Hot Line Presentation of MAPLE-HCM to Elaborate on Positive Topline Results in Patients with Obstructive Hypertrophic Cardiomyopathy Late Breaking Clinical Science Session to Present Incidence and Impact of Atrial Fibrillation Across Three Clinical Trials of Aficamten in Obstructive Hypertrophic Cardiomyopathy SOUTH SAN FRANCISCO, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced five presentations related to aficamten at the European Society of Cardiology C ...

Financial Position & Pipeline - Cytokinetics had approximately $1.1 billion in cash, cash equivalents, and investments as of March 31, 2025[9] - Cytokinetics has further access to capital, including up to $275 million in term loan facilities with Royalty Pharma[176] - Royalty Pharma has the option to invest up to $150 million in a Phase 3 trial of CK-586 in exchange for an additional 3.5% revenue participation interest in worldwide net sales of CK-586[9, 176] - 2025 GAAP operating expense is guided to be between $670 million and $710 million, including $110 million to $120 million in stock-based compensation[178] Aficamten Program - The U S PDUFA date for aficamten is December 26, 2025, with China NDA and EU MAA on file[8, 92, 181] - Positive topline results from MAPLE-HCM demonstrated superiority of aficamten to metoprolol in patients with obstructive HCM[96, 99, 181] - SEQUOIA-HCM pivotal Phase 3 trial enrolled 282 patients with oHCM treated with standard of care[42] - SEQUOIA-HCM showed a statistically significant improvement in exercise capacity compared to placebo, with a least squares mean difference of 1 74 mL/kg/min (p=0 000002)[46, 47] - In the SEQUOIA-HCM CMR sub-study, aficamten was associated with a significant improvement in Left Ventricular Mass Index (LVMI) of -15 4 g/m2 (p=0 001)[62, 63] Omecamtiv Mecarbil Program - COMET-HF is a Phase 3 confirmatory clinical trial for omecamtiv mecarbil[128, 181] - The COMET-HF trial is targeting a patient population of approximately 840,000 high-risk heart failure patients with EF<30% in the US[21, 133] CK-586 Program - AMBER-HFpEF is a Phase 2 clinical trial evaluating CK-586 in HFpEF patients with LVEF ≥ 60%[163, 166] - Approximately 84% of HFpEF patients will die within five years of initial hospitalization[143, 144]

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]

SOUTH SAN FRANCISCO, Calif., May 29, 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 Jefferies Global Healthcare Conference on Wednesday, June 4, 2025 at 9:20 AM Eastern Time at the New York Marriott Marquis Hotel in New York, NY. Interested parties may access the live webcast of the fireside chat by visiting the Investors & Media section of the Cytokinetics website at http ...

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]

Trial Demonstrates Superiority of Aficamten to Standard of Care Beta Blocker in Improving Peak Exercise Capacity in Patients with Obstructive Hypertrophic Cardiomyopathy SOUTH SAN FRANCISCO, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced positive topline results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), a Phase 3 clinical trial comparing aficamten as monotherapy to the standard of care beta bloc ...

Core Insights - Cytokinetics is set to present three Late Breaking Science presentations and one ePoster at the Heart Failure 2025 congress in Belgrade, Serbia from May 17 to May 20, 2025 [1] Group 1: Late Breaking Science Presentations - The first presentation will focus on the efficacy and safety of Aficamten in patients with obstructive hypertrophic cardiomyopathy and mild symptoms, presented by Dr. Iacopo Olivotto on May 17, 2025 [2] - The second presentation will discuss the effect of Aficamten treatment on patients with hypertrophic obstructive cardiomyopathy by geographical region, presented by Dr. Caroline Coats on May 18, 2025 [2] - The third presentation will analyze the effect of Omecamtiv Mecarbil on outcomes using the Win Ratio, as part of an exploratory analysis of the GALACTIC-HF trial, presented by Dr. Kieran F. Docherty on May 19, 2025 [2] Group 2: ePoster Presentation - An ePoster will be presented by Dr. Paulos Gebrehiwet on May 17, 2025, discussing the associations between age and sex and cardiovascular outcomes in patients with non-obstructive hypertrophic cardiomyopathy [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, following positive results from the SEQUOIA-HCM Phase 3 clinical trial [4] - Cytokinetics is also developing Omecamtiv Mecarbil for heart failure with severely reduced ejection fraction, CK-586 for heart failure with preserved ejection fraction, and CK-089 for specific muscular dystrophies and other conditions [4]

Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities of Cytokinetics' produ ...