Acrivon Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Mar 19, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 19, 2026
ACRV$1.61+2.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-27.
0000950170-25-046056
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-19.
0001193125-26-115123
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 148 previous paragraphs and 144 current paragraphs.
93 unchanged; 38 reworded; 12 added; 16 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (12)
Current report
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.
Current report
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.
Current report
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.
Current report
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).
Current report
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 95 thpercentile 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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
Costs related to the establishment of our CLIA laboratory;
Current report
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;
Removed paragraphs (16)
Previous report
We are a clinical stage biopharmaceutical company discovering and developing precision oncology medicines for patients whose tumors are predicted to be sensitive to each specific medicine by utilizing our proprietary Generative Phosphoproteomics platform, Acrivon Predictive Precision Proteomics, or AP3. Previously approved precision oncology treatments, such as kinase inhibitors, have transformed the cancer treatment landscape, and while the therapeutic benefit of these agents has provided significant benefit to patients, these precision oncology treatments unfortunately only address the less than 10% of patients with cancers that harbor certain easily-identifiable genetic mutations. In diseases outside oncology, e.g. autoimmune, inflammatory, fibrotic, and metabolic disorders, recurrent mutations in individual patients that can be linked to disease pathogenesis are exceedingly rare. Accordingly, genetics-based precision medicine approaches to treat only the patients that benefit from a particular therapeutic have been even more challenging in such diseases.
Previous report
Our approach is designed to overcome the limitations of genomics-based patient selection methods. We do this by using AP3 to discover and develop our pipeline of innovative oncology drug candidates. AP3 is engineered to measure compound-specific effects on the entire tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner and is modality and disease agnostic. These distinctive capabilities enable AP3’s direct application for drug design optimization for monotherapy activity, the identification of rational drug combinations, and the creation of drug-specific proprietary OncoSignature companion diagnostics that are used to identify the patients most likely to benefit from our drug candidates.
Previous report
We are currently advancing our lead candidate, ACR-368 (also called prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 with sub single-digit nM and single-digit nM potency, respectively, in a potentially registrational Phase 2 trial, focusing on endometrial cancer. We are continuing enrollment and dosing of patients in this multi-center trial based on OncoSignature-predicted sensitivity to ACR-368 in endometrial cancer patients, a tumor type predicted to be sensitive to ACR-368 through preclinical AP3-based indication finding, and not previously evaluated in past clinical trials.
Previous report
Our ACR-368 OncoSignature test, which has not yet obtained regulatory approval, has been extensively evaluated in preclinical studies, including in two separate, blinded, prospectively-designed studies on pretreatment tumor biopsies collected from patients with ovarian cancer treated with ACR-368 in past Phase 2 clinical trials conducted by Lilly and at the National Cancer Institute providing evidence of robust enrichment of responders through our method. Moreover, the ongoing registrational intent trial in endometrial cancer showed initial validation of the ACR-368 OncoSignature for prospective patient selection. Based on these sets of data, the FDA has granted Breakthrough Device designations for the ACR-368 OncoSignature assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment and for the identification of endometrial cancer patients who may benefit from ACR-368 treatment.
Previous report
In May 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. On November 16, 2023, the ACR-368 OncoSignature test was granted Breakthrough Device Designation for the identification of ovarian cancer patients who may benefit from treatment with ACR-368. In January 2025, the ACR-368 OncoSignature test was granted Breakthrough Device Designation for the identification of endometrial cancer patients who may benefit from treatment with ACR-368. These designations reflect the FDA’s determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
Previous report
At ESMO 2024 (September 14, 2024 R&D event and press release), we reported that endometrial cancer was our prioritized indication, as it represents the first potential registrational opportunity for ACR-368. We remain confident in this strategy based on emerging clinical data, competitive positioning given limited treatment options, and the strong commercial opportunity in both second- and front-line settings. Our blinded KOL market research estimates that there are approximately 27,000 U.S. patients annually in the second-line setting alone for endometrial cancer. Due to increased competition and a smaller market opportunity, we set a high internal clinical bar for ovarian cancer, which preliminary data suggests is unlikely to be met. Bladder cancer is also being deprioritized due to lower than preclinically predicted BM+ rate, leading to challenging enrollment with single digit BM+ patient enrollment to date. We have now officially deprioritized ovarian and bladder cancers, reallocating all clinical resources to ACR-368 in endometrial cancer and ACR-2316.
