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Mar 31, 2023
Cytokinetics Q1 2023 Earnings Report
Reported increased spending for clinical development and precommercial launch expenses, while net loss and loss per share increased compared to the same period last year.
Key Takeaways
Cytokinetics reported its Q1 2023 financial results, with a net loss of $131.3 million, or $1.38 per share. The company's cash, cash equivalents, and investments totaled $704.4 million as of March 31, 2023. They are reducing their spending to maintain over two years of cash runway.
SEQUOIA-HCM nearing completion of enrollment with results expected in Q4 2023.
Additional data from Cohort 4 of REDWOOD-HCM to be presented at European Society of Cardiology Heart Failure 2023 Congress.
Company to reduce spending by more than 10% in 2023 to maintain over 2 years of cash runway.
Revenue increased due to recognizing a $2.5 million milestone from Ji Xing Pharmaceuticals.
Cytokinetics
Cytokinetics
Forward Guidance
Cytokinetics anticipates completing patient enrollment in SEQUOIA-HCM in Q2 2023, with results expected in Q4 2023. They also plan to begin MAPLE-HCM in Q2 2023 and a Phase 3 trial of aficamten in non-obstructive HCM in 2H 2023. The company expects to advance CK-586 into a first-in-human study in Q2 2023 and expects single ascending dose data from the Phase 1 study of CK-136 in 2H 2023.
Positive Outlook
- Complete patient enrollment in SEQUOIA-HCM in Q2 2023, with results expected in Q4 2023.
- Begin MAPLE-HCM, the second Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol in patients with obstructive HCM, in Q2 2023.
- Begin a Phase 3 clinical trial of aficamten in non-obstructive HCM in 2H 2023.
- Advance U.S. go-to-market strategy for aficamten.
- Expect to advance CK-586 into a first-in-human study in Q2 2023.
Challenges Ahead
- Conclude clinical trial conduct and complete majority of close-out activities for COURAGE-ALS in Q2 2023.
- Complete majority of close-out activities for COURAGE-ALS in Q2 2023; expect to share results from COURAGE-ALS in 2H 2023.
- Continue to pursue potential international approvals for omecamtiv mecarbil in Europe and China.
- Expect single ascending dose data from the Phase 1 study of CK-136 in 2H 2023.
- The company will conclude study conduct and plans to discontinue treatment with reldesemtiv in all patients, including those in the open-label extension study, COURAGE-ALS OLE.