SAN DIEGO, Aug. 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, arterial disease and heart failure, today
reported financial results for the quarter ended June 30, 2015.
"Our biggest priority in the second quarter of 2015 was
continuing the enthusiasm and momentum for enrollment in EPIC, our
Phase 3 trial of vepoloxamer, and we are pleased to reaffirm that
we anticipate announcing top-line data in the first quarter of
2016. During the second quarter we also initiated our EPIC
extension study, EPIC-E, which we believe will enhance the quality
of our New Drug Application for vepoloxamer in sickle cell disease
by providing additional data on repeat exposures to vepoloxamer, as
well as give our study investigators experience administering
vepoloxamer to sickle cell patients in an unblinded manner.
As we approach completion of the EPIC study, we continue to
be excited about the potential for vepoloxamer, currently the most
clinically-advanced new drug in development for patients with
sickle cell disease, to be the first therapeutic approved for this
rare disease in more than 17 years," stated Brian M. Culley, Chief Executive Officer.
"We also continue to be enthusiastic about clinical progress we
are making with our second asset, AIR001. We are supporting
ongoing Phase 2a studies of AIR001 in patients with heart failure
with preserved ejection fraction (HFpEF) at two elite clinical
institutions, and we continue to anticipate reporting preliminary
data from one of those studies, a 30-patient, placebo-controlled
trial, later this year," continued Mr. Culley.
Second Quarter 2015 Operating Results
The Company's net loss for the second quarter of 2015 was
$10.2 million, or $0.06 per share (basic and diluted), compared to
a net loss of $7.2 million, or
$0.06 per share (basic and diluted),
for the same period in 2014.
Research and development (R&D) expenses for the second
quarter of 2015 were $7.7 million, an
increase of $2.9 million, or 61%,
compared to $4.8 million for the same
period in 2014. The increase was due primarily to increases of
$1.9 million in external nonclinical
study fees and expenses, $0.8 million
in external clinical study fees and expenses and $0.2 million in personnel expenses.
The $1.9 million increase in
external nonclinical study fees and expenses was due primarily to a
$1.7 million increase in
research-related manufacturing costs for vepoloxamer and a
$0.2 million increase in
research-related manufacturing costs for AIR001. The $0.8 million increase in external clinical study
fees and expenses was due primarily to an increase of $1.2 million in EPIC study costs, offset by a
decrease of $0.4 million in AIR001
study costs.
Selling, general and administrative (SG&A) expenses of
$2.4 million for the second quarter
of 2015 were consistent with the same period in 2014.
Year-to-Date Financial Results
The Company's net loss for the six months ended June 30, 2015 was $19.8
million, or $0.12 per share
(basic and diluted), compared to a net loss of $13.5 million, or $0.12 per share (basic and diluted), for the same
period in 2014.
R&D expenses for the six months ended June 30, 2015 were $13.8
million, an increase of $4.7
million, or 51%, compared to $9.1
million for the same period in 2014. The increase was due
primarily to a $2.3 million increase
in external nonclinical study fees and expenses, a $2.0 million increase in external clinical study
fees and expenses and a $0.3 million
increase in personnel costs.
The $2.3 million increase in
external nonclinical study fees and expenses was due primarily to a
$2.0 million increase in
research-related manufacturing costs for vepoloxamer and a
$0.3 million increase in
research-related manufacturing costs for AIR001. The $2.0 million increase in external clinical study
fees and expenses was due primarily to an increase of $2.5 million in EPIC study costs, offset by a
decrease of $0.5 million in AIR001
study costs.
SG&A expenses for the six months ended June 30, 2015 were $6.0
million, an increase of $1.4
million, or 29%, compared to $4.6
million for the same period in 2014. This increase was due
primarily to a $0.8 million increase
in personnel costs and a $0.3 million
increase in professional and consulting fees.
The Company recognized a $0.5
million bargain purchase gain during the six months ended
June 30, 2014 associated with its
acquisition of Aires, which was included in other income.
Balance Sheet Highlights
As of June 30, 2015, the Company
had cash, cash equivalents and investment securities totaling
$43.4 million. Stockholders' equity
amounted to $42.5 million as of
June 30, 2015.
Investor Conference Call
The Company will hold a conference call tomorrow, August 13, 2015, at 8:30
a.m. ET / 5:30 a.m. PT to
discuss its financial results for the second quarter of 2015 and
provide a corporate update. Interested parties may access the
conference call by dialing (877) 870-4263 from the U.S. and (412)
317-0790 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 August 17, 2015 by dialing (877) 344-7529 from
the U.S. and (412) 317-0088 from outside the U.S. and entering
replay access code 10070769.
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.
The Company plans to initiate a Phase 2 study of vepoloxamer in
chronic heart failure in the third quarter of this year and to
pursue clinical development of vepoloxamer in stroke. AIR001
is an investigational new drug 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 and commercialization of the Company's
investigational drugs, 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; 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
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 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 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 June
30,
|
|
Six months
ended June
30,
|
|
(Unaudited)
|
|
(Unaudited)
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
Total net
revenue
|
$
—
|
|
$
—
|
|
$
—
|
|
$
—
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
7,734
|
|
4,820
|
|
13,776
|
|
9,101
|
Selling, general and
administrative
|
2,410
|
|
2,370
|
|
5,988
|
|
4,636
|
Transaction-related
expenses
|
—
|
|
(11)
|
|
—
|
|
269
|
Depreciation and
amortization
|
37
|
|
23
|
|
67
|
|
35
|
Total operating
expenses
|
10,181
|
|
7,202
|
|
19,831
|
|
14,041
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(10,181)
|
|
(7,202)
|
|
(19,831)
|
|
(14,041)
|
|
|
|
|
|
|
|
|
Interest and other
income, net
|
30
|
|
50
|
|
64
|
|
518
|
|
|
|
|
|
|
|
|
Net loss
|
$
(10,151)
|
|
$
(7,152)
|
|
$
(19,767)
|
|
$
(13,523)
|
|
|
|
|
|
|
|
|
Net loss per share –
basic and diluted
|
$
(0.06)
|
|
$
(0.06)
|
|
$
(0.12)
|
|
$
(0.12)
|
|
|
|
|
|
|
|
|
Weighted average
shares – basic and diluted
|
162,128
|
|
115,587
|
|
160,801
|
|
110,350
|
Mast Therapeutics,
Inc.
Balance Sheet
Data
(In
thousands)
(Unaudited)
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
2015
|
|
2014
|
Cash, cash
equivalents and investment securities
|
$
|
43,379
|
|
$
|
57,289
|
|
|
|
|
|
|
Working
capital
|
|
33,953
|
|
|
49,965
|
|
|
|
|
|
|
Total
assets
|
|
56,764
|
|
|
70,500
|
|
|
|
|
|
|
Total
liabilities
|
|
14,229
|
|
|
11,842
|
|
|
|
|
|
|
Stockholders'
equity
|
|
42,535
|
|
|
58,658
|
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SOURCE Mast Therapeutics, Inc.