Aktis Oncology Inc.: Aktis Oncology Reports Financial Results and Business Highlights for First Quarter 2026
Aktis Oncology reported Q1 2026 financial results and announced a two-trial clinical development strategy for its drug AKY-2519, including a Phase 1b trial for metastatic castration-resistant prostate cancer (mCRPC) with preliminary data expected in 2027. The company also presented plans to present AKY-2519 clinical imaging data at the 2026 ASCO Annual Meeting and continue enrolling patients in a Phase 1b trial for AKY-1189, targeting Nectin-4 expressing tumors, with preliminary data due in Q1 2027.
Aktis Oncology, a clinical-stage oncology company based in Boston, reported its first-quarter 2026 financial results and outlined key business updates focused on its radiopharmaceutical pipeline. The company announced a two-trial clinical development strategy for its drug AKY-2519, designed to evaluate its potential in multiple patient segments. This includes initiating a Phase 1b clinical trial for metastatic castration-resistant prostate cancer (mCRPC), with preliminary data anticipated in 2027. A second Phase 1b basket trial for additional solid tumors is planned for the second half of 2026. AKY-2519, a miniprotein radioconjugate targeting B7-H3 expressing tumors, received FDA clearance for its Investigational New Drug (IND) application. The company will present clinical imaging and dosimetry data for AKY-2519 at the 2026 ASCO Annual Meeting, which informed its clinical development strategy. Aktis Oncology aims to accelerate data generation while addressing distinct treatment patterns in mCRPC and other solid tumors. In parallel, the company continues enrolling patients in an ongoing Phase 1b trial for AKY-1189, targeting Nectin-4 expressing tumors such as urothelial, breast, lung, colorectal, cervical, and head and neck cancers. AKY-1189 received Fast Track designation from the FDA for treating adult patients with locally advanced or metastatic urothelial cancer (mUC) after prior systemic therapies. Preliminary data from this trial is expected in the first quarter of 2027. Matthew Roden, Ph.D., President and CEO of Aktis Oncology, emphasized the company’s focus on delivering a new class of radiopharmaceuticals for large patient populations. The clinical development strategy leverages Aktis’ proprietary miniprotein radioconjugate platform and aims to maximize clinical benefits for patients. Both AKY-2519 and AKY-1189 are part of the company’s efforts to advance targeted radiopharmaceutical therapies in oncology.
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