SOUTH SAN FRANCISCO, Calif., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the appointment of James M. Daly to its Board of Directors effective August 19, 2025. Mr. Daly brings over 30 years of global biopharmaceutical leadership experience with particular expertise in commercialization to the Company’s Board of Directors. “Jim has longstanding expertise leading commercial launches of innovative therapies, coupled with extensive Board experience guiding later-st ...

Financial Data and Key Metrics Changes - The company reported a net loss of $134.4 million or $1.12 per share for Q2 2025, an improvement from a net loss of $143.3 million or $1.31 per share in Q2 2024 [33] - Cash, cash equivalents, and investments decreased to approximately $1.04 billion from $1.09 billion at the end of Q1 2025 [32] - R&D expenses increased to $112.6 million from $79.6 million in the same period last year, primarily due to advancing clinical trials and higher personnel costs [32] - G&A expenses rose to $65.7 million from $50.8 million, attributed to investments in commercial readiness and personnel costs [32] Business Line Data and Key Metrics Changes - The company is advancing its clinical trials for aficamtan, with positive top-line results reported from the Maple HCM trial, showing significant improvement in peak oxygen uptake compared to metoprolol [22][11] - The Acacia HCM trial for non-obstructive HCM is fully enrolled, with expected top-line results in 2026 [11][27] - The company is also progressing in its trials for omecamtiv mecarbil and CK-586 (now called ulicamten), with ongoing enrollment in the COMMID HF and AMBER HFpEF trials [30][29] Market Data and Key Metrics Changes - The company is targeting Germany for its first potential launch of aficamtan following EMA approval in 2026, with ongoing preparations for commercial readiness across multiple EU countries [21][9] - In the U.S., the company is focused on recruiting a world-class sales force, with nearly all territories filled, and expects to have the sales team trained by Q4 2025 for a Q1 2026 launch [15][14] Company Strategy and Development Direction - The company aims to be a leading muscle-focused specialty biopharma, with a vision to improve patient lives through global access to innovative medicines [5] - The strategy includes enhancing commercial launch readiness for aficamtan, optimizing distribution networks, and engaging key stakeholders [10][16] - The company is also focused on expanding its market presence in both the U.S. and Europe, with a clear plan for regulatory submissions and commercial strategies [37][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory position of aficamtan, citing strong clinical data and ongoing dialogue with the FDA [7][6] - The company anticipates significant growth opportunities as it approaches key milestones, including potential approvals in the U.S., Europe, and China [36][9] - Management highlighted the importance of addressing unmet needs in heart failure and HCM, positioning aficamtan as a potential first-line treatment option [12][11] Other Important Information - The company has received a PDUFA date extension for aficamtan to December 26, 2025, with a late cycle review meeting scheduled for September [5][6] - The company is actively engaging with payers to educate them on the clinical and economic burden of HCM, aiming to build foundational health economics models [19][20] Q&A Session Summary Question: Can you elaborate on the MAPLE data and its potential impact on treatment guidelines? - Management indicated that the MAPLE data could lead to a reevaluation of treatment guidelines, particularly regarding the superiority of aficamtan over metoprolol in exercise tolerance [41][44] Question: What are the key factors that will support Acacia's success compared to Kymzios? - Management emphasized the importance of trial design and dosing regimens, noting that Acacia's optimized approach could lead to better outcomes [48][50] Question: What does an ideal label for aficamtan look like? - Management stated that an ideal label would reflect the engineered properties of aficamtan and its clinical trial results, supporting differentiation in the market [53][56] Question: What are the expectations for REMS differences between the U.S. and EU? - Management noted that while the EU does not have a formal REMS program, they anticipate similarities in risk mitigation strategies across both regions [77][78] Question: How will the company approach the market opportunity in non-obstructive HCM? - Management indicated that the initial physician target list would remain the same, with potential expansion of the sales force depending on market dynamics [83][90]

Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology and is focused on developing new medicines for cardiac muscle dysfunction [3] - 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 [3] - 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 [3] Upcoming Events - Cytokinetics is scheduled to report its second quarter results on August 7, 2025, at 4:00 PM Eastern Time [1] - Following the results announcement, a conference call will be held at 4:30 PM Eastern Time to discuss financial results and provide business updates [1][2] - The conference call will be available via webcast and an archived replay will be accessible for six months [2]

Core Insights - Cytokinetics is set to present five key studies related to aficamten at the European Society of Cardiology Congress 2025, highlighting its potential in treating obstructive hypertrophic cardiomyopathy (HCM) [1][4] - The MAPLE-HCM trial compares aficamten with metoprolol, focusing on exercise capacity in patients with left ventricular outflow tract (LVOT) obstruction [2][4] - A late-breaking presentation will address the incidence and impact of atrial fibrillation across three clinical trials involving aficamten [1][2] Presentation Details - The MAPLE-HCM presentation will be led by Dr. Pablo Garcia-Pavia on August 30, 2025, at 9:18 AM CEST in Madrid [2] - The late-breaking clinical science presentation on atrial fibrillation will be conducted by Dr. Ahmad Masri on August 31, 2025, at 4:45 PM CEST in Budapest [2] - Another presentation on the long-term efficacy and safety of aficamten will be given by Dr. Sara Saberi on August 31, 2025, at 5:40 PM CEST [2] Additional Research - A poster presentation will analyze the effect of aficamten compared to metoprolol on cardiac structure and function in symptomatic obstructive HCM [3] - An integrated safety analysis of aficamten in patients with obstructive HCM will also be presented [3] Company Overview - Cytokinetics is a biopharmaceutical company specializing in cardiovascular diseases, with over 25 years of experience in muscle biology [4] - The company is preparing for potential regulatory approvals and commercialization of aficamten following positive results from the SEQUOIA-HCM trial [4] - Cytokinetics is also developing other drug candidates targeting heart failure and muscular dystrophy [4]

