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- **Phase II Trial Milestone**: Pivotal Phase II trial for lasme-cel (UCART22) in relapsed/refractory ALL to begin in H2 2025, with regulatory alignment secured.
- **Cash Runway Assurance**: $230 million cash as of June 2025 supports operations into H2 2027, covering both lasme-cel and eti-cel development.
- **Servier Arbitration Deadline**: Decision expected by December 15, 2025, with potential to regain CD19 product control and seek compensation.
- **Alemtuzumab Differentiation**: Cellectis will continue using Sanofi's alemtuzumab in lymphodepletion, contrasting with Allogene's discontinuation of ALLO-647.
- **Eti-cel Uniqueness**: Dual CD20/CD22 targeting positions eti-cel as a post-CD19 allogeneic option for NHL, distinct from autologous competitors.


**【CEO Summary Section】**
- **Upcoming R&D Day**: Cellectis will host an Investors R&D Day on October 16, 2025, to present Phase I data for lasme-cel (UCART22) and outline late-stage development plans for the pivotal Phase II trial in relapsed/refractory acute lymphoblastic leukemia (ALL). A recording will be available post-event.
- **Pivotal Phase II Trial**: Initiation of the Phase II trial for lasme-cel is expected in H2 2025, following successful end-of-Phase I meetings with the FDA and EMA. Regulatory feedback was aligned and supportive.
- **NatHaLi-01 Study**: Data from the Phase I study of eti-cel (UCART20x22) in non-Hodgkin lymphoma (NHL) will be submitted for presentation at ASH 2025, with plans to transition to Phase II in 2026.
- **AstraZeneca Collaboration**: Progress continues on three programs: allogeneic CAR-T for hematological malignancies, solid tumors, and in vivo gene therapy for genetic disorders.
- **Servier Arbitration**: The arbitration tribunal is expected to render a decision by December 15, 2025, regarding termination of the CD19 product agreement and compensation for Servier's failure to develop the licensed products.

**【CFO Financial Commentary】**
- **Cash Position**: As of June 30, 2025, Cellectis had $230 million in cash, cash equivalents, and fixed-term deposits, sufficient to fund operations into H2 2027. The $33.2 million decrease from December 2024 was due to operational expenses and debt repayments.
- **Financial Highlights**: GAAP net loss for the first half of 2025 was not disclosed, but the company emphasized its ability to execute on its pipeline without dilutive funding.
- **Arbitration Impact**: The financial impact of the Servier arbitration outcome will be material if the company prevails, but no specifics were provided due to the ongoing legal process.

**【Q&A Key Highlights】**
- **Servier Arbitration Scenarios**: Management declined to speculate on potential outcomes but expressed confidence in their legal position. The decision could allow Cellectis to regain control of CD19 products and seek compensation.
- **Regulatory Path for lasme-cel**: FDA and EMA provided clear guidance on Phase II trial design, endpoints, and statistical plans. No concerns were raised about the safety database or patient population.
- **Alemtuzumab Use**: Cellectis plans to continue using alemtuzumab (Sanofi's CD52 antibody) in its lymphodepletion regimen, differentiating its approach from Allogene's decision to discontinue ALLO-647. Regulatory feedback on Cellectis' use of alemtuzumab was positive.
- **Cash Runway**: The $230 million cash balance includes funding for both lasme-cel and eti-cel pivotal studies. The company remains cautious about non-dilutive funding but maintains a prudent financial outlook.
- **Competitive Differentiation**: Eti-cel's dual targeting of CD20 and CD22 (vs. CD19) positions it as a unique allogeneic option for NHL patients who have failed CD19-based therapies.


Cellectis S.A. (CLLS) Q2 2025 Earnings Call Transcript

- **Strategic Collaboration Expansion**: AstraZeneca's $140M investment and three new programs (hematological, solid tumors, gene therapy) accelerate pipeline growth.
- **Clinical Milestones Ahead**: Phase 1 data for UCART22 and UCART20x22 in Q3 2025; Phase 2 trials to begin by end-2025.
- **Financial Strength**: $264M cash as of Q4 2024; extended runway to mid-2027 with no reliance on partner milestones.
- **Competitive Differentiation**: Allogeneic CAR T durability (4+ years in Cema-cel) and focus on non-CD19 targets address unmet needs in hematological malignancies.

**【CEO Summary Section】**
- Cellectis announced a strategic collaboration with AstraZeneca, including three programs: allogeneic CAR T for hematological malignancies, solid tumors, and in vivo gene therapy for genetic disorders.
- AstraZeneca invested an additional $140 million, increasing their ownership to ~44% of Cellectis shares and ~30% voting rights.
- The company expects to present Phase 1 data for UCART22 (acute lymphoblastic leukemia) and UCART20x22 (non-Hodgkin lymphoma) in Q3 2025, with Phase 2 registration strategies to be aligned with FDA/EMA.
- Cellectis' cash runway is extended to mid-2027, supported by $140M from AstraZeneca, $20M from EIB, and prudent cost management.

**【CFO Financial Commentary】**
- Total cash as of December 2024: $264 million (vs. $156 million in 2023), driven by AstraZeneca investment and EIB disbursements.
- 2024 revenue: $43 million; operating expenses: $40 million (wages, R&D, lease payments).
- AstraZeneca collaboration contributed $47 million (including $25M upfront, $22M milestones, and R&D reimbursements).
- Focus on UCART22/20x22 development and manufacturing facilities in Paris/Raleigh.

**【CMO Clinical Update】**
- UCART22 (BALLI-01): Enrollment complete for Phase 1 (40 patients); Phase 2 registration strategy to be finalized post-Q3 data release.
- UCART20x22 (NATHALI-01): Enrollment ongoing for Phase 1; Phase 2 preparation planned for 2026.
- Regulatory interactions with FDA/EMA to align on pivotal trial designs.

**【Q&A Highlights】**
- **UCART22 Data Expectations**: Full Phase 1 dataset (efficacy, safety, durability) to be shared in Q3 via ad hoc event; ASH 2025 submission for interim updates.
- **AstraZeneca Collaboration**: Solid tumor and gene therapy programs progressing; IND-enabling studies expected to begin in 2025.
- **Competitive Landscape**: CARGO's CD22 CAR T discontinuation highlights unmet need for non-CD19 targets; Cellectis' allogeneic approach aims to improve durability and reduce toxicity.
- **Allogene Partnership**: Cema-cel (ALLO-501A) shows 4+ year durability in relapsed/refractory ALL; Phase 2 trial (ALPHA3) targeting first-line consolidation expected to report mid-2025.
- **Financial透明度**: Mid-2027 cash runway assumes no partner milestones; $410M potential from Allogene collaboration excluded from runway calculation.

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