COMPANY PROFILE / iPS CELLS & REGENERATIVE MEDICINE
Fate Therapeutics
A company that mass-produces "off-the-shelf immune cells" from iPS cells and is running clinical trials in autoimmune disease and cancer
Fate Therapeutics is an iPS cell and cell therapy company in the sense used in this series. It makes several genetic modifications to human iPS cells, selects a single "clonal master iPSC line", expands it, and mass-produces T cells and NK cells from it. In its own 10-K the company says that it was the first to take iPS cell-derived CAR-T cells into clinical trials. At the end of December 2025 it had 161 employees, its only revenue was collaboration income from ONO (Ono Pharmaceutical), and it held US$153.8 million in cash and investments at the end of June 2026. This profile sets out what it makes, whom it works with, how far it has got and what remains unconfirmed, using only the company's statutory filings and ClinicalTrials.gov.
- Fate Therapeutics 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
- 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 for iPS cells and regenerative medicine
- Technology, products and services on offer
- The risks this company carries
- Glossary, references and claim-to-source audit
1. Fate Therapeutics in 30 seconds, and where it stands in iPS cells and regenerative medicine
California, U.S.Incorporated in Delaware in 2007
CAR-T and CAR-NK cellsOff-the-shelf (allogeneic). Several genetic modifications are added
Most "iPS cell companies" in this field are of the kind that make body tissue such as heart muscle or nerve cells. Fate Therapeutics is of the kind that makes immune cells (T cells and NK cells) Sourced. It treats iPS cells as an "endlessly renewable raw material" and, by making large quantities of identical-quality cells from a single cell line, hopes to avoid the problems of autologous CAR-T made patient by patient (time, cost and variability). The target diseases are autoimmune diseases such as systemic lupus erythematosus (SLE, or lupus), and cancer. All the results quoted here come from small early-stage trials and are no guarantee of a therapeutic effect.
2. The logo and how the name is written
A note on names: the legal entity is Fate Therapeutics, Inc., a Delaware corporation. "FT819", "FT825" and the like are development code names, not the names of approved drugs. FT825 is also called ONO-8250 and is co-developed with Ono Pharmaceutical. The 10-K says the company was the first to take iPS-derived CAR-T cells into clinical trials, but that is the company's own description and this article has not independently verified it.
Official site: https://fatetherapeutics.com/3. Where the company sits in iPS cells and regenerative medicine
In using iPS cells it has something in common with Japanese iPS companies that make heart muscle or nerve cells, but what it makes are immune cells, and the aim is to infuse them into the body to remove diseased cells. The company makes its genetic modifications at the iPS cell stage and then builds a cell line from a single cell that has been modified correctly (a clonal master iPSC line). Related ideas are covered in our explainers on iPS cells, iPS-derived immune cells, CAR-T cells, cell manufacturing and cell banks, and MHC and universal donors.
4. Scale
This is a clinical-stage company, so the figures to watch are R&D spending and cash on hand rather than sales Sourced. Amounts are in US dollars.
| Metric (US$ million) | FY2024 (year to December 2024) | FY2025 (year to December 2025) | January to June 2026 |
|---|---|---|---|
| Revenue (collaboration income from Ono) | 13.6 | 6.6 | 3.4 |
| Research and development expense | 135.0 | 107.8 | 49.1 |
| Net loss | (186.3) | (136.3) | (61.4) |
| Capital expenditure (purchase of property and equipment) | 0.7 | 6.0 | – |
| Item | Detail | As of |
|---|---|---|
| Cash and investments (cash and investments) | US$205.1 million | 31 December 2025 |
| Cash and investments (cash and short-term investments) | US$153.8 million | 30 June 2026 |
| Funding outlook (company) | Expected to fund operations for at least the next 12 months | 10-Q |
| Employees | 161 (27 in research, 103 in clinical development, manufacturing and regulatory affairs, 31 in administration) | 31 December 2025 |
| Accumulated deficit | About US$1.6 billion | 30 June 2026 |
All revenue is collaboration income from Ono; there are no product sales Sourced. R&D expense fell from US$135.0 million in 2024 to US$107.8 million in 2025. The company has been narrowing its focus, but it still relies on raising money from investors.
