Acrivon Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights
Rhea-AI Summary
Acrivon Therapeutics (Nasdaq: ACRV) reported clinical and financial results on March 19, 2026. Key clinical data show a confirmed overall response rate (cORR) of 52% in serous endometrial cancer versus 22% in non-serous subjects. The company initiated Arm 3 in late 2025 and plans Arm 4 in H1 2026. Cash, cash equivalents and marketable securities totaled $118.6 million as of December 31, 2025, expected to fund operations into Q2 2027. Net loss was $19.0M for Q4 2025 and $77.9M for full-year 2025.
Positive
- cORR 52% in serous endometrial cancer (N=23)
- Initiated Arm 3 (ACR-368 + ULDG) late 2025
- $118.6M cash supports operations into Q2 2027
- Plans to start Arm 4 (ACR-368 monotherapy) in H1 2026
Negative
- Full-year net loss $77.9M in 2025
- Lower cORR of 22% in non-serous EC (N=37)
- Cash runway into Q2 2027 may require future financing
Key Figures
Market Reality Check
Peers on Argus
ACRV’s modest -1.2% move contrasts with mixed peers: RE NB up 19.33% while TPST, PSTV, RADX, and TELO show single‑digit declines, and scanner data flags PSTV up and CALC down, indicating stock-specific drivers over a broad sector move.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 13 | Q3 2025 earnings | Positive | +8.2% | Q3 2025 results plus ACR-368 and ACR-2316 clinical progress and cash update. |
| Aug 13 | Q2 2025 earnings | Positive | +6.1% | Q2 2025 loss, R&D spend, and strong cash; pipeline milestones outlined. |
| May 14 | Q1 2025 earnings | Positive | -3.5% | Q1 2025 loss with stronger R&D; positive ACR-368 and ACR-2316 data. |
| Mar 27 | FY 2024 results | Positive | -11.1% | Q4/FY 2024 losses alongside strong ACR-368 response data and cash runway. |
| Nov 13 | Q3 2024 earnings | Positive | -5.5% | Q3 2024 loss plus significant ACR-368 efficacy and ACR-2316 progress. |
Earnings updates often highlighted positive clinical and pipeline progress but produced slightly negative average next-day moves, with more divergences than alignments.
Over the past five earnings cycles from Nov 2024 through Nov 2025, Acrivon consistently paired financial updates with ACR-368 and ACR-2316 clinical progress and maintained multi‑year cash runway. Market reactions were mixed: two earnings reports prompted gains above 6%, while three saw declines between roughly -3% and -11%. Today’s Q4/FY 2025 release continues that pattern of clinical advancement and extended funding visibility within a volatile trading history around earnings.
Historical Comparison
Across five prior earnings releases, ACRV’s average next-day move was about -1.16%, with more negative than positive reactions, framing today’s earnings update within a historically cautious trading pattern.
Earnings updates since late 2024 show steady evolution: advancing ACR-368 into registrational-intent Phase 2b, expanding ACR-2316 Phase 1, and maintaining multi‑year cash runway while quarterly net losses remain typical for a clinical-stage biotech.
Market Pulse Summary
This announcement combines maturing efficacy data for ACR-368 in serous endometrial cancer with early ACR-2316 activity, nomination of ACR-6840, and CLIA lab capabilities, alongside a 2025 net loss of $77.9M. Cash and securities of $118.6M are expected to fund operations into Q2 2027. Investors may track upcoming Phase 2b readouts, Phase 1 expansion for ACR-2316, and the planned ACR-6840 IND to gauge future value inflection points.
Key Terms
phase 2b medical
overall response rate medical
cORR medical
phase 1 medical
non-small cell lung cancer (nsclc) medical
AI-generated analysis. Not financial advice.
Maturing data from the ongoing registrational intent Phase 2b ACR-368 study showed a confirmed overall response rate (cORR) of
Late-breaking oral presentation and corporate KOL panel at ESGO 2026 highlighted strong ACR-368 data in serous EC, a high unmet need subtype responsible for ~
Initiated Arm 3 (ACR-368 + ultra low-dose gemcitabine) and adding Arm 4 (ACR-368) Phase 2b cohorts in all-comer (biopsy-independent) serous EC subjects
Initial Phase 1 ACR-2316 data in AP3-prioritized solid tumor types showed favorable tolerability and promising clinical activity, notably in heavily pre-treated lung cancer subjects
Cash, cash equivalents and marketable securities of
WATERTOWN, Mass., March 19, 2026 (GLOBE NEWSWIRE) -- 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, today reported financial results for the fourth quarter and full year ended December 31, 2025 and reviewed recent business highlights.
