Cellectis(US:CLLS)2024-05-30 18:06Financial Data and Key Metrics Changes - The consolidated net income attributable to shareholders of Cellectis was $5.6 million or $0.08 income per share for the three months ended March 31, 2024, compared to a $30.1 million loss or a $0.58 loss per share for the same period in 2023 [32] - The consolidated adjusted net income attributable to shareholders was $6.5 million or $0.09 income per share for Q1 2024, compared to a net loss of $28.1 million or $0.55 loss per share for Q1 2023 [34] - Cash, cash equivalents, restricted cash, and fixed-term deposits classified as current financial assets as of March 31, 2024, amounted to $143 million, down from $156 million as of December 31, 2023 [22] Business Line Data and Key Metrics Changes - Cellectis continues to focus on advancing its core clinical trials: BALLI-01, NatHaLi-01, and AMELI-01, while also building the next generation of genomic medicine [6] - The BALLI-01 trial showed a higher preliminary response rate of 67% at dose Level 2 compared to a 50% response rate at a higher dose Level 3 using UCART22-P1 [18] - The NatHaLi-01 study continues to enroll patients, with initial data supporting the continued study of UCART20x22 in relapsed/refractory B-cell non-Hodgkin lymphoma [20] Market Data and Key Metrics Changes - AstraZeneca's investment increased its ownership to approximately 44% of Cellectis' share capital and 30% of voting rights, indicating strong market confidence [15] - The company expects its cash runway to fund operations into 2026, bolstered by the recent $140 million equity investment from AstraZeneca [24] Company Strategy and Development Direction - Cellectis aims to leverage its collaboration with AstraZeneca to develop up to 10 cell and gene therapy programs across various indications, including oncology and immunology [44] - The company is focused on maintaining an efficient corporate infrastructure to limit growth in general and administrative expenses while advancing its clinical candidates [35] - The strategic collaboration with AstraZeneca is expected to enhance Cellectis' capabilities in manufacturing and research, positioning the company for significant advancements in the cell and gene therapy space [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for a paradigm shift in treating hard-to-treat cancers through their proprietary technologies [27] - The management highlighted the importance of AstraZeneca's long-term vision and investment in the cell and gene therapy space, which aligns with Cellectis' strategic goals [44] - The company is optimistic about the upcoming data disclosures for its clinical trials by the end of 2024, which are expected to provide insights into the efficacy and safety of its therapies [46] Other Important Information - Research costs under the AstraZeneca collaboration are funded by AstraZeneca, allowing Cellectis to focus its resources on developing its clinical candidates [35] - The company has appointed Arthur Stril as interim Chief Financial Officer, following the resignation of Bing Wang, to guide financial strategies during this critical period [103] Q&A Session Summary Question: Any strategic change regarding the strategy from a Cellectis perspective with AstraZeneca on board? - The strategy on wholly owned assets remains unchanged, with continued focus on UCART22, UCART20x22, and UCART123, while also pursuing novel programs with AstraZeneca across various indications [30] Question: Status of enrollment for both BALLI-01 and NatHaLi-01? - Enrollment continues for both studies, with expectations to complete the escalation phase by the end of the year [31] Question: How many sites are active for UCART20x22 and expectations for RP2D by year-end? - Active sites are open in the U.S. and EU, and the company aims to declare RP2D by the end of the year [48] Question: Can you provide any further granularity on the cadence of readouts across the program this year? - The company will disclose data results for both BALLI-01 and NatHaLi-01 later this year, focusing on durability and response rates [62] Question: Will the dose expansion studies convert to registrational studies? - Discussions with regulatory authorities are ongoing regarding the potential for pivotal expansions, with target populations including relapsed/refractory ALL and non-Hodgkin lymphoma [75][76]