Financial Data and Key Metrics Changes - As of June 30, 2025, the company's cash, cash equivalents, and fixed-term deposits amounted to $230 million, a decrease of $33.2 million from $264 million as of December 31, 2024, primarily due to cash payments to suppliers and operational expenses [14][14][14] - The company reported a consolidated net loss attributable to shareholders for the six months ended June 30, 2025, with specific figures available in the press release [14] Business Line Data and Key Metrics Changes - The recruitment for the dose escalation component of the Phase I BALL E-one study evaluating UCART22 in relapsed/refractory B cell acute lymphoblastic leukemia has been completed, with a pivotal Phase II study expected to commence in the second half of 2025 [9][10] - The NATALI-one study assessing ETICELL product YOCAR T20 in relapsed/refractory non-Hodgkin's lymphoma is ongoing, with data presentation anticipated in late 2025 [5][11] Market Data and Key Metrics Changes - The company is expanding clinical trial sites in the United States and Europe to accelerate recruitment for the Phase II study, with plans to have sites open by the end of the year [10][11] Company Strategy and Development Direction - Cellectis is focused on advancing research and developing solutions for patients with unmet medical needs, with a strategic collaboration with AstraZeneca on three cell and gene therapy programs [4][5] - The company is preparing for an R&D Day on October 16, 2025, to present the Phase I dataset and late-stage development strategy for UCART22 [3][4] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of ongoing clinical trials and the potential for their product candidates to lead to significant advancements in treating hard-to-treat cancers and genetic disorders [15] - The company remains optimistic about its financial position, indicating sufficient cash to fund operations into the second half of 2027 [14] Other Important Information - An arbitration decision regarding the licensing agreement with Servier is expected by December 15, 2025, with the company seeking compensation for losses incurred due to the lack of development of licensed products [5][6][14] - The company welcomed a new board member, Andre Muller, and acknowledged the contributions of departing directors [6][7] Q&A Session Summary Question: Contextualization of Servier arbitration scenarios and actions - Management indicated that it is complicated to predict outcomes but expressed hope for a favorable decision that would restore their CD19 products and provide compensation for losses [18] Question: High-level thoughts on pivotal Phase II trial design - Management confirmed productive interactions with both FDA and EMA, with clear agreement on endpoints and no concerns raised about the statistical plan [20][21] Question: Data points expected at R&D Day and FDA dynamics - The R&D Day will present the full Phase I dataset for LASMA cell, including safety, efficacy, and durability data, along with the late-stage development strategy [26][28] Question: Bar for success in relapsed refractory ALL - Management stated that details on endpoints and timing will be shared during the R&D Day, emphasizing the importance of durability of response [35][36] Question: Feedback from regulators on anti-CD52 inclusion - Management does not foresee changes to the pivotal study design based on Allogene's recent decisions, citing established safety profiles and risk-benefit assessments [58] Question: Cash runway and pivotal study completion - The cash runway into H2 2027 includes costs for pivotal studies for both LASMA cell and ETICELL, with prudent assumptions made regarding cash inflows [60] Question: Size of data set for ETICELL - The data set for ETICELL will be smaller than that for LASMA cell, reflecting the different stages of development [62] Question: Differentiation of ETICELL in dual targeting space - Management highlighted that ETICELL targets different antigens compared to competitors, positioning it uniquely in the market [70][71]

Core Insights - Cellectis is advancing its clinical programs, particularly UCART22 and UCART20x22, with significant regulatory designations and expected data readouts in 2025 [1][8][16] - The partnership with AstraZeneca is pivotal, focusing on three key programs in cell and gene therapy, with a strong cash position supporting operations until mid-2027 [2][4][6][25] - Financial results for 2024 show a substantial increase in revenues and a reduced net loss compared to 2023, indicating improved operational performance [30][34][40] Group 1: Clinical Development - UCART22 has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the FDA, with a Phase 1 dataset and late-stage development strategy expected in Q3 2025 [1][8][16] - The ongoing Phase 1 study of UCART20x22 in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL) is focused on patient enrollment, with results anticipated in late 2025 [1][9] - The BALLI-01 study for UCART22 in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) is progressing, with the addition of alemtuzumab to the lymphodepletion regimen showing promising results [8][10][16] Group 2: Financial Position - As of December 31, 2024, Cellectis reported a cash position of $264 million, a significant increase from $156 million in 2023, providing a financial runway into mid-2027 [2][30][31] - Revenues for 2024 reached $49.2 million, up from $9.2 million in 2023, primarily due to progress in collaboration with AstraZeneca and other development milestones [34][40] - The net loss attributable to shareholders decreased to $36.8 million in 2024 from $101.1 million in 2023, reflecting improved financial performance [40][41] Group 3: Strategic Partnerships - The collaboration with AstraZeneca includes three programs: an allogeneic CAR T for hematological malignancies, an allogeneic CAR T for solid tumors, and an in vivo gene therapy for a genetic disorder [2][4][25] - AstraZeneca's additional equity investment of $140 million enhances Cellectis' financial stability and supports ongoing research and development efforts [6][23] - The partnership aims to leverage Cellectis' gene editing technology to advance next-generation cell and gene therapies [5][25]