COMPANY PROFILE / iPS CELLS & REGENERATIVE MEDICINE
Lineage Cell Therapeutics
Makes "lost cells" from pluripotent stem cells and transplants them. But its clinical products are derived from ES cells, and iPS cells are still at the research stage
Searches in this field tend to lump Lineage in with "iPS cell companies", but it is a little different. Its clinical-stage products (OpRegen for the retina and OPC1 for spinal cord injury) are derived from human embryonic stem (ES) cells, and the only iPS cell programme is RND1, a research-stage evaluation of a gene-edited iPS cell line designed to be harder for the immune system to reject. Even so, the company is one of the few actually running the heart of regenerative medicine through its partnership with Roche and Genentech: making cells in large volumes at consistent quality, and putting them in a form that can be thawed and injected straight away. That is why it appears in this series. This article is neither an introduction to a therapy nor a recommendation. It organises facts from the company's own disclosures.
- Lineage 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 field
- Scale
- Resources committed to iPS cells and regenerative medicine
- What it has done so far
- What comes next
- What the company is aiming for
- Map of partnerships
- Technologies, products and services on offer
- The risks this company carries
- Glossary, references and claim-to-source audit
1. Lineage in 30 seconds, and where it stands in iPS cells and regenerative medicine
United StatesManufacturing is carried out by a subsidiary in Jerusalem, Israel
Tel Aviv Stock ExchangeTicker: LCTX
(pluripotent stem cell transplants)Secondary type: genome editing (edited cell line brought in from outside)
differentiated cellsMostly ES cell-derived. One iPS cell line (RND1)
Phase 2aDevelopment led by Roche and Genentech
Phase 1Safety study of a new delivery device (DOSED)
Lineage is not an "iPS cell company". It is a company that makes differentiated cells from pluripotent stem cells and transplants them, and the cells it has actually given to patients are derived from ES cells Sourced. The 10-K states that OpRegen, OPC1 and ANP1 (ReSonance) are based on human ES cell lines. The only iPS cell line is a single line for RND1 that has been gene-edited (deletion of the B2M gene, insertion of the HLA-E gene and so on), which the company received from its partner in January 2026. It would be a mistake, then, to read Lineage as a typical iPS cell company. It is better read as a case study in how to make, bank and ship cells, a skill that applies to iPS cells and ES cells alike.
2. The logo and how the name is written
A note on names: the legal entity is Lineage Cell Therapeutics, Inc. (short form Lineage, ticker LCTX). It changed its name from BioTime in August 2019. Much of its manufacturing and research is done by a subsidiary, Cell Cure Neurosciences (CCN), in Jerusalem. The logo was taken from the company's official website.
Official site: https://lineagecell.com/3. Where the company sits in the iPS cell and regenerative medicine field
Lineage is placed on the right of Fig. 1 (iPS cell & cell therapy), but the position becomes clearer when the mechanisms of treatment are read separately Sourced.
| Mechanism | What Lineage has | Status |
|---|---|---|
| Differentiated cells derived from ES cells (allogeneic) | OpRegen (retina), OPC1 (spinal cord), ReSonance / ANP1 (hearing) | Two products in the clinic, one preclinical |
| Differentiated cells derived from iPS cells | RND1 (a gene-edited iPS cell line under evaluation) | Cell line received. Whether to proceed depends on further studies |
| Genome editing | Does no editing itself. Brings in a line edited by Factor Biosciences | Evaluated under an option and licence agreement |
| Gene delivery such as AAV and LNP | None | Not described in the 10-K |
| Autologous (the patient's own) cell therapy / mesenchymal stem cells | None | All products are allogeneic (from a donor) |
4. Scale
Sales are small, and most revenue is contract income from partners. Amounts are in U.S. dollars and the fiscal year ends in December Sourced.
| Measure (US$) | Year to December 2024 | Year to December 2025 |
|---|---|---|
| Total revenues | US$9.499 million | US$14.556 million |
| Share from collaboration revenues (Roche, WDI) | 85.8% | 93.5% |
| R&D expenses | US$12.472 million | US$17.729 million |
| Cash, cash equivalents and marketable securities (period end) | - | US$55.8 million (US$50.8 million at 30 June 2026) |
| Employees (31 December 2025) | - | 77 (22 at Lineage, 55 at CCN) |
Two items account for much of the 2025 revenue: the first milestone under the Roche agreement (US$5 million, of which US$4.6 million was booked as revenue) and US$2.5 million from the research collaboration with WDI (William Demant Invest). Neither is recurring product revenue Sourced. There is no approved product yet, and the 10-K says that no biologics licence application (BLA) has been submitted for any product. The company says its cash can fund its operating plan for at least 12 months, but it also states plainly that the cash is not enough to reach approval.
