olivLaw · US equity research
Fate Therapeutics, Inc. FATE
Biological Products, (No Diagnostic Substances) · SIC 2836 · Vertical: Biological Products, (No Diagnostic Substances) (SIC 2836)
Fate Therapeutics is a clinical-stage biopharmaceutical company developing off-the-shelf cell therapies made from induced pluripotent stem cells (iPSCs), aimed at autoimmune diseases and cancer. The company matters now because it has moved its lupus nephritis program into the potentially registrational Phase 2 RECLAIM-LN trial, where the first patient was treated as an outpatient. It has no product revenue, and collaboration revenue with Ono fell from 13.6 million dollars in fiscal 2024 to 6.6 million dollars in fiscal 2025.
At the close of 04 Nov 2026, Fate Therapeutics, Inc. (FATE) stock was 2.09 USD (+2.45% on the day), with market capitalisation 250.4 m USD, beta 1.32, 52-week range 0.96–3.11 USD. Latest reported quarter (Q2 2026): revenue of 2.1 m USD (+9.2% YoY), net income of -30.2 m USD, diluted EPS -0.25 USD.
Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.
Price history
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Technical reading
- RSI (14)
- 47.1
- neutral
- Bollinger (20, 2)
- 1.85 – 2.25
- in the upper half of the band · %B 0.60 · band width 19.6%
- SMA 50 / 200
- 2.27 / 1.96
- mixed trend
- MACD (12, 26, 9)
- -0.05 / -0.07
- MACD above signal
Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).
Performance
| Company | S&P 500 | vs S&P 500 | Vertical median | |
|---|---|---|---|---|
| 1 month | −14.0% | −2.0% | −12.0 pp | — |
| 3 months | −19.6% | −2.2% | −17.4 pp | — |
| 6 months | −8.7% | +4.3% | −13.0 pp | — |
| Year to date | +113.3% | +10.6% | +102.7 pp | — |
| 1 year | +75.6% | +10.5% | +65.2 pp | +9.1% |
| 3 years | −12.6% | +73.7% | −86.2 pp | +16.5% |
| 5 years | −96.6% | +61.7% | −158.3 pp | — |
Price returns, dividends excluded.
Quarterly results
Latest quarter: Q2 2026 · 30 Jun 2026
Quarterly margins
Quarterly statements · USD
| Fiscal year | Q3 '24 | Q4 '24 | Q1 '25 | Q2 '25 | Q3 '25 | Q4 '25 | Q1 '26 | Q2 '26 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 3.1 m | 1.9 m | 1.6 m | 1.9 m | 1.7 m | 1.4 m | 1.3 m | 2.1 m |
| Research & development | 34.7 m | 33.6 m | 29.1 m | 27.4 m | 25.8 m | 25.4 m | 24.7 m | 24.4 m |
| Operating income | -52.4 m | -61.7 m | -41.3 m | -37.0 m | -34.7 m | -34.7 m | -33.0 m | -31.1 m |
| Depreciation & amortisation | 4.6 m ≈ | 4.8 m | 3.3 m | 3.3 m ≈ | 3.2 m ≈ | 3.1 m | 2.9 m | 2.8 m ≈ |
| Net income | -47.7 m | -52.2 m | -37.6 m | -34.1 m | -32.3 m | -32.4 m | -31.2 m | -30.2 m |
| Diluted EPS | -0.40 | -0.44 ≈ | -0.32 | -0.29 | -0.27 | -0.27 ≈ | -0.26 | -0.25 |
| Operating cash flow | -29.4 m ≈ | -27.8 m | -33.8 m | -24.6 m ≈ | -24.4 m ≈ | -23.3 m | -30.8 m | -23.4 m |
| Capex | 495.0 k ≈ | 98.0 k | 1.2 m | 1.4 m ≈ | 2.2 m ≈ | 1.2 m | 239.0 k | 80.0 k ≈ |
≈ derived quarter (cumulative difference / share-days average)
E/P over time
E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.
