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Mar 31, 2022
Fate Therapeutics Q1 2022 Earnings Report
Reported financial results and highlighted operational progress for the first quarter of 2022.
Key Takeaways
Fate Therapeutics reported $18.4 million in revenue for Q1 2022, derived from collaborations with Janssen and Ono Pharmaceutical. The company's cash, cash equivalents, and investments totaled $641.7 million as of March 31, 2022.
FT596+R enrollment is ongoing in single- and multi-dose, multi-cycle cohorts for R/R BCL.
A clinical protocol for FT596+R-CHOP for first-line investigation will be submitted to the FDA in 2Q22.
FT819 enrollment is ongoing in single- and multi-dose cohorts for R/R BCL in a landmark study of off-the-shelf, iPSC-derived CAR T-cell therapy.
A multi-disciplinary RMAT meeting with the FDA is planned for mid-2022 for FT516.
Fate Therapeutics
Fate Therapeutics
Fate Therapeutics Revenue by Segment
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CapyFin.com Forward Guidance
Fate Therapeutics is focused on advancing its iPSC-derived cell therapy programs and expects to provide clinical updates in the second half of 2022.
Positive Outlook
- Preparing for submission to the FDA of a multi-disciplinary RMAT briefing package to inform pivotal study readiness in relapsed / refractory aggressive lymphoma.
- Preparing the FT596 plus R-CHOP clinical protocol to initiate investigation in first-line patients.
- Poised to treat the first solid tumor patient with FT536, a multi-antigen targeted CAR MICA/B NK cell product candidate.
- Initiated IND-enabling activities for two CAR NK cell product candidates under the collaboration with Janssen.
- Second GMP Manufacturing Facility Poised for Launch in 2H22.
Challenges Ahead
- The Company’s product candidates may not demonstrate the requisite safety or efficacy to achieve regulatory approval or to warrant further development.
- Results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, may not be observed in ongoing or future studies involving these product candidates.
- There is a risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical studies.
- The Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons.
- The Company’s expenditures may exceed current expectations for a variety of reasons.