5. Resources committed to iPS cells and regenerative medicine
The table covers people, money and outside collaboration. "Not found" is also a result of checking.
| Resource | What it is | Category |
|---|---|---|
| People (sites and staff) | 77 staff: 22 at Lineage itself (Carlsbad) and 55 at CCN (Jerusalem). 12 hold a doctorate or equivalent. Manufacturing and R&D are carried out at CCN's facility in Jerusalem (about 22,600 square feet) | Sourced |
| Money (R&D) | US$17.729 million in 2025. By programme: OpRegen US$7.653 million (43%), OPC1 US$3.681 million (21%), ANP1 US$2.883 million (16%), RND1 US$2.425 million (14%), other US$1.087 million (6%) | Sourced |
| Money (manufacturing capital expenditure) | No capital expenditure figure could be found. The company describes a cGMP manufacturing facility in a Jerusalem biopark that can run several processes at once | Not confirmed (the facility itself is Sourced) |
| Outside investment, acquisitions and in-licensing | Option and licence agreement with Factor Biosciences for a gene-edited, low-immunogenicity iPS cell line (February 2023, taken over from Eterna). The line was received in January 2026 and a success-based payment was made | Sourced (amount not confirmed) |
| External funding through partnerships | Roche: US$50 million upfront (received January 2022), a US$5 million milestone (received December 2025) and up to US$615 million more. WDI: up to US$12 million, covering costs over about three years | Sourced |
| Universities, research institutions and public funding | Grants from the Israel Innovation Authority (IIA, up to 50% of spending) carry an obligation to pay royalties of 3% to 5% of sales and other conditions. A licence from Hadasit (the technology-transfer company of the Hadassah hospital). Clinical sites include UC San Diego Health and Rancho Los Amigos | Sourced |
According to the 10-K, part of what Lineage receives from Roche is subject to payment obligations to the IIA and Hadasit. From the US$50 million upfront payment, for example, US$12.1 million went to the IIA and US$8.9 million to Hadasit; from the US$5 million milestone, US$1.2 million goes to the IIA, and US$1.1 million has been booked for Hadasit Sourced. Anyone reading the "up to US$615 million" figure should keep this sharing obligation in mind.
6. What it has done so far
| When | What happened | Why it matters |
|---|---|---|
| August 2019 | Renamed from BioTime to Lineage Cell Therapeutics | Narrowed the business to cell transplants |
| November 2020 | Enrolment completed in the Phase 1/2a trial of OpRegen (NCT02286089): 24 patients in four cohorts | An open-label, single-arm study that looks at safety and activity as the dose is raised |
| December 2021 | Global collaboration with Roche, granting exclusive rights to RPE cell therapies including OpRegen | Roche takes over the lead in development and commercialisation |
| February 2023 | Option and licence agreement with Factor (gene-edited, low-immunogenicity iPS cell line) | The first deal to move into iPS cells and genome editing |
| March 2023 | Start of GAlette (NCT05626114), the Phase 2a trial of OpRegen | Its main aim is to optimise the technique for delivery under the retina |
| May 2024 | Services agreement with Genentech (Lineage provides clinical, technical and manufacturing support) | Manufacturing know-how becomes a source of revenue |
| February to July 2025 | Start of the OPC1 DOSED study. In July the first chronic-phase participant was dosed with the new delivery device | The first study in chronic spinal cord injury |
| June 2025 | Roche and Genentech present 36-month OpRegen data at a conference. Development of VAC (cancer vaccines) is stopped | Exit from oncology to focus on non-oncology cell transplants |
| August 2025 | Research collaboration with WDI on auditory neuronal progenitor cells (ReSonance / ANP1) | Up to US$12 million of outside funding |
| September 2025 | Start of ILT1, research on large-scale culture of pluripotent stem cells with type 1 diabetes in view | A first step towards making islet cells |
| December 2025 | First milestone payment of US$5 million received under the Roche collaboration | Conditional on progress in manufacturing and clinical work |
| January 2026 | Gene-edited iPS cell line (RND1) received from Factor | Evaluation of the iPS cell line begins |
| March and July 2026 | A second chronic-phase participant dosed in the DOSED study (March). One-year assessment of the first participant (July) | The company describes the participant as neurologically stable on motor, sensory and upper-extremity motor scores |
A caution on reading the OpRegen Phase 1/2a results
The 36-month results announced by Roche and Genentech in June 2025 covered 10 patients in cohort 4 (the group with relatively mild lesions) who had completed three years of follow-up. The mean change in best-corrected visual acuity (BCVA) was +6.2 letters (+5.5 letters at 24 months) Sourced. However, this was an open-label, single-arm study with no untreated control group to compare against. Its primary objectives were safety and tolerability, and visual acuity was a secondary measure. The primary endpoints of the Phase 2a GAlette study (up to 60 patients at 17 sites in the United States and Israel) are the proportion of cases in which delivery under the retina reaches the target site, and procedure-related adverse events three months after dosing. It is a study to optimise the delivery technique, not one designed to test efficacy. This article does not recommend any particular treatment.