Fiscal years
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 4.7 m | 10.7 m | 31.4 m | 55.8 m | 96.3 m | 63.5 m | 13.6 m | 6.6 m |
| Revenue YoY | +15.4% | +125.3% | +194.3% | +77.7% | +72.4% | −34.0% | −78.5% | −51.2% |
| Net income | -66.6 m | -98.1 m | -173.4 m | -212.2 m | -281.7 m | -160.9 m | -186.3 m | -136.3 m |
| Net income YoY | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable |
| Diluted EPS | unavailable | unavailable | -2.10 | -2.24 | -2.91 | -1.64 | -1.64 | -1.15 |
| Diluted EPS YoY | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable |
| net % | -1,405.0% | -919.0% | -551.6% | -379.9% | -292.5% | -253.3% | -1,366.5% | -2,051.1% |
| Free cash flow | -41.0 m | -90.6 m | -44.2 m | -213.6 m | -283.8 m | -138.4 m | -123.6 m | -112.0 m |
Reported results vs expectations
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Balance sheet & financial health
Fiscal year 2025 · 31 Dec 2025
- Cash
- 46.6 m USD
- Financial debt
- unavailable USD
- Net debt
- unavailable USD
- Equity
- 207.2 m USD
- Total assets
- 318.9 m USD
- Debt / equity
- unavailable
- Current ratio
- 5.79x
- ROE
- -51.8%
- ROA
- -35.9%
- FCF margin
- -1,685.8%
Financial statements (source on every figure)
Revenue and net income (USD)
Margins
Income statement · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Revenue | 31.4 m | 55.8 m | 96.3 m | 63.5 m | 13.6 m | 6.6 m | SEC (XBRL)· 26 Feb 2026verified |
| Research & development | 125.6 m | 215.5 m | 320.5 m | 172.6 m | 135.0 m | 107.8 m | SEC (XBRL)· 26 Feb 2026verified |
| Operating income | -128.1 m | -217.0 m | -308.4 m | -190.5 m | -210.3 m | -147.7 m | SEC (XBRL)· 26 Feb 2026verified |
| Depreciation & amortisation | 3.1 m | 5.9 m | 13.8 m | 18.3 m | 19.0 m | 12.9 m | SEC (XBRL)· 26 Feb 2026verified |
| EBITDA | -125.0 m ≈ | -211.1 m ≈ | -294.6 m ≈ | -172.2 m ≈ | -191.3 m ≈ | -134.8 m ≈ | SEC (XBRL)· 26 Feb 2026derived |
| Interest expense | 0 | 0 | — | — | — | — | SEC (XBRL)· 28 Feb 2022verified |
| Income tax | 0 | 0 | 0 | 0 | 0 | 2.0 k | SEC (XBRL)· 26 Feb 2026verified |
| Net income | -173.4 m | -212.2 m | -281.7 m | -160.9 m | -186.3 m | -136.3 m | SEC (XBRL)· 26 Feb 2026verified |
| Diluted EPS | -2.10 | -2.24 | -2.91 | -1.64 | -1.64 | -1.15 | SEC (XBRL)· 26 Feb 2026verified |
| Weighted average diluted shares | 82.4 m | 94.7 m | 96.8 m | 98.4 m | 113.7 m | 118.8 m | SEC (XBRL)· 26 Feb 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Operating income + Depreciation & amortisation.
Balance sheet · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Cash | 167.3 m | 133.6 m | 61.3 m | 41.9 m | 36.1 m | 46.6 m | SEC (XBRL)· 26 Feb 2026verified |
| Receivables | 5.5 m | 8.7 m | 38.5 m | 1.8 m | 3.5 m | 916.0 k | SEC (XBRL)· 26 Feb 2026verified |
| Current assets | 494.3 m | 633.4 m | 502.1 m | 331.5 m | 291.9 m | 208.7 m | SEC (XBRL)· 26 Feb 2026verified |
| Property, plant & equipment, net | 32.3 m | 91.5 m | 110.0 m | 96.8 m | 64.4 m | 56.9 m | SEC (XBRL)· 26 Feb 2026verified |
| Total assets | 622.5 m | 921.5 m | 705.6 m | 506.2 m | 440.7 m | 318.9 m | SEC (XBRL)· 26 Feb 2026verified |
| Accounts payable | 6.3 m | 8.6 m | 8.3 m | 4.7 m | 9.4 m | 2.7 m | SEC (XBRL)· 26 Feb 2026verified |
| Current liabilities | 85.6 m | 81.3 m | 114.1 m | 39.1 m | 38.5 m | 36.1 m | SEC (XBRL)· 26 Feb 2026verified |
| Equity | 384.4 m † | 678.8 m † | 483.9 m † | 368.4 m † | 318.7 m † | 207.2 m † | SEC (XBRL)· 26 Feb 2026verified |
† equity attributable to the parent's shareholders: in these years the issuer no longer reports the total including non-controlling interests.
