Cytokinetics Highlights Progress of Activities Directed to Muscle Biology at Today's Research & Development Day
Two First-In-Class Programs Advancing in Phase IIb Clinical Trials
Company Convenes Panel of Experts to Discuss the Integrated Care of ALS Patients
South San Francisco, CA, December 12, 2012 - Cytokinetics, Incorporated (Nasdaq: CYTK) is scheduled today to provide a corporate update on the company's research and development pipeline and will be highlighting its focus to advancing novel, internally-discovered drug candidates that are directed to the biology of muscle function and contractility.
"We are pleased to elaborate today on our industry leading expertise focused to the pharmacology of muscle function which has resulted in two first-in-class programs. Each of these novel development programs has progressed to a large, international Phase IIb clinical trial and both trials are expected to deliver results in 2013," stated Robert I. Blum, President and Chief Executive Officer of Cytokinetics. "We believe that our R&D activities, directed to activating cardiac and skeletal muscle contractility respectively, represent potential major advances for patients suffering from severe and grievous illnesses. At this R&D Day, we also look forward to providing updates on promising new research at Cytokinetics related to neuromuscular diseases and heart failure."
Senior members of the Cytokinetics management team will discuss recent progress with respect to tirasemtiv and omecamtiv mecarbil in each of the ongoing BENEFIT-ALS and ATOMIC-AHF Phase IIb trials respectively, and will update plans and other progress in research and development for each of Cytokinetics' skeletal and cardiac muscle contractility programs. In addition, company management will provide insights into the value proposition for these advanced programs and how they may address important clinical unmet needs that directly relate to Cytokinetics' commercial strategies. The Cytokinetics' management team will also be joined by Jeremy Shefner, MD, PhD, Professor and Chair, Department of Neurology Upstate Medical University, State University of New York and Christopher O'Connor, MD, Professor of Medicine and Director of Duke Heart Center & Chief, Division of Cardiology, Duke University Medical Center.
Following company presentations, a panel of experts will also discuss the integrated care of ALS patients. Joining Dr. Shefner on the panel will be Lucie Bruijn, PhD, Chief Scientist, The ALS Association, and Dallas Forshew, RN, BSN, Manager of Clinical Research, Forbes Norris MDA/ALS Research Center, California Pacific Medical Center, San Francisco.
Interested parties may access the live video webcast of this presentation and accompanying slides starting at 8:00 AM Eastern Standard Time, today by visiting the Investor Relations section of the Cytokinetics' website at www.cytokinetics.com. The live audio of the forum will also be accessible by dialing either (866) 999-2985 (United States and Canada) or (706) 679-3078 (International) and typing in the passcode 72489467. The webcast replay of the presentation will be archived on the Presentations page within the Investor Relations section of Cytokinetics' website following the event. The replay will also be available via telephone from December 12, 2012 at 1:00 PM Eastern Time until December 26, 2012 by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (International) and typing in the passcode 72489467.
Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Cytokinetics' lead drug candidate from its cardiac muscle contractility program, omecamtiv mecarbil, is in Phase II clinical development for the potential treatment of heart failure. Amgen Inc. holds an exclusive license worldwide (excluding Japan) to develop and commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization participation rights. Cytokinetics is independently developing tirasemtiv, a skeletal muscle activator, as a potential treatment for diseases and conditions associated with aging, muscle wasting or neuromuscular dysfunction. Tirasemtiv is currently the subject of a Phase II clinical trials program and has been granted orphan drug designation and fast track status by the U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency for the potential treatment of amyotrophic lateral sclerosis, a debilitating disease of neuromuscular impairment in which treatment with tirasemtiv produced potentially clinically relevant pharmacodynamic effects in Phase II trials. All of these drug candidates have arisen from Cytokinetics' muscle biology focused research activities and are directed towards the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Additional information about Cytokinetics can be obtained at www.cytokinetics.com.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' research and development activities, including the progress, conduct and results of clinical trials, the expected timing for the results of clinical trials and the significance and utility of clinical trial results; the potential benefits of Cytokinetics' focus on muscle function and contractility; the properties and potential benefits of tirasemtiv, omecamtiv mecarbil and Cytokinetics' other compounds; and planned presentations. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, Cytokinetics will require significant additional funding to conduct a registration program for tirasemtiv for the potential treatment of ALS and may be unable to obtain such additional funding on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results, patient enrollment for or conduct of clinical trials may be difficult or delayed, Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy, and the U.S. Food and Drug Administration (FDA) or foreign regulatory agencies may delay or limit Cytokinetics' or its partners' ability to conduct clinical trials; Amgen's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Cytokinetics may incur unanticipated research and development and other costs; Cytokinetics may be unable to enter into future collaboration agreements for its drug candidates and programs on acceptable terms, if at all; standards of care may change, rendering Cytokinetics' drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target; regulatory authorities may not grant tirasemtiv orphan drug exclusivity in ALS even if it is approved for marketing; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics' collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
Jodi L. Goldstein
Manager, Marketing & Corporate Communications