7. What comes next
The 10-K says there are several research programmes on cell types not yet named, and that progress is expected to be shared during 2026 Not yet confirmed.
None of the following appears in the 10-K or the 10-Q Not yet confirmed.
The timing of an approval filing for OpRegen; the start date and size of a comparative OPC1 study; the facility and capital expenditure for commercial production; the target disease of RND1 (undisclosed); and clinical studies in Japan. This article uses no figures on approval or launch timing, including those from press reports.
8. What the company is aiming for
This section goes beyond what the company says directly. It sets out inferences that can be drawn from primary sources, each with its basis.
| What can be read | Primary evidence behind it | Category |
|---|---|---|
| It is trying to become a company that sells how to make cells rather than the cells themselves | The services agreement with Genentech (technical training and supplies towards commercial manufacturing), and the strategy statement that some programmes are advanced in house and others with partners | Inference |
| Its policy for iPS cells is to bring in edited lines from outside rather than make them itself | The agreement to in-license the line from Factor. There is no mention of making iPS cells or doing genome editing in house | Inference |
| It sees manufacturing scale as the challenge for type 1 diabetes | The ILT1 description cites up to one billion cells per patient and the need for large-scale production, and reports successful culture at the 0.5-litre scale | Sourced (success at 0.5 litre) / Inference (the aim) |
| It has withdrawn from oncology | The VAC licence and collaboration were terminated effective 30 June 2025 and development was abandoned | Sourced |
| It treats Japan's conditional and time-limited approvals as separate from its own path | The 10-K notes that the February 2026 conditional and time-limited approvals in Japan of two iPS cell-derived products do not establish safety or efficacy | Sourced (the existence of the note) |
The 10-K repeatedly cites as a strength that the company has run cGMP manufacturing from a two-tier cell bank and produced lots of clinical-trial quality Sourced. Yet 93.5% of revenue is collaboration revenue, and there are no product sales. From this, the centre of Lineage's value appears to lie in the process of differentiation and mass production rather than in any individual cell type Not yet confirmed. Whether that process works as well with another company's iPS cell lines or with other cell types cannot be confirmed until the results from RND1 and ILT1 are in.
9. Map of partnerships
10. Technologies, products and services on offer
There is no approved product. What Lineage offers is a manufacturing platform, and manufacturing and technical support for its partner Sourced.
| Item | What the 10-K says |
|---|---|
| AlloSCOPE (manufacturing platform) | A two-tier cell bank approach in which a single pluripotent cell line passes through a master cell bank (MCB) and a working cell bank (WCB) to yield hundreds to thousands of vials of final product. cGMP manufacturing has been completed for two products, and at least one of them was used in a study that the FDA cleared to proceed in 2025 |
| Thaw-and-inject formulation | A form that can be thawed and injected straight away, reducing preparation before dosing. Developed for OpRegen (cohort 4) and OPC1 |
| OpRegen (RG6501) | A suspension of allogeneic RPE cells, given under the retina. FDA Fast Track and RMAT designations |
| OPC1 | Allogeneic oligodendrocyte progenitor cells, given into the spinal cord. FDA RMAT and orphan drug designations. A new delivery device is being evaluated with Neurgain Technologies |
| Services agreement | Support for Genentech in clinical, technical, training, manufacturing and procurement work (May 2024) |
| Royalties, licensing and other | 6.5% of revenue (2025). Arising from the patent family that Asterias acquired from Geron and from the services agreement with Genentech |
The company's strength lies in the reproducibility of the process more than in the type of cell Sourced. There are three points to note on the materials side. (1) Culture without animal-derived components: OpRegen is described as cultured without animal-derived components, but the risk factors also state that some ES cell and iPS cell lines were exposed to fetal bovine serum, human serum or human serum albumin during derivation or early expansion. Control of the culture medium is therefore judged not only on today's process but on the history of the cell line. (2) Cryopreservation and the fluid after thawing: for a thaw-and-inject product, the design of the freezing medium and of the suspension after thawing translates directly into ease of use. (3) Scaling up suspension culture: the next question is whether the 0.5-litre dynamic culture in ILT1 can be taken to larger scales. For more, see our explainers on cell manufacturing and cell banking, bioreactors, and GMP.
