Aktis Oncology (AKTS) Q4 2025 earnings summary

Executive summary

• FDA cleared IND applications for AKY-2519, enabling a Phase 1b clinical trial in mid-2026 targeting B7-H3 in solid tumors.

• Lead program AKY-1189, targeting Nectin-4, is enrolling in a Phase 1b trial and received FDA Fast Track designation in February 2026.

• IPO in January 2026 raised $365.4M gross, supporting expansion and clinical development.

Financial highlights

• Cash, cash equivalents, and marketable securities were $226.8M as of December 31, 2025; pro forma as adjusted cash post-IPO is $562.1M.

• Collaboration revenue rose to $6.5M for 2025 from $1.5M in 2024, mainly from the Eli Lilly partnership.

• R&D expenses increased to $67.5M in 2025 from $41.0M in 2024, driven by higher headcount and program advancement.

• G&A expenses were $13.7M in 2025, up from $12.6M in 2024, reflecting business growth.

• Net loss widened to $63.7M in 2025 from $44.0M in 2024, primarily due to increased R&D spending.

Outlook and guidance

• Preliminary data from Part 1 of the AKY-1189 Phase 1b trial expected in Q1 2027.

• Results from AKY-2519 imaging and dosimetry assessment expected mid-2026; Phase 1b trial to start mid-2026.

• Early pipeline programs aim for development candidate nomination and IND-enabling activities in Q1 2027.

• In-house GMP facility expected operational in H2 2026 to support clinical supply.

• Pro forma cash position expected to fund operations into 2029.