The $15M CIRM grant extends cash runway for a potentially registrational Phase 2 trial in a large unmet-need indication (~150,000 US patients). Monitor for enrollment updates and any preliminary efficacy signals from the RECLAIM-LN study, as the binary Phase 2 data outcome is the primary catalyst.
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Executive Summary
Fate Therapeutics received a $15 million CLIN2 grant from the California Institute for Regenerative Medicine (CIRM) to support its Phase 2 RECLAIM-LN potentially registrational trial of FT819 off-the-shelf CAR T-cell therapy in lupus nephritis. The non-dilutive funding provides cash runway support for a key clinical catalyst but does not change the binary risk of the Phase 2 data readout.
Key Facts
- CIRM awarded Fate Therapeutics a $15.0 million CLIN2 grant on September 25, 2026.
- Grant supports the Phase 2 RECLAIM-LN trial (FT819-201; NCT07570862) of FT819 off-the-shelf CAR T-cell therapy in refractory moderate-to-severe SLE with lupus nephritis.
- The trial is potentially registrational and expected to enroll approximately 53 patients.
- FT819 has FDA RMAT designation and was selected for the FDA's CDRP program.
- The grant is non-dilutive capital, providing funding without equity issuance.
Financial Impact
$15.0 million non-dilutive grant from CIRM to fund clinical trial costs
Risk Factors
- Phase 2 trial may fail to meet primary endpoint (complete renal response at Week 26).
- FT819 is still in clinical development with no approved product; regulatory and manufacturing risks remain.
- The company is a clinical-stage biotech with no revenue; the grant does not change fundamental risk profile.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-403429 |
| Document: fate-ex99_1.htm | 0001193125-26-403429 |
| Document: 0001193125-26-403429-index-headers.html | 0001193125-26-403429 |
| Document: 0001193125-26-403429-index.html | 0001193125-26-403429 |
| Document: 0001193125-26-403429.txt | 0001193125-26-403429 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 1, 2026 26d ago | Press Release | $2.30 $2.13 | ▼ −7.39% | ▼ −8.69% | $2.06 (−10.43%) |
Sep 28, 2026 28d ago | 8-K | $2.38 $2.43 | ▲ +2.10% | ▲ +0.90% | $2.06 (−13.45%) |
Aug 14, 2026 10w ago | Press Release | $2.57 $2.33 | ▼ −9.34% | ▼ −7.97% | $2.06 (−19.84%) |
Aug 13, 2026 10w ago | 8-K | $2.52 $2.44 | ▼ −3.17% | ▼ −1.21% | $2.06 (−18.25%) |
Aug 5, 2026 11w ago | Insider Cluster | $2.49 $2.52 | ▼ −1.20% | ▲ +0.01% | $2.06 (+17.27%) |
Jun 11, 2026 19w ago | Institutional Cluster | $1.97 $1.96 | ▲ +0.51% | ▲ +0.94% | $2.06 (−4.57%) |
Jun 4, 2026 20w ago | 8-K | $1.98 $2.06 | ▲ +4.04% | ▲ +3.47% | $2.06 (+4.04%) |
Jun 1, 2026 21w ago | Press Release | $2.74 $1.98 | ▼ −27.74% | ▼ −24.99% | $2.06 (−24.82%) |
May 13, 2026 23w ago | 8-K | $2.14 $1.89 | ▼ −11.68% | ▼ −10.52% | $2.06 (−3.74%) |
May 11, 2026 24w ago | Press Release | $2.18 $1.73 | ▼ −20.64% | ▼ −20.56% | $2.06 (−5.50%) |
US Market Status
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