Cellectis S.A. (CLLS) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call summary indicates a positive sentiment due to strategic collaborations, particularly with AstraZeneca, and promising recruitment progress in pivotal studies. While financial specifics are lacking, optimistic guidance is given for upcoming milestones and data readouts. The Q&A reveals management's confidence in ongoing trials and commercial opportunities, despite some confidentiality constraints. The market is likely to respond positively, anticipating future growth and successful milestone achievements.
Key Financial Performance
Cash, cash equivalents, restricted cash, and fixed-term deposits $211 million as of December 31, 2025, compared to $264 million as of December 31, 2024, representing a decrease of $53 million. The decrease is mainly due to $36.9 million cash in from revenue, $8.4 million of interest received from financial and cash equivalent investments, partially offset by cash payments to suppliers ($50.5 million), wages, bonuses, and social expenses ($40 million), lease debts ($11 million), and repayment of the PGE loan ($5.4 million).
Revenue Positively impacted by the strategic collaboration with AstraZeneca in 2025. Exact revenue figures were not disclosed.
Net loss attributable to shareholders Figures related to consolidated net loss for the 12 months ended December 31, 2025, were mentioned but not detailed in the transcript.
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Operating Highlights
Lasme-cel Phase I Data: Achieved 100% overall response rate in the target Phase II population for relapsed or refractory B-cell acute lymphoblastic leukemia. Converted all patients in the target population to transplant-eligible candidates.
Eti-cel Phase I Data: Demonstrated an 88% overall response rate and a 63% complete response rate in heavily pretreated non-Hodgkin lymphoma patients. Investigating low-dose interleukin-2 support to enhance CAR T efficacy.
Geographic Expansion: Pivotal Phase II trial for lasme-cel initiated with site openings in North America and Europe. Targeting approximately 75 recruiting centers.
Partnerships: Collaborations with Servier, Allogene, Iovance, and AstraZeneca to advance CAR T and gene therapy products. Notable programs include Servier's cema-cel and Iovance's IOV-4001.
Manufacturing Capabilities: Internal manufacturing demonstrated higher response rates compared to external CDMO. Facilities in Paris and Raleigh operational.
Financial Position: Cash position of $211 million as of December 31, 2025, sufficient to fund operations into H2 2027.
Focus on Gene Editing: Cellectis' gene editing platform serves as the backbone for CAR T ecosystem and partnerships.
Bridge to Transplant Strategy: Lasme-cel positioned as a rapid, off-the-shelf solution to enable bone marrow transplants for relapsed or refractory BLL patients.
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Risk or Challenges
Cash Management and Financial Runway: The company has managed its cash with discipline, but there is a risk of financial insufficiency beyond H2 2027, as the current cash position is only sufficient to fund operations until then. This could impact the execution of pivotal trials and strategic objectives.
Regulatory and Product Development Timelines: The anticipated BLA submission for lasme-cel is planned for H2 2028, and for eti-cel in H2 2029. Delays in regulatory approvals or trial milestones could adversely affect the company's strategic plans and market entry timelines.
Manufacturing Capabilities: While internal manufacturing has shown improved efficacy compared to external CDMO, any disruptions or inefficiencies in the manufacturing facilities in Paris and Raleigh could impact product availability and trial outcomes.
Clinical Trial Risks: The pivotal Phase II trial for lasme-cel and Phase I for eti-cel are critical milestones. Any setbacks in patient enrollment, site openings, or achieving interim analysis results could delay progress and impact investor confidence.
Competitive Pressures: The biotechnology sector is highly competitive, and other companies are also advancing CAR T therapies. Failure to demonstrate superior efficacy or safety could limit market share and revenue potential.
Dependence on Partnerships: The company relies on partnerships with Servier, Allogene, Iovance, and AstraZeneca. Any setbacks in partner programs or collaborations could impact revenue and technological advancements.
Economic and Market Conditions: Broader economic uncertainties and market conditions could affect funding opportunities, investor sentiment, and operational costs.
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Guidance & Outlook
Pivotal Phase II trial for lasme-cel: The trial is now initiated, with site openings in North America and Europe continuing into 2026. Enrollment expansion is planned, and the first interim analysis is expected in Q4 2026. A BLA submission is anticipated in the second half of 2028.
Eti-cel Phase I and future plans: The Phase I trial for eti-cel is ongoing, with plans to present the full data set, including IL-2 cohort results, later in 2026. The program is expected to progress to pivotal Phase II in 2027, with a BLA submission anticipated in H2 2029.
Partner programs and collaborations: Servier and Allogene's cema-cel program is in a pivotal Phase II study, with an interim futility analysis expected in Q2 2026. Iovance's IOV-4001 clinical results in melanoma are anticipated in 2026. Collaboration with AstraZeneca continues to advance, focusing on developing up to 10 novel cell and gene therapy products.
Financial outlook: The company has sufficient cash to fund operations into H2 2027, supporting pivotal Phase II for lasme-cel and Phase I for eti-cel. Key readouts for lasme-cel and eti-cel are expected in Q4 2026.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:How is recruitment tracking in the pivotal study for lasme-cel and BALLI-01, and when is enrollment for the dose selection portion expected to complete?
A:Recruitment is progressing well with many sites engaged. Site opening is on track, and data analysis for the first 40 patients' interim analysis (dose optimization phase) is expected to complete by the end of the year.
Q:What differences are expected between the two alemtuzumab dose levels in terms of efficacy and safety?
