StemRIM Inc.
4599・Growth Market・Pharmaceuticals
Regenerative Inducing Medicine Business (Single Segment)
A drug discovery venture centered on HMGB1-derived peptide pharmaceuticals. Currently in the research and development phase, prior to commercialization.
| Period | Current | Previous | Change |
|---|---|---|---|
| Business revenue (cumulative Q3) | ¥0 million | ¥0 million | — |
| Operating loss (cumulative Q3) | -¥1,484 million | -¥1,512 million (same period prior year) | ↑ |
| Ordinary loss (cumulative Q3) | -¥1,438 million | -¥1,511 million (same period prior year) | ↑ |
| Quarterly net loss (cumulative Q3) | -¥1,409 million | -¥1,469 million (same period prior year) | ↑ |
| Research and development expenses (cumulative Q3) | ¥1,120 million | ¥1,077 million (same period prior year) | ↓ |
| Selling, general and administrative expenses (cumulative Q3) | ¥365 million | ¥434 million (same period prior year) | ↑ |
| Total assets | ¥6,358 million | ¥7,519 million (end of prior fiscal year) | ↓ |
| Net assets | ¥6,126 million | ¥7,314 million (end of prior fiscal year) | ↓ |
| Equity ratio | 72.4% | 78.0% (end of prior fiscal year) | ↓ |
| Cash and deposits | ¥5,706 million | ¥6,995 million (end of prior fiscal year) | ↓ |
| Quarterly net loss per share | -¥22.51 | -¥23.76 (same period prior year) | ↑ |
Business Details
The Company is a single-segment enterprise whose sole business is the research and development of "Regenerative Inducing Medicine®." Without using living cells, it has a proprietary mechanism that mobilizes the patient's own bone marrow mesenchymal stem cells to damaged tissue through administration of peptides and other compounds, thereby promoting regeneration. Its flagship product, Redasemtide, has already been licensed out to Shionogi & Co., Ltd., with milestone income and royalties expected to be the primary future revenue sources. The Company is currently in a development stage with zero business revenue, recording losses centered on research and development expenses.
Recent Overview
Cumulative Q3 losses narrowed year-on-year. Patient enrollment was completed in multiple clinical trials.
Operating loss for the cumulative nine months of FY2026 (ending March 2026) (August 2025 to April 2026) was ¥1,484 million, narrowing from ¥1,512 million in the same period of the prior year. While selling, general and administrative expenses were reduced from ¥434 million to ¥365 million, research and development expenses increased from ¥1,077 million to ¥1,120 million. Progress was made on three trials: the additional Phase II trial of Redasemtide for epidermolysis bullosa (patient enrollment completed July 2025), the global late-phase II trial for acute-phase cerebral infarction (patient enrollment completed December 2025), and the investigator-initiated trial for ischemic cardiomyopathy (patient enrollment completed April 2026). As a subsequent event, the Company resolved to implement a reduction of capital without consideration (reducing capital stock from ¥85,755 thousand to ¥10,000 thousand, with the difference transferred to capital reserves), aimed at securing flexibility in capital policy and reducing tax burden, effective July 30, 2026.
Key Products
Growth Drivers
- Additional Phase II trial of Redasemtide for epidermolysis bullosa: preliminary trial results expected by September 2026, domestic manufacturing and marketing approval application planned for October 2026 to March 2027, and launch planned for April 2027 to March 2028 (as disclosed by Shionogi & Co., Ltd.)
- Global late-phase II trial for acute-phase cerebral infarction: preliminary trial results expected by September 2026, with launch planned for April 2028 to March 2031 (as disclosed by Shionogi & Co., Ltd.), presenting potential future milestone income
- Potential for new licensing agreements as out-licensing negotiations for TRIM3/TRIM4 progress with multiple domestic and overseas companies
- Reduction in research and development expense burden through AMED grant selection for SR-GT1 (up to ¥179 million, FY2024 to FY2026)
- Improvement in the development environment through the Japanese government's support measures for strengthening drug discovery capabilities (development of drug discovery ecosystem, response to new modalities, enhanced R&D support)
- Financial stability due to research and development funding already secured through 2028
Risks
- Business revenue depends on milestone income, which is heavily influenced by the development strategy and schedule of the partner (Shionogi & Co., Ltd.), making it difficult to formulate earnings forecasts
- Risk of clinical trial failure: in the global late-phase II trial for acute-phase cerebral infarction, the low-dose group previously received a discontinuation recommendation at interim analysis
- Cash and deposits have decreased from ¥6,995 million at the end of the prior fiscal year to ¥5,706 million, reflecting continued depletion of funds due to research and development expenditures (projected at ¥1,300-1,700 million annually)
- Risk of delayed commercialization if out-licensing negotiations for TRIM3/TRIM4 fail to reach agreement
- Technical and operational challenges in the regenerative medicine and pharmaceutical industry, including safety and efficacy, sophistication of quality control and manufacturing processes, securing specialized personnel, and establishing a stable supply system
- Risk of diminished research and development capability if the Company is unable to secure and develop excellent research personnel
Last updated: October 21, 2025