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Investor releaseQuarter not tagged2026-08-12Acrivon Reports Second Quarter 2026 Financial Results and Highlights Upcoming 2026 Clinical Data Catalysts
GlobeNewswire
Acrivon Reports Second Quarter 2026 Financial Results and Highlights Upcoming 2026 Clinical Data Catalysts
ACR-368 Phase 2b prespecified interim analysis and data from all-comer serous endometrial cancer (EC) treatment arms on track for second half of 2026 ACR-2316 Phase 1/2 trial in AP3-prioritized tumor types advancing in randomized dose expansion phase supported by a promising, favorable safety profile and durable single-agent clinical activity in several tumor types Cash, cash equivalents, and marketable securities of $90.0 million as of June 30, 2026 expected to fund operations into fourth quarter of 2027 WATERTOWN, Mass., Aug. 12, 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 second quarter ended June 30, 2026 and reviewed recent business highlights. “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) 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…Read full documentShow less
ACR-368 Phase 2b prespecified interim analysis and data from all-comer serous endometrial cancer (EC) treatment arms on track for second half of 2026 ACR-2316 Phase 1/2 trial in AP3-prioritized tumor types advancing in randomized dose expansion phase supported by a promising, favorable safety profile and durable single-agent clinical activity in several tumor types Cash, cash equivalents, and marketable securities of $90.0 million as of June 30, 2026 expected to fund operations into fourth quarter of 2027 WATERTOWN, Mass., Aug. 12, 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 second quarter ended June 30, 2026 and reviewed recent business highlights. “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) 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 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 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. 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 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 EC. 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 EC. 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 AI-driven Phosphoproteomics AP3 platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity. The Phase 1/2 study of ACR-2316 is advancing in a randomized dose expansion phase. Initial data has shown a highly differentiated, favorable safety profile primarily limited to only transient, mechanism-based hematological adverse events, predominantly only neutropenia. Clinical activity has been observed across multiple tumor types, including SCLC, squamous NSCLC and lung adenocarcinoma, tumor types not shown sensitive to current single-agent WEE1 or PKMYT1 inhibitors. Durable clinical activity has been observed, with certain lung cancer subjects remaining on treatment more than one year. In addition, the company is in early IND-enabling studies with several potential first-in-class development candidates 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. Acrivon intends to use its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. For more information, please visit www.acrivon.com. Investor and Media Contacts: Adam D. Levy, Ph.D., [email protected] Alexandra Santos [email protected]
Investor releaseQuarter not tagged2026-05-14Acrivon Reports First Quarter 2026 Financial Results and Highlights Progress Towards Key 2026 Clinical Catalysts
GlobeNewswire
Acrivon Reports First Quarter 2026 Financial Results and Highlights Progress Towards Key 2026 Clinical Catalysts
The registrational intent ACR-368 Phase 2b study is advancing with a prespecified simultaneous interim analysis and data update for both all-comer (biopsy-independent) serous endometrial cancer arms in second half 2026 The ACR-2316 Phase 1/2 study is advancing towards expansion phase demonstrating favorable tolerability, primarily transient neutropenia, with durable clinical activity at weekly dosing regimens in subjects with AP3-prioritized tumors, including heavily pretreated lung cancers Cash, cash equivalents, and marketable securities of $97.7 million as of March 31, 2026, plus proceeds of $7.3 million from subsequent equity financing, expected to fund operations into third quarter of 2027 and through multiple anticipated clinical milestones WATERTOWN, Mass., May 13, 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 first quarter ended March 31, 2026 and reviewed recent business highlights. “2026 is an important catalyst year for Acrivon as we advance our two differentiated, AP3-guided clinical oncology programs towards key data read-outs,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. “For ACR-368, we are increasingly focused on serous endometrial cancer, a disease with high unmet need contributing upwards of 50% of all endometrial cancer deaths every year. This focus is supported by the compelling clinical activity observed thus far and the enthusiastic endorsement by external KOLs. We are particularly excited by the prospect of rapid enrollment of the serous population in our Phase 2b study in the U.S. and EU given that there is no requirement for a biopsy. Given the accelerated enrollment, we are now planning to conduct a pre-specified simultaneous interim analysis of both Arms 3 and 4 in second half of 2026. In parallel, we continue advancing ACR-2316 which has shown exciting initial clinical activity in AP3-prioritized tumor types, including lung cancers which are traditionally not sensitive to WEE1 inhibitors. With cash runway expected…Read full documentShow less
The registrational intent ACR-368 Phase 2b study is advancing with a prespecified simultaneous interim analysis and data update for both all-comer (biopsy-independent) serous endometrial cancer arms in second half 2026 The ACR-2316 Phase 1/2 study is advancing towards expansion phase demonstrating favorable tolerability, primarily transient neutropenia, with durable clinical activity at weekly dosing regimens in subjects with AP3-prioritized tumors, including heavily pretreated lung cancers Cash, cash equivalents, and marketable securities of $97.7 million as of March 31, 2026, plus proceeds of $7.3 million from subsequent equity financing, expected to fund operations into third quarter of 2027 and through multiple anticipated clinical milestones WATERTOWN, Mass., May 13, 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 first quarter ended March 31, 2026 and reviewed recent business highlights. “2026 is an important catalyst year for Acrivon as we advance our two differentiated, AP3-guided clinical oncology programs towards key data