Acrivon Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights
Acrivon Therapeutics (Nasdaq: ACRV) reported Q2 2025 financial results and business updates, highlighting progress in its clinical-stage assets. The company's lead drug ACR-368 is advancing in a registrational-intent Phase 2 study for endometrial cancer, showing promising responses in patients who progressed after chemotherapy and anti-PD1 therapy. Their second asset, ACR-2316, demonstrated initial clinical activity in Phase 1 trials, including a confirmed partial response in endometrial cancer.
The company reported a net loss of $21.0 million for Q2 2025, with R&D expenses of $16.2 million. Acrivon maintains a strong financial position with $147.6 million in cash and equivalents, expected to fund operations into Q2 2027. Key upcoming milestones include updates on the ACR-368 registrational-intent trial and initial clinical data from ACR-2316's Phase 1 study in H2 2025.
Acrivon Therapeutics (Nasdaq: ACRV) ha comunicato i risultati finanziari del Q2 2025 e aggiornamenti aziendali, evidenziando i progressi dei suoi asset in fase clinica. Il farmaco di punta ACR-368 è in avanzamento in uno studio di Fase 2 con intento registrativo per il carcinoma endometriale, mostrando risposte promettenti in pazienti progrediti dopo chemioterapia e trattamento anti‑PD‑1. Il secondo candidato, ACR-2316, ha mostrato attività clinica iniziale nella Fase 1, inclusa una risposta parziale confermata nel carcinoma endometriale.
La società ha riportato una perdita netta di $21.0 million per il Q2 2025, con spese di R&S pari a $16.2 million. Acrivon mantiene una solida posizione finanziaria con $147.6 million in contanti e equivalenti, previsti per finanziare le operazioni fino al Q2 2027. Tra i prossimi traguardi chiave sono previsti aggiornamenti sullo studio registrativo di ACR-368 e i primi dati clinici della Fase 1 di ACR-2316 nella seconda metà del 2025.
Acrivon Therapeutics (Nasdaq: ACRV) informó resultados financieros del 2T 2025 y actualizaciones del negocio, destacando avances en sus activos en fase clínica. Su medicamento principal ACR-368 progresa en un ensayo de Fase 2 con intención registracional para cáncer de endometrio, mostrando respuestas prometedoras en pacientes que progresaron tras quimioterapia y terapia anti‑PD‑1. El segundo activo, ACR-2316, demostró actividad clínica inicial en ensayos de Fase 1, incluida una respuesta parcial confirmada en cáncer de endometrio.
La compañía reportó una pérdida neta de $21.0 million en el 2T 2025, con gastos en I+D de $16.2 million. Acrivon mantiene una posición financiera sólida con $147.6 million en efectivo y equivalentes, que se espera financien las operaciones hasta el 2T 2027. Los hitos próximos incluyen actualizaciones del ensayo registracional de ACR-368 y los primeros datos clínicos del estudio de Fase 1 de ACR-2316 en la segunda mitad de 2025.
Acrivon Therapeutics (Nasdaq: ACRV)는 2025년 2분기 실적 및 사업 업데이트를 발표하며 임상 단계 자산의 진전을 강조했습니다. 주력 약물 ACR-368은 등록 목적의 2상 연구에서 진행 중이며, 화학요법 및 항-PD-1 치료 후 진행한 환자들에서 유망한 반응을 보였습니다. 두 번째 후보물질 ACR-2316은 1상 시험에서 초기 임상 활성을 보였고, 자궁내막암에서 확인된 부분 반응이 포함됩니다.
회사는 2025년 2분기에 순손실 $21.0 million을 보고했으며, 연구개발비는 $16.2 million이었습니다. Acrivon은 $147.6 million의 현금 및 현금성 자산을 보유하고 있어 2027년 2분기까지 운영 자금을 확보할 것으로 예상됩니다. 향후 주요 일정으로는 ACR-368 등록 목적 시험의 업데이트와 2025년 하반기 ACR-2316 1상 시험의 초기 임상 데이터 공개가 예정되어 있습니다.
