Study provides additional proof of concept that combining alnodesertib with DNA-damaging agents in high replication stress cancers delays tumor progression

Phase 2 studies with higher dose alnodesertib plus irinotecan are ongoing in ATM-negative colorectal and pancreatic cancers

��

CAMBRIDGE, United Kingdom and NEW YORK, March 2, 2026 – è��AV���� Limited (“è��AV����”), a clinical-stage biopharmaceutical company pioneering the development of new classes of DNA Damage Response (DDR) medicines to deliver meaningful survival benefits for patients with cancer, today reported data from a randomized Phase 2a clinical study (). The trial evaluated è��AV����’ lead candidate, alnodesertib, in combination with gemcitabine versus gemcitabine alone in patients with platinum-resistant high-grade serous ovarian carcinoma (HGSOC). The results were presented by Principal Investigator Antonio Gonzalez-Martin, MD, PhD, Director of the Medical Oncology Department and Cancer Center Director at Clínica Universidad de Navarra, in a poster session at the 27^th European Society of Gynaecological Oncology (ESGO) Annual Meeting held in Copenhagen, Denmark, from February 26-28, 2026.

Alnodesertib is a highly potent, oral, selective inhibitor of the protein kinase ataxia telangiectasia and Rad3-related (ATR). ATR is a key regulator of the cellular response to replication stress, which can occur endogenously or exogenously, for example, via chemotherapy. Multiple cancer types, including HGSOC, are characterized by high endogenous replication stress and rely on ATR to repair damaged DNA before cancer cells progress through the cell cycle. Combining the ATR inhibitor alnodesertib with the DNA-damaging agent gemcitabine amplifies replication stress and has demonstrated additional and more durable clinical benefit.

“This randomized Phase 2a study evaluating a low dose of alnodesertib and the labelled dose of gemcitabine in platinum-resistant ovarian cancer achieved the primary endpoint of progression-free survival, further establishing proof-of-concept in our differentiated approach of inhibiting ATR in tumors with high replication stress,” said Ian Smith, Chief Medical Officer of è��AV����. “These data support further investigation of alnodesertib plus DNA-damaging agents, which we are currently evaluating at higher doses of alnodesertib plus low dose irinotecan in patients with colorectal and pancreatic cancer.”

Highlights of clinical data presented at ESGO 2026:

In the Phase 2a study, 64 patients with platinum-resistant HGSOC were randomized 1:1 to receive a low dose of alnodesertib plus standard-of-care gemcitabine or the same dose of gemcitabine alone, stratified by platinum-free interval. The gemcitabine treatment with or without alnodesertib was administered during a 21-day cycle at the recommended phase 2 dose, which included alnodesertib (50mg) on days 2 – 4 and 9 – 11, and gemcitabine (800mg/m²) on days 1 and 8.

• Combining a low dose of alnodesertib with gemcitabine was statistically significant (p<0.1, one-sided test) and improved progression-free survival (PFS) with a 29% reduction in the risk of progression or death compared with gemcitabine alone
  • 6-month PFS rate was 34% with low dose alnodesertib plus gemcitabine compared to 23% with gemcitabine alone
  • 13 patients (41%) initially randomized to gemcitabine alone were crossed over to the combination with low dose alnodesertib, following disease progression; several patients experienced longer and clinically relevant disease control when low dose alnodesertib was added to the treatment regimen
  • Key secondary endpoints of overall response rate and overall survival were comparable in both treatment arms, with overall survival analysis confounded by a 41% cross-over rate
• The most frequent adverse events were asthenia, pyrexia, and hematologic and gastrointestinal toxicities
  • Overall rates of grade ≥3 adverse events were similar in both arms (66% with low dose alnodesertib plus gemcitabine vs 63% with gemcitabine alone), although grade ≥3 anemia and thrombocytopenia were more common with the combination
  • No treatment‑related deaths or cases of febrile neutropenia were reported in either arm of the study

“The encouraging clinical signals we observed in patients when low dose alnodesertib was added to gemcitabine suggest that this approach warrants further evaluation,” said Principal Investigator, Antonio Gonzalez-Martin, MD, PhD, Director of the Medical Oncology Department and Cancer Center Director at Clínica Universidad de Navarra. “With approximately 70% of patients with ovarian cancer eventually relapsing following platinum-based chemotherapy, there is a high unmet need for promising new therapies like alnodesertib to improve clinical outcomes in platinum-resistant HGSOC and other tumors with high replication stress.”

About alnodesertib

Alnodesertib, formerly known as ART0380, is a potential first-in-class, orally administered, selective small molecule inhibitor of ataxia-telangiectasia and Rad3-related protein (ATR). It is designed to be used in combination with DNA‑damaging agents and is being evaluated across multiple tumor types characterized by high endogenous replication stress. è��AV����’ differentiated approach combines alnodesertib with low‑dose irinotecan to exploit replication stress in cancers such as ATM protein–deficient metastatic colorectal and pancreatic cancer, and other chemotherapies, like gemcitabine, to address platinum-resistant high-grade serous ovarian cancer (HGSOC).

About �AV���� Ltd.