read-outs,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. “For ACR-368, we are increasingly focused on serous endometrial cancer, a disease with high unmet need contributing upwards of 50% of all endometrial cancer deaths every year. This focus is supported by the compelling clinical activity observed thus far and the enthusiastic endorsement by external KOLs. We are particularly excited by the prospect of rapid enrollment of the serous population in our Phase 2b study in the U.S. and EU given that there is no requirement for a biopsy. Given the accelerated enrollment, we are now planning to conduct a pre-specified simultaneous interim analysis of both Arms 3 and 4 in second half of 2026. In parallel, we continue advancing ACR-2316 which has shown exciting initial clinical activity in AP3-prioritized tumor types, including lung cancers which are traditionally not sensitive to WEE1 inhibitors. With cash runway expected into the third quarter of 2027, we believe we are well positioned to execute through multiple potential value-inflection milestones.” Recent Highlights ACR-368: CHK1 / CHK2 Inhibitor Recently presented interim analysis of the ongoing, multi-arm, registrational intent Phase 2b study across both OncoSignature-positive (BM+) and BM- endometrial cancer (EC) subjects showed a confirmed overall response rate (cORR) of 52% (N = 23) in serous EC subjects versus an ORR of 22% (N = 37) in non-serous EC subjects, with all subjects having received up to two prior lines of therapy (LoT), including chemotherapy and anti-PD-1. This is consistent with the higher BM positivity rate and elevated biomarker levels in subjects with serous versus non-serous EC. Arm 1 is ongoing and is stratifying for treatment of EC based on BM+ predicted sensitivity to ACR-368 Arm 2 was successfully completed, showing that ultra-low dose gemcitabine (ULDG) may contribute to ACR-368 efficacy, while maintaining a favorable tolerability profile, in BM- subjects Arm 3 is investigating ACR-368 with ULDG sensitization in serous EC subjects with up to two prior LoT without the need for pre-treatment tumor biopsy or biomarker stratification (“serous all comer”) Arm 4 enrollment and dosing was recently initiated, investigating single agent ACR-368 without ULDG, in the same “serous all comer” subject population as Arm 3 Clinical data from the Phase 2b trial was featured in a late-breaking oral presentation by Professor Panagiotis Konstantinopoulos of the Dana-Farber Cancer Institute at the European Society of Gynecological Oncology (ESGO) Annual Congress, followed by a company-hosted KOL panel, during which renowned experts expressed strong enthusiasm for the data on ACR-368 and reiterated the high unmet need for patients suffering from serous EC Two presentations at the American Association for Cancer Research (AACR) Annual Meeting uncovered the underlying molecular mechanisms for potent synergies between ACR-368 and anti-PD-L1 checkpoint inhibitors or Topoisomerase 1 (Topo 1) inhibitors identified by AP3. These findings support potential clinical combination studies with antibody-drug conjugates (ADCs) or immune checkpoint inhibitors (ICIs), including a planned Phase 3 confirmatory study of ACR-368 with ICIs. ACR-2316: WEE1 / PKMYT1 Inhibitor Initial data from the Phase 1 monotherapy dose-escalation trial demonstrated a favorable safety profile, primarily limited to only transient neutropenia and notable absence of non-hematological adverse events, and demonstrated clinical activity with both tumor shrinkage as well as prolonged clinical benefit, 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 AP3-based data presented at the AACR Annual Meeting demonstrated the processes driving strong synergy and resulting in complete tumor regression with durable immune memory upon treatment with ACR-2316 and ICI. ACR-2316 was found to boost immune-mediated tumor killing and overcome anti-PD-L1 resistance by modulating T-cell exhaustion, providing a mechanistic rationale for potential combinations with ICIs. CDK11 Inhibitor Program Internally-discovered development candidate from company’s AP3-driven cell cycle program and several equally promising back-up lead compounds 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 Achieve readiness for Phase 3 confirmatory trial for ACR-368 in combination with PD-1 therapy by mid-2026 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 Additional ACR-2316 Phase 1/2 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, or alternative CDK11 inhibitor candidate, in first half of 2027 Initiate additional internal programs utilizing the AP3 platform in 2026 First Quarter 2026 Financial Results Net loss for the quarter ended March 31, 2026 was $19.0 million compared to a net loss of $19.7 million for the same period in 2025. Research and development expenses were $15.2 million for the quarter ended March 31, 2026 compared to $15.4 million for the same period in 2025, which is materially consistent. General and administrative expenses were $4.7 million for the quarter ended March 31, 2026, compared to $6.2 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 March 31, 2026, the company had cash, cash equivalents and investments of $97.7 million which, together with the net proceeds raised from subsequent equity financing, is expected to fund operating expenses and capital expenditure requirements into the third quarter of 2027. 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 AI-driven 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, and other potential development candidates, 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. Acrivon intends to use its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. For more information, please visit www.acrivon.com. Investor and Media Contacts: Adam D. Levy, Ph.D., M.B.A. [email protected] Alexandra Santos [email protected]
Investor releaseQuarter not tagged2026-03-19Acrivon Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights
GlobeNewswire
Acrivon Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights
Maturing data from the ongoing registrational intent Phase 2b ACR-368 study showed a confirmed overall response rate (cORR) of 52% in serous endometrial cancer (EC) 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 ~50% of EC mortality 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 $118.6 million as of December 31, 2025, expected to fund operations into the second quarter of 2027 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 40-50% 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 ac…Read full documentShow less