Acrivon Therapeutics (Nasdaq: ACRV) a publié ses résultats financiers du 2T 2025 et des mises à jour opérationnelles, soulignant les progrès de ses actifs en phase clinique. Le candidat principal ACR-368 progresse dans une étude de phase 2 à visée d'enregistrement pour le cancer de l'endomètre, montrant des réponses prometteuses chez des patients ayant progressé après chimiothérapie et traitement anti‑PD‑1. Le second candidat, ACR-2316, a montré une activité clinique initiale en phase 1, incluant une réponse partielle confirmée dans le cancer de l'endomètre.
La société a enregistré une perte nette de $21.0 million pour le 2T 2025, avec des dépenses de R&D de $16.2 million. Acrivon dispose d'une position financière solide avec $147.6 million en liquidités et équivalents, jugés suffisants pour financer les opérations jusqu'au 2T 2027. Les prochaines étapes clés comprennent des mises à jour sur l'essai d'ACR-368 à visée d'enregistrement et les premières données cliniques de la phase 1 d'ACR-2316 au second semestre 2025.
Acrivon Therapeutics (Nasdaq: ACRV) veröffentlichte die Finanzergebnisse für Q2 2025 und Geschäftsupdates und hob Fortschritte bei seinen klinischen Wirkstoffkandidaten hervor. Der Leitkandidat ACR-368 befindet sich in einer Phase‑2‑Studie mit registrierungsrelevantem Charakter beim Endometriumkarzinom und zeigte vielversprechende Ansprechraten bei Patienten, die nach Chemotherapie und Anti‑PD‑1‑Therapie progredient waren. Der zweite Kandidat, ACR-2316, zeigte in Phase‑1‑Studien erste klinische Aktivität, einschließlich einer bestätigten partiellen Remission beim Endometriumkarzinom.
Das Unternehmen meldete einen Nettoverlust von $21.0 million für Q2 2025, wobei die F&E‑Aufwendungen $16.2 million betrugen. Acrivon verfügt über eine starke Liquiditätsposition mit $147.6 million an Zahlungsmitteln und Äquivalenten, die voraussichtlich bis Q2 2027 die Geschäftstätigkeit finanzieren. Wichtige anstehende Meilensteine sind Updates zur registrierungsintentionierten Studie von ACR-368 und erste klinische Daten aus der Phase‑1‑Studie von ACR-2316 in H2 2025.
- Strong cash position of $147.6 million, providing runway into Q2 2027
- Promising clinical responses for ACR-368 in endometrial cancer patients who failed prior treatments
- Initial clinical activity observed for ACR-2316, including confirmed partial response in endometrial cancer
- No dose-limiting toxicities observed in three cleared dose levels for ACR-2316
- Increased net loss to $21.0 million in Q2 2025 from $18.8 million in Q2 2024
- Higher R&D expenses at $16.2 million compared to $15.0 million in prior year
Insights
Acrivon shows clinical progress in two cancer programs with $147.6M cash runway into Q2 2027, despite widening quarterly losses.
Acrivon's Q2 results reveal a solid financial foundation with
The company's lead asset, ACR-368 (CHK1/CHK2 inhibitor), continues advancing in a registrational-intent Phase 2b trial for endometrial cancer patients who've progressed after receiving both chemotherapy and immunotherapy – a significant unmet need. Importantly, Acrivon has expanded the trial with a third arm using ultra low-dose gemcitabine as a sensitizer, potentially broadening the eligible patient population beyond biomarker-selected individuals.
Their second clinical asset, ACR-2316 (WEE1/PKMYT1 inhibitor), has shown promising initial clinical activity including a confirmed partial response in endometrial cancer. No dose-limiting toxicities have been observed through three dose levels, suggesting a potentially favorable safety profile.
What's particularly compelling is Acrivon's proprietary AP3 platform (Acrivon Predictive Precision Proteomics), which enables pathway-based drug design and provides actionable insights for optimized development. This platform-driven approach has already yielded clinical evidence of efficacy across both pipeline assets, validating their technology-first strategy.
With key data readouts expected in H2 2025 and a new drug discovery program advancing toward candidate nomination, Acrivon maintains momentum while carefully managing its cash position.
Acrivon's dual clinical programs show promising activity in endometrial cancer with their AP3 platform driving mechanism-based development.
Acrivon's clinical data demonstrates encouraging therapeutic potential in addressing the significant unmet need in endometrial cancer. Their lead compound ACR-368, targeting CHK1/CHK2, has shown deep and durable responses in patients with aggressive endometrial cancer who progressed after standard-of-care treatment (chemotherapy and anti-PD1 therapy). This represents a particularly difficult-to-treat population where new options are urgently needed.