Cash flow · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Operating cash flow | -39.2 m | -162.9 m | -248.2 m | -132.3 m | -122.9 m | -106.1 m | SEC (XBRL)· 26 Feb 2026verified |
| Capex | 4.9 m | 50.7 m | 35.6 m | 6.2 m | 730.0 k | 6.0 m | SEC (XBRL)· 26 Feb 2026verified |
| Free cash flow | -44.2 m ≈ | -213.6 m ≈ | -283.8 m ≈ | -138.4 m ≈ | -123.6 m ≈ | -112.0 m ≈ | SEC (XBRL)· 26 Feb 2026derived |
| Investing cash flow | -161.1 m | -324.0 m | 166.8 m | 112.7 m | 12.2 m | 111.2 m | SEC (XBRL)· 26 Feb 2026verified |
| Financing cash flow | 282.8 m | 453.1 m | 9.2 m | 85.0 k | 99.9 m | 5.5 m | SEC (XBRL)· 26 Feb 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Operating cash flow − Capex.
Computed indicators
Growth
Profitability
Returns
Balance sheet
Liquidity
Cash
Efficiency
Market and valuation
1 indicators that do not apply to the sector.
Valuation
olivLaw classification
- indicators available: 4 of at least 6
- score weight coverage: 27.1% of at least 60%
- valuation methods computed: 0 of at least 1
A scoring methodology on indicators and valuation, not investment advice.
Closing price
04 Nov 2026Source: olivLaw, closing series
Market cap: 250.4 m USD
Key indicators
Coverage and freshness
Score by group
27% · Insufficient data
Estimated value range
unavailable — no valuation method could be computed
Valuation assumptions are editorial choices, not measured; beta is not measured.
Valuation methods
- DCF (discounted cash flow)unavailable · the reported interest expense is far older than the latest period (the filer changed its XBRL tag): a stale figure is not used
- Peers: EV/EBITDAunavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
- Peers: P/Eunavailable · the base of the ratio is not positive
- Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption
no valuation method could be computed
Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.
Assumptions (illustrative, editorial)
- Risk-free rate
- 4.3%
- Equity risk premium
- 5.0%
- Beta (default)
- 1.00
- Cost of equity
- 9.3%
- Terminal growth
- 2.5%
Factor scorecard
Insufficient data
Minimum-evidence gate: indicators available: 4 of at least 6; score weight coverage: 27.1% of at least 60%; valuation methods computed: 0 of at least 1
| Factor | Value | Score | Weight used |
|---|---|---|---|
| ROIC · Quality | unavailable | unavailable | — |
| Net margin · Quality | -1,941.1% | 17 (vs peers) | 23% |
| FCF conversion · Quality | unavailable | unavailable | — |
| Revenue CAGR 3Y · Growth | -59.0% | 0 (on a fixed band) | 31% |
| EPS CAGR 3Y · Growth | unavailable | unavailable | — |
| Net debt / EBITDA · Balance sheet | unavailable | unavailable | — |
| Interest coverage · Balance sheet | unavailable | unavailable | — |
| Current ratio · Balance sheet | 4.8x | 100 (on a fixed band) | 15% |
| P/E (TTM) · Valuation | unavailable | unavailable | — |
| EV/EBITDA · Valuation | unavailable | unavailable | — |
| FCF yield · Valuation | -42.2% | 0 (on a fixed band) | 31% |
| Shareholder yield (distributions) · Returns | unavailable | unavailable | — |
| Payout ratio (FCF) · Returns | unavailable | unavailable | — |
Factors without a value were dropped; the remaining weights were renormalised.
Score groups
- Balance sheet· partial100/100 · 1/3 factors with a value
- Growth· partial0/100 · 1/2 factors with a value
- Quality· partial17/100 · 1/3 factors with a value
- Returns· partialunavailable · 0/2 factors with a value
- Valuation· partial0/100 · 1/3 factors with a value
A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.
Memo
FATE THERAPEUTICS INC (FATE). Latest full fiscal year: 2025; data up to 2026-06-30.
Figures computed from the financial statements: revenue 6.6 m USD in 2025; YoY growth -51.2%; net margin -1,941.1%; ROE -60.7%.
Valuation cannot be computed from the available data.
Insufficient data for a verdict (indicators available: 4 of at least 6; score weight coverage: 27.1% of at least 60%; valuation methods computed: 0 of at least 1).
