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Nature of the Business | 9 Months Ended
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Sep. 30, 2025
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
Nature of the Business | 1. Nature of the Business Acrivon Therapeutics, Inc., (the “Company”) is a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics Acrivon Predictive Precision Proteomics (“AP3”) platform designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner. Acrivon is currently focused on oncology and advancing its pipeline of preclinical and clinical-stage small molecule inhibitors. ACR-368 (also known as prexasertib), which is a selective small molecule inhibitor targeting CHK1 and partially CHK2, is in a potentially registrational Phase 2 trial focusing on endometrial cancer. ACR-2316 is a novel, potent and selective inhibitor of WEE1 and PKMYT1 that is currently being advanced in Phase 1 studies for selected solid tumor types predicted sensitive by AP3. In addition, the Company is advancing a preclinical program directed against an undisclosed cell cycle regulatory target, with a development candidate nomination anticipated in 2025. The Company has received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for the investigation of ACR-368 as monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has also granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of endometrial cancer patients who may benefit from ACR-368 treatment. Endometrial cancer had not been previously studied in prior ACR-368 trials sponsored by Eli Lilly and Company (“Lilly”). Using AP3 for indication screening, this tumor type was predicted to be particularly sensitive to ACR-368 prior to the current ongoing Phase 2 study. In March 2025, the Company reported positive clinical data from the ongoing registrational intent, multicenter Phase 2 trial of ACR-368 in patients with recurrent endometrial cancer who had progressed after prior platinum-based chemotherapy and anti-PD-1 therapy. This study, where the OncoSignature is used for prospective response prediction to ACR-368 monotherapy, reported a 35% confirmed overall response rate and 80% tumor shrinkage in OncoSignature-positive patients. The Company’s second clinical-stage asset, ACR-2316, is a novel, selective WEE1/PKMYT1 inhibitor designed using AP3 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. In October 2024, only 15 months after initial lead identification, the Company announced that the first patient had been dosed in the Phase 1 clinical trial that was designed to assess the safety and tolerability of ACR-2316, determine the recommended Phase 2 monotherapy dose, and evaluate preliminary anti-tumor activity. In March 2025, the Company reported significant drug target engagement from patient peripheral blood mononuclear cells in the ongoing trial already at Dose Level (“DL”) 1 using the Company’s proprietary clinical AP3-based mass spectrometry assay. In August the Company reported initial clinical activity with tumor shrinkage observed across several solid tumor types predicted to be sensitive by AP3, including a confirmed partial response at DL3,which is below the projected recommended phase 2 dose. The Company was incorporated in March 2018 under the laws of the state of Delaware, and its principal offices are in Watertown, Massachusetts. Also in March 2018, the Company formed Acrivon AB, a wholly-owned subsidiary of the Company, established in Lund, Sweden. In December 2021, the Company formed Acrivon Securities Corporation, a wholly-owned subsidiary, established in Massachusetts. Liquidity As an emerging growth entity, the Company has devoted substantially all of its resources since inception to organizing and staffing the Company, business planning, raising capital, establishing its intellectual property portfolio, acquiring and discovering drug candidates, research and development activities for the Company’s in-licensed lead candidate ACR-368 and for the Company’s internally discovered clinical stage asset, ACR-2316, and other compounds, establishing arrangements with third parties for the manufacture of its drug candidates and component materials, and providing general and administrative support for these operations. As a result, the Company has incurred significant operating losses and negative cash flows from operations since its inception and anticipates such losses and negative cash flows will continue for the foreseeable future. The Company has incurred recurring losses since its inception, including net losses of $58.9 million and $57.7 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025 and December 31, 2024, the Company had an accumulated deficit of $255.9 million and $197.0 million, respectively. To date, the Company has not generated any revenues and expects to continue generating operating losses for the foreseeable future as it continues to expand its research and development efforts. Since its inception, the Company has funded its operations primarily with proceeds from the sales of shares of its convertible preferred stock, the issuance of convertible notes, and an initial public offering (“IPO”) and concurrent private placement. Upon the closing of the Company’s IPO on November 17, 2022, only common stock remains issued and outstanding. On April 8, 2024, the Company entered into a Private Investment in Public Equity (“PIPE”) securities purchase agreement (the “PIPE Purchase Agreement”) for a private placement with certain institutional and accredited investors (the “April 2024 Private Placement”). Pursuant to the PIPE Purchase Agreement, the Company agreed to issue and sell to the PIPE investors an aggregate of (i) 8,235,000 shares of the Company’s common stock at a purchase price of $8.50 per share, and (ii) pre-funded warrants (“Pre-Funded Warrants”) to purchase up to an aggregate of 7,060,000 shares of the Company’s common stock at a purchase price of $8.499 per Pre-Funded Warrant, which represents the per share purchase price of the Company’s common stock less the $0.001 per share exercise price for each Pre-Funded Warrant. The Pre-Funded Warrants are exercisable at any time after the date of issuance and do not expire. The April 2024 Private Placement closed on April 11, 2024, for aggregate net proceeds of $123.8 million, after deducting fees and expenses of $6.2 million. The April 2024 Private Placement is further described in Note 8. The Company expects that its existing cash, cash equivalents and investments of $134.4 million as of September 30, 2025, will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the date these condensed consolidated financial statements were issued. With the current projected runway into the second quarter of 2027, the Company will need additional funding to support its planned operating activities. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all, considering the current interest rate environment. If the Company is unable to obtain sufficient funding, it could be required to delay its development efforts, limit activities, and reduce research and development costs, which could adversely affect its business prospects. ATM Program On December 1, 2023, the Company filed a registration statement on Form S-3 (the “Registration Statement”) with the U.S. Securities and Exchange Commission (the “SEC”), which was declared effective on December 15, 2023, which registered the offering, issuance, and sale of up to a maximum aggregate offering price of $300.0 million of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. The Company simultaneously entered into a sales agreement with Cowen and Company, LLC, as sales agent, to provide for the issuance and sale by the Company of up to $100.0 million of common stock from time to time in “at-the-market” offerings under the Registration Statement and related prospectus (“ATM Program”). As of September 30, 2025, no sales had been made pursuant to the ATM Program. One Big Beautiful Bill Act On July 4, 2025, new U.S tax legislation was signed into law (known as the “One Big Beautiful Bill Act” or “OBBBA”) which makes permanent many of the tax provisions enacted in 2017 as part of the Tax Cuts and Jobs Act that were set to expire at the end of 2025. In addition, the OBBBA makes changes to certain U.S. corporate tax provisions, but many are generally not effective until 2026. The Company is currently evaluating the impact of the new legislation on its operations and on its condensed consolidated financial statements and related disclosures.

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