Core Insights - Acrivon Therapeutics is set to present interim clinical data for ACR-368, a treatment for endometrial cancer, at the ESGO 27 Annual Congress in February 2026, highlighting its potential in a high unmet need patient population [1][2] Company Overview - Acrivon Therapeutics is a clinical stage biotechnology company focused on precision medicine, utilizing its proprietary Generative Phosphoproteomics AP3 platform for drug discovery and development [5] - The AP3 platform enables the interpretation and quantification of drug-regulated effects in intact cells, providing actionable insights and overcoming limitations of traditional drug discovery methods [5] Clinical Development - ACR-368, also known as prexasertib, is a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a potentially registrational Phase 2 trial for endometrial cancer [6] - The FDA has granted Fast Track designation for ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in endometrial cancer patients, along with Breakthrough Device designation for the ACR-368 OncoSignature assay [6] Pipeline Programs - Acrivon is advancing ACR-2316, a selective WEE1/PKMYT1 inhibitor, which has shown promising initial clinical activity and a favorable tolerability profile in Phase 1 trials [8] - The company is also developing ACR-6840, targeting CDK11, as part of its internally discovered pipeline programs [8]

ACR-368 Program Updates - Acrivon Therapeutics reported an overall response rate (ORR) of 39% in Arm 1 of the Phase 2b trial for endometrial cancer, with a higher ORR of 44% in subjects with over two prior lines of therapy [2] - The trial will now focus Arm 3 exclusively on subjects with serous endometrial cancer and two or fewer prior treatments due to higher response rates observed in this subgroup [2] - A confirmed ORR of 67% was noted in 12 subjects with serous endometrial cancer who had brain metastases (BM+), while the overall ORR for serous subjects was 52% compared to 22% for non-serous subjects [3] ACR-2316 Phase 1 Study Updates - The ongoing Phase 1 monotherapy dose-escalation study has dosed 33 patients with two weekly oral dosing schedules, establishing regimens of 160 mg QD on a 3d on / 4d off and 240 mg QD 2d on / 5d off [4] - A new cohort has been initiated to explore a bi-weekly 2d on / 12d off dosing regimen, aiming for enhanced single-agent activity and flexibility for future combination studies [5] - Clinical activity was observed at dose levels of 120 mg and above, with tumor shrinkage reported in 9 out of 20 evaluable patients with small cell lung cancer and squamous non-small cell lung cancer [5] Financial and Development Updates - Acrivon nominated ACR-6840 as the next preclinical development candidate, which is a potential first-in-class oral CDK11 inhibitor, with an IND submission anticipated in Q4 2026 [6] - As of December 31, 2025, the company reported preliminary cash and investments of approximately $119 million, expected to fund operations into Q2 2027 [6] Stock Performance - Acrivon Therapeutics shares experienced a decline of 28.81%, trading at $2.10 at the time of publication [7]

Market Performance - U.S. stocks showed mixed performance, with the Dow Jones index increasing by 0.54% to 49,261.60, while the NASDAQ fell by 0.62% to 23,437.73 and the S&P 500 dropped by 0.05% to 6,917.76 [1] - Industrial shares rose by 1.4% on Thursday, indicating strength in that sector [1] Sector Performance - Information technology stocks decreased by 1.4% on Thursday [2] Commodities - Oil prices increased by 1.8% to $56.98, while gold prices slightly decreased by 0.1% to $4,456.70. Silver fell by 3.6% to $74.820, and copper dropped by 1.7% to $5.7600 [6] European Market - European shares were mixed, with the eurozone's STOXX 600 declining by 0.27%, while Spain's IBEX 35 Index rose by 0.27%. London's FTSE 100 fell by 0.06%, Germany's DAX decreased by 0.08%, and France's CAC 40 increased by 0.06% [7] Asian Market - Asian markets closed lower, with Japan's Nikkei 225 down by 1.63%, Hong Kong's Hang Seng Index declining by 1.17%, China's Shanghai Composite slipping by 0.07%, and India's BSE Sensex falling by 0.92% [10] Company News - Flyexclusive Inc shares surged by 126% to $7.10 after being named an authorized Starlink Aviation dealer [9] - Enliven Therapeutics Inc shares increased by 54% to $23.81 following positive initial data from a clinical trial for chronic myeloid leukemia [9] - MoonLake Immunotherapeutics shares rose by 29% to $14.54 after receiving FDA feedback on its treatment for hidradenitis suppurativa [9] - Immuneering Corp shares dropped by 39% to $5.10 after announcing updated trial data for pancreatic cancer [9] - Acrivon Therapeutics Inc shares fell by 31% to $2.05 after releasing clinical data for endometrial cancer [9] - CorMedix Inc shares decreased by 23% to $8.00 following preliminary revenue results for Q4 and FY25 [9] Economic Indicators - U.S. initial jobless claims rose by 8,000 to 208,000, slightly below market expectations of 210,000 [3][12] - Nonfarm business sector labor productivity increased by 4.9% in Q3, following a revised 4.1% gain in the previous quarter [12] - Unit labor costs in the nonfarm business sector fell by 1.9% in Q3, contrasting with market expectations of a 1.0% increase [12] - The U.S. trade deficit narrowed to $29.4 billion in October, the smallest since June 2009, compared to a revised $48.1 billion in September [12]

