Acrivon Therapeutics(ACRV) - 2024 Q2 - Quarterly Report

Financial Performance - Acrivon Therapeutics has incurred net losses of $35.3 million and $26.7 million for the six months ended June 30, 2024, and 2023, respectively, with an accumulated deficit of $151.7 million as of June 30, 2024[90]. - The company expects to continue incurring significant operating losses and will require substantial additional funding to support ongoing operations and growth strategies[92]. - The net loss for the three months ended June 30, 2024, was $18.8 million, compared to a net loss of $13.9 million for the same period in 2023, reflecting an increase of $4.9 million[107]. - Net cash used in operating activities was $31.0 million for the six months ended June 30, 2024, compared to $20.5 million for the same period in 2023, an increase of $10.5 million[119]. - Research and development expenses for the six months ended June 30, 2024, totaled $26.5 million, up from $20.3 million in the same period in 2023, an increase of $6.2 million[113]. - General and administrative expenses for the six months ended June 30, 2024, were $12.6 million, compared to $9.6 million for the same period in 2023, reflecting a $3.0 million increase[114]. - Research and development expenses increased to $15.0 million for the three months ended June 30, 2024, compared to $10.5 million for the same period in 2023, representing a $4.5 million increase[108]. - General and administrative expenses were $6.4 million for the three months ended June 30, 2024, up from $5.0 million in the same period in 2023, marking a $1.4 million increase[110]. - Total other income, net was $2.6 million for the three months ended June 30, 2024, compared to $1.6 million for the same period in 2023, an increase of $1.0 million[111]. Cash and Funding - As of June 30, 2024, Acrivon had cash, cash equivalents, and investments totaling $220.4 million, expected to fund operations into the second half of 2026[93]. - Acrivon entered into a PIPE agreement to issue 8,235,000 shares at $8.50 per share, raising aggregate net proceeds of $123.8 million after fees[89]. - The company raised $123.2 million in net cash from financing activities for the six months ended June 30, 2024, primarily from a private placement[121]. - The company plans to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholder ownership[127]. - Future capital requirements will depend on various factors, including the costs of clinical development, regulatory review, and commercialization activities[124]. - The company may require additional capital for in-licenses or acquisitions of other drug candidates[123]. Drug Development and Clinical Trials - Acrivon is advancing its lead candidate ACR-368 in a Phase 2 trial for patients with locally advanced or metastatic, recurrent platinum-resistant ovarian cancer, with initial clinical observations indicating a favorable tolerability profile[82][84]. - The ACR-368 OncoSignature test has shown a 50% confirmed objective response rate in OncoSignature-positive patients compared to 0% in OncoSignature-negative patients, with a p-value of 0.0038[85]. - The company is leveraging its AP3 platform to develop additional drug candidates, including ACR-2316, with plans to start a Phase I clinical study in Q4 2024[87]. - Acrivon has incurred significant research and development expenses, primarily related to ACR-368 and the ACR-368 OncoSignature, with costs including external research and manufacturing[98]. - The company has received Fast Track designations for ACR-368 from the FDA for specific cancer treatments, reflecting its potential therapeutic benefits[86]. - The company anticipates significant expenses and operating losses as it advances drug candidates through clinical development and seeks regulatory approval[123]. - If regulatory approval is obtained, significant commercialization expenses related to drug manufacturing, sales, and marketing are expected[123]. Regulatory and Compliance - The company remains classified as an "emerging growth company," allowing it to delay the adoption of certain accounting standards[131]. - The market value of the company's stock held by non-affiliates is less than $700 million, qualifying it as a "smaller reporting company"[133]. - The company may continue to rely on exemptions from certain disclosure requirements available to smaller reporting companies[134]. Contractual Obligations - There were no material changes to contractual obligations during the six months ended June 30, 2024, compared to the previous annual report[128].