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.
October 7, 2015
The Palace Hotel, New York City
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.
Mast Therapeutics, Ioana C. Hone (email@example.com), 858-552-0866 Ext. 303