Text generated deterministically from the figures shown; no language model. Not investment advice.
What supports the thesis
- Current ratio: 4.8x
What contradicts it
- Net margin: -1,941.1%
- Revenue CAGR 3Y: -59.0%
- FCF yield: -42.2%
Not assessed (insufficient data or a ratio without meaning): ROIC, FCF conversion, EPS CAGR 3Y, Net debt / EBITDA, Interest coverage, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).
Versus the vertical median
Biological Products, (No Diagnostic Substances) (SIC 2836) · same industry (4-digit SIC) · compared with 39 companies
Multiples and returns vs the median
Price rebased to 100 (monthly, 5 years)
Companies in the vertical
| Market cap | P/E | ROE | Net margin | Revenue YoY | 1A / 3A | |
|---|---|---|---|---|---|---|
| AMGNAmgen Inc. | 249.4 bn | 28.7 | 91.5% | 23.0% | +10.0% | +34% / +71% |
| GILDGilead Sciences, Inc. | 207.7 bn | — | -22.3% | -12.5% | +2.4% | +33% / +119% |
| MRNAModerna, Inc. | 91.2 bn | — | -39.0% | -141.4% | −39.9% | +779% / +194% |
| ARGXArgenx Se | 57.6 bn | 47.6 | 20.2% | — | +254.4% | +2% / +107% |
| RVMDRevolution Medicines, Inc. | 41.6 bn | — | -79.1% | — | unavailable | +150% / +733% |
| BIIBBiogen Inc. | 36.8 bn | 106.4 | 1.9% | 3.4% | +2.2% | +37% / +6% |
| EXELExelixis, Inc. | 17.6 bn | 21.6 | 44.3% | 35.5% | +7.0% | +64% / +232% |
| NBIXNeurocrine Biosciences, Inc. | 16.8 bn | 24.6 | 20.4% | 19.0% | +21.4% | +9% / +42% |
| HALOHalozyme Therapeutics, Inc. | 14.8 bn | 38.4 | 173.7% | 24.9% | +37.6% | +83% / +238% |
| KYMRKymera Therapeutics, Inc. | 11.6 bn | — | -27.3% | -341.8% | −16.7% | +101% / +556% |
| RGENRepligen Corp | 11.4 bn | — | -0.6% | -1.5% | +16.4% | +4% / +13% |
| QGENQiagen N.V. | 11.0 bn | 26.2 | 11.6% | 20.3% | +5.7% | +6% / +20% |
| KRYSKrystal Biotech, Inc. | 9.2 bn | 42.2 | 17.5% | 47.9% | +33.9% | +43% / +198% |
| SCNIScinai Immunotherapeutics Ltd. | 6.2 bn | — | -91.9% | -633.6% | +99.2% | −96% / −99% |
| DNLIDenali Therapeutics Inc. | 3.4 bn | — | -33.9% | -1,470.5% | unavailable | +8% / +13% |
| BCRXBiocryst Pharmaceuticals, Inc. | 2.1 bn | — | — | -40.9% | +94.1% | +15% / +40% |
| VIRVir Biotechnology, Inc. | 2.0 bn | — | -26.1% | -83.0% | −7.6% | +83% / +24% |
| EVAXEvaxion A | 1.2 bn | — | -100.2% | -102.4% | +125.1% | −50% / −93% |
| DNAGinkgo Bioworks Holdings, Inc. | 742.2 m | — | -56.3% | -260.0% | −25.1% | +26% / −77% |
| ATYRaTYR PHARMA INC | 606.2 m | — | -98.4% | -32,003.7% | −19.1% | +691% / +375% |
| ALLOAllogene Therapeutics, Inc. | 411.1 m | — | -42.4% | -3,566.7% | −100.0% | −18% / −49% |
| CCCCC4 Therapeutics, Inc. | 383.8 m | — | -48.1% | -289.4% | +1.0% | +15% / +91% |
| XFORX4 Pharmaceuticals, Inc | 321.2 m | — | -113.1% | -1,040.1% | +150.0% | −11% / −86% |
| IPSCCentury Therapeutics, Inc. | 302.4 m | — | -49.7% | -100.6% | +1,556.8% | +206% / +22% |
| LCTXLineage Cell Therapeutics, Inc. | 260.5 m | — | -59.0% | -246.6% | +53.2% | −41% / +5% |
1- and 3-year price returns: for FATE from daily closes (the same as the performance table), for the other companies from month-end closes.
olivLaw engine forecast
The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.