Group 1: Corporate Giving Program - Cytokinetics has announced its annual Corporate Giving Program, which aims to provide charitable donations to eligible non-profit organizations in the U.S. to support equitable healthcare initiatives, diversity in science education, and essential services for local and at-risk communities [2][3] - The program offers individual charitable donations of up to $20,000 for qualified 501(c)(3) organizations that are not directly involved in healthcare practices [3] - Applications for the program can be submitted online, with a deadline set for August 4, 2025 [3] Group 2: Corporate Values and Impact - The Corporate Giving Program is designed to partner with non-profit organizations to advance shared missions, particularly focusing on health equity in cardiovascular disease [3] - Cytokinetics aims to expand its impact in its second year of formalized corporate giving, building on the foundation established in 2024 [3] Group 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 [4] - 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 [4] - Cytokinetics is also developing other product candidates, including omecamtiv mecarbil for heart failure, CK-586 for heart failure with preserved ejection fraction, and CK-089 for muscular dystrophy [4]

Core Insights - Cytokinetics will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025, at 9:20 AM Eastern Time [1] - The event will be accessible via a live webcast on the Cytokinetics website, with a replay available for 90 days post-event [2] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology [3] - 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 [3] - Aficamten is also being evaluated in additional trials for obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) [3] - Cytokinetics is 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 [3]

Cytokinetics (CYTK) Conference Call Summary Company Overview - **Company**: Cytokinetics (CYTK) - **Event**: 2025 Conference on May 21, 2025 - **Key Speakers**: CEO Robert and CFO Sung Key Industry and Company Insights Regulatory Updates on Aficamten - Cytokinetics has engaged in multiple discussions with the FDA regarding aficamten, particularly after the SEQUOIA HCM pivotal clinical study results [3][4] - The FDA accepted the NDA submission without a Risk Evaluation and Mitigation Strategy (REMS) initially, but later determined that a REMS is necessary [5][4] - The company believes that aficamten will have a differentiated risk mitigation profile despite the REMS requirement [5][6] Market Positioning and Competitive Landscape - The cardiac myosin inhibitors category, including aficamten and mavacamten, is expected to grow, with a significant portion of eligible patients currently untreated [10][11] - Mavacamten is projected to generate over $1 billion in sales for BMS this year, with a concentrated prescription base among about 600 physicians [10] - Cytokinetics aims to differentiate aficamten through its dosing regimen, drug-drug interaction (DDI) profile, and overall convenience [6][11] Clinical Evidence and Ongoing Studies - Positive results from the MAPLE HCM study comparing aficamten to metoprolol were announced, which could enhance the drug's positioning in the market [12][13] - Ongoing studies like MAPLE and Acacia are expected to provide further evidence supporting aficamten's efficacy and safety [13][30] - The Acacia study has been modified to harmonize endpoints across regulatory jurisdictions, with increased enrollment to enhance statistical power [27][28] Commercial Strategy - Cytokinetics has been preparing for aficamten's launch, focusing on market analytics, segmentation, and omnichannel planning [18][19] - The company plans to target both new patients and those switching from other therapies, with a tailored approach for physicians and payers [18][24] - The launch strategy will be informed by lessons learned from the mavacamten launch, with a focus on driving category penetration beyond centers of excellence [20][24] Financial Position - As of Q1, Cytokinetics reported $1.1 billion in cash and investments, with access to an additional $425 million from partner Royalty Pharma [40][41] - This financial strength positions the company well for the launch of aficamten and advancement of its pipeline [41] Future Outlook - The PDUFA date for aficamten is set for the end of 2025, with expectations for market entry in 2026 [18] - The company is optimistic about the potential for omecamtiv and CK-586, with ongoing studies expected to yield significant insights [31][39] Additional Important Points - The company emphasizes the importance of ongoing clinical evidence and studies to support aficamten's market uptake beyond regulatory approvals [12][13] - There is a growing patient population with non-obstructive hypertrophic cardiomyopathy (NHCM), which could enhance aficamten's commercial profile if the Acacia study is positive [30] - Cytokinetics is focused on creating a patient hub to enhance the patient experience and drive demand for aficamten [26]