Maturing data from the ongoing registrational intent Phase 2b ACR-368 study showed a confirmed overall response rate (cORR) of 52% in serous endometrial cancer (EC) 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 ~50% of EC mortality 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 $118.6 million as of December 31, 2025, expected to fund operations into the second quarter of 2027 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 40-50% 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. 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. [email protected] Alexandra Santos [email protected]
Investor releaseQuarter not tagged2025-11-14Acrivon Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights
GlobeNewswire
Acrivon Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights
Advancement of ACR-368 in registrational-intent Phase 2b trial for the treatment of patients with endometrial cancer Preparing for initial clinical data disclosure for ACR-2316 from the Phase 1 trial in AP3-prioritized solid tumor types Expanding power of Generative Phosphoproteomics AP3 supersedes conventional target-centric drug discovery, yielding differentiated compounds with desired pathway effects Cash, cash equivalents and marketable securities of $134.4 million as of September 30, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., Nov. 13, 2025 (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 designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the third quarter ended September 30, 2025 and reviewed recent business highlights. “Our team continues to efficiently advance our AP3-enabled pipeline of targeted agents, maintaining strong momentum over the past quarter,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and co-founder of Acrivon. “With our prospective biomarker-driven registrational intent Phase 2b trial of ACR-368 in endometrial cancer we aim to address a high unmet need in relapsed patients. Additionally, we are pursuing another opportunity in endometrial cancer with a biomarker-unselected Phase 2b arm in patients with limited prior lines of therapy using low dose gemcitabine as a sensitizer to ACR-368 based on insights by the AP3 platform. We also recently showcased three presentations at the AACR-NCI-EORTC International Conference highlighting the ability of our innovative AP3 generative ensemble model (KaiSR) to accurately assess compound-induced pathway effects, thereby enabling rational drug design aimed at superior activity, as demonstrated by robust preclinical data for ACR-2316. We look forward to sharing initial Phase 1 data for ACR-2316 later this year, expanding upon the early safety and initial clinical activity observed during dose escalation, with tumor shrinkage and a confirmed partial res…Read full documentShow less
Advancement of ACR-368 in registrational-intent Phase 2b trial for the treatment of patients with endometrial cancer Preparing for initial clinical data disclosure for ACR-2316 from the Phase 1 trial in AP3-prioritized solid tumor types Expanding power of Generative Phosphoproteomics AP3 supersedes conventional target-centric drug discovery, yielding differentiated compounds with desired pathway effects Cash, cash equivalents and marketable securities of $134.4 million as of September 30, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., Nov. 13, 2025 (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 designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the third quarter ended September 30, 2025 and reviewed recent business highlights. “Our team continues to efficiently advance our AP3-enabled pipeline of targeted agents, maintaining strong momentum over the past quarter,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and co-founder of Acrivon. “With our prospective biomarker-driven registrational intent Phase 2b trial of ACR-368 in endometrial cancer we aim to address a high unmet need in relapsed patients. Additionally, we are pursuing another opportunity in endometrial cancer with a biomarker-unselected Phase 2b arm in patients with limited prior lines of therapy using low dose gemcitabine as a sensitizer to ACR-368 based on insights by the AP3 platform. We also recently showcased three presentations at the AACR-NCI-EORTC International Conference highlighting the ability of our innovative AP3 generative ensemble model (KaiSR) to accurately assess compound-induced pathway effects, thereby enabling rational drug design aimed at superior activity, as demonstrated by robust preclinical data for ACR-2316. We look forward to sharing initial Phase 1 data for ACR-2316 later this year, expanding upon the early safety and initial clinical activity observed during dose escalation, with tumor shrinkage and a confirmed partial response across several AP3-prioritized solid tumor types.” Recent Highlights ACR-368: CHK1 and CHK2 Inhibitor Continued advancement of the ongoing, registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with recurrent high-grade endometrial cancer who have all received prior platinum-based chemotherapy and immune checkpoint inhibitor treatment regimens Enrollment and dosing ongoing in the third arm of the study, which does not require a pre-treatment biopsy for biomarker assessment. This arm is designed to evaluate ACR-368 with ultra-low dose gemcitabine (ULDG) as a tumor sensitizer in patients with endometrial cancer with limited prior lines of therapy who have all received prior treatment with chemotherapy and anti-PD-1 ACR-2316: WEE1/PKMYT1 Inhibitor Continued dosing patients in the Phase 1 monotherapy dose-escalation trial for certain high unmet need, AP3-prioritized solid tumor types Initial clinical activity with tumor shrinkage, and a confirmed partial response, observed across several solid tumor types Presented data at the AACR-NCI-EORTC conference demonstrating: ACR-2316 was rationally designed using AP3 to achieve superior activity through potent WEE1 inhibition with concomitant suppression of WEE1 inhibitor-induced PKMYT1 resistance mechanisms, while triggering robust activation of CDK1, CDK2, and PLK1 to induce potent tumor cell death In cancer xenograft models, ACR-2316 induces complete regression, while treatment with benchmark WEE1 inhibitors or a PKMYT1 inhibitor results in only stable disease at maximum tolerated/formulable doses Generative Phosphoproteomics AP3 Platform Also at the AACR-NCI-EORTC conference, presented data showing that the company’s AP3 generative AI KaiSR model accurately predicts and expands unbiased understanding of actionable global pathway activity states, enabling novel therapeutic target identification and the assessment of compound effects on the entire intracellular protein signaling network for optimal drug design and precision medicine development