Oncology Pipeline - Acrivon Therapeutics is focused on oncology, advancing its pipeline of preclinical and clinical-stage small molecule inhibitors, including ACR-368 and ACR-2316[100]. - ACR-368 is in a potentially registrational Phase 2B trial for endometrial cancer, with initial data showing a confirmed overall response rate (ORR) of 35% and a disease control rate (DCR) of 80% among 20 biomarker-positive patients[105]. - The company reported that 80% of biomarker-positive patients demonstrated tumor shrinkage, indicating significant anti-tumor activity in aggressive, refractory tumors[105]. - ACR-368 received Fast Track designation from the FDA for endometrial cancer and the OncoSignature test received Breakthrough Device Designation, reflecting its potential for effective treatment[102]. - ACR-2316, a selective WEE1/PKMYT1 inhibitor, is currently in Phase 1 trials, with initial clinical activity observed and a clinical data update expected in the second half of 2025[108]. - The company plans to continue exploring drug combinations and has initiated a Phase 2 trial of ACR-368 with ultra low-dose gemcitabine in endometrial cancer patients[106]. Financial Performance - Acrivon has incurred net losses of $58.9 million and $57.7 million for the nine months ended September 30, 2025, and 2024, respectively, with an accumulated deficit of $255.9 million as of September 30, 2025[113]. - The company raised $123.8 million in net proceeds from a PIPE transaction in April 2024, selling 8,235,000 shares at $8.50 per share[112]. - Research and development expenses for Q3 2025 were $13.6 million, a decrease of $5.2 million from $18.9 million in Q3 2024[137]. - The company reported a net loss of $18.2 million for Q3 2025, an improvement of $4.2 million compared to a net loss of $22.4 million in Q3 2024[135]. - Total operating expenses for the nine months ended September 30, 2025, were $63.998 million, a slight decrease of $0.247 million from $64.245 million in the same period of 2024[139]. - Interest income for Q3 2025 was $1.5 million, down from $2.7 million in Q3 2024, reflecting a decrease of $1.2 million[138]. - Total other income, net for the nine months ended September 30, 2025, was $5.1 million, compared to $6.5 million for the same period in 2024, a decrease of $1.4 million[143]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $48.4 million, slightly increasing from $48.3 million in the same period of 2024[146]. - Net cash provided by investing activities was $44.6 million for the nine months ended September 30, 2025, resulting from $114.5 million in proceeds from maturities of investments[148]. - Net cash used in financing activities was $0.6 million for the nine months ended September 30, 2025, primarily due to tax withholding payments[150]. Research and Development - Acrivon is leveraging its proprietary AP3 platform for drug discovery and optimization, which has enabled rapid advancement of its drug candidates[109]. - The company anticipates a substantial increase in research and development expenses as it continues the development of ACR-368 and ACR-2316[126]. - Research and development expenses for the nine months ended September 30, 2025, were $45.2 million, a decrease of $0.1 million from $45.4 million in the same period of 2024[142]. - ACR-368 direct research and development expenses for Q3 2025 were $3.985 million, down from $11.098 million in Q3 2024, a decrease of $7.113 million[136]. - The company experienced a $6.5 million net decrease in costs due to fewer scheduled milestones in the current period[147]. - A $3.8 million net increase in costs was related to the clinical trial of ACR-2316, initiated in Q3 2024[147]. Future Outlook - Acrivon anticipates significant ongoing expenses related to clinical development and commercialization efforts, necessitating additional funding to support its growth strategy[115]. - The company expects to incur significant expenses and operating losses as it advances drug candidates through clinical development and seeks regulatory approval[153]. - The company anticipates that existing cash will fund operations into the second quarter of 2027, based on current assumptions[152]. - The company may require additional capital for in-licenses or acquisitions of other drug candidates in the future[153]. - As of September 30, 2025, the company had cash, cash equivalents, and investments totaling $134.4 million, expected to fund operations into Q2 2027[118]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates below $700 million[164].

