NEW YORK, May 21, 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 it will hold its annual general meeting on June 26, 2025 at 2:30 p.m. CET at the Biopark auditorium, 11 rue Watt, 4th floor, 75013 Paris, France. The notice convening the annual general meeting stating the detailed agenda and modalities of participati ...

Cellectis SA (NASDAQ: CLLS ) is a company I've expressed tentative optimism about their upcoming data updates in 2025. In particular, the company is positioning itself to truly begin answering questions about their pipeline. Today, I wantI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get b ...

Lasme-cel (UCART22) Phase 1 dataset and late-stage development strategy expected in the third quarter of 2025Eti-cel (UCART20x22) Phase 1 study in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL) ongoing with readout expected in late 2025AstraZeneca partnership: R&D activities ongoing on three programs – one allogeneic CAR T for hematological malignancies, one allogeneic CAR T for solid tumors, and one in vivo gene therapy for a genetic disorderCellectis will present novel non-viral gene editing ...

Financial Data and Key Metrics Changes - Cellectis reported a cash position of $264 million as of December 31, 2024, compared to $156 million at the end of 2023, reflecting a $108 million increase primarily due to a $140 million equity investment from AstraZeneca [24][25]. - The company experienced a net cash burn of a little over $100 million in 2024, with a net cash burn of $60 million after accounting for cash inflows from partnerships [70]. Business Line Data and Key Metrics Changes - Cellectis announced the start of research and development activities for three programs under its collaboration with AstraZeneca, including allogeneic CAR T therapies for hematological malignancies and solid tumors, as well as an in vivo gene therapy for a genetic disorder [8][9]. - The company received $47 million under the joint research and collaboration agreement with AstraZeneca, which included $25 million upfront and $22 million for development milestones [24]. Market Data and Key Metrics Changes - Cellectis received Orphan Drug Designation from the FDA for its product candidate UCART22 for the treatment of relapse or refractory acute lymphoblastic leukemia, and a similar designation from the European Commission [13]. - The company is focusing on advancing its core clinical trials, particularly BALLI-01 and NATHALI-01, which target unmet medical needs in hematological malignancies [15][20]. Company Strategy and Development Direction - Cellectis aims to leverage its strategic collaboration with AstraZeneca to shape the future of cell and gene therapies, focusing on developing next-generation genomic medicines [9][15]. - The company plans to continue its efforts on core clinical trials while building its preclinical pipeline, emphasizing the importance of addressing high unmet medical needs [15][28]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the strategic collaboration with AstraZeneca, highlighting the potential for paradigm shifts in treating hard-to-treat cancers and genetic disorders [28]. - The company anticipates presenting Phase 1 data sets for its clinical product candidates later in 2025, which will inform future development strategies [27][29]. Other Important Information - Cellectis has drawn down the final tranches of a €40 million credit facility from the European Investment Bank, enhancing its cash runway into mid-2027 [11][25]. - The company is actively engaging with regulatory authorities to align on Phase 2 registration strategies for its clinical programs [18][53]. Q&A Session Summary Question: Upcoming data for UCART22 - Management confirmed that a full Phase 1 dose escalation data set will be available in Q3 2025, with additional data to be shared at the ASH Annual Conference [31][34]. Question: Internal bar for success regarding UCART22 - Management expressed confidence in the data seen thus far, particularly for heavily pretreated patients, and ongoing interactions with regulatory authorities are planned [39][40]. Question: Near-term milestones for AstraZeneca collaboration - Management indicated that significant progress has been made, with potential disclosures of comprehensive data sets later in the year [45][46]. Question: Late-stage development strategies for UCART22 - Management is planning interactions with regulatory authorities to establish a clear registration path, with further details expected in Q3 [51][53]. Question: Safety program and registration trials - Management noted that while there are similarities to autologous CAR T trials, the unique nature of allogeneic therapies will be considered in their approach [57][59]. Question: Updates on Servier discussions - Management refrained from commenting on ongoing legal matters related to Servier [75]. Question: Implications of CARGO's CD22 asset discontinuation - Management highlighted the unmet need for non-CD19 CAR T therapies and expressed optimism about the opportunity for UCART20x22 [78][80]. Question: Recent data from ALLO-501A Cema-Cel program - Management acknowledged the encouraging long-term durability data from Allogene, which supports confidence in the allogeneic CAR T approach [88][90]. Question: Enrollment progress for UCART22 and UCART20x22 - Management confirmed that enrollment for UCART22 is on track, with plans for a realistic number of patients for Phase 2 studies [94][96].

