- CEO
- Tadahisa S. Kagimoto
- Full Time Employees
- 65
- Sector
- Healthcare
- Industry
- Biotechnology
- Address
- Yurakucho Denki Building Tokyo Japan 100-0006
- IPO Date
- Nov 9, 2020
- Business
- Healios K.K. (TSE: 4593) develops, manufactures and commercializes cell and gene therapies focused on regenerative medicine products targeting unmet needs in acute respiratory distress syndrome (ARDS), ischemic stroke, trauma and solid tumors; its lead asset HLCM051 (MultiStem), a bone marrow-derived somatic stem cell product licensed globally following the April 2024 acquisition of substantially all assets from bankrupt Athersys Inc., advances in late-stage trials including Phase 3 confirmatory studies planned in the US for ARDS with conditional time-limited approval targeted in Japan by 2025, Phase 2/3 data integration for ischemic stroke and US Department of Defense-funded Phase 2 for trauma; the company pursues immuno-oncology via gene-edited iPSC-derived natural killer (eNK) cells such as HLCN061 for solid tumors including gastric cancer, mesothelioma, lung cancer and hepatocellular carcinoma with pre-IND activities underway and first clinical trials planned for 2025, alongside universal donor cells (UDC), iPSC-derived retinal pigment epithelial (RPE) cells for age-related macular degeneration and RPE tear in partnership with Sumitomo Pharma Co. Ltd. via joint venture Sighregen Co. Ltd., and medical materials including cultured supernatants for beauty clinics and cosmetics; additional offerings encompass secure integrated freezer units (SIFU) for cell therapy storage and 3D bioreactor technology for scalable production. Founded in 2011 and headquartered in Tokyo with a research institute in Kobe, Healios operates primarily in Japan, the US, Europe and Asia through subsidiaries including ProcellCure Inc. for ARDS development, eNK Therapeutics Inc., Healios NA Inc. and fund vehicles like Saisei Bioventures L.P. Recent developments include a June 2024 basic business alliance and 1.6 billion yen bond purchase with Alfresa Corp. for product distribution, an April 2024 joint research agreement with AND Medical Group yielding upfront payments and projected several billion yen in supernatant sales by FY2026, a non-exclusive license to Astellas Pharma subsidiary Astellas Institute for Regenerative Medicine for RPE cell production patents excluding Japan, a January 2025 master collaboration with Akatsuki Therapeutics Inc. for eNK cell R&D, and selection for Japanese government grants including 7 billion yen METI funding and AMED support for eNK industrialization.