Acrivon Therapeutics(ACRV) - 2025 Q1 - Quarterly Report

Clinical Development - Acrivon Therapeutics is advancing its lead candidate ACR-368 in a Phase 2 trial for endometrial cancer, focusing on patients predicted to be sensitive based on the OncoSignature test [102]. - The ACR-368 OncoSignature test has shown a confirmed overall response rate (ORR) of 35% and a disease control rate (DCR) of 80% among 20 patients with endometrial cancer [106]. - The FDA granted Fast Track designation to ACR-368 for the treatment of OncoSignature-positive endometrial cancer patients, indicating a potential for expedited development [104]. - The ongoing registrational trial for ACR-368 in endometrial cancer is based on a market research estimate of approximately 27,000 U.S. patients annually in the second-line setting [105]. - Acrivon is also developing ACR-2316, a selective WEE1/PKMYT1 inhibitor, which has entered Phase 1 trials with initial dosing in Q3 2024 [108]. - Acrivon anticipates providing a clinical data update for ACR-2316 in the second half of 2025, with encouraging early results observed in patients [108]. Financial Performance - The company reported a net loss of $19.7 million for the three months ended March 31, 2025, compared to a net loss of $16.5 million for the same period in 2024, with an accumulated deficit of $216.7 million as of March 31, 2025 [113]. - The net loss for Q1 2025 was $19.7 million, compared to a net loss of $16.5 million in Q1 2024, reflecting an increase of $3.2 million [135][138]. - Net cash used in operating activities was $19.5 million for Q1 2025, up from $17.1 million in Q1 2024, driven by increased net loss and personnel-related costs [140][141]. - Research and development expenses for Q1 2025 were $15.4 million, an increase of $3.9 million from $11.5 million in Q1 2024 [135][137]. - General and administrative expenses remained relatively stable at $6.2 million for both Q1 2025 and Q1 2024 [135][137]. - The accumulated deficit as of March 31, 2025, was $216.7 million, indicating significant losses since inception [139]. - The company has not generated any revenue to date and does not expect to do so in the foreseeable future from drug sales [121]. Funding and Capital Requirements - Acrivon has raised $123.8 million in net proceeds from a Private Investment in Public Equity (PIPE) transaction, selling 8,235,000 shares at $8.50 per share [112]. - The company anticipates a substantial increase in research and development expenses as it continues to develop ACR-368 and ACR-2316 [127]. - Future capital requirements will depend on various factors, including the costs of preclinical and clinical development activities and regulatory review outcomes [149]. - The company may need to finance cash needs through equity offerings, debt financings, and collaborations, which could dilute stockholder ownership [151]. - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $164.8 million, expected to fund operations into Q2 2027 [118][139][147]. Regulatory and Compliance - The company remains classified as an "emerging growth company," allowing it to delay compliance with new accounting standards [156]. - The market value of the company's stock held by non-affiliates is less than $700 million, qualifying it as a "smaller reporting company" [158]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company [159]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its smaller reporting company status [160]. - There were no material changes to contractual obligations during the three months ended March 31, 2025, compared to the previous year [152]. Strategic Plans - The company plans to continue its research and development activities, including the discovery of additional drug candidates and the expansion of its intellectual property portfolio [116]. - The company expects to incur significant expenses and operating losses as it advances drug candidates through clinical development and seeks regulatory approval [148]. - Research and development costs are anticipated to increase due to planned clinical activities and operating as a public company [148].