Curis Provides Fourth Quarter 2024 Business Update

Core Insights - Curis, Inc. has received Orphan Drug Designation for emavusertib in the treatment of primary central nervous system lymphoma (PCNSL) from both the FDA and EMA, supporting a potential accelerated approval path [6][8] - The company reported a net loss of $43.4 million for the year ended December 31, 2024, an improvement from a net loss of $47.4 million in 2023 [10] - Curis has initiated a Phase 1 clinical study of emavusertib in combination with venetoclax and azacitidine for frontline acute myeloid leukemia (AML), with positive early results [4][8] Operational Highlights - Emavusertib is being evaluated in multiple studies, including the TakeAim Lymphoma study for relapsed/refractory PCNSL and the TakeAim Leukemia study for relapsed/refractory AML [19] - In the TakeAim Lymphoma study, 9 out of 13 BTKi-experienced patients showed a reduction in tumor burden, with 6 objective responses [6] - The TakeAim Leukemia study reported that 10 out of 19 response-evaluable patients achieved an objective response, including 6 complete responses [6] Financial Performance - For the fourth quarter of 2024, Curis reported a net loss of $9.6 million, compared to a net loss of $11.7 million in the same period of 2023 [10] - Revenues for the year ended December 31, 2024, were $10.9 million, up from $10.0 million in 2023, primarily from royalty revenues related to Erivedge® [11] - Research and development expenses decreased to $38.6 million in 2024 from $39.5 million in 2023, attributed to lower clinical and consulting costs [12] Corporate Developments - Curis has successfully concluded discussions with the FDA and EMA regarding the potential for accelerated approval for emavusertib [6][8] - The company priced a registered direct offering of common stock and concurrent private placement with gross proceeds of approximately $10.0 million, expected to close on March 31, 2025 [7] - As of December 31, 2024, Curis had cash and cash equivalents totaling $20.0 million, which, along with expected proceeds from the March 2025 offerings, is anticipated to fund operations into the fourth quarter of 2025 [15][16]