è��AV����’ mission is to develop new classes of medicines that harness DNA Damage Response (DDR) pathways, targeting DNA replication stress and synthetic lethality, to deliver meaningful survival benefits for patients with cancer. Its three potentially first-in-class programs, each with a novel mechanism of action, include ATR inhibitor alnodesertib, the DNA polymerase theta (Polθ) inhibitor ART6043, and a preclinical portfolio of DDRi-ADC candidates with novel payloads. Together, these programs are designed to eliminate cancer cells’ survival mechanisms, driving cancer cell death and improving clinical outcomes.

Visit our website at to learn more about �AV����.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

�AV���� is launching a global randomized Phase 2 study to evaluate ART6043 in patients with BRCA-mutant HER2-negative breast cancer who are eligible to receive a PARP inhibitor

CAMBRIDGE, United Kingdom and NEW YORK, February 23, 2026 – è��AV���� Limited (“è��AV����”), a clinical-stage biopharmaceutical company pioneering the development of new classes of DNA Damage Response (DDR) medicines to deliver meaningful survival benefits for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its potentially first-in-class DNA polymerase theta (Polθ) inhibitor, ART6043, in combination with the PARP inhibitor, olaparib, for the treatment of adult patients with germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer who have received no prior treatment with a PARP inhibitor.

“Breast cancer remains the second leading cause of cancer death in women in the United States. Granting of U.S. Fast Track designation is an important recognition of ART6043’s clinical profile to treat gBRCAm HER2-negative breast cancer and supports our mission to rapidly deliver potential first-in-class therapies to patients who have limited treatment options,” said Mike Andriole, Chief Executive Officer of è��AV����. “Importantly, breast cancer patients with a BRCA mutation often develop resistance to treatment with a PARP inhibitor alone. There remains a significant need to improve clinical outcomes and rates of survival through inhibition of Polθ.”

The designation was granted based on data from the ongoing, first-in-human, Phase 1/2a study (), evaluating ART6043 in combination with olaparib in patients with advanced solid tumors harboring mutations in DDR pathways, including gBRCAm HER2-negative breast cancer. In data presented at the European Society for Medical Oncology (ESMO) Congress 2025, ART6043 demonstrated an attractive tolerability profile, expected PK/PD activity, and promising clinical signals.

“gBRCA-mutated HER2-negative breast cancer presents significant treatment challenges due to its frequently aggressive nature and high risk of recurrence, often due to BRCA reversions, with patients requiring intensive therapy,” said Ian Smith, Chief Medical Officer of è��AV����. “In our ongoing Phase 1/2a study, ART6043, in combination with olaparib, has shown encouraging clinical activity in the relevant genetic background, together with a favorable tolerability and pharmacology profile. These early results support ART6043 as a potential new targeted therapy capable of removing a cancer cell’s reliance on Polθ as a DNA repair mechanism to enhance anti-tumor activity in a well-defined patient population.”

“Our experiments to date with ART6043 have been rationally designed following our team’s pioneering work with the industry’s first PARP inhibitor and recognizing that inhibition of Polθ may enhance the cancer cell killing effects of PARP inhibition and overcome key mechanisms of resistance to improve survival in these patients,” added Graeme Smith, Chief Scientific Officer of è��AV����.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Product candidates with Fast Track designation are eligible for priority review and accelerated approval if relevant criteria are met. This designation will enable è��AV���� to interact more frequently and earlier with the FDA to discuss ART6043’s development path.

��

About ART6043

ART6043 is a potential first-in-class, selective, orally bioavailable, small‑molecule inhibitor of the polymerase domain of DNA polymerase theta (Polθ), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Polθ, ART6043 targets microhomology-mediated end joining (MMEJ) to exploit tumor dependence on error-prone DNA repair, with broad rationale for use as monotherapy and in combination with PARP inhibition and other DNA‑damaging modalities. è��AV����’ differentiated approach is to evaluate ART6043 with olaparib in molecularly defined solid tumors, including settings with BRCA variants and PARP inhibitor resistance, to enhance target engagement and anti-tumor activity while maintaining tolerability.

About �AV���� Ltd.

è��AV����’ mission is to develop new classes of medicines that harness DNA Damage Response (DDR) pathways, targeting DNA replication stress and synthetic lethality, to deliver meaningful survival benefits for patients with cancer. Its three potentially first-in-class programs, each with a novel mechanism of action, include ATR inhibitor alnodesertib, the DNA polymerase theta (Polθ) inhibitor ART6043, and a preclinical portfolio of DDRi-ADC candidates with novel payloads. Together, these programs are designed to eliminate cancer cells’ survival mechanisms, driving cancer cell death and improving clinical outcomes.

Visit our website at to learn more about �AV����.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

Caryn Barnett appointed as VP, Clinical Operations

Pablo Lee, MD, MBA, appointed as VP, Medical Affairs

CAMBRIDGE, United Kingdom and NEW YORK, February 16, 2026 – è��AV���� Limited (“è��AV����”), a clinical-stage biopharmaceutical company pioneering the development of new classes of DNA Damage Response (DDR) medicines to deliver meaningful survival benefits for patients with cancer, today announced the appointment of three senior leaders to strengthen its late-stage development capabilities and preparation for commercial readiness. Roy W. Ware, PhD, MBA, joins è��AV���� as Chief Manufacturing and Technology Officer (CMTO), leading its Chemistry, Manufacturing and Supply Chain (CMSC) operations for the company’s DDR-based therapeutics pipeline. Caryn Barnett has been appointed Vice President of Clinical Operations, and Pablo Lee, MD, MBA, as Vice President of Medical Affairs. These leadership appointments collectively establish an integrated, late-stage drug development capability that aligns manufacturing, clinical execution, and global medical affairs as the company rapidly advances alnodesertib into late-stage development and potential commercialization in the U.S. while simultaneously executing a Phase 2 study for ART6043.

