ACRV 10-K & 10-Q changes, risk factors and insider trading

Since our inception, we have incurred significant losses, and we expect to continue to incur significant expenses and operating losses for the foreseeable future. Our net loss was $80.6$77.9 million and $60.4$80.6 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $197.0$274.9 million. Since our inception, we have financed our operations primarily with proceeds from the sales of shares of our convertible preferred stock and the issuance of convertible notes, proceeds raised in our IPO and concurrent private placement and proceeds from our private placement with certain institutional and accredited investors, or the April 2024 Private Placement. We have no products approved for commercialization and have never generated any revenue from product sales.

We are a clinical-stage biopharmaceuticalbiotechnology company with a limited operating history. We commenced operations in March 2018, and our operations to date have been largely focused on organizing and staffing our company, business planning, raising capital, building our AP3 platform, developing our manufacturing capabilities and developing our clinical and preclinical drug candidates, including undertaking preclinical studies and conducting clinical trials. To date, we have not yet demonstrated our ability to successfully complete pivotal clinical trials, obtain regulatory approvals, manufacture a product on a commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization, and we may not be successful in doing so. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing products.

As of December 31, 2024,2025, we had cash, cash equivalents and investments of $184.6$118.6 million. We believe that our existing cash, cash equivalents and investments as of December 31, 2024,2025, will be sufficient to fund our operating expenses and capital expenditure requirements into the second quarter of 2027. This estimate is based on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Changes may occur beyond our control that would cause us to consume our available capital before that time, including changes in and progress of our development activities, acquisitions of additional drug candidates and changes in regulation. The timing and amount of our funding requirements will depend on many factors, including but not limited to:

the scope, progress, results and costs of non-clinical studies, preclinical development, laboratory testing and clinical trials for ACR-368, ACR-2316, and our future drug candidates and associated development programs;

the scope, progress, results and costs as well as timing of process development and manufacturing scale-up and validation activities associated with ACR-368ACR-368, ACR-2316, and our future drug candidates and other programs as we advance them through preclinical and clinical development;

the ability of our AP3 platform to identify sensitive tumor types and patient responders;

the costs of operating as a public company; and business disruptions affecting the initiation, patient enrollment, development and operation of our clinical trials, including a public health emergency (PHE) or geopolitical events, including the ongoing Russian invasion of Ukraine, related sanctions against Russia and conflicts in the Middle East.

We will require additional capital to achieve our business objectives. Additional funds may not be available on a timely basis, on favorable terms or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our drug candidates. Further, our ability to raise additional capital may be adversely impacted by potential worsening global economic conditionsconditions, such as new or increased tariffs and other barriers to trade, and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from geopolitical tensions, such as the ongoing Russian invasion of Ukraine and related sanctions against Russia and conflicts in the Middle East. If we are unable to raise sufficient additional capital, we could be forced to curtail our planned operations and the pursuit of our growth strategy.

Using our AP3 platform, we have developed predictive OncoSignature tests for our clinical drug candidate, ACR-368, as well as for two other clinical stageclinical-stage drug candidates. Negative results in the development of ACR-368 may also impact our ability to successfully develop other drug candidates, either at all or within anticipated timeframes because, although other drug candidates may target different indications, the underlying technology platform, and specifically the use of an OncoSignature test, to identify patient responders is conceptually the same for certain of our drug candidates requiring an OncoSignature for patient selection. Accordingly, a failure in any one program may decrease trust in our AP3 platform’s ability to successfully deploy OncoSignature tests in the clinic. In addition, if ACR-368 shows unexpected adverse events or a lack of efficacy in the indications we intend to treat, or if we experience other regulatory or developmental issues, our development plans and business could be harmed. We cannot guarantee the successful clinical development, approval and commercialization of ACR-368.

Our lead drug candidate is currently in Phase 2 clinical development under a master protocol designed for expedited drug development in certain contexts using our ACR-368 OncoSignature test. Although we are using our OncoSignature test to specifically treat patients predicted to be sensitive to ACR-368, weWe cannot guarantee that we will achieve sufficient ORR for marketing approval. For our preclinical drug candidates, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our drug candidate in humans before obtaining marketing approval from regulatory authorities. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to the outcome.

