SAN DIEGO, May 5, 2014 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) today reported financial
results for the quarter ended March 31,
2014.
During the period, the Company made progress across multiple
clinical and corporate fronts, including the ex‑U.S. expansion of
EPIC, it's pivotal Phase 3 study of MST-188 in sickle cell disease,
and pipeline expansion with the acquisition of AIR001, a
clinical-stage program. Other highlights included initiating
a Phase 2 study of MST-188 in combination with recombinant tissue
plasminogen activator in patients with acute limb ischemia,
announcing positive nonclinical data in heart failure, and
presenting new nonclinical data supportive of MST-188's development
in sickle cell disease at a prominent sickle cell disease research
symposium.
"This past quarter, we enhanced our value proposition via the
clinical progress we made with MST-188 and our acquisition of Aires
Pharmaceuticals," said Brian M.
Culley, Chief Executive Officer of Mast Therapeutics.
"Looking ahead, we will continue to focus on enrolling patients in
our Phase 3 EPIC study and reaching our goal of 70 EPIC study sites
open globally by year-end. We also look forward to announcing our
clinical development plans for MST-188 in heart failure and for
AIR001."
First Quarter 2014 Operating Results
The Company's net loss for the first quarter of 2014 was
$6.4 million, or $0.06 per share (basic and diluted), compared to
a net loss of $5.6 million, or
$0.12 per share (basic and diluted),
for the same period in 2013.
Research and development expenses for the first quarter of 2014
were $4.3 million, an increase of
$0.9 million, or 24%, compared to
$3.4 million for the same period in
2013. The increase was primarily due to an increase of $0.5 million in external nonclinical study fees
and expenses and $0.3 million in
personnel costs. The increase in external nonclinical study
fees and expenses was primarily related to manufacturing additional
clinical trial material for EPIC and our phase 2 study of MST-188
in acute limb ischemia. The increase in personnel costs was
primarily related to additional clinical and research-related
manufacturing staff hired after the first quarter of 2013.
Selling, general and administrative expenses for the first
quarter of 2014 were $2.3 million, an
increase of $0.2 million, or 7%,
compared to $2.1 million for the same
period in 2013. The increase resulted primarily from an increase in
personnel costs.
The Company recognized a $0.5
million bargain purchase gain during the first quarter of
2014 associated with its acquisition of Aires, which was included
in other income.
Balance Sheet Highlights
As of March 31, 2014, the Company
had cash, cash equivalents and investment securities totaling
$49.6 million. Stockholders' equity
amounted to $52.8 million as of
March 31, 2014.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical
company headquartered in San
Diego, California. The Company is leveraging the MAST
(Molecular Adhesion and Sealant Technology) platform, derived from
over two decades of clinical, nonclinical and manufacturing
experience with purified and non-purified poloxamers, to develop
MST-188, its lead product candidate, for serious or
life-threatening diseases and conditions typically characterized by
impaired microvascular blood flow and damaged cell
membranes.
The Company is enrolling subjects in EPIC, a pivotal phase 3
study of MST-188 in sickle cell disease, and in a phase 2, clinical
proof-of-concept study to evaluate whether MST-188 improves the
effectiveness of recombinant tissue plasminogen activator therapy
in patients with acute limb ischemia. The Company also is
developing MST-188 in heart failure and expects to announce its
clinical development plans in this indication in the second half of
2014. More information can be found on the Company's web site
at www.masttherapeutics.com. (Twitter: @MastThera)
Mast Therapeutics™ and the corporate logo are trademarks of Mast
Therapeutics, Inc.