“Roy brings a proven track record of advancing complex, first-in-class oncology programs from early development through approval and into global supply,” said Mike Andriole, Chief Executive Officer of è��AV����. “Combined with Caryn’s deep expertise in late-stage clinical operations and NDA submissions, and Pablo’s extensive experience building high-performing global medical affairs organizations, these leaders further strengthen an already exceptional team at è��AV����. Every day we are reminded that patients with the late-stage cancers our pipeline is designed to address do not have time to wait. These appointments enhance our ability to deliver potential new medicines to patients as quickly as possible.”

“è��AV���� has firmly established itself as a leader in targeting the DNA Damage Response, advancing an industry‑leading pipeline and delivering positive clinical data for its lead program, alnodesertib, in hard‑to‑treat solid tumors,” said Roy W. Ware, PhD, MBA, Chief Manufacturing and Technology Officer of è��AV����. “Joining the company at this pivotal stage presents an exciting opportunity to help drive late‑stage development, enable potential approval, and ultimately bring a novel treatment option to patients who need it most.”

Roy W. Ware, PhD, MBA, Chief Manufacturing and Technology Officer

Dr. Ware joins è��AV���� with more than two decades of experience spanning CMC strategy, manufacturing, and global supply chain leadership from drug discovery through commercial launch. Most recently, he served as Chief Manufacturing and Technology Officer at Chimerix (acquired by Jazz Pharmaceuticals), where he led Chemistry, Manufacturing and Controls (CMC) and Supply Chain operations and oversaw submissions that supported FDA approvals for Tembexa® (brincidofovir) for smallpox and Modeyso® (dordaviprone) for H3 K27M‑mutant diffuse midline glioma, while engaging extensively with global regulatory authorities. He holds a PhD in Organic Chemistry from Wake Forest University, and an MBA from the University of North Carolina at Chapel Hill’s Kenan‑Flagler Business School.

Caryn Barnett, VP of Clinical Operations

Ms. Barnett brings over 30 years of biopharmaceutical industry experience spanning clinical operations, late-stage development, regulatory submissions and inspection readiness. She has led late-phase solid tumor oncology programs through registration and approval, contributing to the successful development and approvals of Cyramza® (ramucirumab), Verzenio® (abemaciclib), Pluvicto® (lutetium 177 vipivotide tetraxetan) and Modeyso® (dordaviprone). Prior to joining è��AV����, Ms. Barnett held senior clinical operations leadership roles at Eli Lilly, Endocyte, and Chimerix, where she led clinical operations through registration trials, FDA submissions and FDA inspections.

Pablo Lee, MD, MBA, VP of Medical Affairs

Dr. Lee is a board-certified internist with more than 25 years of experience spanning medical practice, clinical development and global medical affairs. He has led U.S. and global medical affairs organizations at companies including Chimerix and Verastem Oncology, including the recent launch planning and execution of Modeyso® (dordaviprone) in H3 K27M-mutant diffuse midline glioma. Earlier in his career at Eli Lilly, he held several senior roles spanning global clinical development and medical leadership, during which he helped shape late-stage strategy and advance registrational programs for Cyramza® (ramucirumab), Retevmo® (selpercatinib), Jaypirca® (pirtobrutinib), and Lartruvo® (olaratumab). Dr. Lee earned his MD degree from the University of Buenos Aires School of Medicine and an MBA from The Wharton School at the University of Pennsylvania.

About �AV���� Ltd.

è��AV����’ mission is to develop new classes of medicines that harness DNA Damage Response (DDR) pathways, targeting DNA replication stress and synthetic lethality, to deliver meaningful survival benefits for patients with cancer. Its three potentially first-in-class programs, each with a novel mechanism of action, include ATR inhibitor alnodesertib, the DNA polymerase theta (Polθ) inhibitor ART6043, and a preclinical portfolio of DDRi-ADC candidates with novel payloads. Together, these programs are designed to eliminate cancer cells’ survival mechanisms, driving cancer cell death and improving clinical outcomes.

Visit our website at to learn more about �AV����.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

Mike Andriole, è��AV����’ Chief Executive Officer, will highlight the company’s strategic priorities for its two differentiated, potential first-in-class clinical programs in cancers with high unmet need. The company’s ATR inhibitor, alnodesertib, selects for ATM-deficient patients whose tumors harbor high degrees of DNA replication stress where the program has generated responses across eight different tumor types in early clinical development. It is currently being evaluated in two Phase 2 expansion cohorts in colorectal and pancreatic cancers. The company is also initiating a randomized Phase 2 study of its potentially first-in-class DNA polymerase Theta (Polθ) inhibitor, ART6043, in patients with BRCA-mutant HER2-negative breast cancer who are eligible to receive a PARP inhibitor.

The presentation will take place on Thursday, January 15, at 07:30 am PST (10:30 am EST / 03:30 pm UTC) in the Elizabethan B room (2^nd floor) at The Westin St. Francis, 335 Powell Street, San Francisco.

About �AV���� Ltd.

