Cytokinetics (CYTK) investor relations material

Key clinical and regulatory updates

• ACACIA-HCM data presented at a major congress received positive feedback and may support regulatory submissions for MYQORZO as the first cardiac myosin inhibitor for all HCM patients.

• MYQORZO's commercial launch in OHCM is progressing rapidly, with expectations to achieve a leading share of new prescriptions by year-end.

• The NHCM market is now seen as roughly equal in size to OHCM, with a significant portion of NHCM patients potentially eligible for CMI treatment.

• Clinician feedback on ACACIA-HCM results is highly positive, with anticipation for the first NHCM-specific therapy.

• Safety concerns from ACACIA-HCM, such as heart failure events, were mostly manageable and linked to patient comorbidities, with lower incidence when clinician judgment is applied.

Commercial strategy and market evolution

• Preparations are underway for a potential NHCM label expansion, with efforts focused on education, strategy, and identifying NHCM patients.

• The commercial team is building messaging and outreach to maximize reach across both OHCM and NHCM, emphasizing flexibility and differentiation in REMS and clinical profile.

• SG&A expenses are expected to rise as the company prepares for NHCM launch and European expansion, with new field forces planned for major EU markets.

• Marketing efforts will combine traditional and innovative approaches to reach both healthcare providers and patients, adapting to changing information access trends.

• Academic publication strategy is robust, aiming for transparency and broad dissemination of clinical data.

Pipeline and future outlook

• Omecamtiv mecarbil is in a confirmatory trial (COMET-HF) for advanced heart failure with EF <30%, targeting a concentrated patient segment.

• COMET-HF includes a run-in phase to ensure patient compliance and exclude early non-modifiable events, aiming to improve trial outcomes.

• If successful, COMET-HF could read out in 2028 and provide significant upside, as there is currently no direct-acting heart muscle therapy for this population.

• The company is optimistic about regulatory and commercial prospects for both MYQORZO and omecamtiv, with ongoing engagement with FDA on REMS and labeling.

• Flexibility in dosing and titration protocols is expected, allowing clinician judgment to guide therapy in real-world settings.