11. The risks this company carries
| Risk | Substance | Category |
|---|---|---|
| Dependence on one partner | Roche leads development and commercialisation of OpRegen, the most advanced product, and can terminate the agreement at any time on prior written notice | Sourced |
| Funding | Cash and equivalents were US$55.8 million at the end of December 2025. The company states that this does not cover the path to approval and that more financing will be needed | Sourced |
| Manufacturing concentrated at one site in Israel | All cGMP manufacturing is done at one facility in Jerusalem. The company spells out risks from conflict in the Middle East, such as supply disruption, power cuts and staff shortages (saying it has had no major impact so far). For products funded by IIA grants, moving manufacturing abroad would require approval and bring higher royalties | Sourced |
| History of the cell lines | The ES cell lines were derived before today's donor eligibility standards, and have a history of contact with animal and human-derived materials | Sourced |
| Chromosomal abnormalities and changes in properties | Pluripotent cells can develop chromosomal abnormalities as they are cultured repeatedly, which could affect the quality and safety of shipped product | Sourced |
| Few precedents for approval | The FDA has never approved an ES cell- or iPS cell-derived therapy (10-K). The company itself notes that Japan's conditional and time-limited approvals do not establish efficacy | Sourced |
| Policy on ES cells | The filing notes that the NIH changed its policy on funding human ES cell research on 22 January 2026. Government restrictions or ethical objections could impede the business | Sourced |
| Lag in iPS cells | RND1 is the only iPS cell line and whether to proceed is undecided. Its track record in this area is limited compared with companies that centre on iPS cells | Inference |
12. Glossary
- Pluripotent stem cell
- A cell with the ability to become many kinds of cell. The two types are ES cells and iPS cells.
- ES cell (hES)
- A pluripotent stem cell made from an early human embryo. The cell source for Lineage's clinical products.
- iPS cell
- A cell made pluripotent by introducing genes into an ordinary body cell. See our explainer on iPS cells.
- Allogeneic
- Using cells from another person. They can be made in advance and stocked.
- RPE cell
- Retinal pigment epithelium cell. The layer that supports the light-sensing cells, and is lost in geographic atrophy from age-related macular degeneration.
- Geographic atrophy (GA)
- A state in dry age-related macular degeneration in which parts of the retina waste away in map-like patches.
- Hypoimmunogenic
- Cells edited so that they are less likely to provoke rejection. In RND1 this includes deletion of the B2M gene and insertion of the HLA-E gene.
- RMAT designation
- The FDA's Regenerative Medicine Advanced Therapy designation. It allows close consultation with the agency during development.
- cGMP
- Current good manufacturing practice, the quality standard for making medicines. MCB and WCB are the master and working cell banks.
- Form 10-K / 10-Q
- The annual and quarterly reports filed with the U.S. SEC.
