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Dec 31, 2024
Curis Q4 2024 Earnings Report
Curis reported a net loss of $9.6 million on revenues of $3.3 million for the fourth quarter of 2024.
Key Takeaways
Curis, Inc. reported a net loss of $9.6 million for the fourth quarter of 2024, an improvement from a net loss of $11.7 million in the same period last year. Revenues for the quarter were $3.3 million, up from $2.7 million in Q4 2023. The company also announced positive clinical data for emavusertib in TakeAim Lymphoma and Leukemia studies, and secured Orphan Drug Designation for PCNSL in both the US and EU.
Curis successfully concluded meetings with the FDA and EMA regarding a potential accelerated approval path for emavusertib in PCNSL.
Emavusertib received Orphan Drug Designation for PCNSL in both the US and Europe.
In BTKi-experienced PCNSL patients, 9 of 13 evaluable patients showed tumor burden reduction, including 6 objective responses.
In BTKi-naïve PCNSL patients, 5 of 6 evaluable patients showed tumor burden reduction, including 5 objective responses.
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CapyFin.com Forward Guidance
Curis expects its cash and cash equivalents as of December 31, 2024, together with the expected proceeds from the March 2025 Offerings, will enable the Company to fund its planned operations into the fourth quarter of 2025.
Positive Outlook
- Expected proceeds from March 2025 Offerings will extend cash runway.
- Focus on enrolling 30-40 additional patients to support regulatory filing for accelerated approval.
- Supportive feedback from FDA and EMA for accelerated approval path for emavusertib.
- First dosing cohort for Ema-Ven-Aza Triplet Study completed and well tolerated.
- External Clinical Safety Review Committee recommended escalation to the next dosing cohort for Ema-Ven-Aza Triplet Study.
Challenges Ahead
- Requires substantial additional capital to fund business beyond Q4 2025.
- Risk of adverse results, delays, or failures in drug development programs.
- Drug candidates may cause unexpected toxicities or fail to demonstrate sufficient safety and efficacy.
- May not achieve project timeline to fully enroll patients and submit regulatory filings within 18-24 months.
- Safety and efficacy data from TakeAim Lymphoma study may not be sufficient for conditional marketing authorization or accelerated approval.