Exhibit 99.1 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 • ...

Core Insights - Acrivon Therapeutics is advancing its clinical pipeline, particularly focusing on ACR-368 for endometrial cancer, with a registrational-intent Phase 2b trial aimed at addressing unmet medical needs in relapsed patients [2][5] - The company is also preparing to disclose initial clinical data for ACR-2316 from its Phase 1 trial, which targets solid tumor types prioritized by its AP3 platform [1][2] - Acrivon's proprietary Generative Phosphoproteomics AP3 platform is enhancing drug discovery by enabling the design of differentiated compounds with desired pathway effects [1][6] Recent Highlights - ACR-368 is a CHK1 and CHK2 inhibitor currently in a multicenter Phase 2b trial for recurrent high-grade endometrial cancer [3][5] - ACR-2316, a WEE1/PKMYT1 inhibitor, has shown promising preclinical data, demonstrating tumor regression in xenograft models [4][5] - The AP3 platform's generative AI model, KaiSR, has been presented at conferences, showcasing its ability to predict pathway activity and support rational drug design [6] Financial Overview - For Q3 2025, Acrivon reported a net loss of $18.2 million, an improvement from a net loss of $22.4 million in Q3 2024 [8] - Research and development expenses decreased to $13.6 million in Q3 2025 from $18.9 million in the same period in 2024, reflecting a focus on endometrial cancer [9] - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $134.4 million, expected to fund operations into Q2 2027 [10] Upcoming Milestones - Acrivon plans to provide updates on the registrational-intent trial for ACR-368 and report initial clinical data for ACR-2316 in the second half of 2025 [13][14] - The company is also advancing a new potential first-in-class cell cycle drug discovery program towards candidate nomination in 2025 [13]

Company Overview - Acrivon Therapeutics is a clinical-stage biotech company focused on precision oncology, utilizing its proprietary Generative Phosphoproteomics AP3 platform to identify which patients are most likely to benefit from specific therapies [2][4] - The company has advanced two drug candidates into human clinical trials, with ACR-368 being its lead program [1][8] Drug Candidates - ACR-368 is a selective CHK1/CHK2 inhibitor currently in a registrational-intent Phase 2b trial for recurrent, high-grade endometrial cancer, showing encouraging early clinical readouts, particularly in OncoSignature-positive patients [1][7] - ACR-2316 is a dual WEE1/PKMYT1 inhibitor undergoing a Phase 1 monotherapy dose-escalation study, with preclinical data indicating strong single-agent activity and an ongoing confirmed partial response in a patient with endometrial cancer [8][10] Regulatory Designations - ACR-368 has received FDA Fast Track designation as a monotherapy for ovarian and endometrial cancer, while its companion diagnostic, OncoSignature, has been granted Breakthrough Device status [7][10] Market Potential - ACR-2316's positive emerging profile could potentially add approximately $150 million in market capitalization, with analysts noting its best-in-class potential due to its dual-targeting approach [10][11] - Acrivon’s stock, currently trading at $1.99, has a price target of $13, indicating a potential upside of 553% [9][12] Analyst Sentiment - The broader analyst consensus for Acrivon is a Strong Buy, with 6 Buy ratings and an average price target of $11.75, suggesting a potential upside of 490% over the next year [12]

Core Insights - Acrivon Therapeutics is advancing its precision medicine development through its proprietary Generative Phosphoproteomics AP3 platform, which enables the assessment of drug effects on intracellular protein signaling networks for optimal drug design and precision medicine [1][4][5] - The company has reported favorable preclinical data for its lead asset ACR-2316, a novel WEE1/PKMYT1 inhibitor, demonstrating superior pathway effects compared to benchmark inhibitors [1][7] - Initial clinical data for ACR-2316 is expected to be reported later this year, with confirmed partial responses observed during the dose escalation phase of the trial [1][2][7] Presentation Details - Acrivon will present three posters at the AACR-NCI-EORTC International Conference, showcasing the AP3 platform and the preclinical activity of ACR-2316 [2][3] - The posters will cover topics such as the global pharmacodynamic effects of ACR-2316, the generative AI ensemble model (KaiSR), and the design of ACR-2316 for optimal pro-apoptotic pathway effects [3] Company Overview - Acrivon Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing precision medicines using its AP3 platform [4][5] - The company is also advancing ACR-368, 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 [6][7] - Acrivon is leveraging its platform for developing additional pipeline programs, including ACR-2316, which has shown strong preclinical activity and is currently in a Phase 1 trial [7]

