Cellectis(CLLS) - 2020 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Cellectis reported a standalone cash position of $282 million as of June 30, 2020, down from $304 million at the end of 2019, reflecting $28 million in proceeds from Servier and $48 million in net cash flows used in operations [23][24] - The standalone net income attributable to shareholders was $3 million in the first half of 2020, a significant improvement from a net loss of $37 million in the same period of 2019, driven by a $26 million increase in revenues [25] - The consolidated net loss attributable to shareholders, including Calyxt, was $12 million or $0.29 per share in the first half of 2020, compared to a loss of $49 million or $1.50 per share in the first half of 2019 [26] Business Line Data and Key Metrics Changes - The advancement of partner programs, particularly UCART19 and UCARTBCMA, is expected to generate up to $410 million in milestone payments and royalties for Cellectis [10] - Cellectis is progressing with its proprietary allogenic CAR T-cell programs, including UCART22 and UCART123, both currently in Phase I dose escalation trials [11][14] Market Data and Key Metrics Changes - UCART19 (ALLO-501) showed a complete response rate of 44% and an overall response rate of 75% in a subgroup of patients naive to CAR T-cell treatment [8] - The company is focusing on the high unmet medical need in the CD22 and BCMA markets, which are less crowded compared to CD19 [72] Company Strategy and Development Direction - Cellectis aims to provide early interim data updates on proprietary programs in Q4 2020, with plans for regular updates at scientific meetings [13] - The company is investing in its in-house manufacturing capabilities to achieve full manufacturing independence by mid-2021, which is crucial for establishing itself as a leader in the allogeneic CAR T-cell field [30][92] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of clinical programs and the potential for significant data releases in the near future, emphasizing the importance of patient safety and regulatory compliance [32][52] - The company is optimistic about its position in the market, with a healthy lineup of clinical programs expected to deliver value [31] Other Important Information - Cellectis has filed protocol amendments with the FDA for its trials to include the evaluation of alemtuzumab in the lymphodepletion regimen [18] - The company is working closely with the FDA to address requests related to the clinical hold on the UCARTCS1 trial [22] Q&A Session Summary Question: What is the timeline for updates on alemtuzumab preconditioning? - Management hopes to provide updates by the end of the year, depending on the FDA's protocol amendment process [34][35] Question: Can you provide details on the adverse patient outcome in UCARTCS1? - Management is still gathering data and has not disclosed specifics, but the incident occurred towards the end of the DLT observation period [39][40] Question: What gives confidence in the dose level for UCARTCS1? - The initial dose was set higher based on the dual action of targeting both myeloma cells and patient T-cells, with ongoing data collection to support further exploration [42][45] Question: What is the strategy regarding alemtuzumab dosing in trials? - The focus is on balancing effective T-cell depletion with patient safety, with plans to explore optimal dosing strategies [48][49] Question: What is the status of communication with the FDA regarding UCARTCS1? - Ongoing discussions are supportive, and the company is working to ensure patient safety while moving the program forward [50][52] Question: How does Cellectis view the potential for retreatment strategies in CAR-T therapy? - The company is excited about the potential for allogeneic CAR-T to allow for repeat dosing, which could be a significant advantage [85][86] Question: What is the manufacturing strategy moving forward? - Cellectis plans to produce both clinical and commercial-grade materials from the outset, ensuring compliance with GMP standards [92][93]