The engine has no published run for this company yet.
Valuation scenarios (editable assumptions)
Illustrative scenarios
Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.
Estimated price (USD)
| Estimated price | Bear | Base | Bull |
|---|---|---|---|
| 1 years | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable |
| 3 years | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable |
| 5 years | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable |
AI analysis
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
In brief
Fate Therapeutics is a clinical-stage biopharmaceutical company developing off-the-shelf cell therapies made from induced pluripotent stem cells (iPSCs), aimed at autoimmune diseases and cancer. The company matters now because it has moved its lupus nephritis program into the potentially registrational Phase 2 RECLAIM-LN trial, where the first patient was treated as an outpatient 3. It has no product revenue, and collaboration revenue with Ono fell from 13.6 million dollars in fiscal 2024 to 6.6 million dollars in fiscal 2025 1.
SWOT
Strengths
- The iPSC platform with a clonal master line produces uniform, reproducible batches, and the patent portfolio is extensive.
- The first RECLAIM-LN patient was treated as an outpatient with same-day discharge, supporting the case for broader access.
- RMAT designation and FDA discussions on quality control give the programs a supportive regulatory framework.
Weaknesses
- The company has never been profitable and relies on outside funding to continue operations.
- Revenue comes from collaborations and grants rather than products, and Ono revenue declined in fiscal 2025.
- Experience in autoimmune disease is limited and no product is yet approved.
Opportunities
- Extending FT819 into more autoimmune indications, including systemic sclerosis, could open new markets.
- The FT839 IND could accelerate programs across several autoimmune and hematologic indications.
- New partnerships for the iPSC platform could bring outside funding and external validation.
Threats
- Clinical results could be weaker than the Phase 1 data, delaying or halting programs.
- Other cell therapies or biologics for lupus could reach the market first.
- If funding cannot be obtained on favorable terms, development could be scaled back.
Risks
- Completing clinical trialshigh
Clinical studies can be delayed, modified or stopped for reasons related to dosing, safety or enrollment, and no therapy is yet approved.
- Funding and cash runwayhigh
The company could need additional capital if the trial timeline lengthens, and the runway into 2028 depends on the pace of spending.
- Manufacturing and scale-upmedium
Producing iPSC cells at scale and keeping batch quality consistent are complex and could affect the timeline.
- Dependence on Onomedium
Collaboration revenue depends on the joint development plan, and an end or reduction of funding could affect revenue.
- Safety of cell therapiesmedium
Serious adverse events or safety signals in trials could lead to temporary or permanent suspension of development.
Investment thesis
What would need to be true (bull case)
- If RECLAIM-LN confirms clinical benefit, the company could become the first to bring an iPSC-derived CAR T therapy to the autoimmune market.
- Outpatient treatment and on-demand availability could substantially expand the number of eligible patients.
- Extending FT839 and FT819 into more indications could diversify portfolio risk.
What would break the thesis
- With no product revenue and no history of profitability, programs could be reduced if financing becomes more expensive.
- Phase 1 results are preliminary, and a setback in Phase 2 could compromise the entire lupus program.
- Ono collaboration revenue has declined, which could signal dependence on the partner's terms.
What to watch
- Enrollment pace in RECLAIM-LN and treatment of additional patients2026
- Enrollment update for the FT839 Phase 1/2 trial promised by the company2026
- Cash position and any new financing or collaboration dealsQ1 2027
- Timing of RECLAIM-LN enrollment completion and RMAT-related milestones2028
Products, market & competition
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
The business
Fate Therapeutics, headquartered in San Diego, California, builds its approach around cellular programming, creating clonal master iPSC lines from which multiplexed-engineered T cells and NK cells with CAR targeting are produced in a standardized, off-the-shelf format 1. The company reports over 600 issued patents supporting its platform and a GMP facility of more than 40,000 square feet 1. It has never been profitable and funds operations through equity, debt and collaboration revenue 1.
Key programs include FT819, a CD19-targeted CAR T therapy for systemic lupus erythematosus and lupus nephritis, FT522, a CD19-targeted CAR NK therapy for autoimmune disease, and FT825, FT836 and FT839, next-generation programs for solid tumors and autoimmune disease 13. The Ono collaboration covers research on solid tumor candidates, and amendments have increased the estimated total research fees payable to the company 1. The company says its resources could fund operations into 2028, with enrollment in RECLAIM-LN targeted for the first half of 2028 3.
