Aktis Oncology Reports Financial Results and Business Highlights for First Quarter 2026

Aktis Oncology, a clinical-stage oncology company based in Boston, reported first-quarter 2026 financial results and business updates on May 11, 2026. The company announced a two-trial clinical development strategy for its lead candidate, AKY-2519, designed to evaluate its potential in multiple patient populations. The first Phase 1b trial, initiated in metastatic castration-resistant prostate cancer (mCRPC), aims to generate preliminary data in 2027. A second Phase 1b basket trial for additional solid tumors is expected to begin in the second half of 2026. AKY-2519 is a novel miniprotein radioconjugate targeting B7-H3 expressing tumors, including prostate, lung, and other solid tumors. The company received FDA clearance for its Investigational New Drug (IND) application to proceed with the trial. Aktis Oncology also plans to present clinical imaging and dosimetry data for AKY-2519 at the 2026 ASCO Annual Meeting, which will inform future development decisions. In parallel, Aktis Oncology continues enrolling patients in its ongoing Phase 1b trial of AKY-1189, a miniprotein radioconjugate targeting Nectin-4 expressing tumors. The trial includes patients with locally advanced or metastatic urothelial cancer (mUC), breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. AKY-1189 received FDA Fast Track designation for mUC treatment in patients who progressed after prior therapies, with preliminary data expected in the first quarter of 2027. Matthew Roden, Ph.D., President and CEO, emphasized the company’s focus on expanding the potential of targeted radiopharmaceuticals for large patient populations. The clinical strategy aims to accelerate data generation while addressing distinct treatment patterns across different tumor types. Aktis Oncology remains committed to advancing both AKY-2519 and AKY-1189 to maximize clinical benefit for patients.