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Cellectis Announces 2026 Strategy and Catalysts
Globenewswire· 2026-01-08 21:30
Core Insights - Cellectis is focusing on advancing its late-stage allogeneic CAR-T therapies, particularly lasme-cel and eti-cel, with significant clinical trials and partnerships expected to drive growth in 2026 [2][3][4]. Clinical Development - The pivotal Phase 2 trial for lasme-cel in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has commenced, with interim data anticipated in Q4 2026 [2][3]. - Lasme-cel has shown a 68% overall response rate (ORR) and a 56% complete remission rate in early trials, indicating strong efficacy [5]. - The NATHALI-01 trial for eti-cel in relapsed/refractory non-Hodgkin lymphoma (NHL) reported an 88% ORR and a 63% complete remission rate, with further data expected in Q4 2026 [6]. Strategic Partnerships - Cellectis is collaborating with AstraZeneca to develop up to 10 novel cell and gene therapy products targeting high unmet medical needs, leveraging Cellectis' gene editing and manufacturing capabilities [4]. Financial Position - The company projects that its cash reserves will sustain operations into the second half of 2027, indicating a stable financial outlook [8]. Upcoming Events - Cellectis management will participate in the J.P. Morgan Healthcare Conference from January 12-15, 2026, for investor meetings [9].
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].
Lightwave Logic, Kyverna Therapeutics And Other Big Stocks Moving Lower In Tuesday's Pre-Market Session - Argo Blockchain (NASDAQ:ARBK), Ascent Solar Technologies (NASDAQ:ASTI)
Benzinga· 2025-12-16 13:06
Market Overview - U.S. stock futures are lower, with Dow futures down approximately 0.2% [1] Company-Specific Movements - Lightwave Logic Inc (NASDAQ:LWLG) shares fell 14.5% to $3.22 in pre-market trading following the announcement of a $35 million public offering of common stock [1] - Ascent Solar Technologies, Inc. (NASDAQ:ASTI) shares decreased by 15.1% to $3.54 after a previous increase of 34% on Monday [2] - Fractyl Health Inc (NASDAQ:GUTS) shares dropped 10.4% to $2.00 in pre-market trading [2] - Ready Capital Corp (NYSE:RC) shares fell 9% to $2.12, despite declaring a quarterly cash dividend of $0.01 per share for the quarter ended December 31, 2025 [2] - Cellectis SA (NASDAQ:CLLS) shares declined 8.4% to $4.39 following arbitration results with Servier [2] - Destiny Tech100 Inc (NYSE:DXYZ) shares decreased by 7.4% to $31.59 [2] - Kyverna Therapeutics Inc (NASDAQ:KYTX) shares fell 7.2% to $10.04 after announcing a $100 million offering [2] - Maase Inc (NASDAQ:MAAS) shares dropped 6.3% to $4.16 [2] - Argo Blockchain PLC – ADR (NASDAQ:ARBK) shares fell 6% to $5.32 after an 18% decline on Monday [2] - Canopy Growth Corp (NASDAQ:CGC) shares decreased by 5.4% to $1.57 [2] - Neogen Corp (NASDAQ:NEOG) shares fell 4.5% to $6.54 [2]
Lightwave Logic, Kyverna Therapeutics And Other Big Stocks Moving Lower In Tuesday's Pre-Market Session
Benzinga· 2025-12-16 13:06
Market Overview - U.S. stock futures are lower, with Dow futures down approximately 0.2% [1] Company-Specific Movements - Lightwave Logic Inc (NASDAQ:LWLG) shares fell 14.5% to $3.22 in pre-market trading following the announcement of a $35 million public offering of common stock [1] - Ascent Solar Technologies, Inc. (NASDAQ:ASTI) shares decreased 15.1% to $3.54 after a previous jump of 34% on Monday [2] - Fractyl Health Inc (NASDAQ:GUTS) shares fell 10.4% to $2.00 in pre-market trading [2] - Ready Capital Corp (NYSE:RC) shares dipped 9% to $2.12, despite declaring a quarterly cash dividend of $0.01 per share for the quarter ended December 31, 2025 [2] - Cellectis SA (NASDAQ:CLLS) shares declined 8.4% to $4.39 following arbitration results with Servier [2] - Destiny Tech100 Inc (NYSE:DXYZ) shares decreased 7.4% to $31.59 [2] - Kyverna Therapeutics Inc (NASDAQ:KYTX) shares fell 7.2% to $10.04 after announcing a $100 million offering [2] - Maase Inc (NASDAQ:MAAS) shares dropped 6.3% to $4.16 [2] - Argo Blockchain PLC – ADR (NASDAQ:ARBK) shares fell 6% to $5.32 after an 18% decline on Monday [2] - Canopy Growth Corp (NASDAQ:CGC) shares decreased 5.4% to $1.57 [2] - Neogen Corp (NASDAQ:NEOG) shares fell 4.5% to $6.54 [2]
Allogene Therapeutics Reports Favorable Result for Servier in Arbitration with Cellectis
Globenewswire· 2025-12-15 22:39
Core Insights - Allogene Therapeutics has achieved a favorable arbitration outcome with Servier regarding cemacabtagene ansegedleucel (cema-cel), reaffirming its full development and commercial control in the U.S., EU, and UK, while paving the way for global commercialization rights [1][5][8] Group 1: Arbitration Outcome - The tribunal rejected Cellectis's allegations against Servier regarding development obligations and financial claims, determining that milestone payments are contingent upon FDA acceptance of a Biologics License Application (BLA) [6] - A partial termination of the license was ordered, limited to the UCART19 V1 product, and Cellectis was directed to negotiate a direct license to Allogene if pursued [6] Group 2: Future Developments - Allogene is entering 2026 with improved fundamentals and is approaching a significant catalyst period in the allogeneic CAR T field, including an interim futility analysis in 1H 2026 for cema-cel in first-line patients with large B-cell lymphoma (LBCL) [2][5]
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]
Cellectis’ Allogeneic CAR-T Potential Still Justifies A “Buy” (NASDAQ:CLLS)
Seeking Alpha· 2025-12-12 02:31
Core Insights - Cellectis S.A. (CLLS) is a biotech company focused on developing allogeneic CAR-T therapies using its proprietary Transcription Activator-Like Effector Nucleases (TALEN) technology and PulseAgile electroporation [1] Company Overview - Cellectis targets high-unmet medical needs and heavily pretreated patients suffering from B-cell malignancies [1]
