Cytokinetics Announces Data to Be Presented at the HFSA Virtual Annual Scientific Meeting 2020

Rhea-AI Summary

Cytokinetics (Nasdaq: CYTK) has announced that new data will be presented at the Heart Failure Society of America Virtual Annual Scientific Meeting from September 30 to October 6, 2020. The data will focus on heart failure patients and include findings from the Phase 3 GALACTIC-HF trial and the completed Phase 2 COSMIC-HF trial involving omecamtiv mecarbil. Key presentations will take place on October 1 and October 2, featuring insights on myosin activators and their impact on cardiac function.

Positive

• Cytokinetics will showcase significant new data regarding heart failure treatments at a prominent scientific meeting.
• The company continues to advance research on omecamtiv mecarbil, indicating ongoing clinical development.

Negative

• No specific positive clinical outcomes or results from trials were reported, which may raise concerns about current drug efficacy.
• There is a potential risk related to regulatory approvals that could delay product development.

SOUTH SAN FRANCISCO, Calif., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new data will be presented at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting 2020 taking place online from September 30, 2020 – October 6, 2020.

The new data include analyses characterizing real-world patients with heart failure with reduced ejection fraction (HFrEF) representative of patients in GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 event driven cardiovascular outcomes clinical trial of omecamtiv mecarbil. Additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), the completed Phase 2 clinical trial which evaluated omecamtiv mecarbil in patients with HFrEF, will also be presented.

Title: Characteristics And Outcomes Of A Real-world Population With Heart Failure With Reduced Ejection Fraction Representative Of Clinical Trial Patients
ePoster Number: 229
Date: Wednesday, September 30, 2020 – Tuesday, October 6, 2020

Title: Progress from Bench to Bedside and Insights Learned - Myosin Activators
Session: Excellence in Translation Science: Fast Track Discovery to Application (Joint Session with CVCT)
Speaker: Fady I. Malik, M.D., Ph.D., FACC, FHFA, Executive Vice President of Research & Development, Cytokinetics
Date: Thursday, October 1, 2020
Presentation Time: 6:00 – 8:15 PM ET

Title: The Effect Of The Cardiac Myosin Activator, Omecamtiv Mecarbil, On Right Ventricular Structure And Function In Chronic Systolic Heart Failure (COSMIC-HF)
Session: Jay N. Cohn New Investigator Award: Clinical/Basic Science Session
Speaker: Tor Biering-Sørensen, M.D., Ph.D., MPH, Associate Professor, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen; Research Director, Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev & Gentofte Hospital
Date: Friday, October 2, 2020
Presentation Time: 7:15 – 8:15 PM ET
ePoster Number: 003

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA) for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is considering potential advancement of reldesemtiv to Phase 3. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to research, develop and commercialize other novel mechanism skeletal sarcomere activators (excluding FSTAs). Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies (HCM). Cytokinetics has granted Ji Xing Pharmaceuticals Limited an exclusive license to develop and commercialize CK-274 in China and Taiwan, in accordance with Cytokinetics’ planned global registration programs. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

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 the GALACTIC-HF clinical trial, including the expected timing of the availability of top-line results; statements relating to the METEORIC-HF clinical trial; the potential benefits of omecamtiv mecarbil, including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; Cytokinetics' and its partners' research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics' other drug candidates. 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, 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; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics' or its partners' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; 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; 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.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Communications, Investor Relations
(415) 290-7757

FAQ

What data will Cytokinetics present at the HFSA Annual Meeting?

Cytokinetics will present new data on heart failure patients and findings from the GALACTIC-HF and COSMIC-HF trials.

When is the Cytokinetics presentation at the HFSA meeting?

Cytokinetics will present from September 30 to October 6, 2020.

What is omecamtiv mecarbil's role in Cytokinetics' research?

Omecamtiv mecarbil is being investigated as a cardiac muscle activator in heart failure treatment.

What are the implications of the COSMIC-HF results for CYTK stockholders?

While the study's results are yet to be disclosed, the ongoing clinical trials could impact investor sentiment and stock performance.