Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes and other financial information included elsewhere in this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Special Note Regarding Forward-Looking Statements” and “Risk Factors” sections of this Annual Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Unless the context requires otherwise, references in this Annual Report to “Acrivon” the “Company”, “we”, “us”, and “our” refer to Acrivon Therapeutics, Inc. and its subsidiaries.
Overview
We are a clinical-stage biotechnology company discovering and developing precision medicines utilizing our proprietary Generative Phosphoproteomics Acrivon Predictive Precision Proteomics, or AP3, platform. We have established the Generative Phosphoproteomics AP3 platform which is designed to allow us to quantify the drug-regulated compound-specific effects and pathway activity levels inside the intact cell in an unbiased manner. As such, all drug-regulated effects on the disease-driving, upregulated pathways and active proteins are revealed for each compound that we profile. The Generative Phosphoproteomics AP3 platform is comprised of a growing suite of powerful, internally developed tools, including the AP3 Interactome, the AP3 Kinase Substrate Relationship Predictor, the AP3 Data Portal, designed to enable the conversion of multimodal data into structured data amenable for generative AI analyses, and the AP3 Chatbot. Through the combination of these distinctive tools and capabilities, the platform enables us to go beyond current AI target-centric drug discovery and to rapidly design highly differentiated compounds with high target specificity and optimal, desirable pathway effects on the intracellular signaling network to mechanistically address the underlying molecular cause of disease. The integrated analyses of our AP3-generated proprietary datasets through a unified computational interface enables streamlined transition from preclinical to the clinical phase, as exemplified by the development of ACR-2316. Importantly, all drug-regulated effects on the disease-driving, upregulated pathways and active proteins are revealed for each compound that we profile. We apply these distinctive capabilities of AP3 for rational drug design optimization for monotherapy activity, the identification of drug combinations, novel target identification, the evaluation of potential in-licensing candidates, identification of potential mechanism based adverse events, and patient response prediction.
By applying our highly specific patient selection approach, and other AP3 applications, to drug development, we seek to both accelerate clinical development and significantly increase the probability of successful treatment outcomes for patients. Our pipeline includes our Phase 2b lead program, ACR-368, also known as prexasertib, a precision oncology asset in-licensed from Lilly that targets CHK1 and CHK2, or CHK1/2. In past Lilly-sponsored trials, ACR-368 was dosed in more than 400 patients at the recommended Phase 2 dose, or RP2D, with reported deep, durable responses, including complete responses, or CRs, in a proportion of patients with solid tumors in past single center and multi-center Phase 2 clinical trials in tumor indications with high unmet need. ACR-368 also demonstrated a generally favorable safety and tolerability profile with primarily reversible hematological toxicity and very limited non-hematological adverse events.
While Lilly had explored ACR-368 in many solid tumor types in the above-mentioned studies, they never tested EC. Using our AP3 platform we generated a protein-based tumor biopsy test, called OncoSignature, designed to prospectively predict treatment benefit of ACR-368 at an individual patient level. Using the OncoSignature for screening across routine-processed human tumor types (so-called “Indication finding”) we identified EC as a tumor type which was predicted to be particularly sensitive to ACR-368. Based on this, we received clearance from the FDA for an IND application to advance ACR-368 in Phase 2 single arm clinical trials in multiple tumor types including EC, conducted under the FDA program known as the master protocol, which was developed to help expedite drug development in multiple tumor types for drugs with an established RP2D within the same overall trial structure. Subjects in arm 1 of the ACR-368-201 study are stratified for treatment based on BM+ predicted sensitivity to ACR-368, across multiple sites in the United States in this registrational intent trial. Through the use of our OncoSignature test for prospective responder identification, we intend to significantly increase the overall response rate, or ORR, across tumor types sensitive to ACR-368.
Based on interim clinical data from the ACR-368-201 trial, we found that the confirmed ORR in Arm 1 or EC was 39%, and 44% in patients treated with ≤2 prior lines of therapy, or pLoT. Across pooled BM+ and BM- subjects with serous EC, ≤2 pLoT showed a confirmed ORR of 52%. Serous EC is a very high unmet need and extremely aggressive form of EC, contributing to ~50% of all EC mortality. Based on this finding, arms 3 and 4 have been added to the study. Arm 3 is investigating ACR-368 in serous EC subjects with up to two pLoT without the need for pre-treatment tumor biopsy or biomarker stratification (“a serous all comer”), and utilizes ULDG as a sensitizer. Arm 4 will investigate the same “serous all comer” subject group but without ULDG sensitization (ACR-368 monotherapy).
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Exploratory arm 2 of the study has been completed having achieved our objectives which were to assess whether ULDG might contribute to the efficacy of ACR-368 in tumors that otherwise are BM- and predicted not to respond and to assess the safety of ULDG. Both objectives have been achieved. We have observed separation of the lower bound of the 95th percentile confidence interval from the prespecified target ORR indicating ULDG may contribute to ACR-368 clinical activity, and per the above a manageable tolerability profile with primarily mechanism-based AEs.
We have previously confirmed in preclinical studies that ULDG sensitizes both BM- and BM+ tumors to ACR-368, as predicted by the AP3 platform, and this is consistent with an upregulation of the ACR-368 OncoSignature biomarkers in both human tumor cell lines and in human tumor xenograft mouse models after ULDG treatment. Consistent with this, ACR-368 is also being studied in combination with ULDG in additional indications, such as squamous cell carcinomas, including squamous cell cancer, or SCC, of head and neck (H&N), or SCCHN, in an Investigator-Initiated Trial (IIT). Given broad anti-tumor activity observed in past trials in other tumor types, we will potentially study ACR-368 in additional tumor types, potentially with ULDG, where there is high unmet need and competitive positioning opportunity. For example, we are assessing trial initiation in myelodysplastic syndrome/myeloproliferative neoplasms (MDS/MPN), diseases with high unmet need, based on transcription factor gene mutations rendering these malignancies sensitive to CHK1/2 as observed in various preclinical studies, including studies using ACR-368.
We are also leveraging our proprietary Generative Phosphoproteomics AP3 precision medicine platform for streamlined drug discovery through AP3-based drug optimization in intact cells and co-crystallography and to develop our internally-discovered pipeline programs. These include ACR-2316, our second clinical-stage asset, which is a novel, selective, dual WEE1/PKMYT1 inhibitor designed specifically for enhanced therapeutic index by achieving 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, combined with exquisite selectivity.
ACR-2316 entered clinical development in the third quarter of 2024, two quarters ahead of original timelines, and the Phase 1 monotherapy clinical trial of ACR-2316 is currently in the dose escalation portion of this trial. The Phase 1 study is designed to assess the safety and tolerability of ACR-2316. Additionally, the study will seek to establish the pharmacokinetic profile, evaluate preliminary anti-tumor activity and determine the recommended Phase 2 monotherapy dose. Dose optimization is being guided by drug target engagement in alignment with the FDA’s Project Optimus. The company provided initial clinical data in January 2026 based on a December 22, 2025 EDC data extract. Data from a total of 33 patients were dosed across two weekly oral dosing schedules was reported. Based on this data, the company has successfully established two weekly oral dosing regimens of 160 mg QD on a 3d on / 4d off and 240 mg QD 2d on / 5d off weekly administration schedules, with a favorable tolerability profile with transient, mechanism-based hematological adverse events, predominantly neutropenia. A cohort aiming to establish a bi-weekly 2d on / 12d off dosing regimen has been initiated, based on projected enhanced single agent activity and to provide for further dosing flexibility in potential future combination studies. Clinical activity observed at dose level 120 mg and above, with tumor shrinkage in 9 out of 20 evaluable patients, including a confirmed PR in a subject with EC and unconfirmed partial responses in subjects with SCLC and sqNSCLC, two tumor types which have not shown sensitivity to other clinical WEE1 or PKMYT1 inhibitors currently in development.
In addition, the company is advancing ACR-6840, an internally discovered development candidate targeting CDK11. In preclinical studies, ACR-6840 has been shown to be pro-apoptotic in aggressive AML cell lines, potently downregulates MCL1, and shown synergy with BCL2 inhibitors.
Since our inception in 2018, we have devoted substantially all of our resources toward conducting discovery and research activities, organizing and staffing our company, business planning, acquiring and internally discovering drug candidates, establishing and protecting our intellectual property portfolio, developing and progressing ACR-368 and the ACR-368 OncoSignature, preparing for and conducting preclinical studies and clinical trials, establishing arrangements with third parties for the manufacture of ACR-368, the ACR-368 OncoSignature and component materials, advancing our internal co-crystallography-driven, AP3-enabled preclinical programs, conducting preclinical studies, establishing arrangements with third parties for the manufacture of ACR-2316, initiating a Phase 1b clinical trial for ACR-2316, and initiating IND enabling studies for ACR-6840, as well as raising capital. We do not have any drug candidates approved for sale and have not generated any revenue from drug sales.