[Special Note Regarding Forward-Looking Statements](index=3&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) This report contains forward-looking statements about future operations, financial conditions, clinical trial timing, regulatory approvals, and market opportunities, subject to risks and uncertainties - This report contains forward-looking statements concerning future operations, financial conditions, clinical trial timing, regulatory approvals, and market opportunities, based on current expectations and subject to risks and uncertainties[8](index=8&type=chunk)[9](index=9&type=chunk) - Key areas covered include clinical trial progress for ACR-368 and ACR-2316, regulatory submission timing, commercialization ability, capital requirements, and intellectual property protection[10](index=10&type=chunk) [PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements, management's discussion and analysis, market risk disclosures, and internal controls [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for the period ended June 30, 2025, show decreased total assets and stockholders' equity due to an increased net loss, with cash and investments totaling $147.6 million [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $158.6 million from $196.6 million, primarily due to reduced short-term investments, leading to a decline in stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $41,895 | $39,818 | | Short-term investments | $95,528 | $139,662 | | **Total current assets** | **$138,412** | **$181,629** | | **Total assets** | **$158,583** | **$196,588** | | **Liabilities & Equity** | | | | Total current liabilities | $13,431 | $17,214 | | **Total liabilities** | **$15,546** | **$19,802** | | **Total stockholders' equity** | **$143,037** | **$176,786** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net losses increased for both the three and six months ended June 30, 2025, driven by higher research and development expenses, with the six-month net loss reaching $40.7 million Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $16,182 | $15,025 | $31,596 | $26,498 | | General and administrative | $6,467 | $6,412 | $12,715 | $12,607 | | **Loss from operations** | **$(22,649)** | **$(21,437)** | **$(44,311)** | **$(39,105)** | | **Net loss** | **$(21,006)** | **$(18,798)** | **$(40,686)** | **$(35,284)** | | Net loss per share | $(0.55) | $(0.52) | $(1.06) | $(1.20) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $36.1 million for the six months ended June 30, 2025, while investing activities provided $38.7 million, a significant shift from the prior year Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(36,145) | $(30,986) | | Net cash provided by (used in) investing activities | $38,665 | $(82,194) | | Net cash (used in) provided by financing activities | $(440) | $123,178 | [Notes to the Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's oncology focus, cash runway into Q2 2027, $123.8 million PIPE financing, and potential milestone payments up to $168.0 million to Lilly - The company is a clinical-stage biotech focused on oncology, advancing its lead candidates ACR-368 (Phase 2 for endometrial cancer) and ACR-2316 (Phase 1 for solid tumors)[31](index=31&type=chunk) - Existing cash, cash equivalents, and investments of **$147.6 million** as of June 30, 2025, are expected to fund operations into the **second quarter of 2027**[39](index=39&type=chunk)[114](index=114&type=chunk) - In April 2024, the company closed a PIPE financing, raising aggregate net proceeds of **$123.8 million** through the sale of common stock and pre-funded warrants[38](index=38&type=chunk)[64](index=64&type=chunk) - The company has potential future