[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]

Clinical Development - Acrivon Therapeutics is advancing its lead candidate ACR-368 in a Phase 2 trial for endometrial cancer, focusing on patients predicted to be sensitive based on the OncoSignature test [102]. - The ACR-368 OncoSignature test has shown a confirmed overall response rate (ORR) of 35% and a disease control rate (DCR) of 80% among 20 patients with endometrial cancer [106]. - The FDA granted Fast Track designation to ACR-368 for the treatment of OncoSignature-positive endometrial cancer patients, indicating a potential for expedited development [104]. - The ongoing registrational trial for ACR-368 in endometrial cancer is based on a market research estimate of approximately 27,000 U.S. patients annually in the second-line setting [105]. - Acrivon is also developing ACR-2316, a selective WEE1/PKMYT1 inhibitor, which has entered Phase 1 trials with initial dosing in Q3 2024 [108]. - Acrivon anticipates providing a clinical data update for ACR-2316 in the second half of 2025, with encouraging early results observed in patients [108]. Financial Performance - The company reported a net loss of $19.7 million for the three months ended March 31, 2025, compared to a net loss of $16.5 million for the same period in 2024, with an accumulated deficit of $216.7 million as of March 31, 2025 [113]. - The net loss for Q1 2025 was $19.7 million, compared to a net loss of $16.5 million in Q1 2024, reflecting an increase of $3.2 million [135][138]. - Net cash used in operating activities was $19.5 million for Q1 2025, up from $17.1 million in Q1 2024, driven by increased net loss and personnel-related costs [140][141]. - Research and development expenses for Q1 2025 were $15.4 million, an increase of $3.9 million from $11.5 million in Q1 2024 [135][137]. - General and administrative expenses remained relatively stable at $6.2 million for both Q1 2025 and Q1 2024 [135][137]. - The accumulated deficit as of March 31, 2025, was $216.7 million, indicating significant losses since inception [139]. - The company has not generated any revenue to date and does not expect to do so in the foreseeable future from drug sales [121]. Funding and Capital Requirements - Acrivon has raised $123.8 million in net proceeds from a Private Investment in Public Equity (PIPE) transaction, selling 8,235,000 shares at $8.50 per share [112]. - The company anticipates a substantial increase in research and development expenses as it continues to develop ACR-368 and ACR-2316 [127]. - Future capital requirements will depend on various factors, including the costs of preclinical and clinical development activities and regulatory review outcomes [149]. - The company may need to finance cash needs through equity offerings, debt financings, and collaborations, which could dilute stockholder ownership [151]. - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $164.8 million, expected to fund operations into Q2 2027 [118][139][147]. Regulatory and Compliance - The company remains classified as an "emerging growth company," allowing it to delay compliance with new accounting standards [156]. - The market value of the company's stock held by non-affiliates is less than $700 million, qualifying it as a "smaller reporting company" [158]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company [159]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its smaller reporting company status [160]. - There were no material changes to contractual obligations during the three months ended March 31, 2025, compared to the previous year [152]. Strategic Plans - The company plans to continue its research and development activities, including the discovery of additional drug candidates and the expansion of its intellectual property portfolio [116]. - The company expects to incur significant expenses and operating losses as it advances drug candidates through clinical development and seeks regulatory approval [148]. - Research and development costs are anticipated to increase due to planned clinical activities and operating as a public company [148].

Financial Performance - Acrivon reported a net loss of $19.7 million for Q1 2025, compared to a net loss of $16.5 million in Q1 2024, reflecting an increase in operational expenses[5]. - Research and development expenses increased to $15.4 million in Q1 2025 from $11.5 million in Q1 2024, primarily due to ongoing clinical trials for ACR-368 and ACR-2316[6]. - As of March 31, 2025, Acrivon had cash, cash equivalents, and marketable securities totaling $164.8 million, expected to fund operations into Q2 2027[7]. Clinical Trials and Drug Development - The confirmed overall response rate (cORR) for ACR-368 in OncoSignature-positive patients was 35%, with a disease control rate (DCR) of 80%[4]. - For patients who relapsed after prior therapy, the cORR for ACR-368 was 50%, with a median duration of response (mDOR) not yet reached, exceeding 10 months[4]. - ACR-2316 demonstrated approximately 25% tumor shrinkage in a patient after six weeks of treatment at dose level 3, indicating potential for monotherapy activity[3]. - The company advanced to dose level 4 in the Phase 1 trial of ACR-2316, with no safety concerns reported at previous dose levels[4]. - Upcoming milestones include updates on the registrational trial for ACR-368 and initial clinical data from the Phase 1 study of ACR-2316 in the second half of 2025[10]. Leadership and Strategic Initiatives - Acrivon appointed Dr. Mansoor Raza Mirza as Chief Medical Officer, bringing extensive experience in leading registrational trials in oncology[4]. - The company is leveraging its Generative Phosphoproteomics AP3 platform to enhance drug discovery capabilities and streamline development processes[8].

