Analyses of SEQUOIA-HCM Elaborate on Dosing and Measures of Safety During Treatment with Aficamten Results from Cardiopulmonary Exercise Testing Showed Improvement in Exercise Performance were Strongly Correlated to Other Measures of Clinical Improvement Company to Host Investor Event and Webcast Today at 4:00 PM Western European Summer Time (11:00 AM Eastern Time) SOUTH SAN FRANCISCO, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that additional results ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-50633 CYTOKINETICS, INCORPORATED (Exact name of registrant as specified in its charter) Delaware 94-3291317 (State or other jur ...

Financial Data and Key Metrics Changes - The company ended the first quarter with approximately $634.3 million in cash, representing a two-year cash runway, including capital expected from a deal with Royalty Pharma [21][162] - The company maintains a strong financial position alongside maturing R&D programs, indicating an advantageous position for accessing diversified capital [6][162] Business Line Data and Key Metrics Changes - Aficamten is at the forefront of the Phase 3 development program, with two ongoing Phase 3 clinical trials evaluating its efficacy, which could expand its clinical evidence use case [5][12] - The ACACIA-HCM trial is entering a rapid phase of site activation and enrollment, with expectations for significant progress in the second quarter [14][171] - The CEDAR-HCM trial is now open for enrollment in a pediatric population, focusing on symptomatic obstructive HCM [172] Market Data and Key Metrics Changes - The diagnosed obstructive HCM patient population is approximately 200,000 in the U.S. and Europe, with around 130,000 eligible for treatment [47] - The pediatric population with HCM is estimated to be around 6,000 to 8,000 patients, with a significant unmet need for treatment options [48][60] Company Strategy and Development Direction - The company is focused on regulatory submissions in the second half of the year, ongoing clinical trials, and accelerating commercial readiness activities [161] - The company aims to diversify access to capital and strengthen its balance sheet through primarily non-dilutive transactions [44][162] - The strategy includes engaging with U.S. payers and initiating preapproval information exchange to review SEQUOIA-HCM results [41][162] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the discussions with healthcare professionals and payers, which are expected to inform proposals for a differentiated approach to risk mitigation in the NDA [11][41] - The company anticipates that the results from SEQUOIA-HCM will reaffirm positive feedback from KOLs and clinicians, supporting the efficacy and safety of aficamten [167][168] Other Important Information - The company plans to present results from SEQUOIA-HCM at the European Society of Cardiology Heart Failure Congress, with three late-breaking clinical trial presentations scheduled [4][166] - The company is preparing for a marketing application submission to the EMA in the fourth quarter of this year [169] Q&A Session Summary Question: What are the expectations for CK-586's Phase 2 design? - Management indicated that it is challenging to provide details on CK-586's Phase 2 design, but they aim to simplify dosing compared to aficamten [28] Question: What is the expected dose range for pediatric patients in the CEDAR trial? - The expected dose range for adolescents is between 5 and 20 milligrams, with individualized dose selection based on achieving target gradients [63] Question: What is the unmet need for aficamten in the pediatric population? - The pediatric population has significant unmet needs, as they generally have fewer treatment options available compared to adults, and surgery is less preferred [60] Question: How does the company plan to approach risk mitigation strategies with the FDA? - The company does not intend to provide detailed feedback on regulatory interactions but expects to gain clarity on potential risk mitigation strategies after discussions with the FDA [74] Question: What is the potential for diagnosis expansion in the obstructive HCM market? - Management believes that the symptom burden and quality of life improvements will drive diagnosis expansion, as patients are likely to adhere to new therapies [111]

Cytokinetics (CYTK) came out with a quarterly loss of $1.33 per share versus the Zacks Consensus Estimate of a loss of $1.16. This compares to loss of $1.38 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -14.66%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1.03 per share when it actually produced a loss of $1.38, delivering a surprise of -33.98%.Over the last four quarters, the com ...

SOUTH SAN FRANCISCO, Calif., May 8, 2024 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2024. Net loss for the first quarter was $135.6 million, or $1.33 per share, compared to net loss for the first quarter of 2023 of $131.3 million, or $1.38 per share. Cash, cash equivalents and investments totaled $634.3 million at March 31, 2024. "In the first quarter, we advanced our muscle-biology portfolio anchored by the broad development program of aficamten. In para ...

Data Support Advancement to Phase 2 Clinical Trial in Patients with Heart Failure with Preserved Ejection Fraction Expected to Begin in Q4 2024 Full Data from the Phase 1 Study to be Presented at a Medical Congress in 2H 2024 SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced topline data from the Phase 1 study of CK-4021586 (CK-586). The study met its primary and secondary objectives to assess the safety, tolerability and pharmacokinetics ...

SOUTH SAN FRANCISCO, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that on April 30, 2024 it granted stock options to purchase an aggregate of 29,646 shares of common stock and 17,012 shares of restricted stock units (RSUs) convertible into shares of common stock upon vesting to five new employees, whose employment commenced in April 2024, as a material inducement to their employment. The RSUs will vest over 3 years, with 40% of the RSUs vesting on the fir ...

Cytokinetics (CYTK) is expected to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended March 2024. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The earnings report, which is expected to be released on May 8, 2024, might help the stock move higher if these key numbers are better than expect ...

SOUTH SAN FRANCISCO, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced it will host an investor event and conference call on May 13, 2024 at 4:00 PM Western European Summer Time (11:00 AM Eastern Time) to discuss the primary results from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), which are being presented in a Late Breaking Clinical Trial session at Heart Failure 2024, an International Congress o ...

SOUTH SAN FRANCISCO, Calif., April 24, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it is scheduled to report first quarter results on May 8, 2024 at 4:00 PM Eastern Time. Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future. The conference call will be simultaneously webcast and can be accessed from the Investors & Media ...