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Cytokinetics Reports Fourth Quarter 2022 Financial Results
Company Received Complete Response Letter from FDA for New Drug Application for Omecamtiv Mecarbil Data from Cohort 4 of REDWOOD-HCM to be Presented at the
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Company Received Complete Response Letter from FDA for New Drug Application for Omecamtiv Mecarbil Data from Cohort 4 of REDWOOD-HCM to be Presented at the American College of Cardiology Scientific Sessions; Results Expected from SEQUOIA-HCM in Q4 2023 Second Interim Analysis of COURAGE-ALS Expected to Occur in Q2 2023 Company Provides 2023 Financial Guidance; More than 2 Years of Cash Runway SOUTH SAN FRANCISCO, Calif., March 01, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the fourth quarter and full year 2022. Net loss for the fourth quarter was $137.4 million or $1.45 per share and the net loss for the year 2022 was $389.0 million or $4.33 per share. Net loss for the fourth quarter of 2021 was $30.6 million or $0.36 per share and net loss for the year 2021 was $215.3 million or $2.80 per share. Cash, cash equivalents and investments totaled $829.3 million at December 31, 2022. “Aficamten remains our top priority and is advancing in a broad development program with emphasis on the conduct of SEQUOIA-HCM, our pivotal Phase 3 clinical trial in obstructive HCM, and the start of two additional Phase 3 trials,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “At the same time, COURAGE-ALS, our Phase 3 clinical trial of reldesemtiv, is continuing to enroll with the planned second interim analysis expected to occur in the second quarter. These activities will continue as company priorities while we will also assess potential next steps for omecamtiv mecarbil. We entered 2023 with a strong balance sheet as we advance multiple late-stage programs as well as make progress in our early-stage pipeline, continuing our 25-year commitment to bringing forward potential new medicines for patients in need.” Q4 and Recent Highlights Cardiac Muscle Programs omecamtiv mecarbil (cardiac myosin activator) Cytokinetics announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for omecamtiv mecarbil, stating that GALACTIC-HF is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with reduced ejection fraction, in lieu of evidence from at least two adequate and...