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# Pipeline Development
Acrivon Therapeutics specializes in oncology through its Acrivon Predictive Precision Proteomics (AP3) platform, which identifies compound-specific protein signatures to predict patient response. While the company positions AP3 as a repeatable discovery engine, it currently remains a single-asset story that needs evidence of cross-indication reproducibility and independent biomarker validation that goes beyond the current scope of a few clinical candidates. To benchmark this platform risk, we looked to the trajectories of genomic leaders like Foundation Medicine and Guardant Health. While those companies successfully established Next-Generation Sequencing (NGS) as a clinical standard, they reached maturity only after proving high concordance with gold-standard tissue biopsies and overcoming coding and payment hurdles from CMS. Acrivon faces an even steeper hurdle as phosphoproteomics lacks the standardized, high-sensitivity historical datasets that genomic platforms used to be adopted early. Moreover, we note the lack of historical regulatory precedent for phosphoproteomic-based companion diagnostics and question the prospective predictivity and inter-lab reproducibility of these assays compared to established genomic standards.
The lead product, ACR-368 (prexasertib), is a selective small-molecule inhibitor of checkpoint kinases 1 and 2 (CHK1/2) currently in a registrational-intent Phase 2b trial for endometrial cancer. It blocks the phosphorylation of CHK proteins to disrupt DNA replication and prevent repair, forcing cancer cells into mitotic catastrophe. This effect is especially pronounced in G1-S-deficient tumors, such as uterine serous carcinoma, which rely a lot on the G2-M checkpoint. Updated interim data from January 2026 for the OncoSignature-positive monotherapy arm showed an overall response rate (ORR) of 67% in patients with serous endometrial cancer. The data also revealed a 52% confirmed ORR across all-comer serous patients with two or fewer prior lines of therapy. However, our analysis of the ACR-368-101 trial design shows a high dependency on an open-label, single-arm structure that lacks a formal comparator, introducing cross-trial comparison invalidity when benchmarked against the pembrolizumab plus lenvatinib results from KEYNOTE-775. The statistical powering of the 90-patient Arm 3 relies on a Bayesian hierarchical model designed to detect a treatment effect size well above the historical 10-15% ORR for chemotherapy in the second-line setting. However, differences in patient stratification, especially the exclusion of patients with more than three prior lines of therapy, may create a healthier trial population compared to the real-world, late-line cohorts typically seen in gynecologic oncology. Furthermore, the endpoint hierarchy prioritizes ORR as the primary measure for accelerated approval, which carries regulatory risk since the FDA has historically demanded that such endpoints be supported by mature Duration of Response (DOR) and a clear triage logic for the companion diagnostic to make sure it identifies the responder population without any false positives.
The company is also advancing ACR-2316, a dual WEE1 and PKMYT1 inhibitor. Unlike single-target inhibitors such as AstraZeneca’s saruparib, ACR-2316 is designed to prevent the compensatory signaling that typically causes WEE1 resistance. Dual inhibition makes sure the cell cannot bypass the checkpoint blockade, which could let the asset move into multiple solid tumor indications if initial signals in Small Cell Lung Cancer (SCLC) are validated. Initial Phase 1 data from 33 subjects showed tumor shrinkage in nearly half of evaluable patients. However, we remain cautious until these signals are replicated in larger, controlled expansion cohorts. Furthermore, Acrivon recently nominated ACR-6840 as a development candidate targeting CDK11, with an IND planned for late 2026.
