COMPANY PROFILE / iPS CELLS & REGENERATIVE MEDICINE
Healios
It has an iPS cell technology base, but its lead product today is HLCM051, an adult bone-marrow stem cell therapy. It has no approved product yet
Healios was founded in 2011 to treat age-related macular degeneration with retinal cells derived from iPS cells. As of October 2026, however, it has no approved product, and its revenue for the year ended December 2025 was just ¥104 million. Its top priority now is not iPS cells but a treatment for acute respiratory distress syndrome (ARDS) based on HLCM051 (invimestrocel), a somatic stem cell product derived from adult bone marrow, for which it is preparing an application for conditional and time-limited approval in Japan. On the iPS cell side it has the "universal donor cell" (UDC), an iPS cell line gene-edited to be less prone to immune rejection; a genetically modified NK cell, "eNK"; and the ophthalmic retinal pigment epithelial cell product "HLCR011" (led by RACTHERA, successor to Sumitomo Pharma's business). Its Annual Securities Report also records a situation that casts material doubt on the going-concern assumption. This profile sets out what the company has invested, who it works with, what has been confirmed and what remains open, using primary sources only.
- Healios 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 iPS cells and regenerative medicine
- Scale of the company
- Resources committed to iPS cells and regenerative medicine
- Track record so far
- Plans ahead
- What the company is aiming for in iPS cells and regenerative medicine
- Partnership map
- Technologies, products and services
- The risks this company carries
- Glossary, references and claim-to-source audit
1. Healios in 30 seconds, and where it stands in iPS cells and regenerative medicine
TokyoAs stated in the interim report (August 2026). Research laboratory in Kobe
(led by a somatic stem cell product)iPS cells are a pillar of long-term strategy; the near-term lead is somatic stem cells
Healios is known as an "iPS cell company", but its business has two layers Sourced. The company's strategy has two parts: in the short term, a somatic stem cell product (HLCM051) with a prospect of approval in Japan; in the long term, a base technology that uses iPS cells. On the iPS side, the trial of retinal pigment epithelial cells for the eye has been led since 2019 by the Sumitomo Pharma side (now RACTHERA), and as far as the primary sources show, no trial of an iPS cell-derived product led by Healios itself has started. In addition, the company expressly states in its financial results that there is a situation that casts material doubt on the going-concern assumption (the company judges that, given its countermeasures, there is no material uncertainty). This article does not judge the merits of any product or whether a treatment is appropriate; it sets out the company's current state from primary sources.
2. The logo and how the name is written
A note on names: the company is HEALIOS K.K. It was established in February 2011 as Japan Retinal Research Institute Co., Ltd. and took its present name in September 2013. Its US subsidiary is Healios NA, Inc., so care is needed not to confuse it with companies of similar name. The product name "HLCM051" corresponds to MultiStem (generic name invimestrocel), developed by the US company Athersys; in April 2024 Healios acquired substantially all of Athersys's assets and holds the global rights. The iPS cell-derived ophthalmic product "HLCR011" is being taken through trials mainly by RACTHERA, which took over Sumitomo Pharma's business.
Official site: https://www.healios.co.jp/3. Where the company sits in iPS cells and regenerative medicine
In terms of how it treats patients, Healios's lead is an allogeneic cell therapy: somatic stem cells from the bone marrow of a healthy adult donor, given intravenously by drip. The Annual Securities Report explains that these cells are thought to work by suppressing the activation of inflammatory immune cells Sourced. On the iPS cell side, there are allogeneic iPS cells (UDC) engineered to be less prone to immune rejection, as a "raw material", NK cells strengthened by gene introduction (eNK), a suspension of retinal pigment epithelial cells and so on. For the difference between allogeneic and autologous cells, see our explainer on autologous and allogeneic cells in this series; for how immune rejection is suppressed, see our explainer on MHC and universal donor cells.
