Business Context and Reporting Period
This Form 8-K was filed by Acrivon Therapeutics, Inc. on January 8, 2026. The report discloses preliminary unaudited financial information as of December 31, 2025, and announces significant clinical data updates for its pipeline candidates ACR-368, ACR-2316, and ACR-6840.
Key Financial Metrics
- Cash and Investments: Approximately $119 million in cash, cash equivalents, and investments as of December 31, 2025 (preliminary and unaudited).
- Liquidity Runway: Current operating plans indicate funds are expected to support operations into the second quarter of 2027.
- Revenue and Profit: The filing does not provide specific revenue, profit, or margin figures for the period.
- Debt: The filing does not disclose specific debt levels.
Material Changes and Clinical Updates
The filing details material progress in clinical trials rather than financial performance changes:
- ACR-368 (CHK1/CHK2 Inhibitor):
- Updated interim analysis in Arm 1 (monotherapy, BM+ subjects) showed an Objective Response Rate (ORR) of 39%.
- In subjects with serous endometrial cancer (EC), the confirmed ORR (cORR) was 67% (N=12) in BM+ subjects and 52% (N=23) across BM+ and BM- subjects.
- Arm 3 will now focus exclusively on serous EC subjects with up to two prior lines of therapy.
- EU Clinical Trial Application submitted for Arm 3 expansion across Germany, Italy, France, and Spain.
- ACR-2316 (WEE1/PKMYT1 Inhibitor):
- Established two weekly oral dosing regimens with a favorable tolerability profile.
- Observed tumor shrinkage in 9 of 20 evaluable patients, including a confirmed partial response (PR) in a subject with high-grade Mullerian EC and unconfirmed PRs in SCLC and squamous NSCLC.
- ACR-6840 (CDK11 Inhibitor):
- Nominated as the next development candidate from the AP3-driven cell cycle program.
- IND submission anticipated in the fourth quarter of 2026.
Guidance, Outlook, and Risks
Management Outlook and Milestones:
- Initiate EU enrollment for ACR-368 Arm 3 in Q1 2026.
- Provide additional ACR-368 data and achieve readiness for Phase 3 confirmatory trial design in mid-2026.
- Complete enrollment for ACR-368 Arm 3 (N=90) in Q4 2026.
- Report additional ACR-2316 Phase 1 data and transition to dose expansion in 1H 2026.
- Submit IND for ACR-6840 in Q4 2026.
Risks and Contingencies:
- The $119 million cash figure is preliminary and unaudited; actual amounts may differ materially.
- Forward-looking statements regarding clinical milestones and timelines are subject to substantial risks and uncertainties, including regulatory feedback and trial enrollment rates.
Investor Verification Checklist
- Verify the final audited cash balance for the year ended December 31, 2025, upon release of the 10-K.
- Monitor the FDA's response to the proposed Phase 3 protocol design for ACR-368 in combination with anti-PD-1 agents.
- Track the actual enrollment rates for the EU expansion of the ACR-368 Phase 2b trial starting in Q1 2026.
- Confirm the safety and efficacy data from the ACR-2316 dose expansion cohorts in 1H 2026.
- Review the final IND submission status for ACR-6840 in Q4 2026.