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Cytokinetics Announces Three Presentations to Occur at the European Society of Cardiology Heart Failure 2021 Congress

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Cytokinetics (Nasdaq: CYTK) will present at the virtual Heart Failure 2021 congress from June 29 to July 1, 2021. Key topics include analyses from the GALACTIC-HF trial, focusing on how atrial fibrillation affects the efficacy of omecamtiv mecarbil in heart failure treatment. A Late Breaking Clinical Trial Session on June 29 will feature Dr. Scott Solomon discussing these findings. Additional presentations will cover treatment efficacy based on N-terminal pro-B-type natriuretic peptide levels and outcomes in severe heart failure.

Positive
  • Cytokinetics prepares for a U.S. NDA submission of omecamtiv mecarbil following favorable GALACTIC-HF trial results.
  • Conducting METEORIC-HF Phase 3 trial for omecamtiv mecarbil.
  • Developing CK-274 for hypertrophic cardiomyopathies, advancing toward Phase 3 trials.
Negative
  • Possible delays in clinical trial developments due to regulatory challenges.
  • Risks related to the efficacy and side effects of drug candidates.

SOUTH SAN FRANCISCO, Calif., June 23, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) today announced three presentations at Heart Failure 2021, an International Congress of the European Society of Cardiology taking place online from June 29, 2021 – July 1, 2021. The presentations will include a Late Breaking Clinical Trial Session with additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) relating to the influence of baseline atrial fibrillation on the treatment effect of omecamtiv mecarbil. Additional presentations will include secondary analyses from GALACTIC-HF relating to the effects of treatment with omecamtiv mecarbil on subgroups of patients in the trial.

Late Breaking Clinical Trial Session

Title: Influence of Atrial Fibrillation on Efficacy of Omecamtiv Mecarbil in Heart Failure: The GALACTIC-HF Trial
Presenter: Scott Solomon, M.D., Edward D. Frohlich Distinguished Chair, Professor of Medicine, Harvard Medical School and Director of Noninvasive Cardiology, Brigham and Women's Hospital
Date: June 29, 2021
Topic: Chronic Heart Failure
Session Title: Late-Breaking Trials 1
Session Type: Special Session
Session Time: 4:40 PM CET

Clinical Trial Updates

The following presentations will be available on demand for registered attendees beginning on June 29, 2021 at 8:00 AM CET.

Title: Efficacy of Omecamtiv Mecarbil in Heart Failure with Reduced Ejection Fraction According to N-Terminal Pro-B-Type Natriuretic Peptide Level: Insights from the GALACTIC-HF Trial
Presenter: John McMurray, M.D., Professor of Medical Cardiology & Honorary Consultant Cardiologist, Institute of Cardiovascular & Medical Sciences, BHF Cardiovascular Research Centre, University of Glasgow
Date: June 29, 2021
Topic: Chronic Heart Failure
Session Title: Clinical Trial Updates
Session Type: Clinical Trial Update

Title: Omecamtiv Mecarbil in Patients with Severe Heart Failure: An Analysis from Global Approach to Lowering Adverse Cardiac Outcomes through Improving Contractility in Heart Failure (GALACTIC-HF)
Presenter: Michael Felker, M.D., Professor of Medicine, Duke Clinical Research Institute
Date: June 29, 2021
Topic: Chronic Heart Failure
Session Title: Clinical Trial Updates
Session Type: Clinical Trial Update

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 preparing a U.S. NDA submission of omecamtiv mecarbil, its novel cardiac muscle activator, following positive results from GALACTIC-HF, a large, international Phase 3 clinical trial in patients with heart failure. Cytokinetics is conducting METEORIC-HF, a second Phase 3 clinical trial of omecamtiv mecarbil. Cytokinetics is developing CK-274, a next-generation cardiac myosin inhibitor, for the potential treatment of hypertrophic cardiomyopathies (HCM). Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics is also developing reldesemtiv, a fast skeletal muscle troponin activator for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is preparing for the potential advancement of CK-274 to a Phase 3 clinical trial in obstructive HCM and reldesemtiv to a Phase 3 clinical trial in ALS. 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, statements relating to the potential benefits of omecamtiv mecarbil. Cytokinetics' 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' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics' drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target. 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 will Cytokinetics present at Heart Failure 2021?

Cytokinetics will present analyses from the GALACTIC-HF trial, focusing on omecamtiv mecarbil's efficacy in patients with atrial fibrillation.

When is Cytokinetics' presentation scheduled?

Cytokinetics' presentations are scheduled for June 29, 2021, during the Heart Failure 2021 congress.

What is omecamtiv mecarbil?

Omecamtiv mecarbil is a cardiac muscle activator developed by Cytokinetics, aimed at treating heart failure.

What are the objectives of the GALACTIC-HF trial?

The GALACTIC-HF trial aims to assess the efficacy of omecamtiv mecarbil in reducing adverse cardiac outcomes in heart failure patients.

Is Cytokinetics developing other drug candidates?

Yes, Cytokinetics is also developing CK-274 for hypertrophic cardiomyopathies and reldesemtiv for ALS.

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