Strong Clinical Momentum — 2025
Six programs entered clinical development in FY2025, bringing the total to 13 clinical programs (an addition of 6 programs in the year). In total, 13 programs staged advanced across the portfolio during 2025.
Late-Stage Radiopharmaceuticals with NDA Timelines
PDRadiopharma has three late-stage programs on a regulatory path: Copper-64-ATSM (Phase III, malignant brain tumors) targeting NDA submission in 2027; Gallium-64 PSMA-I&T diagnostic (first patients dosed, on path for 2027 NDA); and 177-Lutetium PSMA I&T therapeutic registrational bridging study on path toward potential submission in 2029.
In-house IND Filings and Upcoming Phase I Starts
INDs for in-house CAXI diagnostic (Copper-64) and therapeutic (Actinium-225) were accepted at end of 2025, with Phase I start planned in 2026. Additional in-house programs (CAIX, cadherin-3) progressed into IND-enabling or planning early human validation studies.
Revenue Guidance and Cash Position
Management guided FY2026 revenue around JPY 32 billion (plus expected lump-sum/upfront receipts discussed on the call). Consolidated cash position at end-December 2025 was JPY 28.6 billion and the company remains net cash positive with an improving equity ratio.
PDRadiopharma Growth and Manufacturing Expansion Plans
PDRadiopharma positioned as Japan's radiopharmaceutical leader (450+ employees) with planned Kazusa manufacturing site construction starting late 2026 and expected operational capability around 2028 to support Lu-177, Ac-225 and Cu-64 programs.
Platform and Scientific Breakthroughs
Key scientific progress included a reported large-animal demonstration (with Alnylam) of extrahepatic, tissue-specific delivery for peptide-oligonucleotide conjugates and successful in vivo proof-of-concept for in-house immune-engager MPCs, strengthening multiple core therapeutic area approaches.
Ambitious Clinical Pipeline Outlook for 2026
Management expects 6–12 additional programs to enter clinical development in 2026, with an end-2026 target of ~19–25 clinical programs (roughly balanced between RI and non-RI).
Maintained Profitability and Conservative Financial Discipline
Company emphasized four consecutive years of profitability post-merger, maintained net cash positive status, improving equity ratio, and a conservative FY2026 forecast designed to avoid repeating 2025 over-optimism.