What StemRIM does

StemRIM Inc. (株式会社ステムリム) is a clinical-stage Japanese biotechnology company founded in 2006 and headquartered in Ibaraki City, Osaka, that develops Regeneration-Inducing Medicine™ — a class of chemically synthesized peptides derived from the active domain of the human HMGB1 protein. The company's lead compound, Redasemtide (development code TRIM2), mobilizes the patient's own mesenchymal stem cells from bone marrow into the bloodstream, where they accumulate at sites of tissue damage and exert immunomodulatory, trophic, and anti-fibrotic effects to promote functional tissue regeneration. StemRIM is currently advancing Redasemtide in Phase 2 clinical trials for five indications: dystrophic epidermolysis bullosa (DEB), acute ischemic stroke, ischemic cardiomyopathy, knee osteoarthritis, and chronic liver disease, and is additionally developing next-generation peptides (TRIM3, TRIM4, TRIM5) and an autologous stem-cell gene therapy (SR-GT1) for DEB. The company is pre-revenue with zero operating revenue in FY2025, supported by ¥6.99B of cash and a runway into 2028.

The business model is a capital-light, out-licensed R&D platform. StemRIM generated the foundational IP through a long-standing collaborative research relationship with Osaka University (since 2007) and operates the jointly-controlled StemRIM Institute of Regeneration-Inducing Medicine on the Suita Campus. In 2014, StemRIM out-licensed global development and commercialization rights to Redasemtide to Shionogi & Co., Ltd., under which Shionogi funds and runs all corporate-sponsored clinical trials while StemRIM conducts investigator-initiated trials with university partners (Osaka, Niigata, Hirosaki) and receives upfront, milestone, and royalty payments. Additional revenue streams include joint-research income from collaborations (Osaka University, Shiseido anti-aging research) and non-dilutive grants from Japanese government agencies (AMED, JST, NEDO). The company has secured Orphan Drug Designation for Redasemtide and built a multi-jurisdictional patent estate covering the platform and its indications.

StemRIM has 69 employees as of July 31, 2025, and is listed on the Tokyo Stock Exchange Growth Market under securities code 4599, with 62,136,200 issued shares and 22,373 shareholders. R&D expenses for FY2025 totaled ¥1,394,651 thousand against zero operating revenue, producing an operating loss of approximately ¥13.1B and a net loss of ¥12.8B. The company executed a ¥106,400 thousand capital reduction in July 2025 to repair the balance sheet ahead of further clinical-stage spending. Leadership is anchored by President & CEO Masatsune Okajima (appointed CEO October 2023, ex-Medicinova, Daiwa Securities) and Founder/CSO Professor Katsuto Tamai, who continues as Guest Professor at Osaka University.

Name

StemRIM

Legal name

株式会社ステムリム

Website

https://stemrim.com

Company type

Public

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

StemRIM is a clinical-stage Japanese biotech developing Regeneration-Inducing Medicine™ — synthetic HMGB1-derived peptides (lead: Redasemtide) that mobilize endogenous stem cells to repair damaged tissue, out-licensed to Shionogi for indications including epidermolysis bullosa, stroke, and cardiomyopathy.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Stem Cell–Based Regenerative Therapies (HLAAAGAA)

akta.pro secondary industries

Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE), Regenerative Immunology & Inflammation Modulation (pro-regenerative biologics) (HLAAAGAL), Cartilage, Bone & Musculoskeletal Regeneration (HLAAAGAH), Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis) (HLAAAGAJ)

Keywords

• Regenerative medicine
• Peptide drug discovery
• Stem cell therapy
• Biotech pharmaceuticals
• Clinical drug development

Headquarters

HQ city

Osaka

HQ country

Japan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Infrastructure

Revenue model

1. Licensing Revenue (Shionogi & Co., Ltd.): Out-licensing agreement with Shionogi for Redasemtide (HMGB1 peptides). Expected revenue streams include upfront payments upon contract signing, milestone payments at each development stage achievement, and royalty income as a fixed percentage of product sales after commercialization.
2. Joint Research Income: Income obtained as remuneration for conducting joint research using company intellectual property with partners such as Osaka University, Shiseido, and others.
3. Milestone Income: Lump-sum income obtained each time set targets for each development stage (development milestone) are reached, or after product launch when sales target values (sales milestone) are achieved.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

