Cytokinetics Q3 2022 Earnings Report
Key Takeaways
Cytokinetics reported a net loss of $142.3 million, or $1.52 per share, for the third quarter of 2022. The company's cash, cash equivalents, and investments totaled $896.2 million at September 30, 2022.
Engaged with the FDA regarding the New Drug Application for omecamtiv mecarbil.
Continued commercial preparations for the potential U.S. launch of omecamtiv mecarbil.
Advanced the clinical trial site activation and enrollment of patients in SEQUIOA-HCM.
Announced that the Data Monitoring Committee for COURAGE-ALS recommended that the Phase 3 trial continue.
Cytokinetics
Cytokinetics
Forward Guidance
Cytokinetics anticipates several corporate milestones, including participating in an Advisory Committee meeting for omecamtiv mecarbil, launching omecamtiv mecarbil in the U.S. subject to FDA approval, submitting a Marketing Authorization Application to the European Medicines Agency, continuing enrollment in SEQUOIA-HCM, completing enrollment in Cohort 4 of REDWOOD-HCM, beginning a second Phase 3 clinical trial of aficamten, and beginning a Phase 1 study of CK-136.
Positive Outlook
- Participate in Advisory Committee meeting to review the NDA for omecamtiv mecarbil on December 13, 2022.
- Launch omecamtiv mecarbil in the U.S. subject to FDA approval in Q1 2023.
- Submit Marketing Authorization Application (MAA) to the European Medicines Agency by the end of 2022.
- Continue enrolling patients with obstructive HCM in SEQUOIA-HCM through 1H 2023 with results expected in 2H 2023.
- Complete enrolling patients with non-obstructive HCM in Cohort 4 of REDWOOD-HCM with data expected in 1H 2023.
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.