SAN DIEGO, March 24, 2015 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage
biopharmaceutical company leveraging its molecular adhesion and
sealant technology (MAST) platform to develop novel therapies for
sickle cell disease, arterial disease and heart failure, today
reported financial results for the fourth quarter and year ended
December 31, 2014.
"2014 was a year of significant progress for Mast
Therapeutics. We continued to make good progress with our
lead compound, vepoloxamer, and we added another product candidate,
AIR001, to our pipeline with our acquisition of Aires
Pharmaceuticals, Inc. in February
2014," stated Brian M.
Culley, Chief Executive Officer. "Vepoloxamer remains the
most clinically-advanced new drug in development for sickle cell
disease and we continue to anticipate top-line results of the Phase
3 EPIC study in the first quarter of 2016."
Mr. Culley continued: "While enrollment in EPIC is a top
priority, data generated from our MAST platform has enabled us to
enter other indications as well. We have been particularly
pleased with results of recent studies of vepoloxamer in models of
thrombotic stroke and advanced heart failure, both large markets
with significant unmet medical needs, and, as announced yesterday,
we look forward to initiating a Phase 2 study of vepoloxamer in
chronic heart failure in the third quarter of this year."
"We also are pleased with the progress of our AIR001 program in
heart failure with preserved ejection fraction. With
Phase 2a studies of AIR001 underway at Mayo Clinic and the
University of Pittsburgh, we expect to
announce preliminary data in the second half of this year. We
believe the hemodynamic benefits of AIR001 are particularly suited
to a HFpEF population with elevated pulmonary artery and pulmonary
capillary wedge pressures, for which no FDA-approved therapies are
currently available."
Fourth Quarter 2014 Operating Results
The Company's net loss for the fourth quarter of 2014 was
$7.3 million, or $0.05 per share (basic and diluted), compared to
a net loss of $5.7 million, or
$0.06 per share (basic and diluted),
for the same period in 2013.
Research and development (R&D) expenses for the fourth
quarter of 2014 were $4.9 million, an
increase of $1.4 million, or 40%,
compared to $3.5 million for the same
period in 2013. The increase was due mainly to increases of
$0.9 million in external clinical
study fees and expenses related primarily to increased enrollment
in EPIC, the Company's Phase 3 study of vepoloxamer in sickle cell
disease, and $0.5 million in
nonclinical study fees and expenses related primarily to
research-related manufacturing costs for vepoloxamer.
Selling, general and administrative (SG&A) expenses for the
fourth quarter of 2014 were $2.4
million, an increase of $0.3
million, or 12%, compared to $2.1
million for the same period in 2013. The increase resulted
primarily from an increase in fees for accounting, tax and legal
services and personnel costs.
Year-to-Date Operating Results
The Company's net loss for the year ended December 31, 2014 was $28.7 million, or $0.23 per share (basic and diluted), compared to
a net loss of $21.5 million, or
$0.28 per share (basic and diluted),
for the same period in 2013.
R&D expenses for the year ended December 31, 2014 were $19.4 million, an increase of $6.5 million, or 51%, compared to $12.9 million for the same period in 2013. The
increase was due to increases of $3.6
million in external clinical study fees and expenses,
$1.6 million in nonclinical study
fees and expenses, $1.0 million in
personnel costs and $0.3 million in
share-based compensation expense. The increase in external
clinical study fees and expenses was related primarily to EPIC
study costs ($3.3 million), our Phase
2 study of vepoloxamer in acute limb ischemia ($1.1 million), and the wind-down of the AIR001
studies in pulmonary arterial hypertension ($1.0 million), offset by a decrease due largely
to lack of costs related to the thorough QT/QTc clinical study of
vepoloxamer completed in 2013 ($1.8
million). The increase in nonclinical study fees and
expenses resulted primarily from research-related manufacturing
costs for vepoloxamer ($1.2 million)
and AIR001 ($0.2 million). The
increase in personnel costs resulted primarily from additional
clinical and research-related manufacturing staff hired after the
first half of 2013 and severance expenses related to the departure
of our former chief medical officer.
