FATE THERAPEUTICS INC Q2 FY2022 earnings call

• Top near-term focus is on T cell malignancy franchise, advancing into late-stage development for relapsed/refractory aggressive lymphoma and assessing community setting treatment with FT596+R-CHOP.
• Collaborations with Janssen and Ono have key inflection points with programs poised for IND submission.
• iPSC technology is seen as the winning platform for mass production of off-the-shelf engineered cell products.
• Progress in clinical, regulatory, and manufacturing operations for iPS-derived NK cell programs for relapsed refractory aggressive B-cell lymphoma, including favorable safety profile in FT596 study.
• Manufacturing facility in Poway, CA opened and poised for GMP production.
• Phase I study of FT536, first iPSC-derived CAR NK cell program for solid tumors, with first patient treated.
• Collaborations with Janssen and Ono advancing multiple programs towards IND submission, with expansions and new antigen programs added.

At the end of the second quarter of 2022, Fate Therapeutics had cash, cash equivalents, and investments of approximately $581 million. Collaboration revenue increased to $18.5 million compared to $13.4 million in the same period last year. Research and development expenses rose to $81.3 million, while general and administrative expenses were $20.4 million. The net loss for the second quarter was $76.1 million or $0.79 per share. Year-end cash guidance remains unchanged, with the company expecting to end the year with at least $400 million in cash, cash equivalents, and investments, not including potential success-based milestone payments from collaborations.

• Year-end cash guidance remains unchanged, expecting at least $400 million in cash, cash equivalents, and investments by year-end.
• Contingent milestone payments to Memorial Sloan Kettering Cancer Center are assessed quarterly, with a noncash $5.9 million nonoperating benefit recorded in the second quarter.

Forward-looking statements involve risks and uncertainties, including those related to clinical development, regulatory approvals, competition, and the ability to successfully advance product candidates. Undue reliance should not be placed on forward-looking statements, which are subject to change based on future events and circumstances.

Q: Ahead of the ASH update that you've mentioned, should we still be thinking that there's an update around summer time such as August for 516 and 596. And would you be including an update on the outcomes for the RMAT meeting at this time? Or would it be too soon?

A: Scott Wolchko said it would be very difficult to provide an RMAT discussion in August, as they will wait for minutes from the FDA before fully digesting the regulatory discussion. They plan to provide a comprehensive update on their development strategy in lymphoma within the next 6 months.

Q: I have a question on the RMAT, on the RMAT meeting. Will you also discuss the CMC aspect of the product in addition to the clinical discussion? And also, obviously, depending on the outcome of the meeting and the possibility of the trial start, does that -- do you anticipate a change to the thoughts about cash for 2023?

A: Scott Wolchko said the RMAT discussion in the third quarter will include some CMC topics. The company's thoughts on cash for 2023 are based on current burn and projections, with the RMAT outcome potentially affecting trial start but not a direct change to cash thoughts at this point.