Fate Therapeutics(US:FATE)2022-03-01 04:01Financial Data and Key Metrics Changes - The company's cash, cash equivalents, and investments at the end of 2021 were approximately $717 million [29] - Collaboration revenue increased by $1.2 million to $17.1 million in Q4 2021 compared to $15.9 million in the same period last year [29] - Research and development expenses for Q4 2021 increased by $30.5 million to $69.5 million compared to $39 million in the same period last year [31] - General and administrative expenses for Q4 2021 increased by $6.6 million to $16.9 million compared to $10.3 million in the same period last year [32] - The net loss for Q4 2021 was $69.3 million or $0.72 per share [34] Business Line Data and Key Metrics Changes - The company is pursuing off-the-shelf iPSC-derived NK cell programs for patients with B-cell lymphoma, aiming to address unmet medical needs [6][10] - Clinical responses were reported from FT516 and FT596 programs, with 3 of 8 patients treated with FT516 and 5 of 8 patients treated with FT596 achieving complete responses [9] - FT819, the first iPSC-derived T-cell therapy, is undergoing clinical investigation with a focus on its unique CAR construct and manufacturing process [17][70] Market Data and Key Metrics Changes - The company is actively engaging the FDA to discuss pivotal study design and manufacturing for its NK cell programs [10] - The second GMP manufacturing facility is expected to be operational by mid-2022, enhancing the company's production capabilities [11] Company Strategy and Development Direction - The company aims to launch pivotal studies for FT516 or FT596 by the end of 2022, focusing on patients with aggressive lymphomas previously treated with autologous CD19-targeted CAR T-cell therapy [10] - The strategy includes expanding into community settings for earlier treatment with cell-based cancer immunotherapy [12] - The company is developing multiplexed-engineered iPSC-derived NK and T-cell product candidates for solid tumors, emphasizing the potential for improved patient outcomes [24][25] Management's Comments on Operating Environment and Future Outlook - Management highlighted the critical unmet medical need for patients who have progressed on multiple lines of therapy, particularly in the context of B-cell lymphoma [7] - The company is optimistic about the potential of its iPSC-derived therapies to transform outcomes for patients with aggressive diseases [13] - Management acknowledged the challenges in the current operating environment but expressed confidence in the company's strategic direction and product pipeline [34] Other Important Information - The company recorded a non-cash $0.5 million non-operating benefit associated with the change in fair value of contingent milestone payments [33] - The company expects to end the year with at least $400 million in cash, cash equivalents, and investments, excluding potential milestone payments [34] Q&A Session All Questions and Answers Question: Can you comment on the ongoing FT538 study in combination with antibodies? - Management indicated that they are early in the FT538 study and expect to provide an update in the second half of the year [36] Question: What are the key factors in choosing between FT516 and FT596 for the post-CD19 CAR-T expansion study? - Management highlighted that data generation and FDA input will be critical in making a data-driven decision [38] Question: What proportion of patients are being treated in the community setting for the bendamustine cohort? - Management stated that future updates will clarify data timelines for both FT516 and FT596 [41] Question: Can you discuss the design of the trial for R-CHOP? - Management noted that it is early to discuss the development strategy for R-CHOP but emphasized the importance of safety and translational data [45] Question: How many cycles are planned for FT596 in multi-dose multi-cycle treatment? - Management confirmed that the decision around the lymphoma strategy is multifactorial and they are comfortable with a multiproduct franchise in lymphoma [51] Question: Do you think NK-cell therapy can be curative on its own? - Management believes that earlier intervention in AML provides the best chance for a curative outcome [64]