Fate Therapeutics(FATE) - 2019 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue for Q3 2019 was $2.4 million, an increase from $1 million in the same period last year, primarily derived from the iPSC-derived CAR-T cell collaboration with Ono Pharmaceutical [40] - Research and development expenses rose to $23.2 million from $13.6 million year-over-year, attributed to increased employee compensation and clinical development costs [40] - General and administrative expenses increased to $6.3 million from $4.1 million, mainly due to higher employee compensation [41] - Total operating expenses were $25 million for Q3 2019, net of approximately $4.6 million in non-cash stock-based compensation [41] - The company ended Q3 2019 with $303 million in cash, cash equivalents, and short-term investments following a $173 million common stock offering [42] Business Line Data and Key Metrics Changes - The company achieved significant milestones, including the treatment of the first patient with FT516 and FDA clearance for FT596, marking advancements in their iPSC product platform [6][7][8] - FT516 is being investigated as a monotherapy for relapsed refractory acute myeloid leukemia and in combination with CD20 directed monoclonal antibodies for B-cell lymphoma [13][15] - FT596 is designed to engage multiple tumor-associated antigens and is the first cell therapy cleared by the FDA for clinical investigation with three active anti-tumor modalities [19][20] Market Data and Key Metrics Changes - The company is positioned as a leader in the development of off-the-shelf engineered NK cell and T-cell cancer immunotherapy, with a focus on generating clinical data across multiple product candidates [6][10] - The competitive landscape includes other companies like Allogene, which are also pursuing iPSC technologies, but the company believes its platform offers unique advantages in engineering and manufacturing [45][46] Company Strategy and Development Direction - The company aims to leverage its iPSC product platform to deliver disruptive cellular immunotherapies to cancer patients, focusing on operational capabilities for consistent and cost-effective manufacturing [10][43] - There is a commitment to both NK and T-cell therapies, with ongoing exploration of combining both cell types for enhanced therapeutic effects [75][76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the operational progress and expanding leadership position in the cellular immunotherapy space, anticipating significant clinical data generation from their product pipeline [43] - The company is optimistic about the potential of FT500 to re-sensitize patients to checkpoint inhibitor therapy and overcome disease resistance [28][27] Other Important Information - The company completed patient enrollment for the ProTmune clinical trial, which aims to prevent acute graft versus host disease, a significant achievement in their operational timeline [38][39] - The company plans to present at major conferences, including the Society for Immunotherapy of Cancer and the American Society of Hematology, showcasing their advancements and clinical data [36][37] Q&A Session Summary Question: Differentiation from Allogene's iPSC technology - Management discussed the differences in technology, emphasizing their expertise in iPSC culture and the unique aspects of their platform compared to Allogene's focus on T-cell maturation [45][46] Question: Safety and implications of FT500 - Management highlighted the positive safety profile observed in FT500 trials, noting that patients tolerated the treatment well without dose-limiting toxicities [49][50] Question: Regulatory response to increased complexity in edits - Management indicated that their platform's unique approach to gene editing provides a significant advantage in regulatory discussions, allowing for more complex edits without the challenges faced by batch-engineered therapies [52][54] Question: Updates on FT596 and ProTmune trial endpoints - Management confirmed that the primary endpoint for the ProTmune trial is the cumulative incidence of grade two through four GvHD at day 100, with discussions ongoing about secondary endpoints [63][64] Question: Efficacy expectations for FT596 - Management anticipates that FT596 will achieve efficacy levels comparable to other adoptive cell therapies while maintaining a manageable safety profile [71][72]