COMPANY PROFILE / iPS CELLS & REGENERATIVE MEDICINE
ReproCELL
A small company that earns its living as a supplier of iPS cell materials while stepping into four regenerative medicine products
ReproCELL (REPROCELL Inc., Tokyo Stock Exchange Growth market, code 4978) is a Yokohama company that earns about 90% of its revenue by supplying iPS cells, the cells differentiated from them, reagents and contract services to researchers, and is now stepping into the development of regenerative medicine products. Stemchymal, the product that has reached a marketing application in Japan, is an adipose-derived mesenchymal stem cell product, not an iPS cell-derived one. The iPS cell-derived candidate is at the stage of preparing a clinical trial for ALS. In the year ended March 2026 it reported revenue of ¥2.233 billion (-25.0%) and an operating loss of ¥860 million. This profile relies only on the company's earnings releases, briefing materials and official announcements, and on ClinicalTrials.gov registrations. It is not medical advice on treatment choices.
- ReproCELL in 30 seconds, and where it stands in iPS cells and regenerative medicine
- The logo and how the name is written
- Where the company sits in the iPS cell and regenerative medicine landscape
- Scale (a small listed company)
- Resources committed to the field
- Track record so far
- Plans ahead
- What the company is aiming for
- Partnership map
- The technologies and products it offers
- The risks this company carries
- Glossary, references and claim-to-source audit
1. ReproCELL in 30 seconds, and where it stands in iPS cells and regenerative medicine
Yokohama, Kanagawa, Japan9F MetLife Shin-Yokohama Building (as stated in the briefing materials)
(research cell supply plus development of regenerative medicine products)The main source of revenue is the research support business
Application filed in JapanFiled on 24 June 2026. Not iPS cell-derived
Companies involved in iPS cells and regenerative medicine fall into three broad groups: large pharma & strategic partners, genome editing & gene therapy, and iPS cell & cell therapy. ReproCELL is an "iPS cell & cell therapy" company, but its main earner is not a therapeutic: it is research cells, reagents and contract services that use iPS cells Sourced. Of revenue of ¥2.233 billion in the year ended March 2026, the research support business accounted for ¥1.952 billion (about 87%, our calculation) and the medical business for ¥281 million Our calculation. Among the regenerative medicine products in development, Stemchymal, which has reached a marketing application in Japan, is an adipose-derived mesenchymal stem cell product, not an iPS cell-derived one. The iPS cell-derived candidate (neuroglial cells) is at the stage of preparing a clinical trial for ALS Sourced. So ReproCELL is a company that runs three things in parallel: a business as an "iPS cell materials supplier", a business of in-licensing and selling cells whose clinical trials are already well advanced, and its own iPS cell-derived candidate.
2. The logo and how the name is written
A note on names: the company is "ReproCELL Co., Ltd." in Japanese and is written REPROCELL Inc., in capitals, in English. The logo is the image listed in the structured data of the official website (a group logo shown together with the sub-brands bioserve, stemgent, alvetex and biopta), downloaded and placed here; we have not recreated it with generated imagery. Its overseas subsidiaries are REPROCELL USA, REPROCELL Europe (Glasgow, U.K.) and Bioserve Biotechnologies India (Hyderabad).
Official site: https://www.reprocell.com/3. Where the company sits in the iPS cell and regenerative medicine landscape
Seen by mechanism, ReproCELL is a small company that holds several mechanisms at the same time. The issues covered in this series' explainers on iPS cells, mesenchymal stem cells, exosomes, CAR-T cells, genome editing, MHC and universal donor cells, cell manufacturing and cell banks, and GMP all sit side by side inside one company.