milestone payment obligations of up to **$168.0 million** to Eli Lilly and up to **$20.3 million** to Akoya Biosciences for its companion diagnostic test[88](index=88&type=chunk)[92](index=92&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's precision oncology focus, clinical updates for ACR-368 and ACR-2316, increased R&D expenses, and a cash runway extending into the second quarter of 2027 [Overview](index=28&type=section&id=Overview) Acrivon, a clinical-stage biotech, uses its AP3 platform to develop precision oncology drugs, with lead candidate ACR-368 in Phase 2 for endometrial cancer and ACR-2316 showing initial clinical activity - The company's lead drug, ACR-368, is in a Phase 2 trial for endometrial cancer, with interim data showing a **35% confirmed overall response rate (ORR)** and **80% tumor shrinkage** in OncoSignature-positive (BM+) patients[100](index=100&type=chunk)[105](index=105&type=chunk) - The second clinical asset, ACR-2316, a WEE1/PKMYT1 inhibitor, has shown initial clinical activity in its Phase 1 trial, including an ongoing confirmed partial response in an endometrial cancer patient[107](index=107&type=chunk) - The company's proprietary AP3 platform is used for drug design, identifying rational drug combinations, and creating drug-specific companion diagnostics (OncoSignature tests)[99](index=99&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Operating expenses increased for both the three and six-month periods ended June 30, 2025, primarily due to a **$5.1 million** rise in R&D costs, driven by the ACR-2316 program and personnel expenses Research & Development Expenses Breakdown (Six Months Ended June 30, in thousands) | Program | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | ACR-368 | $13,660 | $13,000 | $660 | | ACR-2316 | $2,930 | $— | $2,930 | | Other drug discovery programs | $1,208 | $3,122 | $(1,914) | | Personnel related | $11,152 | $8,520 | $2,632 | | Facilities, supplies and other | $2,646 | $1,856 | $790 | | **Total R&D Expenses** | **$31,596** | **$26,498** | **$5,098** | - The **$5.1 million** increase in six-month R&D expenses was primarily due to a **$2.9 million** increase in costs for the ACR-2316 clinical program and a **$2.6 million** increase in personnel-related costs from higher headcount[142](index=142&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$147.6 million** in cash and investments, sufficient to fund operations into the second quarter of 2027, with net cash used in operations at **$36.1 million** - The company had **$147.6 million** in cash, cash equivalents, and investments as of June 30, 2025[141](index=141&type=chunk)[149](index=149&type=chunk) - The current cash position is expected to fund operations into the **second quarter of 2027**[141](index=141&type=chunk)[149](index=149&type=chunk) - Net cash used in operating activities increased to **$36.1 million** for the six months ended June 30, 2025, from **$31.0 million** in the prior-year period, reflecting higher net loss[143](index=143&type=chunk)[144](index=144&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Acrivon Therapeutics is exempt from providing quantitative and qualitative disclosures about market risk - The company is exempt from providing market risk disclosures as it qualifies as a "smaller reporting company" under SEC rules[162](index=162&type=chunk) [Item 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[163](index=163&type=chunk) - No material changes were made to the company's internal control over financial reporting during the second quarter of 2025[165](index=165&type=chunk) [PART II. OTHER INFORMATION](index=46&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, other disclosures, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) As of the filing date, the company is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[168](index=168&type=chunk) [Item 1A. Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) The company faces risks including a history of significant losses, the need for substantial additional funding, and potential stock price volatility from future sales of restricted shares - The company has a history of significant losses, with an accumulated deficit of **$237.7 million** as of June 30, 2025, and expects to incur further losses[170](index=170&type=chunk) - Substantial additional funding will be required to support operations and pursue business objectives, with failure to raise capital potentially forcing curtailment of plans[175](index=175&type=chunk) - A significant portion of outstanding shares are restricted but may be sold in the near future, which could cause the market price of the common stock to drop[178](index=178&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=50&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the quarter, and the planned use of IPO proceeds remains consistent - The company did not conduct any sales of unregistered securities in the three months ended June 30, 2025[181](index=181&type=chunk) - The planned use of proceeds from the company's IPO remains consistent with the description in its final prospectus[182](index=182&type=chunk) [Item 5. Other Information](index=52&type=section&id=Item%205.%20Other%20Information) The company disclosed that its Chief Medical Officer terminated a Rule 10b5-1 trading plan on May 2, 2025 - A Rule 10b5-1 trading plan for the Chief Medical Officer was terminated on May 2, 2025[188](index=188&type=chunk) [Item 6. Exhibits](index=53&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report, including CEO and CFO certifications and XBRL data files - Exhibits filed include certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act of 2002[191](index=191&type=chunk)

[Business Highlights](index=1&type=section&id=Business%20Highlights) Acrivon advances clinical assets ACR-368 and ACR-2316, showcasing the AP3 platform's role in drug development and initial clinical activity [ACR-368: CHK1 and CHK2 Inhibitor](index=1&type=section&id=ACR-368%3A%20CHK1%20and%20CHK2%20Inhibitor) The registrational-intent Phase 2b trial for ACR-368 in endometrial cancer is ongoing, with a new arm evaluating combination therapy for broader patient access - The company is continuing to advance its registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with recurrent high-grade endometrial cancer who have failed prior platinum-based chemotherapy and immune checkpoint inhibitor treatments[3](index=3&type=chunk)[4](index=4&type=chunk) - A third arm has been initiated in the Phase 2b study to evaluate ACR-368 with ultra low-dose gemcitabine (ULDG) in all-comer, biomarker-unselected 2nd line endometrial cancer patients, which does not require a pre-treatment biopsy[4](index=4&type=chunk) - Clinical data has shown deep and durable responses in patients with aggressive endometrial cancer who had progressed on prior chemotherapy and anti-PD1 therapy[2](index=2&type=chunk) [ACR-2316: WEE1/PKMYT1 Inhibitor](index=2&type=section&id=ACR-2316%3A%20WEE1%2FPKMYT1%20Inhibitor) The Phase 1 dose-escalation trial for ACR-2316 is enrolling patients, showing no dose-limiting toxicities, target engagement, and early clinical activity - The Phase 1 monotherapy dose-escalation trial is enrolling patients with high unmet need solid tumor types, prioritized based on AP3-predicted sensitivity[9](index=9&type=chunk) - Key early findings from the Phase 1 trial include: - 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 seen, including an ongoing confirmed partial response in endometrial cancer[9](index=9&type=chunk)[2](index=2&type=chunk) [Generative Phosphoproteomics AP3 Platform](index=1&type=section&id=Generative%20Phosphoproteomics%20AP3%20Platform) The AI-driven AP3 platform accelerates novel compound design and development, demonstrating its ability to uncover key molecular mechanisms - The AI-driven AP3 platform enables a new paradigm for accelerated design and development of novel compounds by providing optimal intracellular pathway selectivity[1](index=1&type=chunk) - At the AACR Annual Meeting in April 2025, the company presented AP3 analyses that uncovered key molecular mechanisms by which ACR-2316 induces strong, pro-apoptotic tumor cell death[5](index=5&type=chunk) [Future Outlook](index=2&type=section&id=Future%20Outlook) Acrivon anticipates providing updates on ACR-368 and ACR-2316 clinical data in H2 2025, alongside advancing a new cell cycle drug discovery program - Key anticipated milestones for the remainder of 2025 include: - An update on the registrational-intent trial and confirmatory trial design for ACR-368 in H2 2025 - A report of initial clinical data from the Phase 1 clinical study of ACR-2316 in H2 2025 - Advancement