Fate Therapeutics, Inc. Q4 FY2023 earnings call

Key Points

• FT819: Awarded $7.9 million by CIRM for Phase 1 SLE trial; enrolling patients in Phase 1 B-cell lymphoma trial; data from B-cell lymphoma trial to be shared in 2024.
• FT825: Phase 1 clinical trial for advanced solid tumors initiated in collaboration with Ono; incorporates multiple antitumor mechanisms.
• NK cell programs: FT522 in Phase 1 B-cell lymphoma trial with two regimens; FT576 in Phase 1 multiple myeloma trial enrolling patients at higher doses.
• Autoimmunity: Planning to expand FT819 IND to additional autoimmune indications and submit FT522 IND for autoimmunity.

In the fourth quarter of 2023, Fate Therapeutics' revenue declined to $1.7 million from $44.4 million in the same period last year. Research and development expenses decreased over 60% to $31.8 million. General and administrative expenses decreased by 17% to $17.9 million. Total operating expenses declined 54% to $49.8 million. Net loss for the quarter was $44.1 million or $0.45 per share. Cash, cash equivalents, and investments at the end of the quarter were approximately $316 million.

Forward-Looking

• Cash operating expenses run rate in first half 2024 is expected to be around $35-40 million based on recent quarters.
• Go/no-go decisions for further development of programs like FT576 will be made later in 2024 based on safety and activity data.

Risks

• Forward-looking statements involve risks such as clinical trial uncertainties, competition in the cell therapy space, and regulatory challenges that could affect actual results.

Q: Michael Yee asked about the status of FT819 in the lupus program and if results would replicate autologous CAR T-cell therapy.

A: Scott Wolchko responded that they are well-positioned to treat the first patient in the coming weeks, FT819 has shown behavior in patients similar to autologous CAR T-cell therapy with clean safety profile, dose-dependent expansion, and B-cell suppression.

Q: Yigal Nochomovitz inquired about evidence of FT819 clearing plasma cells and trafficking into tissue components.

A: Scott Wolchko stated FT819 has reached tissues harboring CD19 positive cancer cells in B-cell lymphoma, showing ability to traffic outside blood and reach secondary/tertiary tissues with tumor cells.

Q: Tara Bancroft asked about choosing between FT819 and FT522 for autoimmune disorders.

A: Scott Wolchko said they plan to pursue both; FT522 has ADR technology and potential to deliver cell therapy without chemotherapy conditioning, and is exciting for targeting B-cells and plasma cells in combination with monoclonal antibodies.

Q: Tazeen Ahmad asked about data expectations for FT576 in multiple myeloma and efficacy bar.

A: Scott Wolchko said 576 needs a therapeutic profile similar to T-cell engagers, with high response rates and complete response rates in the 40% range and ORR north of 60%.

Q: Daina Graybosch asked about challenges in enrolling lupus studies and timing of data.

A: Scott Wolchko noted challenges in pioneering a new field with autoimmunity, but committed to updating on FT819 in autoimmunity this year, with enrollment governed by 28-day patient staggers.