SAN DIEGO, Nov. 8, 2016 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage
biopharmaceutical company, today reported financial results for the
quarter ended September 30, 2016.
"We are rapidly advancing the clinical development of AIR001 in
heart failure with preserved ejection fraction. Notably, we were
pleased to announce positive results this quarter on the first 10
out of 20 planned PH-HFpEF patients in an ongoing 50-patient study
of AIR001 in pulmonary hypertension. We also are pleased that
enrollment in the 100-patient study of AIR001 in HFpEF being
conducted by the Heart Failure Clinical Research Network continues
to be on track, with data from this Phase 2 proof-of-concept study
anticipated in the fourth quarter of 2017," stated Brian M. Culley, Chief Executive Officer.
"As reflected by our markedly reduced operating expenses last
quarter, we have moved quickly to wind down our vepoloxamer
programs in sickle cell disease and heart failure, so that our cash
can be redeployed to development of AIR001. Because all three
active clinical trials of AIR001 are being funded substantially by
sources other than Mast, we anticipate that our 2017 operating
expenses will be approximately $8 to $9
million, excluding share-based compensation expense. We also
continue to work on our nonclinical study of vepoloxamer in
ischemic stroke, which is entirely funded by a Small Business
Innovation Research grant from the National Institute of
Neurological Disorders and Stroke of the National Institutes of
Health. We will continue to evaluate additional opportunities for
partnerships which can bring value to shareholders," continued Mr.
Culley.
Third Quarter 2016 Operating Results
The Company's net loss for the third quarter of 2016 was
$8.2 million, or $0.04 per share (basic and diluted), compared to
a net loss of $9.9 million, or
$0.06 per share (basic and diluted),
for the same period in 2015.
The Company recognized $45,000 of
revenue for the third quarter of 2016, representing reimbursement
of costs related to the nonclinical study of vepoloxamer that is
being funded by a grant from the National Institutes of Health
(NIH). The Company recognized no revenue for the same period
in 2015.
Research and development (R&D) expenses for the third
quarter of 2016 were $5.1 million, a
decrease of $2.2 million, or 31%,
compared to $7.3 million for the same
period in 2015. The decrease was due primarily to decreases
of $1.6 million in external
nonclinical study fees and expenses, $0.4
million in external clinical study fees and expenses and
$0.2 million in personnel costs for
the 2016 period.
The decrease in external nonclinical study fees and expenses was
due primarily to decreases in research-related manufacturing costs
for vepoloxamer ($1.2 million),
nonclinical studies of vepoloxamer ($0.7
million) and research-related manufacturing for AIR001
($0.1 million), offset by increased
costs related to preparing a new drug application for vepoloxamer
($0.4 million), which project was
discontinued in September 2016. The decrease in external
clinical study fees and expenses was due primarily to decreases in
costs for the Phase 3 study of vepoloxamer in sickle cell disease
($0.8 million) and the Phase 2 study
of vepoloxamer in acute limb ischemia, which the Company
discontinued and began to wind down in the third quarter of 2015
($0.1 million), offset by increased
costs related to the Phase 2 studies of AIR001 in HFpEF
($0.4 million) and the Phase 2 study
of vepoloxamer in heart failure ($0.1
million).
Selling, general and administrative (SG&A) expenses for the
third quarter of 2016 were $2.1
million, a decrease of $0.4
million, or 13%, compared to $2.5
million for the same period in 2015. The decrease was
primarily due to reduced personnel costs and fees for consulting
and legal services compared to the 2015 period.
Interest expense was $0.9 million
for the third quarter of 2016, compared to $0.1 million for the same period in 2015.
The increase in interest expense was primarily due to a full
quarter of interest expense on a $15.0
million principal balance under our debt facility in 2016
versus a partial quarter in 2015, as well as increased amortization
of debt issuance costs as a result of a change in the amortization
schedule of such costs due to prepayment of $10.0 million of the principal balance in
October 2016, which was triggered by
negative top-line results in the Phase 3 study of vepoloxamer in
September 2016.