“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
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) versus22% (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
- 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
- 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
Research and development expenses were
General and administrative expenses were
As of December 31, 2025, the company had cash, cash equivalents and investments of
About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 platform. The platform allows the company to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. The Generative Phosphoproteomics AP3 platform is comprised of a growing suite of powerful, internally-developed tools, including the AP3 Data Portal, converting multimodal data into structured data for generative AI analyses, the AP3 Kinase Substrate Relationship Predictor and the AP3 Interactome. These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery, and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development.
Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has granted a Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer who may benefit from ACR-368 treatment.
In addition to ACR-368, Acrivon is also leveraging its proprietary Generative Phosphoproteomics AP3 platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as observed in preclinical studies against benchmark inhibitors. The Phase 1 trial of ACR-2316 is advancing, with weekly dosing regimens established. Initial data has shown a favorable tolerability profile limited to transient, mechanism-based hematological adverse events, predominantly neutropenia and initial clinical activity across AP3-selected solid tumor types, including PRs in endometrial cancer, as well as SCLC and sqNSCLC, two tumor types which have not shown sensitivity to other clinical WEE1 or PKMYT1 inhibitors currently in development. In addition, the company is advancing ACR-6840, an internally discovered development candidate targeting CDK11.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on Acrivon’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and Acrivon undertakes no duty to update such information except as required under applicable law.
Investor and Media Contacts:
Adam D. Levy, Ph.D., M.B.A.
alevy@acrivon.com
Alexandra Santos
asantos@wheelhouselsa.com
| Acrivon Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) | |||||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 14,746 | $ | 18,630 | $ | 59,990 | $ | 63,992 | |||||||||
| General and administrative | 5,370 | 6,324 | 24,124 | 25,207 | |||||||||||||
| Total operating expenses | 20,116 | 24,954 | 84,114 | 89,199 | |||||||||||||
| Loss from operations | (20,116 | ) | (24,954 | ) | (84,114 | ) | (89,199 | ) | |||||||||
| Other income (expense), net: | |||||||||||||||||
| Interest income | 1,247 | 2,363 | 6,479 | 9,201 | |||||||||||||
| Other expense, net | (116 | ) | (240 | ) | (270 | ) | (558 | ) | |||||||||
| Total other income, net | 1,131 | 2,123 | 6,209 | 8,643 | |||||||||||||
| Net loss | $ | (18,985 | ) | $ | (22,831 | ) | $ | (77,905 | ) | $ | (80,556 | ) | |||||
| Net loss per share - basic and diluted | $ | (0.49 | ) | $ | (0.60 | ) | $ | (2.02 | ) | $ | (2.38 | ) | |||||
| Weighted-average common stock outstanding - basic and diluted | 38,660,626 | 38,242,412 | 38,509,281 | 33,791,817 | |||||||||||||
| Comprehensive loss: | |||||||||||||||||
| Net loss | $ | (18,985 | ) | $ | (22,831 | ) | $ | (77,905 | ) | $ | (80,556 | ) | |||||
| Other comprehensive income (loss): | |||||||||||||||||
| Unrealized (loss) gain on available-for-sale investments, net of tax | (1 | ) | (335 | ) | (336 | ) | 530 | ||||||||||
| Comprehensive loss | $ | (18,986 | ) | $ | (23,166 | ) | $ | (78,241 | ) | $ | (80,026 | ) | |||||
| Acrivon Therapeutics, Inc. Condensed Consolidated Balance Sheets (in thousands) | |||||||
| December 31, | |||||||
| 2025 | 2024 | ||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 41,499 | $ | 39,818 | |||
| Investments | 77,083 | 144,751 | |||||
| Other assets | 11,135 | 12,019 | |||||
| Total assets | $ | 129,717 | $ | 196,588 | |||
| Liabilities and Stockholders' Equity | |||||||
| Liabilities | $ | 17,201 | $ | 19,802 | |||
| Stockholders' Equity | 112,516 | 176,786 | |||||
| Total Liabilities and Stockholders' Equity | $ | 129,717 | $ | 196,588 | |||
FAQ
What clinical response did Acrivon report for ACR-368 in serous EC (ACRV) on March 19, 2026?
How much cash did Acrivon (ACRV) have at year-end 2025 and how long is the runway?
What are the planned ACR-368 Phase 2b study expansions announced by Acrivon (ACRV)?
What were Acrivon's (ACRV) reported losses for Q4 and full-year 2025?
What early data did Acrivon (ACRV) report for ACR-2316 in 2026 updates?