5. Resources committed to iPS cells and regenerative medicine
We give amounts only where they have been disclosed, and write "not confirmed" where they have not.
| Type of resource | Detail | Category |
|---|---|---|
| People | 161 employees (end of December 2025): 27 in research, 103 in clinical development, manufacturing and regulatory affairs, and 31 in administration | Sourced |
| Research and manufacturing sites | About 200,000 square feet of office, laboratory and GMP manufacturing space at its San Diego headquarters (leased to May 2036). It operates its own GMP facility of more than 40,000 square feet. In October 2024 it terminated early a lease of about 72,000 square feet in Torrey Pines | Sourced |
| Money: R&D expense | US$107.8 million in FY2025 (US$135.0 million the year before). US$49.1 million in January to June 2026 | Sourced |
| Money: manufacturing capital expenditure | Purchases of property and equipment were US$6.0 million in 2025 and US$0.7 million in 2024 | Sourced |
| Manufacturing | In addition to its own cGMP manufacturing facility (San Diego), it outsources some steps to hospital cell-therapy facilities and CMOs. Some key raw materials are research grade, and some come from a single supplier | Sourced |
| In-licensing from outside | Memorial Sloan Kettering Cancer Center (iPS-derived CAR-T and NK cells; 2016, amended 2018), Whitehead Institute (reprogramming; 2009) and the University of Minnesota (NK cells; December 2016) | Sourced |
| Outside investments and acquisitions | The 10-K lists no investments in or acquisitions of start-ups | Not confirmed |
| Public funding | Up to US$7.9 million from the California Institute for Regenerative Medicine (CIRM) for FT819 (2024) and US$4.0 million for FT836 (2025) | Sourced |
| Tie-up with a pharmaceutical company | Ono Pharmaceutical (Ono). Joint research on iPS-derived CAR-T and CAR-NK cells for solid tumours since 2018 | Sourced |
| Intellectual property | More than 600 issued patents and more than 550 pending applications | Sourced |
The 10-K describes manufacturing in three stages: (1) healthy donor cells are reprogrammed into iPS cells without integrating DNA, genetically modified, and a cell line is built from a single cell; (2) the line is differentiated and expanded through haematopoietic progenitors into T cells or NK cells; and (3) the cells are washed, formulated and filled into single-dose cryobags. On the materials side, what matters is the quality of the media and growth factors that drive differentiation (the company itself says some raw materials are still research grade), the cryopreservation medium and post-thaw viability, and the culture bags and equipment used in closed systems Sourced. The company lists as a risk that some raw materials come from a single supplier and that there is no long-term supply contract. Specific materials and suppliers are not disclosed Not yet confirmed.
6. Track record so far
The timeline is limited to what we could confirm in statutory filings and ClinicalTrials.gov.
| When | What happened | Why it matters |
|---|---|---|
| 2007 | Incorporated in Delaware. Headquartered in San Diego | Founded around the time iPS cells emerged |
| February 2009 | Licence agreement with the Whitehead Institute (reprogramming patents) | Licensed in part of the foundational iPS cell patents |
| 2016 | Licence agreement with MSKCC (amended May 2018) and licence agreement with the University of Minnesota (December) | Secured rights to iPS-derived CAR-T and NK cells |
| September 2018 | Collaboration agreement with Ono Pharmaceutical. Upfront payment of US$10.0 million | Joint research for solid tumours |
| November 2022 | Ono exercised its option on FT825 (ONO-8250), at a cost of US$12.5 million. Fate chose to co-develop and co-commercialise in the U.S. and Europe | FT825 became a jointly developed programme |
| January 2024 | Started the Phase 1 trial of FT825 (NCT06241456) | iPS-derived CAR-T for solid tumours |
| February to March 2024 | CIRM awarded up to US$7.9 million for FT819. Started the Phase 1 trial of FT819 in SLE (NCT06308978) | A serious move into autoimmune disease |
| October 2024 | The FDA cleared the IND for FT522 (CAR-NK). Terminated the Torrey Pines lease early | Narrowing of the business |
| April 2025 | FT819 received RMAT designation from the FDA for SLE | Advantages in development and review |
| July to November 2025 | The FDA cleared the IND for FT836 (July). FT819 trials authorised in the U.K. (August) and the EU (October). First patient with systemic sclerosis dosed in October, and first FT836 patient dosed in November | Trials extended outside the U.S. |
| July 2026 | Started RECLAIM-LN (NCT07570862), a Phase 2 trial of FT819 in lupus nephritis | Moved to a trial designed with registration in mind |
7. Plans ahead
In the 10-K the company says its end goal is to take FT819 first through a Phase 2 in lupus nephritis (a registration-enabling trial), then run a second trial in extra-renal lupus, and move to a Biologics License Application (BLA) over the next several years Not yet confirmed. As a further step with the FDA, the 10-Q states that the FT819-201 trial has been selected for the FDA's CMC Development and Readiness Pilot Program (CDRP), which is aimed at speeding up the manufacturing and quality-control (CMC) side.