4. Scale of the company
Healios is a small research-led company with almost no revenue. Amounts are in Japanese yen under IFRS, and the fiscal year runs from January to December Sourced.
| Metric (consolidated, ¥ millions) | FY ended Dec 2023 | FY ended Dec 2024 | FY ended Dec 2025 | Jan to Jun 2026 |
|---|---|---|---|---|
| Revenue | 121 | 560 | 104 | 15 |
| Loss before tax | −3,626 | −4,061 | −2,126 | −2,278 |
| Loss attributable to owners of the parent | −3,823 | −4,235 | −2,217 | −2,286 |
| Cash flow from operating activities | −2,822 | −1,817 | −3,165 | −2,514 |
| Cash and cash equivalents at period-end | 6,722 | 3,672 | 5,679 | 9,074 |
| Employees (people, at period-end) | 64 | 65 | 75 | - |
R&D expense for the year ended December 2025 was ¥2,024 million (¥1,960 million the year before), and for January to June 2026 it was ¥1,733 million (¥1,066 million in the same period a year earlier). There were 115,727,200 shares in issue (31 December 2025), and potential shares from stock acquisition rights came to 24,404,700 (21.1% of shares in issue).
The Annual Securities Report and the Interim Report both state that a situation exists that casts material doubt on the going-concern assumption. The reason is continuing operating losses and negative operating cash flow. The company has judged that there is currently no material uncertainty, because it is taking countermeasures: securing revenue sources, developing the ARDS treatment, finding partners, cutting costs and having stock acquisition rights exercised Sourced. This does not mean the company is failing, but it does show that this is a company whose business plan depends directly on whether it can raise funds.
5. Resources committed to iPS cells and regenerative medicine
Healios spends the same company's money on two fields, somatic stem cells and iPS cells, and the amount for iPS cells alone is not disclosed. We separate what could be confirmed from what could not.
| Type of resource | Details | Category |
|---|---|---|
| People (headcount) | 75 consolidated employees (57 in R&D and 18 in administration, 31 December 2025; 27 temporary staff not included). 66 on a non-consolidated basis. The number dedicated to iPS cells is not disclosed | Could not be confirmed (dedicated headcount) |
| People (sites) | Kobe Research Laboratory in Kobe (opened 2013). A company-managed cell processing facility for eNK cells in the Kobe Medical Innovation Center (operating since July 2022), and a cell processing facility for culture supernatant in the Kobe Biomedical Creation Center (operating since January 2026) | Sourced |
| Money (R&D expense) | ¥2,024 million in the year ended December 2025 (¥1,960 million the year before) and ¥1,733 million in January to June 2026 (¥1,066 million a year earlier). The split between somatic stem cells (HLCM051) and iPS cells is not disclosed | Sourced |
| Money (fundraising) | On 29 January 2026 the board resolved to issue 19,275,000 new shares (¥325 each, about ¥6.26 billion) and the 27th series of stock acquisition rights to seven overseas investment funds; payment was completed on 13 February. Proceeds from "issuance of new shares" in January to June 2026 were ¥6,098 million. Cash and cash equivalents at the end of June 2026 were ¥9,074 million | Sourced |
| Money (manufacturing facilities and public funding) | A subsidy of about ¥7 billion under the Ministry of Economy, Trade and Industry (METI) subsidy for regenerative-medicine CDMO capacity (award decided on 27 March 2026). A cell processing facility is to be built in rented laboratory space in Kobe, with operations planned for January 2028. The company says it aims for a scale able to supply an ARDS treatment for 40,000 patients a year, with a 500 L bioreactor | Sourced |
| Investment in and acquisition of other companies | In April 2024 it acquired substantially all of the assets of the US company Athersys (after Athersys entered bankruptcy proceedings), gaining the global rights to MultiStem/HLCM051. It holds as a consolidated subsidiary a fund investing in regenerative medicine (Saisei Bioventures, L.P.). No acquisition of an iPS cell-related company is stated in the Annual Securities Report | Sourced |
| Technology brought in (licences) | iPS Academia Japan (the basic patents on establishing iPS cells; non-exclusive), RIKEN (patents on retinal pigment epithelial cells; exclusive), Yokohama City University (organ bud technology), and RIKEN and Osaka University (the manufacturing method for retinal pigment epithelial cells, April 2024). The consideration is a certain royalty, and the amount is not disclosed | Sourced |
| Technology licensed out | A non-exclusive licence outside Japan of the manufacturing patents for retinal pigment epithelial cells to Astellas Institute for Regenerative Medicine (upfront payment of US$3 million, and US$8 million on US approval). A GMP-grade iPS cell line supplied to RxCell (upfront payment of US$0.5 million). UDC and iPS cell lines supplied to more than ten companies in Japan and overseas for evaluation | Sourced |