Since inception, we have funded our operations primarily with proceeds from the sales of shares of our convertible preferred stock, the issuance of convertible notes, our IPO and concurrent private placement, and the 2024 PIPE. Upon the closing of our IPO on November 17, 2022, only common stock remains issued and outstanding. In addition, on April 8, 2024, we entered into a Private Investment in Public Equity, or PIPE, securities purchase agreement, or the PIPE Purchase Agreement, for the April 2024 Private Placement. Pursuant to the PIPE Purchase Agreement, we agreed to issue and sell to the PIPE investors an aggregate of (i) 8,235,000 shares of our common stock at a purchase price of $8.50 per share, and (ii) Pre-Funded Warrants to purchase up to an aggregate of 7,060,000 shares of our common stock at a purchase price of $8.499 per Pre-Funded Warrant, which represents the per share purchase price of our common stock less the $0.001 per share exercise price for each Pre-Funded Warrant. As of December 31, 2025, the
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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.
We have incurred recurring operating losses since inception. Our net losses for the years ended December 31, 2025 and 2024 were $77.9 million and $80.6 million, respectively. As of December 31, 2025, we had an accumulated deficit of $274.9 million. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, particularly if and as we:
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continue to conduct or initiate new preclinical studies and clinical trials for our clinical-stage assets, ACR-368 and ACR-2316;
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continue to discover and develop additional drug candidates and drug-tailored OncoSignature tests;
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acquire or in-license other drug candidates and technologies;
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maintain, expand, and protect our intellectual property portfolio;
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hire additional clinical and scientific personnel;
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further develop and refine the manufacturing processes for ACR-368, the ACR-368 OncoSignature, ACR-2316, or any future drug candidates;
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seek regulatory approvals and pursue commercialization for any drug candidates that successfully complete clinical trials; and
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add operational, financial, and management information systems and personnel, including personnel to support our drug development and planned future commercialization efforts, as well as to support our obligations as a public reporting company.
We are incurring and expect to continue to incur significant costs associated with operating as a public company. Furthermore, we will not generate revenue from drug sales until we successfully complete clinical development and obtain regulatory approval for a drug candidate. In addition, if we obtain regulatory approval for a drug candidate and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support drug sales, marketing, manufacturing and distribution activities. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical studies, milestones achieved, and our expenditures on other research and development activities.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time that we can generate significant revenue from drug sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. If we are unable to raise capital as needed, this could have a negative impact on our financial condition and ability to pursue our business strategies including requiring us to delay, reduce or eliminate drug development or future commercialization efforts. The amount and timing of our future funding requirements will depend on many factors including the successful advancement of ACR-368, the ACR-368 OncoSignature, ACR-2316, or any future drug candidates. Our ability to raise additional funds may also be adversely impacted by potential worsening global economic conditions, and disruptions to, and volatility in the credit and financial markets in the United States and worldwide, such as those resulting from conflicts in the Middle East and the war in Ukraine and the uncertainties related to international trade policies and tariffs. There can be no assurances that the current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all.
As of December 31, 2025, we had cash, cash equivalents and investments of $118.6 million. We believe that our existing cash, cash equivalents and investments as of December 31, 2025, will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See the section titled “—Liquidity and Capital Resources”.
Companion Diagnostic Agreement
In June 2022, we entered into a companion diagnostic agreement, or the Akoya Agreement, with Akoya, pursuant to which we agreed to co-develop, validate, and commercialize our proprietary ACR-368 OncoSignature test, the companion diagnostic that will be used to identify patients with EC most likely to respond to ACR-368.
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Pursuant to the agreement, Akoya, in partnership with us, agreed to develop, clinically validate, seek regulatory approval for, and, pending ACR-368 approval, commercialize the OncoSignature test required for prescribing ACR-368. Development of the CDx will be overseen by a joint steering committee. Each party was required to use commercially reasonable efforts to carry out its activities under the agreement. The agreement contained certain mutual exclusivity obligations of the parties with respect to the biomarkers and drug target, subject to certain specified limitations, including in the event that Akoya is unable to sufficiently supply commercial needs of such CDx.
On February 18, 2026, we announced the completion and certification of our internally, wholly-owned and operated CLIA certified laboratory, located on premises in Watertown, Massachusetts. With these in-house capabilities, including the ability to receive human ptient samples to ultimately run the OncoSignature test in-house, on February 25, 2026, we and Akoya entered into a Termination and Transition Agreement pursuant to which we have mutually agreed to terminate the OncoSignature Companion Diagnostic Agreement, dated June 17, 2022, by and between us and Akoya. The termination does not involve any financial payments from or to any of the parties to such agreement. Akoya and we have agreed to a transition plan to ensure all applicable procedures, materials and know-how related to Akoya’s previous ACR-368 OncoSignature related testing and development activities are transferred to us. We will transition ACR-368 OncoSignature testing to our newly launched, fully certified, internal CLIA laboratory. By bringing CLIA operations and laboratory resources in-house, we believe that we have gained enhanced capabilities and efficiencies to support the development of its current and future targeted therapeutic agents. This includes full control over the identification of predictive biomarkers, the development of companion diagnostics, indication finding, and the streamlining of potential co-regulatory approvals and co-commercialization of therapeutic and diagnostic products. As part of the termination, during the transfer of clinical testing to our CLIA laboratory, Akoya is expected to continue to meet all ACR-368 OncoSignature clinical testing requirements to support our ongoing registrational-intent Phase 2b study. Effective immediately and as part of the termination, we have ensured full development and commercialization rights to our proprietary ACR-368 OncoSignature test.
Components of Results of Operations
Revenue
To date, we have not generated any revenue, and we do not expect to generate any revenue in the foreseeable future from drug sales. We may in the future generate revenue from payments received under collaboration agreements, which could potentially include (but not be limited to) payments of upfront fees, license fees, milestone-based payments and reimbursements for research and development efforts.
Operating Expenses
Research and Development
The majority of our expenses have been research and development expenses, which consist primarily of costs incurred in connection with the development of ACR-368 and ACR-2316, and the ACR-368 OncoSignature, as well as our research and development activities, including our drug discovery efforts. We expense research and development costs as incurred, which include:
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external research and development expenses incurred under agreements with CROs, as well as investigative sites and consultants that conduct our clinical trials and other scientific development services;
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costs related to manufacturing material for our clinical trials, including fees paid to CMOs;
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manufacturing scale-up expenses and the cost of acquiring and manufacturing clinical trial materials;
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direct cost for conducting internal research and development to generate preclinical validation data for ACR-368 including the ACR-368 OncoSignature, for ACR-2316, and for our internal preclinical drug discovery programs inclusive of ACR-6840;
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Costs related to the establishment of our CLIA laboratory;
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the cost to obtain and maintain licenses to intellectual property, such as those with Lilly and related future payments should certain milestones be achieved;
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employee-related expenses, including salaries, bonuses, benefits, stock-based compensation, and other related costs for those employees involved in research and development efforts;
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costs of outside consultants, including their fees, stock-based compensation, and related travel expenses;
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expenses to acquire technologies to be used in research and development;
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upfront and maintenance fees incurred under license, acquisition, and other third-party agreements;
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costs related to regulatory activities, including filing fees paid to regulatory agencies and compliance with regulatory requirements; and
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facilities, depreciation, and other expenses, which include direct and allocated expenses for rent, maintenance of facilities, and equipment and software.
Research and development costs are expensed as incurred. We recognize external development costs as related goods are delivered or services are performed. Significant judgments and estimates are made in determining the accrued expense balances at the end of any reporting period.
We record direct costs for our development, discovery, and early-stage drug candidates at the program level. Our indirect research and development costs are primarily personnel-related costs, facilities, and other costs. Employees and infrastructure are not directly tied to any one program and are deployed across our programs. As such, we do not track these costs on a specific program basis.
Our external research and development expenses consist primarily of fees paid to CROs, CMOs, research laboratories, and outside consultants in connection with our process development, manufacturing, and clinical development activities. Our direct external research and development expenses also include fees incurred under license and intellectual property purchase agreements. We track these external research and development costs on a program-by-program basis once we have identified a drug candidate.
The successful development of our ACR-368 and ACR-368 OncoSignature test, ACR-2316, or any other future drug candidates, is highly uncertain. We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development and manufacturing of ACR-368 and ACR-2316 and conduct discovery and research activities for our preclinical programs, inclusive of ACR-6840.
