Advancement of Fast Skeletal Muscle Troponin Activator Expands Pipeline of Muscle-Directed Drug Candidates SOUTH SAN FRANCISCO, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-4015089 (CK-089) in healthy human participants. CK-089 is a fast skeletal muscle troponin activator (FSTA) with p ...

Table of Contents 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 September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | --- | |-----------------------------------------------------------------------------------------------------------|---- ...

Financial Data and Key Metrics Changes - The company reported total revenues of $0.5 million for Q3 2024, an increase from $0.4 million in the same period of 2023 [48] - R&D expenses rose to $84.6 million in Q3 2024 from $82.5 million in Q3 2023, driven by higher personnel-related expenses [48] - G&A expenses increased to $56.7 million in Q3 2024 compared to $40.1 million in Q3 2023, primarily due to investments in commercial readiness [49] - The net loss for Q3 2024 was $160.5 million, or $1.36 per share, compared to a net loss of $129.4 million, or $1.35 per share, in Q3 2023 [50] - Cash, cash equivalents, and investments decreased to approximately $1.3 billion at the end of Q3 2024 from $1.4 billion at the end of Q2 2024 [47] Business Line Data and Key Metrics Changes - The company is advancing its clinical development programs, particularly for aficamten, with significant progress reported in the third quarter [6][10] - Aficamten's clinical data presented at various medical congresses showed improvements in exercise capacity, cardiac structure, and function [14][16] - The company is preparing to initiate two new clinical trials: COMET-HF for omecamtiv mecarbil and AMBER-HFpEF for CK-586 [11][39] Market Data and Key Metrics Changes - The company is executing pre-launch activities for aficamten, including a disease awareness campaign for healthcare professionals [27][28] - The commercial readiness activities in Europe are being prioritized, with plans to launch aficamten first in Germany [35] Company Strategy and Development Direction - The company aims to build momentum across its pipeline, focusing on multiple muscle-directed drug candidates to address diseases of high unmet need [13] - The strategic focus remains on specialty cardiology, with aficamten as a key product for obstructive HCM, followed by omecamtiv mecarbil and CK-586 [56] - The company is committed to prudent capital deployment to realize the full potential of its muscle biology platform [13][51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming milestones for aficamten, including the expected launch in the U.S. in 2025, pending FDA approval [59] - The company is well-funded and positioned for future successes, with a focus on expanding its specialty cardiology franchise [55][56] Other Important Information - The company has strengthened its executive leadership team with the addition of a new Chief Legal Officer [54] - The company is preparing for potential global launches of aficamten, with a submission planned for the EMA in Q4 2024 [59] Q&A Session Summary Question: What is the confidence level in the MAPLE-HCM trial results? - Management believes the MAPLE-HCM trial will play an important role in the adoption of aficamten, with a conservative power analysis for the trial [68][70] Question: What is the expected timeline for guideline updates based on MAPLE results? - Management indicated that guidelines are updated regularly, and they aim to publish results quickly to influence treatment guidelines [76][78] Question: How does the company view the competitive position of omecamtiv mecarbil? - Management believes omecamtiv mecarbil fills an unmet need in the heart failure market, particularly for patients with severely reduced ejection fraction [112]

Cytokinetics (CYTK) came out with a quarterly loss of $1.36 per share versus the Zacks Consensus Estimate of a loss of $1.27. This compares to loss of $1.35 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -7.09%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1.02 per share when it actually produced a loss of $1.31, delivering a surprise of -28.43%.Over the last four quarters, the comp ...

Rolling Submission of NDA for Aficamten Completed and Submitted to FDA in Q3 COMET-HF, Confirmatory Phase 3 Clinical Trial of Omecamtiv Mecarbil,and AMBER-HFpEF, Phase 2 Clinical Trial of CK-586, Expected to Begin in Q4 Plan to Advance CK-089, Fast Skeletal Muscle Troponin Activator, into First-In-Human Study in Q4 2024 ~$1.3 Billion in Cash, Cash Equivalents and Investments as of September 30, 2024 SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) repo ...

