SAN DIEGO, Feb. 10, 2014 /PRNewswire/ -- Mast Therapeutics,
Inc. (NYSE MKT: MSTX) today announced that it has entered into a
definitive agreement to acquire Aires Pharmaceuticals, Inc.
(Aires), a privately-held, clinical stage pharmaceutical company
developing therapies to treat pulmonary vascular disorders such as
pulmonary arterial hypertension and pulmonary hypertension due to
heart failure. Aires' lead product, AIR001, is an intermittently
nebulized formulation of nitrite and has orphan drug status with
the U.S. Food and Drug Administration and the European Medicines
Agency for the treatment of pulmonary arterial
hypertension.
"The acquisition of Aires will enhance our pipeline with a phase
2 asset with more than 120 human subject exposures and which is a
strategic complement to our lead program, MST-188. With total
consideration of approximately 6% of Mast equity, it represents
excellent value for our stockholders," stated Brian M. Culley, Chief Executive Officer of Mast
Therapeutics, Inc.
"Nitrite has demonstrable beneficial properties, including
vasodilation and the reduction of inflammation and undesirable cell
growth. These are important therapeutic objectives and an
ideal complement to MST-188 and its ability to improve blood flow
and seal cellular membranes. In addition, we intend to investigate
the hypothesis that AIR001 positively affects mitochondrial
activity and myocyte energetics. With this acquisition, and the
initiation of our phase 2 trial of MST-188 for the treatment of
acute limb ischemia later this quarter, we are taking additional
steps towards building a sustainable company with a valuable
pipeline addressing significant unmet needs in both specialized and
major markets," Mr. Culley continued.
"Another highlight of this acquisition is its favorable
economics. Aires had completed several venture financings,
including a $20 million Series B
round. We are paying significantly less than that to acquire the
program and we currently estimate that our development costs for
AIR001 for the first 12 months will be approximately
$2 million. Our estimated costs for AIR001 will change
as we refine our development strategy over the next few months, but
Aires is expected to contribute approximately $3 million of net cash at the closing of the
merger, so, as currently contemplated, our first year of
development of AIR001 will not require additional capital
investment by Mast," Mr. Culley concluded.
Under the terms of the all-stock transaction, Aires would become
a wholly-owned subsidiary of Mast Therapeutics, Inc. in exchange
for shares of Mast common stock representing approximately 6% of
Mast's outstanding common stock, 80% of which would be subject to a
six-month holdback for certain indemnification claims of Mast.
There are no milestone obligations payable to Aires. The
acquisition is expected to close in February
2014, subject to customary closing conditions.
About AIR001
AIR001 (sodium nitrite) inhalation
solution, also known as Aironite®, is an intermittently nebulized
formulation of nitrite. Under hypoxic conditions, AIR001 is
converted to nitric oxide. Nitrite mediated nitric oxide
formation has several beneficial effects, including dilation of
blood vessels and reduction of inflammation and undesirable cell
growth.
AIR001 has been granted orphan drug status by the U.S. Food and
Drug Administration and the European Medicines Agency for the
treatment of pulmonary arterial hypertension.
Conference Call Information
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 Corporate Update Call. The webcast will be
available live via the Internet by accessing the Investors section
of Mast's website at www.masttherapeutics.com/investors/. Replays
of the webcast will be available on the Company's website for 30
days and a phone replay will be available through March 5, 2014 by dialing (877) 344-7529 from the
U.S. and (412) 317-0088 from outside the U.S. and entering
conference reference number 10040517.
About Mast Therapeutics
Mast Therapeutics, Inc. is a
publicly traded biopharmaceutical company headquartered in
San Diego, California. The
Company is leveraging the MAST (Molecular Adhesion and Sealant
Technology) platform, derived from over two decades of clinical,
nonclinical and manufacturing experience with purified and
non-purified poloxamers, to develop MST-188, its lead product
candidate, for serious or life-threatening diseases with
significant unmet needs. MST-188 is a cytoprotective,
hemorheologic, anti-inflammatory and anti-thrombotic agent that has
potential utility in diseases or conditions characterized by
microcirculatory insufficiency (endothelial dysfunction and/or
impaired blood flow).
The Company is enrolling subjects in EPIC, a pivotal phase 3
study of MST-188 in sickle cell disease. In the first quarter
of 2014, the Company plans to initiate a phase 2, clinical proof of
concept study in acute limb ischemia that will evaluate whether
MST-188 improves the effectiveness of existing thrombolytic agents.
The Company is also evaluating development options for MST-188 in
heart failure. 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. Aironite® is a trademark of Aires
Pharmaceuticals, 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 the completion of the acquisition of Aires
Pharmaceuticals, the amount of the Company's common stock issuable
as merger consideration, the amount of Aires' net cash at closing
of the merger, the Company's development plans for AIR001, as well
as the cost and timing of activities related to those plans, and
the Company's development plans for MST-188 in acute limb ischemia
and heart failure, including the timing of initiation of any
clinical studies. 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 potential that the acquisition may be delayed
and/or terminated; the potential that the number of shares of the
Company's common stock issuable to Aires' stockholders as merger
consideration will be greater or less than the Company's estimated
amount as a result of differences between the Company's estimate of
and Aires' actual net cash at closing and/or the volatility in the
closing sales prices of the Company's common stock; the uncertainty
of outcomes in ongoing and future studies of any investigational
drug, including MST-188 and AIR001, and the risk that they 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
institutional review boards or the FDA or other regulatory agencies
to require additional nonclinical or clinical studies prior to
initiation of any planned phase 2 clinical study of MST-188 or
AIR001; 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 risk that, even if
clinical studies are successful, the FDA or other regulatory
agencies may determine they are not sufficient to support a new
drug application; 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 and regulatory activities for MST-188, 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 with
its products and may never generate revenue sufficient to achieve
profitability; the risk that the Company is not able to adequately
protect its intellectual property rights relating to the MAST
platform and MST-188, and, following the acquisition, AIR001, and
prevent competitors from duplicating or developing equivalent
versions of its product candidates; 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.
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SOURCE Mast Therapeutics