è��AV���� is pioneering next-generation approaches in the DNA damage response (DDR) field through its comprehensive anti-cancer approach and the deep experience of its team of DDR drug developers. The company’s clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Polθ) inhibitor ART6043, as well as its pre-clinical programs, including DDRi-ADCs, are designed with differentiated pharmaceutical properties and novel biological approaches to precisely eliminate a cancer cell’s remaining survival mechanisms. è��AV����’ mission is to develop new classes of medicines that exploit DDR pathways with the aim of improving outcomes for patients with hard-to-treat cancers.

Visit our website at to learn more about the company.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

Following encouraging ESMO data presentation, è��AV���� will initiate a randomized Phase 2 study for potential first-in-class Polθ inhibitor, ART6043, in breast cancer

Financing co-led by SV Health and new investor, RA Capital Management, with participation from new investor Janus Henderson Investors alongside existing investors

CAMBRIDGE, United Kingdom and NEW YORK, November 17, 2025 – è��AV���� Limited (“è��AV����”), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response (“DDR”) in cancer, today announced the successful close of an oversubscribed $115 million Series D financing. The round was co-led by founding investor SV Health Investors and new investor RA Capital Management, with participation from new investor Janus Henderson Investors and broad support from è��AV����’ existing investors.

The Series D proceeds will expand the clinical evaluation of è��AV����’ lead program, alnodesertib, to enroll additional ATM-negative¹ patients in each of second-line pancreatic cancer and third-line colorectal cancer, for which the program was recently granted U.S. FDA Fast Track Designation. At the AACR meeting in April 2025, è��AV���� reported that alnodesertib, in combination with low-dose irinotecan, demonstrated a 50% confirmed overall response rate in patients with ATM-negative solid tumors at the recommended Phase 2 dose in the STELLA Phase 1/2a trial. There are currently no approved therapies specifically for patients whose tumors harbor ATM-deficiency, a population where alnodesertib has demonstrated durable responses across eight different solid tumors.

The proceeds from the financing will also be used to initiate a Phase 2 randomized clinical trial for è��AV����’ second potential first-in-class candidate, ART6043, in patients with BRCA-mutant HER2-negative breast cancer who are eligible to receive a PARP inhibitor. The DNA polymerase Theta (Polθ) inhibitor, ART6043, demonstrated an attractive tolerability profile, expected PK/PD activity, and promising clinical signals in data from a Phase 1/2a study presented at the ESMO Congress in September 2025. The company is also advancing a first-in-class and highly differentiated DDR inhibitor-Antibody Drug Conjugate (DDRi-ADC) program and expects to name a lead candidate in Q1 2026.

“This Series D accelerates our potential path to registration for both alnodesertib and ART6043, broadening development for the next generation of DNA damage response (DDR) therapeutics to indications among the highest of unmet need across pancreatic, colorectal, and breast cancers, where median survival is often measured in months,” said Mike Andriole, Chief Executive Officer of è��AV����. “As we address these indications and prepare for others, I would like to thank our existing investors, led by SV Health, for their ongoing support, and also our new investors, RA Capital Management and Janus Henderson Investors, for joining our mission to bring these potential medicines to patients as quickly as possible.”

Nikola Trbovic, Managing Partner, SV Health Investors, added, “We are thrilled to have supported è��AV����’ evolution, from an early-stage DDR pioneer when we founded the company to the established company it has become, distinguished by a promising and differentiated pipeline. We look forward to continuing to do so as it deploys the Series D proceeds to drive late-stage development of alnodesertib as well as its pipeline. This financing, and the recent appointment of Mike Andriole as CEO, are exciting steps in è��AV����’ continued growth and its transition toward becoming a commercially oriented organization.”

Jake Simson, Partner, RA Capital Management, commented, “We are excited to co-lead this financing round to advance the next generation of DNA damage response therapeutics. è��AV����’ differentiated clinical programs, alnodesertib and ART6043, together have the potential to meaningfully expand the impact of DDR-targeted therapies. The rate and durability of responses observed to date for alnodesertib across a range of solid tumors and the early clinical results with ART6043 underscore the strength of è��AV����’ approach and ability to deliver novel, potentially first-in-class treatments for patients while building significant long-term value.”

The investors who supported the Series D round include Andera Partners, Avidity Partners, EQT Life Sciences, Invus, IP Group plc, Janus Henderson Investors, M Ventures, Novartis Venture Fund, Omega Funds, Pfizer Ventures, Piper Heartland, RA Capital Management, Sofinnova Partners, Schroders Capital, and SV Health Investors.

About �AV���� Ltd.

è��AV���� is pioneering next-generation approaches in the DNA damage response (DDR) field through its comprehensive anti-cancer approach and the deep experience of its team of DDR drug developers. The company’s clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Polθ) inhibitor ART6043, as well as its pre-clinical programs, including DDRi-ADCs, are designed with differentiated pharmaceutical properties and novel biological approaches to precisely eliminate a cancer cell’s remaining survival mechanisms. è��AV����’ mission is to develop new classes of medicines that exploit DDR pathways with the aim of improving outcomes for patients with hard-to-treat cancers.��Visit our website at to learn more about the company.