Acrivon Therapeutics Conference Call Summary Company Overview - **Company**: Acrivon Therapeutics (NasdaqGM:ACRV) - **Focus**: Development of precision oncology therapies utilizing the AP3 generative phosphoproteomics platform Key Industry Insights - **Industry**: Oncology, specifically targeting endometrial cancer and other solid tumors - **Market Need**: Significant unmet need in treating relapsed serous endometrial cancer, which accounts for approximately 40% of all endometrial cancer deaths, translating to about 20,000 deaths annually in the U.S. and EU combined [15][16] Core Points and Arguments 1. **AP3 Platform**: Acrivon's AP3 platform allows for unbiased identification and quantification of drug effects on disease-causing signaling pathways, enhancing drug discovery and development [4][5] 2. **Pipeline Overview**: The pipeline includes: - ACR368: A potent selective CHK1/2 inhibitor with promising clinical data - ACR2316: A dual WEE1/PKMYT1 inhibitor designed to overcome resistance mechanisms - ACR6840: A new candidate targeting CDK11, with potential first-in-class status [6][29] 3. **Clinical Data for ACR368**: - Overall response rate of 39% in biomarker-positive endometrial cancer patients treated with ACR368 monotherapy [11] - Disease control rate of over 80% in the same population [11] - Notable response rates of 67% in serous tumors, indicating a strong potential for this subgroup [13] 4. **Regulatory Pathway**: A phase 3 confirmatory trial protocol for ACR368 has been submitted to the FDA, aiming to improve progression-free and overall survival in advanced endometrial cancer [18][20] 5. **Combination Therapy Potential**: ACR368 shows strong synergy with anti-PD-L1 therapies, which may enhance treatment efficacy [9][34] 6. **Safety Profile**: ACR368 has a favorable tolerability profile, primarily associated with transient hematological adverse events, with no significant non-hematological adverse events reported [9][40] Additional Important Insights - **Market Opportunity**: The prevalence of relapsed serous endometrial cancer is estimated at 55,000-60,000 patients, with a significant portion progressing to second-line therapy, highlighting the potential market for ACR368 [15][16] - **Emerging Candidates**: ACR6840 is positioned as a potential first-in-class agent targeting CDK11, with promising preclinical anti-tumor activity and a planned IND submission in Q4 2026 [29][31] - **Dosing Regimens**: ACR2316 has established two-weekly oral dosing regimens, showing activity in heavily pretreated patients with aggressive cancers like small cell lung cancer and squamous non-small cell lung cancer [34][35] Conclusion Acrivon Therapeutics is advancing its innovative oncology pipeline with a focus on precision medicine, particularly in addressing the unmet needs in endometrial cancer. The promising clinical data for ACR368 and the strategic regulatory submissions position the company favorably within the oncology landscape.