We cannot determine with certainty the timing of initiation, the duration, or the completion costs of current or future clinical trials of our drug candidates due to the inherently unpredictable nature of preclinical and clinical development. Clinical development timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which drug candidates to pursue and how much funding to direct to each drug candidate on an ongoing basis in response to the results of ongoing and future clinical trials, regulatory developments and our ongoing assessments as to each drug candidate’s commercial potential. We will need to raise substantial additional capital in the future. Our clinical development costs are expected to increase significantly with our ongoing and planned clinical trials. We anticipate that our expenses will increase substantially, particularly due to the numerous risks and uncertainties associated with developing drug candidates, including the uncertainty of:
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the scope, rate of progress and expenses of our ongoing research activities and clinical trials and other research and development activities;
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confirming the appropriate safety profile established in past clinical trials;
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successful enrollment in and completion of clinical trials;
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whether our drug candidates show efficacy with an increased ORR through patient responder identification in our clinical trials;
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receipt of marketing approvals from applicable regulatory authorities;
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establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
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obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our drug candidates;
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the extent to which we establish additional collaboration or license agreements;
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commercializing drug candidates, if and when approved, whether alone or in collaboration with others; and
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continued acceptable safety profile of the products following any regulatory approval.
Any changes in the outcome of any of these variables with respect to the development of our drug candidates in clinical development could mean a significant change in the costs and timing associated with the development of these drug candidates. We may never succeed in achieving regulatory approval for any of our drug candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some drug candidates or focus on others. For example, if the FDA, European Medicines Agency or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that drug candidate.
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General and Administrative
General and administrative expenses consist primarily of employee-related costs, including salaries, bonuses, benefits, and stock-based compensation expenses for personnel in executive, finance, accounting, human resources and other administrative functions. Other significant general and administrative expenses include legal fees relating to patent, intellectual property and corporate matters, fees paid for accounting, audit, consulting and other professional services, and expenses for rent, insurance and other operating costs.
We anticipate that our general and administrative expenses will continue to increase in the future as we increase our headcount and services to support our continued research activities and development of our drug candidates. We also anticipate that we will continue to incur significant accounting, audit, legal, regulatory, compliance and director and officer insurance costs, as well as investor and public relations expenses associated with operating as a public company.
Other Income (Expense), Net
Interest Income
Interest income consists of income earned on cash equivalents and investments and amortization of premiums and accretion of discounts to maturity for available-for-sale debt securities.
Other Expense, Net
Other expense, net primarily consists of realized and unrealized gains and losses on foreign currency transactions, state and franchise taxes, and investment management fees.
Income Taxes
Since our inception, we have not recorded any income tax benefits for the net losses we have incurred or for the research and development tax credits earned in each year and interim period, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credit carryforwards will not be realized.
As of December 31, 2025, we had $153.2 million and $156.4 million of federal and state net operating loss carryforwards, respectively. The federal net operating losses are not subject to expiration and the state net operating losses begin to expire in 2038. These loss carryforwards are available to reduce future federal and state taxable income, if any.
Results of Operations
Comparison of the Years Ended December 31, 2025 and 2024
The following table summarizes our results of operations (in thousands):
Year Ended December 31,
Operating expenses:
Other income (expense), net:
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Research and Development Expenses
The following table summarizes our research and development expenses (in thousands):
Year Ended December 31,
Direct research and development expenses by program:
Unallocated research and development expenses:
Personnel related (including stock-based compensation) 21,816 18,184 3,632
Research and development expenses were $60.0 million for the year ended December 31, 2025, compared to $64.0 million for the year ended December 31, 2024. The decrease of $4.0 million was primarily due to:
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a $11.1 million net decrease in costs driven by fewer scheduled and incurred milestones in the year, as well as the prioritization of EC over other tumor types in the ACR-368 clinical trial;
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a $4.1 million net increase in costs related to ACR-2316, our novel, internally-discovered clinical-stage asset. We initiated a clinical trial and related activities in the third quarter of 2024, which has continued to progress through 2025;
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a $1.7 million net decrease in costs related to preclinical drug discovery activities progression, which prior to ACR-2316 initiation in the third quarter of 2024, had included ACR-2316 and in 2025 is significantly comprised of investment in ACR-6840, our internally discovered development candidate targeting CDK11;
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a $3.6 million increase in personnel-related costs, including $0.9 million of changes to stock-based compensation expense, primarily due to an increase in research and development headcount and salaries over time; and
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a $1.1 million increase in facilities, supplies and other expenses, primarily driven by an increase in headcount and related research activities.
General and Administrative Expenses
General and administrative expenses were $24.1 million for the year ended December 31, 2025, compared to $25.2 million for the year ended December 31, 2024. The decrease of $1.1 million was primarily due to a $0.9 million decrease in payroll and employee-related expenses, including $0.5 million of stock-based compensation expense, and a $0.2 million decrease in professional fees, facilities, supplies, and other expenses.
Total Other Income, Net
Total other income, net was $6.2 million for the year ended December 31, 2025, compared to total other income, net of $8.6 million for the year ended December 31, 2024. The change of $2.4 million is primarily attributable to a decrease in interest income and accretion earned on our investments.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have not recognized any revenue and have incurred significant losses in each period and on an aggregate basis. We have not yet commercialized any drug candidates, and we do not expect to generate revenue from sales of any drug candidates or from other sources for several years, if at all. As of December 31, 2025, we had $118.6 million in cash, cash equivalents and investments, and we had an accumulated deficit of $274.9 million. We have funded our operations primarily with proceeds from the sales of shares of our convertible preferred stock, the issuance of convertible notes, our IPO and concurrent private placement, and our April 2024 Private Placement. We believe that our existing cash, cash equivalents and investments of $118.6 million as of December 31, 2025, will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2027.
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Cash Flows
The following table summarizes our cash flows (in thousands):
Year Ended December 31,
Net cash used in operating activities $ (63,665 ) $ (65,669 )
Net cash provided by (used in) investing activities 66,100 (51,771 )
Net cash (used in) provided by financing activities (749 ) 121,027
Net increase in cash, cash equivalents and restricted cash $ 1,686 $ 3,587
Net Cash Used in Operating Activities
Net cash used in operating activities was $63.7 million for the year ended December 31, 2025, compared to net cash used in operating activities of $65.7 million for the year ended December 31, 2024. The decrease in net cash used in operating activities of 2.0 million was primarily driven by an decrease in net loss of $2.7 million.
Net Cash Provided by (Used in) Investing Activities
Net cash provided by investing activities was $66.1 million for the year ended December 31, 2025, resulting from $149.5 million received in proceeds from maturities of investments, offset by purchases of investments of $81.7 million and purchases of property and equipment of $1.7 million.
Net cash used in investing activities was $51.8 million for the year ended December 31, 2024, resulting from purchases of investments of $202.9 million and purchases of property and equipment of $2.8 million, offset by $153.9 million in proceeds from maturities of investments.
Net Cash (Used in) Provided by Financing Activities
Net cash used in financing activities was $0.7 million for the year ended December 31, 2025, resulting from $0.7 million of payments for tax withholdings related to the vesting of restricted stock units.
Net cash provided by financing activities was $121.0 million for the year ended December 31, 2024, resulting from $130.0 million in proceeds from the April 2024 Private Placement and $0.1 million in proceeds from the exercise of stock options, offset by $6.5 million of payments of offering costs and $2.5 million of payments for tax withholdings related to the vesting of restricted stock units.
Funding Requirements
As of December 31, 2025, our cash, cash equivalents and investments were $118.6 million. We believe that our existing cash, cash equivalents and investments as of December 31, 2025, will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect.
We expect to incur significant expenses and operating losses for the foreseeable future as we advance our drug candidates through clinical development, seek regulatory approval and pursue commercialization of any approved drug candidates. We expect that our research and development and general and administrative costs will increase in connection with our planned research and clinical activities and operating as a public company. If we receive regulatory approval for any of our drug candidates, we expect to incur significant commercialization expenses related to drug manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other drug candidates.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical drug candidates, we are unable to accurately predict the amount of our operating expenditures. Our future capital requirements will depend on many factors, including but not limited to:
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the scope, timing, progress, results and costs of preclinical and clinical development activities;
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the costs, timing and outcome of regulatory review of drug candidates;
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the costs of future activities, including drug sales, medical affairs, marketing, manufacturing and distribution, for any drug for which we receive marketing approval;
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the costs of establishing and maintaining arrangements with third party manufacturers for the commercial supply of products that receive marketing approval, if any;
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the revenue, if any, received from commercial sale of our products, should any drug candidates receive marketing approval;
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the cash requirements of any future in-licenses,acquisitions or discovery of drug candidates;
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the cost and timing of attracting, hiring and retaining skilled personnel to support our operations and continued growth;
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the cost of implementing operational, financial and management systems;
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the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
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our ability to establish and maintain collaborations, strategic partnerships or marketing, distribution, licensing or other strategic arrangements with third parties on favorable terms, if at all; and
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the timing, receipt and amount of sales of, or milestone payments related to or royalties on, current or future drug candidates, if any.