Moreover, Congress hasis recentlyconsidering enactedpotential changes to the Accelerated Approval Program that could impact our ability to obtain Accelerated Approval, or increase the burdens associated with postmarketing requirements in the event we do obtain Accelerated Approval. In particular, the FDA must specify certain conditions for required postapproval studies for products that receive Accelerated Approval, which may include enrollment targets and milestones, including the target date for study completion, by the time the drug is approved. The FDA may also require postapproval studies to be underway at the time of Accelerated Approval or within a specified time period following Accelerated Approval for such drugs, and must explain any instances where it does not require such studies. The FDA’s January 2025 draft guidance on “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway,” while not finalized, suggests that the FDA generally intends to consider a confirmatory trial to be “underway” prior to accelerated approval if (1) the trial has a target completion date that is consistent with diligent and timely conduct of the trial, considering the nature of the trial’s design and objectives, (2) the sponsor’s progress and plans for postapproval conduct of the trial provide sufficient assurance to expect timely completion of the trial, and (3) enrollment of the confirmatory trial has been initiated.

The successful clinical development of some of our drug candidates dependsmay depend in part on the co-approval of an OncoSignature test as a companion diagnostic test. If we or our companion diagnostic collaborator are unable to obtain regulatory approval for our OncoSignature companion diagnostic tests for such drug candidates, we may not obtain regulatory approval and realize the commercial potential of certain drug candidates.

We do not have experience or capabilities in developing or commercializing diagnosticsdiagnostics, and planwe tohave relylimited inhistory largewith part onoperating our collaborationCLIA-certified partnerlaboratory. AkoyaWe to perform these functions. Akoya hashave not commercialized or submitted or obtained 510(k) clearance, De Novo classification, or Premarket Approval Application, or PMA, for any companion diagnostic, and any setbacks theywe encounter could delay any commercial launch of ACR-368, if approved. It may be necessary to resolve issues such as selectivity/specificity, analytical validation, reproducibility, or clinical validation of companion diagnostics during the development and regulatory approval processes. Moreover, even if data from preclinical studies and early clinical trials appear to support development of a companion diagnostic for a drug candidate, data generated in later clinical trials may fail to support the analytical and clinical validation of the companion diagnostic. We and our future collaborators may encounter difficulties in developing, obtaining regulatory approval for, manufacturing and commercializing companion diagnostics similar to those we face with respect to our drug candidates, including issues with achieving regulatory clearance or approval, production of sufficient quantities at commercial scale and with appropriate quality standards, and in gaining market acceptance. If we are unable to successfully develop companion diagnostics for our drug candidates, or experience delays in doing so, the development of these drug candidates may be adversely affected, these drug candidates may not obtain marketing approval, and we may not realize the full commercial potential of any of these therapeutics that have or may obtain marketing approval. We may not be able to enter into arrangements with another diagnostic company to develop and obtain regulatory approval for an alternative diagnostic test for use in connection with the development and commercialization of our drug candidates or do so on commercially reasonable terms, which could adversely affect and/or delay the development or commercialization of our therapeutic candidates or therapeutics.

Although we received clearance from the FDA for an IND to advance ACR-368 in Phase 2 single arm clinical trials conducted under the master protocol as well as IND clearance for ACR-2316 to advance into a Phase 1 a clinical trial, we may not be able to file INDs for our other drug candidates on the timelines we expect. For example, we may experience, or our partners may experience, manufacturing delays or other delays with IND-enabling studies. Further, requirements for master protocols may evolve and we may not be able to conduct future trials under a master protocol. In December 2023, the FDA published a draft guidance, Master Protocols for Drug and Biological Product Development, which provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on the submission of documentation to support regulatory review. Evolving requirements for master protocols may delay or inhibit future trials relying on a master protocol. Moreover, we cannot be sure that submission of an IND will result in the FDA allowing further clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate clinical trials. Additionally, even if such regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND, we cannot guarantee that such regulatory authorities will not change their requirements in the future. These considerations also apply to new clinical trials we may submit as amendments to existing INDs or to a new IND. Any failure to file INDs on the timelines we expect or to obtain regulatory approvals for our trials may prevent us from completing our clinical trials or commercializing our products on a timely basis, if at all.