Anticipated Upcoming Milestones Provide update on registrational-intent trial and confirmatory trial design for ACR-368 in the second half of 2025 Report initial clinical data from the Phase 1 clinical study of ACR-2316 in the second half of 2025 Advance a new potential first-in-class cell cycle drug discovery program for an undisclosed target towards development candidate nomination in 2025 Third Quarter 2025 Financial Results Net loss for the quarter ended September 30, 2025 was $18.2 million compared to a net loss of $22.4 million for the same period in 2024. Research and development expenses were $13.6 million for the quarter ended September 30, 2025, compared to $18.9 million for the same period in 2024. The difference was driven by fewer scheduled and incurred milestones in the current period, combined with the prioritization of endometrial cancer over other tumor types in the ACR-368 clinical trial. General and administrative expenses were $6.0 million for the quarter ended September 30, 2025, which is materially consistent with $6.3 million for the same period in 2024. As of September 30, 2025, the company had cash, cash equivalents and investments of $134.4 million, which is expected to fund operating expenses and capital expenditure requirements into the second quarter of 2027. 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 the development of 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 enrollment in the first three dose-escalation cohorts completed. Drug target engagement was observed at DL1 and 2 using the company’s clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses, and initial clinical activity with tumor shrinkage observed at DL3. In addition, the company is advancing a preclinical program directed against an undisclosed cell cycle regulatory target. 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 preclinical and clinical results, 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. [email protected] Alexandra Santos [email protected]
Investor releaseQuarter not tagged2025-08-14Acrivon Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights
GlobeNewswire
Acrivon Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights
Continued advancement of two clinical-stage assets, both with clinically demonstrated single-agent anti-tumor activity -- ACR-368 in a registrational-intent Phase 2 study in endometrial cancer and ACR-2316 in a Phase 1 study in AP3-predicted tumor types New paradigm for accelerated design and development of novel compounds, like ACR-2316, based on optimal intracellular pathway selectivity, uniquely enabled by AI-driven AP3 Generative Phosphoproteomics platform Cash, cash equivalents and marketable securities of $147.6 million as of June 30, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., Aug. 13, 2025 (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 designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the second quarter ended June 30, 2025 and reviewed recent business highlights. “The strength of the clinical data across our two clinical assets speaks to the expanding capabilities of our AP3 platform to enable pathway-based drug design and optimized drug development by delivering actionable insights,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “With ACR-368, we have seen deep and durable responses in patients with various types of aggressive endometrial cancer who had all progressed on prior chemotherapy and anti-PD1 therapy – a high unmet need population. Based on our clinical data, and the AP3-discovered insight that ultra low-dose gemcitabine sensitizes tumors to ACR-368 treatment, we believe there is an opportunity to further expand the patient population benefiting from ACR-368 by treating all-comer, biomarker-unselected 2nd line patients, who have all received prior chemotherapy and anti-PD-1, with ACR-368 and ultra low-dose gemcitabine. Our fully internally developed second clinical-stage asset, ACR-2316, which is being advanced in a Phase 1 trial, has demonstrated initial clinical activity during dose escalation in several solid tumor types, including an ongoing confirmed partial re…Read full documentShow less
Continued advancement of two clinical-stage assets, both with clinically demonstrated single-agent anti-tumor activity -- ACR-368 in a registrational-intent Phase 2 study in endometrial cancer and ACR-2316 in a Phase 1 study in AP3-predicted tumor types New paradigm for accelerated design and development of novel compounds, like ACR-2316, based on optimal intracellular pathway selectivity, uniquely enabled by AI-driven AP3 Generative Phosphoproteomics platform Cash, cash equivalents and marketable securities of $147.6 million as of June 30, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., Aug. 13, 2025 (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 designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the second quarter ended June 30, 2025 and reviewed recent business highlights. “The strength of the clinical data across our two clinical assets speaks to the expanding capabilities of our AP3 platform to enable pathway-based drug design and optimized drug development by delivering actionable insights,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “With ACR-368, we have seen deep and durable responses in patients with various types of aggressive endometrial cancer who had all progressed on prior chemotherapy and anti-PD1 therapy – a high unmet need population. Based on our clinical data, and the AP3-discovered insight that ultra low-dose gemcitabine sensitizes tumors to ACR-368 treatment, we believe there is an opportunity to further expand the patient population benefiting from ACR-368 by treating all-comer, biomarker-unselected 2nd line patients, who have all received prior chemotherapy and anti-PD-1, with ACR-368 and ultra low-dose gemcitabine. Our fully internally developed second clinical-stage asset, ACR-2316, which is being advanced in a Phase 1 trial, has demonstrated initial clinical activity during dose escalation in several solid tumor types, including an ongoing confirmed partial response in endometrial cancer, signaling the broad potential of this agent.” Recent Highlights ACR-368: CHK1 and CHK2 Inhibitor Continued advancement of the ongoing registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with recurrent high-grade endometrial cancer who have all received prior platinum-based chemotherapy and prior immune checkpoint inhibitor treatment regimens Initiated a third arm to the Phase 2b study without the need for a pre-treatment biopsy to evaluate ACR-368 with ultra low-dose gemcitabine (ULDG) as a tumor sensitizer in all-comer, biomarker-unselected 