Cellectis SEC Filings

Cellectis reported that the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasme-cel), its CD22‑targeting allogeneic CAR‑T cell therapy candidate for patients with relapsed or refractory B‑cell acute lymphoblastic leukemia. The company states this designation reflects FDA recognition of lasme‑cel’s potential to address unmet medical need, based on Phase 1 BALLI‑01 data showing promising efficacy and a manageable safety profile. Final Phase 1 BALLI‑01 data will be presented in an oral session at the 2026 European Hematology Association Congress on June 13. A pivotal Phase 2 portion of the BALLI‑01 trial is open for enrollment.

Cellectis S.A. is convening a combined general meeting of shareholders on June 25, 2026 in Paris to approve 2025 accounts, board renewals and extensive capital authorizations. The 2025 annual financial statements show a loss of 61,849,605 euros, while consolidated accounts show a loss of 67,592,758 US dollars. The loss will be allocated to retained earnings, which will then be cleared by transferring 61,849,605 euros from the share premium account, reducing it from 194,582,155.02 euros to 132,732,550.02 euros. Shareholders are asked to renew a share buyback program with a maximum unit price of 10 euros, a total cap of 10,000,000 euros and a limit of 10% of outstanding shares, with possible cancellation of up to 10% of capital every 24 months. Numerous resolutions would delegate to the board the power to issue new shares and securities, often with cancellation of preferential subscription rights, with aggregate nominal caps generally set at 2,514,775 euros (50% of current share capital of 5,029,549.70 euros) and debt issuance ceilings of up to 300,000,000 euros, including targeted issuances to sector investors, financing partners, development banks and via an at-the-market program in the U.S.

Cellectis S.A. has scheduled its annual shareholders general meeting for June 25, 2026 at 2:30 p.m. CET at the Biopark auditorium, 11 rue Watt, 4th floor, 75013 Paris, France. The formal notice and related meeting information are available on the company’s investor website.

Cellectis, a clinical-stage gene-editing company, announced that new clinical data on its allogeneic CAR-T candidates lasme-cel and eti-cel will be presented at the EHA 2026 congress in Stockholm. An oral presentation will cover full Phase 1 BALLI-01 results in relapsed or refractory B-cell acute lymphoblastic leukemia, which support a pivotal Phase 2 program now recruiting in Europe and North America. A poster will present preliminary Phase 1 NATHALI-01 data in relapsed or refractory B-cell non-Hodgkin lymphoma, exploring how alemtuzumab exposure and cytokine dynamics relate to expansion and response of the dual-targeting CD20/CD22 product. Interim BALLI-01 Phase 2 data and Phase 1 NATHALI-01 clinical data are planned to be disclosed in Q4 2026.

Cellectis reported a consolidated net loss attributable to shareholders of $17.8 million, or $0.18 per share, for the first quarter of 2026, similar to the prior year. Revenue and other income fell to $7.5 million from $12.0 million, mainly due to lower activity under the AstraZeneca collaboration, while R&D and SG&A expenses increased as the company invested in its pipeline.

The company ended March 31 2026 with $188 million in cash, cash equivalents, restricted cash and fixed-term deposits and believes this will fund operations into Q4 2027. Key programs include the pivotal Phase 2 BALLI‑01 trial of lasme‑cel in relapsed or refractory B‑ALL, with a first interim analysis expected in Q4 2026 and a planned BLA submission in 2028, and the Phase 1 NATHALI‑01 trial of eti‑cel in relapsed or refractory NHL, with a full Phase 1 dataset also expected in Q4 2026.

Cellectis highlighted interim pivotal ALPHA3 data from partner Allogene’s cema‑cel program, showing 58.3% MRD negativity in the cema‑cel arm versus 16.7% in the observation arm and a favorable safety profile. The company is also advancing a TALE‑based epigenetic editing platform and continues its AstraZeneca collaboration. Subsequently, Life Technologies Corporation, a Thermo Fisher subsidiary, purported to terminate certain license agreements and initiated arbitration over alleged underpaid royalties, which Cellectis contests.

Cellectis S.A. reported unaudited results for the three-month period ended March 31, 2026. Total revenues and other income were $7.5 million, down from $12.0 million a year earlier, mainly reflecting lower collaboration revenue recognized under its AstraZeneca joint research and collaboration agreement.

Research and development expenses rose to $27.2 million from $21.9 million, driven by higher personnel costs and clinical spending on the BALLI-01 and NATHALI-01 studies. The company posted an operating loss of $25.2 million and a net loss of $17.8 million, similar to the prior-year net loss, with earnings per share at $(0.18). A $6.5 million fair value gain on EIB warrants contributed to a net financial gain of $7.4 million. Cash and cash equivalents stood at $34.8 million, with an additional $150.6 million in fixed-term deposits classified as current financial assets, and management states these resources are sufficient to fund operations for at least twelve months after approval of the statements.

Cellectis S.A. filed a Form 6-K announcing it will release first quarter 2026 financial results, for the period ending March 31, 2026, on May 11, 2026 after the close of the U.S. market. The release will be posted in the Investors section of its website and no conference call will be held.

The filing also reiterates that Cellectis is a clinical-stage biotechnology company using its gene-editing platform to develop allogeneic CAR T immunotherapies and other cell and gene therapies, with headquarters in Paris and additional locations in New York and Raleigh.

Cellectis filed a Form 6-K sharing a press release on new epigenetic editing research presented at the ASGCT annual meeting. The work uses TALE-based epigenetic modulators (TALEM) to turn genes off without cutting or permanently changing DNA, which the company describes as a potentially safer genome-editing approach.

Cellectis developed a high-throughput screening system to rapidly assemble and test hundreds of TALEM constructs and identified combinations that strongly control specific genes. In hepatocytes and T-cells, the method achieved more than 90% sustained reduction in target gene activity, supporting Cellectis’ broader gene-editing and allogeneic CAR T therapy platform.

Cellectis reports interim data from Allogene’s pivotal ALPHA3 trial of cema-cel in first-line consolidation for large B‑cell lymphoma. In the futility analysis, 58.3% of patients in the cema‑cel arm achieved minimal residual disease negativity versus 16.7% in the observation arm, suggesting a strong signal for disease control. Allogene also reported that cema‑cel was generally well tolerated, with most patients treated as outpatients and no serious treatment‑related safety events at the cutoff. Cellectis notes that, under its Servier agreement, it may receive up to $340 million in milestones plus low double‑digit royalties if licensed CD19 products like cema‑cel reach the market.