Curis (CRIS) Q3 2024 earnings summary

Executive summary

• Emavusertib combination therapy in relapsed refractory PCNSL and FLT3-mutated AML showed encouraging early efficacy, with multiple complete and partial responses and ongoing regulatory engagement for accelerated approval.

• Focused on developing emavusertib for hematologic malignancies and solid tumors, with ongoing Phase 1/2 studies and a Phase 1 triplet study in AML.

• Streamlined operations in May 2024, reducing workforce by 30% to prioritize key clinical programs.

• Accumulated deficit reached $1.2 billion as of September 30, 2024; net loss for the nine months ended September 30, 2024 was $33.8 million.

• Substantial doubt exists about ability to continue as a going concern beyond mid-2025 without additional funding.

Financial highlights

• Q3 2024 net loss was $10.1 million ($1.70/share), improved from $12.2 million ($2.13/share) in Q3 2023; net loss for the first nine months of 2024 was $33.8 million ($5.77/share), compared to $35.7 million ($6.96/share) in the same period of 2023.

• Revenues, primarily from Erivedge royalties, were $2.9 million for Q3 2024, up 3% year-over-year; $7.6 million for the nine months, up 3%.

• Q3 2024 R&D expenses were $9.7 million, down from $10.4 million year-over-year; G&A expenses were $3.8 million, down from $4.8 million.

• Cash and cash equivalents were $20.9 million as of September 30, 2024, with an additional $10.8 million raised in October 2024, bringing cash and equivalents to $31.6 million and supporting operations into mid-2025.

Outlook and guidance

• Cash runway expected to support planned operations into mid-2025, but not expected to last 12 months from filing date.

• 2025 operating burn projected to remain around $10 million per quarter, with some variability due to manufacturing timing.

• Additional data from key clinical studies expected in December 2024 and Q1 2025.

• Will require further funding through equity, collaborations, or strategic transactions to continue operations and advance emavusertib.

• Prioritization focus remains on PCNSL, with AML, MDS, and solid tumor programs to be evaluated as new data emerge.