Fate Therapeutics(FATE)2023-11-09 02:12Financial Data and Key Metrics - Revenue for Q3 2023 declined to $1.9 million compared to $15 million in the same period last year, driven exclusively by the collaboration with ONO Pharmaceutical [59] - General and administrative expenses decreased by 12% to $18.9 million, primarily due to reduced salaries and benefits, including share-based compensation [16] - Total operating expenses declined by 47% to $53.2 million, including $10.1 million of non-cash share-based compensation expense [16] - Net loss for the quarter was $45.2 million or $0.46 per share [60] - Cash, cash equivalents, and investments at the end of Q3 were approximately $350 million [59] Business Line Data and Key Metrics - FT522, the off-the-shelf CD19-targeted CAR-NK cell program, has opened enrollment for its Phase 1 study in relapsed refractory B-cell lymphoma, with two regimens: one with conditioning chemotherapy and one without [6][7] - FT825, a multiplexed engineered iPSC-derived CAR T-cell program, received FDA clearance for clinical investigation in solid tumors, incorporating seven novel synthetic controls of cell function [8][9] - FT819, the off-the-shelf CD19-targeted CAR T-cell program, initiated Phase 1 studies in SLE (systemic lupus erythematosus) with multiple sites starting enrollment [30][31] - FT576, a CAR T-cell program for multiple myeloma, is enrolling patients in three-dose treatment cohorts at 1 billion cells per dose, both as monotherapy and in combination with CD38-targeted monoclonal antibody therapy [32] Market Data and Key Metrics - The company is expanding its iPSC product platform into solid tumors and autoimmunity, with significant clinical readouts expected in 2024 across multiple programs [24] - The collaboration with ONO Pharmaceutical for FT825 in solid tumors has resulted in $2.1 million of contra R&D expense recognized in Q3 [34] - The company is exploring the potential of off-the-shelf cell therapy in autoimmunity, with FT819 showing promise in SLE and other autoimmune diseases [31][66] Company Strategy and Industry Competition - The company is focused on advancing its iPSC-derived cellular immunotherapies, with a strong emphasis on reducing or eliminating the need for conditioning chemotherapy, which could significantly improve patient access and safety [25][26] - The ADR (alloimmune defense receptor) technology in FT522 is designed to mitigate rejection and promote NK cell proliferation, potentially enabling clinical responses without intense conditioning chemotherapy [25] - The company is positioning itself as a leader in off-the-shelf cell therapy, with a differentiated approach that leverages multiple mechanisms of action to target both cancer and autoimmune diseases [58][66] Management Commentary on Operating Environment and Future Outlook - Management remains confident in the company's ability to achieve important clinical readouts in 2024, particularly in oncology and autoimmunity [24] - The company is well-positioned to extend its operating runway into the second half of 2025, thanks to significant cost control measures and reduced cash utilization [24] - Management highlighted the potential for FT522 to demonstrate proof-of-concept without conditioning chemotherapy, which could be a game-changer in the field of cell therapy [65] Other Important Information - The company has a contingent milestone payment of $700,000 related to the development of FT819, with up to two additional milestone payments possible based on the company's stock performance [16] - The Phase 1 study of FT819 in SLE allows for assessment of higher dose levels and multiple dose expansion cohorts, with a favorable review from the Lupus Therapeutics Protocol Design Committee [31] Q&A Session Summary Question: What is the threshold for acceptable drop-off in engraftment or activity for FT522 between patients with and without preconditioning? [61] - The focus is on patient benefit, with the potential for no conditioning being a key element of FT522's unique profile [62] Question: How does FT825 compare to other CAR T-cell therapies in solid tumors? [45] - FT825 is a multiplexed engineered iPSC-derived CAR T-cell therapy with a fine-tuned binding domain against HER2, showing early promise in solid tumors [45] Question: Why start with FT819 in autoimmunity rather than FT522? [68] - FT819 has human clinical experience, a differentiated safety profile, and strong proof-of-concept for autologous CAR T-cell therapy, making it a strong candidate for autoimmunity [69] Question: What are the major value-creating events expected in the next 6-12 months? [65] - Key events include demonstrating proof-of-concept for FT522 without conditioning chemotherapy, advancing FT825 in solid tumors, and expanding into autoimmunity with FT819 [65][66] Question: What is the rationale for choosing lupus as the initial autoimmune indication for FT819? [73] - There is strong clinical precedent for CD19-targeted therapy in lupus, and significant enthusiasm from the lupus community for cell therapy [84] Question: How does the company view the competitive landscape for CD19 CAR-T therapies? [63] - The company believes there is a significant need for off-the-shelf cell therapies, particularly in post-auto CAR-T patients, and sees opportunities to combine with standard immunotherapy regimens [63][64] Question: What is the expectation for T-cell removal with the starting dose of FT522? [86] - The starting dose of 300 million cells is expected to remove a significant portion of T-cells, with potential for dose escalation based on anti-tumor activity [86] Question: How does FT819 compare to other emerging assets in systemic lupus? [87] - Preclinical data for FT819 shows distinct and specific elimination of the B-cell compartment, with strong in vitro and in vivo evidence of durable activity [88][89] Question: How many sites will be involved in the autoimmune study for FT819? [93] - The company is working with 12-15 sites that are already familiar with FT819 from oncology studies, aiming to partner with oncologists and rheumatologists for effective patient treatment [93]