Aktis Oncology (AKTS) TD Cowen 46th Annual Health Care Conference summary

Industry landscape and opportunity

• Radiopharmaceuticals are at an inflection point, with strong clinical and commercial validation, robust deal flow, and a projected therapeutic segment market of $6–9 billion by decade's end, potentially expanding to $25–60+ billion post-2030 as more tumor types are addressed.

• Current therapies target only two antigens, leaving a large untapped market, while the company is pursuing first-in-class agents for Nectin-4 and B7-H3, where competition is lower.

• Radiopharmaceuticals could move from niche indications to multi-tumor, multi-disease opportunities, fundamentally changing standards of care.

• Multi-indication opportunities for lead assets are supported by strong comparables in pricing and market potential, with forecasted peak sales in the billions.

• Market and industry data are sourced from reputable third parties and internal analyses, supporting robust market opportunity assessments.

Platform technology and pipeline

• Developed a novel miniprotein binder platform for radioconjugates, enabling high tumor penetrance, rapid clearance, and reduced off-target toxicity, with screening libraries exceeding 5 billion variants enhanced by generative AI.

• Lead programs: AKY-1189 (Nectin-4, in Phase I-B NECTINIUM-2 study) and AKY-2519 (B7-H3, IND submission and Phase I-B planned for 2024), both showing promising imaging and dosimetry data.

• Additional pipeline agents are in development, with plans to advance two more programs in the next 1–2 years and further product candidates identified.

• The platform is isotope-agnostic, supporting both imaging and therapeutic applications, and is designed for rapid, capital-efficient scale-up.

• The miniprotein radioconjugate platform is designed to expand addressable tumor types and enable use in earlier therapy lines, targeting large patient populations.

Clinical development and regulatory strategy

• AKY-1189 received FDA Fast Track designation; NECTINIUM-2 study is enrolling across multiple tumor types, with data readouts expected through 2026 and initial conference presentation in early 2027.

• Bayesian backfill design accelerates dose finding and optimization, with expansion cohorts planned for efficacy assessment.

• AKY-2519 is preparing for Phase I-B dose escalation in 2024, with imaging and dosimetry data to be presented mid-year.

• Key milestones include IND filing in 1H'26, imaging/dosimetry data mid'26, and preliminary data in 1Q'27.

• Advisory boards and regulatory discussions support moving into earlier lines of therapy, aiming for maximum patient impact and potential label expansion.