CAMBRIDGE, United Kingdom and NEW YORK, May 26, 2026 鈥� 黑料福利社 Limited (鈥満诹细＠玮�� or 鈥渢he Company鈥�), 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 dosing of the first patient in a randomized Phase 2 clinical trial (). The global study is evaluating 黑料福利社鈥� potential first-in-class DNA Polymerase Theta (Pol胃) inhibitor, ART6043, in combination with the PARP inhibitor olaparib, in adult patients with germline BRCA-mutated (gBRCAm) HER2-negative breast cancer who are eligible to receive a PARP inhibitor.

The Phase 2 POLKA trial is supported by Phase 1/2a clinical data for ART6043, which show an attractive tolerability profile, expected PK/PD activity, and promising clinical signals. The POLKA trial is designed to investigate the safety and tolerability of ART6043 plus olaparib and to evaluate the preliminary efficacy of the combination compared to olaparib alone. 黑料福利社 was granted a Fast Track designation by the U.S. Food and Drug Administration (FDA) in February 2026 for the combination treatment regimen in this patient population. The supporting Phase 1/2a data were presented at the 2025 European Society of Medical Oncology (ESMO) Congress.

鈥淒osing the first patient in the Phase 2 POLKA study marks a significant step in realizing the potential of ART6043 and advancing a new class of targeted therapies for patients with gBRCAm HER2-negative breast cancer,鈥� said Ian Smith, Chief Medical Officer of 黑料福利社. 鈥淧atients continue to face limited effective treatment options, underscoring the need for new therapies beyond current standards of care. With Fast Track designation and this study now underway, we are focused on establishing ART6043 as a potential first鈥慽n鈥慶lass therapy that can deliver more meaningful benefits for patients.鈥�

鈥淲hile PARP inhibitors have become a cornerstone of treatment for HER2-negative breast cancer, there remains a significant need for more effective combination strategies to overcome resistance,鈥� added Graeme Smith, Chief Scientific Officer of 黑料福利社. 鈥淏y targeting the complementary DNA repair pathway mediated by Pol胃, ART6043 is rationally designed to enhance the cancer cell killing activity of PARP inhibition and to potentially prevent the emergence of resistance to PARP inhibition. We look forward to evaluating this in the Phase 2 POLKA study.鈥�

The global, multicentre, Phase 2 trial is enrolling 80 patients randomized 1:1 with gBRCAm HER2-negative, locally advanced or metastatic breast cancer who received up to three prior lines of chemotherapy and no or 鈮� 1 month of prior treatment with a PARP inhibitor. Eligible patients will be assigned to receive ART6043 plus olaparib or olaparib alone to assess comparative efficacy as measured by the primary endpoint, progression-free survival. Secondary endpoints include overall response rate, overall survival, and a comparison of the rate of BRCA mutation reversion.

About ART6043

ART6043 is a potential first-in-class, selective, orally bioavailable, small鈥憁olecule inhibitor of the polymerase domain of DNA polymerase theta (Pol胃), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Pol胃, ART6043 targets microhomology-mediated end joining (MMEJ) to exploit tumor dependence on error-prone DNA repair, with broad rationale for use as a combination partner with PARP inhibition and other DNA鈥慸amaging modalities. 黑料福利社鈥� differentiated approach is to evaluate ART6043 with olaparib in molecularly defined solid tumors such as gBRCAm cancers. The Phase1/2a study of ART6043 highlighted an attractive tolerability profile in combination with the leading PARP inhibitor olaparib, expected PK/PD activity, and promising clinical signals.

About 黑料福利社 Ltd.

黑料福利社鈥� 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 (Pol胃) inhibitor ART6043, and a preclinical portfolio of DDRi-ADC candidates with novel payloads. Together, these programs are designed to eliminate cancer cells鈥� survival mechanisms, driving cancer cell death and improving clinical outcomes.

Visit our website at to learn more about 黑料福利社.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 219 412 77

Email: artios@trophic.eu

鈥淲e鈥檙e excited to collaborate with GSK to investigate the potential of this combination strategy to provide meaningful benefit to patients with GI tumors,鈥� said Mike Andriole, Chief Executive Officer of 黑料福利社. 鈥淎s we advance the development of alnodesertib in multiple solid tumors, this collaboration enables 黑料福利社 to broaden our combinatorial strategy and unlock the full potential of exploiting replication stress biology in cancer.鈥�

Under the terms of the agreement, GSK will sponsor and conduct the Phase 1 study and provide its B7-H3 Topo-1 ADC, while 黑料福利社 will supply alnodesertib. Each party will maintain rights to its respective products, and the agreement is mutually non-exclusive. The clinical study is expected to open by the end of the year.