None of the following is stated in the primary sources Not yet confirmed.
The specific timing of a BLA submission; the actual date of the first FT839 dosing; the manufacturing scale for each programme (doses per year); the expected price; and the names of the commercial manufacturing contractors. This article does not assert timing such as "approval will come at X".
8. What the company is aiming for in iPS cells and regenerative medicine
This chapter includes points the company does not state directly. We set out inferences that can be read from the primary sources, together with the grounds for each.
| What can be read from the sources | Primary-source basis | Category |
|---|---|---|
| The centre of gravity of the business has shifted from cancer to autoimmune disease | FT819 in SLE heads the strategy in the 10-K. RMAT designation for FT819, the start of Phase 2 and the widening of the basic autoimmune trials have followed | Inference |
| Differentiation rests on reducing or eliminating preconditioning (strong chemotherapy) | FT819 is being tested with a fludarabine-free conditioning regimen and with a no-conditioning arm (Regimen B). FT522 and FT836 are designed to dispense with conditioning through an allo-immune defense receptor (ADR) | Sourced |
| It is aiming for a cell therapy with shorter hospital stays and outpatient use | The 10-K says that for FT836 the first dose is expected to involve a 24-hour hospital stay and the second dose to be given as an outpatient | Sourced |
| For solid tumours it relies on Ono's funds and strength | FT825 for solid tumours is co-developed, and Fate's revenue comes only from Ono. The agreement with Ono has been amended several times | Inference |
| At present it relies on partnership income and financing, not product sales | Revenue is collaboration income alone. The company states the need to raise funds | Sourced |
The first item in the 10-K's strategy is "to establish therapeutic differentiation in SLE with FT819" Sourced. The RMAT designation in April 2025, the start of Phase 2 in July 2026, the widening of the Phase 1 indications and selection for the FDA's CDRP all show that procedures have been piling up on a single programme. From this we read the company as directing its resources first and foremost at FT819. Whether it was right to move to a Phase 2 in lupus nephritis on the basis of small Phase 1 data (10 patients followed for at least a month as of 22 October 2025) cannot be confirmed until the Phase 2 results are in Not yet confirmed.
9. Partnership map for iPS cells and regenerative medicine
10. Technology, products and services on offer
There are no products yet. What the company offers is its development candidates, which are immune cells derived from iPS cells, and the technology for building the iPS cell lines behind them Sourced.
| Programme | Cell type | Target | Stage (as of September 2026) |
|---|---|---|---|
| FT819 | CAR-T (targets CD19) | SLE, lupus nephritis, systemic sclerosis, vasculitis, myositis | Phase 1 (NCT06308978) and Phase 2 RECLAIM-LN (NCT07570862). RMAT designation (SLE) |
| FT522 | CAR-NK (targets CD19, with ADR) | B-cell lymphoma, autoimmune disease | Phase 1 in lymphoma completed. Timing in autoimmune disease under evaluation |
| FT825 / ONO-8250 | CAR-T (targets HER2) | Solid tumours | Phase 1 (NCT06241456). With Ono |
| FT836 | CAR-T (targets MICA/B) | Solid tumours | Phase 1 (NCT07216105). Combination trial without preconditioning |
| FT839 | Dual CAR-T (CD19 and CD38) | Cancer and autoimmune disease | Phase 1/2 (NCT07800871) to start in October 2026 (estimate) |
Clinical data for FT819 (published by the company; all small trials)
In the Phase 1 trial in SLE (NCT06308978), 12 patients had been dosed as of 25 November 2025. Of the 10 patients who could be followed for at least a month as of 22 October 2025, six had lupus nephritis. The company reports that the mean SLEDAI-2K score at dose level 1 (360 million cells) fell from a baseline of 15.2 (5 patients) to 10.7 at 3 months (2 patients) and 6 at 6 months (2 patients). At dose level 2 (900 million cells) it went from 14.3 (3 patients) to 6 at 3 months (2 patients) and 4 at 6 months (1 patient). On kidney function, two lupus nephritis patients followed for more than 3 months are recorded as reaching a complete renal response at 2 months and 6 months respectively. Because these cover only a handful of patients, have no comparison group and have short assessment periods, none of this demonstrates efficacy Sourced.
On safety, the company states that there was no dose-limiting toxicity and no report of CRS, ICANS or GvHD above grade 2. In an earlier trial in B-cell malignancies (43 patients), no ICANS or GvHD was reported and mild CRS occurred in 14%.
