Acrivon Therapeutics(ACRV)
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Acrivon Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights
Globenewswire· 2026-03-19 11:21
Core Insights - Acrivon Therapeutics reported a confirmed overall response rate (cORR) of 52% for ACR-368 in serous endometrial cancer (EC), a subtype responsible for approximately 50% of EC mortality [1][3] - The company is expanding its clinical trials for ACR-368 by initiating Arm 3 and Arm 4 to explore its efficacy in serous EC patients [1][2] - Acrivon has a strong financial position with $118.6 million in cash and equivalents as of December 31, 2025, expected to fund operations into Q2 2027 [1][13] ACR-368 Development - ACR-368 is a CHK1/CHK2 inhibitor currently in a registrational-intent Phase 2b trial, with promising data presented at the ESGO Congress [3][15] - The trial includes an interim analysis showing a cORR of 52% in serous EC subjects, compared to 22% in non-serous EC subjects [3][4] - A fourth cohort (Arm 4) will investigate ACR-368 monotherapy in biomarker-unselected serous EC subjects, similar to Arm 3 [3][4] ACR-2316 and ACR-6840 - Initial data from the Phase 1 trial of ACR-2316, a WEE1/PKMYT1 inhibitor, showed favorable tolerability and clinical activity in small cell lung cancer and squamous non-small cell lung cancer [5][16] - ACR-6840, an oral CDK11 inhibitor, has been nominated as a development candidate from the company's AP3-driven cell cycle program [6][16] Financial Performance - The net loss for Q4 2025 was $19.0 million, compared to $22.8 million in Q4 2024, while the full-year net loss was $77.9 million, down from $80.6 million in 2024 [9][20] - Research and development expenses decreased to $14.7 million for Q4 2025 from $18.6 million in Q4 2024, reflecting a focus on endometrial cancer trials [11][20] Upcoming Milestones - The company anticipates achieving CTA approval in the EU for Arm 3 by Q1 2026 and plans to initiate enrollment for Arm 4 in the first half of 2026 [10] - Additional clinical data for ACR-2316 is expected in 2026, along with an IND filing for ACR-6840 [10][16]
Acrivon Therapeutics(ACRV) - 2025 Q4 - Annual Report
2026-03-19 11:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________________ TO ____________________ Commission File Number 001-41551 Acrivon Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) | D ...
Acrivon Therapeutics to Present Pre-Clinical AP3 Data at the 2026 AACR Annual Meeting Revealing Strong Synergy of ACR-368 with ADC Topo 1 Inhibitor Payloads and of both ACR-368 and ACR-2316 with Immune Checkpoint Inhibitors
Globenewswire· 2026-03-17 21:54
ACR-368, a CHK1/2 inhibitor in a registrational-intent Phase 2b study, showed potent preclinical synergy with Topoisomerase 1 (Topo 1) inhibitors, commonly used payloads in antibody-drug conjugates (ADCs) ACR-2316, a WEE1/PKMYT1 inhibitor currently in Phase 1, demonstrated complete and durable tumor regression in immunocompetent, syngeneic tumor mouse models in combination with anti-PD-L1 checkpoint inhibition WATERTOWN, Mass., March 17, 2026 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Ac ...
Acrivon Therapeutics, Inc. (ACRV) Upgraded to Buy: Here's Why
ZACKS· 2026-03-03 18:00
Core Viewpoint - Acrivon Therapeutics, Inc. (ACRV) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is primarily based on a company's changing earnings picture, specifically the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - The Zacks rating upgrade reflects a positive outlook on Acrivon Therapeutics' earnings, which could lead to increased buying pressure and a rise in stock price [4][6]. Impact of Earnings Estimates on Stock Prices - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements [5]. - Institutional investors utilize earnings estimates to determine the fair value of a company's shares, influencing their buying or selling actions, which subsequently affects stock prices [5]. Acrivon Therapeutics' Earnings Outlook - Acrivon Therapeutics is projected to earn -$2.02 per share for the fiscal year ending December 2025, with no year-over-year change [9]. - Over the past three months, the Zacks Consensus Estimate for Acrivon has increased by 2.1%, indicating a positive trend in earnings estimates [9]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [8]. - Acrivon Therapeutics' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [11].
