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Cytokinetics and the ALS Association announce the release of

SOUTH SAN FRANCISCO, Calif., AND WASHINGTON, Aug. 04, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) and the ALS Association today announced a new release of open-access ALS clinical trials resources Shared (PRO-ACT) database update with clinical data from completed Cytokinetics ALS clinical trials, including BENEFIT-ALS (Bline Eevaluation of NOTeuromuscular Eeffects and Functional Iimprovement with Jirasemtiv in ALS), VITALITY-ALS (Ventilatory Iinvestigation about Jirasemtiv and Aevaluation of Llongitudinal Iclue after Jtreatment for a Yesear in ALS) and FORTITUDE-SLA (Functional Oresults in a Randomized Jrial of Iinvestigative Jtreatment with CK-2127107 for youto understand Dbow in Endpoints – in ALS).

“We are excited to share this data with the ALS community to further research, understanding and potential breakthroughs for people living with this serious disease,” said Fady I. Malik, MD, Ph.D., Vice -Executive President of Research and Research at Cytokinetics. Development. “We recognize that we all benefit from shared ideas, successes and even failures if we are ultimately to make a difference in the lives of many. We thank the people living with ALS who participated in our clinical trials for making this possible. »

“We are grateful to Cytokinetics for their partnership and transparency, enabling the global research community to leverage this data in their ongoing analyzes and research activities,” said Neil Thakur, Ph.D., Director of mission to the ALS Association.

The PRO-ACT database, which is sponsored by the ALS Association and managed by the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital, is home to the largest clinical trial data set for ALS, containing nearly 11,000 anonymized ALS patient records from 23 completed clinical studies. trials. The platform harmonizes and merges anonymized data from existing publicly and privately conducted ALS clinical trials to generate a single, freely available resource for the scientific community to help find cures for ALS. The PRO-ACT platform was selected as winner of Bio-IT World’s Best Practices Awards in 2013 and winner of Clinical Informatics News Best Practices in the Clinical Data Intelligence category in 2015.

The PRO-ACT platform was created by Prize4Life Israel, a non-profit organization, in partnership with the Northeast ALS Consortium (NEALS) and NCRI, and with initial funding from The ALS Therapy Alliance, Prize4Life, NCRI and The ALS Association. To date, PRO-ACT has served as the primary data source for over 80 publications and has been critical for many more. The platform has allowed researchers to better understand disease heterogeneity, develop new predictive models of disease progression, and has been an essential tool to support the design of several ALS clinical trials.

About ALS

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects approximately 27,000 people in the United States and a comparable number of patients in Europe. Approximately 6,300 new cases of ALS are diagnosed each year in the United States. The average life expectancy for someone with ALS is about three to five years after diagnosis and only about 10% of people with ALS survive more than 10 years. Death is usually due to respiratory failure due to a decrease in the strength of the skeletal muscles responsible for breathing. Few treatment options exist for these patients, resulting in a high unmet need for new therapies to address functional deficits and disease progression.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class muscle activators and cutting-edge muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company develops small molecule drug candidates specifically designed to impact muscle function and contractility. Cytokinetics prepares for potential commercialization of mecarbil omecamtiv, its heart muscle enhancer, following positive results from GALACTIC-HF, a large international Phase 3 clinical trial in patients with heart failure. Cytokinetics also develops to affirma next-generation cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, the phase 3 clinical trial of to affirm in patients with symptomatic hypertrophic obstructive cardiomyopathy (HCM). Aficamten is also being evaluated in non-obstructive HCM in Cohort 4 of the Phase 2 clinical trial, REDWOOD-HCM. Cytokinetics also develops relative, an investigational fast skeletal muscle troponin activator, which is currently undergoing COURAGE-ALS, a Phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS). Cytokinetics continues its more than 20-year history of pioneering innovation in muscle biology and related pharmacology focused on muscle dysfunction diseases and muscle weakness states.

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

About the ALS Association

The ALS Association is the largest philanthropic funder of ALS research in the world. The Association funds global research collaborations, helps people with ALS and their families through its national network of care, and advocates for better public policies for people with ALS. The ALS Association strives to make ALS a livable disease while urgently searching for new treatments and a cure. For more information about the ALS Association, visit our website at www.als.org

Forward-looking statements

This press release contains forward-looking statements for the purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intention or obligation to update these forward-looking statements and claims the protection of the safe harbor of law for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to one of our other clinical trials, statements relating to the potential benefits of relative, mecarbil omecamtiv, to affirm, or any of our other drug candidates; the research and development activities of Cytokinetics; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of other Cytokinetics drug candidates. These 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 development, testing, regulatory approvals for the initiation of testing, development or sale of products or the manufacture or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have undesirable side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may not be able to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics drug candidates obsolete; and competing products or alternative therapies may be developed by others for the treatment of indications that Cytokinetics’ drug candidates and potential drug candidates may target. For more information regarding these and other risks associated with Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.

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Diane Weiser
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(650) 624-3071