Revenue depends almost entirely on collaborations and grants rather than product sales, so its trajectory tracks the timing of Ono payments and any new partnerships 1. Research and development costs are the main expense, and the company expects operating losses to continue for at least the foreseeable future 1.
Segments
Lupus and autoimmunity (FT819, FT839)
This is the current center of strategy. FT819 was the first iPSC-derived CAR T candidate in clinical investigation, and in the second quarter of 2026 the first patient was dosed in RECLAIM-LN, a potentially registrational study with 53 patients planned 3. FT839 received FDA IND clearance in July 2026 and moves into a Phase 1/2 basket trial across several autoimmune diseases 3.
Solid tumors (FT825, FT836, Ono collaboration)
Oncology programs target solid tumors, where no CAR T therapy is yet FDA-approved. FT825 is in Phase 1 with Ono, and FT836, aimed at MICA/B, shows preliminary anti-tumor activity in colorectal cancer without conditioning chemotherapy 13. Ono collaboration revenue declined in fiscal 2025 compared with fiscal 2024 1.
Market context
The CAR T market faces logistical limits and high costs for autologous therapies, and the company argues off-the-shelf products could widen patient access 1. Refractory moderate-to-severe lupus nephritis affects approximately 100,000 U.S. patients, of whom only a small share achieve complete renal response with available therapies, a clear unmet need 3.
The filing describes the autoimmune market as broad and growing, with over 80 known autoimmune diseases affecting up to 8% of the U.S. population 1. If off-the-shelf cell therapies were approved, they could change long-term treatment with corticosteroids and biologics 1.
Trends
- CAR T expansion into autoimmune diseasetailwind
Academic and company studies suggest that deep B-cell depletion could induce remission in lupus and other autoimmune diseases, opening a market far larger than oncology.
- Supportive regulatory pathways for advanced therapiestailwind
RMAT designation and inclusion in the FDA CDRP program could speed development and CMC discussions if those discussions continue on the current track 3.
- Cost and logistics of cell manufacturingmixed
Manufacturing autologous cells remains expensive and hard to standardize, which makes the off-the-shelf approach relevant, but scale-up and quality control remain technical challenges.
- Dependence on external fundingheadwind
With no product revenue, financing through equity or collaborations could become more costly if clinical results are delayed.
Competitive position
The filing mentions approved autologous CAR T therapies for lymphomas and myeloma, along with other allogeneic approaches, all competing for patients, investigators and clinical sites 1. The company acknowledges that no cell therapy is yet approved in the U.S. for autoimmune diseases, which could give it first-mover advantage but also invites competition from other sponsors 1.
Ono Pharmaceutical is both a partner and a potential competitor in solid tumors, and approvals of other drugs in the same indications could change the standard of care and study requirements 1.
- Ono Pharmaceutical
Collaboration partner for CAR T and NK candidates in solid tumors, with research payments described in the filing.
- Makers of approved autologous CAR T therapies
FDA-approved B-cell lymphoma and multiple myeloma therapies competing for patients and specialized centers.
- Developers of allogeneic CAR T therapies
Companies using donor-derived approaches that compete on uniformity and scalability.
- Existing lupus biologic treatments
Standard corticosteroid, immunosuppressant and biologic regimens are the current alternatives for patients.
Links, dependencies and risks
Who the company is tied to, from its own SEC filings (customers, suppliers, production, partners, competitors, countries, regulation), from the 5 %+ holders' statements (13D/13G) and from what other companies say about it. Click a node for its evidence; on a listed company the graph moves to it.
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News & filings
In the press
No news in our archive over the last 180 days.
SEC filings
- Current report28 Sept 2026Other events · Financial statements and exhibits
- Quarterly report13 Aug 2026
- Current report13 Aug 2026Results of operations · Financial statements and exhibits
- Current report15 Jun 2026Departure or appointment of officers · Shareholder vote · Financial statements and exhibits
- Current report04 Jun 2026Other events · Financial statements and exhibits
- Quarterly report13 May 2026
- Current report13 May 2026Results of operations · Financial statements and exhibits
- Proxy statement24 Apr 2026
- Annual report26 Feb 2026
- Current report26 Feb 2026Results of operations · Financial statements and exhibits
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Fate Therapeutics, Inc. · 26 Feb 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Fate Therapeutics, Inc. · 13 Aug 2026
- [3] Form 8-K, results release (exhibit 99.1) · SEC / Fate Therapeutics, Inc. · 13 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.