| Links with universities and research institutes | National Cancer Center Japan, Hyogo Medical University, Hiroshima University, Kyushu University (eNK/CAR-eNK cells), the Institute of Medical Science of the University of Tokyo (liver bud), the National Center for Global Health and Medicine (pancreatic beta cells from UDC), and Northwestern University in the United States. A grant from CIRM (California Institute for Regenerative Medicine) for research on next-generation UDC (decided October 2023), and a grant from Japan's AMED for non-clinical research on eNK cells (decided December 2024) | Sourced |
6. Track record so far
| When | What happened | What it means |
|---|---|---|
| February 2011 | Founded as Japan Retinal Research Institute Co., Ltd. Began developing a treatment for age-related macular degeneration by transplanting retinal pigment epithelial cells derived from iPS cells | Ophthalmic use of iPS cells was the starting point |
| February to December 2013 | Obtained patent licences from iPS Academia Japan and RIKEN. In December agreed with Dainippon Sumitomo Pharma (now Sumitomo Pharma) to co-develop retinal pigment epithelial cell products in Japan | The ophthalmic development set-up was settled |
| June 2015 | Listed on the TSE Mothers market | - |
| January 2016 | Signed a licence agreement with the US company Athersys for the somatic stem cell product MultiStem in Japan | The somatic stem cell pillar was created |
| June 2019 | New co-development agreement with Sumitomo Pharma. The party running clinical trials changed to the Sumitomo Pharma side. Healios is to receive royalties totalling ¥1 billion as development milestones, according to progress of the retinal pigment epithelial cell product | Leadership of the ophthalmic trials moved over |
| 2020 to 2021 | UDC clinical-grade line (2020) and master cell bank (2021) completed | Base technology for iPS cells put in place |
| June 2023 | Phase 1/2 trial of HLCR011 in retinal pigment epithelium tear began (led by the Sumitomo Pharma side) | Start of a trial using Healios's technology |
| April 2024 | Acquired Athersys's assets and gained the global rights to MultiStem/HLCM051 | The somatic stem cell rights came in-house |
| June 2024 | Basic business alliance agreement and a bond purchase agreement with Alfresa. Licence agreement with Astellas Institute for Regenerative Medicine | Securing a sales network and funding |
| January 2025 | Established Akatsuki Therapeutics (a consolidated subsidiary), and signed a joint business agreement and a licence option agreement under which it leads R&D on eNK cells | A mechanism for raising money for eNK cells outside the company |
| August 2025 | A Japanese patent on UDC was granted (a Chinese patent grant on 19 August 2026 was also disclosed) | Intellectual property for the base technology |
| October 2025 | Collaboration with Minaris Advanced Therapies on commercial production of HLCM051. The business and capital alliance with Nikon was dissolved | Manufacturing set-up rearranged |
| 9 December 2025 | Announced that it would prioritise development of the ARDS treatment and would not make a rolling submission of application materials for acute ischaemic stroke | Resources narrowed |
| 3 February 2026 | Ready to start the Japanese part of the global Phase 3 trial of the ARDS treatment (REVIVE-ARDS) (the clinical trial notification was filed on 20 January) | The confirmatory trial for conditional and time-limited approval |
| 27 March 2026 | METI subsidy (about ¥7 billion) awarded | Foundation for the CDMO business |
| 24 August 2026 | Obtained again a marketing authorisation holder licence for regenerative medicine products from the Governor of Hyogo Prefecture (disclosed on 31 August) | Part of the set-up needed to sell after approval |
7. Plans ahead
up to 550 patientsPreparing to start in Japan from February 2026. Preparing in the US and elsewhere outside Japan
January 2028Kobe. 500 L bioreactor, subsidy of about ¥7 billion
| Planned or in-development item | Where it stands (company's account) | Category |
|---|---|---|
| HLCM051 (ARDS) | Preparing to apply in Japan for conditional and time-limited approval, on the basis of the results of the ONE-BRIDGE trial (Phase 2) in Japan and the MUST-ARDS trial in the US and UK, with the REVIVE-ARDS trial as the confirmatory trial. REVIVE-ARDS is double-blind, randomised and placebo-controlled, with up to 550 patients (275 on HLCM051, 275 on placebo) and interim analyses at 300 and 400 patients. The primary endpoint is ventilator-free days (VFD) over 28 days, and a secondary endpoint is mortality within 90 days of dosing | Not yet confirmed |
| HLCM051 (acute ischaemic stroke, trauma) | For stroke, because the primary endpoint was not met in the TREASURE trial in Japan, the company is considering its development policy in discussion with regulators and does not plan a rolling submission of application materials. For trauma, a 156-patient Phase 2 trial (MATRICS-1), funded by the US Department of Defense and others, is under way | Not yet confirmed |