of a new cell cycle drug discovery program towards development candidate nomination[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) Acrivon reported a **$21.0 million net loss** in Q2 2025, driven by R&D, with **$147.6 million cash** funding operations into Q2 2027 [Summary of Operations](index=2&type=section&id=Summary%20of%20Operations) Q2 2025 net loss increased to **$21.0 million** from **$18.8 million** in Q2 2024, primarily due to higher R&D Statement of Operations (Three Months Ended June 30, in thousands) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :--- | :--- | :--- | | Net Loss | ($21,006) | ($18,798) | | R&D Expenses | $16,182 | $15,025 | | G&A Expenses | $6,467 | $6,412 | - The increase in R&D expenses was primarily due to increased personnel to support the clinical trials for ACR-368 and ACR-2316, as well as preclinical drug discovery[7](index=7&type=chunk) [Financial Position and Runway](index=1&type=section&id=Financial%20Position%20and%20Runway) Acrivon's cash, cash equivalents, and marketable securities totaled **$147.6 million** as of June 30, 2025, providing funding into Q2 2027 - Cash, cash equivalents and marketable securities totaled **$147.6 million** as of June 30, 2025[1](index=1&type=chunk)[8](index=8&type=chunk) - The company's cash position is expected to fund operations into the second quarter of 2027[1](index=1&type=chunk)[8](index=8&type=chunk) [Company Overview](index=3&type=section&id=Company%20Overview) Acrivon is a clinical-stage biopharmaceutical company leveraging its AI-driven AP3 platform to develop precision medicines, including lead programs ACR-368 and ACR-2316 - Acrivon uses its proprietary Generative Phosphoproteomics AP3 platform to interpret and quantify drug-regulated pathway activity, enabling the design of differentiated compounds[10](index=10&type=chunk) - The lead program, ACR-368 (a CHK1/CHK2 inhibitor), is in a potentially registrational Phase 2 trial for endometrial cancer and has received FDA Fast Track designation[11](index=11&type=chunk) - The second clinical asset, ACR-2316 (a WEE1/PKMYT1 inhibitor), is advancing in a Phase 1 trial and has shown initial clinical activity and drug target engagement[12](index=12&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The financial statements detail a **$21.0 million net loss** for Q2 2025 and total assets of **$158.6 million** as of June 30, 2025, reflecting a decrease from year-end 2024 [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Acrivon reported a **$21.0 million net loss** for Q2 2025, or **($0.55) per share**, compared to a **$18.8 million net loss** in Q2 2024 Statement of Operations (Three Months Ended June 30, in thousands) | | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | Research and development | $16,182 | $15,025 | | General and administrative | $6,467 | $6,412 | | **Total operating expenses** | **$22,649** | **$21,437** | | Loss from operations | ($22,649) | ($21,437) | | Total other income, net | $1,643 | $2,639 | | **Net loss** | **($21,006)** | **($18,798)** | | Net loss per share | ($0.55) | ($0.52) | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were **$158.6 million**, a decrease from **$196.6 million** at year-end 2024, with total liabilities at **$15.5 million** Balance Sheet Summary (in thousands) | | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $41,895 | $39,818 | | Investments | $105,727 | $144,751 | | **Total assets** | **$158,583** | **$196,588** | | Total Liabilities | $15,546 | $19,802 | | Total Stockholders' Equity | $143,037 | $176,786 |

Core Insights - Acrivon Therapeutics is advancing two clinical-stage assets, ACR-368 and ACR-2316, both demonstrating anti-tumor activity in clinical studies [1][2] - The company utilizes its proprietary AI-driven Generative Phosphoproteomics AP3 platform to enhance drug design and development [1][10] - As of June 30, 2025, Acrivon has $147.6 million in cash and equivalents, expected to fund operations until Q2 2027 [1][9] Clinical Development - ACR-368 is in a registrational-intent Phase 2b trial for endometrial cancer, showing deep and durable responses in patients previously treated with chemotherapy and anti-PD-1 therapy [2][7] - ACR-2316, a WEE1/PKMYT1 inhibitor, is in a Phase 1 trial, with initial clinical activity observed in several solid tumor types, including