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Jun 30, 2023
Cytokinetics Q2 2023 Earnings Report
Reported financial results for the second quarter of 2023, completed enrollment in SEQUOIA-HCM, and initiated enrollment in MAPLE-HCM.
Key Takeaways
Cytokinetics reported a net loss of $128.6 million for the second quarter of 2023. The company completed enrollment in the SEQUOIA-HCM trial and initiated enrollment in the MAPLE-HCM trial. They also reduced projected spending by approximately 15% and revised 2023 financial spending guidance.
Completed enrollment in SEQUOIA-HCM, a pivotal Phase 3 trial of aficamten in obstructive HCM.
Initiated enrollment in MAPLE-HCM, a Phase 3 clinical trial comparing aficamten and metoprolol in obstructive HCM.
ACACIA-HCM, a pivotal Phase 3 clinical trial of aficamten in non-obstructive HCM, is expected to start in September 2023.
Reduced projected spending by approximately 15% and revised 2023 financial spending guidance.
Cytokinetics
Cytokinetics
Forward Guidance
The company revised its financial guidance due to the reduction in expected operating expenses. Operating expenses for 2023 are anticipated to be in the range of $390 to $410 million, and net cash utilization will be approximately $310 to $320 million. The company expects to end 2023 with more than $510 million.
Positive Outlook
- Expect topline results from SEQUOIA-HCM by the end of 2023.
- Continue enrollment of MAPLE-HCM.
- Start ACACIA-HCM in September 2023.
- Continue advancing go-to-market strategy for aficamten.
- Continue enrollment of the Phase 1 study of CK-586.
Challenges Ahead
- Potential difficulties or delays in the development, testing, regulatory approvals for trial commencement.
- Patient enrollment for or conduct of clinical trials may be difficult or delayed.
- The FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials.
- Cytokinetics may incur unanticipated research and development and other costs.
- Standards of care may change, rendering Cytokinetics’ drug candidates obsolete.