2nd line patients with endometrial cancer who have all received prior treatment with chemotherapy and anti-PD-1 ACR-2316: WEE1/PKMYT1 Inhibitor Continued enrolling patients in the Phase 1 monotherapy dose-escalation trial for certain high unmet need solid tumor types prioritized based on AP3-predicted sensitivity to ACR-2316 No dose-limiting toxicities observed in three cleared dose levels Evidence of drug target engagement observed as early as dose level 1 Initial clinical activity observed during dose escalation in several solid tumor types, including an ongoing confirmed partial response in endometrial cancer Generative Phosphoproteomics AP3 Platform At the AACR Annual Meeting in April 2025, presented Generative Phosphoproteomic AP3 analyses uncovering key molecular mechanisms by which ACR-2316 induces strong mitotic, pro-apoptotic tumor cell death believed to be critical for its potent, preclinical single-agent activity Anticipated Upcoming Milestones Provide update on registrational-intent trial and confirmatory trial design for ACR-368 in the second half of 2025 Report initial clinical data from the Phase 1 clinical study of ACR-2316 in the second half of 2025 Advance a new potential first-in-class cell cycle drug discovery program for an undisclosed target towards development candidate nomination in 2025 Second Quarter 2025 Financial Results Net loss for the quarter ended June 30, 2025 was $21.0 million compared to a net loss of $18.8 million for the same period in 2024. Research and development expenses were $16.2 million for the quarter ended June 30, 2025 compared to $15.0 million for the same period in 2024. The difference was primarily due to increased personnel to support the continued execution of the clinical trials for ACR-368 and ACR-2316, as well as preclinical drug discovery advancement. General and administrative expenses were $6.5 million for the quarter ended June 30, 2025, which is materially consistent with $6.4 million for the same period in 2024. As of June 30, 2025, the company had cash, cash equivalents and investments of $147.6 million, which is expected to fund operating expenses and capital expenditure requirements into the second quarter of 2027. 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 enrollment in the first three dose-escalation cohorts completed. Drug target engagement was observed at DL1 and 2 using the company’s clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses, and initial clinical activity with tumor shrinkage observed at DL3. In addition, the company is advancing a preclinical program directed against an undisclosed cell cycle regulatory target. 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, preclinical and clinical results, 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. [email protected] Alexandra Santos [email protected]
Investor releaseQuarter not tagged2025-05-15Acrivon Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights
GlobeNewswire
Acrivon Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights
Corporate R&D event highlighted positive ACR-368 data in endometrial cancer patients who had all received prior anti-PD-1 and platinum-based chemotherapy Confirmed overall response rate (cORR) of 35% and median duration of response (mDOR) >5.6 months (not yet reached) observed in OncoSignature-positive (BM+) patients, a majority of whom were refractory to last prior therapy, and cORR of 50% and mDOR >10 months (not yet reached) for BM+ patients who had relapsed on last prior therapy Three dose escalation cohorts completed in ACR-2316 Phase 1 trial with tumor shrinkage observed already at dose level (DL)3, below projected recommended Phase 2 dose AACR presentation of ACR-2316 revealing mechanisms underlying its superior preclinical activity with potent mitotic tumor cell death using AP3 Generative Phosphoproteomics Mansoor Raza Mirza, M.D. appointed chief medical officer; accomplished clinician with stellar track record of successfully leading registrational trials through regulatory approvals, and establishing new standards of care in gynecological oncology Cash, cash equivalents and marketable securities of $164.8 million as of March 31, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision oncology medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the first quarter ended March 31, 2025 and reviewed recent business highlights. “We made substantial progress in the first quarter in the advancement of our clinical pipeline and the expansion of our Generative Phosphoproteomics AP3 capabilities, as well as strengthening the executive team,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “At our corporate R&D event, we reported positive updated interim data from our ongoing ACR-368 Phase 2b study in endometrial cancer patients with large tumors and aggressive histopathologies – all of whom had progressed after prior platinum-based chemothera…Read full documentShow less
Corporate R&D event highlighted positive ACR-368 data in endometrial cancer patients who had all received prior anti-PD-1 and platinum-based chemotherapy Confirmed overall response rate (cORR) of 35% and median duration of response (mDOR) >5.6 months (not yet reached) observed in OncoSignature-positive (BM+) patients, a majority of whom were refractory to last prior therapy, and cORR of 50% and mDOR >10 months (not yet reached) for BM+ patients who had relapsed on last prior therapy Three dose escalation cohorts completed in ACR-2316 Phase 1 trial with tumor shrinkage observed already at dose level (DL)3, below projected recommended Phase 2 dose AACR presentation of ACR-2316 revealing mechanisms underlying its superior preclinical activity with potent mitotic tumor cell death using AP3 Generative Phosphoproteomics Mansoor Raza Mirza, M.D. appointed chief medical officer; accomplished clinician with stellar track record of successfully leading registrational trials through regulatory approvals, and establishing new standards of care in gynecological oncology Cash, cash equivalents and marketable securities of $164.8 million as of March 31, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision oncology medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the first quarter ended March 31, 2025 and reviewed recent business highlights. “We made substantial progress in the first quarter in the advancement of our clinical pipeline and the expansion of our Generative Phosphoproteomics AP3 capabilities, as well as strengthening the executive team,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “At our corporate R&D event, we reported positive updated interim data from our ongoing ACR-368 Phase 2b study in endometrial cancer