FATE THERAPEUTICS INC Q3 FY2022 earnings call

• Upcoming clinical and preclinical data presentations at SITC and ASH for various CAR NK and T cell programs.
• Details on FT536, including Phase I study progress and preclinical data for new CAR T cell candidates.
• Updates on FT819 and FT576 clinical trials, including enrollment and data presentation plans.
• Collaboration updates with Janssen and ONO, including progress on FT555 and FT862.
• FDA feedback on FT516 RMAT and plans for R&D Day in Q1 next year.
• Opening of a state-of-the-art manufacturing facility in Poway, California for GMP production.

At the end of the third quarter of 2022, Fate Therapeutics had cash, cash equivalents, and investments of approximately $519 million. Collaboration revenue in the third quarter was $15 million, compared to $14.2 million in the same period last year. Research and development expenses increased to $79.8 million from $53.1 million last year. General and administrative expenses rose to $21.6 million from $15.7 million last year. Net loss for the third quarter was $83.6 million or $0.86 per share. Year-end cash, cash equivalents, and investments are now expected to be at least $440 million, up from the prior guidance of at least $400 million.

• Year-end cash, cash equivalents, and investments expected to be at least $440 million.
• Milestones in Q4 with Janssen and Ono not included in the year-end cash guidance.

Forward-looking statements involve risks and uncertainties, as detailed in the Form 10-Q for the quarter ended September 30, 2022, filed with the SEC, which can cause actual results to differ materially from forward-looking statements.

Q: Tazeen Ahmad of Bank of America asked about FDA commitments for registration regarding FT516.

A: Scott Wolchko discussed active FDA discussions, focusing on the post-CAR T cell setting for aggressive B-cell lymphoma and potential single-arm study with ORR as a primary endpoint.

Q: Michael Yee of Jefferies asked about myeloid programs and iPSC CAR T value.

A: Scott Wolchko talked about multi-dose schedules for NK cells and the importance of iPSC-derived CAR T as a pioneer in the field.

Q: Tyler Van Buren of Cowen asked about B-cell lymphoma data and dose escalation.

A: Scott Wolchko explained considerations of cell load and safety profile for NK cells and decision-making on moving to pivotal studies.

Q: Yigal Nochomovitz of Citigroup asked about FDA feedback on FT596 and 825.

A: Scott Wolchko discussed broad applicability of FDA feedback and target disclosure for 825.

Q: Michael Schmidt of Guggenheim Securities asked about multiple myeloma strategy for FT576.

A: Scott Wolchko discussed positioning in post-CAR T cell setting and combination with monoclonal antibodies.

Q: Daina Graybosch of SVB Securities asked about portfolio prioritization and R&D burn.

A: Scott Wolchko mentioned Janssen and ONO programs being partially funded and prioritization of programs.

Q: Peter Lawson of Barclays asked about lymphoma data timing and TCR editing.

A: Scott Wolchko and Bob Valamehr discussed Analyst Day timing, genomic stability, and durability of responses.

Q: Gil Blum of Needham asked about FT819 safety vs allogeneic peers.

A: Scott Wolchko noted early dose escalation and novel CAR construct of FT819.

Q: Unidentified Analyst asked about FT538 data.

A: Scott Wolchko mentioned FT538 data presentation at 50 with details on patients and monoclonal combinations.