FATE

• Presented translational data for FT819 Phase I study in relapsed refractory B-cell malignancies, showing potential for B cell-mediated autoimmune diseases, including the first lupus patient treated in a Phase I autoimmunity study.
• Showcased promising data for FT522 off-the-shelf CD19-targeted CAR NK cell program, including preclinical data with SLE disease cells and initial translational data from Phase I study.
• Announced the first patient treated in Phase I study of FT825 in collaboration with Ono Pharmaceutical, a multiplexed engineered iPSC-derived CAR-T cell program.
• Highlighted the financial position with a strong cash balance providing operating runway into late 2026, following a $80 million underwritten offering and $20 million private placement in March.

• Expect to report 5 key clinical milestones in 2024, including initial Phase I data for FT819 in moderate to severe SLE, amendment of IND for FT819 to include single-agent cytoxan, readout of first 5 no conditioning patients with FT522, submit IND for FT522 for autoimmunity, and initial clinical proof of concept for FT825 in advanced solid tumors.
• Anticipate GAAP operating expenses for the full year between $215 million and $230 million, ending the year with more than $270 million in cash and cash equivalents and investments.

The company reported revenue of $1.9 million in the first quarter, consistent with prior quarters, from research funding related to the development of a second product candidate against an undisclosed target in solid tumors under the collaboration with Ono Pharmaceutical. Research and development expenses for the first quarter were $32.1 million, general and administrative expenses increased to $20.9 million. Cash, cash equivalents, and investments at the end of the first quarter were approximately $391 million. Total operating expenses for the first quarter were $53 million, including $11 million in noncash share-based compensation expense. For the full year, GAAP operating expenses are expected to be between $215 million and $230 million, ending the year with more than $270 million in cash and cash equivalents and investments.

• Risks associated with forward-looking statements, including uncertainties in clinical trial outcomes, regulatory approvals, and market acceptance of cell therapies.
• Potential differences between actual results and forward-looking statements due to various risks and uncertainties outlined in the Form 10-Q and earnings press release.

Q: Michael Yee from Jefferies asked about the autoimmune study enrolling, the plan to use single-agent cytoxan, and the results for 522 in the second cohort without lympho depletion.

A: Scott Wolchko discussed the autoimmune study's conditioning regimens, including cy/flu, bendamustine, and considering single-agent cytoxan, and Bob Valamehr talked about preclinical data for 522 showing potential in allogeneic systems.

Q: Ashiq Mubarack from Citi asked about tissue biopsies in FT819 and expectations for efficacy in FT522 for autoimmunity.

A: Bob Valamehr mentioned tissue biopsies in FT819 studies and Scott Wolchko discussed the importance of safety and efficacy in autoimmunity.

Q: Jeffrey LaRosa from Leerink Partners asked about competitive landscape with CD19 engagers and BCMA programs.

A: Scott Wolchko discussed the disruptive potential of CD19 engagers and the role of ADR technology in future programs.

Q: Rohit Bhasin from Morgan Stanley asked about the first lupus patient treated with FT819 and other autoimmune diseases.

A: Scott Wolchko provided details on the first lupus patient and discussed expanding into other autoimmune indications.

Q: Li Wang Watsek from Cantor Fitzgerald asked about other indications for 522 and patient enrollment in FT819 studies.

A: Scott Wolchko talked about ongoing work in expanding indications and patient enrollment plans.

Q: Gregory Williams from TD Cowen asked about the timeline for clinical data in lupus for FT819.

A: Scott Wolchko mentioned guiding to an update on first 3-5 patients with FT819 in SLE by the end of 2024.

Q: Alexandre Bouilloux from Barclays asked about recapping ASGCT data for FT819 vs FT522 and implications for autoimmune indications.

A: Bob Valamehr discussed differences in behavior between FT819 and FT522, including ADR technology and biodistribution.

Q: Yanan Zhu from Wells Fargo Securities asked about bispecific literature, repeat administration, and additional doses for FT819.

A: Scott Wolchko discussed the potential of bispecific engagers and multi-dosing potential of off-the-shelf cell therapies.

Q: William Maughan from Canaccord Genuity asked about translating FT819 data from oncology to autoimmunity and impact of program wind-downs on R&D spend.

A: Scott Wolchko and Edward Dulac discussed translational aspects and cash burn expectations.

Q: Ethan Markowski from Needham & Company asked about B-cell depletion comparison and impact of program wind-downs on R&D spend.

A: Scott Wolchko and Bob Valamehr discussed B-cell depletion data and cash burn expectations.