patients with large tumors and aggressive histopathologies – all of whom had progressed after prior platinum-based chemotherapy and anti-PD-1. With a significant unmet need for second-line treatment options and the potential for label expansion through a confirmatory trial in the front-line setting with ACR-368 used as switch maintenance, we remain very excited by the opportunities for this program. For our second clinical-stage asset, ACR-2316, we have observed tumor shrinkage (~25%) in a patient with significant metastatic solid tumor burden after only six weeks of treatment at dose level 3 - well before reaching our projected RP2D, supporting its potential for monotherapy activity. Finally, we are thrilled and feel privileged that Dr. Mansoor Raza Mirza, a globally recognized oncologist, is now leading the development of our pipeline as CMO. Mansoor has made significant contributions in clinical oncology as a lead investigator for multiple approved drugs and senior author of national cancer guidelines.” Recent Highlights Presented interim data (February 25, 2025) from the ongoing Phase 2b registrational-intent trial of ACR-368 in patients with heavily pretreated endometrial cancer who had all progressed on prior anti-PD-1 and chemotherapy Among the 20 OncoSignature-positive (BM+) patients, the confirmed overall response rate (cORR) was 35%, more than double that in the prior line of therapy, and the disease control rate (DCR) was 80% In the BM+ patients that had relapsed after the prior line of therapy, the cORR was 50%, mDOR was not yet reached (>10 months), and DCR was 100% In the BM+ patients with tumors refractory to last prior line of therapy, significant clinical activity was observed with a cORR of 33% and DCR of 75% Provided an overview of the expanded capabilities of the company’s Generative Phosphoproteomics AP3 platform highlighting the growing suite of powerful, internally-developed tools, including the AP3 Data Portal, designed to convert 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. Advanced to DL4 in the Phase 1 monotherapy clinical trial of ACR-2316, with encouraging observations at DLs 1-3: DL 1, 2, and 3 cleared without safety concerns or dose-limiting toxicities (DLTs) by the safety review committee, and DL4 is now enrolling Drug target engagement observed at DL1 and 2 using the company’s clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses Notably, initial clinical activity of ~25% RECIST tumor shrinkage and a reduction of metastatic lesions throughout the chest, abdomen and pelvis was observed after six weeks of treatment in a patient at DL3 (below projected RP2D) who had received three prior lines of therapy including chemotherapy and anti-PD1 Presented at the AACR Annual Meeting Generative Phosphoproteomic AP3 analyses uncovering key molecular mechanisms by which ACR-2316 induces strong mitotic and replicative tumor cell death believed to be critical for its potent single-agent activity Appointed Mansoor Raza Mirza, M.D., as chief medical officer, bringing decades of experience as a distinguished and highly accomplished oncology key opinion leader with a stellar track record of successfully leading numerous registrational trials through global regulatory approvals, and establishing new standards of care in gynecological oncology Promoted Adam D. Levy, Ph.D., M.B.A., to chief financial officer, having served as the company’s head of investor relations and with prior finance and strategy leadership roles at Zentalis Pharmaceuticals, Turning Point Therapeutics, Novartis, Gilead, and McKinsey & Company Anticipated Upcoming Milestones Provide update on registrational-intent trial and confirmatory trial design for ACR-368 Report initial clinical data from the Phase 1 clinical study of ACR-2316 in the second half of 2025 Advance a new potential first-in-class cell cycle drug discovery program for an undisclosed target towards development candidate nomination in 2025 First Quarter 2025 Financial Results Net loss for the quarter ended March 31, 2025 was $19.7 million compared to a net loss of $16.5 million for the same period in 2024. Research and development expenses were $15.4 million for the quarter ended March 31, 2025 compared to $11.5 million for the same period in 2024. The difference was primarily due to the continued execution of the clinical trials for ACR-368 and ACR-2316, as well as preclinical drug discovery advancement and increased personnel to support these research and development activities. General and administrative expenses were $6.2 million for the quarter ended March 31, 2025, which is materially consistent with the same period in 2024. As of March 31, 2025, the company had cash, cash equivalents and investments of $164.8 million, which is expected to fund operating expenses and capital expenditure requirements into the second quarter of 2027. About Acrivon Therapeutics Acrivon is a clinical stage biopharmaceutical company discovering and developing precision oncology 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 enrollment in the first three dose-escalation cohorts completed. Drug target engagement was observed at DL1 and 2 using the company’s clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses, and initial clinical activity with tumor shrinkage observed at DL3. The company also has a preclinical cell cycle program with an undisclosed target. 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, preclinical and clinical results, 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., [email protected] Alexandra Santos [email protected]
Investor releaseQuarter not tagged2025-03-28Acrivon Therapeutics Provides Program Updates and Fourth Quarter and Full Year 2024 Financial Results
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Acrivon Therapeutics Provides Program Updates and Fourth Quarter and Full Year 2024 Financial Results
