Acrivon Therapeutics, Inc.
For the period ended Mar 31, 2026. Filed May 13, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 13, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001193125-25-280215
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-13.
0001193125-26-221634
Item 2. 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 139 previous paragraphs and 124 current paragraphs.
82 unchanged; 29 reworded; 11 added; 25 removed; 3 previous and 2 current paragraphs rearranged.
Tables are not compared: 5 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 (11)
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 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-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 endometrial cancer, or 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 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 arm 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.
Current report
Based on interim clinical data from the ACR-368-201 trial, we found that the 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 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, 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 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.
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 of head and neck, or SCCHN, in an Investigator-Initiated Trial, or 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, or 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 1/2 monotherapy clinical trial of ACR-2316 is currently in the dose escalation portion of this trial. The Phase 1/2 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 Phase 1/2 trial is advancing, with weekly dosing regimens established. Initial data from the Phase 1/2 monotherapy dose-escalation trial showed a favorable tolerability profile and demonstrated clinical activity with tumor shrinkage in tumor types predicted sensitive to ACR-2316 by AP3. Notably these included partial responses and strong disease control in small cell lung cancer, or SCLC, and squamous non-small cell lung cancer, or NSCLC, tumor types that have shown sensitivity to current WEE1 or PKMYT1 inhibitors in development.
Current report
In addition, we are advancing ACR-6840, an internally discovered development candidate targeting CDK11, and other equally promising series. In preclinical studies, our CDK11 inhibitors result in potent, pro-apoptotic tumor cell death in aggressive AML cell lines and show complete tumor regressionin vivo. They potently downregulate MCL1, a major resistance mechanism in AML to BCL2 inhibitors, and, consistent with this, have 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 companion diagnostic, or 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 Clinical Laboratory Improvement Amendment, or CLIA certified laboratory, located on premises in Watertown, Massachusetts. With these in-house capabilities, including the ability to receive human patient 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, as part of strengthening our precision medicine capabilities. 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, and of added value for strategic partners. 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
Other Expense, Net
Current report
a $0.6 million net decrease in costs for the ACR-368 clinical trial and its related supporting activities; and
Removed paragraphs (25)
Previous 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 designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner. Our approach is designed to overcome the limitations of genetics-based precision medicine. 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 focused on oncology and advancing our pipeline of preclinical and clinical-stage small molecule inhibitors. ACR-368 (also known as prexasertib), which is a selective small molecule inhibitor targeting CHK1 and partially CHK2, is in a potentially registrational Phase 2 trial focusing on endometrial cancer. ACR-2316 is a novel, potent and selective inhibitor of WEE1 and PKMYT1 that is currently being advanced in Phase 1 studies for selected solid tumor types predicted sensitive by AP3. In addition, we are advancing a preclinical program directed against an undisclosed cell cycle regulatory target, with a development candidate nomination anticipated in 2025.
Previous report
The ACR-368 registrational-intent multi-center Phase 2B trial is 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. 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.
Previous report
In May 2023, ACR-368 was granted Fast Track designation from the FDA for the investigation of ACR-368 monotherapy for patients with OncoSignature-positive, or BM+, endometrial cancer. 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 for high-grade endometrial cancer.
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 OncoSignature-negative, or BM-, treated with ACR-368 plus ultra low-dose gemcitabine, or ULDG, 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. Based on available EDC data, 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 progressive disease 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 overall response rate, or ORR, was 50% and the disease control rate, or 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% with median duration of response >5.6 months (not yet reached). 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 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. We now have obtained further evidence of such OncoSignature biomarker upregulation in human patient tumors based on serial pre- and post-ULDG biopsies in an ongoing Investigator-Initiated Trial at the Moffitt Cancer Center in patients with head and neck cancer. Consistent with this preclinical and now clinical evidence of sensitization by ULDG in BM- patients, we are continuing to explore the combination of ACR-368 with ULDG 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 + ULDG 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 ULDG sensitization to ACR-368 in BM- patients. To study this, in July 2025 we initiated a Phase 2 single arm trial of ACR-368 with ULDG sensitization, in a biomarker unselected (“all comer”) population in 2 nd line endometrial cancer patients.