ACR-368 - In OncoSignature-positive endometrial cancer subjects, the Objective Response Rate (ORR) with ACR-368 single agent is 39% (n=31)[31] - In subjects with ≤ 2 prior lines of therapy, the ORR in BM+ subjects is 44% (n=25) and in BM- subjects is 26% (n=35) with ACR-368 single agent and ACR-368 + ULDG combo, respectively[34] - In BM+ subjects with ≤ 2 prior lines, the ORR in serous carcinosarcoma is 67% (n=12)[37] - In biomarker-unselected subjects with ≤ 2 prior lines, the ORR in serous subjects is 52% (n=23) and in non-serous subjects is 22% (n=37)[40] - In serous subjects with ≤ 2 prior lines, the Disease Control Rate (DCR) is 92% and Clinical Benefit Rate (CBR) at 16 weeks is 83% in Arm 1 (BM+), while in Arm 2 (BM-) the DCR is 55% and CBR at 16 weeks is 45%[43] - Serous endometrial cancer accounts for approximately 40% of all endometrial cancer deaths, equating to roughly 20,000 deaths per year in the US and EU[46, 52] ACR-2316 - In the Phase 1 dose escalation study, clinical activity was observed at dose level 120 mg and above, with tumor shrinkage in 9 out of 20 evaluable patients[74] - A total of 33 patients were dosed across two weekly dosing schedules in the ongoing Phase 1 monotherapy dose-escalation study[68, 74] - In the Phase 1 study, 79% of the subjects were White, 9% were Black/African American, 3% were Asian, 3% were Native Hawaiian/Pacific Islander, and 6% were Unknown/Other[69] Financials - As of December 31, 2025, Acrivon has approximately $119 million in cash and investments, projecting a runway into Q2 2027[96]

Financial Position - As of December 31, 2025, Acrivon Therapeutics reported preliminary unaudited cash, cash equivalents, and investments of approximately $119 million, expected to fund operations into Q2 2027[6] Clinical Trials and Research - In the ACR-368 Phase 2b trial, an updated interim analysis showed an overall response rate (ORR) of 39% in monotherapy BM+ subjects, with a higher ORR of 44% in subjects with ≤2 prior lines of therapy[11] - The clinical trial application for Arm 3 of the ACR-368 trial in serous subjects has been submitted, with initial patient enrollment in the EU expected in Q1 2026[11] - ACR-2316, a potential first-in-class WEE1/PKMYT1 inhibitor, has shown clinical activity with tumor shrinkage in 9 out of 20 evaluable patients[14] - ACR-6840, a potential first-in-class CDK11 inhibitor, is anticipated to have an IND submission in Q4 2026[14] - The company plans to complete enrollment in the biopsy-independent Phase 2 Arm 3 trial for ACR-368, targeting 90 subjects, by Q4 2026[17] - Acrivon aims to achieve readiness for a Phase 3 confirmatory trial for ACR-368 in combination with PD-1 therapy by mid-2026[17] - Initial clinical data from the ACR-2316 study will be reported in 1H 2026, transitioning into dose expansion in select tumor types[17] - The company has identified several promising backup series for ACR-6840, which was designed to achieve optimal on-target pathway effects[14] - Acrivon continues to focus on selected, AP3-prioritized solid tumor types in its ongoing clinical trials[14]

Core Insights - Acrivon Therapeutics has reported significant progress in its clinical pipeline, particularly with ACR-368 for endometrial cancer, showing a 39% overall response rate (ORR) in monotherapy and 44% in subjects with ≤2 prior lines of therapy [1][5] - The company is advancing ACR-2316, a potential first-in-class WEE1/PKMYT1 inhibitor, with initial Phase 1 data indicating favorable tolerability and tumor shrinkage in various cancer types [1][2] - Acrivon has nominated ACR-6840, a potential first-in-class CDK11 inhibitor, for preclinical development, with an IND submission planned for Q4 2026 [1][3] ACR-368 Program - The ongoing Phase 2b trial of ACR-368 has shown a confirmed overall response rate (cORR) of 52% in serous endometrial cancer subjects with ≤2 prior lines of therapy, and 67% in biomarker-positive (BM+) subjects [1][5] - Arm 3 of the trial will enroll up to 90 subjects with serous subtype and ≤2 prior lines of therapy, without requiring a tumor biopsy, with enrollment completion expected in Q4 2026 [1][5] - A Phase 3 confirmatory protocol for ACR-368 in combination with anti-PD-1 therapy has been submitted to the FDA, with global trial readiness anticipated by mid-2026 [1][2] ACR-2316 Development - Initial data from the Phase 1 dose escalation study of ACR-2316 (N=33) demonstrated favorable tolerability and tumor shrinkage at doses ≥120 mg, including confirmed partial responses in endometrial cancer and unconfirmed responses in small cell lung cancer (SCLC) [1][2][5] - The study has established two weekly oral dosing regimens, with a bi-weekly regimen initiated to enhance dosing flexibility [1][5] ACR-6840 Nomination - ACR-6840 has been nominated as the next preclinical development candidate, targeting CDK11, with an IND submission expected in Q4 2026 [1][3][12] - The development of ACR-6840 is based on its potential to achieve optimal on-target pathway effects, leveraging the company's proprietary AP3 platform [1][12] Financial Position - As of December 31, 2025, Acrivon reported preliminary cash, cash equivalents, and investments of approximately $119 million, expected to fund operations into Q2 2027 [8][9]

