SAN DIEGO, Sept. 23, 2015 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage
biopharmaceutical company leveraging its molecular adhesion and
sealant technology (MAST) platform to develop novel therapies for
sickle cell disease, heart failure, and stroke, today announced
that it will host its first Analyst & Investor Day on
October 7, 2015 at the Palace Hotel
in New York City. Mast
Therapeutics' full executive management team will provide an update
on its vepoloxamer and AIR001 programs, including:
- EPIC patient enrollment and blinded demographics, including
hydroxyurea use among the study population;
- EPIC statistical assumptions versus blinded performance,
including stratification factors and primary endpoint;
- Initiation of 150-patient, Phase 2 study of vepoloxamer in
chronic heart failure;
- Progress with two AIR001 Phase 2a studies; and
- Overview of commercial opportunity and strategy for vepoloxamer
in sickle cell disease.
"As a leader in the space, and with less than two quarters until
top-line results from EPIC, the largest interventional study ever
conducted in sickle cell disease, are announced, we believe this is
an opportune time to provide substantive updates on EPIC and our
other clinical programs," said Brian M.
Culley, the Company's Chief Executive Officer. "We also look
forward to discussing our ongoing activities to prepare for
vepoloxamer's New Drug Application and our commercialization plans
for vepoloxamer in sickle cell disease."
A live webcast of the presentations will be available online
from the Investors section of Mast's website at
http://www.masttherapeutics.com/investors/events/, and a replay of
the webcast will be available on the Company's website for 30
days.
Event
October 7,
2015
The Palace Hotel, New York
City
Schedule
Registration and Lunch: Noon EDT
Management Presentations: 1:00 p.m. –
2:30 p.m. EDT
Q&A: 2:30 p.m. – 3:00 p.m. EDT
About Mast Therapeutics
Mast Therapeutics, Inc. is a
publicly traded biopharmaceutical company headquartered in
San Diego, California. The
Company is leveraging its MAST platform, derived from over two
decades of clinical, nonclinical and manufacturing experience with
purified and non-purified poloxamers, to develop vepoloxamer (also
known as MST-188), its lead product candidate, for serious or
life-threatening diseases and conditions typically characterized by
impaired microvascular blood flow and damaged cell membranes.
The Company is also developing AIR001, a sodium nitrite solution
for inhalation via nebulizer, for the treatment of heart failure
with preserved ejection fraction (HFpEF).
Vepoloxamer is an investigational new drug being tested in a
pivotal Phase 3 study called EPIC for the treatment of
vaso-occlusive crisis in patients with sickle cell disease.
AIR001 is an investigational new drug being tested in multiple
institution-sponsored Phase 2a studies 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, or made during
Analyst & Investor Day, 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 prospects for successful development and
commercialization of the Company's investigational drugs,
vepoloxamer and AIR001, and anticipated timing of achievement of
development milestones, such as commencement and completion of
clinical studies or regulatory activities, and of announcement of
study data. 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 the
Company's product candidates and the risk that its product
candidates, including vepoloxamer, 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 additional
nonclinical or clinical studies to be required prior to initiation
of a planned clinical study; the risk that, even if planned
clinical studies are successful, the FDA or other regulatory
agencies may determine they are not sufficient to support a new
drug application; 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
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, manufacturing, and
regulatory activities for its product candidates, 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 and
may never achieve profitability; the risk that the Company is not
able to adequately protect its intellectual property rights and
prevent competitors from duplicating or developing equivalent
versions of its product candidates or that the use or manufacture
of its products or product candidates infringe 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, or made
during Analyst & Investor Day, 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.