Acrivon Therapeutics(ACRV) - 2025 Q2 - Quarterly Results

Business Highlights Acrivon advances clinical assets ACR-368 and ACR-2316, showcasing the AP3 platform's role in drug development and initial clinical activity ACR-368: CHK1 and CHK2 Inhibitor The registrational-intent Phase 2b trial for ACR-368 in endometrial cancer is ongoing, with a new arm evaluating combination therapy for broader patient access - The company is continuing to advance its registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with recurrent high-grade endometrial cancer who have failed prior platinum-based chemotherapy and immune checkpoint inhibitor treatments[3][4] - A third arm has been initiated in the Phase 2b study to evaluate ACR-368 with ultra low-dose gemcitabine (ULDG) in all-comer, biomarker-unselected 2nd line endometrial cancer patients, which does not require a pre-treatment biopsy[4] - Clinical data has shown deep and durable responses in patients with aggressive endometrial cancer who had progressed on prior chemotherapy and anti-PD1 therapy[2] ACR-2316: WEE1/PKMYT1 Inhibitor The Phase 1 dose-escalation trial for ACR-2316 is enrolling patients, showing no dose-limiting toxicities, target engagement, and early clinical activity - The Phase 1 monotherapy dose-escalation trial is enrolling patients with high unmet need solid tumor types, prioritized based on AP3-predicted sensitivity[9] - Key early findings from the Phase 1 trial include: - No dose-limiting toxicities observed in three cleared dose levels - Evidence of drug target engagement observed as early as dose level 1 - Initial clinical activity seen, including an ongoing confirmed partial response in endometrial cancer[9][2] Generative Phosphoproteomics AP3 Platform The AI-driven AP3 platform accelerates novel compound design and development, demonstrating its ability to uncover key molecular mechanisms - The AI-driven AP3 platform enables a new paradigm for accelerated design and development of novel compounds by providing optimal intracellular pathway selectivity[1] - At the AACR Annual Meeting in April 2025, the company presented AP3 analyses that uncovered key molecular mechanisms by which ACR-2316 induces strong, pro-apoptotic tumor cell death[5] Future Outlook Acrivon anticipates providing updates on ACR-368 and ACR-2316 clinical data in H2 2025, alongside advancing a new cell cycle drug discovery program - Key anticipated milestones for the remainder of 2025 include: - An update on the registrational-intent trial and confirmatory trial design for ACR-368 in H2 2025 - A report of initial clinical data from the Phase 1 clinical study of ACR-2316 in H2 2025 - Advancement of a new cell cycle drug discovery program towards development candidate nomination[9] Second Quarter 2025 Financial Results Acrivon reported a $21.0 million net loss in Q2 2025, driven by R&D, with $147.6 million cash funding operations into Q2 2027 Summary of Operations Q2 2025 net loss increased to $21.0 million from $18.8 million in Q2 2024, primarily due to higher R&D Statement of Operations (Three Months Ended June 30, in thousands) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :--- | :--- | :--- | | Net Loss | ($21,006) | ($18,798) | | R&D Expenses | $16,182 | $15,025 | | G&A Expenses | $6,467 | $6,412 | - The increase in R&D expenses was primarily due to increased personnel to support the clinical trials for ACR-368 and ACR-2316, as well as preclinical drug discovery[7] Financial Position and Runway Acrivon's cash, cash equivalents, and marketable securities totaled $147.6 million as of June 30, 2025, providing funding into Q2 2027 - Cash, cash equivalents and marketable securities totaled $147.6 million as of June 30, 2025[1][8] - The company's cash position is expected to fund operations into the second quarter of 2027[1][8] Company Overview Acrivon is a clinical-stage biopharmaceutical company leveraging its AI-driven AP3 platform to develop precision medicines, including lead programs ACR-368 and ACR-2316 - Acrivon uses its proprietary Generative Phosphoproteomics AP3 platform to interpret and quantify drug-regulated pathway activity, enabling the design of differentiated compounds[10] - The lead program, ACR-368 (a CHK1/CHK2 inhibitor), is in a potentially registrational Phase 2 trial for endometrial cancer and has received FDA Fast Track designation[11] - The second clinical asset, ACR-2316 (a WEE1/PKMYT1 inhibitor), is advancing in a Phase 1 trial and has shown initial clinical activity and drug target engagement[12] Financial Statements The financial statements detail a $21.0 million net loss for Q2 2025 and total assets of $158.6 million as of June 30, 2025, reflecting a decrease from year-end 2024 Condensed Consolidated Statements of Operations Acrivon reported a $21.0 million net loss for Q2 2025, or ($0.55) per share, compared to a $18.8 million net loss in Q2 2024 Statement of Operations (Three Months Ended June 30, in thousands) | | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | Research and development | $16,182 | $15,025 | | General and administrative | $6,467 | $6,412 | | Total operating expenses | $22,649 | $21,437 | | Loss from operations | ($22,649) | ($21,437) | | Total other income, net | $1,643 | $2,639 | | Net loss | ($21,006) | ($18,798) | | Net loss per share | ($0.55) | ($0.52) | Condensed Consolidated Balance Sheets As of June 30, 2025, total assets were $158.6 million, a decrease from $196.6 million at year-end 2024, with total liabilities at $15.5 million Balance Sheet Summary (in thousands) | | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $41,895 | $39,818 | | Investments | $105,727 | $144,751 | | Total assets | $158,583 | $196,588 | | Total Liabilities | $15,546 | $19,802 | | Total Stockholders' Equity | $143,037 | $176,786 |