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CLLS

Cellectis S.A.

NASDAQ · Healthcare · Biotechnology · FR

$3.24
−2.41%
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Analyst consensus

Next report date
Nov 13, 2026
EPS estimate
-$0.20
Revenue estimate
$15.2M

Latest reported

Last report date
Aug 6, 2026
EPS actual
-$0.22
EPS estimate
-$0.26
Revenue actual
$6.9M
Revenue estimate
$11.0M

Track record

Trailing twelve quarters

EPS beats (12Q)
6
EPS misses (12Q)
6
EPS in line (12Q)
0
Avg surprise (4Q)
+32.2%
Revenue beats (12Q)
2
Earnings call summaryRead the full call →

Q1 FY2026 · May 11, 2026

AI summary of management’s prepared remarks and analyst Q&A · For informational purposes only, not investment advice

Management highlights

  • Upcoming Investor Event: Selectus will host an in-person Investors R&D Day in New York City on October 16, 2025. Leadership and key opinion leaders will present the Phase 1 dataset and late-stage development strategy for Lasmacel (UCAR T22) for relapsed or refractory acute lymphoblastic leukemia, and share the company's strategic vision. A recording of the event will be made available after the event.
  • Lead Pipeline Progress (Lasmacel/UCAR T22, BALI-01 Study): In July 2025, Selectus completed end-of-Phase 1 discussions with both the FDA and EMA. Recruitment for the Phase 1 dose-escalation portion of the BALI-01 study for relapsed/refractory B-cell acute lymphoblastic leukemia is complete. The study addresses unmet need for patients who have relapsed after multiple prior lines of therapy (including CD19 bispecifics or autologous CAR-T), who have few remaining treatment options. The full Phase 1 dose escalation dataset will be publicly shared at the October 16 R&D Day, and additional data has been submitted for presentation at the ASH annual conference in Q4 2025. Additional trial sites are being set up to accelerate Phase 2 accrual, with sites expected to open for enrollment by the end of 2025.
  • Second Pipeline Progress (Eticelle/UCAR T20by22, Nathalie 01/NAFSA 01 Study): Enrollment is ongoing in the Phase 1 study of the dual CAR-T product UCAR 2022 for relapsed/refractory non-Hodgkin's lymphoma, which addresses unmet need for patients who have relapsed after prior therapy (including autologous CD19 CAR-T when available). The clinical trial footprint is being expanded to accelerate recruitment, with transition to Phase 2 preparation planned for 2026. Data from this program has also been submitted for presentation at the ASH annual conference in Q4 2025. Phase 1 data and a late-stage development strategy are expected to be presented by the end of 2025.
  • AstraZeneca Partnership: Three cell and gene therapy programs under the joint research and collaboration agreement with AstraZeneca remain in active development: one allogenic CAR-T for hematological malignancies, one allogenic CAR-T for solid tumors, and one in vivo gene therapy for a genetic disorder.
  • Servier Arbitration: After Servier's 2022 decision to cease development of the licensed CD19 products, Selectus initiated arbitration with the Paris Mediation and Arbitration Center to protect its interests. The company is seeking termination of the agreement with Servier and fair compensation for losses incurred from halted development and unpaid contractual milestones. A final arbitral decision is expected to be issued on or before December 15, 2025.
  • Corporate Governance Update: Mr. Andre Muller was appointed to Selectus' board of directors at the 2025 annual shareholders meeting. The company thanked outgoing directors Mr. Pierre Bastide and Mr. Axel Sven Malkamas for their exceptional contributions to the company's strategic advancement over their tenure.
  • Financial Position: As of June 30, 2025, the company holds $230 million in total cash, cash equivalents, restricted cash and fixed-term deposits, which management confirms is sufficient to fund operations into H2 2027.

Guidance

  • A pivotal Phase 2 trial for Lasmacel (UCAR T22) in relapsed/refractory acute lymphoblastic leukemia is planned to initiate in the second half of 2025, with all trial costs included in the cash runway projection that extends into H2 2027.
  • Phase 1 data presentation for Eticelle (UCAR T20by22) and a finalized late-stage development strategy for the program are expected to be released by the end of 2025, with transition to Phase 2 preparation planned for 2026.
  • The arbitral decision in the Servier arbitration proceeding is confirmed to be expected on or before December 15, 2025.
  • Cash runway is projected to extend into the second half of 2027, and this projection includes all costs required to complete the pivotal Phase 2 trial for Lasmacel, plus planned costs for Eticelle development. Probabilistic assumptions have been used for potential milestone and non-diluted funding inflows, leaving room for upside if these are realized.
  • No upward or downward revisions to prior core operational or financial guidance were announced.