Previous report
Based on additional preclinical drug combination and AP3 mechanistic studies, we believe that ACR-368 may exhibit broad synergy with numerous other chemotherapeutic agents, in particular topoisomerase inhibitor which is one of the most commonly incorporated payloads in antibody-drug conjugates, or ADCs. This supports the potential for ACR-368 treatment benefit in combination with such ADCs. We plan on conducting additional preclinical and clinical evaluations to further assess this synergistic potential and its utility in combination regimens.
Previous report
Pursuant to the agreement, as subsequently amended, we paid Akoya, now a wholly owned subsidiary of Quanterix Corporation, 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 November 13, 2025, development and pre-commercialization milestones totaling $18.2 million have been achieved by 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
Other Income (Expense), Net
Previous report
a $7.1 million net decrease in costs driven by fewer scheduled and incurred milestones in the current period, as well as the prioritization of endometrial cancer over other tumor types in the ACR-368 clinical trial;
Previous report
a $0.9 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; and
Previous report
a $0.7 million increase in personnel-related costs, including $0.2 million of changes to stock-based compensation expense, primarily due to higher annual salaries over time.
Previous report
General and administrative expenses of $6.0 million for the three months ended September 30, 2025 were consistent with general and administrative expenses for the three months ended September 30, 2024.
Previous report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Previous report
Research and Development Expenses
Previous report
a $6.5 million net decrease in costs driven by fewer scheduled and incurred milestones in the current period, as well as the prioritization of endometrial cancer over other tumor types in the ACR-368 clinical trial;
Previous report
a $1.8 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 our preclinical cell cycle program with an undisclosed target;
Previous report
a $3.3 million increase in personnel-related costs, including $0.7 million of changes to stock-based compensation expense, primarily due to an increase in research and development headcount and higher annual salaries over time; and
Previous report
a $1.0 million increase in facilities, supplies and other expenses, primarily driven by an increase in headcount and related research activities.
Previous report
General and Administrative Expenses
Previous report
General and administrative expenses of $18.8 million for the nine months ended September 30, 2025 were consistent with general and administrative expenses for the nine months ended September 30, 2024.
Previous report
Total Other Income, Net
Previous report
Net Cash (Used In) Provided by Financing Activities
Previous report
Net cash provided by financing activities was $121.7 million for the nine months ended September 30, 2024, resulting from $130.0 million in proceeds from the April 2024 Private Placement and $0.1 million in proceeds from the exercise of stock options, offset by $1.9 million of payments for tax withholdings related to the vesting of restricted stock units and $6.5 million of payments of offering costs.
Reworded paragraphs (29)
Previous wording
We have established the Generative Phosphoproteomics AP3 platform which is designed to allow us to interpret and quantify the drug-regulated pathway activity levels inside the intact cell. 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 optimal, desirable pathway effects on the intracellular signaling network to mechanistically address the underlying molecular cause of disease. The integrated analyses of our AP3generated proprietary datasets through a unified computational interface enables streamlined transition from preclinical to the clinical phase, as exemplified by the development of ACR-2316.
Current wording
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 Phosphoproteomics 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 enables 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.
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. ACR-2316, our second clinical stage asset, is a novel, selective WEE1/PKMYT1 inhibitor designed using AP3 for superior single-agent activity through strong activation of not only CDK1 and CDK2 but also of PLK1 to drive pro-apoptotic cell death, as observed in preclinical studies against benchmark inhibitors. Utilizing AP3, we were able to advance ACR-2316 to first dosing in a Phase 1 trial in 15 months, with dosing initiated in the third quarter of 2024. The Phase 1 study will assess the safety and tolerability of ACR-2316. Additionally, the study will seek to establish the pharmacokinetic, or PK, 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 PK analysis we have observed encouraging approximate dose proportionality in the first two dose level, or DL, cohorts. Moreover, using our internal MS-based AP3 profiling to support the clinical trial of ACR-2316, we have observed significant drug target engagement in peripheral blood mononuclear cells already at DL 1. In addition, initial clinical activity with tumor shrinkage has been observed across several solid tumor types predicted to be sensitive to ACR-2316 by AP3 during our dose escalation phase, including a confirmed partial response already at DL3, which is well below the anticipated RP2D. In addition, we are advancing a preclinical program directed against an undisclosed cell cycle regulatory target, with a development candidate nomination anticipated in 2025.