A change in the outcome of any of these or other variables with respect to the development of ACR-368, the ACR-368 OncoSignature, ACR-2316, or any drug or development candidate we may develop in the future could significantly change the costs and timing associated with our development plans. Further, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.
Until such time, if ever, as we can generate substantial drug revenues to support our expenses, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations and other similar arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, drug candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market our drug candidates even if we would otherwise prefer to develop and market such drug candidates ourselves
Contractual Obligations
Leases
We lease laboratory and office space in Watertown, Massachusetts. This lease is classified as an operating lease, and will expire in April 2028, with an option to extend the term for an additional five years at then-market rental rates. Additionally, we also lease laboratory and office space in Lund, Sweden, which is classified as an operating lease. The term of the lease commenced in December 2023, has an initial term of three years, and will automatically renew for an additional term of three years unless we provide written notice of termination nine months prior to the termination date. In addition, we entered into an operating lease agreement in July 2024 for additional office and laboratory space adjacent to its existing leased space located in Lund, Sweden. The term of the lease commenced in September 2024. The lease has an initial term of three years and will automatically renew for an additional term of three years unless we provide written notice of termination nine months prior to the termination date. Future minimum commitments under these leases are $3.0 million as of December 31, 2025. Of the $3.0 million, $1.3 million is due in 12 months or less. See Note 7 in our consolidated financial statements appearing at the end of this Annual Report for more information on our lease obligations.
License Agreement
We may incur contingent royalty and milestone payments that we are required to make under our license agreement with Lilly, pursuant to which we have in-licensed certain intellectual property. We are required to pay Lilly aggregate development and commercial milestone payments of up to $168.0 million, of which $5.0 million is due prior to NDA. Due to the uncertainty of the achievement and timing of the events requiring payment under our license agreement with Lilly, the amounts to be paid by us are not fixed or determinable at this time. We are also obligated to pay a tiered percentage royalty on annual net sales ranging from a low single-digit up to a maximum
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of 10%, subject to certain specified reductions. For additional information, see the section titled “Business—Licensing and Collaborations.”
Companion Diagnostic Agreement
On February 25, 2026, we and Akoya entered into a Termination and Transition Agreement pursuant to which we have mutually agreed to terminate the OncoSignature Companion Diagnostic Agreement, dated June 17, 2022, by and between us and Akoya. Until this time, we had incurred contingent milestone payments that we were required to make under the companion diagnostic agreement. As of December 31, 2025, development and pre-commercialization milestones totaling $18.2 million have been achieved and paid to Akoya under the agreement. For additional information, see the section titled “Business—Licensing and Collaborations.”
Purchase and Other Obligations
We enter into contracts in the normal course of business with CROs and other third-party vendors for clinical trials and testing and manufacturing services. These contracts do not contain minimum purchase commitments and are cancelable by us upon written notice. Payments due upon cancellation consist of payments for services provided or expenses incurred, including non-cancelable obligations of our service provided up to one year after the date of cancellation.
Critical Accounting Policies and Significant Judgments and Estimates
Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 2 in our consolidated financial statements appearing elsewhere in this Annual Report, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
Research and Development Expenses
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses as of each balance sheet date. This process involves reviewing open contracts and purchase orders, communicating with our personnel and with vendors to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary.
We base our expenses related to research and development activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with vendors that conduct research and development on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the research and development expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid balance accordingly. Non-refundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.
Although we do not expect our estimates to be materially different from amounts incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed, it could result in us reporting amounts that are too high or too low in any particular period. To date, there have been no material differences between our estimates of such expenses and the amounts incurred.
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Stock-Based Compensation Expense
We measure stock-based compensation based on the grant date fair value of the stock-based awards and recognize stock-based compensation expense on a straight-line basis over the requisite service period of the awards, which is generally the vesting period of the respective award. Forfeitures are accounted for as they occur. For non-employee awards, compensation expense is recognized as the services are provided, which is generally ratably over the vesting period. At inception, prior to the issuance of any stock option grants, we adopted the guidance of Accounting Standards Update, or ASU, No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Non-employee Share-based Payment Accounting, ASU 2018-07, and account for awards to non-employees using the grant date fair value without subsequent periodic remeasurement.
Stock-based compensation expense is classified in our consolidated statements of operations and comprehensive loss based on the function to which the related services are provided or in the same manner in which the grantee’s payroll costs are classified or in which the grantee’s service payments are classified.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and our expected dividend yield. Since there is limited historical data of our share price on the public market, we determined the volatility for awards granted based on an analysis of reported data for a group of guideline companies that issued options with substantially similar terms. The expected volatility has been determined using a weighted-average of the historical volatility measures of this group of guideline companies. We expect to estimate expected volatility based on the group of guideline companies until we have adequate historical data regarding the volatility of our own traded stock price. The expected term of our stock options granted to employees and non-employees has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. We have not paid, and do not anticipate paying, dividends on our common stock; therefore, the expected dividend yield is assumed to be zero. The fair value of our common stock is determined based on the quoted market price of our common stock.
Recent Accounting Pronouncements
A description of recently adopted and recently issued but not yet adopted accounting pronouncements that may potentially impact our financial position, results of operations and cash flows is disclosed in Note 2 to our consolidated financial statements appearing elsewhere in this Annual Report.
Emerging Growth Company and Smaller Reporting Company Status
The JOBS Act provides that, among other things, an “emerging growth company” can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. As an emerging growth company, we have elected not to “opt out” of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards and, as a result, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for private companies on a case-by-case basis until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. As a result, our consolidated financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies. We intend to rely on certain of the other exemptions and reduced reporting requirements provided by the JOBS Act. As an emerging growth company, we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b), and (ii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis).
We will remain an emerging growth company until the earlier to occur of (1) the last day of our fiscal year (a) following the fifth anniversary of the closing of our IPO, (b) in which we have total annual gross revenues of at least $1.235 billion or (c) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means the market value of our common shares that is held by non-affiliates exceeds $700 million as of the last day of our second quarter, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual
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revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million.
If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
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Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
Under SEC rules and regulations, because we are considered to be a “smaller reporting company,” we are not required to provide the information required by this item in this report.
Item 8. Financial Statements and Supplementary Data.
Our consolidated financial statements, together with the reports of our independent registered public accounting firms, appear beginning on page F-1 of this Annual Report for the years ended December 31, 2025 and 2024.
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, have evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) of the Exchange Act) as of the end of the period covered by this Annual Report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of December 31, 2025, our disclosure controls and procedures were effective at the reasonable assurance level.
The Company’s disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed by us in reports that we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms; and (ii) accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely discussions regarding required disclosure. We believe that a control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
Management's Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of the effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies and procedures included in such controls may deteriorate. Our management conducted an assessment of the effectiveness of our internal control over financial reporting based on the criteria set forth in “Internal Control - Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, our management concluded that, as of December 31, 2025, our internal control over financial reporting was effective.
Attestation Report of the Registered Public Accounting Firm
This Annual Report does not include an attestation report of our registered public accounting firm due to an exemption provided by the JOBS Act for “emerging growth companies.”
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
Rule 10b5-1 Trading Plans
As of the date of this Annual Report, none of our directors or executive officers maintains an active Rule 10b5-1 trading arrangement.
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Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
None.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance.
Information relating to our board of directors is found in the Company’s definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the SEC no later than 120 days after the close of the Company’s fiscal year ended December 31, 2025 (the “Proxy Statement”), under “Proposal No. 1: Election of Class III Directors” and is incorporated herein by reference.
Information relating to our executive officers is found in the Proxy Statement under “Executive Officers” and is incorporated herein by reference.
Information relating to our insider trading procedure and processes is found in the Proxy Statement under “Corporate Governance and Our Board of Directors—Other Governance Matters—Insider Trading Policy” and is incorporated herein by reference.
Information relating to our code of ethics is found in the Proxy Statement under “Corporate Governance and Our Board of Directors—Other Governance Matters—Code of Business Conduct and Ethics” and is incorporated herein by reference.
Information about our audit committee is found in the Proxy Statement under “Corporate Governance and Our Board of Directors—Board Committees—Audit Committee” and is incorporated herein by reference.