We may not be able to initiate or continue our ongoing or planned clinical trials if we are unable to identify and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or comparable foreign regulatory authorities. In addition, some of our competitors currently have ongoing clinical trials for drug candidates that would treat the same patients as our lead clinical drug candidate, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ drug candidates. We rely on our external companion diagnostic partner, Akoya, toalso perform ACR-368 OncoSignature testing in our clinical trial. If Akoyawe encountersencounter delays or technical challenges, enrollment in our clinical trials may be substantially delayed. Patient enrollment is also affected by other factors, including but not limited to:

Additionally, the FDA may modify or enhance trial requirements which may affect enrollment. In August 2023, the FDA published a guidance document, Informed Consent, Guidance for IRBs, Clinical Investigators, and Sponsors, which supersedes past guidance and finalizes draft guidance on informed consent. TheFurther, FDA’sin newDecember 2023, the FDA published a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows exceptions from informed consent requirements when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. These guidance presentsdocuments present evolving requirements for informed consent which may affect recruitment and retention of patients in clinical trials. Effects on recruitment and retention of patients may hinder or delay a clinical trial and could cause a significant setback to an applicable program.

ChangesDisruptions in funding forat the FDAFDA, the SEC and other government agencies could hinder their ability to hireperform andnormal retainbusiness keyfunctions leadershipon andwhich otherthe personnel,operation orof otherwiseour preventbusiness newmay products and services from being developed or commercialized in a timely manner,rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels,funding, ability to hire and retain key personnel,personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC, and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

DisruptionsFuture disruptions at the FDA and other agencies may also lengthenslow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, overin the last severalrecent years, including forin 35October days beginning on December 22, 2018,2025, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA,FDA haveand the SEC, had to furlough critical FDA employees and stop critical activities. Our business depends upon the ability of the FDA to accept and review our potential regulatory filings. If a prolonged government shutdown occurs,were to occur in the future, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our businessbusiness. andFurther, the current or future government shutdowns could impact our ability to advanceaccess clinicalthe developmentpublic ofmarkets and obtain necessary capital in order to properly capitalize and continue our drug candidates.operations.

InIt addition,is also possible that current or future litigation or action by Congress iscould considering updates tochange the orphan drug provisionsscope of theavailable FDCAorphan in response to a recent decision by the U.S. Court of Appeals for the Eleventh Circuit.exclusivity. Any changes to the orphan drug provisions could change our opportunities for, or likelihood of success in obtaining, orphan drug designation and/or exclusivity and would materially adversely affect our business, results of operations, financial condition and prospects.

On May 8, 2023, ACR-368 was granted two Fast Track designations from the FDA for the investigation of ACR-368 monotherapy for patients with OncoSignature-positive platinum-resistant ovarian cancer and endometrial cancer.EC. We may seek Fast Track designation for certain of our future drug candidates, but there is no assurance that the FDA will grant this status to any of our proposed drug candidates and we might only be successful in receiving a Fast Track designation from the FDA for a drug candidate after applying on more than one occasion. Sponsors may have greater interactions with the FDA and marketing applications filed by sponsors of products in Fast Track development may qualify for priority review and rolling review under the policies and procedures offered by the FDA, but the receipt of a Fast Track designation does not assure any such qualification or ultimate marketing approval by the FDA. The FDA has broad discretion whether or not to grant a Fast Track designation, so even if we believe a particular drug candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it. Even if we do receive a Fast Track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures, and receiving a Fast Track designation does not provide assurance of ultimate FDA approval. In addition, the FDA may withdraw a Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program. In addition, the FDA may withdraw any Fast Track designation at any time.