# Intellectual Property, Regulatory Moats, and M&A Potential
An important component of Acrivon’s terminal value is its intellectual property and regulatory strategy. ACR-368 is protected by patents with market exclusivity expected to extend through at least 2030, and supplemental protection potentially reaching 2037. Beyond the molecule itself, the OncoSignature assay has been granted Breakthrough Device designation by the FDA, but this status is not a guarantee of commercial success nor does it enhance the probability of success. From a strategic standpoint, Acrivon represents a target for large-cap pharma, but the M&A thesis requires careful strategy modeling. The 2019 acquisition of Tesaro by GSK for 5.1 billion dollars is a good precedent to use; GSK paid a 110% premium primarily for the PARP inhibitor Zejula, but the deal was driven by a portfolio rebuild strategy. GSK sought to use Tesaro’s specialized US and European oncology commercial footprint to pivot away from its legacy primary care focus. Furthermore, GSK aimed to combine Zejula with Tesaro’s internal anti-PD-1 (dostarlimab) to capture the emerging maintenance market, showing that a single asset is often valued higher if it brings an entire therapeutic beachhead with it.
Similarly, the 2023 ImmunoGen acquisition by AbbVie for 10.1 billion dollars was a big move for the Folate Receptor alpha (FRα) targeting ADC, Elahere. This deal was accretive to AbbVie’s long-term growth strategy because Elahere had already secured accelerated approval and was demonstrating rapid commercial uptake, which provided an immediate revenue stream to offset the Humira cliff. By acquiring the lead ADC and the underlying platform, AbbVie secured a monopoly on the FRα-high patient segment. For a potential acquirer like Eli Lilly, the original developer of prexasertib, an acquisition would represent a buy-back of an asset they once deemed low priority. However, Lilly’s existing oncology pipeline, which includes the CDK4/6 inhibitor Verzenio and a deep interest in targeted protein degradation, could present internal cannibalization risks if ACR-368 is viewed as competing for the same gynecological patient starts. Additionally, if the OncoSignature test needs specialized equipment that a buyer’s existing diagnostic partner cannot support, the integration costs could erode the deal’s net present value.
# Financial Position
Acrivon maintains a capital base with approximately 119 million dollars in cash and equivalents as of December 31, 2025. With a trailing twelve-month cash burn of approximately 73 million dollars, or 6.1 million dollars monthly, the company has a runway into the second quarter of 2027. However, to fund the registration-enabling Phase 3 trial and the commercial build-out for the OncoSignature assay, Acrivon will likely face a funding gap by the third quarter of 2026. At the current market cap, a 50 million dollar raise would result in roughly 50% dilution for current holders, which means management needs to either achieve a valuation adjustment following mid-2026 data or secure a partnership that includes a large upfront payment. A non-dilutive path may involve an acquisition before Phase 3 initiation, shifting the capital expenditure onto a larger partner. Insider confidence was shown by a January 2026 purchase of 49,000 shares by the CEO at 1.68 dollars per share.
# Management Experience
The leadership team is anchored by Founder and CEO Dr. Peter Blume-Jensen, formerly of Merck and Co., who has a documented history of leading drug programs into the clinic but has yet to shepherd a first-in-class diagnostic through a full commercial launch at this scale. His technical leadership is complemented by Chief Medical Officer Dr. Mansoor Raza Mirza, an oncologist who pioneered Phase 3 trials for PARP inhibitors, including the registrational NOVA study for Zejula. While Dr. Mirza’s regulatory execution record is great, the aggressive expansion into multiple ACR-2316 and ACR-6840 cohorts simultaneously could strain the company’s limited cash reserves if enrollment in the lead ACR-368 program slows. The financial strategy is led by CFO Adam Levy, who holds a PhD in Molecular Biology and an MBA from Kellogg, giving him the dual expertise required to communicate complex proteomics data to investors. Further operational depth is provided by Chief Operating Officer Dr. Eric Devroe and EVP Dr. Kristina Masson, who co-founded the company and lead its research hub in Sweden.
