Monitor upcoming clinical data readouts at EULAR (June 2026) and ASCO (June 2026) for FT819 and FT836, respectively. The CDRP selection and RMAT designation provide regulatory tailwinds, but the stock remains binary on Phase 2 data. The extended cash runway removes near-term dilution risk.
Price Chart
Executive Summary
Fate Therapeutics reported Q1 2026 results with a net loss of $0.26 per share, slightly narrower than the $0.32 loss in Q1 2025, and revenue of $1.3M from its Ono collaboration. The key catalysts are regulatory and clinical: FT819 was selected for the FDA's CDRP program, the Phase 2 RECLAIM-LN trial is on track for H2 2026, and the operating runway was extended into 2028 with $174.8M in cash. However, the company remains a pre-revenue clinical-stage biotech with no approved products and a net loss of $31.2M for the quarter.
Key Financial Metrics
Key Facts
- Cash, cash equivalents, and investments of $174.8M as of March 31, 2026, providing runway into 2028
- Net loss of $31.2M for Q1 2026, improved from $37.6M loss in Q1 2025
- Revenue of $1.3M from Ono Pharmaceutical collaboration, down from $1.6M in Q1 2025
- FT819 selected for FDA's CDRP program, potentially accelerating regulatory pathway
- Phase 2 RECLAIM-LN trial for lupus nephritis on track to initiate in H2 2026
- FT819 Phase 1 enrollment at 27 patients across 18 global sites as of May 5, 2026
- FT836 Phase 1 solid tumor study has treated 9 patients; FT839 IND submission planned for H2 2026
- Operating expenses reduced 20% YoY to $34.3M in Q1 2026
- Total operating expenses of $34.3M included $3.9M non-cash stock-based compensation
Financial Impact
No material financial impact from this filing; company is pre-revenue with $174.8M cash runway into 2028
Risk Factors
- Clinical trial failure or delay in RECLAIM-LN or other programs
- Regulatory setbacks despite CDRP and RMAT designations
- Cash burn rate of ~$10.4M/month may require future capital raises
- Competition from approved CAR-T therapies and other autoimmune treatments
- Dependence on Ono collaboration for revenue
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-220691 |
| Document: fate-20260513.htm | 0001193125-26-220691 |
| Document: 0001193125-26-220691-index-headers.html | 0001193125-26-220691 |
| Document: 0001193125-26-220691-index.html | 0001193125-26-220691 |
| Document: 0001193125-26-220691.txt | 0001193125-26-220691 |
| 8-K Data (Synthetic) | 0001193125-26-220691 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 14, 2026 7w ago | Press Release | $2.57 $2.34 | ▼ −8.95% | ▼ −6.96% | $2.32 (−9.73%) |
Aug 13, 2026 7w ago | 8-K | $2.52 $2.31 | ▼ −8.33% | ▼ −6.59% | $2.32 (−7.94%) |
Aug 5, 2026 8w ago | Insider Cluster | $2.49 $2.42 | ▲ +2.81% | ▲ +3.41% | $2.32 (+6.83%) |
Jun 11, 2026 16w ago | Institutional Cluster | $1.97 $3.11 | ▼ −57.87% | ▼ −55.98% | $2.32 (−17.77%) |
Jun 4, 2026 17w ago | 8-K | $1.98 $2.99 | ▲ +51.01% | ▲ +49.15% | $2.32 (+17.17%) |
Jun 1, 2026 17w ago | Press Release | $2.74 $2.70 | ▼ −1.46% | ▼ −0.16% | $2.32 (−15.33%) |
May 13, 2026 20w ago | 8-K | $2.14 $1.97 | ▼ −7.94% | ▼ −7.33% | $2.32 (+8.41%) |
May 11, 2026 20w ago | Press Release | $2.18 $1.90 | ▼ −12.84% | ▼ −12.54% | $2.32 (+6.42%) |
Apr 24, 2026 23w ago | DEFA14A | $1.31 $2.15 | ▲ +64.12% | ▲ +59.17% | $2.32 (+77.10%) |
US Market Status
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