| Mechanism | How ReproCELL uses it | Category |
|---|---|---|
| iPS cells (RNA reprogramming) | At the core is technology for making iPS cells with a virus-free RNA method. It supplies clinical-grade (GMP) iPS cells as master cell banks and has registered a DMF (Drug Master File) with the FDA | Sourced |
| Mesenchymal stem cells | Stemchymal: an adipose-derived mesenchymal stem cell product developed by Steminent of Taiwan. ReproCELL holds the exclusive commercial rights in Japan for spinocerebellar degeneration. Given by intravenous infusion | Sourced |
| iPS cell-derived cells | Developing neuroglial cells made from iPS cells for neurodegenerative diseases such as ALS (preparing for clinical trials). Also manufactures and sells iPS cell-derived exosomes | Sourced |
| Genome editing | Launched HLA-knockout iPS cell lines (StemEdit) in April 2025. In January 2026 began a clinical-grade editing service that uses an AI-designed genome editing system | Sourced |
| CAR-T and TIL (autologous) | TIL therapy (lymphocytes taken from the patient's own tumour tissue are expanded and returned) and a CAR-T targeting GPC-1. Both use the patient's own cells, so they are autologous | Sourced |
4. Scale (a small listed company)
ReproCELL is a small company listed on the Tokyo Stock Exchange Growth market. Its fiscal year ends in March, and it discloses amounts in millions of yen.
| ¥ millions | Year ended March 2025 | Year ended March 2026 | Change |
|---|---|---|---|
| Revenue | 2,978 | 2,233 | -25.0% |
| Operating profit (loss) | -130 | -860 | - |
| Ordinary profit (loss) | 45 | -581 | - |
| Profit (loss) attributable to owners of the parent | 103 | -591 | - |
| Research support business revenue | - | 1,952 | -19.1% |
| Medical business revenue | - | 281 | -50.2% |
| Cash and cash equivalents at year end | 2,823 | 2,603 | - |
Source: earnings release (year ended March 2026). Segment results in the release are stated on an ordinary-profit basis: the research support business earned ¥96 million (-84.5% year on year); the medical business lost ¥43 million (against a profit of ¥158 million the year before); company-wide common expenses were ¥633 million, giving an ordinary loss of ¥581 million in total (a different measure from the ¥860 million operating loss).
| Financial position (end of March 2026) | Value |
|---|---|
| Total assets | ¥9.652 billion |
| Net assets | ¥8.846 billion |
| Equity ratio | 91.7% |
| Cash flow from operating activities (year ended March 2026) | -¥383 million |
| Forecast for the year ending March 2027 | Revenue of ¥2.629 billion (+17.7%), operating loss of ¥630 million |
| First quarter of the year ending March 2027 (April to June) | Revenue of ¥546 million (+14.9%), operating loss of ¥310 million |
Losses continue, but the equity ratio is high at 91.7%, and the assets are mainly cash and securities. The earnings release explains that securities rose by ¥2,785 million and investment securities fell by ¥2,489 million Sourced. In May 2026 the company resolved on a funding programme of up to about ¥5 billion through private placements to a U.S. investor (CVI Investments), described below Sourced.
5. Resources committed to iPS cells and regenerative medicine
We sort four points (people, money, outside investments, acquisitions and in-licensing, and links with universities and public funding) by whether the primary sources let us confirm them.
