UCART19 V1
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Cellectis Reports Full Year 2025 Financial Results and Provides a Business Update
Globenewswire· 2026-03-19 23:21
Core Insights - Cellectis is advancing its clinical-stage biotechnology efforts with promising data from its CAR-T therapies, particularly lasme-cel, which has shown a 100% overall response rate in a pivotal Phase 2 trial for relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) [3][5][11] - The company reported financial results for the year ending December 31, 2025, highlighting a significant increase in revenues and ongoing investments in research and development [2][33][39] Clinical Developments - Lasme-cel has demonstrated a 100% overall response rate in the target Phase 2 population, converting all patients into transplant-eligible candidates [3][10] - The pivotal Phase 2 trial (BALLI-01) is currently enrolling, with interim analysis expected in Q4 2026 and a Biologics License Application (BLA) submission anticipated in 2028 [3][11] - Eti-cel, another product in development for relapsed or refractory non-Hodgkin lymphoma (r/r NHL), has shown an 88% overall response rate and 63% complete response rate in preliminary Phase 1 data [16][33] Financial Performance - Cellectis reported consolidated revenues of $79.6 million for the year ended December 31, 2025, compared to $49.2 million in 2024, marking a $30.4 million increase primarily driven by research activities and collaboration agreements [33][39] - The company had cash, cash equivalents, and fixed-term deposits totaling $211 million as of December 31, 2025, providing a financial runway into H2 2027 [4][30] - Consolidated net loss attributable to shareholders was $67.6 million for 2025, compared to a loss of $36.8 million in 2024, reflecting increased revenues offset by higher operating expenses and financial losses [39][40] Research and Development - Cellectis is focusing on the development of its pipeline, including lasme-cel and eti-cel, with ongoing clinical trials and the exploration of new product candidates [32][33] - The company is also advancing its gene editing technologies, including the use of circular single-stranded DNA (cssDNA) as a non-viral template for gene therapy, which has shown superior efficiency compared to traditional methods [13][17] Partnerships - Cellectis has established a Joint Research and Collaboration Agreement with AstraZeneca to develop up to 10 novel cell and gene therapy products targeting high unmet medical needs [21][27] - The company is also collaborating with Servier and Allogene on various CAR-T therapies, with potential milestone payments and royalties from these partnerships [27][21]
Allogene Arbitration Victory Pressures Cellectis Shares Tuesday
Benzinga· 2025-12-16 18:09
Core Viewpoint - Cellectis S.A. shares declined significantly following a favorable arbitration outcome for Allogene Therapeutics, which confirmed Allogene's control over the CAR-T therapy cema-cel and its path to global commercialization rights from Servier [1][4]. Group 1: Legal Outcome and Implications - The arbitration tribunal ruled in favor of Allogene, rejecting Cellectis's claims regarding Servier's development obligations and financial claims related to milestone payments [4]. - The tribunal ordered a partial termination of the license concerning the UCART19 V1 product, directing Cellectis to negotiate a direct license with Allogene under similar terms if Allogene chooses to pursue it [4]. Group 2: Market Reaction - Following the arbitration news, Cellectis's stock fell by 17.35% to $3.96, while Allogene's stock rose by 1.37% to $1.49 [3]. Group 3: Future Developments - Allogene is entering a critical period in the allogeneic CAR T field, with an interim futility analysis scheduled for the first half of 2026, which will compare MRD conversion with cema-cel against standard treatment in first-line patients with large B-cell lymphoma [2].
Cellectis Announces Arbitral Decision in Dispute with Servier
Globenewswire· 2025-12-15 21:51
Core Insights - Cellectis announced a decision from the Arbitral Tribunal regarding its arbitration with Servier related to the License Agreement established on March 6, 2019 [1][2] - The Tribunal partially terminated the License Agreement concerning product UCART19 V1 and mandated Cellectis to engage in discussions for a direct license at Allogene's request [2] Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing cell and gene therapies using its gene-editing platform [3] - The company specializes in allogeneic CAR T immunotherapies, aiming to provide off-the-shelf gene-edited CAR T-cells for cancer treatment [3] - Cellectis maintains in-house manufacturing capabilities, positioning itself as a comprehensive player in the gene editing value chain [3] Company Locations and Listings - Cellectis is headquartered in Paris, France, with additional locations in New York and Raleigh, NC [4] - The company is publicly traded on the Nasdaq Global Market under the ticker CLLS and on Euronext Growth under the ticker ALCLS [4]