Cellectis S.A. Q3 FY2024 earnings call

• Collaborations: Research and development activities started for three programs under the AstraZeneca agreement, with $47 million triggered so far.
• Clinical trials: BALLI-01 study for UCART22 has completed patient identification for all remaining open slots, with 40 subjects to be treated and Phase I dataset expected in 2025; NATHALI-01 study for UCART20x22 ongoing; UCART123 trial in relapsed/refractory acute myeloid leukemia de-prioritized.
• Financials: Cash position improved, with $264 million as of September 30th, 2024, sufficient to fund operations into 2027; focus on clinical product candidates and manufacturing facilities.

Under the AstraZeneca joint research and collaboration agreement, $47 million has been triggered so far, including $25 million upfront and $22 million in development milestones. As of September 30th, 2024, cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets amount to $264 million, a $108 million increase from December 31st, 2023, due to cash received from AstraZeneca, the European Investment Bank, and financial investments, partially offset by cash payments to suppliers.

• Cash runway extended to 2027 through partnerships and prudent cash management.
• Focus on developing clinical product candidates UCART22 and UCART20x22, and sharing Phase I dataset in 2025.

Forward statements are subject to risks and uncertainties that may cause actual results to differ from forecasted, with a description of these risks found in Cellectis' most recent Form 20-F and subsequent SEC filings.

Q: Details on UCART22 BALLI-01 Phase I data and reason for deprioritizing UCART123 A: BALLI-01 study has 40 patients in dose escalation phase, Phase I dataset expected in 2025; UCART123 deprioritized to optimize cash and focus on key assets Q: Durability of UCART22 and breadth of UCART20x22 dataset A: Discussing durability with regulators; UCART20x22 has brisk recruitment with robust dataset anticipated by 2025 Q: Evolution of revenues from AstraZeneca deal A: Revenue numbers differ due to accounting treatment of revenue, with milestones triggered being key; refer to 6-K for details Q: Dose expansion and regulatory interaction for BALLI-01 A: Focus on regulatory endpoints, thoughtful approach to Phase II development with regulatory authorities Q: Safety in BALLI-01 and Phase II controls for 20x22 A: No dose-limiting toxicities seen; likely single-arm studies for Phase II of 20x22 Q: Updates on AstraZeneca programs A: Programs underway with daily activities, updates likely next year when progress is meaningful Q: R&D and SG&A costs A: Costs trending as start of year, cash runway extended through partnerships and cash management Q: Shift in BALLI-01 data timing and Phase II dose factors A: Need for more patient data to inform Phase II development, strategic path to optimize outcomes Q: Medical team changes and Iovance royalties A: Expanding clinical team with new hematologist oncologist; IOV-4001 program in clinic, economics not disclosed