About SV Health Investors

SV Health Investors is a leading healthcare fund manager committed to investing in tomorrow’s healthcare breakthroughs. The SV funds invest across stages, geographic regions, and sectors, with expertise spanning biotechnology, dementia, medical devices, healthcare growth and healthcare technology. With approximately $2bn in assets under management and a truly transatlantic presence with offices in London and Boston, SV has built an extensive network of talented investment professionals and experienced industry veterans. Since its founding in 1993, SV has invested in, created and built more than 200 companies attracting global talent, entrepreneurs and pharma partners. To date, these investments have resulted in the licensing of 28 novel drugs and six new drug classes able to treat indications with unmet medical needs and deliver positive impact to patients.��For more information, please visit��.

��About RA Capital Management

Founded in 2004, RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital creates and funds innovative companies, from private seed rounds to public follow-on financings, allowing management teams to drive value creation from inception through commercialization and beyond. RA Capital’s knowledge engine is guided by its dedicated internal research division; and Raven, RA Capital’s healthcare incubator, offers entrepreneurs and innovators a collaborative and comprehensive platform to explore the novel and the re-imagined. RA Capital has more than 170 employees and over $10 billion in assets under management. Learn more at .

Media Inquiries

Trophic Communications

Jacob Verghese

Tel: +49 151 7441 6179

Email: artios@trophic.eu

¹ATM protein levels determined by immunohistochemistry and depicted on an H-score scale: ATM negative = 0; ATM low = 1-50; H-score scale goes from 0 to 300

Results support the potential advancement of ART6043��into Phase 2 clinical development

CAMBRIDGE, United Kingdom and NEW YORK, October 17, 2025 – è��AV���� Limited (“è��AV����”), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response (“DDR”) in cancer, today announced the first clinical data from its Phase 1/2a study () of its novel DNA polymerase Theta (Polθ) inhibitor, ART6043. The data were featured in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin by Principal Investigator Dr. Timothy A. Yap, VP and Head of Clinical Development in the Therapeutics Discovery Division at The University of Texas MD Anderson Cancer Center. The results highlighted ART6043 in combination with the PARP inhibitor, olaparib, in patients with advanced solid tumors harboring mutations in a DNA damage response pathway.

ART6043 targets Polθ, a key DNA repair enzyme that is overexpressed in many cancers but present at low levels or absent in most healthy tissues. Cancer cells rely on Polθ as a backup DNA repair mechanism to survive when their primary homologous recombination (HR) DNA repair pathway is defective or when they acquire resistance to DNA-damaging therapies such as PARP inhibitors. By blocking Polθ, ART6043 is designed to shut down this alternative repair route, rendering tumors unable to effectively repair DNA damage and thereby enhancing anti-tumor activity.

“The emerging clinical data validate our approach to inhibit Polθ to selectively cripple tumor cells and exploit a cancer’s dependency on DNA repair,” said Ian Smith, Chief Medical Officer of è��AV����. “The initial data and efficacy signals in the relevant genetic background are encouraging, and we look forward to advancing ART6043’s clinical development to realize its potential to increase the effectiveness of PARP inhibition, where resistance to standard of care has become increasingly prevalent.”

Summary of Key Clinical Results:

��Baseline characteristics

• ART6043 Monotherapy: 19 patients; median age: 58 years; prior treatment with PARP inhibitor: 37%
• ART6043+olaparib: 42 patients; median age: 65.5 years; prior treatment with PARP inhibitor: 31%
• All patients received a median of 4 prior therapies

Highlights of clinical data presented at ESMO 2025

• ART6043 demonstrated an expected, benign tolerability profile as a monotherapy, with no additional toxicity to that of olaparib when combined
• Pharmacokinetic data support convenient and oral once-daily dosing, and no drug-drug interaction (DDI) between ART6043 and olaparib was observed
• Pharmacodynamic engagement of ART6043 alone was enhanced in combination with olaparib in patients, and was similar to preclinical models where tumor regressions were seen

��

“The first-in-class Polθ inhibitor, ART6043, represents a much-needed therapeutic option for patients with advanced, hard-to-treat cancers where resistance to existing treatments is a major clinical challenge,” said Dr. Timothy A. Yap, Principal Investigator of the study. “The initial clinical signals observed to date reinforce the potential of ART6043 to address this significant unmet need for patients who currently have limited treatment options. I look forward to the further evaluation of Polθ inhibition as additional clinical data become available.”

ART6043 continues to be evaluated in a first-in-human Phase 1/2a study in patients with advanced solid tumors. ART6043 has the potential to advance into dedicated Phase 2 trials to assess efficacy across molecularly selected cohorts and expand its potential into new combinations and disease settings.

The full abstracts will be published in the ESMO Congress 2025 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.

About ART6043

ART6043 is a potential first-in-class, selective, orally bioavailable, small‑molecule inhibitor of the polymerase domain of DNA polymerase theta (Polθ), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Polθ, ART6043 targets microhomology‑mediated end joining (MMEJ) to exploit tumor dependence on error‑prone DNA repair, with broad rationale for use as monotherapy and in combination with PARP inhibition and other DNA‑damaging modalities. è��AV����’ differentiated approach is evaluating ART6043 with olaparib in molecularly defined solid tumors, including settings of BRCA variants and PARP inhibitor resistance, to enhance target engagement and anti-tumor activity while maintaining tolerability.

About �AV���� Ltd.

