Cellectis S.A. (CLLS) Q2 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
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.
Key Financial Performance
Cash, Cash Equivalents, and Fixed-Term Deposits $230 million as of June 30, 2025, compared to $264 million as of December 31, 2024, a decrease of $33.2 million. The decrease is mainly due to $13.4 million of cash inflow from revenue and $5.1 million of interest income, offset by cash payments to suppliers ($23.2 million), wages, bonuses, and social expenses ($23.6 million), lease debt payments ($5.4 million), and repayment of the PGE loan ($2.6 million).
You have reached the limit. Sign up to access full content
Get started
Operating Highlights
UCART22 (lasme-cel): Completed Phase I trials for relapsed or refractory acute lymphoblastic leukemia. Preparing for pivotal Phase II trial in H2 2025. Additional trial sites being set up in the US, Europe, and UK.
UCART20x22 (eti-cel): Phase I trials ongoing for relapsed or refractory non-Hodgkin lymphoma. Data to be presented at ASH Annual Conference in Q4 2025. Transition to Phase II preparation expected in 2026.
Geographic Expansion: Expanding clinical trial sites in the US, Europe, and UK to accelerate recruitment for UCART22 and UCART20x22 trials.
Financial Position: Cash, cash equivalents, and fixed-term deposits as of June 30, 2025, amount to $230 million, sufficient to fund operations into H2 2027.
R&D Collaboration: Ongoing research and development under partnership with AstraZeneca, including three cell and gene therapy programs for hematological malignancies, solid tumors, and a genetic disorder.
Arbitration with Servier: Arbitral decision expected by December 15, 2025, regarding termination of agreement and compensation for losses due to halted CD19 product development.
Leadership Changes: André Muller appointed to Board of Directors. Gratitude expressed to outgoing directors Pierre Bastid and Axel-Sven Malkomes for their contributions.
You have reached the limit. Sign up to access full content
Get started
Risk or Challenges
Regulatory Challenges: The company faces regulatory challenges in advancing its clinical trials, including the need for productive interactions with the FDA and EMA to progress to Phase II trials. This could delay timelines or impact trial outcomes.
Arbitration with Servier: Cellectis is involved in an arbitration with Servier regarding the termination of a licensing agreement and compensation for losses. The outcome of this arbitration, expected by December 2025, could impact financials and strategic plans.
Financial Sustainability: While the company has sufficient cash to fund operations into H2 2027, there has been a $33.2 million decrease in cash reserves in the first half of 2025, which could pose risks if revenue generation does not improve.
Clinical Trial Recruitment: Challenges in recruiting patients for clinical trials, particularly for Phase II studies, could delay the development and approval of key product candidates.
Market Challenges in Biotech: The company acknowledges the challenges of the biotech market, which could impact funding, partnerships, and overall business operations.
You have reached the limit. Sign up to access full content
Get started
Guidance & Outlook
Initiation of pivotal Phase II trial for lasme-cel (UCART22): Cellectis plans to initiate the pivotal Phase II trial for lasme-cel (UCART22) in relapsed or refractory acute lymphoblastic leukemia in the second half of 2025. Additional trial sites are being set up in the United States, Europe, and the United Kingdom to accelerate recruitment.
NatHaLi-01 study progress: Cellectis anticipates presenting Phase I data and outlining the late-stage development strategy for the NatHaLi-01 study (UCART20x22) in relapsed or refractory non-Hodgkin lymphoma by late 2025. Transition to Phase II preparation is expected in 2026.
R&D Day announcement: Cellectis will host an Investors R&D Day on October 16, 2025, to present Phase I data and late-stage development strategy for lasme-cel (UCART22) and share insights on the company's vision and capabilities.
ASH Annual Conference submissions: Phase I data from both the BALLI-01 (UCART22) and NatHaLi-01 (UCART20x22) studies have been submitted for presentation at the ASH Annual Conference in Q4 2025.
AstraZeneca partnership: Research and development activities are ongoing under the partnership with AstraZeneca, focusing on three programs: one allogeneic CAR-T for hematological malignancies, one allogeneic CAR-T for solid tumors, and one in vivo gene therapy for a genetic disorder.
Arbitration with Servier: The arbitral decision regarding the dispute with Servier is expected to be rendered on or before December 15, 2025.
Financial outlook: Cellectis' cash, cash equivalents, and fixed-term deposits as of June 30, 2025, are sufficient to fund operations into the second half of 2027.
You have reached the limit. Sign up to access full content
Get started
Shareholder Return Plan
The selected topic was not discussed during the call.
You have reached the limit. Sign up to access full content
Get started
Key Q&A
Q:What are the potential outcomes and actions regarding the Servier arbitration decision by December 15?
A:Andre Choulika stated that it is difficult to forecast the arbitration decision. He hopes to prevail, which would mean regaining CD19 products and receiving compensation for losses. However, he emphasized keeping all scenarios open and refrained from speculating on potential outcomes.
Q:What are the high-level thoughts on the pivotal Phase II trial design for lasme-cel after meetings with the FDA and EMA?