Information about our compliance with Section 16(a) is found in the Proxy Statement under “Corporate Governance and Our Board of Directors—Delinquent Section 16(a) Reports” and is incorporated herein by reference.
Item 11. Executive Compensation.
Information on executive compensation, director compensation and compensation committee matters is found in the Proxy Statement under “Corporate Governance and Our Board of Directors—Board Committees,” “Director Compensation,” “Executive Compensation” and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Information regarding security ownership of certain beneficial owners and management and securities authorized for issuance under our equity compensation plans and arrangements is found in the Proxy Statement under “Ownership of Our Common Stock” and “Equity Compensation Plan Information” and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
Information regarding transactions with related persons and director independence is found in the Proxy Statement under “Proposal No. 1: Election of Class III Directors—Nominees and Continuing Directors,” “Corporate Governance and Our Board of Directors,” and “Certain Relationships And Related Person Transactions” and is incorporated herein by reference.
Item 14. Principal Accounting Fees and Services.
Information related to the fees and services of our principal independent accountants, PricewaterhouseCoopers LLP, is found in the Proxy Statement under “Proposal No. 2. Ratification of Appointment of the Independent Registered Public Accounting Firm” and is incorporated herein by reference.
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PART IV
Item 15. Exhibits, Financial Statement Schedules.
(1)
For a list of the financial statements included herein, see Index to the Consolidated Financial Statements on page F-1 of this Annual Report, incorporated into this Item by reference.
(2)
Financial statement schedules have been omitted because they are either not required or not applicable or the information is included in the consolidated financial statements or the notes thereto.
(3)
Exhibits:
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ExhibitNumber Description
4.1* Description of registrant’s securities.
19.1* Insider Trading Policy
21.1* List of Subsidiaries
98
24.1 Power of Attorney (included on signature page)
101.SCH Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
* Filed herewith.
+ Indicates management contract or compensatory plan or arrangement.
† Certain confidential information contained in this exhibit, indicated by asterisks, has been omitted pursuant to Item 601(b)(10)(iv) or Item 601(a)(5), as applicable, of Regulation S-K.
** The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Annual Report and are not deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act, irrespective of any general incorporation language contained in such filing.
Item 16. Form 10-K Summary
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
Acrivon Therapeutics, Inc.
Date: March 19, 2026 By: /s/ Peter Blume-Jensen
Peter Blume-Jensen, M.D., Ph.D.
Chief Executive Officer and President
(Principal Executive Officer)
Date: March 19, 2026 By: /s/ Adam Levy
Adam Levy, Ph.D., M.B.A.
Chief Financial Officer
(Principal Financial Officer)
POWER OF ATTORNEY
KNOW ALL BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Peter Blume-Jensen and Adam Levy, and each of them, as his or her true and lawful agents, proxies and attorneys-in-fact, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitutes or substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.
Signature Title Date
Peter Blume-Jensen, M.D., Ph.D. (Principal Executive Officer)
/s/ Adam Levy Chief Financial Officer March 19, 2026
Adam Levy, Ph.D., M.B.A. (Principal Financial Officer)
/s/ Katharine Peterson Chief Accounting Officer March 19, 2026
Katharine Peterson (Principal Accounting Officer)
/s/ Derek DiRocco Director March 19, 2026
Derek DiRocco, Ph.D.
Kristina Masson, Ph.D., M.B.A.
/s/ Sharon Shacham Director March 19, 2026
Sharon Shacham, Ph.D., M.B.A.
/s/ Michael Tomsicek Director March 19, 2026
Michael Tomsicek, M.B.A.
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/s/ Charles Baum Director March 19, 2026
Charles Baum, M.D., Ph.D.
/s/ Ivana Magovcevic-Liebisch Director March 19, 2026
Ivana Magovcevic-Liebisch, Ph.D., J.D.
/s/ Santhosh Palani Director March 19, 2026
Santhosh Palani, Ph.D., C. F.A.
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INDEX TO THE CONSOLIDATED FINANCIAL STATEMENTS
Consolidated Financial Statements for the Years Ended December 31, 2025 and 2024:
Report of Independent Registered Public Accounting Firm – PCAOB ID No. 238 F-2
Consolidated Balance Sheets F-3
Consolidated Statements of Operations and Comprehensive Loss F-4
Consolidated Statements of Stockholders’ Equity F-5
Consolidated Statements of Cash Flows F-6
Notes to the Consolidated Financial Statements F-7
F-1
Report of Independent Registered Public Accounting Firm
Tothe Board of Directors and Stockholders of Acrivon Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidatedbalance sheets of Acrivon Therapeutics, Inc. and its subsidiaries (the “Company”) as of December 31, 2025 and 2024, and the related consolidatedstatements of operations and comprehensive loss, of stockholders’ equity and of cash flowsfor the years then ended, including the related notes (collectively referred to as the “consolidatedfinancial statements”). In our opinion, the consolidatedfinancial statements present fairly, in all material respects, the financial position of the Companyas ofDecember 31, 2025 and 2024, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidatedfinancial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidatedfinancial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidatedfinancial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidatedfinancial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidatedfinancial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidatedfinancial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidatedfinancial statements. We believe that our audits provide a reasonable basis for our opinion.
Emphasis of Matter
As discussed in Note 1 to the consolidated financial statements, the Company has incurred significant losses since inception and negative cash flows from operations. Management’s evaluation of the events and conditions related to this matter are also described in Note 1.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
March 19, 2026
We have served as the Company's auditor since 2022.
F-2
ACRIVON THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
December 31,
Assets
Current assets:
Prepaid expenses and other current assets 1,863 2,149
Operating lease right-of-use assets 2,527 3,554
Long-term investments — 5,089
Liabilities and stockholders’ equity
Current liabilities:
Accrued expenses and other current liabilities 12,215 15,399
Operating lease liabilities, current 1,172 1,057
Operating lease liabilities, non-current 1,537 2,588
Commitments and contingencies (Note 13)
Stockholders’ equity:
Accumulated other comprehensive income 111 447
Total liabilities and stockholders’ equity $ 129,717 $ 196,588
The accompanying notes are an integral part of these consolidated financial statements.
F-3
ACRIVON THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
Year Ended December 31,
Operating expenses:
Other income (expense), net:
Other expense, net (270 ) (558 )
Net loss per share—basic and diluted $ (2.02 ) $ (2.38 )
Comprehensive loss:
Other comprehensive (loss) income:
Unrealized (loss) gain on available-for-sale investments, net of tax (336 ) 530
The accompanying notes are an integral part of these consolidated financial statements.
F-4
ACRIVON THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share data)
Common Stock
Exercise of common stock options 30,875 — 90 — — 90
Stock-based compensation expense — — 14,288 — — 14,288
Unrealized gain on available-for-sale investments, net of tax — — — 530 — 530
Exercise of common stock options 225 — 1 — — 1
Stock-based compensation expense — — 14,720 — — 14,720
The accompanying notes are an integral part of these consolidated financial statements.
F-5
ACRIVON THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year Ended December 31,
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash operating lease expense 1,027 932
Changes in operating assets and liabilities:
Prepaid expenses and other current assets 190 237
Accrued expenses and other liabilities (3,353 ) 8,021
Operating lease liabilities (936 ) (1,055 )
Net cash used in operating activities (63,665 ) (65,669 )
Cash flows from investing activities:
Purchases of property and equipment (1,669 ) (2,768 )
Net cash provided by (used in) investing activities 66,100 (51,771 )
Cash flows from financing activities:
Proceeds from issuance of common stock in private placement — 69,997
Proceeds from issuance of pre-funded warrants in private placement — 60,003
Proceeds from exercise of stock options 1 90
Payments of offering costs — (6,543 )
Net cash (used in) provided by financing activities (749 ) 121,027
Net increase in cash, cash equivalents, and restricted cash 1,686 3,587
Cash, cash equivalents and restricted cash at beginning of period 40,016 36,429
Cash, cash equivalents and restricted cash at end of period $ 41,702 $ 40,016
Supplemental disclosure of non-cash investing and financing activities:
Purchases of property and equipment included in accounts payable $ — $ 17
Right-of-use assets obtained in exchange for operating lease liability $ — $ 56
Reconciliation of cash, cash equivalents, and restricted cash:
Total cash, cash equivalents, and restricted cash $ 41,702 $ 40,016
The accompanying notes are an integral part of these consolidated financial statements.
F-6
ACRIVON THERAPEUTICS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. Nature of the Business
Acrivon Therapeutics, Inc. (the “Company”) is a clinical-stage biopharmaceutical 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 manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. The Company 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 CHK2, is in a potentially registrational Phase 2 trial focusing on endometrial cancer (“EC”). 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 ACR-6840, an internally discovered development candidate targeting CDK11 with planned IND filing in the fourth quarter 2026.
