Cellectis(CLLS) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of December 31, 2025, Cellectis reported cash equivalents, restricted cash, and fixed-term deposits amounting to $211 million, a decrease of $53 million from $264 million as of December 31, 2024, primarily due to cash payments and operational expenses [19][20] - The company managed its cash with discipline, focusing on the development of lasme-cel and eti-cel, and believes its current cash position is sufficient to fund operations into the second half of 2027 [18][19] Business Line Data and Key Metrics Changes - Lasme-cel achieved a 100% overall response rate in the target phase 2 population, with 80% of patients achieving minimal residual disease (MRD) negative status [5][12] - Eti-cel demonstrated an 88% overall response rate and a 63% complete response rate in heavily pre-treated patients during phase 1 trials [8][16] Market Data and Key Metrics Changes - Cellectis is advancing its pivotal phase 2 trial for lasme-cel, with site openings in North America and Europe expected to continue into 2026 [7][12] - The company is also investigating eti-cel's potential impact with low-dose interleukin-2 support to enhance CAR-T efficacy without increasing toxicity [8][16] Company Strategy and Development Direction - Cellectis aims to transform into a late-stage development organization, with 2026 expected to be a year of significant milestones and data readouts [10][17] - The company is focused on delivering clinical results for patients with no therapeutic solutions, emphasizing the importance of its allogeneic CAR-T approach [4][5] Management's Comments on Operating Environment and Future Outlook - Management highlighted the challenges faced by biotechnology companies in recent years but emphasized Cellectis's commitment to advancing its clinical programs [4][5] - The management expressed confidence in the potential of lasme-cel and eti-cel to provide significant therapeutic options for patients with difficult-to-treat cancers [6][8] Other Important Information - Cellectis's gene editing platform is becoming the backbone of a broader allogeneic CAR-T ecosystem, with partnerships with Servier and Iovance advancing their respective programs [9][10] - The company anticipates presenting full phase 1 data for eti-cel later this year and expects to submit a Biologics License Application (BLA) for lasme-cel in the second half of 2028 [17][19] Q&A Session Summary Question: Update on lasme-cel and BALLI-01 enrollment - Management confirmed that recruitment is on track and expects to complete data analysis by the end of the year for the first 40 patients [23][24] Question: Expectations for dose optimization in the pivotal study - Management indicated that they have a strong analysis plan to differentiate between the two alemtuzumab dose levels, focusing on efficacy and safety [25][26] Question: Details on Servier arbitration and its impact - Management clarified that the arbitration ruling allows Cellectis to develop UCART19 independently while remaining eligible for milestones related to cema-cel [28][30] Question: Safety of CD52 preconditioning - Management emphasized the importance of alemtuzumab in optimizing lymphodepletion and achieving better outcomes [32][33] Question: Update on esiCell and patient follow-up - Management provided a top-line update on esiCell, indicating strong complete remission rates and plans for further data on IL-2 cohorts [35][36] Question: Competitive landscape regarding CD19 therapies - Management noted that their focus is on CD22, differentiating their product from others targeting CD19, and emphasized the need for alternative therapies for patients [41][42] Question: Expectations for EHA updates - Management indicated that they will present an updated dataset at EHA, including additional patients and insights on optimal lymphodepletion [50][52] Question: Outpatient setting for lymphodepletion procedures - Management stated that regulatory requirements currently necessitate inpatient delivery, but there is potential for outpatient use in the future [56][57] Question: AstraZeneca partnership updates - Management expressed satisfaction with the collaboration and indicated that updates will be provided when appropriate [58][60]