Aktis Oncology (AKTS) Morgan Stanley 24th Annual Global Healthcare Conference summary

Industry landscape and platform strategy

• Radiopharmaceuticals are an emerging, validated category with only two approved products targeting two antigens, leaving significant unmet needs across many tumor types.

• The proprietary miniprotein radioconjugate platform enables targeting a broad array of antigens with favorable pharmacologic profiles, supporting multi-tumor development.

• Two lead programs, AKY-1189 (Nectin-4) and AKY-2519 (B7-H3), are in clinical development, both aiming for first-in-class radiopharmaceutical status.

• Strategic collaboration with Eli Lilly, valued over $1.2 billion, expands platform reach while retaining full commercialization rights for the internal pipeline.

• Robust end-to-end supply chain for actinium-225 supports near-term and global scale-up, with ongoing investments in manufacturing capacity.

Technology and clinical development approach

• Miniproteins, inspired by de novo protein design, combine small size for rapid clearance with high target affinity, maximizing therapeutic index and minimizing bone marrow toxicity.

• Libraries encode over 6 billion miniprotein variants, with generative AI expanding design space to accelerate innovation and pipeline expansion.

• Platform is isotope-agnostic but prioritizes actinium-225 for its potent alpha emission and 10-day half-life, supporting centralized manufacturing and global distribution.

• Phase 0 imaging with PET/CT or SPECT/CT enables early assessment of tumor targeting, tissue distribution, and dosimetry, informing dose selection and safety margins.

• Dose escalation in phase I leverages imaging data for rational starting doses and safety, with backfill design to accelerate dose finding.

Lead program updates and market opportunities

• AKY-1189 (Nectin-4) targets a validated antigen with a multi-tumor strategy, including bladder, breast, colorectal, head and neck, and lung cancers.

• Dose escalation includes five levels (4–12 MBq), with eligibility based on Nectin-4 positivity via imaging; preliminary data expected in the first quarter, with expansion cohorts to follow.

• Post-PADCEV bladder cancer patients represent a high unmet need, with current therapies yielding ~20% response rates and short survival, positioning AKY-1189 as a potential fast-to-market candidate.

• AKY-2519 (B7-H3) addresses a larger patient population, notably prostate and lung cancers, with high tumor uptake and low normal tissue exposure demonstrated in imaging studies.

• Prostate cancer chosen as initial focus due to high B7-H3 expression, low salivary gland exposure (differentiating from PSMA agents), and strong investigator enthusiasm; preliminary dose escalation data expected in 2027.