Core Insights - Acrivon Therapeutics reported positive interim data from the ACR-368 Phase 2b study in endometrial cancer patients, showing a confirmed overall response rate (cORR) of 35% and a median duration of response (mDOR) exceeding 5.6 months in OncoSignature-positive patients [1][3] - The company has completed three dose escalation cohorts in the ACR-2316 Phase 1 trial, with tumor shrinkage observed at dose level 3, indicating potential for monotherapy activity [1][9] - Acrivon has appointed Dr. Mansoor Raza Mirza as chief medical officer, enhancing the executive team with his extensive experience in oncology [2][9] Clinical Developments - The ACR-368 study demonstrated a cORR of 50% and mDOR not yet reached (>10 months) in patients who had relapsed after prior therapy, with a disease control rate (DCR) of 100% in this subgroup [3][11] - ACR-2316 has shown approximately 25% tumor shrinkage in a patient after six weeks of treatment at dose level 3, supporting its potential as a single-agent therapy [2][9] - The company is advancing a new potential first-in-class cell cycle drug discovery program targeting an undisclosed target, with development candidate nomination expected in 2025 [9][12] Financial Performance - For the first quarter of 2025, Acrivon reported a net loss of $19.7 million, compared to a net loss of $16.5 million for the same period in 2024 [5][15] - Research and development expenses increased to $15.4 million in Q1 2025 from $11.5 million in Q1 2024, primarily due to ongoing clinical trials and increased personnel [6][15] - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $164.8 million, expected to fund operations into the second quarter of 2027 [7][15] Technological Advancements - Acrivon is leveraging its Generative Phosphoproteomics AP3 platform to enhance drug discovery, with tools designed to convert multimodal data into structured data for generative AI analyses [4][8] - The platform includes the AP3 Data Portal, the AP3 Kinase Substrate Relationship Predictor, and the AP3 Interactome, enabling the design of differentiated compounds with desirable pathway effects [4][8] Upcoming Milestones - The company plans to provide updates on the registrational-intent trial and confirmatory trial design for ACR-368, as well as initial clinical data from the Phase 1 study of ACR-2316 in the second half of 2025 [9][12]

Core Viewpoint - Acrivon Therapeutics, Inc. (ACRV) has experienced a 14% decline in stock price over the past week, but a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging to counteract selling pressure [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with reduced selling pressure, suggesting that bulls may be regaining control [2][5]. - The hammer pattern is characterized by a small candle body and a long lower wick, indicating that the stock opened lower, reached a new low, but closed near or above the opening price, reflecting buying interest [4][5]. - This pattern can occur across various timeframes and is utilized by both short-term and long-term investors [5]. Fundamental Analysis - Recent upward revisions in earnings estimates for ACRV serve as a bullish indicator, correlating strongly with near-term stock price movements [7]. - The consensus EPS estimate for ACRV has increased by 3.4% over the last 30 days, indicating strong agreement among analysts regarding improved earnings potential [8]. - ACRV holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9].

Core Insights - Acrivon Therapeutics is advancing its clinical-stage asset ACR-2316, a selective WEE1/PKMYT1 inhibitor, which has shown superior anti-cancer activity in preclinical studies and is currently in a Phase 1 clinical trial with promising early results [1][2][3] Group 1: Clinical Development - ACR-2316 has completed three dose-escalation cohorts in its Phase 1 trial ahead of schedule, with solid tumor shrinkage observed at dose level three [1][2] - The trial has shown no safety concerns or dose-limiting toxicities (DLTs) at dose levels 1, 2, and 3, with dose level 4 currently enrolling [2] - Initial clinical activity of approximately 25% RECIST tumor shrinkage has been noted, along with a reduction of metastatic lesions in the chest, abdomen, and pelvis at dose level three [2] Group 2: Mechanism of Action - ACR-2316 was designed using Acrivon's AP3 platform to activate CDK1, CDK2, and PLK1 pathways, aiming to induce pro-apoptotic tumor cell death and achieve superior single-agent activity [3][7] - The drug's mechanism is intended to overcome limitations associated with single-target WEE1 and PKMYT1 inhibitors, demonstrating a favorable therapeutic index in preclinical studies [3][7] Group 3: Research and Technology - Acrivon utilizes its proprietary Acrivon Predictive Precision Proteomics (AP3) platform for drug discovery, which measures compound-specific effects on tumor cell protein signaling networks [5][6] - The AP3 platform enables the identification of patients most likely to benefit from Acrivon's drug candidates through OncoSignature companion diagnostics [6][7] - Acrivon is also developing ACR-368, a selective small molecule inhibitor targeting CHK1 and CHK2, which is in a potentially registrational Phase 2 trial for endometrial cancer [6][7]