About risvutatug rezetecan

Ris-Rez is a novel investigational B7-H3-targeted antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. GSK acquired exclusive worldwide rights (excluding China鈥檚 mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of Ris-Rez. GSK鈥檚 global phase III trial (NCT07099898) for Ris-Rez in relapsed extensive stage small-cell lung cancer (ES-SCLC) began in August 2025.

Regulatory designations received for Ris-Rez to date include orphan drug designations from the US Food and Drug Administration (FDA) and Japan鈥檚 Ministry of Health, Labor and Welfare in SCLC and the European Medicines Agency (EMA) in a category of cancer that includes SCLC, called pulmonary neuroendocrine carcinoma; Priority Medicines (PRIME) Designation from the EMA for relapsed or refractory ES-SCLC; and Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma from the US FDA.

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).听 黑料福利社 is developing alnodesertib in patients whose tumor harbours high degrees of replication stress using ATM status as a key biomarker.听 When used in combination with low-dose chemotherapy to further amplify replication stress, alnodesertib demonstrated unprecedented response rates across eight different solid tumors in ATM-deficient patients. Alnodesertib has received U.S. Fast Track designation 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.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at听

About 黑料福利社 Ltd.

黑料福利社鈥� 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 (Pol胃) inhibitor ART6043, and a preclinical portfolio of DDRi-ADC candidates with novel payloads. Together, these programs are designed to eliminate cancer cells鈥� survival mechanisms, driving cancer cell death and improving clinical outcomes.

Visit our website at to learn more about 黑料福利社.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

Michael A. Alrutz, J.D., Ph.D., appointed as General Counsel听

Guy C. Ruble, PharmD, appointed as VP, Regulatory Affairs

CAMBRIDGE, United Kingdom and NEW YORK, May 4, 2026 鈥� 黑料福利社 Limited (鈥満诹细＠玮��), 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 executives to the leadership team as the Company accelerates its potential first-in-class oncology pipeline. Jeremy B. Fitch, MBA, joins as Chief Business Officer (CBO) and will shape 黑料福利社鈥� corporate business development and strategic partnerships. Michael A. Alrutz, J.D., Ph.D., joins as General Counsel and will oversee 黑料福利社鈥� legal, corporate governance, regulatory compliance, risk management, and intellectual property management, while serving as a strategic partner to the Board of Directors and executive leadership team. Guy C. Ruble, PharmD, has been appointed as Vice President of Regulatory Affairs to lead the Company鈥檚 regulatory strategy and initiatives. These appointments come as 黑料福利社 advances alnodesertib into late-stage development and prepares for potential U.S. commercialization, executes a randomized Phase 2 study for ART6043, and rapidly advances its DNA Damage Response antibody drug conjugate platform toward clinical development.

鈥淛eremy brings a proven track record of executing high鈥慽mpact transactions and shaping portfolio and corporate strategy,鈥� said Mike Andriole, Chief Executive Officer of 黑料福利社. 鈥淗is appointment as CBO, together with Michael鈥檚 deep legal and governance expertise and Guy鈥檚 leadership in global regulatory strategy, comes at a pivotal inflection point as we progress alnodesertib toward potential registration and commercialization. These leadership additions further strengthen our ability to execute with discipline, accelerate paths to registration, and urgently deliver first鈥慽n鈥慶lass therapies to patients with late鈥憇tage cancers who need more treatment options.鈥�

鈥淲ith three potentially first-in-class DDR programs under rapid development, 黑料福利社 is uniquely positioned with a differentiated pipeline and clear opportunities to create long-term value,鈥� said Jeremy B. Fitch, MBA, Chief Business Officer of 黑料福利社. 鈥淚 look forward to working with the rest of the management team to develop and execute value-creating transactions which leverage our substantial DDR scientific and clinical expertise.鈥�

Jeremy B. Fitch, MBA, Chief Business Officer

Jeremy joins 黑料福利社 with more than 30 years of experience in the biopharmaceutical industry with Eli Lilly and Company (鈥淟illy鈥�), across operational, financial, and corporate business development roles. Jeremy spent the past 15 years in Lilly鈥檚 Corporate Business Development group, most recently as Vice President of Transactions, where he led strategic deal-making spanning M&A, asset acquisitions/divestitures, and licensing agreements. Having led more than $5 billion in transactions during his career, Jeremy has been central to developing and implementing strategies that have driven substantial value creation across Lilly鈥檚 pipeline. Jeremy is a Certified Licensing Professional and holds an MBA from Duke University鈥檚 Fuqua School of Business.