Forward Looking Statements
Mast Therapeutics cautions you that statements included in this
press release that are not a description of historical facts are
forward-looking statements that are based on the Company's current
expectations and assumptions. Such forward-looking statements
include, but are not limited to, statements relating to progress
with the EPIC study, including the total number of study sites
expected to be open at year-end, and with the Company's other
development programs, including the timing of announcement of
clinical development plans for MST-188 in heart failure and for
AIR001. Among the factors that could cause or contribute to
material differences between the Company's actual results and the
expectations indicated by the forward-looking statements are risks
and uncertainties that include, but are not limited to: the
uncertainty of outcomes in ongoing and future studies of the
Company's product candidates and the risk that its product
candidates, including MST-188, may not demonstrate adequate safety,
efficacy or tolerability in one or more such studies, including
EPIC; delays in the commencement or completion of clinical studies,
including as a result of difficulties in obtaining regulatory
agency agreement on clinical development plans or clinical study
design, opening trial sites, enrolling study subjects,
manufacturing sufficient quantities of clinical trial material,
being subject to a "clinical hold," and/or suspension or
termination of a clinical study, including due to patient safety
concerns or lack of funding; the potential for institutional review
boards or the FDA or other regulatory agencies to require
additional nonclinical or clinical studies prior to initiation of a
phase 2 clinical study of MST-188 in heart failure or other
indications; the risk that, even if clinical studies are
successful, the FDA or other regulatory agencies may determine they
are not sufficient to support a new drug application; the potential
that, even if clinical studies of a product candidate in one
indication are successful, clinical studies in another indication
may not be successful; the Company's reliance on contract research
organizations (CROs), contract manufacturing organizations (CMOs),
and other third parties to assist in the conduct of important
aspects of development of its product candidates, including
clinical studies, manufacturing, and regulatory activities for its
product candidates, and that such third parties may fail to perform
as expected; the Company's ability to obtain additional funding on
a timely basis or on acceptable terms, or at all; the potential for
the Company to delay, reduce or discontinue current and/or planned
development activities, including clinical studies, partner its
product candidates at inopportune times or pursue less expensive
but higher-risk and/or lower return development paths if it is
unable to raise sufficient additional capital as needed; the risk
that, even if the Company successfully develops a product candidate
in one or more indications, it may not realize commercial success
with its products and may never generate revenue sufficient to
achieve profitability; the risk that the Company is not able to
adequately protect its intellectual property rights relating to the
MAST platform and MST-188 or AIR001 and prevent competitors from
duplicating or developing equivalent versions of its product
candidates; and other risks and uncertainties more fully described
in the Company's press releases and periodic filings with the
Securities and Exchange Commission. The Company's public filings
with the Securities and Exchange Commission are available at
www.sec.gov.
You are cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date when made. Mast
Therapeutics does not intend to revise or update any
forward-looking statement set forth in this press release to
reflect events or circumstances arising after the date hereof,
except as may be required by law.
[Tables to Follow]
Mast Therapeutics,
Inc.
|
(A Development Stage
Enterprise)
|
Condensed
Consolidated Statements of Operations
|
(In thousands except
per share data)
|
|
|
Three months
ended
March
31,
(Unaudited)
|
|
2014
|
2013
|
|
|
|
Total net
revenue
|
$
—
|
$
—
|
|
|
|
Operating
expenses:
|
|
|
Research and
development
|
4,281
|
3,443
|
Selling, general and administrative
|
2,266
|
2,113
|
Transaction-related
expenses
|
280
|
27
|
Depreciation and
amortization
|
12
|
10
|
Total operating
expenses
|
6,839
|
5,593
|
|
|
|
Loss from
operations
|
(6,839)
|
(5,593)
|
|
|
|
Interest and other
income, net
|
468
|
12
|
|
|
|
Net loss
|
$
(6,371)
|
$
(5,581)
|
|
|
|
Net loss per share –
basic and diluted
|
$
(0.06)
|
$
(0.12)
|
|
|
|
Weighted average
shares – basic and diluted
|
105,054
|
46,265
|
Mast Therapeutics,
Inc.
|
(A Development Stage
Enterprise)
|
Balance Sheet
Data
|
(In
thousands)
|
|
|
March
31,
2014
(Unaudited)
|
|
December
31,
2013
|
|
|
|
|
Cash, cash
equivalents and investment securities
|
$
49,620
|
|
$
44,393
|
|
|
|
|
Working
capital
|
44,447
|
|
40,695
|
|
|
|
|
Total
assets
|
62,359
|
|
55,250
|
|
|
|
|
Total
liabilities
|
9,569
|
|
7,442
|
|
|
|
|
Stockholders'
equity
|
52,790
|
|
47,808
|
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SOURCE Mast Therapeutics