| HLCR011 (iPS cell-derived retinal pigment epithelial cells) | A Phase 1/2 trial in Japan in retinal pigment epithelium tear (jRCT2073230077, company-sponsored) is under way, led by RACTHERA (formerly Sumitomo Pharma's regenerative and cell medicine business). Status: recruiting | Not yet confirmed |
| eNK cells (AKT-01 / HLCN061) | Research on gene-engineered iPS cell-derived NK cells for solid tumours. The company is consulting the PMDA and the US FDA with the aim of starting a trial. R&D is led by Akatsuki Therapeutics, with Healios acting as contractor. Research on CAR-eNK cells (brain tumour, glioma) is also under way | Not yet confirmed |
| UDC (universal donor cell) | An allogeneic iPS cell platform that suppresses immune rejection regardless of HLA type. The clinical-grade line and master cell bank are complete. Supplied to more than ten companies in Japan and overseas for evaluation. Pancreatic beta cells have been made from UDC (joint research with the National Center for Global Health and Medicine). The company's own trial has not started | Not yet confirmed |
| Liver bud (HLCL041) | Being prepared for carve-out from the company, to be advanced jointly with outside partners such as venture capital | Not yet confirmed |
| Culture supernatant (HLSI071 and others) | An effort to sell culture supernatant, a by-product of cell manufacturing, as a cosmetics ingredient and similar. Shipment of the first order from JENECELL (Korea), worth ¥144 million, slipped to October 2026 because of delays in logistics procedures, so the revenue is expected to be booked in the fourth quarter (disclosure of 30 September 2026) | Not yet confirmed |
None of the following appears in the primary sources, or the company has not disclosed it Not yet confirmed.
The specific timing of the ARDS treatment's approval application and its expected approval date / when a trial of eNK cells will start / plans for a company-led trial using UDC / when HLCR011 will be filed for approval (RACTHERA's plan) / when the REVIVE-ARDS trial will start in the United States (it says only that an IND is being prepared). In its results briefing materials of August 2026 the company explains that the timing of the Japanese application does not wait for the REVIVE-ARDS results, but that the results are a precondition for full approval and for expansion into the US and Europe. This article does not use timings or market-size figures from press reports.
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 |
|---|---|---|
| For now the axis of the business has shifted to HLCM051 (ARDS), not iPS cells | In December 2025 it announced that it would prioritise development of the ARDS treatment and set aside the rolling submission. The main milestones in the 2026 results briefing materials are also centred on the ARDS approval application, commercial manufacturing and building a sales organisation | Inference |
| For iPS cells the weight is on taking the materials and base technology outside and earning from them | UDC and iPS cell lines supplied to more than ten companies; an upfront payment from supplying RxCell; and an upfront payment of US$3 million (US$8 million on US approval) for licensing patents to Astellas Institute for Regenerative Medicine | Inference |
| Development of iPS cell-derived therapeutics is being handed to outside funding and outside parties | The Sumitomo Pharma side leads on retinal pigment epithelial cells, Akatsuki leads on eNK cells with Healios as contractor, and the liver bud is to be carved out | Sourced |
| It sees the CDMO business as a candidate for a stable source of revenue | It is building a CDMO site in Kobe with a subsidy of about ¥7 billion and sets becoming the world's number one cell medicine maker as its business policy. Sales of culture supernatant are also described as a way of securing revenue | Inference |
| The ultimate goal is to keep a set-up that takes iPS cell products through to approval and sales in-house | The basic management policy says build a system to carry out approval and sales ourselves around the world. This differs, however, from its present priorities | Sourced |
The reading that "iPS cells are a matter of taking the materials outside and earning from them" rests on the kinds of consideration the company is actually receiving. The material contracts in the Annual Securities Report include an upfront payment of US$0.5 million from RxCell, an upfront payment of US$3 million from Astellas Institute for Regenerative Medicine with US$8 million due on US approval, and development milestones totalling ¥1 billion from the Sumitomo Pharma side (according to progress of the retinal pigment epithelial cell product) Sourced. Yet revenue for the year ended December 2025 was only ¥104 million, so most of this consideration has not yet turned into revenue. We therefore think that the iPS cell technology is valued by outside parties, but this is not yet showing up much in the company's own earnings Not yet confirmed. This inference says nothing about which technology is better or whether it will succeed.
