Financial Data and Key Metrics Changes - The company reported a net loss of $161.4 million or $1.36 per share for Q1 2025, compared to a net loss of $135.6 million or $1.33 per share for the same period in 2024, indicating an increase in losses year-over-year [40] - Cash, cash equivalents, and investments decreased to approximately $1.1 billion from $1.2 billion at the end of Q4 2024, reflecting a decline of about $132.2 million during the first quarter [38] Business Line Data and Key Metrics Changes - R&D expenses increased to $99.8 million in Q1 2025 from $81.6 million in Q1 2024, primarily due to advancing clinical trials and higher personnel costs [39] - G&A expenses rose to $57.4 million in Q1 2025 from $45.5 million in Q1 2024, driven by investments in commercial readiness activities and higher personnel costs [39] Market Data and Key Metrics Changes - The company is focused on the U.S. market for the potential commercialization of aficamtan, with a PDUFA date extension to December 26, 2025, allowing for additional review time by the FDA [6][11] - The company is also preparing for potential approval by the EMA in the first half of 2026, with ongoing regulatory activities in Europe [12] Company Strategy and Development Direction - The primary focus remains on the new drug application for aficamtan, with a strategy to differentiate it based on its unique pharmacological properties and risk mitigation profile [6][10] - The company is advancing its commercial readiness activities in both the U.S. and Europe, including sales force recruitment and promotional campaigns [17][20] - The company aims to leverage its strong balance sheet to fund the potential launch of aficamtan and advance its pipeline [41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the distinct benefit-risk profile of aficamtan despite the PDUFA extension, emphasizing that no additional clinical data was requested by the FDA [11][43] - The company remains optimistic about the potential for aficamtan to address significant unmet needs in both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) [15][31] Other Important Information - The company completed enrollment for the Acacia HCM trial months ahead of schedule, with top-line results expected in the first half of 2026 [15][27] - The company is also progressing with its later-stage development programs, including CK-586 and omecamtiv mecarbil, targeting heart failure populations [33][35] Q&A Session Summary Question: What does the failure of OHDSI mean for Acacia? - Management expressed optimism about Acacia's design based on previous Phase II experiences and the successful enrollment ahead of schedule, indicating confidence in the trial's potential success [50][52] Question: Did the FDA initially guide against submitting a REMS? - Management clarified that the FDA did not initially require a REMS submission, and it was during the review that the FDA requested it, which the company was prepared to submit [58][60] Question: Will the REMS submitted be consistent with previous communications? - Management indicated that while they would not disclose specific details about the REMS, it aligns with the differentiated properties of aficamtan as previously discussed [68][71] Question: What are the implications of the recent changes to the Kamsiyos label? - Management noted that while there have been updates to the Kamsiyos REMS, they believe there remains ample opportunity for differentiation based on the REMS submitted for aficamtan [78][81] Question: Will MAPLE data be submitted for EMA or NMPA? - Management confirmed that they do not plan to submit MAPLE data during the current review cycle for either EMA or NMPA, as it would be disruptive [104]

Enrollment Completed in ACACIA-HCM; Topline Results Expected in 1H 2026 CYTOKINETICS REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE PDUFA Date for Aficamten in Obstructive HCM Extended by FDA to December 26, 2025 Topline Results from MAPLE-HCM Expected in May ~$1.1 Billion in Cash, Cash Equivalents and Investments as of March 31, 2025 SOUTH SAN FRANCISCO, Calif., May 06, 2025 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the fir ...

Core Insights - The FDA has extended the PDUFA date for aficamten in obstructive HCM to December 26, 2025, allowing more time for the review of a REMS submission [3][2] - Cytokinetics is advancing its specialty cardiology pipeline and expects topline results from MAPLE-HCM in May 2025 and from ACACIA-HCM in the first half of 2026 [2][3] Financial Overview - As of March 31, 2025, the company reported approximately $1.1 billion in cash, cash equivalents, and investments, a decrease from $1.2 billion at the end of 2024 [9] - Total revenues for Q1 2025 were $1.6 million, up from $0.8 million in Q1 2024 [10] - R&D expenses for Q1 2025 were $99.8 million, compared to $81.6 million in Q1 2024, primarily due to advancing clinical trials [11] - G&A expenses for Q1 2025 were $57.4 million, an increase from $45.5 million in Q1 2024, attributed to investments in commercial readiness [12] - The net loss for Q1 2025 was $161.4 million, or $(1.36) per share, compared to a net loss of $135.6 million, or $(1.33) per share, in Q1 2024 [13] Clinical Development Updates - Enrollment in ACACIA-HCM has been completed, with over 500 patients enrolled, and topline results are expected in 1H 2026 [3][5] - The primary endpoint for ACACIA-HCM has been updated to include both KCCQ Clinical Summary Score and peak VO2 change [5] - Ongoing clinical trials include COMET-HF for omecamtiv mecarbil and AMBER-HFpEF for CK-586, with expected completion of enrollment in 2026 [4] Corporate Activities - The company is enhancing its commercial readiness for aficamten, including recruiting sales force and establishing distribution partnerships [5] - Cytokinetics has launched EARTH-HCM, an online public health education tool, and awarded grants to patient advocacy organizations [15] - The company maintains its full-year 2025 financial guidance, projecting GAAP operating expenses between $670 million and $710 million [16][17]

