NEW YORK, Oct. 07, 2025 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, announced today that findings highlighting the strong potential of circular single-stranded DNA (CssDNA) as a universal, efficient non-viral template for gene therapy, along with a comprehensive study of TALE base editors (TALEB) off-targets in the nuclear genome, will b ...

Group 1: U.S. Stock Market Overview - U.S. stock futures were higher, with Dow futures gaining over 100 points on Monday [1] Group 2: Inventiva ADR Performance - Inventiva reported losses of $(1.84) per share, significantly worse than the analyst consensus estimate of a loss of 41 cents per share [1] - The company reported quarterly sales of $5.050 million, missing the analyst consensus estimate of $5.310 million [1] - Inventiva shares dipped 5.5% to $5.72 in pre-market trading [1] Group 3: Other Stocks in Pre-Market Trading - MoonLake Immunotherapeutics saw a significant decline of 86.3% to $8.50 in pre-market trading [4] - Cellectis SA declined 10.4% to $3.01 in pre-market trading [4] - Quantum-Si Inc fell 10.1% to $1.34 in pre-market trading after filing for a mixed shelf of up to $300 million [4] - Penguin Solutions Inc decreased by 8.4% to $24.00 in pre-market trading [4] - Lithium Americas Corp declined 5.4% to $5.99 in pre-market trading after a 14% drop on Monday [4] - Platinum Analytics Cayman Ltd fell 5.3% to $16.20 in pre-market trading after a 44% increase on Monday [4] - Novo Nordisk A/S decreased by 2.9% to $54.01 in pre-market trading [4] - Lexicon Pharmaceuticals Inc declined 2.9% to $1.36 in pre-market trading, recently announcing an update on submission of additional data to the U.S. FDA regarding Zynquista® in Type 1 Diabetes [4]

Group 1: U.S. Stock Market Overview - U.S. stock futures were higher, with Dow futures gaining over 100 points on Monday [1] Group 2: Inventiva ADR Performance - Inventiva reported a loss of $(1.84) per share, significantly worse than the analyst consensus estimate of a loss of 41 cents per share [1] - The company’s quarterly sales were $5.050 million, missing the analyst consensus estimate of $5.310 million [1] - Inventiva shares fell 5.5% to $5.72 in pre-market trading [1] Group 3: Other Stocks in Pre-Market Trading - MoonLake Immunotherapeutics saw a significant decline of 86.3% to $8.50 in pre-market trading [4] - Cellectis SA declined 10.4% to $3.01 in pre-market trading [4] - Quantum-Si Inc fell 10.1% to $1.34 in pre-market trading after filing for a mixed shelf of up to $300 million [4] - Penguin Solutions Inc dropped 8.4% to $24.00 in pre-market trading [4] - Lithium Americas Corp declined 5.4% to $5.99 in pre-market trading after a 14% dip on Monday [4] - Platinum Analytics Cayman Ltd fell 5.3% to $16.20 in pre-market trading after a 44% jump on Monday [4] - Novo Nordisk A/S decreased by 2.9% to $54.01 in pre-market trading [4] - Lexicon Pharmaceuticals Inc declined 2.9% to $1.36 in pre-market trading, with an update on additional data submission to the U.S. FDA regarding Zynquista® in Type 1 Diabetes [4]

