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 ...

Core Insights - The analyses from SEQUOIA-HCM demonstrate that aficamten has a consistent effect on exercise capacity, symptoms, hemodynamics, and cardiac biomarkers in patients with obstructive HCM, regardless of baseline symptom severity and geographic region [2][4] Group 1: Aficamten Efficacy in Different Symptom Severity - In the SEQUOIA-HCM trial, patients with mild symptoms (n=118) and moderate-to-severe symptoms (n=150) showed similar improvements in peak oxygen uptake (pVO2) with changes of 1.6 mL/kg/min and 1.8 mL/kg/min respectively [3] - The improvement in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) was greater in the moderate-to-severe symptom group compared to the mild symptom group, with an interaction p-value of 0.02 [3] - At the end of treatment, 54% of patients with mild symptoms and 36% of those with moderate-to-severe symptoms were asymptomatic, indicating a positive response to aficamten across symptom severities [3] Group 2: Aficamten Efficacy Across Geographic Regions - The SEQUOIA-HCM trial included patients from Europe (n=142), North America (n=94), and China (n=46), with no significant differences in the effect of aficamten on pVO2 and secondary endpoints across these regions [4] - Baseline characteristics varied, with North American patients generally older and having higher BMI and comorbidities compared to those in Europe and China [4] - The safety profile of aficamten was consistent across regions, with similar incidences of serious adverse events and infrequent occurrences of left ventricular ejection fraction (LVEF) <50% [4] Group 3: Real-World Data on Non-Obstructive HCM - A retrospective cohort study of 9,842 patients with non-obstructive HCM revealed that female patients had higher rates of stroke (RR 1.32), heart failure (RR 1.22), and cardiovascular hospitalization (RR 1.23) compared to male patients [5] - Older patients (75 years or older) had the highest all-cause mortality rate at 16.6%, emphasizing the need for effective treatments in this demographic [5] - The study highlights disparities in morbidity and survival among females and older patients with non-obstructive HCM, suggesting a potential market for novel treatments [5] Group 4: About Aficamten - Aficamten is a selective cardiac myosin inhibitor designed to reduce myocardial hypercontractility associated with HCM, showing promise in improving exercise capacity and relieving symptoms [6][7] - The drug has received Breakthrough Therapy Designation from the FDA for symptomatic HCM and is currently under regulatory review in the U.S. and Europe [9][12] - Aficamten is also being evaluated in multiple clinical trials, including those for non-obstructive HCM and pediatric populations [8][12]

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]

Core Points - Cytokinetics (NASDAQ: CYTK) received a three-month extension on its Prescription Drug User Fee Act (PDUFA) date, now set for December 26, 2025, for FDA review [2] Group 1 - The FDA's extension allows more time for the review of Cytokinetics' regulatory application [2] - The article highlights the importance of the PDUFA date in the drug approval process [2]

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 ...