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 EC. The FDA has also granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of EC patients who may benefit from ACR-368 treatment. EC 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 EC 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 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 $77.9 million and $80.6 million for the years ended December 31, 2025, and 2024, respectively, and negative cash flows from operations. As of December 31, 2025 and 2024, the Company had an accumulated deficit of $274.9 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.
F-7
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. As of December 31, 2025, 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 $118.6 million as of December 31, 2025, will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the date these consolidated financial statements were issued.
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.
2. Summary of Significant Accounting Policies
Basis of Presentation and Consolidation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include the operations of Acrivon Therapeutics, Inc. and its wholly-owned subsidiaries. All intercompany accounts, transactions and balances have been eliminated in consolidation.
Use of Estimates
The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual of research and development expenses and the valuation of stock-based awards. The Company bases its estimates on historical experience when available, known trends and other market specific data, or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates and assumptions are reflected in reported results in the period in which they become known. Actual results could differ from those estimates.
Segment Information
The Company has one reportable segment focused on the research and development of precision oncology therapies and manages its operations on a consolidated basis for the purpose of allocating resources. The Company’s chief operating decision maker is its chief executive officer, who reviews financial information presented on a consolidated basis for purposes of making operating decisions, assessing financial performance, and allocating resources. As of December 31, 2025, $5.1 million and $2.3 million of the Company’s long-lived assets are held in the United States and in Sweden, respectively.As of December 31, 2024, $4.9 million and $3.1 million of the Company’s long-lived assets are held in the United States and in Sweden, respectively.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include standard checking accounts and amounts held in money market funds. Money market funds include amounts held in a cash sweep account. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits.
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Restricted Cash
Cash accounts with any type of restriction are classified as restricted cash. The Company has restricted cash deposits with a bank, which serve as collateral for a letter of credit issued to the landlord of the Company’s leased facility for a security deposit. The Company classified this amount as restricted cash in the accompanying consolidated balance sheets within non-current assets based on the release date of restrictions.
Deferred Offering Costs
The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs in the accompanying consolidated balance sheets within other assets until such financings are consummated. After consummation of an equity financing, these costs are recorded as a reduction of the proceeds from the offering in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering. Should the Company choose to not initiate such financing, the deferred offering costs would be immediately expensed as operating expenses.
Deferred offering costs associated with the ATM Program are reclassified to additional paid-in-capital on a pro-rata basis when the Company completes offerings under the ATM Program. Any remaining deferred offering costs will be expensed to the consolidated statements of operations and comprehensive loss should the planned offering be abandoned. As of December 31, 2025, $0.5 million of such deferred offering costs are capitalized.
Concentration of Credit Risk and Significant Suppliers
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and investments. The Company has not experienced any credit losses on its cash, cash equivalents, or investments. The Company maintains its cash, cash equivalents and investments, which at times exceed insurance limits, at major financial institutions. The Company has not experienced any losses in such accounts and management believes that such funds are not exposed to any significant credit or concentration risk. However, the Company may face exposure, including constraint on liquidity and access to capital, if there is failure by these or other financial institutions.
The Company is dependent on third-party contract research organizations (“CROs”) and contract manufacturing organizations to supply certain intellectual property and services for research activities in its drug candidates. In particular, the Company relies and expects to continue to rely on a small number of these organizations to supply it with its requirements for key raw materials related to these programs. These drug candidates could be adversely affected by a significant interruption in the supply of key raw materials. Additionally, the Company relies on a single companion diagnostic collaborator to perform ACR-368 OncoSignature tests in the Company’s clinical trials (see Note 13).
Comprehensive Loss
Comprehensive loss is defined as a change in equity of a business enterprise during a period resulting from transactions from non-owner sources. Comprehensive loss includes net loss and certain changes in stockholders' equity that are excluded from net loss. The Company had a net change in available-for-sale securities during the years ended December 31, 2025 and 2024, which met the criteria as other comprehensive (loss) income and, therefore, the Company’s comprehensive loss includes unrealized loss and unrealized gain on those available-for-sale securities during the years ended December 31, 2025 and 2024, respectively.
Investments
The Company classifies all investments with an original maturity of greater than three months and less than one year upon purchase as short-term investments. The Company classifies all investments with an original maturity of greater than one year upon purchase as long-term investments. The Company's investments are classified as available-for-sale securities when investments are available to fund operations, even if the Company intends to hold the investments to maturity. As of December 31, 2025 and 2024, all investments have been classified as available-for-sale securities. Available-for-sale securities are recorded at fair value based upon market prices at period end, with the unrealized gains and losses reported in other comprehensive income (loss). The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is included in interest income in the consolidated statements of operations and comprehensive loss. Realized gains and losses and declines in value due to credit-related factors on available-for-sale securities are included in other expense, net in the consolidated statements of operations and comprehensive loss. The cost of securities sold is based on the specific identification method. Interest on securities classified as available-for-sale is included in interest income in the consolidated statements of operations and comprehensive loss.
At each balance sheet date, the Company assesses available-for-sale debt securities in an unrealized loss position to determine whether the unrealized loss or any potential credit losses should be recognized in the consolidated statements of operations and
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comprehensive loss. The Company evaluates whether it intends to sell, or it is more likely than not that it will be required to sell, the security before recovery of its amortized cost basis. The Company also evaluates whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, the Company considers the severity of the impairment, any changes in interest rates, changes to the underlying credit ratings and forecasted recovery, among other factors. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in other expense, net. There have been no impairment or credit losses recognized during any of the periods presented.
Fair Value Measurements
Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.
ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following:
Level 1—Quoted prices in active markets for identical assets or liabilities.
Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
Property and Equipment, net
Property and equipment are stated at cost, less accumulated depreciation. Costs for capital assets not yet placed in service are capitalized as construction in progress and depreciated once placed in service. Costs of major additions and betterments are capitalized. Maintenance and repairs which do not improve or extend the life of the respective assets are charged to expense as incurred. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from three to seven years. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. The Company's leasehold improvements as of December 31, 2025 and 2024 were immaterial. When an item is sold or retired, the costs and related accumulated depreciation are eliminated, and the resulting gain or loss, if any, is credited or charged to the consolidated statements of operations and comprehensive loss. Property and equipment to be disposed of are carried at fair value less costs to sell. The estimated useful lives of the Company’s property and equipment are as follows:
Estimated Useful Life (in Years)
Laboratory equipment and computer equipment 3-5 years
Furniture and fixtures 5-7 years
Leasehold improvements Lesser of asset useful life or lease term
Impairment of Long-Lived Assets
The Company recognizes an impairment loss in the consolidated statements of operations and comprehensive loss only if the carrying amount of a long-lived asset is not recoverable based on its undiscounted future cash flows and in such case, measures an impairment loss as the difference between the carrying amount and the fair value of the asset.
The Company tests long-lived assets to be held and used, including property and equipment and operating lease right-of-use (“ROU”) assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of assets or asset groups
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may not be fully recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their fair values. The Company has not recognized any impairment losses during the years ended December 31, 2025 and 2024.
Research and Development Expenses
Research and development costs include (i) employee-related expenses, including salaries, benefits, and stock-based compensation expense; (ii) external research and development expenses incurred under arrangements with third parties, such as CRO agreements and consultants; (iii) costs associated with preclinical activities; and (iv) lab supplies, lab expenses and an allocation of rent, depreciation, and infrastructure. Costs incurred in connection with research and development activities are expensed as incurred.
The Company enters into various consulting, research, and other agreements with commercial firms, researchers, universities and other external parties for the provision of goods and services. Such arrangements are generally cancelable upon reasonable notice and payment of costs incurred.
Costs are considered incurred based on an evaluation of the progress to completion of specific tasks under each contract using information and data provided by the Company’s clinical sites and vendors. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company. Depending upon the timing of payments to the service providers, the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s estimates of the work performed under service agreements, milestones achieved, and experience with similar contracts. Milestone payments under license agreements are accrued, with a corresponding expense being recognized, in the period in which the milestone is determined to be probable of achievement and the related amount is reasonably estimable. The Company monitors each of these factors and adjusts estimates accordingly. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception.
Patent Costs
All patent-related costs incurred in connection with filing and prosecuting patent applications such as direct application fees, and legal and consulting expenses are expensed as incurred due to the uncertainty about the recovery of the expenditure. Patent-related costs are classified as general and administrative expenses within the Company’s consolidated statements of operations and comprehensive loss.