Segment performance

Selectus does not break out financial performance for multiple distinct product segments in this earnings call. Only overall corporate cash position and consolidated operating cash flows are reported: as of June 30, 2025, total cash, cash equivalents, restricted cash and fixed-term deposits (classified as current and non-current financial assets) amounted to $230 million, down from $264 million as of December 31, 2024. The $33.2 million decrease was primarily driven by $23.2 million in supplier cash payments, $23.6 million in payroll, bonus and social expense payments, $5.4 million in lease debt payments, and $2.6 million in PGE loan repayments, partially offset by $13.4 million in cash from revenue and $5.1 million in interest income. No separate segment-level revenue or profit figures are provided.

Risks & headwinds

  • All forward-looking statements regarding clinical trial progress, trial outcomes, partnership activities, the Servier arbitration result, and sufficiency of cash to fund operations are subject to inherent risks and uncertainties that could cause actual results to differ materially from current expectations. A full description of material risks is available in the company's most recent Form 20-F filed with the SEC for the year ended December 31, 2024 and subsequent SEC filings.
  • The outcome of the ongoing Servier arbitration cannot be predicted with certainty; any outcome from a ruling in Selectus' favor to a ruling against the company is possible.
  • Clinical trial success is dependent on achieving positive safety and efficacy results, which cannot be guaranteed prior to trial completion.
  • Allogene's recent decision to discontinue development of its CD52 lymphodepletion antibody introduces market uncertainty around this regimen, though management has stated that its regimen is meaningfully different from Allogene's, reducing direct risk to Selectus' programs.

Analyst Q&A

Q1 (Gina Wang, Barclays): 1) Can you describe the different possible scenarios for the December 15 Servier arbitration decision and outline your likely actions for each scenario? 2) You have completed meetings with the FDA and EMA about the pivotal Phase 2 trial design for Lasmacel; can you share high-level insights on the path forward?
A1: For the arbitration question, it is not possible to outline specific scenarios because the final decision is still pending, and any outcome is possible. Management believes its position is fully justified, hopes to prevail, regain rights to the CD19 programs, and receive compensation for losses from Servier's halted development, but it has not pre-planned specific actions for any potential outcome and does not have a pre-set backup plan at this time. For the regulatory question: interactions with both agencies were productive. EMA provided clear written feedback on the company's submission, and the FDA meeting was held face-to-face. Both agencies provided clear guidance, agreed on trial endpoints, raised no concerns about the statistical plan, and raised no issues regarding the size of the database required for a future BLA. Full details of the trial design will be shared at the October 16 R&D Day. Overall, there is a clear path forward for the Phase 2 program, with aligned feedback from both regulators.


Q2 (NTU, on behalf of Kelly Shih, Jefferies): 1) What specific data points can we expect to be released at the October R&D Day? 2) If the trial design will only be disclosed at the event, how do you assess potential impacts from FDA dynamics that could affect the pivotal trial?
A2: The R&D Day will have two core focuses: first, presentation of the full Phase 1 dataset for Lasmacel, including safety, efficacy, and durability data for all dosed patients with a specific focus on patients treated at the recommended Phase 2 dose; second, presentation of the full late-stage development strategy, including the final Phase 2 trial design, target patient population, and context on the path to BLA and commercialization. Regarding regulatory risks, no barriers to progressing to Phase 2 were identified in interactions with either regulator. Both agencies acknowledged the high unmet need in the patient population and are broadly supportive of the program. There is alignment on endpoints, study design, and planned patient numbers, and management sees no significant roadblocks. The registration path for Lasmacel is currently clear, and full details will be shared at R&D Day.