FT819 is designed so that the CAR is inserted at the TCR locus and TCR expression is eliminated (to prevent GvHD), while FT522 and FT836 add an allo-immune defense receptor (ADR) Sourced. In terms of materials and process, the core of quality is whether cells carrying many modifications expand stably as a single cell line and keep the same properties after differentiation, and what supports this is the medium composition, the presence or absence of a scaffold, the passaging conditions and the freezing and thawing conditions. The specific conditions are not disclosed, so this is a general discussion Not yet confirmed.
11. The risks this company carries
| Risk | Details | Category |
|---|---|---|
| Funding | Cash and investments were US$153.8 million at the end of June 2026. There are no product sales, so further financing is a given | Sourced |
| Early clinical stage | The FT819 data come from a small Phase 1. Phase 2 only started in July 2026, with results around 2029 (estimate) | Sourced |
| Manufacturing and raw materials | Some key raw materials are research grade, some have a single supplier, and there is no long-term supply contract. Consistent quality of iPS-derived cells is a challenge | Sourced |
| Dependence on a partner | Revenue comes from Ono alone. The agreement has been amended several times, and progress in solid tumours depends on the relationship with Ono | Sourced |
| Licence payments | The company owes MSKCC payments of up to US$75.0 million, linked to its share price after clinical milestones are met | Sourced |
| Competition | The 10-K says that many companies are working on cellular immunotherapy, both autologous and allogeneic | Sourced |
| Shift of focus | The centre of gravity has moved from cancer to autoimmune disease, and the solid-tumour programmes may lose priority | Inference |
12. Glossary
- iPS cell
- A pluripotent stem cell made by reprogramming a body cell, which can multiply almost without limit. Fate uses it as the raw material for immune cells.
- Clonal master iPSC line
- A cell line expanded from a single cell whose genetic modifications have been verified. The same cell product is made from it repeatedly.
- Off-the-shelf
- A model in which many doses are made and stored in advance and used when needed, rather than being made for each patient.
- CAR-T / CAR-NK
- T cells or NK cells given a receptor (CAR) that recognises a marker on cancer or other target cells.
- TRAC locus
- The location of the T-cell receptor gene. Inserting the CAR here makes its expression uniform and also helps suppress GvHD.
- ADR (allo-immune defense receptor)
- A Fate technology that targets the patient's activated immune cells, to stop the infused cells from being eliminated.
- SLE (systemic lupus erythematosus)
- An autoimmune disease in which the immune system attacks the body's own tissues. When it affects the kidneys it is called lupus nephritis.
- SLEDAI-2K
- A scoring index of SLE disease activity. The lower the number, the lower the activity.
- RMAT
- Regenerative Medicine Advanced Therapy. An FDA designation for regenerative medicine products aimed at serious diseases.
- CIRM
- California Institute for Regenerative Medicine. An agency that uses state public funds to support clinical trials and other work in regenerative medicine.
- GvHD
- Graft-versus-host disease. A complication in which donor-derived cells attack the patient's tissues.
- CMC / CDRP
- Chemistry, manufacturing and controls (CMC). The CDRP is an FDA pilot programme to speed up discussions on the manufacturing side.