| Aspect | What the primary sources confirm | Status |
|---|---|---|
| People (sites and headcount) | Four sites: Japan (Yokohama), the U.S. (Maryland), the U.K. (Glasgow) and India. It has a regenerative medicine centre, the Tonomachi REPROCELL Regenerative Medicine Center (a licensed facility for manufacturing specified processed cell products). Headcount cannot be read from the earnings release and briefing materials we consulted | Sites confirmed. Headcount could not be confirmed |
| Money (R&D spending and facilities) | The earnings release gives no R&D expense figure. Purchases of property, plant and equipment were ¥98 million (year ended March 2026) and subsidies received ¥89 million. From June 2026 it started a programme to raise up to about ¥5 billion through private placements | Partly confirmed. R&D expense could not be confirmed |
| Outside investments, acquisitions and in-licensing | In-licensed the exclusive commercial rights to Stemchymal in Japan from Steminent (Taiwan). Has invested in Histocell of Spain (an affiliate). The fund (Cell Innovation Partners) was removed from consolidation in the year ended March 2026 | Confirmed |
| Universities, research institutions and public funding | Joint research on TIL therapy with the Keio University Department of Obstetrics and Gynecology; joint research on GPC-1 CAR-T with Kyoto University and the International University of Health and Welfare; selected for a public call programme of the Japan Agency for Medical Research and Development (AMED) (December 2024). Because of its orphan regenerative medicine product designation, it qualifies for support such as development subsidies (up to 50%) | Confirmed |
According to the earnings release, ReproCELL's iPS cells are made by RNA reprogramming, and are described as cells "optimal for clinical use" because they reduce the risk of genetic mutation and the risk that foreign genes or viruses remain Sourced. From a materials standpoint, quality is decided by (1) the synthesis and quality of the RNA used for reprogramming, (2) the donor cells (collection and storage), (3) the preparation and testing of master cell banks, and (4) records that meet Japanese, U.S. and European regulations. The company writes that by October 2025 it had a system to produce master and working cell banks at three sites, in Japan, the U.S. and Spain (at its partner Histocell), and that its U.S. site began a master cell bank manufacturing service in March 2026 Sourced. In genome editing it has launched, for research use, iPS cell lines in which HLA has been knocked out, candidates for "universal donor" cells. For clinical-grade editing, it explains that it uses an AI-designed editing system intended to simplify the patent licensing position Sourced.
Specific materials such as culture media, growth factors and cryopreservation media are not disclosed Not yet confirmed.
6. Track record so far
| When | What happened | What it means |
|---|---|---|
| December 2018 | Stemchymal designated an orphan regenerative medicine product in Japan | Eligible for priority review and development subsidies |
| February 2020 to May 2022 | Phase 2 trial of Stemchymal in Japan. Dosing began in February 2020 and observation was complete by May 2022 | Confirmation of safety and assessment of efficacy |
| June 2023 | Signed a joint research agreement with Keio University on technology transfer of the TIL therapy manufacturing method | Entry into autologous immune cell therapy |
| October 2024 | Added a joint research agreement with Keio University on a new culture method for TIL therapy | The company says the aim is early commercialisation |
| November 2024 | Steminent, the maker of Stemchymal, obtained accreditation as a foreign manufacturer from Japan's Minister of Health, Labour and Welfare | Meets one of the requirements for a marketing application in Japan |
| December 2024 | Research and development of GPC-1 CAR-T selected for an AMED public call programme | Development with public funding |
| February 2025 | Gameto of the U.S., a recipient of its cells, received FDA IND clearance for a Phase 3 trial of a technology based on ReproCELL's iPS cells | A record of supplying clinical-grade iPS cells |
| April 2025 | Launched the HLA-knockout iPS cell line series "StemEdit Human iPSC non-HLA" | For research on universal donor cells that avoid rejection |
| October 2025 | Histocell (Spain) obtained GMP certification for manufacturing master cell banks using ReproCELL's clinical-grade iPS cells | A three-region system covering Japan, the U.S. and Europe |
| January 2026 | Began "StemEdit", a clinical-grade editing service using an AI-designed genome editing system | Described as an alternative to earlier technology with complicated patent licensing |
| March 2026 | Began a service in its U.S. site to manufacture clinical-grade iPS cell MCBs. In Japan, two regenerative medicine products using iPS cells received conditional and time-limited approval for the first time (per the company) | A change in the domestic market environment |
| 24 June 2026 | Filed a marketing application for Stemchymal in Japan (spinocerebellar degeneration, SCA3 and SCA6). The first private placement followed on 11 June | The target review period under priority review is 9 months from acceptance of the application |
| September 2026 | Basic agreement with TOHO HOLDINGS on domestic distribution of Stemchymal (dated 17 September, announced 29 September). A collaboration to supply iPS cells to Polyphron of the U.S. (announced 28 September) | A supply system after approval, and supply to AI-driven drug discovery |
7. Plans ahead
For the year ending March 2027 the company forecasts revenue of ¥2.629 billion (+17.7% year on year) and an operating loss of ¥630 million, and writes that early commercialisation of its four regenerative medicine products is the top priority Sourced. The proceeds of the private placements are planned for uses such as clinical trials and preparation of a marketing application for TIL therapy (¥300 million in the second tranche) Sourced.