Michael A. Alrutz, J.D., Ph.D., General Counsel

Dr. Alrutz is a seasoned General Counsel and Corporate Secretary, bringing 25 years of biotechnology legal affairs experience to 黑料福利社 across both private and public biopharmaceutical companies. Dr. Alrutz brings a strong track record advising leadership teams through complex corporate inflection points, including IPOs, follow-on financings, intellectual property matters, pre-commercialization matters, and high-value corporate transactions. Most recently, he was SVP, General Counsel, Secretary, and Chief Compliance Officer at Chimerix, where he led SEC compliance, board governance, intellectual property management, and the legal facets of corporate transactions, including the company鈥檚 $935 million all-cash merger with Jazz Pharmaceuticals as the company prepared for commercialization of Modeyso庐 (dordaviprone). Previously, while General Counsel at Trimeris, Inc., he provided legal counsel for the company鈥檚 commercial launch of its antiretroviral, Fuzeon庐 (enfuvirtide). Dr. Alrutz is registered to practice before the USPTO, and holds a J.D. from Duke University School of Law, and a Ph.D. in Microbiology and Molecular Biology from Tufts University.

Guy C. Ruble, PharmD, VP of Regulatory Affairs

Guy brings more than 20 years of regulatory affairs leadership and nearly three decades of biopharmaceutical industry experience to 黑料福利社. He most recently served as Vice President of Regulatory Affairs at Iovance Biotherapeutics, where he led the U.S. FDA accelerated approval of AMTAGVI庐 (lifileucel), the first tumor-infiltrating lymphocyte (TIL) therapy approved in the United States and Canada, and also led global submissions across Europe and Asia. Prior to Iovance, Guy spent nearly 23 years at Eli Lilly and Company, leading global regulatory strategy for multiple oncology programs, including the U.S. FDA approval of Verzenio庐 (abemaciclib). He earned recognition as a Top 100 Lilly Innovator. Guy holds a Doctor of Pharmacy (PharmD) from Purdue University and is Regulatory Affairs Certified (RAC-US). He is a member of the Regulatory Affairs Professional Society and the American Society of Clinical Oncology.

About 黑料福利社 Ltd.

黑料福利社鈥� 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 (Pol胃) inhibitor ART6043, and a preclinical portfolio of DDRi-ADC candidates with novel payloads. Together, these programs are designed to eliminate cancer cells鈥� survival mechanisms, driving cancer cell death and improving clinical outcomes.

Visit our website at to learn more about 黑料福利社.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

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

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CAMBRIDGE, United Kingdom and NEW YORK, March 2, 2026 鈥� 黑料福利社 Limited (鈥満诹细＠玮��), 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 黑料福利社鈥� 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 Cl铆nica 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.

鈥淭his 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,鈥� said Ian Smith, Chief Medical Officer of 黑料福利社. 鈥淭hese 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.鈥�

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 鈥� 4 and 9 鈥� 11, and gemcitabine (800mg/m虏) 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 鈮�3 adverse events were similar in both arms (66% with low dose alnodesertib plus gemcitabine vs 63% with gemcitabine alone), although grade 鈮�3 anemia and thrombocytopenia were more common with the combination
  • No treatment鈥憆elated deaths or cases of febrile neutropenia were reported in either arm of the study

鈥淭he encouraging clinical signals we observed in patients when low dose alnodesertib was added to gemcitabine suggest that this approach warrants further evaluation,鈥� said Principal Investigator, Antonio Gonzalez-Martin, MD, PhD, Director of the Medical Oncology Department and Cancer Center Director at Cl铆nica Universidad de Navarra. 鈥淲ith 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.鈥�

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鈥慸amaging agents and is being evaluated across multiple tumor types characterized by high endogenous replication stress. 黑料福利社鈥� differentiated approach combines alnodesertib with low鈥慸ose irinotecan to exploit replication stress in cancers such as ATM protein鈥揹eficient metastatic colorectal and pancreatic cancer, and other chemotherapies, like gemcitabine, to address platinum-resistant high-grade serous ovarian cancer (HGSOC).