StemRIM develops Regeneration-Inducing Medicines, a novel class of peptide drugs based on HMGB1 fragment peptides that activate and mobilize the patient's own endogenous mesenchymal stem cells from bone marrow to damaged tissues for functional regeneration. The lead compound Redasemtide (TRIM2) is in Phase 2 clinical trials for five indications including dystrophic epidermolysis bullosa, acute ischemic stroke, ischemic cardiomyopathy, knee osteoarthritis, and chronic liver disease. The company out-licenses Redasemtide to Shionogi & Co., Ltd. for development and commercialization while conducting investigator-initiated trials in partnership with Japanese universities.

Product overview

StemRIM is a biotechnology company developing Regeneration-Inducing Medicine™, a novel platform technology based on HMGB1 peptides that activate the body's own stem cells to induce functional tissue regeneration. The core product portfolio includes Redasemtide (TRIM2) as the first approved/clinical-stage Regeneration-Inducing Medicine™, along with next-generation candidates TRIM3 and TRIM4 (novel peptides), TRIM5 (stem cell guidance molecule), and SR-GT1 (stem cell gene therapy). All products share the common mechanism of mobilizing or guiding endogenous mesenchymal stem cells to damaged tissues for regeneration, offering a platform approach across multiple disease areas.

Differentiator

Problem solved

Functional benefit

Products and services

• Redasemtide (TRIM2) The first Regeneration-Inducing Medicine, a chemically synthesized HMGB1 fragment peptide administered intravenously that mobilizes the patient's own mesenchymal stem cells from bone marrow into the bloodstream, where they accumulate at damaged tissue sites to promote functional tissue regeneration through immunomodulation, trophic effects, and fibrosis suppression. In Phase 2 clinical trials for five indications: dystrophic epidermolysis bullosa, acute ischemic stroke, ischemic cardiomyopathy, knee osteoarthritis, and chronic liver disease. Out-licensed to Shionogi & Co., Ltd. for development and commercialization.
• TRIM3 Peptide Next-generation Regeneration-Inducing Medicine peptide that mobilizes mesenchymal stem cells residing in the bone marrow. Developed using proprietary peptide design and screening methods for activating mesenchymal stem cells, representing an advancement beyond the first-generation TRIM2 platform.
• TRIM4 Peptide Next-generation Regeneration-Inducing Medicine peptide that mobilizes mesenchymal stem cells residing in the bone marrow. Developed using proprietary peptide design and screening methods for activating mesenchymal stem cells, designed to address limitations of first-generation approaches.
• TRIM5 (Stem Cell Guidance Molecule) A chemokine-based molecule that guides innate mesenchymal stem cells to damaged tissue. Injected around lesions to attract circulating stem cells to treatment areas, addressing cases where insufficient SDF-1alpha secretion limits natural stem cell migration to damaged tissues.
• SR-GT1 (Stem Cell Gene Therapy) Gene therapy for dystrophic epidermolysis bullosa using the patient's own mesenchymal stem cells harvested from blisters, transduced with lentiviral vector carrying functional collagen type VII gene, expanded, and administered back to the patient. Aims at curative treatment by delivering functional collagen VII gene to the patient's own stem cells ex vivo.

Quantifiable outcome

• Phase 2 clinical trial results for dystrophic epidermolysis bullosa: 7 of 9 patients showed symptom improvement, 4 showed significant improvement with long-lasting therapeutic effects
• +2 more outcomes

