SAN DIEGO, Aug. 9, 2016 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX), a biopharmaceutical company
developing novel, clinical-stage therapies for sickle cell disease
and heart failure, today reported financial results for the quarter
ended June 30, 2016.
"We continued to advance our assets toward valuable inflection
points during the second quarter. Announcing top-line data
from the EPIC study continues to be our top priority. With
388 subjects randomized at study sites around the globe, EPIC was
the largest placebo-controlled study in sickle cell disease ever
concluded and we look forward to announcing results next
month. To support our NDA for vepoloxamer, we also continue
to enroll patients in EPIC-E, our repeat exposure study for EPIC
patients, and in a clinical pharmacokinetics study of vepoloxamer
in individuals with varying degrees of renal insufficiency," stated
Brian M. Culley, Chief Executive
Officer.
"In addition, clinical development of AIR001 in heart failure
with preserved ejection fraction is progressing through multiple
Phase 2 studies. In particular, we are pleased that the first
patient was dosed in the 100-patient Phase 2 study being conducted
by the Heart Failure Clinical Research Network," continued Mr.
Culley.
Second Quarter 2016 Operating Results
The Company's
net loss for the second quarter of 2016 was $10.7 million, or $0.05 per share (basic and diluted), compared to
a net loss of $10.2 million, or
$0.06 per share (basic and diluted),
for the same period in 2015.
Research and development (R&D) expenses for the second
quarter of 2016 were $7.8
million, compared to $7.7
million for the same period in 2015. Increases of
$0.5 million in external clinical
study fees and expenses and $0.1
million in share-based compensation expense were offset by a
$0.5 million decrease in external
nonclinical study fees and expenses.
The increase in external clinical study fees and expenses was
due primarily to increased costs related to the Company's Phase 2
study of vepoloxamer in heart failure ($0.7
million) and the Phase 2 studies of AIR001 in HFpEF
($0.4 million), offset by decreases
in costs for the EPIC study ($0.4
million) and the Phase 2 study of vepoloxamer in acute limb
ischemia, which the Company began to wind-down in the third quarter
of 2015 ($0.2 million). The
decrease in external nonclinical study fees and expenses was due
primarily to decreases in research-related manufacturing costs for
vepoloxamer ($1.2 million) and
nonclinical studies of vepoloxamer ($0.4
million), offset by increased costs related to preparing a
new drug application for vepoloxamer ($0.9
million) and research-related manufacturing for AIR001
($0.2 million).
Selling, general and administrative (SG&A) expenses were
$2.4 million in each of the second
quarter of 2016 and the second quarter of 2015.
Interest expense for the second quarter of 2016 was $512,000, $511,000
of which was related to the Company's debt facility. There
was interest expense of $1,000 for
the second quarter of 2015.
Year-to-Date Financial Results
The Company's net loss
for the six months ended June 30,
2016 was $21.9 million, or
$0.12 per share (basic and diluted),
compared to a net loss of $19.8
million, or $0.12 per share
(basic and diluted), for the same period in 2015.
R&D expenses for the six months ended June 30, 2016 were $15.6
million, an increase of $1.8
million, or 13%, compared to $13.8
million for the same period in 2015. The increase was due
primarily to increases of $1.0
million in external clinical study fees and expenses,
$0.4 million in external nonclinical
study fees and expenses, $0.2 million
in personnel expenses and $0.2
million in share-based compensation.
The $1.0 million increase in
external clinical study fees and expenses was due primarily to
increases in costs for our Phase 2 study of vepoloxamer in heart
failure ($1.2 million) and the Phase
2 studies of AIR001 in HFpEF ($0.4
million), offset by a decrease in costs for the Phase 2
study of vepoloxamer in ALI ($0.5
million). The $0.4
million increase in external nonclinical study fees and
expenses was due primarily to increases in costs related to
preparing a new drug application for vepoloxamer ($1.4 million) and research-related manufacturing
for AIR001 ($0.2 million), offset by
decreases in research-related manufacturing costs for vepoloxamer
($0.8 million) and costs for
nonclinical studies of vepoloxamer ($0.3
million).
SG&A expenses for the six months ended June 30, 2016 were $5.3
million, a decrease of $0.7
million, or 12%, compared to $6.0
million for the same period in 2015. SG&A expenses for
the first six months of 2015 included $0.4
million of severance expenses and $0.3 million of share-based compensation
resulting from the termination of employment of the Company's
former president and chief operating officer in February 2015 and the acceleration of stock
option vesting pursuant to the terms of his option agreements.
Interest expense for the six months ended June 30, 2016 was $1,031,000, $1,029,000 of which was related to the Company's
debt facility. There was interest expense of $1,000 for the same period of 2015.
