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Jun 30, 2021
Curis Q2 2021 Earnings Report
Curis reported a net loss for Q2 2021, but made progress with CA-4948 clinical trials and presented positive data at EHA.
Key Takeaways
Curis reported a net loss of $10.8 million, or $0.12 per share, for the second quarter of 2021. The company continued to advance its pipeline of cancer therapies, particularly CA-4948, and presented updated clinical data at the European Hematology Association (EHA) Virtual Congress.
Curis presented positive updated data from Phase 1/2 study of CA-4948 monotherapy in AML and MDS at EHA 2021.
Clear anticancer activity was observed in molecularly-enriched AML/MDS population with spliceosome or FLT3 mutations.
Further anticancer activity was also observed in a broader population of AML/MDS patients.
Curis expects to report additional clinical data by year-end in AML/MDS patients with SF3B1 and U2AF1 spliceosome mutations.
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CapyFin.com Forward Guidance
Curis plans to initiate dosing in the combination stage of the Phase 1/2 study of CA-4948 plus azacitidine and CA-4948 plus venetoclax, report additional clinical data from the Phase 1/2 monotherapy study of CA-4948 in AML/MDS patients with spliceosome mutations, and report initial safety data from the ongoing Phase 1 monotherapy study of CI-8993 for the treatment of R/R solid tumors.
Positive Outlook
- Initiate dosing in the combination stage of the Phase 1/2 study of CA-4948 plus azacitidine and CA-4948 plus venetoclax in the second half of 2021.
- Report additional clinical data from the Phase 1/2 monotherapy study of CA-4948 in AML/MDS patients with spliceosome mutations by year-end 2021.
- Report initial safety data from the ongoing Phase 1 monotherapy study of CI-8993 for the treatment of R/R solid tumors by year-end 2021.
- Report initial data at a medical meeting from the ongoing Phase 1/2 combination study of CA-4948 plus ibrutinib in patients with B cell cancers in the first half of 2022.
- Existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2024.
Challenges Ahead
- Curis may experience adverse results, delays and/or failures in its drug development programs.
- Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization.
- Favorable results seen in preclinical studies and early clinical trials of Curis's drug candidates may not be replicated in later trials.
- Curis faces risks relating to the transfer and encumbrance of certain royalty and royalty-related payments on commercial sales of Erivedge.
- Curis faces substantial competition.