13. References
- Fate Therapeutics Form 10-K for the year ended December 2025 (filed with the U.S. SEC on 26 February 2026). Business description, pipeline, clinical results, collaborations, finances, employees, manufacturing and licences. https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm
- Fate Therapeutics Form 10-Q for the quarter ended 30 June 2026 (filed with the U.S. SEC on 13 August 2026). Cash balance, the agreement with Ono, the CIRM award and first-half 2026 finances. https://www.sec.gov/Archives/edgar/data/1434316/000119312526347988/fate-20260630.htm
- U.S. National Library of Medicine ClinicalTrials.gov NCT06308978 (FT819, Phase 1 trial in autoimmune disease). https://clinicaltrials.gov/study/NCT06308978
- U.S. National Library of Medicine ClinicalTrials.gov NCT07570862 (FT819, Phase 2 trial RECLAIM-LN in lupus nephritis). https://clinicaltrials.gov/study/NCT07570862
- U.S. National Library of Medicine ClinicalTrials.gov NCT06241456 (FT825 / ONO-8250, Phase 1 trial in solid tumours). https://clinicaltrials.gov/study/NCT06241456
- U.S. National Library of Medicine ClinicalTrials.gov NCT07216105 (FT836, Phase 1 trial in solid tumours). https://clinicaltrials.gov/study/NCT07216105
- U.S. National Library of Medicine ClinicalTrials.gov NCT07800871 (FT839, Phase 1/2 trial in autoimmune disease). https://clinicaltrials.gov/study/NCT07800871
- Fate Therapeutics Official website (used to check the logo and company overview). https://fatetherapeutics.com/
14. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Legal name (Fate Therapeutics, Inc.), head office location, Nasdaq listing, incorporated in 2007 | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm |
| 161 employees and the breakdown by function | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm |
| Facilities (San Diego, about 200,000 square feet, leased to May 2036) and the GMP facility of more than 40,000 square feet | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm |
| Revenue, R&D expense and net loss (FY2024 and FY2025), and capital expenditure | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm |
| Revenue, R&D expense and net loss for January to June 2026, cash and investments of US$153.8 million, accumulated deficit and 12 months of operating funds | Sourced | Reference 2 https://www.sec.gov/Archives/edgar/data/1434316/000119312526347988/fate-20260630.htm |
| Cash and investments of US$205.1 million at the end of December 2025 | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm |
| The three stages of manufacturing; use of its own cGMP facility together with CMOs and hospitals; research-grade raw materials and single suppliers | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm |
| Licences from MSKCC, Whitehead and the University of Minnesota, and the share-price-linked payments of up to US$75.0 million to MSKCC | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm |
| Collaboration agreement with Ono (September 2018, US$10.0 million upfront, US$12.5 million for exercise of the FT825 option) | Sourced | References 1 and 2 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm https://www.sec.gov/Archives/edgar/data/1434316/000119312526347988/fate-20260630.htm |
| CIRM awards (US$7.9 million for FT819, US$4.0 million for FT836) | Sourced | References 1 and 2 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm https://www.sec.gov/Archives/edgar/data/1434316/000119312526347988/fate-20260630.htm |
| Outline, start date, endpoints and planned enrolment of the Phase 1 trial of FT819 in SLE | Sourced | Reference 3 https://clinicaltrials.gov/study/NCT06308978 |
| Phase 2 RECLAIM-LN of FT819 in lupus nephritis (start date, primary endpoint, planned enrolment of 53) | Sourced | Reference 4 https://clinicaltrials.gov/study/NCT07570862 |
| Phase 1 of FT825 (started January 2024, planned enrolment of 351) | Sourced | Reference 5 https://clinicaltrials.gov/study/NCT06241456 |
| Phase 1 of FT836 (started November 2025, planned enrolment of 119) and the design without preconditioning | Sourced | References 1 and 6 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm https://clinicaltrials.gov/study/NCT07216105 |
| Phase 1/2 of FT839 (planned start October 2026, planned enrolment of 446) | Sourced | Reference 7 https://clinicaltrials.gov/study/NCT07800871 |
| FT819 SLE data (as of 22 October and 25 November 2025) and results in 43 patients with B-cell malignancies | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm |
| RMAT designation for FT819 (April 2025), trial authorisations from the MHRA and EMA, and selection of FT819-201 for the CDRP | Sourced | References 1 and 2 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm https://www.sec.gov/Archives/edgar/data/1434316/000119312526347988/fate-20260630.htm |
| IND clearance for FT522 (October 2024) and completion of the Phase 1 in lymphoma | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1434316/000119312526073699/fate-20251231.htm |
| Timing of a BLA submission, the actual first-dosing date of FT839, manufacturing scale, price and commercial manufacturing contractors | Not yet confirmed | Not stated in the primary sources. This article does not estimate them |
| Investments in or acquisitions of start-ups, and public funding other than CIRM | Not yet confirmed | Not mentioned in the 10-K. This article does not assert that they do not exist either |
| The reading that the centre of gravity has shifted from cancer to autoimmune disease | Inference | This article's interpretation of the order of the strategy in the 10-K and the accumulation of procedures around FT819 |
| The reading that for solid tumours it relies on Ono's funds and strength | Inference | This article's interpretation of the structure of the agreement with Ono and the composition of revenue |
| The possibility that a shift of focus lowers the priority of the solid-tumour programmes | Inference | This article's own interpretation |
| Materials challenges around media, freezing and raw materials | Not yet confirmed | A general discussion in this article. The company has not disclosed its control values |
Last updated 1 October 2026 / Troy Technical
Every figure in this article comes from the statutory filings Fate Therapeutics has made with the U.S. Securities and Exchange Commission (SEC) and from ClinicalTrials.gov. 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 particular treatment and is not medical advice.