SAN DIEGO, Oct. 31, 2014 /PRNewswire/ -- Mast Therapeutics,
Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company,
today reported financial results for the quarter ended September 30, 2014.
Brian M. Culley, the Company's
Chief Executive Officer, said: "The third quarter was
productive for Mast. Consistent with prior guidance, our
388-patient pivotal Phase 3 study of MST-188 for sickle cell
disease is on track to complete enrollment by the end of next
year. We now have opened 50 study sites in the U.S. and more
than ten study sites in six countries outside of the
U.S."
Mr. Culley continued: "We are further encouraged by the
increased attention sickle cell disease is receiving, as evidenced
by the FDA's recent press release highlighting its commitment to
encouraging development of new SCD treatments as an agency priority
and growing attendance at the 3rd Annual Sickle Cell
Disease Drug Development Conference, which we hosted during
National Sickle Cell Awareness Month in September. We are proud to
be a leader in this field with the most advanced new drug in
development for patients with sickle cell disease."
"During the quarter, we also announced positive preliminary data
from a Phase 2 study of AIR001, which we believe support further
clinical development in pulmonary hypertension, and our plans to
support multiple, institution-sponsored studies of AIR001 in PH
associated with left heart disease."
Upcoming News and Events
•
|
Phase 2 Study (heart
failure): submit protocol to FDA
|
Q4 2014
|
•
|
Nonclinical Study
(heart failure): data
|
Q1 2015
|
•
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Nonclinical Study
(embolic stroke): data
|
Q2 2015
|
•
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Phase 2 Study (heart
failure): initiate enrollment
|
1H 2015
|
•
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EPIC Extension Study
(repeat exposure): initiate enrollment
|
1H 2015
|
•
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Phase 2a Study of
AIR001 (WHO Group 2 PH): preliminary data
|
2H 2015
|
•
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Phase 2 Study (heart
failure): interim safety analysis
|
2H 2015
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•
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EPIC Study: complete
enrollment
|
Q4 2015
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•
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EPIC Study: top-line
data
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Q1 2016
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•
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Phase 2 Study (acute
limb ischemia): complete enrollment
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2H 2016
|
Third Quarter 2014 Financial Results
The Company's net loss for the third quarter of 2014 was
$7.9 million, or $0.06 per share (basic and diluted), compared to
a net loss of $5.3 million, or
$0.05 per share (basic and diluted),
for the same period in 2013.
Research and development expenses for the third quarter of 2014
were $5.4 million, an increase of
$2.3 million, or 74%, compared to
$3.1 million for the same period in
2013. The increase was primarily due to a $1.6 million increase in external clinical study
fees and expenses, and a $0.4 million
increase in personnel costs.
The $1.6 million increase in
external clinical study fees and expenses was due primarily to an
increase of $1.1 million related to
the EPIC study, an increase of $0.3
million related to our Phase 2 study of MST-188 in acute
limb ischemia (ALI), and an increase of $0.1
million related to the wind-down of the phase 2 studies of
AIR001 in pulmonary arterial hypertension (PAH). The increase
in personnel costs resulted primarily from severance expenses
related to the departure of Dr. Vetticaden, the Company's former
Chief Medical Officer.
Selling, general and administrative expenses for the third
quarter of 2014 were $2.5 million, an
increase of $0.3 million, or 14%,
compared to $2.2 million for the same
period in 2013. The increase resulted primarily from an increase in
personnel costs.
Year-to-Date Financial Results
The Company's net loss for the nine months ended September 30, 2014 was $21.4 million, or $0.19 per share (basic and diluted), compared to
a net loss of $15.8 million, or
$0.23 per share (basic and diluted),
for the same period in 2013.
Research and development expenses for the nine months ended
September 30, 2014 were $14.5 million, an increase of $5.1 million, or 55%, compared to $9.4 million for the same period in 2013. The
increase was primarily due to a $2.7
million increase in external clinical study fees and
expenses, a $1.2 million increase in
external nonclinical study fees and expenses, and a $1.0 million increase in personnel
costs.
The $2.7 million increase in
external clinical study fees and expenses was due primarily to an
increase of $2.7 million related to
the EPIC study, an increase of $1.0
million related to our Phase 2 study of MST-188 in ALI, and
an increase of $0.8 million related
to the wind-down of the AIR001 studies in PAH, offset by a decrease
of $1.8 million related to the
thorough QT/QTc clinical study of MST-188 that we completed in
2013. The $1.2 million increase in
external nonclinical study fees and expenses is primarily due to an
increase of $0.9 million in
research-related manufacturing costs for MST-188 and an increase of
$0.3 million for research-related
manufacturing costs for the wind-down of the AIR001 studies in PAH.
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 Dr. Vetticaden.
Selling, general and administrative expenses for the nine months
ended September 30, 2014 were
$7.1 million, an increase of
$0.7 million, or 11%, compared to
$6.4 million for the same period in
2013. The increase resulted primarily from an increase in personnel
costs and consulting expenses.
The Company recognized a $0.5
million bargain purchase gain during the nine months ended
September 30, 2014 associated with
its acquisition of Aires, which was included in other income.
Balance Sheet Highlights
As of September 30, 2014, the
Company had cash, cash equivalents and investment securities
totaling $43.1 million. Stockholders'
equity amounted to $45.2 million as
of September 30, 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 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 planning to initiate a Phase 2
clinical study of MST-188 in patients with acute decompensated
heart failure in the first half of 2015. 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 our product candidates, including
MST-188 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 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
planned clinical study of a product candidate; 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.
Condensed
Consolidated Statements of Operations
(In thousands except
per share data)
|
|
|
Three months
ended
September
30,
(Unaudited)
|
Nine months
ended
September
30,
(Unaudited)
|
|
2014
|
2013
|
2014
|
2013
|
|
|
|
|
|
Total net
revenue
|
$
—
|
$
—
|
$
—
|
$
—
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
5,402
|
3,102
|
14,503
|
9,382
|
Selling, general and
administrative
|
2,455
|
2,159
|
7,091
|
6,371
|
Transaction-related
expenses
|
2
|
--
|
271
|
35
|
Depreciation and
amortization
|
25
|
10
|
60
|
29
|
Total operating
expenses
|
7,884
|
5,271
|
21,925
|
15,817
|
|
|
|
|
|
Loss from
operations
|
(7,884)
|
(5,271)
|
(21,925)
|
(15,817)
|
|
|
|
|
|
Interest and other
income, net
|
18
|
17
|
536
|
41
|
|
|
|
|
|
Net loss
|
$
(7,866)
|
$
(5,254)
|
$
(21,389)
|
$
(15,776)
|
|
|
|
|
|
Net loss per share –
basic and diluted
|
$
(0.06)
|
$
(0.05)
|
$
(0.19)
|
$
(0.23)
|
|
|
|
|
|
Weighted average
shares – basic and diluted
|
123,287
|
102,710
|
114,709
|
67,782
|
Mast Therapeutics,
Inc. Balance Sheet Data (In thousands)
|
|
|
September
30,
2014
(Unaudited)
|
|
December
31,
2013
|
|
|
|
|
Cash, cash
equivalents and investment securities
|
$
43,074
|
|
$
44,393
|
|
|
|
|
Working
capital
|
36,547
|
|
40,695
|
|
|
|
|
Total
assets
|
56,164
|
|
55,250
|
|
|
|
|
Total
liabilities
|
10,915
|
|
7,442
|
|
|
|
|
Stockholders'
equity
|
45,249
|
|
47,808
|
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SOURCE Mast Therapeutics, Inc.