Generative Phosphoproteomics AP3 platform designed to enable streamlined, rational drug discovery, with proprietary, proteome-wide SAR delivering desirable pathway effects R&D event highlighted positive ACR-368 endometrial cancer data in OncoSignature-positive (BM+) patients with heavily pretreated aggressive tumors, and who had all progressed on prior anti-PD-1 and chemotherapy, with 35% confirmed overall response rate (cORR), which is >2-fold higher than last prior line of therapy (15%) In the BM+ patients who had relapsed after prior anti-PD-1 and chemotherapy, the cORR was 50% with the median duration of response (mDOR) not yet reached (>10 months), while in BM+ patients who were refractory to their last prior line of therapy, the cORR was 33% and mDOR was ~3.4 months Endometrial cancer prioritized given limited treatment options and compelling commercial opportunity; represents first potential regulatory approval opportunity for ACR-368 Phase 1 trial of ACR-2316 ahead of schedule with enrollment in first three dose-escalation cohorts completed; initial clinical activity with tumor shrinkage already observed at dose level three Cash runway extended into 2027 WATERTOWN, Mass., March 27, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage precision medicine company utilizing its Acrivon Predictive Precision Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment, today reported financial results for the fourth quarter and full year ended December 31, 2024 and reviewed recent business highlights. “We continue executing our highly differentiated Generative Phosphoproteomics AP3-enabled strategy, delivering rapid progress towards key milestones across all programs, including our clinical assets, ACR-368 and ACR-2316,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “We previously identified endometrial cancer as a sensitive tumor type with our AP3 platform prior to clinical entry. At our recent R&D event, we shared positive data for ACR-368 in patients with stage III/IV endometrial cancer who had all progressed after prior anti-PD-1 and chemotherapy. Despite patients presenting with large, heavily pretreated…Read full documentShow less
Generative Phosphoproteomics AP3 platform designed to enable streamlined, rational drug discovery, with proprietary, proteome-wide SAR delivering desirable pathway effects R&D event highlighted positive ACR-368 endometrial cancer data in OncoSignature-positive (BM+) patients with heavily pretreated aggressive tumors, and who had all progressed on prior anti-PD-1 and chemotherapy, with 35% confirmed overall response rate (cORR), which is >2-fold higher than last prior line of therapy (15%) In the BM+ patients who had relapsed after prior anti-PD-1 and chemotherapy, the cORR was 50% with the median duration of response (mDOR) not yet reached (>10 months), while in BM+ patients who were refractory to their last prior line of therapy, the cORR was 33% and mDOR was ~3.4 months Endometrial cancer prioritized given limited treatment options and compelling commercial opportunity; represents first potential regulatory approval opportunity for ACR-368 Phase 1 trial of ACR-2316 ahead of schedule with enrollment in first three dose-escalation cohorts completed; initial clinical activity with tumor shrinkage already observed at dose level three Cash runway extended into 2027 WATERTOWN, Mass., March 27, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage precision medicine company utilizing its Acrivon Predictive Precision Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment, today reported financial results for the fourth quarter and full year ended December 31, 2024 and reviewed recent business highlights. “We continue executing our highly differentiated Generative Phosphoproteomics AP3-enabled strategy, delivering rapid progress towards key milestones across all programs, including our clinical assets, ACR-368 and ACR-2316,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “We previously identified endometrial cancer as a sensitive tumor type with our AP3 platform prior to clinical entry. At our recent R&D event, we shared positive data for ACR-368 in patients with stage III/IV endometrial cancer who had all progressed after prior anti-PD-1 and chemotherapy. Despite patients presenting with large, heavily pretreated tumors (including 65% treated with prior pembrolizumab and lenvatinib) with aggressive histopathologies (75% serous or carcinosarcomas), pMMR, and p53 mutations, we observed strong anti-tumor activity, both among refractory and relapsed patients. Interestingly, amongst the patients that had relapsed after their last prior line, we observed 50% cORR and mDOR (not yet reached) of greater than 10 months, and 33% cORR in refractory patients who did not respond at all to their last prior line of therapy. In our ACR-2316 Phase 1 trial, we have completed enrollment in the first three dose-escalation cohorts, and have observed approximate dose proportionality, target engagement, and initial clinical activity with significant tumor shrinkage already at dose level three. Finally, we continue to expand the actionable capabilities of our Generative Phosphoproteomics AP3 platform to enable us to optimize therapeutic compounds for desired pathway effects, which drives our streamlined drug discovery, design and development.” Program Updates Presented at Corporate R&D Event on March 25, 2025 Reviewed continued expansion of the differentiated capabilities of the Generative Phosphoproteomics AP3 platform, highlighting the growing suite of powerful, internally-developed tools, including the AP3 Interactome, the AP3 Kinase Substrate Relationship Predictor, the AP3 Data Portal and the AP3 Chatbot. Together, these proprietary tools have enabled the company to go beyond the limitations of traditional drug discovery to rapidly design and advance innovative agents into clinical development. Presented data (from February 25, 2025) from the ongoing Phase 2b registrational-intent trial of ACR-368 that included 20 BM+ endometrial cancer patients treated with ACR-368 monotherapy and 38 BM- patients treated with ACR-368 plus ultra-low dose gemcitabine (LDG) that were efficacy-evaluable by RECIST (2 BM- had treatment discontinued without scan) All BM+ patients had progressed after prior platinum-based chemotherapy and prior anti-PD-1, and the median and mean prior lines of therapy for these patients were 2 and 2.6, respectively. A majority of these BM+ patients were refractory to the last prior line of therapy, with aggressive, generally heavily pre-treated tumors: 12 had refractory disease (best overall response of PD in last prior line of therapy), 6 had relapsed disease, and 2 were unknown. Among the 20 BM+ patients, 15 were either serous or carcinosarcomas, 13 were pMMR (2 deficient DNA mismatch repair, 5 not tested), and 11 had p53 mutations (3 wild-type; 6 unknown) The ACR-368 OncoSignature assay accurately identified patients whose tumors are sensitive to ACR-368, with 80% of BM+ patients demonstrating tumor shrinkage. Among all 20 BM+ patients, the cORR was 35%, more than double than in the prior line of therapy, and the disease control rate (DCR) was 80%. In patients that had relapsed after the prior line of therapy (N=6), the cORR was 50%, mDOR was not yet reached (>10 months), and DCR was 100%. In the 12 patients with tumors refractory to last prior line of therapy (ORR = 0%), significant clinical activity was observed with a cORR of 33% and DCR of 