None of the following appears in the primary sources Not yet confirmed.
Whether and when Stemchymal will be approved (it is under review and the likelihood of approval is not settled) / the drug price / when the clinical trial of the iPS cell-derived neuroglial cells will start / headcount / the amount of R&D spending / the trial number of the Phase 2 trial in Japan. Press-based figures and research-firm estimates are not used in this article.
8. What the company is aiming for in iPS cells and regenerative medicine
This section includes things the company does not say directly. We set them out as inferences within what the primary sources support, with the evidence for each.
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| It positions the research support business as its short-to-medium-term earnings base and the medical business as its medium-to-long-term growth pillar | The earnings release describes the two businesses in just those terms | Sourced |
| It aims to support cell therapy development worldwide as a supplier and contract manufacturer of iPS cell materials | A GMP system in three regions across Japan, the U.S. and Europe, DMF registration, an MCB manufacturing service, and clinical-grade editing with StemEdit | Inference |
| Before its own iPS cell-derived candidates, it in-licenses and sells cells whose clinical trials are already advanced | Stemchymal is an in-licensed product with a marketing application filed. The iPS neuroglial cells are at the stage of preparing a clinical trial | Inference |
| It is building links with AI and data | Supply of iPS cells to Polyphron, and a machine learning platform with IBM Research and the Hartree Centre (Pharmacology-AI) | Sourced |
| It is also widening into health and prevention markets | Personal iPS (sold with JTB), Well-Mill and a genetic age test kit | Sourced |
The research support business, which accounts for about 87% of ReproCELL's revenue, saw revenue fall 19.1% and operating profit fall 84.5% in the year ended March 2026 Sourced. The medical business also saw revenue fall 50.2% and its segment result (ordinary-profit basis) turned to a loss Sourced. Even so, what the company puts first is the four products of the medical business. The use of the funds raised through the private placements is also centred on clinical trials of TIL therapy and preparation for early clinical trials of GPC-1 CAR-T Sourced. From this we read ReproCELL as being at a stage where it is keeping its stable, income-producing "materials business" while making up for the decline in that income with outside funding in order to step into clinical development. The company itself has not said so Inference.
9. Partnership map for iPS cells and regenerative medicine
ReproCELL's partnerships are a mixture of the in-licensing side and the supplying side. Stemchymal is in-licensed from Steminent of Taiwan, which also manufactures it, and ReproCELL handles sales in Japan Sourced. Its iPS cells, on the other hand, are supplied to companies such as Gameto. Set beside our FUJIFILM Cellular Dynamics profile, a difference appears within the same business of supplying iPS cells: FCDI has large manufacturing sites backed by a big group's capital, while ReproCELL is small and spreads its sites across Japan, the U.S. and Europe, working through partners (our view).
10. The technologies and products it offers
As of this article there is no approved regenerative medicine product (Stemchymal is under review). The candidates in development are listed below. All are unapproved investigational or development products, and neither efficacy nor safety has been established.