Year-to-Date Financial Results
The Company's net loss for the nine months ended September 30, 2016 was $30.1 million, or $0.15 per share (basic and diluted), compared to
a net loss of $29.7 million, or
$0.18 per share (basic and diluted),
for the same period in 2015.
The Company recognized $45,000 of
revenue for the nine months ended September
30, 2016, representing reimbursement of costs related to the
nonclinical study of vepoloxamer that is being funded by a grant
from the NIH. The Company recognized no revenue for the same
period in 2015.
R&D expenses for the nine months ended September 30, 2016 were $20.7 million, a decrease of $0.4 million, or 2%, compared to $21.1 million for the same period in 2015. The
decrease was due primarily to a decrease of $1.2 million in external nonclinical study fees
and expenses, offset by increases of $0.6
million in external clinical study fees and expenses and
$0.2 million in share-based
compensation expense.
The $1.2 million decrease in
external nonclinical study fees and expenses was due primarily to
decreases in research-related manufacturing costs for vepoloxamer
($2.1 million) and costs for
nonclinical studies of vepoloxamer ($1.0
million), offset by increases in costs related to preparing
a new drug application for vepoloxamer ($1.8
million) and research-related manufacturing for AIR001
($0.1 million). The $0.6 million increase in external clinical study
fees and expenses was due primarily to increases in costs for the
Phase 2 study of vepoloxamer in heart failure ($1.4 million) and the Phase 2 studies of AIR001
in HFpEF ($0.7 million), offset by a
net decrease in costs associated with clinical studies of
vepoloxamer for its development in sickle cell disease
($0.9 million) and the Phase 2 study
of vepoloxamer in ALI ($0.5
million).
SG&A expenses for the nine months ended September 30, 2016 were $7.4 million, a decrease of $1.0 million, or 12%, compared to $8.4 million for the same period in 2015.
The decrease was primarily due to reduced severance and
share-based compensation expenses and fees for consulting and legal
services compared to the 2015 period.
Interest expense was $2.0 million
for the nine months ended September
30 2016, compared to $0.1
million for the same period in 2015. The
increase in interest expense was primarily due to a full nine
months of interest expense on a $15
million principal balance under our debt facility in 2016
versus approximately a month in 2015, as well as increased
amortization of debt issuance costs as a result of a change in the
amortization schedule of such costs due to prepayment of
$10 million of the principal balance
in October 2016.
Investor Conference Call
The Company will hold a conference call today, November 8, 2016, at 4:30
p.m. Eastern Time / 1:30 p.m. Pacific
Time to discuss its financial results for the third quarter
of 2016 and provide a general business 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. Third Quarter 2016 Conference
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 15, 2016 by dialing (877) 344-7529 from
the U.S. and (412) 317-0088 from outside the U.S. and entering
replay access code 10096120.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical
company headquartered in San Diego,
California. The Company has two clinical-stage
investigational new drugs, AIR001 and vepoloxamer. AIR001, a
sodium nitrite solution for intermittent inhalation via
nebulization, is in Phase 2 clinical development for the treatment
of heart failure with preserved ejection fraction (HFpEF). More
information can be found on the Company's web site at
www.masttherapeutics.com. Mast Therapeutics™ and the corporate logo
are trademarks of Mast Therapeutics, Inc.