Acrivon Therapeutics (NasdaqGM:ACRV) FY Conference Transcript
2026-03-02 19:52
Acrivon Therapeutics FY Conference Summary Company Overview - **Company**: Acrivon Therapeutics (NasdaqGM:ACRV) - **Focus**: Development of precision medicine platforms and clinical assets, particularly in oncology Key Points Industry and Market Context - **Endometrial Cancer**: - Serous endometrial cancer accounts for 50% of all endometrial cancer mortality and is characterized by aggressive behavior and limited treatment options [9][10] - Current standard of care shows modest benefits, with a second-line treatment response rate of only 15% [10][14] Acrivon’s AP3 Platform - **Platform Description**: - A proteomics-based precision medicine platform utilizing generative AI to optimize drug discovery and clinical asset advancement [5][6] - Focused on pathway-based drug design to enhance efficacy and minimize survival pathways in cancer cells [6] Lead Asset: ACR-368 - **Clinical Activity**: - ACR-368, a dual CHK1/2 inhibitor, shows strong clinical activity in serous endometrial cancer, with a confirmed response rate of 44% in ongoing trials [19] - The drug is particularly effective in a patient population with limited treatment options, contributing to a significant unmet need [10][41] Clinical Trial Insights - **Trial Structure**: - Three arms in the ongoing trial: - Arm 1: Registrational intent for ACR-368 monotherapy in biomarker-positive patients - Arm 2: Exploratory arm assessing the contribution of ultra-low dose gemcitabine (ULDG) - Arm 3: New arm expanding the trial without the need for pretreatment biopsies, expected to enroll 90 patients by Q4 2026 [28][29] - **Enrollment Strategy**: - Rapid enrollment anticipated due to the use of serous subtype as a lineage biomarker, which simplifies patient selection [29] Efficacy and Safety Profile - **Efficacy**: - ACR-368 demonstrates a competitive response rate of approximately 50% in serous endometrial cancer, significantly higher than the standard of care [21][22] - Clinical benefit rate of 65% for patients maintaining stable disease for over 16 weeks [23] - **Safety**: - Favorable safety profile with minimal adverse events, primarily transient hematological issues [22][72] Future Development Plans - **Phase 3 Trial**: - A protocol for a Phase 3 trial has been submitted, focusing on the combination of ACR-368 with immunotherapy for enhanced efficacy [43] - **New Targets**: - Development of a CDK11 inhibitor, a potential first-in-class program, is underway with IND-enabling studies expected to conclude by the end of the year [78][80] Market Adoption and Physician Sentiment - **Commercial Potential**: - High enthusiasm from treating physicians, with expectations that 75% of second-line and 100% of third-line patients may be candidates for ACR-368 [40][41] - **Unmet Need**: - The significant unmet need in serous endometrial cancer is emphasized, with the potential for ACR-368 to fill a critical gap in treatment options [10][41] Conclusion Acrivon Therapeutics is positioned to address significant unmet needs in the oncology market, particularly in serous endometrial cancer, through its innovative AP3 platform and promising clinical assets like ACR-368. The company's strategic focus on rapid trial enrollment and favorable safety profiles enhances its potential for successful market adoption and regulatory approval.
Acrivon Therapeutics (NasdaqGM:ACRV) 2026 Conference Transcript
2026-02-27 14:02
Acrivon Therapeutics (NasdaqGM:ACRV) 2026 Conference February 27, 2026 08:00 AM ET Company ParticipantsAdam Levy - CFO and Head of Investor RelationsBrian Slomovitz - Co-Chair of the Cervical Cancer CommitteeDomenica Lorusso - GOG-Foundation/ENGOT LiaisonMansoor Raza Mirza - CMOPeter Blume-Jensen - CEO, President, and Co-founderRamez N. Eskander - Ovarian Portfolio LeadRobert L. Coleman - CSOAdam LevyGood morning, everyone, and welcome to today's webcast. My name is Adam Levy, and I'm Chief Financial Office ...
Acrivon Therapeutics (NasdaqGM:ACRV) 2026 Earnings Call Presentation
2026-02-27 13:00
Acrivon T h e r a p e u t i c s Acrivon T h e r a p e u t i c s KOL PANEL DISCUSSION ACR-368 ENDOMETRIAL C ANCER TRIAL Certain information contained in this presentation and related webcast includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations. In some cases, you can identify forward-looking statements becau ...
Acrivon Therapeutics to Present at the TD Cowen 46th Annual Health Care Conference
Globenewswire· 2026-02-24 13:00
WATERTOWN, Mass., Feb. 24, 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 announced the company’s president and chief executive officer, Peter Blume-Jensen, M.D., Ph.D., will parti ...
Key Opinion Leader (KOL) Panel to Discuss Acrivon’s ACR-368 Endometrial Cancer (EC) Trial during the 2026 European Society of Gynecological Oncology (ESGO) Congress
Globenewswire· 2026-02-23 13:00
Live webcast of event on February 27 at 8:00 a.m. ET will include participation of globally renowned gynecological oncology KOLs from the US and EU KOL panel to discuss maturing data from the ACR-368 registrational-intent trial, including recently disclosed promising results in serous EC, in the context of high unmet need in EC Panos Konstantinopoulos, M.D., Ph.D., Dana-Farber Cancer Institute, professor, Harvard Medical School, will deliver late-breaking oral presentation of ACR-368 interim clinical data a ...
Acrivon Therapeutics Strengthens its Precision Medicine Therapeutics Capabilities with Launch of Internal CLIA-Certified Laboratory
Globenewswire· 2026-02-18 13:00
Wholly-owned laboratory has received CLIA certification from Massachusetts with full license to conduct patient testing and develop companion diagnostics Laboratory provides significant operational and strategic benefits for internal and future partnered assets WATERTOWN, Mass., Feb. 18, 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 Gener ...