Curis, Inc. reported a net loss of $43.4 million for the year ended December 31, 2024, compared to a net loss of $47.4 million in 2023, representing an 8% decrease. Net revenues increased by 9% to $10.9 million in 2024, primarily driven by royalties from Genentech's sales of Erivedge, a Hedgehog pathway inhibitor. Research and development expenses decreased slightly by 2% to $38.6 million, while general and administrative expenses fell by 10% to $16.8 million. The company's accumulated deficit stood at $1.2 billion as of December 31, 2024.

Significant developments during the year included the granting of Orphan Drug Designation for emavusertib (CA-4948), an IRAK4 inhibitor, by both the European Commission and the U.S. Food and Drug Administration for the treatment of primary central nervous system lymphoma (PCNSL). The company also completed productive meetings with the European Committee for Medicinal Products for Human Use (CHMP) and the FDA regarding potential accelerated regulatory pathways for emavusertib in Europe and the U.S., respectively. Further clinical data for emavusertib in combination with ibrutinib in relapsed or refractory PCNSL was presented in September 2024 and March 2025. Additionally, Curis initiated a Phase 1 clinical study of emavusertib in combination with azacitidine and venetoclax in acute myeloid leukemia (AML).

The company's financial performance was also impacted by the March 2019 Oberland Purchase Agreement, which resulted in the sale of a portion of Curis Royalty's Erivedge royalty rights for $65 million in upfront payments. Further milestone payments of $53.5 million are contingent upon exceeding specified sales thresholds by December 31, 2026. The company also completed several equity offerings throughout the year, raising approximately $36.6 million in net proceeds. As of December 31, 2024, Curis had $20 million in cash and cash equivalents.

Curis's operational developments included the substantial completion of enrollment in the TakeAim Leukemia Phase 1/2 study and continued enrollment in the AML Triplet study. The company employed 34 employees as of December 31, 2024, with 22 involved in research and development. Curis does not have its own manufacturing capabilities and relies on third-party manufacturers and suppliers. The company also highlighted the competitive landscape for emavusertib and Erivedge, noting several competitors with greater resources and experience.

The company's outlook indicates that its available cash resources, along with proceeds from a March 2025 offering, are expected to fund operations into the fourth quarter of 2025. However, the 10-K filing explicitly states that conditions and events raise substantial doubt about the company's ability to continue as a going concern, emphasizing the need for substantial additional funding to support ongoing operations and the development of emavusertib. The company's future success hinges on the successful development and commercialization of emavusertib and the continued commercial success of Erivedge by its collaborators.

About CURIS INC

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