The company's mechanistic insight regarding ultra low-dose gemcitabine as a tumor sensitizer for ACR-368 represents a scientifically sound approach. By leveraging this combination, they're expanding beyond biomarker-selected patients to potentially benefit a broader "all-comer" population in the second-line setting. This strategy could significantly increase the addressable patient population if successful.
Their second clinical asset, ACR-2316, targeting WEE1/PKMYT1, demonstrates the evolution of their platform capabilities. The confirmed partial response in endometrial cancer during dose escalation is noteworthy, especially with no dose-limiting toxicities observed through three dose levels. The clean safety profile to date is promising, as cell cycle inhibitors can often encounter narrow therapeutic windows.
The mechanistic data presented at AACR provides valuable context, showing ACR-2316 induces mitotic, pro-apoptotic tumor cell death. This aligns with the compound's molecular targets and supports its potential efficacy. The AP3 platform's ability to guide patient selection through phosphoproteomic analysis represents a sophisticated approach to precision medicine, potentially improving response rates by identifying the patients most likely to benefit from these specific pathway inhibitors.
Continued advancement of two clinical-stage assets, both with clinically demonstrated single-agent anti-tumor activity -- ACR-368 in a registrational-intent Phase 2 study in endometrial cancer and ACR-2316 in a Phase 1 study in AP3-predicted tumor types
New paradigm for accelerated design and development of novel compounds, like ACR-2316, based on optimal intracellular pathway selectivity, uniquely enabled by AI-driven AP3 Generative Phosphoproteomics platform
Cash, cash equivalents and marketable securities of
WATERTOWN, Mass., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the second quarter ended June 30, 2025 and reviewed recent business highlights.
“The strength of the clinical data across our two clinical assets speaks to the expanding capabilities of our AP3 platform to enable pathway-based drug design and optimized drug development by delivering actionable insights,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “With ACR-368, we have seen deep and durable responses in patients with various types of aggressive endometrial cancer who had all progressed on prior chemotherapy and anti-PD1 therapy – a high unmet need population. Based on our clinical data, and the AP3-discovered insight that ultra low-dose gemcitabine sensitizes tumors to ACR-368 treatment, we believe there is an opportunity to further expand the patient population benefiting from ACR-368 by treating all-comer, biomarker-unselected 2nd line patients, who have all received prior chemotherapy and anti-PD-1, with ACR-368 and ultra low-dose gemcitabine. Our fully internally developed second clinical-stage asset, ACR-2316, which is being advanced in a Phase 1 trial, has demonstrated initial clinical activity during dose escalation in several solid tumor types, including an ongoing confirmed partial response in endometrial cancer, signaling the broad potential of this agent.”
Recent Highlights
ACR-368: CHK1 and CHK2 Inhibitor
- Continued advancement of the ongoing registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with recurrent high-grade endometrial cancer who have all received prior platinum-based chemotherapy and prior immune checkpoint inhibitor treatment regimens
- Initiated a third arm to the Phase 2b study without the need for a pre-treatment biopsy to evaluate ACR-368 with ultra low-dose gemcitabine (ULDG) as a tumor sensitizer in all-comer, biomarker-unselected 2nd line patients with endometrial cancer who have all received prior treatment with chemotherapy and anti-PD-1
ACR-2316: WEE1/PKMYT1 Inhibitor
- Continued enrolling patients in the Phase 1 monotherapy dose-escalation trial for certain high unmet need solid tumor types prioritized based on AP3-predicted sensitivity to ACR-2316
- No dose-limiting toxicities observed in three cleared dose levels
- Evidence of drug target engagement observed as early as dose level 1
- Initial clinical activity observed during dose escalation in several solid tumor types, including an ongoing confirmed partial response in endometrial cancer
Generative Phosphoproteomics AP3 Platform
- At the AACR Annual Meeting in April 2025, presented Generative Phosphoproteomic AP3 analyses uncovering key molecular mechanisms by which ACR-2316 induces strong mitotic, pro-apoptotic tumor cell death believed to be critical for its potent, preclinical single-agent activity
Anticipated Upcoming Milestones
- Provide update on registrational-intent trial and confirmatory trial design for ACR-368 in the second half of 2025
- Report initial clinical data from the Phase 1 clinical study of ACR-2316 in the second half of 2025
- Advance a new potential first-in-class cell cycle drug discovery program for an undisclosed target towards development candidate nomination in 2025
Second Quarter 2025 Financial Results
Net loss for the quarter ended June 30, 2025 was
Research and development expenses were
General and administrative expenses were
As of June 30, 2025, the company had cash, cash equivalents and investments of
About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 platform. The platform allows the company to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. The Generative Phosphoproteomics AP3 platform is comprised of a growing suite of powerful, internally-developed tools, including the AP3 Data Portal, converting multimodal data into structured data for generative AI analyses, the AP3 Kinase Substrate Relationship Predictor and the AP3 Interactome. These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery, and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development.
Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has granted a Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer who may benefit from ACR-368 treatment.
In addition to ACR-368, Acrivon is also leveraging its proprietary Generative Phosphoproteomics AP3 platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed 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. The Phase 1 trial of ACR-2316 is advancing with enrollment in the first three dose-escalation cohorts completed. Drug target engagement was observed at DL1 and 2 using the company’s clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses, and initial clinical activity with tumor shrinkage observed at DL3. In addition, the company is advancing a preclinical program directed against an undisclosed cell cycle regulatory target.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, preclinical and clinical results, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on Acrivon’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and Acrivon undertakes no duty to update such information except as required under applicable law.
Investor and Media Contacts:
Adam D. Levy, Ph.D., M.B.A.
alevy@acrivon.com
Alexandra Santos
asantos@wheelhouselsa.com
| Acrivon Therapeutics, Inc. | |||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||
| (unaudited, in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 16,182 | $ | 15,025 | $ | 31,596 | $ | 26,498 | |||||||
| General and administrative | 6,467 | 6,412 | 12,715 | 12,607 | |||||||||||
| Total operating expenses | 22,649 | 21,437 | 44,311 | 39,105 | |||||||||||
| Loss from operations | (22,649 | ) | (21,437 | ) | (44,311 | ) | (39,105 | ) | |||||||
| Other income (expense), net: | |||||||||||||||
| Interest income | 1,730 | 2,694 | 3,726 | 4,140 | |||||||||||
| Other expense, net | (87 | ) | (55 | ) | (101 | ) | (319 | ) | |||||||
| Total other income, net | 1,643 | 2,639 | 3,625 | 3,821 | |||||||||||
| Net loss | $ | (21,006 | ) | $ | (18,798 | ) | $ | (40,686 | ) | $ | (35,284 | ) | |||
| Net loss per share - basic and diluted | $ | (0.55 | ) | $ | (0.52 | ) | $ | (1.06 | ) | $ | (1.20 | ) | |||
| Weighted-average common stock outstanding - basic and diluted | 38,461,619 | 36,132,616 | 38,406,339 | 29,361,710 | |||||||||||
| Comprehensive loss: | |||||||||||||||
| Net loss | $ | (21,006 | ) | $ | (18,798 | ) | $ | (40,686 | ) | $ | (35,284 | ) | |||
| Other comprehensive income (loss): | |||||||||||||||
| Unrealized (loss) gain on available-for-sale investments, net of tax | (177 | ) | 51 | (341 | ) | 64 | |||||||||
| Comprehensive loss | $ | (21,183 | ) | $ | (18,747 | ) | $ | (41,027 | ) | $ | (35,220 | ) | |||
| Acrivon Therapeutics, Inc. | |||||
| Condensed Consolidated Balance Sheets | |||||
| (unaudited, in thousands) | |||||
| June 30, | December 31, | ||||
| 2025 | 2024 | ||||
| Assets | |||||
| Cash and cash equivalents | $ | 41,895 | $ | 39,818 | |
| Investments | 105,727 | 144,751 | |||
| Other assets | 10,961 | 12,019 | |||
| Total assets | $ | 158,583 | $ | 196,588 | |
| Liabilities and Stockholders' Equity | |||||
| Liabilities | $ | 15,546 | $ | 19,802 | |
| Stockholders' Equity | 143,037 | 176,786 | |||
| Total Liabilities and Stockholders' Equity | $ | 158,583 | $ | 196,588 | |
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