The FDA has also implemented a Breakthrough Device program that is intended to help patients receive more timely access to breakthrough medical technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. A device also must meet one of the following criteria: (i) it represents breakthrough technology; (ii) there is no approved or cleared alternative; (iii) it offers significant advantages over existing cleared or approved devices; or (iv) availability of the device is in the best interest of patients. Under the program, device candidates are eligible to receive priority review and interactive communications from the FDA regarding device development and clinical trial protocols, all the way through to commercialization decisions. On November 16, 2023, the FDA granted Breakthrough Device Designation to the ACR-368 OncoSignature assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment. On January 21, 2025, the FDA granted Breakthrough Device Designation to the ACR-368 OncoSignature Assay for the identification of endometrial cancerEC patients who may benefit from treatment with ACR-368.

On June 28, 2024, the U.S. Supreme Court issued an opinion holding that courts reviewing agency action pursuant to the Administrative Procedure Act (APA) “must exercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.” The decision will have a significant impact on how lower courts evaluate challenges to agency interpretations of law, including those by the HHS, FDA, CMS and other agencies with significant oversight of the biopharmaceutical industry. The new framework is likely to increase both the frequency of such challenges and their odds of success by eliminating one way in which the government previously prevailed in such cases. As a result, significant regulatory policies will be subject to increased litigation and judicial scrutiny.

In addition, federal agency priorities, leadership, policies, rulemaking, communications, spending, and staffing may be significantly impacted by election cycles.cycles and legislative developments. For example, the current presidential administration’s commitment to significantly reduce government spending through cuts to federal healthcare programs and reductions in the workforces of key government agencies, such as the HHS, FDA, and CMS. Efforts by the current administration to limit federal agency budgets or personnel may result in reductions to agency budgets, employees, and operations,operations. whichThe administration and agencies have also made abrupt announcements about new or changed regulatory policies, such as policies related to the use of artificial intelligence to review product applications. And, the recent federal government shutdown may prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, and may significantly impact the ability of the FDA to timely review and process our regulatory submissions. These developments may lead to greater uncertainty regarding FDA policies, slower response times and longer review periods, potentially affecting our ability to progress development of our product candidates or obtain regulatory approval for our product candidates.

Any resulting changes in regulation may result in unexpected delays, increased costs, or other negative impacts on our business that are difficult to predict. Also, changes in the administration’s policies and personnel may result in decisions contrary to or overriding those previously made by government personnel under prior administrations.

If we were to experience an unexpected loss of supply of or if any supplier were unable to meet our demand for any of our drug candidates, we could experience delays in our research or ongoing and planned clinical trials or commercialization. We could be unable to find alternative suppliers of acceptable quality, in the appropriate volumes who could meet our timelines at an acceptable cost. Moreover, our suppliers are often subject to strict manufacturing requirements and rigorous testing requirements, which could limit or delay production. The long transition periods necessary to switch manufacturers and suppliers, if necessary, could significantly delay our preclinical studies, our clinical trials and the commercialization of our products, if approved, which could materially adversely affect our business, financial condition and results of operation.operations.

We have existing partnerships and license agreements, including with Lilly for ACR-368 and with Akoya to co-develop, validate and commercialize our ACR-368 OncoSignature test.ACR-368. Moreover, a part of our business strategy is to carefully evaluate and, as deemed appropriate, potentially enter into partnerships in the future, including with major biotechnology or pharmaceutical companies. We have limited capabilities for product development and do not yet have any capability for commercialization. Accordingly, we may enter into partnerships with other companies to provide us with additional drug candidates and funding for our programs and AP3 platform. If we fail to enter into or maintain partnerships on reasonable terms or at all, our ability to develop our existing or future research programs and drug candidates or to identify future drug candidates through the application of our AP3 platform and OncoSignature companion diagnostics could be delayed, the commercial potential of our product could change and our costs of development and commercialization could increase. Furthermore, we may find that our programs require the use of intellectual property rights held by third parties, and the growth of our business may depend in part on our ability to acquire or in-license these intellectual property rights.

