GLOBAL RESEARCH ARCHIVE
FT819 Phase I Regimen B Positive Results; Phase II Study Start in 2H:26
Research evidence excerpt
FT819 Phase I Regimen B Positive Results; Phase II Study Start in 2H:26
ith no DLTs, ICANs or GvHD. Fate plans to update with more Shares Out (mil) 134.2
initial response and safety data at EULAR (N=~15-18) in June and durability data at ACR 10Q as of May 7th + PFWs + Series A
in November. Fate plans to initiate the Phase II RECLAIM-LN study of 900M FT819 cells Convert
following bendamustine conditioning in 53 refractory moderate-to-severe lupus nephritis Market Cap. (mil) US$286.6
patients in 2H:26 with complete renal response at 6 months as the primary endpoint. Total Assets ($mil) 285
Avg Daily Vol (000) 1,961 Fate also plans to report data from systemic sclerosis patients this summer. In addition
Book Value/Share US$1.34
to RMAT designation, the FDA has selected FT-819 for the CMC and Development and Price/Book 159%
Readiness Pilot (CDRP) program. Net Cash Per Share US$1.30
Debt to Total Capital 0.0%
• Positive FT819 Conditioning-Free Regimen B Data. At ASGCT (#1370), Fate Div Yield 0.00%
reported Phase I Regimen B data from 3 patients who received a single dose of 360M Fiscal Year End Dec
FT819 cells on top of background therapy without conditioning chemotherapy; 67%
Price Performance - 1 Year
(2/3) of patients achieved LLDAS, which could potentially be used as an approvable
endpoint in extrarenal SLE patients. All three patients (100%) achieved SRI-4 at 1 month, USD
a composite endpoint requiring a ≥4-point reduction in SLEDAI-2K score alongside 2.5
no worsening in organ-specific or global disease activity. An average of 79% B cell 2
compartment depletion was observed in the peripheral blood and lymphoid tissues for
up to 12 months. Importantly, B-cell re-population was characterized by a predominance 1.5
of naive B cells.
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