,610,822
|
$6,948,816
|
$3,510,118
|
General and
administrative
|
1,302,401
|
274,512
|
2,792,424
|
1,054,479
|
Loss from
operations
|
3,359,822
|
1,885,334
|
9,741,240
|
4,564,597
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest
income
|
2,993
|
136
|
4,819
|
174
|
Interest
expense
|
(120,229)
|
—
|
(242,982))
|
—
|
Loss on disposal of
asset
|
(967)
|
—
|
(967)
|
—
|
Total other income
(expense), net
|
(118,203)
|
136
|
(239,130)
|
174
|
|
|
|
|
|
Net
loss
|
$(3,478,025)
|
$(1,885,198)
|
$(9,980,370)
|
$(4,564,423)
|
|
|
|
|
|
Net loss per share
- basic and diluted
|
$(1.09)
|
$(0.77)
|
$(3.69)
|
$(1.86)
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
3,199,796
|
2,450,000
|
2,702,678
|
2,450,000
|
3
Selected
Balance Sheet Data:
|
|
|
|
September
30,
2017
|
December
31,
2016
|
|
(unaudited)
|
|
Cash and cash
equivalents
|
$8,404,332
|
$1,834,018
|
Other current
assets
|
836,756
|
540,053
|
Property and
equipment, net
|
5,062
|
6,217
|
Total
assets
|
17,012,016
|
2,773,104
|
Total
liabilities
|
2,250,740
|
821,439
|
Convertible
redeemable preferred stock
|
—
|
12,136,440
|
Total stockholders'
equity (deficit)
|
14,761,276
|
(10,184,775)
|
|
|
|
Investor
Contact:
Hans
Vitzthum
LifeSci
Advisors
Ph:
617-535-7743
hans@lifesciadvisors.com
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