We anticipate several biopharmaceutical companies will aim to develop precision oncology approaches for the larger subsets of cancers where genetics has proven insufficient for patient responder identification over the next decade. We expect that the broader biopharmaceutical field will eventually recognize proteomics as the next era of precision medicine. We are aware of several competitors with CHK1/2CHK inhibitorsinhibitors, including Boundless Bio (BBI-355, discontinued), Sierra Oncology (SRA737, discontinued), and Sentinel Oncology (SOL578), WEE1 inhibitors, including Sierra OncologyAstrazeneca/Merck (SRA737adavosertib, discontinued), Zentalis (azenosertib), Debiopharm (Debio0123), Impact Therapeutics (IMP7068) and, Shouya Holdings (SY-4835), oneAprea company(APR-1051), withBioCity aBiopharma (SC0191), Wigen Biomedicine Technology (WJ05), HUYA Biomedicines (HBI-2448), and WEE1 degrader from Bristol Myers Squibb (WEE1 CELMoD), and PKMYT1 inhibitor,inhibitors, including Repare Therapeutics (lunresertib), Qilu Pharma (QLS1209), and Evariste (EVT-0003023). There is one companycompetitor withthat we know of developing a dual WEE1/PKMYT1 inhibitor, Schrödinger (SGR-3515).

As of December 31, 2024,2025, we had 7574 full-time employees and three2 part-time employees. As our development progresses, we expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of clinical product development, regulatory affairs and, if any of our drug candidates receives marketing approval, sales, marketing and distribution. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. Our choice to focus on multiple therapeutic areas may negatively affect our ability to develop adequately the specialized capability and expertise necessary for operations. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

We have issued US patents covering the composition-of-matter and the salt form of ACR-368 through 2030 and 2037, respectively, including PTA, but without patent term extension, and also seek protection through our OncoSignature patent filings. Corresponding rest of world patents are through 2029 and 2036. We expect to seek extensions of patent terms in the United States and, if available, in other countries where we are prosecuting patents. In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years beyond the normal expiration of the patent, which is limited to the approved indication (or any additional indications approved during the period of extension). However, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. If this occurs, our competitors may be able to take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data and launch their drug earlier than might otherwise be the case.

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,Company”, “we,we”, “us,us”, and “our” refer to Acrivon Therapeutics, Inc. and its subsidiaries.

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 studiesstudies, andestablishing 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.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. TheAs 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.

continue to conduct or initiate new preclinical studies and clinical trials for our clinical-stage assets, ACR-368 and ACR-2316;

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.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, 2024,2025, we had cash, cash equivalents and investments of $184.6$118.6 million. We believe that our existing cash, cash equivalents and investments as of December 31, 2024,2025, 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.Resources”.

In June 2022, we entered into a companion diagnostic agreementagreement, or the Akoya Agreement, with AkoyaAkoya, 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 cancerEC most likely to respond to ACR-368.

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 and the development of ACR-368 and ACR-2316, and the ACR-368 OncoSignature.efforts. We expense research and development costs as incurred, which include:

expenses to acquire technologies, such as intellectual property,technologies to be used in research and development;

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.

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.programs, inclusive of ACR-6840.

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.

Interest income consists of interest 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 primarily consists of realized and unrealized gains and losses on foreign currency transactions, state and franchise taxes, and investment management fees.

