SAN DIEGO, Feb. 27, 2014 /PRNewswire/ -- Mast Therapeutics,
Inc. (NYSE MKT: MSTX) today announced that it has completed its
acquisition of Aires Pharmaceuticals, Inc. Aires' lead product
candidate, AIR001, is an intermittently nebulized formulation of
nitrite that has orphan drug designation in the U.S. and European
Union for the treatment of pulmonary arterial hypertension.
"The addition of AIR001 provides us with not only an exciting
phase 2 asset in the area of pulmonary disease, but also an ideal
complement to our lead product, MST-188," said Brian M. Culley, Chief Executive Officer. "With
MST-188 in an ongoing pivotal trial for sickle cell disease and a
phase 2 trial expected to initiate this quarter in acute limb
ischemia, the addition of another phase 2-ready asset further
enhances our pipeline, providing us with diversity across
specialized indications as well as cohesion in addressing
significant unmet medical needs. In addition, as previously
reported, although our estimated costs for AIR001 will change as we
refine our development strategy over the next few months, we
currently anticipate that our first year of development of AIR001
will be covered by Aires' net cash at closing of $2.6 million."
Under the terms of the all-stock transaction, which was
completed on February 27, 2014, Aires
became a wholly-owned subsidiary of Mast Therapeutics in exchange
for a total of 5.2 million shares of Mast common stock,
representing approximately 5% of Mast's outstanding common
stock. Approximately 80% of the shares comprising the merger
consideration are being held back for a period of six months to
satisfy any indemnification obligations of the former Aires'
stockholders under the merger agreement. There are no
milestone obligations payable by Mast.
About AIR001
AIR001 (sodium nitrite) inhalation solution, also known as
Aironite®, is an intermittently nebulized formulation of nitrite,
which can be converted to nitric oxide independent of nitric oxide
synthase activity. 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 designation by
the U.S. Food and Drug Administration and the European
Commission for the treatment of pulmonary arterial
hypertension.
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
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
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 AIR001, 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 or to 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.
Logo -
http://photos.prnewswire.com/prnh/20120612/LA22456LOGO-a
SOURCE Mast Therapeutics, Inc.