9. Partnership map
How to read the figure: Healios leaves development of the ophthalmic iPS cell product to RACTHERA and of eNK cells to Akatsuki, and concentrates itself on the somatic stem cell HLCM051 and the iPS cell base technology (UDC). On manufacturing, it has a two-step approach: it outsources commercial production of HLCM051 to Minaris while building its own CDMO site in Kobe (with a subsidy of about ¥7 billion) Sourced.
10. Technologies, products and services
| Item | Details (from the Annual Securities Report and public materials) |
|---|---|
| HLCM051 (invimestrocel) | Somatic stem cells (MultiStem) derived from the bone marrow of healthy adult donors. An allogeneic product given intravenously for ARDS, acute ischaemic stroke and trauma. Thought to suppress the activation of inflammatory immune cells and so limit excessive inflammation in the lungs and damage to the capillary endothelium. Made by three-dimensional culture (bioreactor). Designated an orphan regenerative medicine product in Japan for ARDS (November 2019). The filings say it has received Fast Track and RMAT designations from the US FDA (stated in a note to the list of development items) |
| UDC (universal donor cell) | Allogeneic iPS cells from which the HLA genes have been removed, into which genes involved in immunosuppression and a suicide gene as a safety switch have been introduced. Supplied as a raw material for cell therapy. Patents granted in Japan (August 2025) and China (August 2026) |
| eNK cells | iPS cell-derived NK cells in which gene introduction has raised cytotoxic activity and strengthened the ability to recruit the patient's immune cells and to infiltrate tumours. Antitumour effects have been confirmed in animal models of lung cancer, mesothelioma, liver cancer and gastric cancer (results in animals and organoids) |
| HLCR011 | A product in which allogeneic iPS cells are differentiated into retinal pigment epithelial cells, purified and given as a suspension under the retina. A Phase 1/2 trial in retinal pigment epithelium tear is under way, led by RACTHERA |
| Culture supernatant | The liquid fraction obtained when cells are cultured. Supplied as a raw material for cosmetics and as material for therapies. Trades with AND medical group, Alfresa, JENECELL and others |
| CDMO (contract development and manufacturing) | A business that takes on process development, manufacturing and quality control as one package. Operations planned for January 2028 in Kobe |
In this company's product, what matters for materials and processes is the step that culture cells in large quantities in three dimensions Sourced. The company's results briefing explains that conventional two-dimensional culture is manual work in culture dishes, which tends to produce lot-to-lot differences and requires experienced staff to be sent for technology transfer, whereas fully automated culture in a closed bioreactor is more reproducible and easier to transfer. It has already completed full-scale manufacturing at the 50 L scale and is carrying out an engineering run (checking under the same conditions as real production); next it plans a PPQ run, repeated commercial-scale manufacture under GCTP to confirm quality. In future it aims for 40,000 patients a year with a 500 L unit (the company's materials assume equipment from Sartorius, with a note that its use is not guaranteed).
In three-dimensional suspension culture in general, the specifications of materials and processes such as culture medium, cell scaffolds (carriers), agitation conditions, harvest and concentration steps, cryopreservation solution and single-use culture bags affect product quality and cost Not yet confirmed. Which materials Healios uses has not been disclosed. On the other hand, the company discloses that moving the commercial production site from overseas to Minaris's Yokohama site meant rebuilding from the technology transfer (section 11). See also our explainers in this series on bioreactors, cell manufacturing and cell banks, GMP, and CDMO.