Previous report
An interim data extract from the EDC clinical database was done on February 25, 2025, including 20 BM+ endometrial cancer patients treated with ACR-368 monotherapy and 38 BM- treated with ACR-368 plus LDG that were efficacy-evaluable by RECIST (2 BM- had treatment discontinued without scan). All BM+ patients had progressed after prior platinum-based chemotherapy and prior anti-PD-1, and the median and mean prior lines of therapy for these patients were 2 and 2.6, respectively. A majority of these BM+ patients were refractory to the last prior line of therapy, with aggressive, generally heavily pre-treated tumors: 12 had refractory disease (best overall response of PD in the last prior line of therapy), 6 had relapsed disease, and 2 unknown. Amongst these 20 BM+ patients, 15 were either serous or carcinosarcomas, 13 were pMMR (2 dMMR, 5 not tested), and 11 p53 mutated (3 wild-type; 6 unknown). In patients that had relapsed after the prior line of therapy (N=6), the confirmed ORR was 50% and the DCR was 100%. Amongst the 12 patients with tumors refractory to the last prior line of therapy (ORR = 0%) we observed meaningful ACR-368 clinical activity with a confirmed ORR of 33% and DCR of 75%. The ACR-368 OncoSignature accurately identified patients whose tumors are sensitive to ACR-368, with 80% of BM+ patients demonstrating tumor shrinkage. Among all 20 BM+ patients the confirmed ORR was 35% and the DCR was 80%. Overall, we observed significant anti-tumor activity and disease control in BM+ patients with aggressive, refractory tumors that did not respond at all (0 % ORR) to the last line of prior therapy, and with a confirmed ORR more than double (35%) the best ORR observed in the last prior line of therapy (15%) for all BM+ patients.
Previous report
We have previously confirmed in preclinical studies that LDG 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 LDG treatment. We now have obtained further evidence of such OncoSignature biomarker upregulation in human patient tumors based on serial pre- and post- LDG biopsies in an ongoing Investigator-Initiated Trial at the Moffitt Cancer Center in patients with H&N cancer. Consistent with this preclinical and now clinical evidence of sensitization by LDG in BM- patients, we are continuing to explore the combination of ACR-368 with LDG in our ongoing endometrial cancer trial. Preliminary analyses of the 38 BM- patients, who are heavily pretreated (median of 3 prior lines of therapy) show a confirmed ORR of ~13% with the ACR-368 + LDG combination, which is comparable to the best ORR in the last prior line of therapy (median = 3) in these patients, which was 17%. Based on the totality of the preclinical and observed clinical data, we believe this supports significant LDG sensitization to ACR-368 in BM- patients. We expect a similar sensitization in BM+ patients which could be explored in a future all-comer study of ACR-368 + LDG.
Previous report
In addition, we have a preclinical cell cycle program with an undisclosed target. We have also developed the AP3 Interactome, a proprietary, computational analytics platform driven by machine learning for integrated comprehensive analyses across all large, in-house AP3 phosphoproteomic drug profiling data sets to advance our in-house research programs.
Previous report
Pursuant to the agreement, as subsequently amended, we paid Akoya a one-time, non-refundable, non-creditable upfront payment in the amount of $0.6 million. We are obligated to pay Akoya up to an aggregate of $20.3 million upon the achievement of specified development and pre-commercialization milestones. As of March 27, 2025, development and pre-commercialization milestones totaling $17.1 million have been paid to Akoya under the agreement. Other than certain specified pass-through costs, each party is responsible for its own costs associated with the development of the companion diagnostic. Akoya will procure and manufacture necessary supplies to perform the ACR-368 OncoSignature test to support our clinical development and commercial requirements, in accordance with a supply agreement to be mutually agreed upon by the parties. We may terminate the agreement at our convenience, subject to the payment of a termination fee in the amount of $1.0 million.
Previous report
For a more detailed description of this agreement, see the sections titled “Business—Licensing and Collaborations” and “—Contractual Obligations.”
Previous report
We record direct costs for our early stage, discovery, and development drug candidates at the program level. Other costs inclusive of personnel, facilities, and supplies are not allocated at the program level.