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, compared to $46.0 million for the year ended December 31, 2023.2024. The increasedecrease of $18.0$4.0 million was primarily due to:

a $3.4$4.1 million net increase in costs related to ACR-2316, our novel, internally-discovered clinical stageclinical-stage asset. ACR-2316We became our second development program upon receiving IND clearance in the third quarter of 2024 and initiatinginitiated a clinical trial and related activities in the third quarter of 2024, which has continued to progress through 2025;

a $2.9$1.7 million net decrease in costs related to preclinical drug discovery activities progression, which prior to ACR-2316 being granted IND clearanceinitiation 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;

a $4.2$3.6 million increase in personnel-related costs, including $0.6$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 a $1.0$1.1 million increase in facilities, supplies and other expenses, primarily driven by an increase in headcount and related research activities, as well as the cessation of sublease rent income, which had been recorded as an offset to research and development expenses.activities.

aGeneral $3.5and administrative expenses were $24.1 million increasefor 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 $2.1$0.5 million of stock-based compensation expense;expense, and a $0.6$0.2 million increasedecrease in professional fees, facilities, supplies, and other expenses, primarily driven by an increase in headcount.expenses.

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, compared to total other income, net of $6.7 million for the year ended December 31, 2023.2024. The change of $1.9$2.4 million is primarily attributable to ana increasedecrease in interest income and accretion earned on our investments.

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, 2024,2025, we had $184.6$118.6 million in cash, cash equivalents and investments, and we had an accumulated deficit of $197.0$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, and our IPO and concurrent private placement. Upon the closing of our IPO on November 17, 2022, only common stock remained issuedplacement, and outstanding. On December 1, 2023, we filed the Registration Statement with the SEC and simultaneously entered into a sales agreement with Cowen and Company, LLC, to provide for the issuance and sale of up to $100.0 million of common stock from time to time in “at-the-market” offerings under the Registration Statement and related prospectus. On April 8, 2024, we entered into the PIPE Purchase Agreement for a private placement with certain institutional and accredited investors. 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. 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.Placement. We believe that our existing cash, cash equivalents and investments of $184.6$118.6 million as of December 31, 2024,2025, will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2027.

The following table summarizes our cash flows for each of the periods presented (in thousands):

Net cash used in operating activities was $65.7$63.7 million for the year ended December 31, 2024,2025, compared to net cash used in operating activities of $42.6$65.7 million for the year ended December 31, 2023.2024. The increasedecrease in net cash used in operating activities of $23.12.0 million was primarily driven by an increasedecrease in net loss of $20.2 million, partially offset by a $2.7 million increase in non-cash stock-based compensation expense.million.

Net Cash Provided by (Used in) Provided by Investing Activities

Since our inception, we have incurred significant losses, and we expect to continue to incur significant expenses and operating losses for the foreseeable future. Our net loss was $77.9 million for the year ended December 31, 2025 and $19.0$37.0 million and $19.7$40.7 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $293.9$311.9 million. Since our inception, we have financed our operations primarily with proceeds from the sales of shares of our convertible preferred stock and the issuance of convertible notes, proceeds raised in our IPO and concurrent private placement andplacement, proceeds from our April 2024 Private Placement.Placement, and proceeds from our April 2026 ATM Program sale. We have no products approved for commercialization and have never generated any revenue from product sales.

As of MarchJune 31,30, 2026, we had cash, cash equivalents and investments of $97.7$90.0 million. We believe that our existing cash, cash equivalents and investments as of MarchJune 31,30, 2026, together with the net proceeds of $7.3 million raised from sales under our ATM Program in April 2026,2026 will be sufficient to fund our operating expenses and capital expenditure requirements into the thirdfourth quarter of 2027. This estimate is based on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Changes may occur beyond our control that would cause us to consume our available capital before that time, including changes in and progress of our development activities, acquisitions of additional drug candidates and changes in regulation. The timing and amount of our funding requirements will depend on many factors, including, but not limited to:

Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our common stock. As of MayAugust 87, 2026, we had 42,801,72942,853,362 shares of common stock outstanding. These shares include 7,550,000 shares sold in our IPO, which may be resold in the public market. As of MayAugust 87, 2026, approximately 20.8 million shares were held by our affiliates, who are generally restricted from selling pursuant to securities laws. Our shares may be resold and the market price of our stock could decline if the holders of currently-restricted shares sell them or are perceived by the market as intending to sell them.

