StemRIM Inc.
4599・Growth Market・Pharmaceuticals
Business
STEMRIM Inc. is a drug discovery venture whose core business is the research and development of "Regenerative Inducing Medicine®," born out of joint research with Osaka University. Without using living cells, the platform employs a unique mechanism of action in which administration of a compound (peptide) mobilizes and recruits the patient's own bone marrow mesenchymal stem cells to damaged tissue, thereby promoting tissue regeneration. The flagship product, Redasemtide (TRIM2), is undergoing clinical trials for epidermolysis bullosa, acute-phase cerebral infarction, ischemic cardiomyopathy, and other indications, and has already been licensed out to Shionogi & Co., Ltd. In parallel, the company is advancing non-clinical development of its second-generation candidate compounds, TRIM3/TRIM4. The company is listed on the Growth Market of the Tokyo Stock Exchange.
Business Model
The company identifies and patents candidate substances through in-house research and joint research with Osaka University, advances development in-house through nonclinical and early-stage clinical trials, and then licenses out the assets to pharmaceutical companies in Japan and overseas. Revenue takes four forms: (a) upfront contract payments, (b) milestone income tied to development progress, (c) royalty income following product launch, and (d) joint research income. At present, the company is in the research and development phase, prior to revenue generation, and covers business expenses primarily through internal funds on hand.
Company Strengths
The Regenerative Inducing Medicine® platform, based on the HMGB1 peptide, leverages the multipotency of mesenchymal stem cells to form a common platform expected to be applicable across multiple disease areas, including cerebral infarction, epidermolysis bullosa, cardiomyopathy, knee osteoarthritis, and chronic liver disease. Numerous patents have already been obtained through joint research with Osaka University.
In November 2014, the company concluded a worldwide exclusive license agreement for Redasemtide (TRIM2) with Shionogi & Co., Ltd. In June 2020, a new agreement was also concluded to expand indications to knee osteoarthritis, chronic liver disease, and cardiomyopathy, establishing a framework that allows the company to leverage the development and sales resources of a major pharmaceutical company.
In May 2023, Redasemtide (TRIM2) received orphan drug designation from the Ministry of Health, Labour and Welfare for dystrophic epidermolysis bullosa, making it eligible for support measures such as priority review. The company also holds cash and deposits of ¥6,994 million as of the end of July 2025, and states that it has secured research and development funding through 2028.
ENVALITH's Perspective
Performance Trend
For the cumulative nine months of FY2026 (ending March 2026) (August 2025 to April 2026), business revenue was zero (also zero in the same period of the prior year). Operating loss was ¥1,484 million, an improvement of approximately ¥28 million from ¥1,512 million in the same period of the prior year. The main driver was a reduction in selling, general and administrative expenses from ¥434 million to ¥365 million. Research and development expenses increased slightly to ¥1,120 million from ¥1,077 million in the same period of the prior year. Non-operating income rose substantially to ¥46 million from ¥0.7 million in the same period of the prior year, driven by interest income of ¥30 million and subsidy income of ¥12 million, among others, compressing the ordinary loss to ¥1,438 million. Cash and deposits decreased by ¥1,289 million, from ¥6,995 million at the end of the previous fiscal year to ¥5,706 million. Annual losses over the past five fiscal years have ranged from ¥1,929 million to ¥2,022 million, and while there is a trend of improved cost management, the company has yet to achieve revenue generation.
Growth Strategy
Multi-stage value realization through Redasemtide's approval application and launch, plus out-licensing of the second-generation pipeline
Patient enrollment for the additional Phase II trial was completed in July 2025. Preliminary trial results are expected to be obtained by September 2026, with a domestic manufacturing and marketing approval application planned between October 2026 and March 2027, and launch expected between April 2027 and March 2028 (per Shionogi & Co., Ltd. disclosure). Realization of the approval application is expected to result in milestone revenue recognition.
Patient enrollment was completed in December 2025. Preliminary trial results are expected to be obtained by September 2026. Launch is expected between April 2028 and March 2031 (per Shionogi & Co., Ltd. disclosure). Success in the global trial could lead to significant milestone revenue.
Patient enrollment was completed in April 2026, and the trial continues to progress. It is advancing as a domestic study led by Osaka University, and favorable results are expected to lead to progression to the next phase and milestone revenue.
For the second-generation Regenerative Inducing Medicine candidates TRIM3/TRIM4, the company continues to accumulate experimental data in disease model animals while advancing partnering activities with multiple domestic and overseas companies. Upfront payment revenue may arise from the conclusion of new licensing agreements.
SR-GT1, a stem cell gene therapy aimed at fundamentally treating epidermolysis bullosa, was selected for AMED's Industrialization Promotion Program in FY2024 (Reiwa 6). Over the three-year period from FY2024 to FY2026 (Reiwa 6 to Reiwa 8, through March 2027), the company may receive subsidies of up to ¥179 million, aiming to reduce the R&D expense burden while progressing toward an investigator-initiated trial.
Last updated: July 17, 2026