Acrivon Therapeutics Reports $80.6 Million Net Loss for 2024, Highlights Clinical Developments

Acrivon Therapeutics, Inc. reported a net loss of $80.6 million for the year ended December 31, 2024, compared to a net loss of $60.4 million in 2023. This increase of $20.2 million reflects a rise in operating expenses, primarily driven by a $18 million increase in research and development costs and a $4.1 million increase in general and administrative expenses. Research and development costs rose due to increased spending on the ACR-368 clinical trial, the initiation of the ACR-2316 clinical trial, and higher personnel costs. General and administrative expenses increased mainly due to higher payroll and employee-related expenses. The company had $184.6 million in cash, cash equivalents, and investments as of December 31, 2024.

Significant developments during the year included the initiation of a Phase 1 clinical trial for ACR-2316, a novel WEE1/PKMYT1 inhibitor, in the third quarter of 2024, two quarters ahead of schedule. Positive clinical data for ACR-368 in endometrial cancer were reported in September 2024, showing a confirmed objective response rate (ORR) of 62.5%. Further data released on February 25, 2025, from an interim analysis of the endometrial cancer trial showed a confirmed ORR of 35% in OncoSignature-positive patients treated with ACR-368 monotherapy, and an ORR of approximately 13% in OncoSignature-negative patients treated with ACR-368 plus low-dose gemcitabine. The company also received Breakthrough Device designations from the FDA for the ACR-368 OncoSignature assay for endometrial and ovarian cancer.

Acrivon's lead clinical candidate, ACR-368, is currently in a Phase 2 trial focusing on endometrial cancer, with ovarian and bladder cancer indications deprioritized due to lower-than-expected response rates. The company is prioritizing ACR-368 in endometrial cancer due to encouraging clinical data, limited treatment options in the second-line setting, and a large potential market opportunity. The ACR-368 OncoSignature test, developed in collaboration with Akoya Biosciences, is being used for prospective patient selection in this trial. The company also reported initial clinical activity for ACR-2316, with a significant decrease in metastatic lesions observed in a patient in dose level 3.

The company's AP3 platform continues to be leveraged for drug discovery and development, including the identification of rational drug combinations and the creation of OncoSignature companion diagnostics. Acrivon's strategy focuses on advancing ACR-368 and ACR-2316 through clinical development, pursuing rational drug combinations, discovering and developing a pipeline of proprietary drug candidates, and opportunistically entering into strategic partnerships. As of December 31, 2024, Acrivon employed 75 full-time and three part-time employees.

Acrivon expects to incur losses over the next several years and will require additional funding to meet its financial obligations and pursue its business objectives. The company's financial projections are based on assumptions that may prove incorrect, and the actual results could differ materially. The company's future success depends on several factors, including the successful clinical development and commercialization of its drug candidates, obtaining regulatory approvals, and securing adequate funding. The company's 10-K filing includes extensive disclosures regarding various risks and uncertainties associated with its business.