SAN DIEGO, May 6, 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 first
quarter ended March 31, 2016.
"The first quarter of 2016 was a productive one for Mast.
Not only did we complete enrollment in our Phase 3 EPIC study of
vepoloxamer in sickle cell disease, but also we announced positive
data from a Phase 2a study of AIR001 in patients with heart failure
with preserved ejection fraction conducted at Mayo Clinic, and the
selection of AIR001 for a double-blind, placebo-controlled Phase 2
study in approximately 100 patients with HFpEF to be conducted at
premier U.S. clinical centers that make up the HFN," stated
Brian M. Culley, Chief Executive
Officer.
"With 388 patients, the EPIC study was the largest
placebo-controlled study in sickle cell disease ever concluded and
should provide many insights into the activity of vepoloxamer in
this indication. Importantly, vepoloxamer has the potential to
become the first and only approved therapy for shortening the
duration of a sickle cell vaso-occlusive crisis and we are working
diligently toward generating top-line results, which we expect to
announce this quarter," continued Mr. Culley. "Meanwhile, we
are advancing our two heart failure programs. Our 150-patient Phase
2 study of vepoloxamer in chronic heart failure is ongoing, with
ten study sites now open, and the HFN's 100-patient Phase 2 study
of AIR001 in HFpEF is expected to begin in the third quarter of
2016."
First Quarter 2016 Operating Results
The Company's net
loss for the first quarter of 2016 was $11.2
million, or $0.06 per share
(basic and diluted), compared to a net loss of $9.6 million, or $0.06 per share (basic and diluted), for the same
period in 2015.
Research and development expenses for the first quarter of 2016
were $7.9 million, an increase of
$1.9 million, or 30%, compared to
$6.0 million for the same period in
2015. The increase was due mainly to increases of
$0.9 million in external nonclinical
study fees and expenses, $0.5 million
in external clinical study fees and expenses, and $0.3 million in personnel expenses.
The increase in external nonclinical study fees and expenses was
due primarily to increased costs related to preparation for a new
drug application for vepoloxamer ($0.5
million) and research-related manufacturing for vepoloxamer
($0.5 million), offset by a decrease
in research-related manufacturing for AIR001 ($0.1 million). The increase in external
clinical study fees and expenses was due primarily to increased
costs related to the Phase 2 study of vepoloxamer in heart
failure ($0.5 million) and the EPIC
study ($0.3 million), offset by a
decrease related to discontinuation of a Phase 2 study of
vepoloxamer in acute limb ischemia, which the Company began to
wind-down in the third quarter of 2015 ($0.3
million).
Selling, general and administrative (SG&A) expenses for the
first quarter of 2016 were $2.8
million, a decrease of $0.8
million, or 21%, compared to $3.6
million for the same period in 2015. SG&A expenses for
the first quarter 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 first quarter of 2016 was $0.5 million, which was related to the Company's
debt facility. There was no interest expense for the first
quarter 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 in
February 2016. 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 a Phase 2a study of AIR001 in patients with HFpEF is ongoing and
AIR001 was recently selected by the Heart Failure Clinical Research
Network for evaluation in a 100-patient, multicenter, randomized,
double-blind, placebo-controlled, Phase 2 study 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
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
commencement and 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 its product
candidates may not demonstrate adequate safety, efficacy or
tolerability in one or more such studies, including vepoloxamer in
the Phase 3 "EPIC" study; 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 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; 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; delays in clinical
study closeouts, including blinded data review and quality control
and assurance procedures; 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
March
31,
(Unaudited)
|
|
2016
|
2015
|
|
|
|
Total net
revenue
|
$
—
|
$
—
|
|
|
|
Operating
expenses:
|
|
|
Research and
development
|
7,875
|
6,042
|
Selling, general and
administrative
|
2,835
|
3,578
|
Depreciation and
amortization
|
32
|
30
|
Total operating
expenses
|
10,742
|
9,650
|
|
|
|
Loss from
operations
|
(10,742)
|
(9,650)
|
|
|
|
Interest income,
interest expense and other income/(expense), net
|
(465)
|
34
|
|
|
|
Net loss
|
$
(11,207)
|
$
(9,616)
|
|
|
|
Net loss per share –
basic and diluted
|
$
(0.06)
|
$
(0.06)
|
|
|
|
Weighted average
shares – basic and diluted
|
178,115
|
159,459
|
|
|
|
Mast Therapeutics,
Inc. Balance Sheet Data (In thousands)
|
|
|
|
|
|
March
31,
2016
|
|
December
31,
2015
|
|
|
|
|
Cash, cash
equivalents and investment securities
|
$
37,089
|
|
$
40,981
|
|
|
|
|
Working
capital
|
15,580
|
|
19,079
|
|
|
|
|
Total
assets
|
50,145
|
|
54,217
|
|
|
|
|
Total
liabilities
|
29,465
|
|
30,328
|
|
|
|
|
Stockholders'
equity
|
20,680
|
|
23,889
|
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SOURCE Mast Therapeutics, Inc.