AKTS

Aktis Oncology, Inc. (AKTS) - 10-K Summary

Business Context and Reporting Period

Company: Aktis Oncology, Inc.
Reporting Period: Fiscal year ended December 31, 2025
Business Model: Clinical-stage oncology company developing targeted radiopharmaceuticals using a proprietary miniprotein radioconjugate platform. The company focuses on delivering alpha-emitting radioisotopes (specifically Actinium-225) to solid tumors.
Key Milestones:

• Completed Initial Public Offering (IPO) in January 2026, raising net proceeds of approximately $335.3 million.
• Commenced a multi-site Phase 1b clinical trial for lead candidate [225Ac]Ac-AKY-1189 (targeting Nectin-4) in the U.S. in 2025; completed first dose level in December 2025.
• Received FDA Fast Track Designation for [225Ac]Ac-AKY-1189 in February 2026.
• Received FDA clearance for INDs for second candidate [225Ac]Ac-AKY-2519 (targeting B7-H3) in March 2026, with Phase 1b initiation expected mid-2026.

Financial Metrics

Note: Revenue is derived primarily from a collaboration agreement with Eli Lilly and Company. The company has no products approved for commercial sale.

Material Changes vs. Prior Period

• Revenue Growth: Collaboration revenue increased by $5.0 million (337%) year-over-year, driven by a full year of revenue recognition from the Eli Lilly agreement entered in May 2024.
• Expense Increase: Total operating expenses increased by $27.6 million (52%). R&D expenses rose $26.5 million, primarily due to:
  • $8.9 million increase in employee-related costs (headcount expansion).
  • $6.9 million increase in direct costs for advancing [225Ac]Ac-AKY-2519.
  • $5.5 million increase in direct costs for the Phase 1b trial of [225Ac]Ac-AKY-1189.
• Liquidity Event: While the balance sheet at year-end 2025 showed $226.8 million in liquid assets, the company completed a significant IPO in January 2026, raising an additional $335.3 million in net proceeds.

Guidance, Outlook, and Risks

Outlook & Guidance:

• Cash Runway: Management believes existing cash ($226.8M) plus IPO proceeds ($335.3M) will fund operations into 2029.
• Clinical Timeline: Preliminary results from the Part-1 dose escalation of the [225Ac]Ac-AKY-1189 Phase 1b trial are anticipated in Q1 2027. The Phase 1b trial for [225Ac]Ac-AKY-2519 is expected to initiate mid-2026.
• Manufacturing: The company is building its own cGMP facility, expected to be fully operational in the second half of 2026.

Key Risks & Contingencies:

• Capital Requirements: The company expects to incur significant losses for the foreseeable future and will require additional funding if clinical trials take longer than expected or if it expands operations more rapidly.
• Supply Chain: Reliance on third-party suppliers for Actinium-225 (225Ac) and other radioisotopes. Shortages or geopolitical issues (e.g., potential reliance on Russian suppliers) could disrupt trials.
• Regulatory & Clinical: No guarantee that clinical trials will demonstrate safety or efficacy. The novel nature of miniprotein radioconjugates presents unpredictable challenges.
• Intellectual Property: The company does not own patents for the radioactive payload (225Ac) and relies on third-party licenses for certain technologies.

Investor Verification Checklist

• Capital Adequacy: Verify the actual cash balance post-IPO and confirm the burn rate aligns with the "into 2029" runway projection.
• Isotope Supply: Review the specific terms of supply agreements for Actinium-225 to assess redundancy and geopolitical risk exposure.
• Clinical Progress: Monitor the Q1 2027 data readout for [225Ac]Ac-AKY-1189, specifically focusing on safety, tolerability, and tumor uptake data.
• Collaboration Terms: Review the Eli Lilly agreement details regarding milestone payments (up to $1.155 billion potential) and the scope of the research targets.
• Manufacturing Status: Track the construction and validation timeline of the internal cGMP facility scheduled for H2 2026.