A:Adrian Kilcoyne mentioned that the EMA provided clear written feedback, while the FDA meeting was face-to-face. Both regulatory authorities were aligned and supportive, with no concerns about endpoints, statistical plans, or database size. Detailed study design will be shared at the R&D Day on October 16.
Q:What data points should be expected at the R&D Day, and how might FDA dynamics impact pivotal trials?
A:Arthur Stril explained that the R&D Day will present the full Phase I data set for lasme-cel, focusing on safety, efficacy, and durability, as well as the late-stage development strategy, including Phase II design and path to BLA. Adrian Kilcoyne added that there are no barriers from regulatory authorities to progressing to Phase II, and alignment on endpoints and study design has been achieved.
Q:What is the bar for success and expectations for durability of response for UCART22 in relapsed or refractory settings?
A:Adrian Kilcoyne emphasized the importance of durability of response in the allogeneic setting. Regulatory authorities are aligned on the approach, and the primary analysis will focus on short-term surrogate endpoints. Long-term follow-up is planned but not part of the primary analysis.
Q:What are the thoughts on Allogene's decision to move away from CD52 lymphodepletion, and will alemtuzumab be included in UCART22 pivotal studies?
A:Adrian Kilcoyne and Arthur Stril stated that alemtuzumab is critical for their programs and emphasized differences between their approach and Allogene's. They are confident in their risk-benefit assessment and have secured access to alemtuzumab. They do not foresee changes to their pivotal study design based on Allogene's decision.
Q:What measures are in place to mitigate infection risks in studies involving CD52 lymphodepletion?
A:Adrian Kilcoyne mentioned that mandatory prophylaxis and significant risk mitigation strategies are already built into their trials.
Q:What is the population and patient number for the pivotal trial in the BALL program?
A:Adrian Kilcoyne stated that the trial will target a late-stage treatment population with a broad age range and significant prior lines of therapy, including CD19 CAR-T. Patient numbers will be driven by safety database requirements, similar to other autologous CD19 CAR-T trials.
Q:What is the size of milestone payments potentially awarded in the Servier arbitration?
A:Arthur Stril declined to provide details, citing the ongoing legal matter.
Q:Does the cash runway include the completion of pivotal studies for lasme-cel?
A:Arthur Stril confirmed that the cash runway into H2 2027 includes costs for pivotal studies for both lasme-cel and eti-cel, with potential upside from milestones and non-dilutive funding.
Q:What is the size of the data set for eti-cel by year-end?
A:Adrian Kilcoyne noted that the eti-cel data set will be smaller than lasme-cel's Phase I program due to fewer patients.
Q:How is eti-cel differentiated in the dual-targeting CAR-T space?
A:Adrian Kilcoyne and Arthur Stril highlighted that eti-cel targets CD20 and CD22, not CD19, making it relevant for patients who have already received CD19-targeted therapies. Its off-the-shelf nature and focus on orthogonal targets differentiate it from autologous dual-targeting CAR-Ts.
Q:Could Allogene's decision on CD52 lymphodepletion influence the design of pivotal studies?
A:Adrian Kilcoyne stated that they do not foresee changes to their pivotal study design based on Allogene's decision, as their safety profile and risk-benefit assessment are well-established.
Q:Review of Unclear Management Responses
A:Management avoided providing details on the size of milestone payments potentially awarded in the Servier arbitration, citing the ongoing legal matter.
You have reached the limit. Sign up to access full content
Get started
Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
ASH Annual
Adrian
Andre
Annual Conference
Cellectis Investors
Chief Officer
II study
Investors RD
LLC Research
Mr
Phase II
Phase stage
RD Day
Research Division
United States
agreement decision
arbitration
cel acute
development lasme
end Phase
eti cel
event
interest
lasme cel
leukemia study
presentation ASH
recruitment Phase
site recruitment
stage development
timing
trial site
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
Frequently Asked Questions
Where does this earnings call transcript come from?
All transcripts are sourced directly from the official live webcast or the company’s official investor relations website. We use the exact words spoken during the call with no paraphrasing of the core discussion.
How soon is the transcript available after the earnings call ends?
Full verbatim transcripts are typically published within 4–12 hours after the call ends. Same-day availability is guaranteed for all S&P 500 and most mid-cap companies.
Is the transcript edited or altered in any way?
No material content is ever changed or summarized in the “Full Transcript” section. We only correct obvious spoken typos (e.g., “um”, “ah”, repeated 10 times”, or clear misspoken ticker symbols) and add speaker names/titles for readability. Every substantive sentence remains 100% as spoken.
Why do some answers appear as “Unclear” or “Inaudible”?
When audio quality is poor or multiple speakers talk over each other, we mark the section instead of guessing. This ensures complete accuracy rather than introducing potential errors.
Who creates the AI Summary and Key Q&A highlights shown above the transcript?
They are generated by a specialized financial-language model trained exclusively on 15+ years of earnings transcripts. The model extracts financial figures, guidance, and tone with 97%+ accuracy and is regularly validated against human analysts. The full raw transcript always remains available for verification.