| Candidate | Description and target | Stage | Primary endpoint |
|---|---|---|---|
| Stemchymal | Adipose-derived allogeneic mesenchymal stem cells. Spinocerebellar degeneration (SCA3 and SCA6) | Marketing application filed (Japan, 24 June 2026). Phase 2 in Japan, 2020 to 2022. Phase 2 in Taiwan is NCT02540655 (Steminent). Phase 2 in the U.S. is NCT06397274 (not yet recruiting) | SARA score (a rating of ataxia) |
| iPS cell-derived neuroglial cells | Neuroglial cells made from iPS cells. Neurodegenerative diseases such as ALS | Preclinical (suppressed decline in motor function in a rat ALS model). Preparing for a clinical trial | - |
| TIL therapy | Lymphocytes taken from the patient's own tumour tissue are expanded and returned. Cervical cancer | Contract manufacturing under Advanced Medical Care B (Japan's advanced medical care system) at Keio University (up to 10 patients by 2026) | - |
| GPC-1 CAR-T | CAR-T targeting GPC-1. Solid tumours such as oesophageal cancer | Preclinical. Preparing for a clinical trial | - |
| Clinical-grade iPS cells | Provided as starting material for regenerative medicine products (to corporate customers) | In supply. DMF registered | - |
The Stemchymal results made public are shown below. They come from a small Phase 2 trial and do not guarantee approval or treatment benefit.
| Result | Content | Comparator and conditions |
|---|---|---|
| Phase 2 in Japan: safety | No serious adverse events were observed in any participant | Dosing began in February 2020 and was complete by May 2022 |
| Phase 2 in Japan: efficacy (SARA score, the primary endpoint) | In the active arm there was a tendency for the rise (worsening) in score to be smaller than in the natural course of disease | Compared with natural history (external data). A tendency; no significant difference is stated |
| Phase 2 in Japan: subgroup | In the group with a pre-dose score of 11 or more, the change up to week 52 was statistically significantly better than with placebo (P=0.042) | Subgroup analysis. We could not confirm from our materials whether it was pre-specified |
Stemchymal is manufactured by Steminent of Taiwan and shipped to Japan (announcement of 24 June 2026) Sourced. Making a live-cell product overseas and using it in Japan requires (1) temperature control for freezing, storage and transport of the cells, (2) accreditation of the manufacturing site as a foreign manufacturer in Japan (obtained in November 2024), and (3) an arrangement with a company that handles domestic distribution (a basic agreement with TOHO HOLDINGS). From a materials and container standpoint, the preservation medium and container that keep the cells viable in transit, and the handling procedure after thawing, decide quality (this is our explanation; the company does not disclose material names).
11. The risks this company carries
| Risk | Details | Category |
|---|---|---|
| Continuing losses | Operating loss of ¥860 million in the year ended March 2026. An operating loss of ¥630 million is forecast again for the year ending March 2027 | Sourced |
| Revenue falling in the main business | Research support revenue fell 19.1% year on year and operating profit fell 84.5% | Sourced |
| Approval not settled | Stemchymal is under review, and whether and when it is approved is not settled. The efficacy in the Phase 2 trial in Japan stops at a tendency and a significant difference in a subgroup | Not yet confirmed |
| Dilution of existing shareholders | The private placement raises up to about ¥5 billion in four tranches, and the shares and the share subscription rights are each described as about 12.3% of shares outstanding (cumulative) | Sourced |
| Manufacturing depends on overseas partners | Stemchymal is manufactured by Steminent (Taiwan). For iPS cell MCB manufacturing it also uses Histocell of Spain and others | Sourced |
| A widening business spreads resources thin | It runs four regenerative medicine products, clinical testing, research cells and health-related services side by side on a small scale (our view) | Inference |
| Exchange-rate effects | The forecast assumes ¥150 to the dollar and ¥200 to the pound, and it also mentions world developments such as the situation in the Middle East | Sourced |
12. Glossary
- RNA reprogramming
- A way of making iPS cells with RNA. Unlike DNA, RNA is thought unlikely to integrate into the cell's genome.
- Mesenchymal stem cell
- A somatic stem cell that can become bone, fat, cartilage and other tissues. Effects such as dampening inflammation are being studied.
- Orphan regenerative medicine product
- A designation in Japan for regenerative medicine products for diseases with few patients and a high medical need. It brings eligibility for development subsidies and priority review.
- Conditional and time-limited approval
- A Japanese system that grants early approval, with conditions and a deadline, to a regenerative medicine product whose safety has been confirmed and whose efficacy is presumed.