11. The risks this company carries
| Risk | Details | Category |
|---|---|---|
| Going-concern assumption | Operating losses (¥3,340 million in the year ended December 2025 and ¥2,404 million in January to June 2026) and negative operating cash flow continue, and the filings state that there is a situation that casts material doubt. The company judges that, given its countermeasures, there is no material uncertainty. The countermeasures include raising funds through the exercise of stock acquisition rights | Sourced |
| Dilution of shares | Potential shares from stock acquisition rights are 24,404,700 (end of December 2025, 21.1% of shares in issue). New shares and the 27th series of stock acquisition rights were also issued in 2026 | Sourced |
| The approval application is delayed | The company says the application is taking time, giving as the reason that moving the commercial production site from overseas to Minaris's Yokohama site meant rebuilding from the technology transfer. The timing of the application is not disclosed | Sourced |
| Dependence on the result of the confirmatory trial | Under conditional and time-limited approval, efficacy must be shown in the confirmatory trial (REVIVE-ARDS) within the period. The company itself explains that the results are a precondition for full approval and for expansion into the US and Europe. There is always a chance that the trial will not proceed as planned or will not meet its primary endpoint | Sourced |
| Missed endpoints in past trials | The TREASURE trial in acute ischaemic stroke (Phase 2/3, double-blind, placebo-controlled, 206 enrolled) did not meet its primary endpoint. The MASTERS-2 trial in the US and Europe concluded that further enrolment was needed for statistical significance, and ClinicalTrials.gov shows it as terminated | Sourced |
| Leadership of iPS cell products lies with other companies | The ophthalmic HLCR011 is led by the Sumitomo Pharma side (now RACTHERA), and eNK cells by Akatsuki. Healios's revenue depends on milestones tied to the progress of the other side's trials | Inference |
| Litigation with a trading partner | AND medical group (a general incorporated association) claims ¥120 million plus litigation costs from Healios, alleging breach of the joint research agreement on culture supernatant (April 2024) (Tokyo District Court, filed November 2025). In June 2026 Healios filed a counterclaim seeking payment of ¥66 million plus delay damages. No ruling has been given | Sourced |
| Small staff and reliance on outside manufacturing | 75 consolidated employees. Commercial production is at Minaris, and its own CDMO site is planned to open in January 2028 and partly depends on the subsidy | Inference |
12. Glossary
- Somatic stem cell
- A stem cell found in tissues such as bone marrow. It can change into fewer kinds of cell than an iPS cell.
- HLCM051 (MultiStem)
- An allogeneic somatic stem cell product from the bone marrow of healthy adult donors, developed by Healios. Generic name invimestrocel.
- ARDS (acute respiratory distress syndrome)
- A condition in which, after pneumonia, injury or the like, fluid builds up in the lungs and causes severe respiratory failure.
- VFD
- Ventilator-free days: the number of days (out of 28) without a ventilator. The primary endpoint of the REVIVE-ARDS trial.
- Conditional and time-limited approval
- A Japanese system that lets a regenerative medicine product go on the market early, with conditions and a time limit, when a small trial has confirmed safety and some efficacy can be expected. Efficacy is then confirmed after launch.
- UDC
- Universal donor cell. An allogeneic iPS cell made less prone to immune rejection by gene editing.
- NK cell
- Natural killer cell. An immune cell (a type of white blood cell) that attacks cancer cells and virus-infected cells.
- Retinal pigment epithelial cell
- A cell that supports the photoreceptors of the retina, supplying nutrients and breaking down waste.
- Culture supernatant
- The liquid left after cells have been cultured. It contains proteins and other substances the cells have secreted.
- CDMO
- Contract development and manufacturing organisation. A company that develops and manufactures drugs or cells on commission.
- PPQ
- Process performance qualification. A step of repeated commercial-scale manufacture to confirm that quality is stable and meets specifications.
- Going-concern assumption
- The accounting premise that a company will continue in business into the future. Where there is doubt, it is noted in the financial statements.