We are a clinical-stage biotechnology company discovering and developing precision medicines utilizing our proprietary Acrivon Predictive Precision Proteomics, or AP3, platform. The AP3 platform is driven by Generative PhosphoproteomicsPhosphoproteomics, which is designed to allow us to quantify the global, 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 AP3 platform is comprised of a growing suite of powerful, internally developed tools, including the AP3 Interactome, the AP3 Kinase Substrate Relationship Predictor, or KaiSR, 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 enablesenable streamlined transition from preclinical to the clinical phase, as exemplified by the development of ACR-2316. 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 otherdifferentiated AP3 applications,applications to drug discovery and 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 Eli Lilly and Company, or 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-centermulticenter 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 endometrial cancer, or EC. Using our AP3 platformplatform, 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-processedroutine 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 U.S. Food and Drug Administration, or FDA, for an Investigational New Drug, or 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 armArm 1 of the ACR-368-201 study are stratified for treatment based on OncoSignature-positive, or 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, with a data cutoff of December 4, 2025, we foundobserved that the ORR in Arm 1 orof EC was 39%, and 44% in patients treated with ≤2 prior lines of therapy, or pLoT. Across pooled BM+ and OncoSignature-negative, or 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, armsArms 3 and 4 have been added to the study. Arm 3 is investigating ACR-368 in serous EC subjects with up to two≤2 pLoT without the need for pre-treatment tumor biopsy or biomarker stratification (“a serous all comer”), and utilizes ultra-low dose gemcitabine, or ULDG, as a sensitizer. Arm 4 is investigating the same “serous all comer” subject group but treated just with single agent ACR-368 without ULDG. A prespecified simultaneous interim analysis and data update from both all comer (biopsy-independent) serous EC arms of the ACR-368 Phase 2b study is expected in the second half of 2026.

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-discoveredinternally discovered pipeline programs. These include ACR-2316, our second clinical-stage asset, which is a novel, selective, dual WEE1/PKMYT1 inhibitor designed specifically for an 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.

In addition, we are advancing ACR-6840, an internally discovered development candidatecandidates targeting CDK11, and other equally promising series.CDK11. In preclinical studies, our CDK11 inhibitors result in potent, pro-apoptotic tumor cell death in aggressive AML cell lines and show complete tumor regression in vivo. They potently downregulate MCL1, a major resistance mechanism in AML to BCL2 inhibitors, and, consistent with this, have 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, establishing arrangements with third parties for the manufacture of ACR-2316, initiating a Phase 1/2 clinical trial for ACR-2316, and initiating IND enabling studies for ACR-6840,candidates from our CDK11 program, and advancing our internal co-crystallography-driven, AP3-enabled preclinical programs, conducting preclinical studies, as well as raising capital. We do not have any drug candidates approved for sale and have not generated any revenue from drug sales.

We have incurred recurring operating losses since inception. Our net losses for the threesix months ended MarchJune 31,30, 2026 and 2025 were $19.0$37.0 million and $19.7$40.7 million, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $293.9$311.9 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:

continue to conduct or initiate new preclinical studies and clinical trials for our clinical stageclinical-stage assets, ACR-368 and ACR-2316;

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time thatas 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. We continue to prioritize investment in activities expected to generate the most significant near-term value, including completion of ongoing clinical studies and key data readouts. Certain discretionary development activities, including initiation of additional studies or earlier-stage programs, may be timed based on the availability of additional capital. 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 assurancesassurance 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 MarchJune 31,30, 2026, we had cash, cash equivalents and investments of $97.7$90.0 million. We believe that our existing cash, cash equivalents and investments as of MarchJune 31,30, 2026, together with the net proceeds of $7.3 million raised from the ATM Program in April 2026,2026 will enable us to fund our operating expenses and capital expenditure requirements into the thirdfourth 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.”

costs related to manufacturing material for our clinical trials, including fees paid to clinicalcontract manufacturing organizations, or CMOs;

costs related to the establishmentestablishment, certification, and continued operations of our CLIA laboratory;

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 increasemaintain 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, including our CDK11 inhibitor program. Upon additional funding, we plan to engage in additional discretionary development activities, including initiation of additional studies or earlier-stage programs.