Q3 (Jack Allen, Baird): 1) What does the company consider the bar for success for Lasmacel (UCAR22) in relapsed/refractory ALL, what are expectations for response durability, and how much follow-up data on Phase 1 patients will be available at the October R&D Day? 2) What are management's high-level thoughts on Allogene's recent decision to move away from CD52 lymphodepletion, and will you still include alimtuzumab in the pivotal UCAR22 study? 3) What protocols have you put in place to mitigate infection risk related to CD52 depletion's extended T cell suppression?
A3: Full details on endpoints, endpoint timing, and success metrics will be shared at the October 16 R&D Day. Durability of response is a key priority for allogeneic CAR-T, and the planned trial design agreed with regulators will generate adequate data to support registration if results are positive. A 15-year long-term follow-up is required for all patients, with extended overall survival follow-up over multiple years, though long-term survival is not part of the primary analysis (the primary analysis uses a shorter-term surrogate endpoint that has been agreed with regulators). Regarding Allogene's decision: management has followed the news closely, but the programs are not comparable. Allogene's candidate targets earlier-stage disease than Selectus' late-stage ALL/NHL indication, Allogene's product uses a higher dose than the dose Selectus uses, and the risk-benefit profile is very different between the two programs. Additionally, Allogene's product (Allo647) is structurally different from the alimthuzumab that Selectus uses (Selectus secured direct access to alimthuzumab from Sanofi years ago, and the structural and glycosylation differences between the two products mean they cannot be directly compared). Selectus remains confident in its risk-benefit assessment with alimthuzumab and will continue to use it. Regarding infection risk mitigation: mandatory infection prophylaxis is already a required part of all trial protocols, and extensive risk mitigation strategies are already built into trial design. The team remains vigilant for any emerging risks.


Q4 (Yanan Zhu, Wells Fargo Securities): 1) Will the pivotal Lasmacel trial target the specific post-CD19 CAR-T patient population, or a broader population? Will the trial size be in a similar range to recent autologous CD19 CAR-T programs for B-ALL, or will it be smaller? 2) Can you share an estimate of the milestone payments that could be awarded as part of the Servier arbitration?
A4: The trial will target late-stage disease with a broad age cutoff, and most enrolled patients will have received multiple prior lines of therapy including prior CD19 CAR-T. A full patient population breakdown will be shared at R&D Day. Trial size is driven primarily by safety database requirements, which take precedence over statistical powering; looking at recent autologous CD19 CAR-T programs for B-ALL will give a reasonable ballpark estimate of the patient count. No details on the potential arbitration award amount can be shared because the arbitration is an ongoing active legal matter.


Q5 (Sebastian van der Schoot, Campton): 1) After Allogene's decision to discontinue their anti-CD52 antibody program, do you expect any regulatory feedback or changes to your pivotal trial design that still includes anti-CD52, since your regulatory meetings predated Allogene's announcement? 2) Does the projected cash runway into H2 2027 include the full cost of completing the Lasmacel pivotal trial? 3) What size data set can we expect for Eticelle when it is presented by the end of the year? Will it be a similar size to the Lasmacel data set presented in October?
A5: No changes to the trial design or regulatory conversations are expected, because Selectus already has an established safety profile and confirmed positive risk-benefit assessment for its alimthuzumab regimen. Allogene's product is different, and Selectus uses a significantly lower dose than Allogene used. Regulators already reviewed the full Phase 1 package including detailed safety data for Selectus' regimen, so no adjustments are anticipated. Yes, the H2 2027 cash runway does include the full cost of the Lasmacel pivotal trial, as well as planned costs for Eticelle development. Management has used conservative probabilistic assumptions for potential milestone and non-diluted funding inflows, so there is upside potential if these are realized. For Eticelle, the Phase 1 data set will be smaller than the Lasmacel Phase 1 data set, as Lasmacel is the lead candidate with more patients dosed in Phase 1. Full details will be available in the ASH presentation when it is released.


Q6 (Mark, on behalf of Salveen Richter, Goldman Sachs): There has been recent positive data from autologous dual-targeting CAR-Ts for NHL; how does this data read through to Eticelle, and what makes Eticelle differentiated in the dual-targeting CAR-T space?
A6: Full details on Eticelle's profile and differentiation will be shared when data is presented at ASH (if accepted), but two key points set it apart from most competing dual-targeting programs. Unlike the majority of recent dual-targeting candidates that target CD19 paired with a second antigen, Eticelle targets CD20 and CD22, with no CD19 targeting. This makes it uniquely suited for patients who have already received one or more CD19-targeted therapies, a large and growing patient population as CD19 CAR-T moves into earlier lines of therapy (a shift that Selectus would benefit from, as it increases unmet need for non-CD19 targeted options). Eticelle is also an off-the-shelf allogeneic product, which means it does not require leukapheresis or patient-specific manufacturing, making it a more immediately accessible option for late-stage patients than autologous alternatives.

Reported results against consensus at the time of each report · Surprise is computed from the estimate on record · Data as of Nov 13, 2026