Group 1 - Humacyte, Inc. (HUMA) has gained approximately 12.4% year-to-date, outperforming the average gain of 7.6% for Medical stocks [4] - The Zacks Rank for Humacyte, Inc. is currently 2 (Buy), indicating a positive outlook based on earnings estimates and revisions [3] - The consensus estimate for Humacyte's full-year earnings has increased by 15.9% over the past quarter, reflecting improved analyst sentiment [3] Group 2 - Humacyte, Inc. is part of the Medical - Biomedical and Genetics industry, which has an average gain of 18.6% this year, indicating that HUMA is slightly underperforming its industry [5] - Acrivon Therapeutics, Inc. (ACRV), another Medical stock, has outperformed the sector with a return of 24.9% year-to-date [4] - The Medical - Drugs industry, to which Acrivon belongs, has gained 3.1% this year and is ranked 90 among 141 stocks [6]

Core Viewpoint - Acrivon Therapeutics is set to provide clinical data for its lead programs ACR-368 and ACR-2316 on January 8, 2026, highlighting advancements in precision medicine through its proprietary platform [1][4][7] Group 1: Company Overview - Acrivon Therapeutics is a clinical stage biotechnology company focused on discovering and developing precision medicines using its Generative Phosphoproteomics AP3 platform [3] - The AP3 platform enables unbiased interpretation and quantification of drug-regulated pathway activity levels in intact cells, generating terabytes of data for actionable insights [3] - Acrivon aims to overcome traditional drug discovery limitations by rapidly designing differentiated compounds and advancing them into clinical development [3] Group 2: Clinical Programs - ACR-368, a selective small molecule inhibitor targeting CHK1 and CHK2, is currently in a Phase 2b trial for endometrial cancer and has received Fast Track designation from the FDA [4] - The ACR-2316 program, a WEE1/PKMYT1 inhibitor, is in Phase 1 trials, with initial clinical activity and dose proportionality observed in early cohorts [5][7] - Upcoming updates will include interim clinical data from the ACR-368 study and initial data from the ACR-2316 study, along with a new preclinical development candidate [7]

Core Insights - Acrivon Therapeutics is a clinical stage biotechnology company focused on precision medicine through its proprietary Generative Phosphoproteomics AP3 platform, which enables the interpretation and quantification of drug-regulated effects in intact cells [2][3] Company Overview - Acrivon Therapeutics utilizes its Generative Phosphoproteomics AP3 platform to develop precision medicines, allowing for unbiased interpretation of compound-specific pathway activity levels, generating terabytes of data for actionable insights [2] - The AP3 platform includes tools such as the AP3 Data Portal, AP3 Kinase Substrate Relationship Predictor, and AP3 Interactome, which enhance drug discovery beyond traditional methods [2] Clinical Programs - Acrivon's lead program, ACR-368 (prexasertib), is a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a Phase 2b trial for endometrial cancer, with Fast Track designation from the FDA [3] - ACR-368 has also received Breakthrough Device designation for its OncoSignature assay to identify suitable patients for treatment [3] - The second clinical asset, ACR-2316, is a WEE1/PKMYT1 inhibitor showing promising early clinical activity and safety in a Phase 1 trial, with initial tumor shrinkage observed [4][6] Upcoming Updates - Acrivon plans to provide updates on ACR-368 and ACR-2316 clinical data through a conference call and webcast in January 2026, including interim data from the Phase 2b study and the Phase 1 study of ACR-2316 [1][6]