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Cytokinetics, Incorporated (Nasdaq: CYTK) reported a net loss of $135.6 million, or $1.33 per share, for the first quarter of 2024 compared to $131.3 million for the same period in 2023. The company has $634.3 million in cash, cash equivalents, and investments as of March 31, 2024. Cytokinetics advanced its muscle-biology portfolio with aficamten, opened enrollment to a pediatric clinical trial for obstructive HCM, and announced topline data from the Phase 1 study of CK-586. The company is preparing for regulatory submissions, engaging in commercial readiness activities, and progressing towards a Phase 2 clinical trial for CK-586. Financially, revenues for Q1 2024 were $0.8 million, a decrease from $4.6 million in Q1 2023, while research and development expenses increased to $81.6 million.
Cytokinetics announced topline data from the Phase 1 clinical study of CK-4021586 (CK-586), showing positive results in safety, tolerability, and pharmacokinetics. The data support the advancement to a Phase 2 clinical trial in patients with heart failure with preserved ejection fraction (HFpEF) starting in Q4 2024. CK-586, a cardiac myosin inhibitor, aims to treat a subgroup of HFpEF patients by addressing underlying hypercontractility. The study met its primary and secondary objectives, with no serious adverse events observed.
Cytokinetics has announced the start of CEDAR-HCM, a clinical trial of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy. The trial aims to evaluate the safety and efficacy of aficamten, a cardiac myosin inhibitor, for the potential treatment of HCM in adolescents and children. The primary endpoint is the change in Valsalva left ventricular outflow tract gradient (LVOT-G) from baseline to Week 12, with secondary endpoints including resting LVOT-G, NYHA Functional Class, pharmacokinetics, and cardiac biomarkers. The trial is expected to enroll two cohorts, with initial enrollment of adolescent patients aged 12 to 17.
Cytokinetics, Incorporated (Nasdaq: CYTK) will hold its Annual Meeting of Stockholders on May 15, 2024, at 10:00 AM Pacific Time, at its headquarters in South San Francisco, CA. Stockholders of record as of March 26, 2024, can attend, vote, and submit questions to management. The CEO will present an overview of the company's performance. Voting can be done in person or via proxy card by May 14, 2024. Interested parties can access the live webcast and a replay on Cytokinetics' website.
Cytokinetics, Incorporated announced the granting of stock options and restricted stock units to five new employees as a material inducement to their employment. The options and RSUs will vest over several years and are subject to specific conditions. The stock options have a 10-year term and an exercise price based on the closing price of the company's common stock on the grant date.
Cytokinetics, Incorporated (CYTK) announced it will host an investor event and conference call on May 13, 2024, to discuss primary results from SEQUOIA-HCM at the European Society of Cardiology Heart Failure 2024 Congress. The event will feature key healthcare professionals and can be accessed online.