è��AV���� is pioneering approaches in the DNA damage response (DDR) field through its comprehensive anti-cancer approach and the deep experience of its team of DDR drug developers. The company’s clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Polθ) inhibitor ART6043, as well as its pre-clinical programs, including DDRi-ADCs, are designed with differentiated pharmaceutical properties and novel biological approaches to precisely eliminate a cancer cell’s remaining survival mechanisms. è��AV����’ mission is to develop new classes of medicines that exploit DDR pathways with the aim of improving outcomes for patients with hard-to-treat cancers.

Visit our website at for more information about the company.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

The presentation will feature the first clinical results for ART6043 from the Phase 1/2a study (), including safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors. This will be the first time that clinical activity for a therapeutic candidate targeting Polθ in humans will be presented.

Details of the oral presentation:

Abstract Title: First data disclosure of the first-in-class DNA polymerase theta inhibitor, ART6043, as monotherapy and in combination with olaparib, in patients with molecularly-selected advanced solid tumors

Session Category and Title: Mini oral session: Developmental therapeutics

Date: Friday, October 17, 2025

Time: 4:30 – 4:35 PM CEST

Presenter: Dr. Timothy A. Yap, VP and Head of Clinical Development in the Therapeutics Discovery Division at The University of Texas MD Anderson Cancer Center

Location: Heidelberg Auditorium, Hall 6.2

The abstract is available on the .

�AV���� will issue a press release detailing the data presented at the conference following the oral presentation at ESMO.

About ART6043

ART6043 is a potential first-in-class, selective, orally bioavailable, small‑molecule inhibitor of the polymerase domain of DNA polymerase Theta (Polθ), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Polθ, ART6043 targets microhomology mediated end joining (MMEJ) to exploit tumor dependence on error-prone DNA repair, with broad rationale for use as monotherapy and in combination with PARP inhibition and other DNA-damaging modalities. è��AV����’ differentiated approach is evaluating ART6043 with olaparib in molecularly defined solid tumors, including settings of BRCA variants and PARP inhibitor resistance, to enhance target engagement and anti-tumor activity while maintaining tolerability.

About �AV���� Ltd.��

è��AV���� is pioneering approaches in the DNA damage response (DDR) field through its comprehensive anti-cancer approach and the deep experience of its team of DDR drug developers. The company’s clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Polθ) inhibitor ART6043, as well as its pre-clinical programs, including DDRi-ADCs, are designed with differentiated pharmaceutical properties and novel biological approaches to precisely eliminate a cancer cell’s remaining survival mechanisms. è��AV����’ mission is to develop new classes of medicines that exploit DDR pathways with the aim of improving outcomes for patients with hard-to-treat cancers.

Visit our website at for more information about the company.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

CAMBRIDGE, United Kingdom and NEW YORK, September 24, 2025 – è��AV���� Limited (“è��AV����”), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response (“DDR”) in cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its ATR inhibitor, alnodesertib, in combination with a low dose of chemotherapeutic agent irinotecan, for the treatment of adult patients with ATM-negative metastatic colorectal cancer (mCRC) in the third-line setting.

“The Fast Track designation for alnodesertib underscores its first-in-class potential for third-line mCRC patients with ATM-negative tumors,” said Mike Andriole, Chief Executive Officer of è��AV����. “Approximately 3,000 patients with ATM-negative third-line mCRC succumb to this disease annually in the United States, with no treatment options that specifically address this protein deficiency. Alnodesertib has the potential to be the first treatment specifically for this invariably lethal disease. Additionally, we are encouraged by the durable responses this program has demonstrated across other tumor types, highlighting its ability to target replication stress across a range of solid tumors.”

The designation is supported by encouraging results from the ongoing STELLA Phase 1/2a study, which is evaluating alnodesertib in combination with a low dose of irinotecan. Beyond third-line mCRC, clinical responses were observed in seven additional solid tumor types with ATM deficiency. The combination of alnodesertib plus low-dose irinotecan has a favorable safety profile to date, has been well tolerated, and has been shown to be suitable for long-term dosing.[i]

“Patients with third-line colorectal cancer face a dismal prognosis, with current standards of care for third-line mCRC delivering response rates in the single digits. In our studies to date, alnodesertib has demonstrated compelling clinical activity in ATM-negative patients with mCRC as well as in other heavily pretreated cancer types with high endogenous replication stress,” said Ian Smith, Chief Medical Officer of è��AV����. “These results, together with activity across other solid tumors, highlight alnodesertib’s potential to deliver meaningful benefit where treatment options are limited. The FDA’s Fast Track designation recognizes both the strength of our early clinical data and the urgent need for new therapies, while also providing the opportunity for enhanced interactions with the Agency.”

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Product candidates with Fast Track designation are eligible for priority review and accelerated approval if relevant criteria are met. The Fast Track designation for alnodesertib was granted based on early Phase 1/2 clinical studies that are currently ongoing in the United States. The designation will enable è��AV���� to interact early and more frequently with the FDA to discuss alnodesertib’s development path.

About Alnodesertib

Alnodesertib, formerly known as ART0380, is a potential first-in-class, orally administered, selective small molecule inhibitor of ataxia-telangiectasia and Rad3-related protein (ATR). è��AV����’ differentiated approach combines alnodesertib with a low dose of the chemotherapy irinotecan, targeting cancers with high endogenous replication stress, such as those with ATM protein deficiency.

About �AV���� Ltd.