# Market and Competition
The market opportunity for ACR-368 focuses on platinum-resistant ovarian and endometrial cancers. By utilizing the OncoSignature assay, Acrivon wants to capture a subset of patients with the highest probability of response. However, the competitive landscape is shifting toward ATR inhibitors, antibody-drug conjugates, and combination checkpoint strategies. ATR inhibitors target the master regulator earlier in the DNA repair process than Acrivon’s target, CHK1, so Acrivon’s success hinges on which treatment produces the most durable response with the least bone marrow toxicity. Antibody-Drug Conjugates, like ImmunoGen’s Elahere, use an antibody to deliver a chemical payload directly to the cancer cell. These are increasingly becoming the standard of care, but they carry a distinct Boxed Warning for ocular toxicity, including visual impairment and keratopathy in up to 61% of patients, which requires ophthalmic monitoring and steroid drops. In contrast, ACR-368’s transient hematological toxicity may be safer for combination therapies. Finally, combination checkpoint strategies involve pairing DNA-damaging agents with immunotherapies like anti-PD-1. By damaging the tumor DNA, drugs like ACR-368 can prime the immune system to recognize the cancer.
# Key Catalysts and Timeline
Critical milestones for 2026 include the completion of enrollment for Arm 3 of the ACR-368 Phase 2b trial in biopsy-independent serous endometrial cancer, expected by the fourth quarter. Arm 3 is biopsy-independent, meaning patients can be enrolled based on archival tissue or clinical subtype alone. This accelerates enrollment timelines and reduces patient screening failure rates, shortening the path toward a potential Biologics License Application. Global trial readiness for the Phase 3 confirmatory study in frontline endometrial cancer, combining ACR-368 with anti-PD-1 therapy, is expected by mid-2026 following protocol submission to the FDA. Additionally, the filing of an IND for the CDK11 inhibitor ACR-6840 is scheduled for year-end.
# rNPV Valuation
An rNPV analysis for ACR-368 in endometrial cancer yields an estimated value of 215 million dollars. This valuation is built upon a peak sales assumption of 650 million dollars by 2031, which assumes a standard S-curve market penetration reaching 25% of the eligible second-line patient population. However, this revenue curve is vulnerable to competitive share erosion from emerging ADCs, which could reduce the average duration of therapy from the modeled 8 months down to 5 months. The probability of success (PoS) is set at 45%, which decomposes into a 70% probability of clinical success given the high ORR, a 65% chance of regulatory approval, and a conservative 40% chance of commercial adoption due to diagnostic implementation hurdles. While this PoS is higher than the industry average, it is contingent on Arm 3 validating the interim signals. A discount rate of 15% is used to reflect micro-cap liquidity and the regulatory hurdles of a first-in-class companion diagnostic. A failure scenario could involve a signal collapse where the 67% ORR regresses to the historical mean in larger cohorts. If this happens, the FDA would likely demand a randomized Phase 3 trial rather than accelerated approval. Combined with a lack of diagnostic reimbursement or a cash crunch forcing a highly dilutive rescue financing, the rNPV collapses to under 80 million dollars, essentially the liquidation value of the remaining pipeline assets.
# Author’s Take
I am bullish on Acrivon because I believe the valuation is disconnected from its cash position and recent clinical signals. The 67% confirmed response rate is high for this indication, but the market is pricing in the dilution risk and the unproven nature of the AP3 platform. While the platform’s ability to generate candidates like ACR-2316 shows unpriced clinical optionality, the main risk remains the regulatory bridge and potential 50% dilution. I am tracking the completion of Arm 3 enrollment in Q4 2026 as the binary event for the stock; if the response rate holds in this larger, biopsy-independent cohort, I think the current market cap will be misaligned with the asset’s potential.
# Disclosure
This Due Diligence report is for informational purposes only and does not constitute financial advice or a recommendation to buy, sell, or hold any securities. The information is based on public filings and media reports and may not be exhaustive or entirely accurate. Investing in biotechnology companies, especially those in clinical stages of development, involves inherent risks, including the complete loss of capital. Clinical trial outcomes, regulatory pathways, and eventual commercial success are subject to uncertainty. Readers should conduct their own thorough due diligence and consult with a qualified financial advisor before making any investment decisions. The author may hold positions in Acrivon Therapeutics ($ACRV) and has received no compensation for this report.

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