About 黑料福利社 Ltd.

黑料福利社鈥� 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 (Pol胃) inhibitor ART6043, and a preclinical portfolio of DDRi-ADC candidates with novel payloads. Together, these programs are designed to eliminate cancer cells鈥� survival mechanisms, driving cancer cell death and improving clinical outcomes.

Visit our website at to learn more about 黑料福利社.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

黑料福利社 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 鈥� 黑料福利社 Limited (鈥満诹细＠玮��), 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 (Pol胃) 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.

鈥淏reast 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鈥檚 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,鈥� said Mike Andriole, Chief Executive Officer of 黑料福利社. 鈥淚mportantly, 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 Pol胃.鈥�

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.

鈥済BRCA-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,鈥� said Ian Smith, Chief Medical Officer of 黑料福利社. 鈥淚n 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鈥檚 reliance on Pol胃 as a DNA repair mechanism to enhance anti-tumor activity in a well-defined patient population.鈥�

鈥淥ur experiments to date with ART6043 have been rationally designed following our team鈥檚 pioneering work with the industry鈥檚 first PARP inhibitor and recognizing that inhibition of Pol胃 may enhance the cancer cell killing effects of PARP inhibition and overcome key mechanisms of resistance to improve survival in these patients,鈥� added Graeme Smith, Chief Scientific Officer of 黑料福利社.

The FDA鈥檚 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 黑料福利社 to interact more frequently and earlier with the FDA to discuss ART6043鈥檚 development path.

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About ART6043

ART6043 is a potential first-in-class, selective, orally bioavailable, small鈥憁olecule inhibitor of the polymerase domain of DNA polymerase theta (Pol胃), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Pol胃, 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鈥慸amaging modalities. 黑料福利社鈥� 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 黑料福利社 Ltd.

黑料福利社鈥� 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 (Pol胃) inhibitor ART6043, and a preclinical portfolio of DDRi-ADC candidates with novel payloads. Together, these programs are designed to eliminate cancer cells鈥� survival mechanisms, driving cancer cell death and improving clinical outcomes.

Visit our website at to learn more about 黑料福利社.

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 鈥� 黑料福利社 Limited (鈥満诹细＠玮��), 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 黑料福利社 as Chief Manufacturing and Technology Officer (CMTO), leading its Chemistry, Manufacturing and Supply Chain (CMSC) operations for the company鈥檚 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.

鈥淩oy brings a proven track record of advancing complex, first-in-class oncology programs from early development through approval and into global supply,鈥� said Mike Andriole, Chief Executive Officer of 黑料福利社. 鈥淐ombined with Caryn鈥檚 deep expertise in late-stage clinical operations and NDA submissions, and Pablo鈥檚 extensive experience building high-performing global medical affairs organizations, these leaders further strengthen an already exceptional team at 黑料福利社. 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.鈥�

鈥満诹细＠� has firmly established itself as a leader in targeting the DNA Damage Response, advancing an industry鈥憀eading pipeline and delivering positive clinical data for its lead program, alnodesertib, in hard鈥憈o鈥憈reat solid tumors,鈥� said Roy W. Ware, PhD, MBA, Chief Manufacturing and Technology Officer of 黑料福利社. 鈥淛oining the company at this pivotal stage presents an exciting opportunity to help drive late鈥憇tage development, enable potential approval, and ultimately bring a novel treatment option to patients who need it most.鈥�

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

Dr. Ware joins 黑料福利社 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庐 (brincidofovir) for smallpox and Modeyso庐 (dordaviprone) for H3 K27M鈥憁utant 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鈥檚 Kenan鈥慒lagler 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庐 (ramucirumab), Verzenio庐 (abemaciclib), Pluvicto庐 (lutetium 177 vipivotide tetraxetan) and Modeyso庐 (dordaviprone). Prior to joining 黑料福利社, 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庐 (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庐 (ramucirumab), Retevmo庐 (selpercatinib), Jaypirca庐 (pirtobrutinib), and Lartruvo庐 (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 黑料福利社 Ltd.

黑料福利社鈥� 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 (Pol胃) inhibitor ART6043, and a preclinical portfolio of DDRi-ADC candidates with novel payloads. Together, these programs are designed to eliminate cancer cells鈥� survival mechanisms, driving cancer cell death and improving clinical outcomes.