Core Insights - Cytokinetics is hosting the second annual Contemporary Landscapes in Muscle Biology Research Symposium (CLIMB) on May 30, 2025, in San Francisco, CA, aimed at fostering scientific exchange in muscle biology [2][3] - The symposium will feature expert speakers and poster presentations focusing on innovations in cardiac and skeletal muscle biology, as well as emerging treatment modalities [3][6] - Cytokinetics is advancing a pipeline of potential new medicines for cardiac muscle dysfunction, including aficamten, which is undergoing regulatory approval following positive Phase 3 trial results [5] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology [5] - The company is developing several drug candidates, including aficamten for obstructive hypertrophic cardiomyopathy (HCM) and omecamtiv mecarbil for heart failure with severely reduced ejection fraction (HFrEF) [5] - Other candidates in development include CK-586 for heart failure with preserved ejection fraction (HFpEF) and CK-089 for specific types of muscular dystrophy [5] Event Details - The CLIMB symposium aims to promote collaboration and networking among scientists and researchers in the field of muscle biology [3] - Registration for the event is open until May 23, 2025 [4] - Keynote speakers include prominent figures from various institutions, highlighting the interdisciplinary nature of the symposium [6]

Financial Data and Key Metrics Changes - The company raised over $1 billion in cash through equity capital fundraising and structured finance, providing a strong financial foundation for commercialization and R&D activities [21][54][55] - The company ended the year with over $1 billion on its balance sheet, reflecting prudent financial planning [54][55] Business Line Data and Key Metrics Changes - Aficamtan is positioned as the anchor of the emerging specialty cardiology franchise, with ongoing clinical trials showing promising results [20][19] - The MAPLE HCM trial met its primary efficacy endpoint, demonstrating significant improvement in peak oxygen uptake compared to metoprolol [19][27] Market Data and Key Metrics Changes - The obstructive HCM market is now estimated to be closer to a 50/50 split with non-obstructive HCM, indicating a growing market opportunity [34] - The company aims to achieve access to over 100,000 patients in the coming years, emphasizing equitable and affordable access to its medicines [24] Company Strategy and Development Direction - The company’s Vision 02/1930 outlines a five-year strategic plan focused on innovation, access, and advancing research to benefit patients and shareholders [16][17] - The strategy includes a focus on specialty cardiology, with plans to advance multiple therapies targeting underserved patient populations [20][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the distinct benefit-risk profile of aficamtan despite the FDA extending the PDUFA date to December 2025 [18] - The company is optimistic about the potential for multiple product approvals and label expansions in the coming years [22][30] Other Important Information - The company is engaging with payers to design health economic studies and budget impact models to facilitate market access for aficamtan [42] - Partnerships with Bayer in Japan and Sanofi in China are part of the global strategy to ensure broad availability of aficamtan [43] Q&A Session Summary Question: What are the expectations for aficamtan's market entry? - The company is preparing for a potential market launch of aficamtan by the end of the year, with ongoing engagement with regulatory authorities [44][59] Question: How does the company plan to address payer concerns? - The company is designing studies to demonstrate the economic advantages of aficamtan, understanding payer motivations to ensure successful market access [42] Question: What is the significance of the recent clinical trial results? - The positive results from the MAPLE HCM trial are expected to be presented at a major medical meeting, potentially enabling expanded labeling for aficamtan [44][27]

Core Insights - Cytokinetics announced positive topline results from the MAPLE-HCM Phase 3 clinical trial, demonstrating that aficamten outperforms the standard beta blocker metoprolol in improving peak exercise capacity in patients with obstructive hypertrophic cardiomyopathy (HCM) [1][2][3] Group 1: Clinical Trial Results - MAPLE-HCM met its primary endpoint, showing a statistically significant improvement in peak oxygen uptake (pVO2) from baseline to Week 24 for aficamten compared to metoprolol [2][4] - The safety and tolerability profile of aficamten was favorable compared to metoprolol [2] - Full results from the MAPLE-HCM trial will be presented at an upcoming medical conference [2][3] Group 2: Trial Design and Patient Enrollment - MAPLE-HCM was a Phase 3, multi-center, randomized, double-blind active-comparator trial involving 175 patients, comparing aficamten to metoprolol [4][5] - The primary endpoint was the change in pVO2 from baseline to Week 24, with secondary endpoints including changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores and left ventricular mass index (LVMI) [4][5] Group 3: Aficamten Overview - Aficamten is an investigational selective cardiac myosin inhibitor designed to reduce myocardial hypercontractility associated with HCM [6][7] - The drug has received Breakthrough Therapy Designation from the FDA and the NMPA in China for the treatment of symptomatic obstructive HCM [8] Group 4: Regulatory Status and Future Trials - Aficamten is currently under regulatory review by the FDA, with a target action date of December 26, 2025, and is also being reviewed by the EMA and NMPA [9] - Additional clinical trials for aficamten include ACACIA-HCM, CEDAR-HCM, and FOREST-HCM, targeting various patient populations with HCM [10] Group 5: Company Background - Cytokinetics is a biopharmaceutical company focused on developing new medicines for cardiac muscle dysfunction, with over 25 years of experience in muscle biology [11] - The company is preparing for potential regulatory approvals and commercialization of aficamten following positive results from previous trials [11]