On August 12, 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 second quarter ended June 30, 2026 and reviewed recent business highlights.
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"As we look ahead to the second half of 2026, we remain excited about the continued rapid clinical advancement of our precision medicine pipeline," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. "For ACR-368, this includes the prespecified interim analysis of the registrational-intent, all-comer, serous endometrial cancer arms of the Phase 2b study. For ACR-2316, we have recently entered the randomized dose expansion stage in our Phase 1/2 study, supported by a favorable, differentiated safety profile and durable single-agent activity, including in heavily pretreated lung cancer subjects. Several subjects from the dose escalation phase now remain on treatment for more than one year."
Recent Highlights
ACR-368
Dosing continues in both all-comer serous EC arms (Arm 4 single agent and Arm 3 with ultra-low dose gemcitabine sensitization) in the registrational-intent Phase 2b study, across both US and European clinical sites.
Two presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighted data showing the underlying molecular mechanisms for potent synergies between ACR-368 and immune checkpoint inhibitors (ICIs) or Topoisomerase 1 (Topo 1) inhibitors identified by AP3. These findings support the potential for clinical combination studies with antibody-drug conjugates (ADCs) or ICIs.
ACR-2316
ACR-2316 advanced into the randomized dose expansion stage of the Phase 1/2 study, supported by observed favorable safety profile and durable antitumor activity. The expansion phase is evaluating 120 mg and 160 mg doses, administered orally, once-daily (QD) utilizing a 3d on / 4d off weekly administration schedule.
Dose expansion phase will assess safety and activity in subjects with AP3-identified, molecularly-defined lung, endometrial, cervical, and esophago-gastric junction cancers.
Data presented at the AACR (Free AACR Whitepaper) Annual Meeting uncovered the molecular underpinnings driving strong synergy and resulting in complete tumor regression with durable immune memory upon treatment with ACR-2316 and ICI, providing a mechanistic rationale for potential combinations with ICIs.
Oral podium and poster presentations at the AACR (Free AACR Whitepaper) Drug Discovery and Development conference demonstrated how AP3 guided the design of ACR-2316 for optimal intracellular pathway effects, including sustained activation of CDK1, CDK2, and importantly also of PLK1, and quenching of the dominant resistance mechanisms to drive potent pro-apoptotic tumor cell death.
CDK11 Inhibitor Program
Internally-discovered development candidate from company’s AP3-driven cell cycle program and several equally promising back-up lead compounds showing complete regression in preclinical in vivo AML models being advanced in Investigational New Drug (IND)-enabling studies.
Anticipated Upcoming Milestones
ACR-368 Ongoing Registrational Intent Phase 2b Study
A prespecified simultaneous interim analysis and data update from both all-comer (biopsy-independent) serous EC arms of the ACR-368 Phase 2b study in second half of 2026
Initiate Phase 3 confirmatory trial for ACR-368 in first half of 2027
Based on interim data read-out, complete enrollment of the registrational intent all-comer (biopsy-independent) serous EC Arm 3 or Arm 4 by fourth quarter of 2026
Broader Pipeline
Submit IND filing to the FDA for CDK11 inhibitor development candidate in first half of 2027
Initiate additional AP3-driven drug discovery programs in 2026
Second Quarter 2026 Financial Results
Net loss for the quarter ended June 30, 2026 was $18.0 million compared to a net loss of $21.0 million for the same period in 2025.
Research and development expenses were $13.8 million for the quarter ended June 30, 2026 compared to $16.2 million for the same period in 2025. The difference is primarily driven by two milestones achieved for ACR-368 in 2025 which did not recur in 2026, as well as timing of the progression of other programs.
General and administrative expenses were $4.8 million for the quarter ended June 30, 2026, compared to $6.5 million for the same period in 2025. The difference was primarily due to a decrease in employee-related expenses, including stock-based compensation.
As of June 30, 2026, the company had cash, cash equivalents and investments of $90.0 million, which is expected to fund operating expenses and capital expenditure requirements into the fourth quarter of 2027.
(Press release, Acrivon Therapeutics, AUG 12, 2026, View Source [SID1234670034])