Visit our website at to learn more about 黑料福利社.

For more information, please contact:

Trophic Communications

Jacob Verghese or Verena Schossmann

Tel: +49 151 7441 6179

Email: artios@trophic.eu

Mike Andriole, 黑料福利社鈥� Chief Executive Officer, will highlight the company鈥檚 strategic priorities for its two differentiated, potential first-in-class clinical programs in cancers with high unmet need. The company鈥檚 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 (Pol胃) 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 黑料福利社 Ltd.

黑料福利社 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鈥檚 clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Pol胃) 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鈥檚 remaining survival mechanisms. 黑料福利社鈥� 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, 黑料福利社 will initiate a randomized Phase 2 study for potential first-in-class Pol胃 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 鈥� 黑料福利社 Limited (鈥満诹细＠玮��), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response (鈥淒DR鈥�) 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 黑料福利社鈥� existing investors.

The Series D proceeds will expand the clinical evaluation of 黑料福利社鈥� 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, 黑料福利社 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 黑料福利社鈥� 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 (Pol胃) 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.

鈥淭his 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,鈥� said Mike Andriole, Chief Executive Officer of 黑料福利社. 鈥淎s 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.鈥�

Nikola Trbovic, Managing Partner, SV Health Investors, added, 鈥淲e are thrilled to have supported 黑料福利社鈥� 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 黑料福利社鈥� continued growth and its transition toward becoming a commercially oriented organization.鈥�

Jake Simson, Partner, RA Capital Management, commented, 鈥淲e are excited to co-lead this financing round to advance the next generation of DNA damage response therapeutics. 黑料福利社’ 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 黑料福利社’ approach and ability to deliver novel, potentially first-in-class treatments for patients while building significant long-term value.鈥�

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 黑料福利社 Ltd.

黑料福利社 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鈥檚 clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Pol胃) 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鈥檚 remaining survival mechanisms. 黑料福利社鈥� 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.听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鈥檚 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.听For more information, please visit听.

听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听into Phase 2 clinical development

CAMBRIDGE, United Kingdom and NEW YORK, October 17, 2025 鈥� 黑料福利社 Limited (鈥満诹细＠玮��), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response (鈥淒DR鈥�) in cancer, today announced the first clinical data from its Phase 1/2a study () of its novel DNA polymerase Theta (Pol胃) 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 Pol胃, 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 Pol胃 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 Pol胃, ART6043 is designed to shut down this alternative repair route, rendering tumors unable to effectively repair DNA damage and thereby enhancing anti-tumor activity.

鈥淭he emerging clinical data validate our approach to inhibit Pol胃 to selectively cripple tumor cells and exploit a cancer鈥檚 dependency on DNA repair,鈥� said Ian Smith, Chief Medical Officer of 黑料福利社. 鈥淭he initial data and efficacy signals in the relevant genetic background are encouraging, and we look forward to advancing ART6043鈥檚 clinical development to realize its potential to increase the effectiveness of PARP inhibition, where resistance to standard of care has become increasingly prevalent.鈥�

Summary of Key Clinical Results:

听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

听

鈥淭he first-in-class Pol胃 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,鈥� said Dr. Timothy A. Yap, Principal Investigator of the study. 鈥淭he 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 Pol胃 inhibition as additional clinical data become available.鈥�

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鈥憁olecule inhibitor of the polymerase domain of DNA polymerase theta (Pol胃), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Pol胃, ART6043 targets microhomology鈥憁ediated end joining (MMEJ) to exploit tumor dependence on error鈥憄rone DNA repair, with broad rationale for use as monotherapy and in combination with PARP inhibition and other DNA鈥慸amaging modalities. 黑料福利社鈥� 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 黑料福利社 Ltd.

黑料福利社 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鈥檚 clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Pol胃) 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鈥檚 remaining survival mechanisms. 黑料福利社鈥� 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 Pol胃 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 鈥� 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 .

黑料福利社 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鈥憁olecule inhibitor of the polymerase domain of DNA polymerase Theta (Pol胃), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Pol胃, 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. 黑料福利社鈥� 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 黑料福利社 Ltd.听

黑料福利社 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鈥檚 clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Pol胃) 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鈥檚 remaining survival mechanisms. 黑料福利社鈥� 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