○ UCART22 Phase 1 dataset and late-stage development strategy expected in the third quarter of 2025; Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) granted by FDA and ODD granted by the European Commission to UCART22 for the treatment of ALL. ○ UCART20x22 Phase 1 study in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL) ongoing with readout expected in late 2025. ○ AstraZeneca partnership: R&D activities ongoing on three programs – one allogeneic CAR T for hematologi ...

NEW YORK, Feb. 24, 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, showcases an innovative strategy for T cell engineering that leverages the pro-inflammatory properties of interleukin 2 (IL-2) with the objective to enhance CAR T cell efficacy against solid tumors, at the American Association for Cancer Research – Immuno-oncology (AACR- ...

Core Insights - Cellectis is presenting a novel T cell engineering strategy that utilizes interleukin 2 (IL-2) to enhance the efficacy of CAR T cells against solid tumors at the AACR-IO conference [1][2] - The company focuses on developing life-saving cell and gene therapies through its gene-editing platform and allogeneic CAR T immunotherapies [3][4] Company Overview - Cellectis is a clinical-stage biotechnology company that employs a pioneering gene-editing platform to create cell and gene therapies [3] - The company is known for its allogeneic approach to CAR T immunotherapies, offering off-the-shelf and ready-to-use gene-edited CAR T cells for cancer treatment [3] - Cellectis has in-house manufacturing capabilities, making it one of the few companies that control the entire cell and gene therapy value chain [3] Research and Development - The research presented at the conference indicates that CAR-induced expression of a synthetically engineered FAP-IL2v immunocytokine enhances the anti-tumor activity of TALEN-edited allogeneic CAR T cells without the toxicity associated with IL-2 [2][5] - The engineered CAR T cells utilize a CAR-inducible IL-2 variant (IL-2v) that is activated by tumor-specific cues, allowing for localized activity within the tumor microenvironment [5] - This strategy aims to improve CAR T cell expansion and anti-tumor activity while minimizing systemic toxicity typically linked to circulating IL-2 [5]

Core Insights - The article emphasizes the importance of understanding the science behind biotech investments to avoid pitfalls in the industry [1]. Group 1 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies [1]. - The mission is to educate investors on the scientific aspects of biotech businesses to facilitate informed decision-making [1].

Core Insights - Cellectis is presenting pre-clinical data aimed at enhancing CAR T cell activity against solid tumors while minimizing potential toxicity at the Society for Immunotherapy of Cancer's 39th Annual Meeting [1][2] Group 1: Presentation Details - The data will be presented in a poster titled "Breaking barriers in solid tumors with SMART allogeneic CAR T-cells" on November 9th, 2024, from 9:00 am to 8:30 pm ET by Beatriz Aranda-Orgilles [2] - The poster number is 254 [2] Group 2: Challenges in Solid Tumors - Despite the success of CAR T-cell therapies in treating blood cancers, challenges remain in solid tumors due to the hostile tumor microenvironment (TME) which creates an immunosuppressive barrier [2] - Factors such as tumor antigen diversity and low expression of CAR-targeted tumor-associated antigens (TAA) can lead to antigen escape or on-target off-tumor toxicity, complicating therapeutic safety [2] Group 3: Innovative Strategies - Cellectis employs TALEN®-mediated gene editing to generate allogeneic CAR T-cells, repurposing PD-1 function to enhance efficacy and avoid toxicities in solid tumors [3] - The company integrates IL-12 into PD-1 regulatory elements to confine IL-12 to the TME and inactivates TGFBR2 to overcome TGFB1-mediated resistance, enhancing CAR T-cell proliferation and infiltration while reducing tumor burden [4] Group 4: Potential Impact - The data suggests the potential of creating armored allogeneic CAR T-cells with improved activity in immunosuppressive microenvironments, offering a therapeutic option for patients with solid malignancies [5] Group 5: Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing life-saving cell and gene therapies using its gene-editing platform [5] - The company specializes in an allogeneic approach for CAR-T immunotherapies, aiming to provide off-the-shelf, ready-to-use gene-edited CAR T-cells for cancer treatment [5]

Cellectis S.A. (NASDAQ:CLLS) Q3 2024 Earnings Conference Call November 5, 2024 8:00 AM ET Company Participants Arthur Stril - Interim Chief Financial Officer Andre Choulika - Chief Executive Officer Adrian Kilcoyne - Chief Medical Officer Conference Call Participants Gena Wang - Barclays Jack Allen - Baird Ashiq Mubarack - Citi Kuan-Hung Lin - Wells Fargo Luisa Morgado - Van Lanschot Kempen Silvan Tuerkcan - Citizens JMP Operator Good morning, everyone, and welcome to the Cellectis Third Quarter 2024 Earnin ...