SG&A expenses for the year ended December 31, 2014 were $9.5 million, an increase of $1.0 million, or 11%, compared to $8.5 million for the same period in 2013. The
increase resulted primarily from an increase in personnel costs and
consulting expenses.
Balance Sheet Highlights
As of December 31, 2014, the
Company had cash, cash equivalents and investment securities
totaling $57.3 million. Stockholders'
equity amounted to $58.7 million as
of December 31, 2014.
About Mast Therapeutics
Mast Therapeutics, Inc. is a
publicly traded biopharmaceutical company headquartered in
San Diego, California. The
Company is leveraging its MAST platform, derived from over two
decades of clinical, nonclinical and manufacturing experience with
purified and non-purified poloxamers, to develop vepoloxamer
(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 also developing AIR001, a sodium nitrite solution
for inhalation via nebulizer, for the treatment of heart failure
with preserved ejection fraction (HFpEF).
Vepoloxamer is being tested in a pivotal Phase 3 study called
EPIC for the treatment of vaso-occlusive crisis in patients with
sickle cell disease and in a Phase 2 study to evaluate whether
vepoloxamer improves the effectiveness of recombinant tissue
plasminogen activator therapy in patients with acute limb
ischemia. The Company plans to initiate a Phase 2 study of
vepoloxamer in chronic heart failure in the third quarter of this
year. AIR001 is being tested in multiple
institution-sponsored Phase 2a studies in patients with HFpEF. 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 prospects for successful development of the
Company's product candidates, including vepoloxamer in sickle cell
disease, and anticipated timing of achievement of development
milestones, including commencement and completion of clinical and
nonclinical studies, and of announcement of study data. 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 vepoloxamer, 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
additional nonclinical or clinical studies to be required prior to
initiation of a planned clinical study; 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 and
may never achieve profitability; the risk that the Company is not
able to adequately protect its intellectual property rights 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
|
Condensed
Consolidated Statements of Operations
|
(In thousands, except
per share data)
|
|
|
|
|
|
Three months
ended
December
31,
(Unaudited)
|
Year
ended
December
31,(1)
|
|
2014
|
2013
|
2014
|
2013
|
|
|
|
|
|
Total net
revenue
|
$
—
|
$
—
|
$
—
|
$
—
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
4,933
|
3,520
|
19,435
|
12,902
|
Selling, general and
administrative
|
2,396
|
2,147
|
9,488
|
8,518
|
Transaction-related
expenses
|
-
|
44
|
271
|
79
|
Depreciation and
amortization
|
25
|
11
|
85
|
40
|
Total operating
expenses
|
7,354
|
5,722
|
29,279
|
21,539
|
|
|
|
|
|
Loss from
operations
|
(7,354)
|
(5,722)
|
(29,279)
|
(21,539)
|
|
|
|
|
|
Interest and other
income, net
|
41
|
17
|
577
|
59
|
|
|
|
|
|
Net loss
|
$
(7,313)
|
$
(5,705)
|
$
(28,702)
|
$
(21,480)
|
|
|
|
|
|
Net loss per share –
basic and diluted
|
$
(0.05)
|
$
(0.06)
|
$
(0.23)
|
$
(0.28)
|
|
|
|
|
|
Weighted average
shares – basic and diluted
|
145,257
|
102,710
|
122,409
|
76,586
|
|
|
|
|
|
(1)
|
The condensed
consolidated statements of operations for the years ended December
31, 2014 and 2013 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
|
Balance Sheet
Data
|
(In
thousands)
|
|
|
December
31,
2014
|
|
December
31,
2013
|
|
|
|
|
Cash, cash
equivalents and investment securities
|
$
57,289
|
|
$
44,393
|
|
|
|
|
Working
capital
|
49,965
|
|
40,695
|
|
|
|
|
Total
assets
|
70,500
|
|
55,250
|
|
|
|
|
Total
liabilities
|
11,842
|
|
7,442
|
|
|
|
|
Stockholders'
equity
|
58,658
|
|
47,808
|
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SOURCE Mast Therapeutics, Inc.