13. References
- Healios Annual Securities Report (15th fiscal year, year ended December 2025, filed with the Kanto Local Finance Bureau on 24 March 2026) (in Japanese). History, business description, management policy, risks, going-concern assumption, R&D activities and material contracts. https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf
- Healios Interim Report (first half of the 16th fiscal year, January to June 2026, filed 12 August 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100YVX6/00.pdf
- Healios Second-quarter results briefing materials for the year ending December 2026 (12 August 2026) (in Japanese). Progress on the ARDS application and manufacturing, and the bioreactor. https://ssl4.eir-parts.net/doc/4593/tdnet/2871247/00.pdf
- Healios Timely disclosure, "On the development and application policy for HLCM051 (ARDS and acute ischaemic stroke)" (9 December 2025) (in Japanese). https://ssl4.eir-parts.net/doc/4593/tdnet/2729220/00.pdf
- Healios Timely disclosure, "Start of the global Phase 3 trial of the ARDS treatment (REVIVE-ARDS) in Japan" (3 February 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4593/tdnet/2749345/00.pdf
- Healios Timely disclosure, "Notice of award decision for the Ministry of Economy, Trade and Industry FY2024 supplementary budget subsidy for investment in manufacturing facilities for regenerative, cell and gene therapies" (27 March 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4593/tdnet/2782569/00.pdf
- Healios Timely disclosure, "Notice on obtaining a marketing authorisation holder licence for regenerative medicine products" (31 August 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4593/tdnet/2879456/00.pdf
- Healios Timely disclosure, "Notice of collaboration with Minaris Advanced Therapies on commercial production of HLCM051" (7 October 2025) (in Japanese). https://ssl4.eir-parts.net/doc/4593/tdnet/2694919/00.pdf
- Healios Timely disclosure, "Notice on the issuance of new shares and the 27th series of stock acquisition rights by third-party allotment" (29 January 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4593/tdnet/2745520/00.pdf
- Healios Timely disclosure, "Notice on the shipment timing of the first order of culture supernatant products to JENECELL" (30 September 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4593/tdnet/2889294/00.pdf
- Healios Timely disclosure, "Notice of a lawsuit for damages filed against the company" (29 December 2025) (in Japanese). https://ssl4.eir-parts.net/doc/4593/tdnet/2736557/00.pdf
- Healios Timely disclosure, "Notice of a counterclaim in the lawsuit against the company" (9 June 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4593/tdnet/2833387/00.pdf
- Ministry of Health, Labour and Welfare (MHLW) Japan Registry of Clinical Trials (jRCT), jRCT2073230077, "Phase I/II study of HLCR011 in patients with retinal pigment epithelium tear" (in Japanese). https://jrct.mhlw.go.jp/latest-detail/jRCT2073230077
- U.S. National Library of Medicine ClinicalTrials.gov NCT03807804 (ONE-BRIDGE trial, Phase 2 in ARDS in Japan). https://clinicaltrials.gov/study/NCT03807804
- U.S. National Library of Medicine ClinicalTrials.gov NCT02611609 (MUST-ARDS trial, Phase 1/2 in ARDS in the US and UK). https://clinicaltrials.gov/study/NCT02611609
- U.S. National Library of Medicine ClinicalTrials.gov NCT02961504 (TREASURE trial, Phase 2/3 in acute ischaemic stroke). https://clinicaltrials.gov/study/NCT02961504
- U.S. National Library of Medicine ClinicalTrials.gov NCT04533464 (MATRICS-1 trial, Phase 2 in trauma). https://clinicaltrials.gov/study/NCT04533464
- U.S. National Library of Medicine ClinicalTrials.gov NCT03545607 (MASTERS-2 trial, acute ischaemic stroke). https://clinicaltrials.gov/study/NCT03545607
- Healios Official website (source of the logo). https://www.healios.co.jp/
14. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Legal name, former name, establishment, listing (TSE Growth 4593), head office, reporting under IFRS | Sourced | References 1, 2 and 19 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100YVX6/00.pdf https://www.healios.co.jp/ |
| Revenue, losses, cash flow and employees (years ended December 2023 to 2025, and January to June 2026) | Sourced | References 1 and 2 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100YVX6/00.pdf |
| R&D expense (¥2,024 million in the year ended December 2025; ¥1,733 million in January to June 2026) and 24,404,700 potential shares | Sourced | References 1 and 2 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100YVX6/00.pdf |
| The statement of a situation casting material doubt on the going-concern assumption, and the countermeasures | Sourced | References 1 and 2 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100YVX6/00.pdf |
| New shares of about ¥6.26 billion and the 27th series of stock acquisition rights (January to February 2026) | Sourced | Reference 9 https://ssl4.eir-parts.net/doc/4593/tdnet/2745520/00.pdf |
