SAN DIEGO, Sept. 26, 2016 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) today provided an update
related to its business strategy and the clinical development of
its product candidates.
- The Company's cash, cash equivalents, and investment securities
were $30.3 million at August 31,
2016.
- The Company will focus on clinical development of AIR001
(sodium nitrite solution for intermittent inhalation) for the
treatment of heart failure with preserved ejection fraction
(HFpEF). Specifically, during 2016 and 2017, the Company will
continue to support three ongoing investigator-sponsored Phase 2
clinical studies of AIR001 being conducted at prestigious research
institutions.
- The Company has begun to wind down its vepoloxamer programs in
sickle cell disease and heart failure and expects those activities
will be completed in the fourth quarter of 2016.
- While furthering the development of AIR001 through the ongoing
Phase 2 clinical studies, the Company is planning to initiate a
process to evaluate partnership opportunities for its
assets.
- As a result of cost savings anticipated by the termination of
its vepoloxamer clinical programs and related operations and the
prioritization of its AIR001 program, the Company estimates that
its operating expenses for 2017 will be in the range of
$9 to $10 million, excluding
share-based compensation expense. This anticipated level of
spend reflects an approximate 70% reduction from estimated
operating expenses for 2016 of approximately $32 to $34 million, excluding share-based
compensation expense.
- The Company will make the $10
million prepayment on its debt facility triggered by the
recently announced results of its Phase 3 study of vepoloxamer
in early October 2016. After that prepayment, the principal
amount of the Company's debt will be approximately $3.5 million, which is scheduled to be repaid in
equal monthly installments of principal and interest through
January 1, 2019.
"Following a critical review of our pipeline and opportunities
we have determined that a focus on AIR001 will provide for a strong
foundation from which we will seek to return value to our
stockholders," stated Brian M.
Culley, the Company's Chief Executive Officer.
"However, these decisions likely will have a significant
impact on our talented team members and I want to personally thank
those who may be affected for their hard work, dedication and
contributions to the vepoloxamer program."
AIR001 Program Update
The Company will
prioritize its AIR001 program with continued support for three
separate, ongoing, investigator-sponsored Phase 2 clinical studies
of AIR001. Earlier this year, the Company reported positive
top-line results from a blinded and randomized Phase 2a clinical
study of AIR001 in HFpEF patients and detailed results were
published on September 16, 2016 in
Circulation Research, Volume 119, Issue 7 (available
here).
- The Company will continue to support an ongoing, randomized,
double-blind, placebo-controlled crossover Phase 2 study of AIR001
in patients with HFpEF being conducted by the Heart Failure
Clinical Research Network (HFN) with support from a grant awarded
by the National Heart, Lung, and Blood Institute, part of the
National Institutes of Health. (ClinicalTrials.gov Identifier:
NCT02742129) Patient enrollment in this study is expected to
complete before the end of 2017. The majority of expenses for
this 100-patient study are being funded by the HFN.
- The Company will continue to support an ongoing,
investigator-sponsored Phase 2 clinical study of AIR001 in patients
with pulmonary hypertension associated with HFpEF.
(ClinicalTrials.gov Identifier: NCT01431313) The Company
previously reported positive interim results from the study, which
results were presented at the American Thoracic Society
International Conference in May 2016
(poster available here). Additional interim results from this
Phase 2 study have been accepted for publication and are expected
to be available in the coming weeks.
- The Company will continue to support an ongoing, randomized,
placebo-controlled Phase 2 study of AIR001 in patients with HFpEF
undergoing cardiac rehabilitation for exercise training to evaluate
whether blinded treatment with AIR001 improves exercise capacity
and hemodynamic reserve compared to placebo. (ClinicalTrials.gov
Identifier: NCT02713126)
Vepoloxamer Program Update
Concurrent with the
wind-down of its vepoloxamer programs, which includes the
termination and closure of all active clinical study sites in the
EPIC extension study known as EPIC-E and the clinical
pharmacokinetics study in individuals with varying degrees of renal
insufficiency, the Company is in the process of analyzing
additional data from the Phase 3 clinical study of vepoloxamer in
sickle cell disease known as EPIC and interim data from a Phase 2
study of vepoloxamer in chronic heart failure and will assess
opportunities to create value from this asset.
The Company recently announced that it received a Small Business
Innovation Research grant from the National Institute Of
Neurological Disorders And Stroke of the National Institutes of
Health to support investigation of vepoloxamer in combination with
tissue plasminogen activator (tPA) in experimental models of
embolic stroke and the Company currently intends that work will
continue as planned. The Company is collaborating with
leading stroke researchers at the Neuroscience Institute at Henry
Ford Health System for the conduct of this preclinical study.
In addition, the Company expects that preclinical work being
conducted by the U.S. military under a Cooperative Research and
Development Agreement (CRADA) to evaluate vepoloxamer's potential
as a resuscitation fluid following major trauma will
continue.
About AIR001
AIR001 is a sodium nitrite
solution for intermittent inhalation via nebulization. Nitrite is a
direct vasodilator and can be recycled in vivo to form
nitric oxide (NO) independent of the classical NO synthase (NOS)
pathway. Nitrite mediated NO formation has several beneficial
effects, including dilation of blood vessels and reduction of
inflammation and undesirable cell growth. Generation of NO from
sodium nitrite is not dependent upon endothelial function and is
enhanced in the setting of tissue hypoxia and acidosis, conditions
in which NOS activity typically is depressed. In early clinical
studies, AIR001 demonstrated positive hemodynamic effects with
reductions observed in right atrial pressure and pulmonary
capillary wedge pressure, as well as improvements in mean pulmonary
artery pressures, cardiac output, and exercise tolerance as
measured by six-minute walk distance. In a randomized,
double-blind, placebo-controlled Phase 2a study of AIR001 in
patients with HFpEF (n=26), the AIR001 treatment group showed a
statistically significant decrease in pulmonary capillary wedge
pressure during exercise compared to the control group and AIR001
was generally well-tolerated.
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 nebulizer, 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, 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 to continue to operate as a going concern; risks
associated with the Company's ability to manage operating expenses
and obtain additional capital as needed; uncertainty related to the
Company's ability to remain in compliance with the terms and
conditions under its debt facility and risk that, in addition to
the $10 million prepayment to be made
in early October 2016, the Company
may be required to repay its remaining outstanding debt obligations
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 that
exchange; completion of a more detailed analysis of EPIC data and
reporting of additional data from the 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 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 lack of control over
the ongoing, investigator-sponsored Phase 2 clinical studies of
AIR001, including whether any of the studies will be completed on
anticipated timelines, or at all; 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 its clinical trial material,
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 and 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.
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SOURCE Mast Therapeutics, Inc.