Foreign Currency Transactions
The functional currency for the Company’s wholly-owned foreign subsidiary, Acrivon AB, is the United States dollar. All foreign currency transaction gains and losses are recognized in the consolidated statements of operations and comprehensive loss through other expense, net. The Company recognized a net foreign currency transaction gain of $0.2 million during the year ended December 31, 2025, and a net foreign currency transaction loss of $0.1 million during the year ended December 31, 2024, which are primarily related to unrealized and realized foreign currency gains and losses as a result of transactions entered into by Acrivon AB in currencies other than the United States dollar.
Leases
Effective on January 1, 2021, the Company accounts for leases in accordance with Accounting Standards Update (“ASU”) No. 2016-02, Leases, as subsequently amended (collectively, “ASC 842”). In accordance with ASC 842, the Company determines whether an arrangement is or contains a lease at inception. A contract is or contains a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. The Company classifies leases at the lease commencement date, when control of the underlying asset is transferred from the lessor to the lessee, as operating or finance leases and records a ROU asset and a lease liability on the consolidated balance sheets for all leases with an initial lease term of greater than 12 months. The Company has elected to not recognize leases with a lease term of 12 months or less, but payments are recognized as expense on a straight-line basis over the lease term.
The Company enters into contracts that contain both lease and non-lease components. Non-lease components may include maintenance, utilities, and other operating costs. For leases of real estate, the Company combines the lease and associated non-lease components in its lease arrangements as a single lease component. Variable costs, such as utilities or maintenance costs, are not included in the measurement of right-of-use assets and lease liabilities, but rather are expensed when the event determining the amount of variable consideration to be paid occurs.
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Finance and operating lease assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term using the discount rate implicit in the lease if readily determinable. If the rate implicit is not readily determinable, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. ROU assets are further adjusted for initial direct costs, prepaid rent, or incentives received. Operating lease payments are expensed using the straight-line method as an operating expense over the lease term. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Finance lease assets are amortized to depreciation expense using the straight-line method over the shorter of the useful life of the related asset or the lease term. Finance lease payments are bifurcated into (i) a portion that is recorded as interest expense using the effective interest method and (ii) a portion that reduces the finance liability associated with the lease.
In addition, the Company examines other contracts with suppliers, vendors and outside parties to identify whether such contracts contain an embedded lease and, as applicable, records such embedded leases in accordance with ASC 842.
Stock-Based Compensation
The Company accounts for all stock-based payment awards granted to employees and non-employees as stock-based compensation expense at fair value, based on the date of the grant, and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. The Company’s stock-based payments include stock options and grants of common stock. The measurement date for employee awards is the date of grant, and stock-based compensation costs are recognized as expense over the employees’ requisite service period, which is the vesting period, on a straight-line basis. The Company adopted ASU No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU No. 2018-07”) prior to the issuance of any stock option grants. The measurement date for non-employee awardsis the date of grant, and stock-based compensation costsfor non-employees are recognized as expense over the vesting period on a straight-line basis.The Company accounts for forfeitures as they occur. Stock-based compensation expense is classified in the accompanying consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipients service payments are classified.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions. The Company has historically been a private company and lacks company-specific historical and implied volatility information. The Company estimates its expected stock volatility based on the historical volatility of a publicly traded set of representative companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The fair value of the Company's common stock is determined based on the quoted market price of common stock.
Pre-Funded Warrants
Warrants are accounted for based on the specific terms of the warrant agreements. The Company's Pre-Funded Warrants are indexed to the Company's common stock and meet the criteria to be classified as equity. Proceeds from the issuance of Pre-Funded Warrants are recorded within additional paid-in capital and are not subject to remeasurement. Refer to Note 8 and Note 11 for further information regarding Pre-Funded Warrants issued by the Company.
Net Loss per Share
Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted-average number of common shares outstanding during the period and, if dilutive, the weighted-average number of potential shares of common stock. Net loss per share attributable to common stockholders is calculated using the two-class method, which is an earnings allocation formula that determines net loss per share for the holders of the Company’s common shares and participating securities. Net loss attributable to common stockholders is allocated to each share on an as-converted basis as if all of the earnings for the period had been distributed. The participating securities did not include a contractual obligation to share in losses of the Company and are not included in the calculation of net loss per share in the periods in which a net loss is recorded.
Diluted net loss per share is computed using the more dilutive of (a) the two-class method or (b) the if-converted method. The Company allocates earnings first to preferred stockholders based on dividend rights and then to common and preferred stockholders
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based on ownership interests. The weighted-average number of common shares included in the computation of diluted net loss per share gives effect to all potentially dilutive common equivalent shares, including outstanding stock options and preferred stock.
Issued and unexercised Pre-Funded Warrants are classified as a component of permanent equity in the Company's consolidated balance sheet as they are freestanding financial instruments that are immediately exercisable, do not embody an obligation for the Company to repurchase its own shares and permit the holders to receive a fixed number of shares of common stock upon exercise. All shares underlying Pre-Funded Warrants are included in the weighted-average number of shares of common stock used to calculate basic and diluted net loss per common share because the shares may be issued for little or no consideration, are fully vested and are exercisable after the original issuance date of the Pre-Funded Warrants.
Common stock equivalent shares are excluded from the computation of diluted net loss per share if their effect is antidilutive. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since dilutive common shares are not assumed to have been issued if their effect is antidilutive. The Company reported a net loss attributable to common stockholders for the years ended December 31, 2025 and 2024.
Income Taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or the Company’s tax returns. Under this method, deferred tax assets and liabilities are determined based on the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established.
The Company accounts for uncertain tax positions recognized in the consolidated financial statements by prescribing a “more likely than not” threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. There are no unrecognized tax benefits included in the Company’s consolidated balance sheets as of December 31, 2025 and 2024. The Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense. The Company has not recognized interest or penalties in its consolidated statements of operations and comprehensive loss since inception.
Recently Adopted Accounting Pronouncements
ASU 2023-09, Income Taxes (Topic 740)
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which includes amendments that further enhance income tax disclosure, primarily through standardization and disaggregation of rate reconciliation categories and income taxes paid by jurisdiction. The new standard is effective for annual periods beginning after December 15, 2024.
Recently Issued Accounting Pronouncements Not Yet Adopted
ASU 2023-06, Disclosure Improvements
In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements:Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. The amendments clarify or improve disclosure and presentation requirements on various disclosure areas, including the statement of cash flows, earnings per share, debt, equity, and derivatives. The amendments will align the requirements in the FASB ASC with the SEC’s regulations. The amendments in this ASU will be effective on the date the related disclosures are removed from Regulation S-X or Regulation S-K by the SEC, and will not be effective if the SEC has not removed the applicable disclosure requirement by June 30, 2027. Early adoption is prohibited. As the Company is currently subject to these SEC requirements, ASU 2023-06 is not expected to have a significant impact on the Company.
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ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40)
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires entities to disclose additional information about specific expense categories in the notes to the financial statements. The ASU is effective for annual periods beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. ASU 2024-03 may be applied retrospectively or prospectively. The Company is currently evaluating the effect of this update on its consolidated financial statements and related disclosures.
3. Investments
The following tables summarize the amortized cost and estimated fair value of the Company's available-for-sale investments as of December 31, 2025 and 2024 (in thousands):
Amortized Cost Gross UnrealizedGains Fair Value
Short-term investments:
U.S. government-sponsored enterprise securities 9,981 10 9,991
Amortized Cost Gross UnrealizedGains Fair Value
Short-term investments:
U.S. government-sponsored enterprise securities 9,926 6 9,932
Long-term investments:
Certain short-term debt securities with original maturities of less than 90 days are included in cash and cash equivalents on the consolidated balance sheets and are not included in the tables above. As of December 31, 2025 and 2024, all short-term investments had contractual maturities within one year. As of December 31, 2024, all long-term investments had contractual maturities between one to two years.
There were no available-for-sale securities held by the Company in an unrealized loss position as of December 31, 2025. As such, the Company does not consider these investments to be impaired and there are no allowances for credit losses as of December 31, 2025.
4. Fair Value Measurement
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy to determine such fair value as of December 31, 2025 and 2024 (in thousands):
Fair Value Measurements at December 31, 2025:
Total Level 1 Level 2 Level 3
Cash equivalents:
Short-term investments:
U.S. government-sponsored enterprise securities 9,991 — 9,991 —
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Fair Value Measurements at December 31, 2024:
Total Level 1 Level 2 Level 3
Cash equivalents:
Short-term investments:
U.S. government-sponsored enterprise securities 9,932 — 9,932 —
Long-term investments:
The Company classifies its money market funds and on-the-run U.S. Treasury securities as Level 1 assets under the fair value hierarchy as these assets have been valued using quoted market prices in active markets without any valuation adjustment. The Company classifies its off-the-run U.S. Treasury securities and U.S. government-sponsored enterprise securities as Level 2 assets under the fair value hierarchy as these assets have been valued using information obtained through a third-party pricing service as of the balance sheet date, using observable market inputs that may include trade information, broker or dealer quotes, bids, offers, or a combination of these data sources.