| Award of the METI subsidy of about ¥7 billion, and the Kobe CDMO site (operations planned for January 2028) | Sourced | Reference 6 https://ssl4.eir-parts.net/doc/4593/tdnet/2782569/00.pdf |
| Acquisition of Athersys's assets (April 2024) and the rights to HLCM051 | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf |
| The co-development agreement with Sumitomo Pharma (now RACTHERA) (June 2019) and development milestones totalling ¥1 billion | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf |
| Content and status of the HLCR011 trial (jRCT2073230077) | Sourced | Reference 13 https://jrct.mhlw.go.jp/latest-detail/jRCT2073230077 |
| Licences with Astellas Institute for Regenerative Medicine, RxCell, RIKEN, Osaka University and others | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf |
| The joint business agreement with Akatsuki Therapeutics, and the content of eNK cell research | Sourced | References 1 and 2 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100YVX6/00.pdf |
| The content of UDC, and patent grants (Japan August 2025, China August 2026) | Sourced | References 1 and 2 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100YVX6/00.pdf |
| The policy of prioritising ARDS and not making a rolling submission for stroke (9 December 2025) | Sourced | Reference 4 https://ssl4.eir-parts.net/doc/4593/tdnet/2729220/00.pdf |
| Design of the REVIVE-ARDS trial (up to 550 patients, VFD, interim analyses) and preparation to start in Japan | Sourced | References 4 and 5 https://ssl4.eir-parts.net/doc/4593/tdnet/2729220/00.pdf https://ssl4.eir-parts.net/doc/4593/tdnet/2749345/00.pdf |
| Outlines of the ONE-BRIDGE, MUST-ARDS, TREASURE, MATRICS-1 and MASTERS-2 trials | Sourced | References 1, 14, 15, 16, 17 and 18 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf https://clinicaltrials.gov/study/NCT03807804 https://clinicaltrials.gov/study/NCT02611609 https://clinicaltrials.gov/study/NCT02961504 https://clinicaltrials.gov/study/NCT04533464 https://clinicaltrials.gov/study/NCT03545607 |
| Collaboration with Minaris, preparation for commercial production (50 L, engineering run), and rebuilding after the change of site | Sourced | References 3 and 8 https://ssl4.eir-parts.net/doc/4593/tdnet/2871247/00.pdf https://ssl4.eir-parts.net/doc/4593/tdnet/2694919/00.pdf |
| Re-acquisition of the marketing authorisation holder licence for regenerative medicine products (dated 24 August 2026) | Sourced | Reference 7 https://ssl4.eir-parts.net/doc/4593/tdnet/2879456/00.pdf |
| Culture supernatant trade (Alfresa, JENECELL) and the shipment timing of the first order | Sourced | References 1, 2 and 10 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100YVX6/00.pdf https://ssl4.eir-parts.net/doc/4593/tdnet/2889294/00.pdf |
| The lawsuit and counterclaim with AND medical group | Sourced | References 11 and 12 https://ssl4.eir-parts.net/doc/4593/tdnet/2736557/00.pdf https://ssl4.eir-parts.net/doc/4593/tdnet/2833387/00.pdf |
| Timing of the ARDS treatment's application in Japan, its expected approval date, and the start of eNK cell trials | Not yet confirmed | No outlook has been published. This article does not estimate them either |
| Headcount dedicated to iPS cells, and the breakdown of R&D expense | Not yet confirmed | Reference 1 https://ssl4.eir-parts.net/doc/4593/yuho_pdf/S100XTBP/00.pdf Not stated in reference 1. This article does not estimate them either |
| The three-type classification (large pharma / genome editing / iPS cell and cell therapy) | Our calculation | This article's own grouping. Company names are examples from this series |
| The reading that the axis of the business has shifted to HLCM051 (ARDS) rather than iPS cells | Inference | This article's interpretation of the December 2025 policy and the main milestones in the 2026 results briefing materials |
| The reading that for iPS cells the weight is on taking materials and base technology outside and earning from them | Inference | This article's interpretation of the descriptions of upfront payments, milestones and more than ten recipients |
| The reading that it sees the CDMO business as a candidate for a stable source of revenue | Inference | This article's interpretation of the subsidy-funded CDMO site and the stated business policy |
| The risk that leadership of iPS cell products lies with other companies | Inference | This article's interpretation of the co-development agreement and the contract structure with Akatsuki |
| The risk of a small staff and reliance on outside manufacturing | Inference | This article's interpretation of the headcount and the outsourcing to Minaris |
Last updated 1 October 2026 / Troy Technical
The figures in this article are based on Healios's Annual Securities Report, Interim Report, timely disclosures and results briefing materials, and on the jRCT and ClinicalTrials.gov registries. 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 does not recommend any treatment or product and is not medical advice.