75%. In BM- patients treated with the ACR-368 + LDG combination, cORR was ~13%, which is comparable to the best overall response rate in the last prior line of therapy (median = 3), which was 17%. The totality of the preclinical and observed clinical data support significant LDG sensitization to ACR-368 in BM- patients. The company expects that a similar sensitization would occur in BM+ patients, which could be explored in a future all-comer study of ACR-368 + LDG. Several case studies were presented with imaging showing clinically significant, powerful tumor shrinkage in endometrial cancer patients treated with ACR-368 Given encouraging, maturing data in endometrial cancer, combined with limited treatment options for second-line therapy (standard of care ORR of 10-12% and mPFS of ~3 months, based on estimates from key opinion leaders and derived from control arms of past Phase 2 trials), and potential market opportunity, the company is prioritizing endometrial cancer, reallocating all clinical resources to ACR-368 in endometrial cancer and ACR-2316 Due to increased competition and a smaller market opportunity, the company set a high internal clinical bar for ovarian cancer, which preliminary data suggests is unlikely to be met Bladder cancer is also being deprioritized due to lower than preclinically predicted BM+ rate, leading to enrollment challenges Continued dosing of patients with a certain advanced solid tumors in the ongoing Phase 1 monotherapy clinical trial of ACR-2316 (initiated 2 quarters ahead of original timelines). ACR-2316 was uniquely designed by AP3 to overcome the limitations of current WEE1 and PKMYT1 inhibitors, for superior therapeutic index, and for potent single-agent activity. Dose levels 1 and 2 were cleared without safety concerns or dose-limiting toxicities (DLTs) by the safety review committee; dose level 3 is fully enrolled and the safety observation period is anticipated to be completed by April 1 Encouraging early observations include: evidence of approximate dose proportionality, based on pharmacokinetic analyses of the first two DLs; drug target engagement, identified using the company’s mass spectrometry-based AP3 profiling capabilities; and initial clinical activity in a DL3 patient, with significant decrease in size of metastatic lesions throughout the chest, abdomen and pelvis. This patient (who had received 3 prior lines of therapy including chemotherapy and anti-PD-1) remains on therapy. Using AP3-based Indication Finding and AP3-based analyses of in-house and publicly available data, the company is enrolling selected, high unmet need solid tumor types predicted sensitive to ACR-2316 in the clinical trial Anticipated Upcoming Milestones Provide update on registrational intent trial and confirmatory trial design for ACR-368 Report initial clinical data from the Phase 1 clinical study of ACR-2316 in the second half of 2025 Advance a new potential first-in-class cell cycle drug discovery program for an undisclosed target towards development candidate nomination in 2025 Fourth Quarter and Full Year 2024 Financial Results Net loss for the quarter and full year ended December 31, 2024 was $22.8 million and $80.6 million, respectively. This compares to a net loss of $19.3 million and $60.4 million, respectively for the same periods in 2023. Research and development expenses were $18.6 million for the quarter ended December 31, 2024, and $64.0 million for the full year 2024, compared to $15.5 million and $46.0 million, respectively, for the same periods in 2023. The difference was primarily due to the continued development of ACR-368 - which included the progression of the ongoing clinical trial and the achievement of milestones for the companion diagnostic, the initiation of the ACR-2316 clinical trial in the third quarter of 2024, and increased personnel to support development activities. General and administrative expenses were $6.3 million for the quarter ended December 31, 2024, and $25.2 million for the full year 2024, compared to $5.6 million and $21.1 million, respectively, for the same periods in 2023. The difference was primarily due to increased personnel costs, inclusive of non-cash stock compensation expense. As of December 31, 2024, the company had cash, cash equivalents and investments of $184.6 million, which is expected to fund operating expenses and capital expenditure requirements into 2027. About Acrivon Therapeutics Acrivon is a clinical stage biopharmaceutical company discovering and developing precision oncology medicines for patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary Generative Phosphoproteomics platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3 platform is engineered to measure compound-specific effects on the entire tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner yielding terabytes of high resolution proprietary quantitative data for pathway-based drug design, indication finding, and response prediction. These distinctive capabilities enable AP3’s direct application for streamlined rational drug discovery for monotherapy activity, the identification of rational drug combinations, and the creation of drug-specific proprietary OncoSignature companion diagnostics that are used to identify the patients most likely to benefit from Acrivon’s drug candidates. Acrivon is currently advancing its lead candidate, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial, focusing on endometrial cancer. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. Acrivon’s ACR-368 OncoSignature test, which has not yet obtained regulatory approval, has been extensively evaluated in preclinical studies, including in two separate, blinded, prospectively-designed studies on pretreatment tumor biopsies collected from past third-party Phase 2 trials in patients with ovarian cancer treated with ACR-368. The FDA has granted Breakthrough Device designations 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 AP3 precision medicine 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 demonstrated in preclinical studies against benchmark inhibitors. In addition, the company has a preclinical cell cycle program with an undisclosed target. Acrivon has developed its AP3 Interactome, a proprietary, computational analytics platform driven by Generative Phosphoproteomics machine learning for integrated comprehensive analyses across all large, in-house AP3 phosphoproteomic drug profiling data sets to advance its in-house research programs. 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, preclinical and clinical results, 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., [email protected] Alexandra Santos [email protected]

