Aktis Oncology (NASDAQ:AKTS) executives outlined the company’s strategy to expand the use of targeted radiopharmaceuticals beyond the limited set of currently approved products, emphasizing a novel “miniprotein” targeting approach, internally built supply chain capabilities, and two lead clinical programs aimed at solid tumors without established radiopharmaceutical options.
Platform approach: “miniproteins” designed for tumor delivery and fast clearance
President and CEO Matt Roden said Aktis is developing targeted radiopharmaceuticals intended to deliver high doses of radiation to tumors while reducing exposure to normal tissues. He framed the company’s thesis around extending clinical benefit seen with approved radiopharmaceuticals such as Pluvicto and Lutathera to additional tumor types where radiopharmaceutical options do not exist.
Roden also contrasted the miniprotein format with other small targeting approaches such as peptides and macrocycles, stating Aktis’ format is the smallest binder with a three-dimensional shape, which he said expands the number of addressable targets.
Building an end-to-end supply chain and actinium access
Roden highlighted manufacturing and supply as a key pillar of Aktis’ strategy. He said the company controls its chemistry, manufacturing, and controls (CMC) work in-house, including formulation and process development, and can tech transfer to qualified contract manufacturers under the company’s INDs.
He added that Aktis is working to open its own GMP manufacturing facility by the end of the year to further verticalize manufacturing while still maintaining multiple manufacturing sites via partners, citing the need for redundancy in radiopharmaceutical manufacturing.
Roden also pointed to “industry-leading actinium supply,” stating the company has publicly announced three actinium supply deals and disclosed that it has also signed additional supply agreements.
Lead program AKY-1189: Nectin-4 targeted radiopharmaceutical in Phase 1b
Discussing AKY-1189, Roden said Nectin-4 was selected because it is broadly expressed across multiple tumor types, including bladder cancer as well as a high proportion of breast, lung, cervical, head and neck, and a “significant chunk” of colorectal cancers. He said those populations lack radiopharmaceutical options. He also emphasized that Nectin-4 is clinically validated by the antibody-drug conjugate Padcev, which he described as a way to reduce stacked development risk.
Roden said Aktis’ Phase 1b study, referred to as the Actinium-two study, includes dose escalation and expansion cohorts. He said the trial is focusing, among other groups, on a second-line urothelial cancer setting after pembrolizumab and Padcev, describing a later-line treatment gap following Trodelvy.
On previously disclosed clinical imaging and dosimetry data presented at the 2024 Triple Meeting in an oral plenary session by Professor Mike Sathekge, Roden said the analysis included patients across five tumor types and showed uniformly high initial tumor uptake, with SUVmax values generally ranging from about 10 to 100. He said normal tissue dosimetry indicated exposure was not higher than what has been published or included in product inserts for approved radiopharmaceuticals such as Pluvicto or Lutathera, suggesting a therapeutic index that could support higher activity dosing.
Roden also highlighted low uptake in blood and bone marrow, describing it as consistent with the platform’s bone marrow-sparing intent. He said uptake and some retention in tumors could be measured through 48 hours, and he referenced non-clinical data showing longer tumor retention in animal models.
Looking ahead, Roden said the company expects to remain in dose escalation throughout the year and described a BOIN backfill component that can expand two dose levels to 30 patients each to optimize dosing and accelerate signal detection. He said Aktis aims to present a “relatively substantive” update from dose escalation at a medical conference in the first quarter of next year.
Second program AKY-2519: B7-H3 targeted radiopharmaceutical with planned IND filing
Roden said Aktis’ second program, AKY-2519, targets B7-H3, which he described as highly expressed in several tumor types including lung cancers—specifically mentioning squamous non-small cell lung cancer—as well as prostate cancer. While noting prostate cancer already has radioligand therapy options, he said B7-H3 is a different target and Aktis intends to use Actinium-225. He also said the company is interested in whether a B7-H3 approach could spare salivary glands, describing salivary gland toxicity as debilitating for some patients treated with Pluvicto.
Roden said competitive intensity is higher for B7-H3 than for Nectin-4, but he believes Aktis was the first to conduct human imaging with a B7-H3 targeted radiopharmaceutical. He said the company has preliminary human imaging data showing good initial tumor uptake across B7-H3–expressing tumor types and relatively quick washout from normal tissues.
Roden said Aktis plans to present B7-H3 imaging and dosimetry data at a medical conference in the middle part of the year, file an IND in the first half of the year, and begin a “big, robust” dose escalation study in the second half of the year. He said upcoming imaging data are expected to include biodistribution and dosimetry, including assessments in prostate cancer such as concordance with uptake versus PSMA and, for the first time at the company’s sites, tumor dosimetry.
He described a development strategy intended to support multiple expansion cohorts and potential parallel accelerated approval opportunities arising from the Phase 1b design.
Lilly collaboration and financial runway
Roden also discussed a discovery collaboration with Eli Lilly signed in 2024. He said Lilly reviewed Aktis’ preclinical package for the Nectin-4 program, leading to an agreement in which Aktis develops novel miniprotein radioconjugates against targets outside its wholly owned pipeline, while Lilly holds rights to take over clinical development and commercialization for those collaboration programs. He emphasized Lilly has no rights to Aktis’ lead programs, including Nectin-4 and B7-H3. Roden added that Aktis disclosed in its S-1 that it achieved the first milestone in the collaboration ahead of schedule.
On capital resources, Roden said Aktis completed an IPO earlier in the year and raised $340 million in net proceeds. He also referenced the company’s third quarter 2025 reported balance sheet with almost $250 million in cash and said, on a pro forma basis, the company projects runway into 2029, which he said should support multiple data readouts for the lead programs as well as additional pipeline development.
About Aktis Oncology (NASDAQ:AKTS)
Aktis Oncology (NASDAQ: AKTS) is a biotechnology company focused on the discovery and development of new therapies for cancer. The firm concentrates on advancing oncology candidates through research and development with the goal of addressing unmet medical needs in oncology. Its work emphasizes targeted and precision approaches intended to improve the safety and efficacy profiles of cancer treatments.
The company’s activities include laboratory research, preclinical studies and clinical development as it advances its pipeline programs toward regulatory milestones.