Previous report
a $12.4 million net increase in costs related to the ACR-368 clinical trial and related activities, of which $2.8 million is related to an increase in companion diagnostic milestones achieved;
Previous report
a $1.0 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.
Previous report
The following table summarizes our general and administrative expenses for each of the periods presented (in thousands):
Previous report
General and administrative expenses were $25.2 million for the year ended December 31, 2024, compared to $21.1 million for the year ended December 31, 2023. The increase of $4.1 million was primarily due to:
Reworded paragraphs (38)
Previous wording
We are also leveraging our proprietary 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, 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. Utilizing AP3, we were able to advance ACR-2316 to first dosing in a Phase 1 trial in 15 months, with dosing beginning in the third quarter of 2024. Using AP3-based Indication Finding and AP3-based analyses of in-house and publicly available data, we are enrolling selected high unmet need solid tumor types predicted sensitive to ACR-2316 in our Phase 1 trial. The Phase 1 monotherapy clinical trial of ACR-2316 is currently in the dose escalation portion of this trial. The Phase 1 study will 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. We anticipate providing a clinical data update in the second half of 2025. Based on pharmacokinetic (PK) analysis in the first two dosing level cohorts, we have observed encouraging approximate dose proportionality. Moreover, using our internal MS-based AP3 profiling to support the clinical trial of ACR-2316, we are already detecting drug target engagement in peripheral blood mononuclear cells (PBMCs) in dose level 1. In addition, initial clinical activity has been observed in a patient in DL3, with significant decrease in size of metastatic lesions throughout the chest, abdomen and pelvis. This patient (who had received 3 prior lines of therapy including chemotherapy and anti-PD-1) remains on therapy.
Current wording
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.
Previous wording
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 and initiating a Phase 1b clinical trial for ACR-2316, as well as raising capital. We do not have any drug candidates approved for sale and have not generated any revenue from drug sales.
Current wording
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.
Previous wording
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. 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. 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.
Current wording
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
Previous wording
We have incurred recurring operating losses since inception. Our net losses for the years ended December 31, 2024 and 2023 were $80.6 million and $60.4 million, respectively. As of December 31, 2024, we had an accumulated deficit of $197.0 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:
Current wording
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:
Previous wording
continue to conduct or initiate new preclinical studies and clinical trials for ACR-368;
Current wording
continue to conduct or initiate new preclinical studies and clinical trials for our clinical-stage assets, ACR-368 and ACR-2316;
Previous wording
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. 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.
Current wording
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.
Previous wording
As of December 31, 2024, we had cash, cash equivalents and investments of $184.6 million. We believe that our existing cash, cash equivalents and investments as of December 31, 2024, will enable us to fund our operating expenses and capital expenditure requirements into 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.”
Current wording
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”.
Previous wording
In June 2022, we entered into a companion diagnostic 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 cancer most likely to respond to ACR-368.
Current wording
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.
Previous wording
The majority of our expenses have been research and development expenses, which consist primarily of costs incurred in connection with our research and development activities, including our drug discovery efforts and the development of ACR-368 and ACR-2316, and the ACR-368 OncoSignature. We expense research and development costs as incurred, which include:
Current wording
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:
Previous wording
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;
Current wording
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;
Previous wording
expenses to acquire technologies, such as intellectual property, to be used in research and development;
Current wording
expenses to acquire technologies to be used in research and development;
Previous wording
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.
Current wording
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.
Previous wording
Our external research and development expenses consist primarily of fees paid to outside consultants, CROs, CMOs and research laboratories 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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
We anticipate that our general and administrative expenses will continue to increase in the future as we increase our headcount 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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
Other expense, net primarily consists of realized and unrealized gains and losses on foreign currency transactions, state taxes, and investment management fees.
Current wording
Other expense, net primarily consists of realized and unrealized gains and losses on foreign currency transactions, state and franchise taxes, and investment management fees.
Previous wording
As of December 31, 2024, we had $55.0 million and $62.4 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.
Current wording
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.