Financial Data and Key Metrics Changes - As of June 30, 2025, the company's cash, cash equivalents, and fixed-term deposits amounted to $230 million, a decrease of $33.2 million from $264 million as of December 31, 2024, primarily due to cash payments to suppliers and operational expenses [14][14][14] - The company reported a consolidated net loss attributable to shareholders for the six months ended June 30, 2025, with specific figures available in the press release [14] Business Line Data and Key Metrics Changes - The recruitment for the dose escalation component of the Phase I BALL E-one study evaluating UCART22 in relapsed/refractory B cell acute lymphoblastic leukemia has been completed, with a pivotal Phase II study expected to commence in the second half of 2025 [9][10] - The NATALI-one study assessing ETICELL product YOCAR T20 in relapsed/refractory non-Hodgkin's lymphoma is ongoing, with data presentation anticipated in late 2025 [5][11] Market Data and Key Metrics Changes - The company is expanding clinical trial sites in the United States and Europe to accelerate recruitment for the Phase II study, with plans to have sites open by the end of the year [10][11] Company Strategy and Development Direction - Cellectis is focused on advancing research and developing solutions for patients with unmet medical needs, with a strategic collaboration with AstraZeneca on three cell and gene therapy programs [4][5] - The company is preparing for an R&D Day on October 16, 2025, to present the Phase I dataset and late-stage development strategy for UCART22 [3][4] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of ongoing clinical trials and the potential for their product candidates to lead to significant advancements in treating hard-to-treat cancers and genetic disorders [15] - The company remains optimistic about its financial position, indicating sufficient cash to fund operations into the second half of 2027 [14] Other Important Information - An arbitration decision regarding the licensing agreement with Servier is expected by December 15, 2025, with the company seeking compensation for losses incurred due to the lack of development of licensed products [5][6][14] - The company welcomed a new board member, Andre Muller, and acknowledged the contributions of departing directors [6][7] Q&A Session Summary Question: Contextualization of Servier arbitration scenarios and actions - Management indicated that it is complicated to predict outcomes but expressed hope for a favorable decision that would restore their CD19 products and provide compensation for losses [18] Question: High-level thoughts on pivotal Phase II trial design - Management confirmed productive interactions with both FDA and EMA, with clear agreement on endpoints and no concerns raised about the statistical plan [20][21] Question: Data points expected at R&D Day and FDA dynamics - The R&D Day will present the full Phase I dataset for LASMA cell, including safety, efficacy, and durability data, along with the late-stage development strategy [26][28] Question: Bar for success in relapsed refractory ALL - Management stated that details on endpoints and timing will be shared during the R&D Day, emphasizing the importance of durability of response [35][36] Question: Feedback from regulators on anti-CD52 inclusion - Management does not foresee changes to the pivotal study design based on Allogene's recent decisions, citing established safety profiles and risk-benefit assessments [58] Question: Cash runway and pivotal study completion - The cash runway into H2 2027 includes costs for pivotal studies for both LASMA cell and ETICELL, with prudent assumptions made regarding cash inflows [60] Question: Size of data set for ETICELL - The data set for ETICELL will be smaller than that for LASMA cell, reflecting the different stages of development [62] Question: Differentiation of ETICELL in dual targeting space - Management highlighted that ETICELL targets different antigens compared to competitors, positioning it uniquely in the market [70][71]

Core Insights - Cellectis reported financial results for Q2 2025, highlighting advancements in its gene editing platform and ongoing clinical trials for its therapies [1][11][34] - The company is preparing for a pivotal Phase 2 trial for lasme-cel (UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), expected to start in the second half of 2025 [3][6] - Cellectis will host an Investor R&D Day on October 16, 2025, to present Phase 1 data and discuss its late-stage development strategy [2][5] Financial Performance - As of June 30, 2025, Cellectis had $230 million in cash, cash equivalents, and fixed-term deposits, providing a financial runway into H2 2027 [11][38] - Consolidated revenues and other income for the first half of 2025 were $30.2 million, up from $16.0 million in the same period of 2024, primarily due to a $20 million increase from the AstraZeneca Joint Research Collaboration Agreement [16] - The net loss attributable to shareholders for the first half of 2025 was $41.9 million, compared to a net loss of $19.6 million in the same period of 2024 [21][27] Clinical Development - The company completed end-of-Phase 1 meetings with the FDA and EMA for lasme-cel in July 2025, marking a significant regulatory milestone [3][6] - Cellectis is also advancing the NatHaLi-01 study for eti-cel (UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL), with a Phase 1 readout expected in late 2025 [4][5] - The company is engaged in ongoing R&D activities under its partnership with AstraZeneca, focusing on three cell and gene therapy programs [8][5] Corporate Updates - André Muller was appointed as a director to Cellectis' Board of Directors [5][13] - The company is involved in arbitration proceedings with Servier, with a decision expected by December 15, 2025 [9][5] - Cellectis continues to manage its operations and pipeline development, focusing on manufacturing and clinical trial expenses for its product candidates [15][11]

Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing life-saving cell and gene therapies using its gene-editing platform [2][3] - The company is pioneering an allogeneic approach for CAR T immunotherapies in oncology, offering off-the-shelf and ready-to-use gene-edited CAR T-cells for cancer treatment [2][3] - Cellectis has in-house manufacturing capabilities, making it one of the few end-to-end gene editing companies that control the entire cell and gene therapy value chain [2] Financial Reporting - Cellectis will report its financial results for the second quarter of 2025 on August 4, 2025, after the close of the US market [1] - An investor conference call and webcast will take place on August 5, 2025, at 8:00 AM ET, to discuss the second quarter results and provide updates on business activities [2] Contact Information - Media contacts include Pascalyne Wilson and Patricia Sosa Navarro for communications inquiries [4] - Investor relations inquiries can be directed to Arthur Stril, the Chief Financial Officer & Chief Business Officer [4]

Core Points - Cellectis held a shareholders general meeting on June 26, 2025, where approximately 57% of voting rights were exercised, resulting in the adoption of resolutions 1 through 23 and resolutions 25 and 26, while resolution 24 was rejected [2] - Mr. André Muller was appointed to the Board of Directors, while Mr. Axel-Sven Malkomes' term expired and Mr. Pierre Bastid's resignation became effective [3][4] - The Chairman of the Board, Jean-Pierre Garnier, expressed gratitude for the contributions of the departing directors and highlighted Mr. Muller's extensive experience as an asset to the company [5] Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing life-saving cell and gene therapies using a pioneering gene-editing platform [6] - The company specializes in an allogeneic approach for CAR T immunotherapies in oncology, aiming to provide off-the-shelf and ready-to-use gene-edited CAR T-cells for cancer treatment [6] - Cellectis maintains in-house manufacturing capabilities, positioning itself as one of the few end-to-end gene editing companies that control the entire cell and gene therapy value chain [6][7]

Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing life-saving cell and gene therapies using its gene-editing platform [2][3] - The company employs an allogeneic approach for CAR T immunotherapies in oncology, introducing off-the-shelf and ready-to-use gene-edited CAR T-cells for cancer treatment [2] - Cellectis has in-house manufacturing capabilities, making it one of the few end-to-end gene editing companies that manage the entire cell and gene therapy value chain [2] Upcoming Events - Cellectis will hold its annual general meeting on June 26, 2025, at 2:30 p.m. CET in Paris, France [1] - Detailed agenda and modalities for participation in the meeting are available on the Cellectis website [2]

Core Points - Cellectis, a clinical-stage biotechnology company, will hold its annual general meeting on June 26, 2025, at 2:30 p.m. CET in Paris, France [1] - The company specializes in developing life-saving cell and gene therapies using its gene-editing platform [2][3] - Cellectis employs an allogeneic approach for CAR T immunotherapies, focusing on off-the-shelf gene-edited CAR T-cells for cancer treatment [2] - The company has in-house manufacturing capabilities, making it one of the few end-to-end gene editing companies that control the entire value chain [2] Company Information - Cellectis is headquartered in Paris, France, with additional locations in New York and Raleigh, NC [3] - The company is listed on the Nasdaq Global Market (ticker: CLLS) and Euronext Growth (ticker: ALCLS) [3] - For more information, Cellectis provides contact details for media and investor relations [4]

Group 1 - Cellectis SA (NASDAQ: CLLS) is preparing to provide significant updates on its pipeline in 2025, which may address key questions regarding its development efforts [1] - The company is positioned to enhance its visibility and understanding of its clinical trials and biotech initiatives [1] Group 2 - The author has a PhD in biochemistry and extensive experience in analyzing clinical trials and biotech companies, indicating a strong foundation for evaluating the company's prospects [1]