Forward Looking Statements
Mast Therapeutics cautions you that statements in this press
release that are not a description of historical fact are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements may be identified by the use of words referencing future
events or circumstances such as "expect," "intend," "plan,"
"anticipate," "believe," and "will," among others. Examples
of forward-looking statements in this press release include
statements relating to the Company's development plans for its
product candidates, AIR001's potential utility to treat HFpEF, the
timing of completion and results of clinical studies of AIR001, the
Company's business plans and objectives, and its anticipated
operating expenses, results of operations and financial
condition. Forward-looking statements should not be read as
guarantees of future performance or results because they involve
the Company's beliefs and assumptions based on currently available
information and are subject to significant known and unknown risks
and uncertainties that may cause actual performance and results to
differ materially from expectations indicated by the
forward-looking statements. Some of the factors that could cause
actual performance or results to differ include, without
limitation: the Company's need for additional funding and risk that
it may not be able to obtain sufficient funding as needed; risks
associated with the Company's ability to manage operating expenses;
uncertainty related to the Company's ability to continue as a going
concern; risk of an event of default under the Company's debt
facility that could result in the Company being required to repay
its outstanding debt obligation and related fees on an accelerated
basis and/or at a time that could be detrimental to the Company's
financial condition, operations and/or business strategy; the
impact of significant reductions in the Company's operations on its
ability to develop its product candidates or maintain compliance
with laws and regulations relating to public companies; the
Company's ability to maintain compliance with NYSE MKT continued
listing standards and policies and to maintain the listing and
trading of its common stock on a national securities exchange;
completion of a more detailed analysis of EPIC data and reporting
of additional data from that study; uncertainties inherent in the
conduct of clinical studies and the risk that the Company's product
candidates may not demonstrate adequate safety, efficacy or
tolerability in one or more clinical studies for approval by
regulatory authorities; the Company's lack of control over the
investigator-sponsored clinical studies of AIR001, including
whether the studies will commence or be completed on anticipated
timelines, or at all; the potential for the Company to sell or
license part or all of its assets; the potential for significant
delays, reductions, or discontinuation of current and/or planned
development activities if the Company is unable to raise sufficient
additional capital as needed; the Company's dependence on third
parties to assist with important aspects of development of the
Company's product candidates, including the conduct of its clinical
studies, the manufacture and supply of clinical trial material,
including drug delivery devices, and the conduct of regulatory
activities, and the risk that such third parties may fail to
perform as expected leading to delays in product candidate
development and additional costs; the risk that the Company is not
able to obtain or maintain effective patent coverage or other
market exclusivity protections for its products, if approved, or
that the use or manufacture of the Company's products may infringe
the proprietary rights of others; and other risks and uncertainties
more fully described in the Company's press releases and its
reports filed 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)
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
Total net
revenue
|
|
$
|
45
|
|
|
$
|
—
|
|
|
$
|
45
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
5,088
|
|
|
|
7,330
|
|
|
|
20,715
|
|
|
|
21,106
|
|
Selling,
general and administrative
|
|
|
2,134
|
|
|
|
2,460
|
|
|
|
7,408
|
|
|
|
8,448
|
|
Depreciation and amortization
|
|
|
24
|
|
|
|
38
|
|
|
|
86
|
|
|
|
105
|
|
Total operating
expenses
|
|
|
7,246
|
|
|
|
9,828
|
|
|
|
28,209
|
|
|
|
29,659
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(7,201)
|
|
|
|
(9,828)
|
|
|
|
(28,164)
|
|
|
|
(29,659)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
(expense)/income, net
|
|
|
(951)
|
|
|
|
(84)
|
|
|
|
(1,901)
|
|
|
|
(20)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,152)
|
|
|
$
|
(9,912)
|
|
|
$
|
(30,065)
|
|
|
$
|
(29,679)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share –
basic and diluted
|
|
$
|
(0.04)
|
|
|
$
|
(0.06)
|
|
|
$
|
(0.15)
|
|
|
$
|
(0.18)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares – basic and diluted
|
|
|
214,714
|
|
|
|
163,614
|
|
|
|
196,528
|
|
|
|
161,749
|
|
Mast Therapeutics,
Inc.
|
Balance Sheet
Data
|
(In
thousands)
|
|
|
|
September
30,
|
|
|
December
31,
|
|
|
|
2016
|
|
|
2015
|
|
Cash, cash
equivalents and investment securities
|
|
$
|
26,950
|
|
|
$
|
40,981
|
|
|
|
|
|
|
|
|
|
|
Working
capital
|
|
|
7,390
|
|
|
|
19,079
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
|
40,118
|
|
|
|
54,217
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
26,931
|
|
|
|
30,328
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
13,187
|
|
|
|
23,889
|
|
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SOURCE Mast Therapeutics, Inc.