Acrivon Therapeutics(ACRV) - 2024 Q3 - Quarterly Report

Financial Performance - Acrivon Therapeutics reported net losses of $57.7 million for the nine months ended September 30, 2024, compared to $41.1 million for the same period in 2023, resulting in an accumulated deficit of $174.1 million[97]. - The net loss for the three months ended September 30, 2024, was $22.4 million, compared to a net loss of $14.5 million for the same period in 2023, an increase of $7.9 million[119]. - Net cash used in operating activities was $48.3 million for the nine months ended September 30, 2024, compared to $30.3 million for the same period in 2023, an increase of $18.0 million[130]. - General and administrative expenses increased to $18.9 million for the nine months ended September 30, 2024, up from $15.5 million in the same period of 2023, reflecting a $3.4 million increase[126]. - Total operating expenses for the three months ended September 30, 2024, were $25.1 million, up from $16.1 million in 2023, reflecting a change of $9.0 million[119]. Revenue Generation - The company has not generated any revenue from drug sales and does not expect to do so in the foreseeable future[105]. Cash and Investments - Acrivon has cash, cash equivalents, and investments totaling $202.8 million as of September 30, 2024, which is expected to fund operations into the second half of 2026[101]. - As of September 30, 2024, the company had $202.8 million in cash, cash equivalents, and investments, with an accumulated deficit of $174.1 million[128]. - The existing cash and investments are expected to fund operating expenses into the second half of 2026[133]. Research and Development - Research and development expenses increased to $18.9 million for the three months ended September 30, 2024, from $10.3 million for the same period in 2023, representing an increase of $8.6 million[120]. - For the nine months ended September 30, 2024, research and development expenses totaled $45.4 million, up from $30.5 million in 2023, an increase of $14.8 million[124]. - The increase in research and development expenses was primarily driven by a $7.1 million net increase related to the ACR-368 clinical trial and $1.7 million for the ACR-2316 development program[120]. - The company anticipates a substantial increase in research and development expenses in the foreseeable future as it continues to develop ACR-368 and ACR-2316[110]. - The company expects to incur significant expenses and operating losses as it advances drug candidates through clinical development and seeks regulatory approval[134]. Clinical Trials and Drug Development - ACR-368 OncoSignature test achieved a 50% confirmed objective response rate (ORR) in OncoSignature-positive patients with ovarian cancer, compared to 0% in OncoSignature-negative patients (p-value=0.0038)[91]. - ACR-368 received two Fast Track designations from the FDA for patients with OncoSignature-positive platinum-resistant ovarian cancer and endometrial cancer[88]. - ACR-368 demonstrated a confirmed overall response rate of 62.5% in OncoSignature-positive patients with endometrial cancer, based on data from 35 safety-evaluable patients[92]. - The company is advancing ACR-2316, a selective WEE1/PKMYT1 inhibitor, with first-in-human dosing anticipated in Q4 2024 following FDA IND clearance[94]. - Costs related to the promotion of the clinical stage asset ACR-2316 amounted to $1.7 million, with a net decrease of $1.4 million in preclinical drug discovery costs[125]. Financing Activities - Acrivon entered into a Private Investment in Public Equity (PIPE) agreement in April 2024, raising net proceeds of $123.8 million from the sale of 8,235,000 shares at $8.50 per share[96]. - Net cash provided by financing activities was $121.7 million for the nine months ended September 30, 2024, resulting from proceeds of $130.0 million from a private placement[132]. - The company plans to raise substantial additional capital in the future to support ongoing clinical trials and development activities[112]. Other Income - Interest income for the three months ended September 30, 2024, was $2.7 million, compared to $1.7 million in the same period of 2023, an increase of $1.0 million[122]. - The total other income, net for the three months ended September 30, 2024, was $2.7 million, compared to $1.7 million in 2023, primarily due to increased interest income[122]. - Total other income, net was $6.5 million for the nine months ended September 30, 2024, compared to $4.9 million for the same period in 2023, an increase of $1.6 million[127]. Operating Losses - Acrivon has incurred significant operating losses primarily due to research and development activities and general administrative costs, with expectations of continued losses as clinical trials progress[98]. - Future capital requirements will depend on various factors, including the costs of clinical development and regulatory review[135].