During the years ended December 31, 2025 and 2024, there were no transfers between levels. The Company uses the carrying amounts of its restricted cash, prepaid expenses and other current assets, accounts payable and accrued expenses and other current liabilities to approximate their fair values due to the short-term nature of these amounts.
5. Property and Equipment, net
Property and equipment, net consisted of the following as of December 31, 2025 and 2024 (in thousands):
December 31,
Laboratory and computer equipment $ 7,091 $ 6,175
Construction in progress 916 58
Less: accumulated depreciation (3,318 ) (1,962 )
Total property and equipment, net $ 4,889 $ 4,471
Depreciation expense related to property and equipment for the years ended December 31, 2025 and 2024 was $1.4 million and $1.0 million, respectively.
6. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following as of December 31, 2025 and 2024 (in thousands):
December 31,
Accrued research and development expenses $ 5,960 $ 9,246
Accrued compensation and benefits 5,558 5,456
Accrued legal, accounting and other professional fees 375 458
Accrued offering costs 143 —
Total accrued expenses and other current liabilities $ 12,215 $ 15,399
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7. Leases
In December 2020, the Company entered into an operating lease agreement for laboratory and office space located at 480 Arsenal Way, Watertown, Massachusetts (the “Arsenal Way Lease”). The lease commenced in April 2021, with a term of seven years and an option to extend the term for an additional five years at then-market rental rates. The Company delivered a letter of credit of $0.3 million to the landlord, which was subsequently reduced to $0.2 million in August 2024 in accordance with the lease, which is included in restricted cash in the accompanying consolidated balance sheets. Under the terms of the lease, the base rent is $1.0 million, subject to a 3% annual rent increase, plus an allocation of operating expenses and taxes.
In August 2023, the Company entered into an operating lease agreement, denominated in Swedish Krona, for office and laboratory space located in Lund, Sweden. The term of the lease commenced in December 2023. The lease has an initial term of three years and will automatically renew for an additional term of three years unless the Company provides written notice of termination nine months prior to the termination date.
In July 2024, the Company entered into an operating lease agreement, denominated in Swedish Krona, for additional office and laboratory space adjacent to its existing leased space located in Lund, Sweden. The term of the lease commenced in September 2024. The lease has an initial term of three years and will automatically renew for an additional term of three years unless the Company provides written notice of termination nine months prior to the termination date.
The following table summarizes the presentation of the Company’s operating leases on its consolidated balance sheets as of December 31, 2025 and 2024 (in thousands):
Leases Balance sheet classification December 31, 2025 December 31, 2024
Assets:
Operating lease assets Operating lease right-of-use assets $ 2,527 $ 3,554
Liabilities:
Current:
Operating lease liabilities Operating lease liability, current $ 1,172 $ 1,057
Noncurrent:
Operating lease liabilities Operating lease liability, non-current 1,537 2,588
The components of lease cost under ASC 842 included within research and development expenses and general and administrative expenses in the Company’s consolidated statements of operations and comprehensive loss for the years ended December 31, 2025 and 2024 were as follows (in thousands):
For the Year Ended December 31,
As of December 31, 2025 and 2024, the weighted-average remaining lease term for operating leases was 2.3 years and 3.2 years, respectively, and the weighted-average discount rate was 8.17% and 8.26%, respectively. Cash paid for amounts included in the measurement of lease liabilities was $1.3 million and $1.4 million for the years ended December 31, 2025 and 2024, respectively.
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Future minimum annual lease commitments under the Company’s non-cancelable operating leases as of December 31, 2025 were as follows (in thousands):
Year ended December 31, Amount
Total lease payments 2,955
Less: interest (246 )
Present value of operating lease liabilities $ 2,709
8. Stockholders' Equity
In October 2022, the Board of Directors (“Board”) approved the amended and restated certificate of incorporation, which was filed upon the closing of the IPO and which authorized the Company to issue up to 10,000,000 shares of preferred stock, with a par value of $0.001. There are no shares of preferred stock issued or outstanding as of December 31, 2025.
As of December 31, 2025 and 2024, the Company’s Amended and Restated Certificate of Incorporation authorized the Company to issue 500,000,000 shares of common stock with a par value of $0.001. The voting, dividend and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers and preferences of the holders of preferred stock.
The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders (and written actions in lieu of meetings), and there are not any cumulative voting rights. The number of authorized shares of common stock may be increased or decreased by the affirmative vote of the holders of shares of capital stock of the Company; however, the issuance of common stock may be subject to the vote of the holders of one or more series of preferred stock that may be required by terms of the Amended and Restated Certificate of Incorporation.
PIPE Securities Purchase Agreement
On April 8, 2024, the Company entered into the PIPE Purchase Agreement for a private placement with certain institutional and accredited investors. 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 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. As of December 31, 2025, the Pre-Funded Warrants are exercisable at any time after the date of issuance and do not expire.
The holders of Pre-Funded Warrants may not exercise a Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 4.99% of the number of shares of common stock outstanding immediately after giving effect to such exercise. The holders of Pre-Funded Warrants may increase or decrease such percentage by providing at least 61 days’ prior notice to the Company, but not in excess of 19.99% in the case of an increase. The Pre-Funded Warrants are indexed to the Company's common stock and were classified as a component of permanent equity in the Company's consolidated balance sheet as they are freestanding financial instruments that are immediately exercisable, do not embody an obligation for the Company to repurchase its own shares and permit the holders to receive a fixed number of shares of common stock upon exercise. 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. As of December 31, 2025, no Pre-Funded Warrants were exercised.
Common Stock
As of December 31, 2025 and 2024, the Company had reserved the following shares of common stock for the potential exercise of stock options, potential exercise of Pre-Funded Warrants, vesting of restricted stock units (“RSUs”), as well as the remaining shares
F-17
available for issuance under the 2022 Equity Incentive Plan (the “2022 Plan”), the 2022 Employee Stock Purchase Plan (the “2022 ESPP”), and the Amended and Restated 2023 Inducement Plan (the “Inducement Plan”):
December 31,
9. Stock-Based Compensation
Equity Incentive Plans
In October 2022, the Board adopted, and in November 2022 its stockholders approved, the 2022 Plan, which became effective immediately prior to and contingent upon the execution of the underwriting agreement related to the Company’s IPO. The 2022 Plan allows the Company to make equity-based and cash-based incentive awards to its officers, employees, directors, and consultants and provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, RSUs, and other stock-based awards. In addition, the number of shares reserved and available for issuance under the 2022 Plan shall automatically increase beginning on January 1, 2023 and each January 1 thereafter, by five percent of the aggregate number of shares of common stock of all classes issued and outstanding on the immediately preceding December 31 or such lesser number of shares of common stock as determined by the compensation committee. As of December 31, 2025, there were 1,834,615 shares reserved for future issuance under the 2022 Plan.
In October 2022, the Board adopted, and in November 2022 its stockholders approved, the 2022 ESPP, which became effective immediately prior to and contingent upon the execution of the underwriting agreement related to the Company’s IPO. The number of shares of common stock that may be issued under the 2022 ESPP shall cumulatively increase beginning on January 1, 2023 and each January 1 thereafter through January 1, 2032, by one percent of the outstanding number of shares of common stock on the immediately preceding December 31 or such lesser number of shares as determined by the compensation committee. No shares of the Company's common stock have been issued. As of December 31, 2025, there were 971,743 shares reserved for future issuance under the 2022 ESPP.
In June 2023, the Board adopted the Inducement Plan to facilitate the granting of equity awards as an inducement material to new employees joining the Company. In April 2025, the Board amended the Inducement Plan to reserve an additional 500,000 authorized and unissued shares of common stock. The only persons eligible to receive awards under the Inducement Plan are individuals who are new employees and satisfy the standards for inducement grants under Nasdaq Listing Rule 5635(c)(4) or 5635(c)(3), as applicable. The terms of the Inducement Plan are identical to the terms of the 2022 Plan, except that no incentive stock options shall be awarded under the Inducement Plan. As of December 31, 2025, there were 613,976 shares reserved for future issuance under the Inducement Plan.
Stock Options
The Company has granted stock options with service-based vesting conditions. Stock options typically vest over four years and have a maximum term of ten years. The Company typically grants stock options to employees and non-employees at exercise prices deemed by the Board to be equal to the fair value of the common stock at the time of grant.
The assumptions that the Company used in the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted during the years ended December 31, 2025 and 2024 were as follows: