SAN DIEGO, March 26, 2014 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) today reported financial
results for the fourth quarter and year ended December 31, 2013.
"2013 was a year of great progress for Mast as we delivered on
our operational goal of opening 40 clinical sites in the U.S. for
EPIC, our pivotal Phase 3 study of MST-188 in sickle cell disease,"
said Brian M. Culley, Chief
Executive Officer. "Already in 2014, we've achieved numerous
operational and strategic milestones. First, we initiated
ex-U.S. enrollment for EPIC. Second, we initiated our Phase 2
study of MST-188 in combination with recombinant tissue plasminogen
activator in patients with acute limb ischemia. Third, we announced
positive nonclinical data in heart failure, which suggests MST-188
provides a new mechanistic approach in an area of significant unmet
need and commercial opportunity. Fourth, we added another
clinical-stage asset in AIR001 as a result of our February
acquisition of Aires Pharmaceuticals. We look forward to
progressing our pipeline across all of our programs and building
upon last year's achievements in 2014, including having a total of
70 EPIC study sites open globally by year-end and announcing our
clinical development plans for MST-188 in heart failure."
Fourth Quarter 2013 Operating Results
The Company's net loss for the fourth quarter of 2013 was
$5.7 million, or $0.06 per share (basic and diluted), compared to
a net loss of $4.0 million, or
$0.08 per share (basic and diluted),
for the same period in 2012.
Research and development (R&D) expenses for the fourth
quarter of 2013 were $3.5 million, an
increase of $1.4 million, or 67%,
compared to $2.1 million for the same
period in 2012. The increase was primarily due to increases of
$1.2 million in external clinical
study fees and expenses related primarily to EPIC, the Company's
phase 3 study of MST-188 in sickle cell disease, and $0.2 million in personnel expenses.
Selling, general and administrative (SG&A) expenses for the
fourth quarter of 2013 were $2.1
million, an increase of $0.3
million, or 20%, compared to $1.8
million for the same period in 2012. The increase resulted
primarily from an increase in personnel costs and consulting
fees.
Year-to-Date Operating Results
The Company's net loss for the year ended December 31, 2013 was $21.5 million, or $0.28 per share (basic and diluted), compared to
a net loss of $15.6 million, or
$0.33 per share (basic and diluted),
for the same period in 2012.
R&D expenses for the year ended December 31, 2013 were $12.9 million, an increase of $4.8 million, or 60%, compared to $8.1 million for the same period in 2012. The
increase was primarily due to increases of $6.2 million in external clinical study fees and
expenses, $0.4 million in personnel
costs and $0.1 million in share-based
compensation expense, offset by a $1.9
million decrease in external nonclinical study fees and
expenses. The increase in external clinical study fees and
expenses was primarily related to EPIC and the thorough QT/QTc
study of MST-188. The decrease in external nonclinical study
fees and expenses resulted primarily from a decrease in
research-related manufacturing activities for ANX-514, which the
Company discontinued in 2012.
SG&A expenses for the year ended December 31, 2013 were $8.5 million, an increase of $1.0 million, or 13%, compared to $7.5 million for the same period in 2012. The
increase resulted primarily from an increase in consulting fees and
legal expenses.
Balance Sheet Highlights
As of December 31, 2013, the
Company had cash, cash equivalents and investment securities
totaling $44.4 million. Stockholders'
equity amounted to $47.8 million as
of December 31, 2013.
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 has initiated 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 plans 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 the Company's clinical
development plans for MST-188 in heart failure. 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, 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
December
31,
(Unaudited)
|
Year
ended
December
31,(1)
|
|
|
2013
|
2012
|
2013
|
2012
|
|
|
|
|
|
|
|
Total net
revenue
|
$
—
|
$
—
|
$
—
|
$
—
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
3,520
|
2,112
|
12,902
|
8,088
|
Selling, general and
administrative
|
2,147
|
1,787
|
8,518
|
7,519
|
Transaction-related
expenses
|
44
|
105
|
79
|
(69)
|
Depreciation and
amortization
|
11
|
12
|
40
|
90
|
Total operating
expenses
|
5,722
|
4,016
|
21,539
|
15,628
|
|
|
|
|
|
Loss from
operations
|
(5,722)
|
(4,016)
|
(21,539)
|
(15,628)
|
|
|
|
|
|
Interest and other
income, net
|
17
|
19
|
59
|
69
|
|
|
|
|
|
Net loss
|
$
(5,705)
|
$
(3,997)
|
$
(21,480)
|
$
(15,559)
|
|
|
|
|
|
Net loss per share –
basic and diluted
|
$
(0.06)
|
$
(0.08)
|
$
(0.28)
|
$
(0.33)
|
|
|
|
|
|
Weighted average
shares – basic and diluted
|
102,710
|
47,419
|
76,586
|
47,641
|
|
|
|
|
|
(1)
|
The condensed
consolidated statements of operations for the years ended December
31, 2013 and 2012 have been derived from the audited financial
statements but do not include all of the information and footnotes
required by accounting principles generally accepted in the United
States for the complete financial statements.
|
Mast Therapeutics,
Inc
|
(A Development Stage
Enterprise)
|
Balance Sheet
Data
|
(In
thousands)
|
|
|
December
31,
2013
|
|
December
31,
2012
|
|
|
|
|
Cash, cash
equivalents and investment securities
|
$
44,393
|
|
$
36,511
|
|
|
|
|
Working
capital
|
40,695
|
|
34,603
|
|
|
|
|
Total
assets
|
55,250
|
|
46,972
|
|
|
|
|
Total
liabilities
|
7,442
|
|
5,179
|
|
|
|
|
Stockholders'
equity
|
47,808
|
|
41,792
|
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SOURCE Mast Therapeutics, Inc.