Previous wording
Research and development expenses were $64.0 million for the year ended December 31, 2024, compared to $46.0 million for the year ended December 31, 2023. The increase of $18.0 million was primarily due to:
Current wording
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:
Previous wording
a $3.4 million net increase in costs related to ACR-2316, our novel, internally-discovered clinical stage asset. ACR-2316 became our second development program upon receiving IND clearance in the third quarter of 2024 and initiating a clinical trial and related activities;
Current wording
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;
Previous wording
a $2.9 million net decrease in costs related to preclinical drug discovery activities progression, which prior to ACR-2316 being granted IND clearance in the third quarter of 2024, had included ACR-2316;
Current wording
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;
Previous wording
a $4.2 million increase in personnel-related costs, including $0.6 million of stock-based compensation expense, primarily due to an increase in research and development headcount; and
Current wording
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
Previous wording
a $0.6 million increase in facilities, supplies, and other expenses, primarily driven by an increase in headcount.
Current wording
a $1.1 million increase in facilities, supplies and other expenses, primarily driven by an increase in headcount and related research activities.
Previous wording
a $3.5 million increase in payroll and employee-related expenses, including $2.1 million of stock-based compensation expense; and
Current wording
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.
Previous wording
Total other income, net was $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. The change of $1.9 million is primarily attributable to an increase in interest income and accretion earned on our investments.
Current wording
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.
Previous wording
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, we had $184.6 million in cash, cash equivalents and investments, and we had an accumulated deficit of $197.0 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 issued 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. We believe that our existing cash, cash equivalents and investments of $184.6 million as of December 31, 2024, will enable us to fund our operating expenses and capital expenditure requirements into 2027.
Current wording
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.
Previous wording
The following table summarizes our cash flows for each of the periods presented (in thousands):
Current wording
The following table summarizes our cash flows (in thousands):
Previous wording
Net cash used in operating activities was $65.7 million for the year ended December 31, 2024, compared to net cash used in operating activities of $42.6 million for the year ended December 31, 2023. The increase in net cash used in operating activities of $23.1 million was primarily driven by an increase in net loss of $20.2 million, partially offset by a $2.7 million increase in non-cash stock-based compensation expense.
Current wording
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.
Previous wording
Net Cash Provided by (Used in) Financing Activities
Current wording
Net Cash Provided by (Used in) Investing Activities
Previous wording
Net cash provided by investing activities was $50.7 million for the year ended December 31, 2023, resulting from $108.5 million in proceeds from maturities of investments, offset by purchases of investments of $56.5 million and purchases of property and equipment of $1.3 million.
Current wording
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.
Previous wording
Net Cash (Used in) Provided by Investing Activities
Current wording
Net Cash (Used in) Provided by Financing Activities
Previous wording
Net cash used in financing activities was $1.5 million for the year ended December 31, 2023, resulting from $1.3 million of payments for tax withholdings related to the vesting of restricted stock units and $1.0 million of payments of offering costs, offset by $0.8 million in proceeds from the exercise of stock options.
Current wording
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.
Previous wording
As of December 31, 2024, our cash, cash equivalents and investments were $184.6 million. We believe that our existing cash, cash equivalents and investments as of December 31, 2024, will enable us to fund our operating expenses and capital expenditure requirements into 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.
Current wording
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.
Previous wording
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. In addition, we expect to continue to incur additional costs associated with 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.
Current wording
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.
Previous wording
the cash requirements of any future acquisitions or discovery of drug candidates;
Current wording
the cash requirements of any future in-licenses,acquisitions or discovery of drug candidates;
Previous wording
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 $4.2 million as of December 31, 2024. Of the $4.2 million, $1.2 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.
Current wording
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.
Previous wording
We may incur contingent milestone payments that we are required to make under our companion diagnostic agreement with Akoya pursuant to which we agreed to co-develop, validate, and commercialize our proprietary ACR-368 OncoSignature test. We are obligated to pay Akoya up to an aggregate of $20.3 million upon the achievement of specified development and pre-commercialization milestones. Due to the uncertainty of the achievement and timing of the events requiring payment under our companion diagnostic agreement with Akoya, the amounts to be paid by us and when are not determinable at this time. As of March 27, 2025, development and pre-commercialization milestones totaling $17.1 million have been paid to Akoya under the agreement. For additional information, see the section titled “Business—Licensing and Collaborations.”
Current wording
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.”
Previous wording
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 at the end of this Annual Report.
Current wording
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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
continue to conduct or initiate new preclinical studies and clinical trials for ACR-2316;