Acrivon Therapeutics(ACRV) - 2025 Q3 - Quarterly Report

Oncology Pipeline - Acrivon Therapeutics is focused on oncology, advancing its pipeline of preclinical and clinical-stage small molecule inhibitors, including ACR-368 and ACR-2316[100]. - ACR-368 is in a potentially registrational Phase 2B trial for endometrial cancer, with initial data showing a confirmed overall response rate (ORR) of 35% and a disease control rate (DCR) of 80% among 20 biomarker-positive patients[105]. - The company reported that 80% of biomarker-positive patients demonstrated tumor shrinkage, indicating significant anti-tumor activity in aggressive, refractory tumors[105]. - ACR-368 received Fast Track designation from the FDA for endometrial cancer and the OncoSignature test received Breakthrough Device Designation, reflecting its potential for effective treatment[102]. - ACR-2316, a selective WEE1/PKMYT1 inhibitor, is currently in Phase 1 trials, with initial clinical activity observed and a clinical data update expected in the second half of 2025[108]. - The company plans to continue exploring drug combinations and has initiated a Phase 2 trial of ACR-368 with ultra low-dose gemcitabine in endometrial cancer patients[106]. Financial Performance - Acrivon has incurred net losses of $58.9 million and $57.7 million for the nine months ended September 30, 2025, and 2024, respectively, with an accumulated deficit of $255.9 million as of September 30, 2025[113]. - The company raised $123.8 million in net proceeds from a PIPE transaction in April 2024, selling 8,235,000 shares at $8.50 per share[112]. - Research and development expenses for Q3 2025 were $13.6 million, a decrease of $5.2 million from $18.9 million in Q3 2024[137]. - The company reported a net loss of $18.2 million for Q3 2025, an improvement of $4.2 million compared to a net loss of $22.4 million in Q3 2024[135]. - Total operating expenses for the nine months ended September 30, 2025, were $63.998 million, a slight decrease of $0.247 million from $64.245 million in the same period of 2024[139]. - Interest income for Q3 2025 was $1.5 million, down from $2.7 million in Q3 2024, reflecting a decrease of $1.2 million[138]. - Total other income, net for the nine months ended September 30, 2025, was $5.1 million, compared to $6.5 million for the same period in 2024, a decrease of $1.4 million[143]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $48.4 million, slightly increasing from $48.3 million in the same period of 2024[146]. - Net cash provided by investing activities was $44.6 million for the nine months ended September 30, 2025, resulting from $114.5 million in proceeds from maturities of investments[148]. - Net cash used in financing activities was $0.6 million for the nine months ended September 30, 2025, primarily due to tax withholding payments[150]. Research and Development - Acrivon is leveraging its proprietary AP3 platform for drug discovery and optimization, which has enabled rapid advancement of its drug candidates[109]. - The company anticipates a substantial increase in research and development expenses as it continues the development of ACR-368 and ACR-2316[126]. - Research and development expenses for the nine months ended September 30, 2025, were $45.2 million, a decrease of $0.1 million from $45.4 million in the same period of 2024[142]. - ACR-368 direct research and development expenses for Q3 2025 were $3.985 million, down from $11.098 million in Q3 2024, a decrease of $7.113 million[136]. - The company experienced a $6.5 million net decrease in costs due to fewer scheduled milestones in the current period[147]. - A $3.8 million net increase in costs was related to the clinical trial of ACR-2316, initiated in Q3 2024[147]. Future Outlook - Acrivon anticipates significant ongoing expenses related to clinical development and commercialization efforts, necessitating additional funding to support its growth strategy[115]. - The company expects to incur significant expenses and operating losses as it advances drug candidates through clinical development and seeks regulatory approval[153]. - The company anticipates that existing cash will fund operations into the second quarter of 2027, based on current assumptions[152]. - The company may require additional capital for in-licenses or acquisitions of other drug candidates in the future[153]. - As of September 30, 2025, the company had cash, cash equivalents, and investments totaling $134.4 million, expected to fund operations into Q2 2027[118]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates below $700 million[164].