è��AV���� is pioneering approaches in the DNA damage response (DDR) field through its comprehensive anti-cancer approach and the deep experience of its team of DDR drug developers. The company’s clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Polθ) inhibitor ART6043, as well as its pre-clinical programs, including DDRi-ADCs, are designed with differentiated pharmaceutical properties and novel biological approaches to precisely eliminate a cancer cell’s remaining survival mechanisms. è��AV����’ mission is to develop new classes of medicines that exploit DDR pathways with the aim of improving outcomes for patients with hard-to-treat cancers.

Visit our website at for more information about the company.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

[i] �AV���� Reports Differentiated Clinical Activity in STELLA Phase 1/2a Study for Lead Program ART0380

CAMBRIDGE, United Kingdom and NEW YORK, August 12, 2025 – è��AV���� Limited (“è��AV����”), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response (“DDR”) in cancer, today announced the appointment of Mike Andriole as Chief Executive Officer (CEO) and Director. He joins the company with a biopharmaceutical career that spans nearly 25 years, marked by a consistent theme of focused execution across clinical, corporate, and strategic development. His appointment supports the company’s transition into a late-stage clinical organization preparing for the potential commercialization of alnodesertib (formerly ART0380) in ATM-deficient solid tumors. Mike Andriole succeeds Niall Martin, è��AV����’ founding CEO, who will remain an advisor to the company through a transition period.

“On behalf of the Board, I’m thrilled to welcome Mike Andriole to è��AV����. As the company advances its lead program into later stages of clinical development, Mike’s extensive late-stage oncology experience and strategic focus make him a perfect fit to lead è��AV����,” said Samantha Truex, newly appointed Board Chair. “I’d like to thank Niall for his outstanding leadership and dedication. He has built è��AV���� based on fundamental scientific leadership in the DDR space and has been instrumental in guiding è��AV���� from its discovery platform roots to having two DNA damage response-based therapeutic candidates in the clinic.”

“è��AV���� is entering its next chapter with tremendous momentum as a leader in the DDR field capable of redefining standards of care in the treatment of certain solid tumors,” said Mike Andriole, Chief Executive Officer of è��AV����. “I’m excited to lead the company at this pivotal stage and build on its strong scientific foundation as we take alnodesertib into late-stage development and prepare for potential commercialization. I look forward to collaborating with the talented è��AV���� team to deliver on our mission to bring life-changing first-in-class therapies to patients ��worldwide who have few treatment options.”

Mike Andriole joins è��AV���� after having most recently served as President, CEO and Director of Chimerix, Inc., where he led the company’s acquisition and development of dordaviprone (Modeyso®), a first-in-class small molecule imipridone approved on August 6, 2025, as the first treatment for recurrent H3 K27M-mutant diffuse midline glioma, a type of malignant brain tumor in children and young adults. Chimerix was acquired in April 2025 by Jazz Pharmaceuticals in a $935 million all-cash transaction. Previously, he was Chief Financial Officer and head of corporate development at Endocyte, Inc., where he led a series of strategic transactions that culminated in a $2.1 billion all-cash acquisition by Novartis driven by the late-phase development of its first-in-class targeted radioligand therapy, Lu¹⁷⁷-PSMA-617, which later became the first product approved specifically for PSMA-positive metastatic castration resistant prostate cancer (Pluvicto®). Earlier in his career, Mike spent 16 years at Eli Lilly and Company in various financial, marketing, and global business development roles.

About Alnodesertib (ART0380)

Alnodesertib, formerly known as ART0380, is a first-in-class, orally administered, selective small molecule inhibitor of ataxia-telangiectasia and Rad3-related protein (ATR). è��AV����’ differentiated approach combines alnodesertib with a low dose of the chemotherapy irinotecan, targeting cancers with high endogenous replication stress, such as those with ATM protein deficiency. Data presented at the AACR Annual Meeting 2025 from the ongoing STELLA Phase 1/2a clinical trial demonstrated a 50% confirmed overall response rate (cORR) in patients with ATM-negative solid tumors at the recommended Phase 2 dose (RP2D), along with a favorable safety profile. In addition, the data highlighted two confirmed complete responses in patients with heavily pretreated pancreatic cancer as well as partial responses in patients with pancreatic cancer, colorectal cancer, and six other ATM deficient tumor types.

About �AV���� Ltd.

è��AV���� is pioneering approaches in the DNA damage response (DDR) field through its comprehensive anti-cancer approach and the deep experience of its team of DDR drug developers. The company’s clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Polθ) inhibitor ART6043, as well as its pre-clinical programs, including DDRi-ADCs, are designed with differentiated pharmaceutical properties and novel biological approaches to precisely eliminate a cancer cell’s remaining survival mechanisms. è��AV����’ mission is to develop new classes of medicines that exploit DDR pathways with the aim of improving outcomes for patients with hard-to-treat cancers.

Visit our website at to learn more about the company.

Media Inquiries

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

¹ è��AV���� received approval of “alnodesertib” as the International Nonproprietary Name (INN) for ART0380 by the World Health Organization (WHO)

² ATM protein levels determined by immunohistochemistry and depicted on an H-score scale: ATM negative = 0; ATM low = 1-50; H-score scale goes from 0 to 300

CAMBRIDGE, United Kingdom and NEW YORK, April 29, 2025 – è��AV���� Limited (“è��AV����”), a clinical-stage biotech company led by pioneers of DNA damage response (“DDR”) drug development, today reported encouraging data from its ongoing STELLA Phase 1/2a trial () in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago. The presentation by Principal Investigator Susanna Ulahannan, MD, Associate Professor, Stephenson Cancer Center at the University of Oklahoma and Director, Drug Development, Sarah Cannon Research Institute (SCRI) at OU Health Stephenson Cancer Center, highlighted the Phase 1/2a clinical data from the STELLA trial of è��AV����’ lead candidate, ART0380, in combination with low-dose irinotecan in advanced or metastatic solid tumors.