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, establishing arrangements with third parties for the manufacture of ACR-2316, 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, 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, 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.
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 initial public offering, or IPO, and concurrent private placement, and the April 2024 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 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. During the three months ended March 31, 2026, all Pre-Funded Warrants were exercised via cashless exercise. As of March 31, 2026, no Pre-Funded Warrants remained outstanding. In April 2026, a sale was made pursuant to the sales agreement with Cowen and Company, LLC, to provide for the issuance and sale of common stock from time to time in “at-the-market” offerings, or the ATM Program. We issued and sold to certain investors 4,054,954 shares of our common stock at a purchase price of $1.80 per share. The ATM Program sale closed for aggregate net proceeds of $7.3 million.
Previous wording
We have incurred recurring operating losses since inception. Our net losses for the nine months ended September 30, 2025 and 2024 were $58.9 million and $57.7 million, respectively. As of September 30, 2025, we had an accumulated deficit of $255.9 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:
Current wording
We have incurred recurring operating losses since inception. Our net losses for the three months ended March 31, 2026 and 2025 were $19.0 million and $19.7 million, respectively. As of March 31, 2026, we had an accumulated deficit of $293.9 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
As of September 30, 2025, we had cash, cash equivalents and investments of $134.4 million. We believe that our existing cash, cash equivalents and investments as of September 30, 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.”
Current wording
As of March 31, 2026, we had cash, cash equivalents and investments of $97.7 million. We believe that our existing cash, cash equivalents and investments as of March 31, 2026, together with the net proceeds of $7.3 million raised from the ATM Program in April 2026, will enable us to fund our operating expenses and capital expenditure requirements into the third 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, or the Akoya Agreement, with Akoya Biosciences, Inc., or 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 endometrial 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 Biosciences, Inc., or Akoya, now a wholly owned subsidiary of Quanterix, 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
external research and development expenses incurred under agreements with contract research organizations, or CROs, as well as investigative sites and consultants that conduct our clinical trials and other scientific development services;
Current wording
external research and development expenses incurred under agreements with clinical research organizations, or CROs, as well as investigative sites and consultants that conduct our clinical trials and other scientific development services;
Previous wording
costs related to manufacturing material for our clinical trials, including fees paid to contract manufacturing organizations, or CMOs;
Current wording
costs related to manufacturing material for our clinical trials, including fees paid to clinical manufacturing organizations, or CMOs;
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 costs 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 our CDK11 inhibitor program;
Previous wording
We record direct costs for our early stage, discovery, and development 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.
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
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, including our CDK11 inhibitor program.
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 income (expense), net primarily consists of realized and unrealized gains and losses on foreign currency transactions, state and franchise 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
Research and development expenses were $13.6 million for the three months ended September 30, 2025, compared to $18.9 million for the three months ended September 30, 2024. The decrease of $5.2 million was primarily due to:
Current wording
Research and development expenses were $15.2 million for the three months ended March 31, 2026, compared to $15.4 million for the three months ended March 31, 2025. The decrease of $0.2 million was primarily due to:
Previous wording
a $3.8 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;
Current wording
a $0.3 million net increase in costs related to the ACR-2316 clinical trial and its related supporting activities, which has continued to progress through 2026.
Previous wording
Research and development expenses were $45.2 million for the nine months ended September 30, 2025, compared to $45.4 million for the nine months ended September 30, 2024. The decrease of $0.1 million was primarily due to:
Current wording
General and administrative expenses were $4.7 million for the three months ended March 31, 2026, compared to $6.2 million for the three months ended March 31, 2025. The decrease of $1.5 million was primarily due to a decrease in employee-related expenses including stock-based compensation expense.
Previous wording
Total other income, net was $1.5 million for the three months ended September 30, 2025, compared to total other income, net of $2.7 million for the three months ended September 30, 2024. The change of $1.2 million is primarily attributable to a decrease in interest income and accretion earned on our investments.
