EX-99.1 2 ck0002035832-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Aktis Oncology Announces FDA Clearance of Investigational New Drug Applications for AKY-2519 and Provides Business Updates and Full Year 2025 Financial Results • Progressing vision to expand the reach of targeted radiopharmaceuticals to large patient populations • Anticipating multiple milestones in the next 12 months, including initiation of Phase 1b clinical trial of AKY-2519 in mid-2026 BOSTON, March 30, 2026 (GLOBE NEWSWIRE) -- Aktis Oncology, Inc. (NASDAQ:AKTS) (the “Company”), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, today announced the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) applications for the Company to proceed to a Phase 1b clinical trial with AKY-25191. AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumor types including prostate and lung cancers, and is the second clinical stage miniprotein radioconjugate discovered using Aktis’ proprietary platform. T…
Open exhibit ↗Current Report · Items 2.02, 9.01 · 8-K
Aktis Oncology, Inc.
AKTSNASDAQEQUITYCurrent
Results of Operations and Financial Condition
Item 2.02. Results of Operations and Financial Condition On March 30, 2026, Aktis Oncology, Inc. issued a press release announcing its financial results for the year ended December 31, 2025 and provided a business update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.…
Company context
We are a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. The field of targeted radiopharmaceuticals is currently led by two marketed products that illustrated transformative survival outcomes and quality of life benefits can be conferred by delivering radioisotopes to solid tumors. These leading products, which target prostate specific membrane antigen or somatostatin-2 receptor, are each currently approved in only one tumor type yet have seen considerable commercial uptake and have become fundamental pillars of cancer treatment. Despite these advances, we believe that the field of radiopharmaceuticals is still in its infancy, with many emerging companies still primarily focused on these same two targets. In contrast, we see a significant opportunity to broaden the cancer patient populations benefiting from targeted radiopharmaceuticals by developing next-generation technologies that expand the scope of tumor targets for which it is possible to safely deliver a powerful payload of an alpha-emitting radioisotope. To ensure patient demand is reliably met, we are also establishing efficient end-to-end supply, with a combination of critical internal capabilities paired with established external vendors. Through these efforts, we seek to maximize clinical utility across multiple indications in multiple tumor types, and to e