è��AV���� is pursuing a differentiated clinical development path with its lead product candidate, ART0380, which selectively targets a protein kinase called Ataxia telangiectasia and Rad3-related (ATR). ATR plays a key role in the cellular response to replication stress, a process that can occur endogenously or exogenously, for example via chemotherapy. Many cancers exhibit high endogenous replication stress, such as Ataxia-Telangiectasia Mutated (ATM) protein deficiency found in up to 24% of high-unmet need solid tumors. è��AV����’ innovative approach exploits replication stress to kill cancer cells through triple targeting: selecting cancers with high replication stress, inducing further replication stress with a low dose of irinotecan, and preventing cellular rescue by inhibiting ATR with ART0380.

“è��AV���� is exploiting a new area of DNA damage response called replication stress with ART0380, and the data from our Phase 1/2a study shows robust clinical activity and good tolerability in a large, identifiable patient population,” said Ian Smith, Chief Medical Officer of è��AV����. “These are unprecedented data for the ATR inhibitor class, and they validate our unique approach of combining ART0380 with a low dose of irinotecan to amplify replication stress. We are encouraged by the incidence and durability of the responses in ATM-deficient cancers, including those of particularly high unmet need, such as pancreatic and colorectal cancer.”

Summary of Key Clinical Results:

è��AV���� completed patient enrollment in the dose escalation and initial expansion. As of the data cut-off in February 2025, 87 patients with advanced/metastatic solid tumors who had no satisfactory alternative therapy available to them were treated with ART0380 in combination with low-dose irinotecan, of which 58 patients were treated at the RP2D (recommended Phase 2 dose). These patients’ tumors had varying levels of ATM protein.

• The combination treatment at the RP2D showed a meaningful duration of response and prolonged clinical benefit across multiple histologies
  • 37% confirmed overall response rate (cORR) in patients with ATM-negative¹ and ATM-low¹ cancers (14/38), according to RECIST
    • 50% cORR in ATM-negative cancers (10/20) with a median duration of response (mDoR) of 5.7 months (several responses ongoing)
    • 22% cORR in ATM-low cancers (4/18) with the median duration of response not reached
  • Responses were observed in 8 different solid tumor types
• The combination had a favorable safety profile, was well tolerated, and was shown to be suitable for long-term dosing

The 21-day combination treatment regimen at the RP2D includes administering ART0380 (200mg) on days 1 – 3 and 8 – 10, and irinotecan (60mg/m²) on days 1 and 8.

��

“The first results from the ongoing STELLA clinical trial are compelling and demonstrate the potential for ART0380-irinotecan combination treatment in ATM biomarker-driven tumors. I am encouraged by the clinical activity and durable responses across multiple cancer indications in heavily pretreated patients, especially considering the complete responses observed in metastatic pancreatic cancer,” added Susanna Ulahannan, MD, Director, Drug Development, SCRI at OU Health Stephenson Cancer Center, USA.

��

The Phase 1/2a trial for ART0380 is conducted with SCRI’s contract research organization, SCRI Development Innovations. Based on the meaningful clinical responses observed, è��AV���� is initiating expansion studies in earlier-line settings, including colorectal and pancreatic cancers, to enable pivotal development of ART0380.

��

About ART0380

ART0380 is an orally administered, selective small molecule inhibitor of ataxia telangiectasia and Rad3-related protein (ATR) with first- and best-in-class potential. ATR is activated as the cell’s response to replication stress frequently occurring in rapidly multiplying cells. Inhibiting ATR with ART0380 removes a cancer cell’s ability to repair damaged DNA, leading to the killing of cancerous cells. ART0380 is designed to maximize the therapeutic window and is optimized for combination with DNA damaging therapy to improve patient outcomes. It is currently being evaluated in multiple clinical settings to identify its potential in high replication stress tumors. ART0380 was originally in-licensed by è��AV���� from The University of Texas MD Anderson Cancer Center and ShangPharma Innovation in 2019.�� The molecule was discovered as part of a collaboration between ShangPharma and MD Anderson’s Therapeutics Discovery Division.

About �AV���� Ltd.

è��AV���� is pioneering approaches in the DNA damage response (DDR) field through its comprehensive anti-cancer approach and the deep experience of its team of DDR drug developers. The company’s clinical-stage candidates, ATR inhibitor ART0380 and DNA Polymerase theta (Polθ) inhibitor ART6043 are designed with differentiated pharmaceutical properties and novel biological approaches to precisely eliminate a cancer cell’s remaining survival mechanisms. è��AV����’ mission is to develop new classes of medicines that exploit DDR pathways with the aim of improving outcomes for patients with hard-to-treat cancers.

Visit our website at to learn more about the company.

Media Inquiries

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

¹��ATM protein levels determined by immunohistochemistry and depicted on an H score scale: ATM negative = 0; ATM low = 1-50; H-score scale goes from 0 to 300