Cellectis(CLLS)2025-03-14 14:36Financial Data and Key Metrics Changes - Cellectis reported a cash position of 156 million at the end of 2023, reflecting a 140 million equity investment from AstraZeneca [24][25]. - The company experienced a net cash burn of a little over 60 million after accounting for cash inflows from partnerships [70]. Business Line Data and Key Metrics Changes - Cellectis announced the start of research and development activities for three programs under its collaboration with AstraZeneca, including allogeneic CAR T therapies for hematological malignancies and solid tumors, as well as an in vivo gene therapy for a genetic disorder [8][9]. - The company received 25 million upfront and $22 million for development milestones [24]. Market Data and Key Metrics Changes - Cellectis received Orphan Drug Designation from the FDA for its product candidate UCART22 for the treatment of relapse or refractory acute lymphoblastic leukemia, and a similar designation from the European Commission [13]. - The company is focusing on advancing its core clinical trials, particularly BALLI-01 and NATHALI-01, which target unmet medical needs in hematological malignancies [15][20]. Company Strategy and Development Direction - Cellectis aims to leverage its strategic collaboration with AstraZeneca to shape the future of cell and gene therapies, focusing on developing next-generation genomic medicines [9][15]. - The company plans to continue its efforts on core clinical trials while building its preclinical pipeline, emphasizing the importance of addressing high unmet medical needs [15][28]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the strategic collaboration with AstraZeneca, highlighting the potential for paradigm shifts in treating hard-to-treat cancers and genetic disorders [28]. - The company anticipates presenting Phase 1 data sets for its clinical product candidates later in 2025, which will inform future development strategies [27][29]. Other Important Information - Cellectis has drawn down the final tranches of a €40 million credit facility from the European Investment Bank, enhancing its cash runway into mid-2027 [11][25]. - The company is actively engaging with regulatory authorities to align on Phase 2 registration strategies for its clinical programs [18][53]. Q&A Session Summary Question: Upcoming data for UCART22 - Management confirmed that a full Phase 1 dose escalation data set will be available in Q3 2025, with additional data to be shared at the ASH Annual Conference [31][34]. Question: Internal bar for success regarding UCART22 - Management expressed confidence in the data seen thus far, particularly for heavily pretreated patients, and ongoing interactions with regulatory authorities are planned [39][40]. Question: Near-term milestones for AstraZeneca collaboration - Management indicated that significant progress has been made, with potential disclosures of comprehensive data sets later in the year [45][46]. Question: Late-stage development strategies for UCART22 - Management is planning interactions with regulatory authorities to establish a clear registration path, with further details expected in Q3 [51][53]. Question: Safety program and registration trials - Management noted that while there are similarities to autologous CAR T trials, the unique nature of allogeneic therapies will be considered in their approach [57][59]. Question: Updates on Servier discussions - Management refrained from commenting on ongoing legal matters related to Servier [75]. Question: Implications of CARGO's CD22 asset discontinuation - Management highlighted the unmet need for non-CD19 CAR T therapies and expressed optimism about the opportunity for UCART20x22 [78][80]. Question: Recent data from ALLO-501A Cema-Cel program - Management acknowledged the encouraging long-term durability data from Allogene, which supports confidence in the allogeneic CAR T approach [88][90]. Question: Enrollment progress for UCART22 and UCART20x22 - Management confirmed that enrollment for UCART22 is on track, with plans for a realistic number of patients for Phase 2 studies [94][96].