Cytokinetics (CYTK) Goldman Sachs 45th Annual Global Healthcare Conference summary

Strategic updates and recent announcements

• Advancing aficamten, a next-in-class cardiac myosin inhibitor, toward commercialization in North America and Europe in 2025, with a broad development program including multiple ongoing studies and a phase I study in Japan.

• Expanded pipeline with omecamtiv mecarbil entering a confirmatory phase III study and CK-586 advancing to phase II, supported by over $1 billion in recent equity and royalty monetization financings.

• Disclosed prior discussions regarding a potential sale to address shareholder concerns, affirming openness to all value-maximizing strategies.

Clinical data and differentiation

• SEQUOIA-HCM trial for aficamten exceeded expectations, showing significant improvement in exercise capacity and hitting all primary and secondary endpoints, with strong physician and audience reception.

• Safety profile highlighted by absence of dose interruptions and heart failure symptoms, with further positive data from the FOREST open-label extension study.

• Differentiation from competitors centers on safety, predictability, and manageable risk management requirements, especially regarding LVEF preservation.

Regulatory and development milestones

• Rolling NDA submission for aficamten to begin and finish in Q3, with FDA feedback on risk mitigation strategies expected to inform the application.

• MAPLE head-to-head study with metoprolol on track to complete enrollment in Q3, aiming for guideline inclusion; ACACIA study in non-obstructive HCM to complete enrollment in 2025, with results expected in 2026.

• Plans to file in Europe and China by year-end, with ongoing stability data collection as the final regulatory requirement.