About Mast Therapeutics
Mast Therapeutics, Inc. is a
publicly traded biopharmaceutical company headquartered in
San Diego, California. The Company
is developing two clinical-stage investigational new drugs for
serious or life-threatening diseases and conditions. Vepoloxamer,
the Company's lead product candidate, is in Phase 3 clinical
development for the treatment of vaso-occlusive crisis in patients
with sickle cell disease and in Phase 2 clinical development for
the treatment of patients with heart failure. Enrollment in
the Company's 388-patient Phase 3 study of vepoloxamer in patients
with sickle cell disease, known as the EPIC study, was completed
earlier this year. Enrollment in the Company's Phase 2 study
of vepoloxamer in patients with chronic heart failure is
ongoing. AIR001, the Company's second product candidate, is
in Phase 2 clinical development for the treatment of patients with
heart failure with preserved ejection fraction (HFpEF). Enrollment
in Phase 2 studies of AIR001 in patients with HFpEF are ongoing,
including a 100-patient, multicenter, randomized, double-blind,
placebo-controlled, Phase 2 study in patients with HFpEF being
conducted by the Heart Failure Clinical Research Network.
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
within the meaning of the Private Securities Litigation Reform Act
of 1995 that are based on the Company's current expectations and
assumptions. Such forward-looking statements may be identified by
the use of forward-looking words such as "expect," "intend,"
"plan," "anticipate," "believe," among others, and include, but are
not limited to, statements relating to prospects for successful
development and commercialization of the Company's product
candidates, including vepoloxamer for the treatment of
vaso-occlusive crisis of sickle cell disease, and anticipated
timing of achievement of development milestones, such as completion
of clinical studies and announcement of study data. There are
a number of factors that could cause or contribute to material
differences between actual events or results and the expectations
indicated by the forward-looking statements. These factors include,
but are not limited to: the inherent uncertainty of outcomes
in ongoing and future studies of the Company's product candidates
and the risk that vepoloxamer may not demonstrate adequate safety,
efficacy or tolerability in one or more such studies, including the
Phase 3 "EPIC" study; the potential for additional delays in EPIC
study closeout procedures, including blinded data validation and
quality control and assurance procedures; risks associated with the
Company's ability to manage operating expenses and obtain
additional capital as needed; the Company's potential inability to
continue as a going concern if it does not raise sufficient
additional capital as needed; the risk that the Company may be
required to repay its outstanding debt obligations on an
accelerated basis and/or at a time that could be detrimental to its
financial condition, operations and/or business strategy, including
the prepayment of $10 million of the
principal balance of its debt facility if results from the EPIC
study are not positive and/or not available on or before
October 14, 2016; the potential for
the Company to significantly delay, reduce or discontinue current
and/or planned development and commercial-readiness activities or
sell or license its assets at inopportune times if it is unable to
raise sufficient additional capital as needed; the risk that, even
if EPIC study results are positive, the FDA may require a second
Phase 3 study or other clinical or nonclinical studies to
demonstrate substantial evidence of vepoloxamer's effectiveness for
sickle cell patients or to provide additional safety and
tolerability data or that the FDA may require changes to
manufacturing controls or processes that could delay filing of a
new drug application; 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 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 dependence on third parties to assist with important
aspects of development of its product candidates, including conduct
of its clinical studies and supply and manufacture of clinical
trial material, and, if approved, commercial product, and the risk
that such third parties may fail to perform as expected, leading to
delays in product candidate development or approval or inability to
meet market demand for approved products, if any; 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 obtain and maintain effective patent coverage or other
market exclusivity protections for its products, if approved,
without infringing 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,
(Unaudited)
|
|
|
Six months
ended
June
30,
(Unaudited)
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
Total net
revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
7,752
|
|
|
|
7,734
|
|
|
|
15,627
|
|
|
|
13,776
|
|
Selling,
general and administrative
|
|
|
2,439
|
|
|
|
2,410
|
|
|
|
5,274
|
|
|
|
5,988
|
|
Depreciation and amortization
|
|
|
30
|
|
|
|
37
|
|
|
|
61
|
|
|
|
67
|
|
Total operating
expenses
|
|
|
10,221
|
|
|
|
10,181
|
|
|
|
20,962
|
|
|
|
19,831
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(10,221)
|
|
|
|
(10,181)
|
|
|
|
(20,962)
|
|
|
|
(19,831)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
(expense)/income, net
|
|
|
(485)
|
|
|
|
30
|
|
|
|
(951)
|
|
|
|
64
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(10,706)
|
|
|
$
|
(10,151)
|
|
|
$
|
(21,913)
|
|
|
$
|
(19,767)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share –
basic and diluted
|
|
$
|
(0.05)
|
|
|
$
|
(0.06)
|
|
|
$
|
(0.12)
|
|
|
$
|
(0.12)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares – basic and diluted
|
|
|
196,554
|
|
|
|
162,128
|
|
|
|
187,335
|
|
|
|
160,801
|
|
Mast Therapeutics,
Inc.
|
Balance Sheet
Data
|
(In
thousands)
|
|
|
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2016
|
|
|
2015
|
|
Cash, cash
equivalents and investment securities
|
|
$
|
35,072
|
|
|
$
|
40,981
|
|
|
|
|
|
|
|
|
|
|
Working
capital
|
|
|
10,455
|
|
|
|
19,079
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
|
47,676
|
|
|
|
54,217
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
31,250
|
|
|
|
30,328
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
16,426
|
|
|
|
23,889
|
|
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SOURCE Mast Therapeutics, Inc.