- SARA score
- A scale that rates the severity of ataxia in a clinical examination. It runs from 0 to 40, and a higher score means more severe disease.
- TIL therapy
- A treatment in which lymphocytes found inside tumour tissue are taken out, expanded and returned to the patient.
- DMF
- Drug Master File. Manufacturing and quality information registered with the FDA that a partner's application can refer to.
- MCB / WCB
- Master cell bank / working cell bank. Reference cells stored so that cells can be supplied consistently.
- Private placement
- A way of raising money by issuing new shares or similar securities to a specific party.
- AMED
- The Japan Agency for Medical Research and Development. The national agency that allocates funding for medical research.
13. References
- REPROCELL Consolidated Financial Results for the Fiscal Year Ended March 31, 2026 (earnings release, 14 May 2026). Business description, revenue by segment, financial position and the forecast for the year ending March 2027. https://www.reprocell.com/hubfs/202603_Consolidated%20Financial%20Results%20for%20the%20Fiscal%20Year%20Ended%20March%2031%2c%202026%20(Under%20Japanese%20GAAP).pdf
- REPROCELL Consolidated Financial Results for the Three Months Ended June 30, 2026 (first-quarter earnings release). The private placement funding programme. https://www.reprocell.com/hubfs/202606_Consolidated%20Financial%20Results%20for%20the%20Three%20Months%20Ended%20June%2030%2c%202026%20(Under%20Japanese%20GAAP).pdf
- REPROCELL Financial Results Briefing for the Fiscal Year Ended March 2026 (results briefing materials). Sites, pipeline and an overview of the funding. https://www.reprocell.com/hubfs/Financial%20Results%20Briefing%20for%20the%20Fiscal%20Year%20Ended%20March%202026.pdf
- REPROCELL REPROCELL Submits Application for Manufacturing and Marketing Approval in Japan for Stemchymal (24 June 2026). https://www.reprocell.com/news/reprocell-submits-application-for-manufacturing-and-marketing-approval-in-japan-for-stem-cell-therapy-stemchymal-for-spinocerebellar-ataxia-sca3-and-sca6
- REPROCELL Notice Regarding Execution of a Basic Agreement with TOHO HOLDINGS CO., LTD. (29 September 2026). Domestic distribution of Stemchymal. https://www.reprocell.com/hubfs/20260929_Notice%20Regarding%20Execution%20of%20a%20Basic%20Agreement%20with%20TOHO%20HOLDINGS%20CO.%2c%20LTD.%20Concerning%20Domestic%20Distribution%20of%20the%20Stem%20Cell%20Product%20%E2%80%9CStemchymal%E2%80%9D.pdf
- REPROCELL Notice Regarding Collaboration to Advance AI-Driven Human Tissue Research Using iPSCs (28 September 2026). The collaboration with Polyphron. https://www.reprocell.com/hubfs/20260928_Notice%20Regarding%20Collaboration%20to%20Advance%20AI-Driven%20Human%20Tissue%20Research%20Using%20iPSCs_revised.pdf
- ClinicalTrials.gov NCT02540655 (Phase 2 of Stemchymal in Taiwan, run by Steminent Biotherapeutics). https://clinicaltrials.gov/study/NCT02540655
- ClinicalTrials.gov NCT06397274 (Phase 2 of Stemchymal in the U.S.; not yet recruiting). https://clinicaltrials.gov/study/NCT06397274
- REPROCELL Official website: top page (to confirm the logo and the business overview). https://www.reprocell.com/
14. Claim-to-source audit
Last updated 1 October 2026 / Troy Technical
Every figure in this article comes from ReproCELL's statutory disclosures (earnings releases), its official announcements and ClinicalTrials.gov registrations. No research-firm estimates or press-based figures have been used. Passages marked "Inference" are this article's interpretation of the primary sources, not statements made by the company. This article is not medical advice, does not recommend any particular treatment or product, and makes no comparison of its merits with other companies' products.