ASH 2025: Cellectis Presents Development Plan to Further Enhance High Response Rate Observed for Eti-cel in r/r NHL
Globenewswire· 2025-12-08 06:30
Core Insights - Cellectis presented encouraging updated data for its eti-cel product candidate at the 67th Annual Meeting of the American Society of Hematology, showing a promising overall response rate of 88% and a complete response rate of 63% in patients with relapsed/refractory non-Hodgkin lymphoma [1][2][9] Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing life-saving cell and gene therapies using its gene-editing platform, with a unique allogeneic approach for CAR T immunotherapies [6][7] Clinical Trial Details - The eti-cel candidate is the first allogeneic dual CAR-T targeting CD20 and CD22 simultaneously, currently in Phase 1 of the NATHALI-01 clinical trial for patients who have undergone at least two lines of therapy [2][4] - Preliminary results from the trial indicate an overall response rate of 88% and a complete response rate of 63% based on a sample size of 8 patients [2][9] Future Directions - The company plans to investigate the impact of low dose Interleukin-2 (IL-2) support on the efficacy of eti-cel and will begin recruiting patients for the IL-2 support cohort in Q1 2026 [4][5][9] - Cellectis expects to present the full Phase 1 dataset in 2026 [5][9] Additional Findings - In vivo data suggest that low dose IL-2 support can enhance the expansion and persistence of CAR-T cells, potentially boosting efficacy without increasing toxicity [3][4]
Cellectis Publishes Nature Communications Article on a Non-Viral Gene Editing Process Enabling Efficient Gene Insertion in Hematopoietic Stem Cells
Globenewswire· 2025-11-19 11:18
Core Insights - Cellectis has established circular single-stranded DNA (CssDNA) as an efficient non-viral DNA donor template for gene insertion in hematopoietic stem and progenitor cells (HSPCs) [1][5] Gene Editing Technology - Gene editing of HSPCs has the potential for long-term therapeutic benefits, with non-viral DNA templates emerging as promising alternatives to viral vectors like AAV6, which pose safety and efficacy concerns [2] - Cellectis has developed a robust gene insertion process using TALEN technology and CssDNA donor templates, enabling precise integration of large genetic sequences within HSPCs, thus expanding the potential of non-viral gene therapy [3] Efficiency and Application - CssDNA demonstrates 3-5 times higher knock-in efficiency than linear single-stranded DNA (LssDNA), with efficiencies surpassing 40% [9] - CssDNA can insert genes at multiple loci in HSPCs and is applicable to other therapeutic cell types, including primary T cells [9] - Comparative studies indicate that CssDNA-edited HSPCs have a higher propensity to engraft and maintain gene edits in murine models compared to AAV6-edited HSPCs [9] Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing life-saving cell and gene therapies, utilizing an allogeneic approach for CAR T immunotherapies in oncology [6] - The company controls the entire cell and gene therapy value chain from start to finish, supported by in-house manufacturing capabilities [6] - Cellectis is headquartered in Paris, France, with additional locations in New York and Raleigh, NC, and is listed on both the Nasdaq Global Market and Euronext Growth [7]
Cellectis Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-07 21:30
Core Insights - Cellectis reported promising clinical data for its product candidates lasme-cel (UCART22) and eti-cel (UCART20x22), indicating their potential to improve outcomes in relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) and non-Hodgkin lymphoma (r/r NHL) respectively [3][4][11] Financial Results - As of September 30, 2025, Cellectis had $225 million in cash, cash equivalents, and fixed-term deposits, which is projected to fund operations into the second half of 2027 [4][26] - Consolidated revenues and other income for the nine-month period ended September 30, 2025, were $67.4 million, up from $34.1 million in the same period in 2024, primarily driven by activities related to the AstraZeneca collaboration [29] - Consolidated net loss attributable to shareholders for the nine-month period ended September 30, 2025, was $41.3 million, compared to a loss of $42.7 million in the same period in 2024 [34] Clinical Development - The Phase 1 BALLI-01 study of lasme-cel showed an overall response rate (ORR) of 68% with the Cellectis-manufactured product, and 100% in the target Phase 2 population [6][7] - The first interim analysis for the pivotal Phase 2 BALLI-01 trial is expected in Q4 2026, with a Biologics License Application (BLA) anticipated in 2028 [8][9] - For eti-cel, preliminary data indicated an ORR of 86% and a complete response (CR) rate of 57% in the ongoing study [11] Pipeline Highlights - Lasme-cel is positioned as a potentially transformative therapy for r/r B-ALL, with a projected peak gross sales potential of approximately $700 million by 2035, which could increase to $1.3 billion with label expansions [9] - The company plans to present further updates on eti-cel at the ASH 2025 Annual Meeting [10][14] Innovation and Collaboration - Cellectis is advancing its gene editing technology, including the use of circular single-stranded DNA (CssDNA) as a non-viral template for gene therapy, which has shown high gene insertion frequency in hematopoietic stem and progenitor cells [16][22] - A strategic collaboration with AstraZeneca aims to develop up to 10 novel cell and gene therapy products targeting high unmet medical needs [23]