SAN DIEGO, March 28, 2013 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX) today announced that it has engaged ESC Advisors, a division of the investment banking firm KEMA Partners LLC, to serve as its exclusive financial advisor to identify potential partners for MST-188 and advise the Company in transaction discussions.
Brian M. Culley, Chief Executive Officer, said: "Given the high unmet need and limited treatment options, sickle cell disease is experiencing significant levels of interest from strategic partners. MST-188 is now the only new molecular entity in phase 3 development in sickle cell disease. Based on its stage of development, the absence of competitive, novel and late-stage products, its designation as an orphan drug in the U.S. and Europe and its potential utility in additional indications, we believe there will be substantial interest in MST-188 from potential partners, both in the U.S. and globally, and we intend to pursue strategic alliances aggressively. ESC's experience in transactions involving orphan product candidates will complement our internal capabilities and expand the scope of our current and future partnering discussions."
About Mast Therapeutics Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, CA. 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 antithrombotic agent that has potential utility in diseases or conditions characterized by microcirculatory insufficiency (endothelial dysfunction and/or impaired blood flow).
The Company is recruiting subjects in EPIC, a pivotal phase 3 study of MST-188 in sickle cell disease. The Company plans to initiate a phase 2 clinical study of MST-188 in acute limb ischemia, a complication of peripheral arterial disease, in late 2013 or early 2014. More information can be found on the Company's web site at www.masttherapeutics.com.Forward-Looking StatementsMast 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 regarding anticipated levels of interest in MST-188 among potential strategic partners in and outside of the U.S., the Company's and its advisors' focus and ability to capitalize on any such interest, prospects for MST-188's clinical, regulatory and commercial success in sickle cell disease and other indications, and the potential benefits of partnering MST-188. Among the factors that could cause or contribute to material differences between the Company's actual results and expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the potential for interest in MST-188 among potential strategic partners to be less than anticipated by the Company; the risk that acceptable partnering opportunities for MST-188 may not be available in particular jurisdictions or indications on a timely basis or at all and, consequently, the Company may not be able to pursue development of MST-188 in certain jurisdictions or indications; the potential that partnering transactions involving MST-188 may not advance its development in other jurisdictions, enhance the overall commercial opportunity of the product candidate or help fund its development within the U.S.; the potential for significant delays in the development of MST-188, including as a result of delays in the commencement or completion of clinical studies, including due to 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, completing necessary manufacturing process development activities, and being subject to a "clinical hold," or suspension or termination of a clinical study, including due to lack of adequate funding or patient safety concerns; the potential for institutional review boards or the FDA, the EMA or other regulatory agencies to require additional nonclinical or clinical studies prior to initiation of planned phase 2 clinical studies of MST-188 in any particular indication in which the Company determines to develop MST-188, including acute limb ischemia, which likely would increase the total time and cost of development in the indication; the risk that clinical studies of MST-188 are not successfully executed and/or do not successfully demonstrate its safety or efficacy; the risk that, even if clinical studies are successful, the FDA, the EMA or other regulatory agencies may determine they are not sufficient to support a new drug application; the risk that even if clinical studies of MST-188 in one indication or jurisdiction are successful, clinical studies in another indication or jurisdiction may not be successful; the potential for unsuccessful nonclinical or clinical studies in one indication or jurisdiction, or by a future partner that may be outside of the Company's control, to adversely affect opportunities for MST-188 in other indications or jurisdictions; 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 MST-188's development, including clinical studies and regulatory activities, 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 MST-188 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 the FDA, the EMA or other regulatory agencies do not grant marketing approval of MST-188, on a timely basis, or at all; the risk that the Company is not able to adequately protect its intellectual property rights relating to the MAST platform and MST‑188 and prevent competitors from duplicating or developing equivalent versions of MST-188; and other risks and uncertainties more fully described in the Company's press releases and periodic filings with the U.S. Securities and Exchange Commission. The Company's public filings with the U.S. 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. the Company 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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