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Dec 31, 2024
Cullinan Oncology Q4 2024 Earnings Report
Reported fourth quarter and full year 2024 financial results and provided a corporate update.
Key Takeaways
Cullinan Therapeutics reported its Q4 and full year 2024 financial results, highlighting key updates for CLN-978 and zipalertinib. The pivotal Phase 2b study for zipalertinib met its primary endpoint, with NDA submission planned for H2 2025. The company's cash and investments totaled $606.9 million, providing runway into 2028.
CLN-978 remains the only development-stage CD19 T cell engager in an autoimmune disease clinical trial in the U.S.
Zipalertinib pivotal Phase 2b study met the primary endpoint.
NDA submission for Zipalertinib planned for H2 2025, pending regulatory discussions.
Cash and investments totaled $606.9 million as of December 31, 2024, providing runway into 2028.
Forward Guidance
Cullinan Therapeutics anticipates delivering meaningful catalysts in 2025, with key updates expected for CLN-978 and zipalertinib. The company plans to share initial clinical data for CLN-978 in SLE in Q4 2025 and submit an NDA for zipalertinib in the second half of 2025.
Positive Outlook
- Initial clinical data from global Phase 1 study of CLN-978 in Systemic Lupus Erythematosus (SLE) expected in Q4 2025.
- CLN-978 remains the first and only development-stage CD19 T cell engager in an autoimmune disease clinical trial in the U.S.
- Zipalertinib pivotal Phase 2b study met primary endpoint.
- Full results for zipalertinib expected mid-year 2025.
- NDA submission for zipalertinib planned for H2 2025, pending regulatory discussions.
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