SOUTH SAN FRANCISCO, Calif., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it is scheduled to report third quarter results on November 6, 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 & Me ...

Core Insights - Cytokinetics has submitted a New Drug Application (NDA) for aficamten to the FDA and is preparing for a potential commercial launch in 2025 [2][8] - The company is advancing its cardiac myosin modulation programs, including the COMET-HF Phase 3 trial for omecamtiv mecarbil and the AMBER-HFpEF Phase 2 trial for CK-586, both expected to begin in Q4 2024 [1][5][6] Company Developments - The NDA submission for aficamten marks a significant step in the company's strategy to build a specialty cardiovascular franchise [2] - Cytokinetics is focusing on differentiated market access and patient experience as part of its go-to-market strategies for aficamten [8] - The company has launched an unbranded disease awareness campaign titled "HCM Beyond The Heart" aimed at healthcare professionals [1][8] Clinical Trials - COMET-HF is a Phase 3 trial designed to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure and severely reduced ejection fraction, with an expected enrollment of approximately 1,800 patients [3][5] - AMBER-HFpEF is a Phase 2 trial aimed at evaluating the safety and tolerability of CK-586 in patients with symptomatic heart failure with preserved ejection fraction, also set to begin in Q4 2024 [6][18] Expert Perspectives - The event will feature insights from leading clinicians specializing in hypertrophic cardiomyopathy (HCM) and heart failure, enhancing the understanding of treatment landscapes [7] Global Launch Preparations - Cytokinetics is actively engaging with payers and conducting health economics research to support the launch of aficamten in the U.S. and Europe [8][10] - The company plans to submit a Marketing Authorization Application (MAA) for aficamten to the European Medicines Agency (EMA) in Q4 2024 [10]

Core Points - Cytokinetics has announced the seventh annual Communications Grant Program, offering five grants of $20,000 each to patient advocacy organizations focused on hypertrophic cardiomyopathy (HCM) and heart failure [1][2] - The program aims to enhance communications, awareness, and community engagement for underfunded nonprofit patient organizations [2] - Eligible organizations must be nonprofit or registered charities in the U.S., Canada, Europe, or the U.K., and serve HCM or heart failure communities [3] Grant Program Details - The deadline for applications is November 4, 2024, with recipients announced in January 2025 [1][3] - The grants can support various initiatives, including programming or personnel, to help organizations implement crucial communications and outreach activities [2][3] - Previous grant recipients include ALS Therapy Development Institute, Cardiomyopathy UK, Global Heart Hub, HeartBrothers Foundation, and WomenHeart [2] Company Overview - Cytokinetics is a late-stage biopharmaceutical company specializing in cardiovascular treatments, focusing on muscle biology and cardiac muscle performance [4] - The company is preparing for regulatory submissions for aficamten, a cardiac myosin inhibitor, following positive Phase 3 trial results [4] - Cytokinetics is also developing other drug candidates, including omecamtiv mecarbil for heart failure and CK-586 for HFpEF [4]

Analyses of Effects of Aficamten on Key Clinical Outcomes from SEQUOIA-HCM to be Featured in Late Breaking Clinical Trial Presentation at HFSA SOUTH SAN FRANCISCO, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced three upcoming presentations at the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions on September 27, 2024 and one Late Breaking Clinical Trial presentation at the Heart Failure Society of America (HFSA) Annual Scientific Mee ...

Monday, Cytokinetics, Incorporated CYTK announced that data from the Phase 1 study of CK-4021586 (CK586) were presented in a poster session at the American College of Clinical Pharmacology Annual Meeting in Bethesda, MD. The study met its primary and secondary objectives to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple oral doses of CK-586. CK-586 is a cardiac myosin inhibitor in development for the potential treatment of a subgroup of patients with symptomatic HFpEF wi ...