SAN DIEGO, Nov. 12, 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, heart failure and stroke, today reported
financial results for the quarter ended September 30, 2015.
"During the third quarter, we continued to make significant
progress with our clinical development of vepoloxamer," stated
Brian M. Culley, Chief Executive
Officer. "We recently surpassed the 80% enrollment mark in our
Phase 3 'EPIC' study in sickle cell disease, we enrolled the first
patient in our open-label, repeat-exposure EPIC-extension study,
and we initiated a Phase 2 study of vepoloxamer in chronic heart
failure with a new formulation."
"Additionally, the two Phase 2a studies of AIR001 in patients
with heart failure with preserved ejection fraction (HFpEF)
continue to enroll patients and we look forward to sharing interim
and complete data from those clinical studies in coming months,"
continued Mr. Culley.
Third Quarter 2015 Operating Results
The Company's net loss for the third quarter of 2015 was
$9.9 million, or $0.06 per share (basic and diluted), compared to
a net loss of $7.9 million, or
$0.06 per share (basic and diluted),
for the same period in 2014.
Research and development (R&D) expenses for the third
quarter of 2015 were $7.3 million, an
increase of $1.9 million, or 36%,
compared to $5.4 million for the same
period in 2014. The increase was due primarily to increases of
$1.8 million in external nonclinical
study fees and expenses and a $0.2
million in external clinical study fees and expenses, offset
by a $0.1 million decrease in
personnel costs and share-based compensation expense. The
$1.8 million increase in external
nonclinical study fees and expenses was due primarily to an
increase in research-related manufacturing costs for
vepoloxamer.
Selling, general and administrative (SG&A) expenses of
$2.5 million for the third quarter of
2015 were consistent with the same period in 2014.
Year-to-Date Financial Results
The Company's net loss for the nine months ended September 30, 2015 was $29.7 million, or $0.18 per share (basic and diluted), compared to
a net loss of $21.4 million, or
$0.19 per share (basic and diluted),
for the same period in 2014.
R&D expenses for the nine months ended September 30, 2015 were $21.1 million, an increase of $6.6 million, or 46%, compared to $14.5 million for the same period in 2014. The
increase was due primarily to a $4.1
million increase in external nonclinical study fees and
expenses, a $2.2 million increase in
external clinical study fees and expenses and a $0.2 million increase in personnel
expenses.
The $4.1 million increase in
external nonclinical study fees and expenses was due primarily to a
$3.8 million increase in
research-related manufacturing costs for vepoloxamer and a
$0.3 million increase in
research-related manufacturing costs for AIR001. The $2.2 million increase in external clinical study
fees and expenses was due primarily to increases of $2.7 million in EPIC study costs and $0.4 million in costs for our Phase 2 study of
vepoloxamer in heart failure, offset by decreases of $0.5 million in AIR001 clinical study costs and
$0.5 million in costs for the
discontinued Phase 2 study of vepoloxamer in acute limb
ischemia.
SG&A expenses for the nine months ended September 30, 2015 were $8.4 million, an increase of $1.3 million, or 19%, compared to $7.1 million for the same period in 2014. This
increase was due primarily to a $0.7
million increase in personnel costs and a $0.5 million increase in professional and
consulting fees.
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, 2015, the
Company had cash, cash equivalents and investment securities
totaling $49.9 million. Stockholders'
equity amounted to $33.5 million as
of September 30, 2015.
Investor Conference Call
The Company will hold a conference call today, November 12, 2015, at 4:30
p.m. ET / 1:30 p.m. PT to
discuss its financial results for the third quarter of 2015 and
provide a corporate update. Interested parties may access the
conference call by dialing (855) 239-3120 from the U.S. and (412)
542-4127 from outside the U.S. and should request the Mast
Therapeutics, Inc. Corporate Update Call. A live webcast of
the conference call will be available online from the Investors
section of Mast's website at
http://www.masttherapeutics.com/investors/events/. Replays of the
webcast will be available on the Company's website for 30 days and
a telephone replay will be available through November 18, 2015 by dialing (877) 344-7529 from
the U.S. and (412) 317-0088 from outside the U.S. and entering
replay access code 10075708.
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 an investigational new drug 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 for the treatment of patients with chronic heart
failure. AIR001 is an investigational new drug being tested
in two 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 may
include, but are not limited to, statements relating to prospects
for successful development and commercialization of the Company's
investigational drugs, including vepoloxamer and AIR001, and
anticipated timing of achievement of development milestones, such
as commencement and completion of clinical studies or regulatory
activities, 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 and the Phase 2 study of
vepoloxamer in chronic heart failure; 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 risk that, even if
planned 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 potential for additional nonclinical or clinical
studies to be required prior to initiation of a planned clinical
study; 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 risk that the Company may be required to repay its
outstanding debt obligations at a time that could be detrimental to
its financial condition, operations and/or business strategy; 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,
through patents or otherwise, and prevent competitors from
duplicating or developing equivalent versions of its product
candidates or that the use or manufacture of its products or
product candidates infringe the proprietary rights of others; 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)
|
|
|
|
2015
|
|
|
2014
|
|
|
2015
|
|
|
2014
|
|
Total net
revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
7,330
|
|
|
|
5,402
|
|
|
|
21,106
|
|
|
|
14,503
|
|
Selling,
general and administrative
|
|
|
2,460
|
|
|
|
2,455
|
|
|
|
8,448
|
|
|
|
7,091
|
|
Transaction-related expenses
|
|
|
—
|
|
|
|
2
|
|
|
|
—
|
|
|
|
271
|
|
Depreciation and amortization
|
|
|
38
|
|
|
|
25
|
|
|
|
105
|
|
|
|
60
|
|
Total operating
expenses
|
|
|
9,828
|
|
|
|
7,884
|
|
|
|
29,659
|
|
|
|
21,925
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(9,828)
|
|
|
|
(7,884)
|
|
|
|
(29,659)
|
|
|
|
(21,925)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
(expense)/income, net
|
|
|
(84)
|
|
|
|
18
|
|
|
|
(20)
|
|
|
|
536
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(9,912)
|
|
|
$
|
(7,866)
|
|
|
$
|
(29,679)
|
|
|
$
|
(21,389)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share –
basic and diluted
|
|
$
|
(0.06)
|
|
|
$
|
(0.06)
|
|
|
$
|
(0.18)
|
|
|
$
|
(0.19)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares – basic and diluted
|
|
|
163,614
|
|
|
|
123,287
|
|
|
|
161,749
|
|
|
|
114,709
|
|
Mast Therapeutics,
Inc. Balance Sheet Data (In thousands)
(Unaudited)
|
|
|
September
30,
|
|
|
|
December
31,
|
|
|
|
2015
|
|
|
|
2014
|
|
Cash, cash
equivalents and investment securities
|
|
$
|
49,913
|
|
|
|
$
|
57,289
|
|
|
|
|
|
|
|
|
|
|
|
Working
capital
|
|
|
37,929
|
|
|
|
|
49,965
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
|
63,438
|
|
|
|
|
70,500
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
29,899
|
|
|
|
|
11,842
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
33,539
|
|
|
|
|
58,658
|
|
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SOURCE Mast Therapeutics, Inc.