confirmed partial responses in endometrial cancer [4][12] Financial Performance - For Q2 2025, Acrivon reported a net loss of $21.0 million, compared to a net loss of $18.8 million in Q2 2024 [8][17] - Research and development expenses increased to $16.2 million in Q2 2025 from $15.0 million in Q2 2024, primarily due to increased personnel for clinical trials [8][17] - General and administrative expenses remained stable at $6.5 million for Q2 2025, compared to $6.4 million in Q2 2024 [9][17] Upcoming Milestones - The company plans to provide updates on the registrational-intent trial for ACR-368 and report initial clinical data from the Phase 1 study of ACR-2316 in the second half of 2025 [14] - Acrivon is also advancing a new cell cycle drug discovery program targeting an undisclosed target towards development candidate nomination in 2025 [14]

Core Insights - Acrivon Therapeutics is advancing two clinical-stage assets, ACR-368 and ACR-2316, both demonstrating anti-tumor activity in clinical studies [1][2] - The company utilizes its proprietary AI-driven Generative Phosphoproteomics AP3 platform to enhance drug design and development [1][10] - As of June 30, 2025, Acrivon has $147.6 million in cash and equivalents, expected to fund operations until Q2 2027 [1][9] Clinical Development - ACR-368 is in a registrational-intent Phase 2b trial for endometrial cancer, showing deep and durable responses in patients previously treated with chemotherapy and anti-PD-1 therapy [2][7] - ACR-2316, a WEE1/PKMYT1 inhibitor, is in a Phase 1 trial, with initial clinical activity observed in several solid tumor types, including confirmed partial responses in endometrial cancer [4][12] Financial Performance - For Q2 2025, Acrivon reported a net loss of $21.0 million, compared to a net loss of $18.8 million in Q2 2024 [8] - Research and development expenses increased to $16.2 million in Q2 2025 from $15.0 million in Q2 2024, primarily due to increased personnel for clinical trials [8] - General and administrative expenses remained stable at $6.5 million for Q2 2025, compared to $6.4 million in Q2 2024 [9] Upcoming Milestones - The company plans to provide updates on the registrational-intent trial for ACR-368 and report initial clinical data from the Phase 1 study of ACR-2316 in the second half of 2025 [14] - Acrivon is also advancing a new cell cycle drug discovery program targeting an undisclosed target towards development candidate nomination in 2025 [14]

Acrivon's AP3 Platform and Pipeline - Acrivon utilizes its Acrivon Predictive Precision Proteomics (AP3) platform to overcome limitations of genetics-based precision medicine [2, 7] - The AP3 platform enables exact matching of disease-driving dysregulated pathways with a drug's mechanism of action [8] - Acrivon's pipeline includes ACR-368 (CHK1/CHK2 inhibitor) in Phase 2 trials for endometrial cancer and ACR-2316 (WEE1/PKMYT1 inhibitor) in Phase 1 for AP3-identified tumor types [18] - A novel cell cycle program with an undisclosed target is anticipated to have a development candidate nomination in 2025 [18, 98] - Additional AP3-driven programs are in early discovery for autoimmune/inflammatory candidates [18] ACR-368 and Endometrial Cancer - ACR-368 is being evaluated in a registrational intent Phase 2 single-arm trial based on predicted sensitivity in OncoSignature-positive endometrial cancer patients [18] - In endometrial cancer patients, ACR-368 monotherapy showed a confirmed ORR of 35% in OncoSignature-positive patients [53] - ACR-368 is also being studied with ultra-low dose gemcitabine (ULDG) as a sensitizer in OncoSignature-negative patients [18] - Preclinical data suggests AP3-predicted sensitization to ACR-368 by LDG correlates with OncoSignature upregulation [64] ACR-2316 and WEE1/PKMYT1 Inhibition - ACR-2316 is a novel dual WEE1/PKMYT1 inhibitor designed using the AP3 platform to overcome limitations of benchmark inhibitors [97, 104] - ACR-2316 demonstrated superior preclinical potency versus benchmark WEE1/PKMYT1 inhibitors [111] - Initial clinical activity was observed with ACR-2316 at Dose Level 3, showing approximately 25% tumor shrinkage in a patient with prior chemotherapy and anti-PD-1 therapy [138] Financial Status - As of March 31, 2025, Acrivon had $1648 million in cash and investments, projecting a runway into Q2 2027 [182]