Named customers4 records

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Shionogi & Co., Ltd.coreOEM/ Whitelabel/ Licensing Partner · 1 January 2014Licensing agreement for HMGB1 peptides (Redasemtide) where Shionogi manages development and commercialization. Shionogi conducts corporate-sponsored clinical trials for acute ischemic stroke and holds rights for multiple indications including epidermolysis bullosa, cardiomyopathy, knee osteoarthritis, and chronic liver disease. Company receives upfront, milestone, and royalty payments.
• Osaka UniversitycoreStrategic or Co-development PartnerLong-standing collaborative research relationship since 2007. Co-founded StemRIM Institute of Regeneration-Inducing Medicine (1,540 sqm facility) on Suita Campus. Professor Katsuto Tamai serves as Scientific Founder and Guest Professor. Joint research in stem cell biology, regenerative medicine, and drug discovery.
• Niigata UniversitycoreStrategic or Co-development PartnerJoint research partnership with Professor Shuji Terai's team conducting investigator-initiated Phase 2 clinical trial for Redasemtide in chronic liver disease. Research on HMGB1 peptide effects on liver inflammation and fibrosis published in scientific journals.
• Hirosaki UniversityminorStrategic or Co-development PartnerInvestigator-initiated Phase 2 clinical trial site for Redasemtide in knee osteoarthritis.
• Shiseido Co., Ltd.minorStrategic or Co-development PartnerTrilateral research agreement for anti-aging research project related to skin, involving Osaka University. Extended in January 2025.
• Japan Post Life Insurance (かんぽ 생명)minorStrategic or Co-development PartnerVisit to StemRIM Institute of Regeneration-Inducing Medicine as part of Osaka University collaboration promotion meeting.

Scale indicators10 records

Recent moves10 records

Expansion highlights7 records

Regional players

• AnGes, Inc. Japan-based clinical-stage biotechnology company developing gene therapy and nucleic acid medicines. Comparable as a Japanese small-cap biotech with similar development-stage profile, though focused on different therapeutic modalities (DNA vaccines, gene therapy).
• Medipost Co., Ltd. Korean biopharmaceutical company marketing CARTISTEM (allogeneic umbilical cord blood-derived MSC product) for knee osteoarthritis. Directly comparable for the knee osteoarthritis indication, though Medipost is a regional competitor with an approved cell-based product.

Direct peers

• Mesoblast Limited: Clinical-stage biotechnology company developing mesenchymal stem cell (MSC) therapies for inflammatory diseases, cardiovascular conditions, and orthopedic indications. Closely comparable given StemRIM's MSC-mobilization mechanism and overlapping therapeutic areas (cardiomyopathy, osteoarthritis).
• Healios K.K. Japanese regenerative medicine company developing stem cell therapies (Multistem) for stroke, ARDS, and other conditions. Directly comparable as a Japan-based clinical-stage regenerative medicine company pursuing indications that overlap with StemRIM's pipeline (notably acute stroke).
• Vericel Corporation: Commercial-stage company selling cell therapy products (MACI for cartilage repair) and burn care products. Directly comparable given StemRIM's knee osteoarthritis and epidermolysis bullosa indications, though Vericel uses a cell-based rather than peptide-based approach.
• Pluristem Therapeutics Inc. Clinical-stage regenerative medicine company developing placenta-derived cell therapies (PLX cells) for multiple indications including muscle injury and critical limb ischemia. Comparable for its MSC-based approach to regenerative medicine and similar multi-indication pipeline strategy.

Emerging players

• Cynata Therapeutics Limited: Clinical-stage company developing Cymerus, a MSC product derived from induced pluripotent stem cells (iPSC), for conditions including osteoarthritis and graft-versus-host disease. Comparable as a developer of MSC-based therapies targeting overlapping indications.
• RegeneRx Biopharmaceuticals, Inc. Clinical-stage biopharmaceutical company developing thymosin beta 4-based peptide therapeutics for tissue regeneration and repair. Comparable as a peptide-based regenerative medicine company with similar mechanism philosophy (using small molecules/peptides rather than cells to induce tissue repair).
• Athersys, Inc. Clinical-stage biotechnology company developing MultiStem cell therapy for stroke, ARDS, and other conditions. Comparable as a stem cell therapy developer with overlapping acute ischemic stroke indication, though Athersys uses ex vivo expanded allogeneic cells rather than endogenous mobilization.

Broad incumbents

• JCR Pharmaceuticals Co., Ltd. Established Japanese biopharmaceutical company with a regenerative medicine franchise (e.g., TEMCELL HS Inj. for GvHD, a registered allogeneic MSC product). Comparable as a Japan-based biopharma with approved cell-based regenerative therapies targeting similar patient populations.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/StemRIM_Inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds5 records

Investors12 records

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M&A

Investments

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Frequently asked questions about StemRIM