A:It is difficult to predict significant differences between the two doses. However, the analysis plan is designed to differentiate based on efficacy, safety, and translational markers like CAR T expansion and host T-cell reconstitution. Both doses are effective, and the focus is on dose optimization.
Q:Could you provide more details on the Servier arbitration and its impact on eligibility for the $340 million in milestones?
A:The arbitration ruled on the partial termination of the license agreement for UCART19 V1 (ALLO-501), which has been returned to Cellectis. This does not impact eligibility for the $340 million in milestones under the Servier agreement for ALLO-501A or cema-cel. The $20 million milestone is expected to be triggered once the pivotal trial is effective.
Q:Why include CD52 preconditioning in studies when competitors are moving away from it?
A:Alemtuzumab (CD52) is critical for optimizing lymphodepletion, leading to deeper responses. Studies without alemtuzumab failed to achieve MRD-negative responses. The company uses a lower dose compared to competitors, balancing efficacy and safety, and has extensive risk mitigation protocols in place.
Q:What updates can be expected for eti-cel in the fourth quarter?
A:The update will include data on cohorts with and without IL-2. Current results show a 63% complete remission rate and 88% overall response rate. Recruitment has doubled, and durability data will be shared, aiming for a 6-month durability mark. The goal is to enhance efficacy further with low-dose IL-2.
Q:What are the thoughts on the commercial opportunity for lasme-cel compared to Aucatzyl?
A:Lasme-cel targets CD22, differentiating it from CD19-focused therapies like Aucatzyl. The off-the-shelf nature of lasme-cel allows for smoother launches and better economies of scale compared to autologous therapies. The company is also exploring earlier lines of therapy for ALL.
Q:What is expected at EHA from the ongoing programs?
A:Updated data sets, including additional patients for dose optimization, will be presented. The focus will be on optimal lymphodepletion and the environment for cell infusion, which are critical for predicting patient responses.
Q:What is the possibility of applying lymphodepletion and allogeneic CAR T in outpatient settings?
A:Currently, regulatory authorities require inpatient delivery. Transition to outpatient settings may occur with more clinical confidence and evidence, assuming a reassuring safety profile.
Q:How is the partnership with AstraZeneca progressing, and are updates expected?
A:The partnership is progressing well with activities across therapeutic areas. However, updates are not expected in the short term due to AstraZeneca's request for confidentiality.
Q:What is the focus of the 4Q readout for the lasme-cel pivotal study, and how will the transition to the final pivotal cohort be managed?
A:The focus is on the 8-week composite data (efficacy, safety, and translational markers) for dose optimization. Recruitment will continue during the transition to the final pivotal cohort, ensuring no study interruptions.
Q:What are the views on in vivo CAR T and its potential applications?
A:In vivo CAR T may not be suitable for aggressive tumors requiring extensive gene editing and patient management. Challenges include reliance on patient T-cell fitness, off-target effects, and safety concerns with vector integration. It may be more applicable to autoimmune diseases or less aggressive conditions.
Q:Review of Unclear Management Responses
A:Management avoided providing specific recruitment numbers for eti-cel updates and did not disclose details about AstraZeneca partnership activities, citing confidentiality. They also did not provide a clear timeline for transitioning lymphodepletion to outpatient settings.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
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European Hematology
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dose IL
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CLLS Transcript
Cellectis S.A. (CLLS) Q4 2025 Earnings Call Transcript
Positive3-20
The earnings call summary indicates a positive sentiment due to strategic collaborations, particularly with AstraZeneca, and promising recruitment progress in pivotal studies. While financial specifics are lacking, optimistic guidance is given for upcoming milestones and data readouts. The Q&A reveals management's confidence in ongoing trials and commercial opportunities, despite some confidentiality constraints. The market is likely to respond positively, anticipating future growth and successful milestone achievements.
Cellectis S.A. (CLLS) Q2 2025 Earnings Call Transcript
Unknown8-5
The earnings call summary presents a mixed picture. Financials show a cash decrease, but the cash runway is secure until 2027. Product development updates are promising, with regulatory alignment and no barriers to Phase II trials. However, uncertainties remain, such as the Servier arbitration decision and lack of milestone payment details. The Q&A session did not reveal major negative sentiments but highlighted cautious optimism from management. The overall sentiment is neutral, as positive product development is offset by financial and legal uncertainties.
Cellectis S.A. (CLLS) Q4 2024 Earnings Call Transcript
Positive3-14
The earnings call reveals a strong financial position with significant investments from AstraZeneca and stable cash reserves. The Q&A section highlights confidence in upcoming data releases, suggesting positive future developments. The collaboration with AstraZeneca is fully reimbursed, reducing cash burn. Despite competitive pressures and supply chain challenges, the overall sentiment leans positive due to strategic partnerships and financial strength.
Cellectis S.A. (CLLS) Q3 2024 Earnings Call Transcript
Unknown11-5
The earnings call presents mixed signals. The AstraZeneca collaboration and strong cash position are positive indicators, but supply chain challenges and intense competition in cell and gene therapy pose risks. The Q&A reveals management's cautious approach to prioritizing projects and lack of clarity on future datasets. Additionally, deprioritizing UCART123 raises concerns. Despite these issues, the partnership with AstraZeneca provides a financial buffer, mitigating some negative impacts. Overall, the sentiment is neutral as positives balance out the negatives.
CLLS Report
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