Aktis Oncology (AKTS) investor relations material

Strategic vision and platform development

• Focus on miniprotein radioconjugates to expand radiopharmaceuticals into new tumor types with unmet needs, leveraging fast-clearing molecules for improved therapeutic index and bone marrow sparing.

• Platform screens over 6 billion protein variants and uses generative AI to sample billions of trillions of variants, aiming for high-affinity, selective binders.

• Two lead programs target Nectin-4 and B7-H3, with additional early-stage projects and a collaboration with Eli Lilly to develop radioconjugates for targets outside the company's core focus.

• The field is seen at an inflection point similar to ADCs five years ago, with format optimization unlocking broader opportunities.

• Strong cash position ($538M as of March 31) supports broad clinical development, pipeline expansion, and in-house manufacturing capabilities.

Clinical pipeline and trial design

• AKY-1189 (Nectin-4 targeting) is in phase I-B, using a Bayesian backfill design for dose escalation and expansion, focusing on bladder, breast, lung, and other high Nectin-4 expressing tumors.

• Tumor uptake data supports advancement, with a substantive phase I-B update expected in 1Q27, including safety and efficacy data across all dose levels.

• Post-Padcev pembrolizumab setting in metastatic urothelial cancer is a key target, with low current standard of care and potential for rapid patient impact.

• Endpoints in early trials focus on safety, with efficacy data included; response rate may guide further development and regulatory strategy.

• Imaging and dosimetry data are used as stage gates for development, informing dose escalation and supporting go-forward decisions.

B7-H3 program and upcoming data

• AKY-2519 (B7-H3 targeting) has initiated clinical trials in metastatic castrate-resistant prostate cancer, with a second protocol for other tumor types planned for the second half of the year.

• ASCO presentations will include tumor uptake and dosimetry data, supporting the basket trial approach and informing dose escalation.

• ClinicalTrials listing is live, with parallel dose escalations for PLUVICTO-exposed and naive patients, and planned expansions in prostate and lung cancer.

• Advances in imaging and dosimetry technology have enabled more detailed analysis, improving trial design and patient selection.