Cellectis(US:CLLS)2020-03-06 04:12Financial Data and Key Metrics Changes - Cellectis reported a consolidated cash position of $364 million as of December 31, 2019, with a net loss attributable to shareholders of $102 million, or $2.41 per share, representing an increase of $23 million over 2018 [29][28] - Revenues and other income for 2019 were $16 million, with $3 million reported in Q4 2019 [28] - R&D expenses increased by $12 million to $18 million for the year 2019 compared to 2018, while SG&A expenses decreased by $9 million to $17 million for the same period [28] Business Line Data and Key Metrics Changes - Cellectis is advancing three wholly controlled allogeneic CAR-T cell product candidates: UCARTCS1, UCART22, and UCART123, all currently in Phase I dose escalation trials [6][15] - The company has entered into two licensing agreements for its allogeneic CAR-T cell platform, including an expanded exclusive worldwide license with Servier for CD19-targeting products [8][9] Market Data and Key Metrics Changes - The company is focusing on the clinical development of its CAR-T cell product candidates, which are designed to address significant unmet medical needs in various hematological malignancies [6][15] - Cellectis is also expanding its manufacturing capabilities with a new facility in Raleigh, North Carolina, expected to be operational next year, alongside a facility in Paris [12] Company Strategy and Development Direction - Cellectis aims to establish itself as a leader in gene-edited cell therapy, with a focus on developing its proprietary gene editing platform and expanding its clinical pipeline [30][31] - The company is integrating its manufacturing expertise as a strategic asset to achieve full manufacturing independence [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of clinical trials and the potential for proof-of-concept data in 2020 [30] - The company is optimistic about the advancements in its R&D efforts and the potential for new patents to strengthen its competitive position in the gene-editing space [31] Other Important Information - Cellectis has made a selective decision to partner with Iovance Biotherapeutics to develop gene-edited tumor infiltrating lymphocytes for cancer therapeutics [10] - The company is monitoring the on-target and off-target interactions of its CAR-T cell therapies closely as it progresses through various dose cohorts [16] Q&A Session Summary Question: What is the ideal balance of the immune system for CAR-T cell therapy? - Management noted that determining the ideal immune system balance for CAR-T treatment is complex and will be informed by data from ongoing studies [34][35] Question: What are the implications of the upheld patent by the European Patent Office? - The upheld patent relates to CRISPR-related technologies for gene editing in T-cells, reinforcing Cellectis' early position in this technology [42][43] Question: Can you provide details on the UCART22 trial design? - The UCART22 trial is focused on adult patients with relapsed/refractory B-ALL, with specific enrollment criteria based on CD22 expression [75] Question: What is the plan for the alemtuzumab cohort? - The initial approach will use a single dose of alemtuzumab, with potential for future studies to explore different dosing strategies [68][69] Question: How many patients are needed to determine the Phase II dose? - The number of patients per cohort may range from 2 to 4, with a systematic approach to determine the optimal dose for each product [65][66]