Current wording
Total other income, net was $0.9 million for the three months ended March 31, 2026, compared to total other income, net of $2.0 million for the three months ended March 31, 2025. The change of $1.1 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 September 30, 2025, we had $134.4 million in cash, cash equivalents and investments, and we had an accumulated deficit of $255.9 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 $134.4 million as of September 30, 2025, will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 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 March 31, 2026, we had $97.7 million in cash, cash equivalents and investments, and we had an accumulated deficit of $293.9 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 $97.7 million as of March 31, 2026, together with the net proceeds of $7.3 million raised from the ATM Program in April 2026, will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2027.
Previous wording
Net cash used in operating activities was $48.4 million for the nine months ended September 30, 2025, compared to net cash used in operating activities of $48.3 million for the nine months ended September 30, 2024. The increase in net cash used in operating activities of $0.1 million was primarily driven by an increase in net loss of $1.2 million, partially offset by a $1.0 million increase in non-cash stock-based compensation expense.
Current wording
Net cash used in operating activities was $20.5 million for the three months ended March 31, 2026, compared to net cash used in operating activities of $19.5 million for the three months ended March 31, 2025. The increase in net cash used in operating activities of $1.0 million was primarily driven 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 million.
Previous wording
Net Cash Provided by (Used in) Investing Activities
Current wording
Net Cash Provided by Investing Activities
Previous wording
Net cash used in investing activities was $66.2 million for the nine months ended September 30, 2024, resulting from purchases of investments of $168.2 million and purchases of property and equipment of $1.9 million, offset by $103.9 million in proceeds from maturities of investments.
Current wording
Net cash provided by investing activities was $13.1 million for the three months ended March 31, 2026, resulting from $30.0 million in proceeds from maturities of investments, offset by purchases of investments of $16.9 million.
Previous wording
Net cash provided by investing activities was $44.6 million for the nine months ended September 30, 2025, resulting from $114.5 million in proceeds from maturities of investments, offset by purchases of investments of $68.5 million and purchases of property and equipment of $1.5 million.
Current wording
Net cash provided by investing activities was $19.2 million for the three months ended March 31, 2025, resulting from $39.5 million in proceeds from maturities of investments, offset by purchases of investments of $20.2 million and purchases of property and equipment of $0.1 million.
Previous wording
Net cash used in financing activities was $0.6 million for the nine months ended September 30, 2025, primarily resulting from $0.6 million of payments for tax withholdings related to the vesting of restricted stock units.
Current wording
Net cash used in financing activities was $0.3 million for the three months ended March 31, 2025, resulting from $0.3 million of payments for tax withholdings related to the vesting of restricted stock units.
Previous wording
As of September 30, 2025, our cash, cash equivalents and investments were $134.4 million. We believe that our existing cash, cash equivalents and investments as of September 30, 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.
Current wording
As of March 31, 2026, our cash, cash equivalents and investments were $97.7 million. We believe that our existing cash, cash equivalents and investments as of March 31, 2026, together with the net proceeds of $7.3 million raised from the ATM Program in April 2026, will enable us to fund our operating expenses and capital expenditure requirements into the third 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
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical drug candidates, we are unable to accurately predict the amount of our operating expenditures. Our future capital requirements will depend on many factors, including but not limited to:
Current wording
Due to the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical drug candidates, we are unable to accurately predict the amount of our operating expenditures. Our future capital requirements will depend on many factors, including, but not limited to:
Previous wording
Except as discussed in Note 12 to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report, during the nine months ended September 30, 2025, 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, 2024, which was filed with the SEC on March 27, 2025.
Current wording
Except as discussed in Note 12 to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report, during the three months ended March 31, 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.
Previous wording
A description of recently adopted accounting pronouncements that may potentially impact our financial position, results of operations and cash flows is disclosed in Note 2 to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report.
Current wording
A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations and cash flows is disclosed in Note 2 to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Net Cash Used In Financing Activities
Current report — wording carried from elsewhere
Net cash used in financing activities was immaterial for the three months ended March 31, 2026, and resulted from payments for tax withholdings related to the vesting of restricted stock units.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
The following table summarizes our results of operations (in thousands):
Previous report — wording carried elsewhere
The following table summarizes our research and development expenses (in thousands):
Previous report — wording carried elsewhere
Total other income, net was $5.1 million for the nine months ended September 30, 2025, compared to total other income, net of $6.5 million for the nine months ended September 30, 2024. The change of $1.4 million is primarily attributable to a decrease in interest income and accretion earned on our investments.