0001193125-26-132524
SEC filingAktis Oncology filed an 8-K on March 30, 2026 disclosing full year 2025 financial results, FDA IND clearance for AKY-2519 and near-term pipeline milestones.
Aktis Oncology’s March 30, 2026 8-K filing, supported by Exhibit 99.1, combines full year 2025 financial results with material clinical and corporate updates relevant for biotech investors. The company reported a 2025 net loss of $63.7 million, up from 2024’s $44.0 million loss, driven by a 64.6% increase in R&D spending to $67.5 million to advance its lead pipeline candidates AKY-1189 and AKY-2519, as well as higher headcount across R&D and G&A functions. Collaboration revenue from its 2024 Eli Lilly partnership rose to $6.5 million for 2025, up from $1.5 million in 2024 when revenue recognition only started in the fourth quarter.
The most material clinical update is the FDA clearance of IND applications for both imaging and therapeutic versions of AKY-2519, the company’s B7-H3 targeted miniprotein radioconjugate, with a Phase 1b trial expected to launch in mid-2026. Its lead candidate AKY-1189, targeting Nectin-4, received FDA Fast Track designation in February 2026 for locally advanced or metastatic urothelial cancer, with preliminary Phase 1b Part 1 data expected in Q1 2027. The company’s January 2026 IPO raised net proceeds of ~$335.3 million, bringing pro forma cash position to $562.1 million as of year-end 2025, which management states will fund operations into 2029, eliminating near-term dilution risk for investors. An in-house GMP facility expected to launch in H2 2026 will support clinical supply needs for its pipeline programs.