On March 19, 2026 Acrivon Therapeutics, Inc. ("Acrivon" or "Acrivon Therapeutics") (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, reported financial results for the fourth quarter and full year ended December 31, 2025 and reviewed recent business highlights.
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"It’s an exciting time for the company as we build on strong maturing data and clinical momentum," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. "Our compelling data from ACR-368 in EC was well received at the ESGO Congress, reinforced by powerful commentary from world-renowned key opinion leaders at our live webcast, after the late-breaking oral presentation by Dr. Konstantinopoulos from the Dana- Farber Cancer Institute. Serous EC represents a particularly significant unmet need with a mortality rate resulting in 40-50% of all EC deaths. Through our rapidly maturing data, we are strategically generating multiple opportunities towards potential registration for ACR-368, including our announcement today of a fourth arm to our study to investigate ACR-368 monotherapy in biomarker-unselected serous EC subjects. Elsewhere in our pipeline, ACR-2316 has already shown promising clinical activity in lung cancer, underscoring the potential of its differentiated mechanism of action. Finally, we continue to build our pipeline with our next development candidate, ACR-6840, and new programs, reflecting our sustained AP3-driven innovation and commitment to long-term value creation."
Recent Highlights
ACR-368: CHK1 / CHK2 Inhibitor
Clinical data from the ongoing, registrational-intent ACR-368 Phase 2b trial was presented in a late-breaking oral presentation at the European Society of Gynecological Oncology (ESGO) Annual Congress by Dr. Panagiotis (Panos) Konstantinopoulos, M.D., Ph.D., from the Dana-Farber Cancer Institute
Consistent with higher BM levels in serous versus non-serous EC, an interim analysis across both OncoSignature-positive (BM+) and BM- serous EC subjects showed a cORR of 52% (N = 23) versus 22% (N = 37) in non-serous EC subjects; all subjects in this analysis received up to two prior lines of therapy (LoT), including chemotherapy and anti-PD-1
Based on this, Arm 3 was initiated in late 2025 to generate prospective data of ACR-368 with ULDG sensitization in all-comer (no pre-treatment biopsy or biomarker stratification) serous EC subjects with ≤2 prior LoT and is actively enrolling and dosing patients in the US, with 4 major EU countries on track to be activated by end of Q1 further accelerating enrollment through the addition of more than 20 EU sites
Following Dr. Konstantinopoulos’ presentation, the company hosted a KOL panel at ESGO, during which KOL experts expressed strong enthusiasm for ACR-368 and discussed the promising clinical data, emphasizing the high unmet need and potential impact for patients suffering from serous EC.
Building on promising clinical data and observed biomarker upregulation in serous EC, the company announced today that it plans to initiate a fourth cohort (Arm 4) in the ongoing ACR-368 Phase 2b study in the first half of 2026. This arm will enroll all-comer (BM-unselected) serous EC subjects, similar to Arm 3, but subjects will be treated with ACR-368 monotherapy and otherwise identical inclusion criteria to Arm 3.
Company also announced today that it has completed the exploratory Arm 2 of the study which treated BM- EC subjects with ≤3 prior LoT using ACR-368 with ULDG sensitization. Objectives of this arm were achieved, supporting that ULDG may contribute to ACR-368 efficacy in BM- subjects with a favorable tolerability profile.
ACR-2316: WEE1 / PKMYT1 Inhibitor
Initial data from the Phase 1 monotherapy dose-escalation trial showed a favorable tolerability profile and demonstrated clinical activity with tumor shrinkage, notably including partial responses and strong disease control in small cell lung cancer (SCLC) and squamous non-small cell lung cancer (NSCLC), tumor types predicted sensitive by AP3 not previously shown sensitive to WEE1 or PKMYT1 inhibitors in development
ACR-6840: Oral CDK11 Inhibitor
Nominated as internally-discovered development candidate from company’s AP3-driven cell cycle program
Strengthened Precision Medicine Therapeutics Capabilities
Launched wholly-owned and operated Clinical Laboratory Improvement Amendment (CLIA) certified laboratory with full license to conduct patient sample testing and develop companion diagnostics
Anticipated Upcoming Milestones
ACR-368 Ongoing Registrational-Intent Phase 2b Study
Achieve CTA approval in EU for the ongoing (US) registrational intent serous EC all-comer Arm 3 (ACR-368 + ULDG) by Q1 2026
Initial clinical data from Arm 3 and additional update on Arm 1 of the ACR-368 Phase 2b trial in mid-2026
Initiate enrollment for the registrational intent serous EC all-comer Arm 4 (ACR-368) in the US in first half of 2026
Achieve readiness for Phase 3 confirmatory trial for ACR-368 in combination with PD-1 therapy by mid-2026
Complete enrollment (up to N = 90 subjects) in the registrational intent serous EC all-comer Arm 3 (ACR-368 + ULDG) in Q4 2026
Broader Pipeline
Additional ACR-2316 Phase 1 clinical data for weekly and bi-weekly dosing regimens and transition into dose expansion in AP3-identified tumor types in 2026
Submit IND filing to the FDA for ACR-6840 in Q4 2026
Initiate additional internal programs utilizing the AP3 platform in 2026
Fourth Quarter and Full Year 2025 Financial Results
Net loss for the quarter and full year ended December 31, 2025 was $19.0 million and $77.9 million, respectively. This compares to a net loss of $22.8 million and $80.6 million, respectively for the same periods in 2024.
Research and development expenses were $14.7 million for the quarter ended December 31, 2025, and $60.0 million for the full year 2025, compared to $18.6 million and $64.0 million, respectively, for the same periods in 2024. The difference was significantly driven by fewer milestones scheduled and incurred in the current period, as well as the prioritization of endometrial cancer in the ACR-368 clinical trial.
General and administrative expenses were $5.4 million for the quarter ended December 31, 2025, and $24.1 million for the full year 2025, compared to $6.3 million and $25.2 million, respectively, for the same periods in 2024. The difference was primarily due to a decrease in personnel costs, inclusive of non-cash stock compensation expense.
As of December 31, 2025, the company had cash, cash equivalents and investments of $118.6 million, which is expected to fund operating expenses and capital expenditure requirements into the second quarter of 2027.
(Press release, Acrivon Therapeutics, MAR 19, 2026, View Source [SID1234663773])