Cellectis(US:CLLS)2023-05-05 17:15Financial Data and Key Metrics Changes - The net loss attributable to shareholders of Cellectis was $30 million, or $0.58 per share in Q1 2023, compared to a loss of $32 million, or $0.70 per share in Q1 2022, reflecting a $2 million decrease in net loss [33] - The cash position, excluding Calyxt, as of March 31, 2023, was $88 million, down from $95 million as of December 31, 2022, primarily due to cash outflows totaling $30 million [22][23] Business Line Data and Key Metrics Changes - Cellectis announced the dosing of the first patient in Europe with UCART22, an allogeneic CAR-T cell product candidate targeting CD22, evaluated in the BALLI-01 clinical study [19][26] - The company decided to stop enrollment and treatment of patients in the MELANI-01 study evaluating UCARTCS1 to focus on the development of UCART22, UCART20x22, and UCART123 [20][28] Market Data and Key Metrics Changes - Cellectis is actively enrolling patients in the NATHALI-01 trial for UCART20x22, which targets both CD20 and CD22, providing a dual antigen approach [31] - The company has presented encouraging preclinical data on TALEN edited MUC1 CART-T cell for treating triple-negative breast cancer, indicating potential market opportunities [4] Company Strategy and Development Direction - Cellectis aims to leverage its in-house manufacturing capabilities as a competitive advantage, allowing for timely treatment of eligible patients [26] - The company is focused on advancing its clinical trials and plans to present data at the American Society of Cell and Gene Therapy Annual Meeting [27] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the progress in clinical trials and the upcoming milestones for 2023, emphasizing the importance of gene editing technologies [35] - The company anticipates its cash runway to extend into the third quarter of 2024, indicating a stable financial outlook [18] Other Important Information - Cellectis closed a global offering of $25 million in February 2023, with net proceeds of approximately $22.8 million [17] - The company received the first tranche of €20 million from the European Investment Bank in April 2023, which will support the development of its pipeline [5][34] Q&A Session Summary Question: What new data will be presented for UCART123 at ASGCT? - The upcoming presentation will be an encore of the ASH presentation, with no new data expected [49] Question: What is the plan for dosing the next patient in the UCART22 trial? - There is a 28-day dose-limiting toxicity waiting period between the first and second patient, but subsequent patients can be enrolled simultaneously [37] Question: Why was the MELANI-01 study halted? - The decision was influenced by competition with BCMA bispecific therapies, making enrollment challenging [42] Question: What is the expected cash burn for the upcoming quarters? - The company expects a largely flat quarter-over-quarter cash burn for the rest of the year [50] Question: Will there be any adjustments to the dose level based on patients' disease burden? - The current trial is structured as a single-dose regimen, but the company will continue to evaluate this as they move forward [77]