whether our drug candidates show sufficient efficacy with an increased ORR through patient responder identification in our clinical trials;

We anticipate that our general and administrative expenses will continuebe to increase in the futureconsistent 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.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Research and development expenses were $15.2$13.8 million for the three months ended MarchJune 31,30, 2026, compared to $15.4$16.2 million for the three months ended MarchJune 31,30, 2025. The decrease of $0.2$2.3 million was primarily due to:

a $0.6$1.4 million net decrease in costs for the ACR-368 clinical trial and its related supporting activitiesactivities, primarily due to milestone achievements recognized in 2025 that did not recur in 2026; and a $0.3$0.5 million net increasedecrease in costs related to the ACR-2316 clinical trialtrial, andprimarily its related supporting activities, which has continueddue to progressscheduled throughdose 2026.escalation activities throughout both periods.

General and administrative expenses were $4.7$4.8 million for the three months ended MarchJune 31,30, 2026, compared to $6.2$6.5 million for the three months ended MarchJune 31,30, 2025. The decrease of $1.5$1.6 million was primarily due to a decrease of $1.4 million in employee-related expenses including stock-based compensation expense.

Total other income, net was $0.9$0.7 million for the three months ended MarchJune 31,30, 2026, compared to total other income, net of $2.0$1.6 million for the three months ended MarchJune 31,30, 2025. The change of $1.1$0.9 million is primarily attributable to a decrease in interest income and accretion earned on our investments.

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 MarchJune 31,30, 2026, we had $97.7$90.0 million in cash, cash equivalents and investments, and we had an accumulated deficit of $293.9$311.9 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.Placement, and our April 2026 ATM Program sale. We believe that our existing cash, cash equivalents and investments of $97.7$90.0 million as of MarchJune 31,30, 2026, together with the net proceeds of $7.3 million raised from the ATM Program in April 2026,2026 will enable us to fund our operating expenses and capital expenditure requirements into the thirdfourth quarter of 2027.

Net cash used in operating activities was $20.5$35.4 million for the threesix months ended MarchJune 31,30, 2026, compared to net cash used in operating activities of $19.5$36.1 million for the threesix months ended MarchJune 31,30, 2025. The increasedecrease in net cash used in operating activities of $1.0$0.7 million was primarily driven by a decrease in net loss of $3.7 million, partially offset by a decrease in non-cash stock-based compensation expense of $1.6 million, partially offset by a decrease in net loss of $0.7$3.3 million.

Net cash provided by investing activities was $13.1$28.1 million for the threesix months ended MarchJune 31,30, 2026, resulting from $30.0$55.0 million in proceeds from maturities of investments, offset by purchases of investments of $16.9$26.8 million.

Net cash provided by investing activities was $19.2$38.7 million for the threesix months ended MarchJune 31,30, 2025, resulting from $39.5$74.5 million in proceeds from maturities of investments, offset by purchases of investments of $20.2$35.3 million and purchases of property and equipment of $0.1$0.6 million.

Net Cash Provided by (Used Inin) Financing Activities

Net cash usedprovided inby financing activities was $0.3$7.2 million for the threesix months ended MarchJune 31,30, 2025,2026, resulting from $0.3approximately $7.3 million in gross proceeds from the issuance of common stock under the ATM offering, offset by $0.1 million of payments for tax withholdings related to the vesting of restricted stock units.units, or RSUs.

As of MarchJune 31,30, 2026, our cash, cash equivalents and investments were $97.7$90.0 million. We believe that our existing cash, cash equivalents and investments as of MarchJune 31,30, 2026, together with the net proceeds of $7.3 million raised from the ATM Program in April 2026,2026 will enable us to fund our operating expenses and capital expenditure requirements into the thirdfourth 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.

Except as discussed in Note 12 to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report, during the threesix months ended MarchJune 31,30, 2026, there were no material changes to our contractual obligations and commitments from those described in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 19, 2026.

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 thatas 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).