PeptiDream (4587) Status Update summary

Strategic R&D Focus and Therapeutic Areas

• R&D is centered on five core therapeutic areas: radiopharmaceuticals, oral/peptide therapeutics, peptide-oligo conjugates, peptide-cytotoxin conjugates, and multifunctional peptide conjugates, with significant advances expected in 2025.

• Radiopharmaceuticals are a major growth driver, with a profitable, cash-generating portfolio and multiple late-stage assets.

• Expansion into oral peptide therapeutics, peptide-oligo conjugates, cytotoxic PDCs, and multifunctional peptide conjugates, with several programs moving toward IND-enabling studies and anticipated clinical entry in 2026.

• Ongoing investments in R&D and manufacturing infrastructure to support expansion and future launches.

• Differentiation strategies focus on leveraging peptide modality advantages, risk-hedged development, and combination potential with existing therapies.

Radiopharmaceuticals Pipeline and Clinical Progress

• AMYVIDⓇ sales grew sevenfold in 2024, with further strong growth expected as amyloid PET becomes standard in Alzheimer's care, driven by new antibody therapies and expanded PET applications.

• RaiattⓇ MIBG therapy for rare endocrine and pediatric cancers expanded access in Japan, closing a long-standing treatment gap and increasing certified treatment centers.

• 64Cu-ATSM for malignant glioma advanced to Phase III, showing promising survival data and progressing toward regulatory filing in late 2027.

• PSMA-targeted radiotherapy platform is positioned for significant market expansion in prostate cancer, leveraging global and Japan-specific trials.

• The radiopharmaceutical ecosystem integrates diagnostics, hardware, software, and services, lowering adoption barriers and strengthening hospital partnerships.

Partnered and Internal Pipeline Updates

• FAP-targeting FXX489 entered Phase 1 with Novartis, showing best-in-class tumor retention and pan-cancer potential.

• GPC3-targeting RYZ801/RYZ811 began Phase 1/1b trials for hepatocellular carcinoma with RayzeBio.

• Three in-house peptide-RI programs (CA9, Claudin 18.2, Cadherin-3) are progressing, with IND filings and Phase 0 studies planned or underway, targeting various solid tumors.

• Internal CA9-targeted radiopharmaceutical PD-32766 completed Phase 0, showing strong tumor targeting and safety, with Phase 1 IND submitted.

• Claudin 18.2 and CDH3 programs advancing toward clinical development, targeting high-incidence gastric, pancreatic, and head & neck cancers.