Group 1 - The FDA has extended the PDUFA action date for Cytokinetics Inc's aficamten to December 26 from September 26 due to the need for additional time to review the proposed REMS [1][3] - Cytokinetics submitted the NDA for aficamten without an accompanying REMS, but the FDA later requested a REMS based on the drug's characteristics [2] - The submission of the REMS is considered a Major Amendment to the NDA, resulting in a standard three-month extension [3] Group 2 - Cytokinetics' CEO expressed confidence in the benefit-risk profile of aficamten and anticipates a differentiated label upon potential FDA approval [4] - Bristol Myers Squibb's Camzyos did not meet its primary endpoints in a recent Phase 3 trial, which may create an opportunity for aficamten [5] - Analysts believe Cytokinetics is well-positioned to benefit from Bristol Myers' groundwork, with expectations for aficamten to secure a differentiated REMS [6]

Core Viewpoint - The FDA has extended the PDUFA action date for Cytokinetics' aficamten to December 26, 2025, due to the need for additional time to review the proposed REMS [1][2]. Group 1: FDA Review Process - Cytokinetics submitted the NDA for aficamten without an accompanying REMS, which was later requested by the FDA during the review process [2]. - The submission of the REMS is considered a Major Amendment to the NDA, resulting in a standard three-month extension to the original PDUFA action date [2]. Group 2: Company Confidence and Product Pipeline - The company remains confident in the benefit-risk profile of aficamten and anticipates a differentiated label and risk mitigation profile upon potential FDA approval [3]. - Cytokinetics is advancing a pipeline of potential new medicines for cardiac muscle dysfunction, including aficamten, omecamtiv mecarbil, CK-586, and CK-089 [3].

Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology, focusing on developing new medicines for cardiac muscle dysfunction [2] - The company is preparing for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor, following positive results from the SEQUOIA-HCM Phase 3 clinical trial for obstructive hypertrophic cardiomyopathy (HCM) [2] - Cytokinetics is also developing omecamtiv mecarbil for heart failure with severely reduced ejection fraction (HFrEF), CK-586 for heart failure with preserved ejection fraction (HFpEF), and CK-089 for specific muscular dystrophies and impaired skeletal muscle function [2] Upcoming Events - The management team will participate in a fireside chat at The Citizens Life Sciences Conference on May 7, 2025, at 10:00 AM Eastern Time in New York [5] - The management team will also participate in the 2025 RBC Capital Markets Global Healthcare Conference on May 21, 2025, at 8:30 AM Eastern Time in New York [5] Investor Access - Interested parties can access live webcasts of the fireside chats through the Investors & Media section of the Cytokinetics website, with replays archived for 90 days post-event [1]

About Cytokinetics Cytokinetics is a specialty biopharmaceutical company building on its over 25-years of pioneering scientific innovation with intention to create a muscle biology franchise business focused on medicines designed to optimize muscle performance for patients with cardiac and other diseases of muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Pha ...

SOUTH SAN FRANCISCO, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that members of the Company's management team are scheduled to participate in a fireside chat at the 24 Annual Needham Virtual Healthcare Conference on Monday, April 7, 2025 at 2:15 PM Eastern Time. Interested parties may access the live webcast of the fireside chat by visiting the Investors & Media section of the Cytokinetics website at http://www.cytokinetics.com. The webcast replay wi ...

Cytokinetics (CYTK) shares rallied 5.4% in the last trading session to close at $45.43. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 15.7% loss over the past four weeks.The company has made good pipeline progress of late. Lead candidate aficamten is under review in the United States for the treatment of obstructive hypertrophic cardiomyopathy. Other pipeline candidates are also advancing well.This biopharm ...

Interactive Tool Harnesses Real-World Data to Visualize Burden of Disease in HCM and Advance Equitable Access to Care SOUTH SAN FRANCISCO, Calif., March 20, 2025 (GLOBE NEWSWIRE) --  Cytokinetics, Incorporated (NASDAQ:CYTK) today announced the launch of EARTH-HCM (Epidemiology, Awareness, Real-world Treatment and Health Outcomes in HCM), an online, open access, interactive public health education tool developed by Cytokinetics in collaboration with leading academic institutions, that leverages real-world, d ...