13. References
- Lineage Cell Therapeutics Form 10-K for the fiscal year ended December 31, 2025 (filed with the U.S. SEC on 5 March 2026). Business, pipeline, the Roche agreement, Factor, WDI, financials, employees and risk factors. https://www.sec.gov/Archives/edgar/data/876343/000119312526093992/lctx-20251231.htm
- Lineage Cell Therapeutics Form 10-Q for the quarter ended June 30, 2026 (filed with the U.S. SEC on 6 August 2026). Progress of the DOSED study, cash and the effects of the situation in the Middle East. https://www.sec.gov/Archives/edgar/data/876343/000119312526338064/lctx-20260630.htm
- ClinicalTrials.gov NCT05626114 (OpRegen Phase 2a, GAlette). Design, primary endpoints and estimated primary completion date. https://clinicaltrials.gov/study/NCT05626114
- ClinicalTrials.gov NCT02286089 (OpRegen Phase 1/2a). Design and enrolment. https://clinicaltrials.gov/study/NCT02286089
- ClinicalTrials.gov NCT06841770 (OPC1 DOSED study). Design, primary endpoints and estimated primary completion date. https://clinicaltrials.gov/study/NCT06841770
- Lineage Cell Therapeutics Official website, used to check the company name and logo. https://lineagecell.com/
14. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Legal name, former name BioTime, head office, listing venues, 77 employees (22 at Lineage, 55 at CCN) | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/876343/000119312526093992/lctx-20251231.htm |
| OpRegen, OPC1 and ANP1 are based on human ES cell lines. The iPS cell line is RND1 (brought in from Factor) | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/876343/000119312526093992/lctx-20251231.htm |
| Total revenues (US$9.499 million in 2024, US$14.556 million in 2025), share from collaboration revenues, breakdown of R&D expenses | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/876343/000119312526093992/lctx-20251231.htm |
| Cash and equivalents of US$55.8 million (31 December 2025) and US$50.8 million (30 June 2026) | Sourced | References 1 and 2 https://www.sec.gov/Archives/edgar/data/876343/000119312526338064/lctx-20260630.htm |
| Terms of the Roche collaboration (US$50 million upfront, US$5 million milestone, up to US$615 million more, royalties) and the allocation to the IIA and Hadasit | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/876343/000119312526093992/lctx-20251231.htm |
| Research collaboration with WDI (up to US$12 million, about three years) and the services agreement with Genentech | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/876343/000119312526093992/lctx-20251231.htm |
| OpRegen Phase 1/2a (24 patients, open-label, single-arm) and the 36-month result (n=10, +6.2 letters) | Sourced | Reference 4 https://clinicaltrials.gov/study/NCT02286089 |
| GAlette study (up to 60 patients, primary endpoints, estimated primary completion March 2031) | Sourced | Reference 3 https://clinicaltrials.gov/study/NCT05626114 |
| DOSED study (up to 10 participants, primary endpoints, estimated primary completion August 2027) | Sourced | Reference 5 https://clinicaltrials.gov/study/NCT06841770 |
| Dosing of chronic-phase participants in DOSED and the one-year assessment | Sourced | References 1 and 2 https://www.sec.gov/Archives/edgar/data/876343/000119312526338064/lctx-20260630.htm |
| The 10-K's note on Japan's conditional and time-limited approvals | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/876343/000119312526093992/lctx-20251231.htm |
| Discontinuation of VAC (cancer vaccines) | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/876343/000119312526093992/lctx-20251231.htm |
| The three types of company in Fig. 1 | Our calculation | Our own classification. Companies shown are examples from those covered in this series |
| Confirmation of the logo and the way the name is written | Sourced | Reference 6 https://lineagecell.com/ |
| Capital expenditure, the payment to Factor, the target disease of RND1, the timing of approval filings and plans for a commercial manufacturing facility | Not yet confirmed | Not in the 10-K or 10-Q. This article makes no estimate https://www.sec.gov/Archives/edgar/data/876343/000119312526093992/lctx-20251231.htm |
| The reading that it is trying to become a company that sells how to make cells | Inference | This article's interpretation of the services agreement and the description of its business strategy |
| The reading that its policy is to bring in iPS cell lines from outside | Inference | This article's interpretation of the structure of the agreement with Factor |
| The reading that it sees manufacturing scale as the challenge for type 1 diabetes | Inference | This article's interpretation of the description of ILT1 |
| The reading that the centre of value lies in the differentiation and mass-production process | Inference | This article's interpretation of the fact that 93.5% of revenue is collaboration revenue |
| The risk that its iPS cell track record is limited | Inference | This article's interpretation of the fact that there is only one iPS cell line |
Last updated 1 October 2026 / Troy Technical
Every figure in this article comes from statutory filings Lineage Cell Therapeutics has made with the U.S. Securities and Exchange Commission and from ClinicalTrials.gov. No research-firm estimates or press-based figures have been used. Passages marked "Inference" are this article's interpretation of primary sources, not statements made by the company. This article is not medical advice. It does not recommend any particular treatment or rank it against others.