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 ...

Financial Performance - Total revenues and other income for the nine-month period ended September 30, 2024, increased to $34,052,000, compared to $7,203,000 for the same period in 2023, representing a significant growth[7]. - The net loss attributable to shareholders for the nine-month period ended September 30, 2024, was $42,683,000, compared to a net loss of $66,648,000 for the same period in 2023, reflecting a reduction in losses[7]. - The basic net loss per share attributable to shareholders for the nine-month period ended September 30, 2024, was $(0.49), compared to $(1.09) for the same period in 2023[7]. - For the nine-month period ended September 30, 2023, net income was a loss of $66,648 thousand, compared to a loss of $42,683 thousand in 2024, reflecting a significant decline[8]. - The company reported a comprehensive income loss of $41.156 million for the nine-month period ended September 30, 2024[13]. - The net loss for the nine-month period ended September 30, 2024, was $42.683 million, compared to a net loss of $59.264 million for the same period in 2023[13]. Cash and Liquidity - Cash and cash equivalents as of September 30, 2024, amounted to $159,087,000, an increase from $136,708,000 as of December 31, 2023[6]. - Cash and cash equivalents at the end of the period for the nine-month period ended September 30, 2023, were $67,358 thousand, increasing to $159,087 thousand in 2024, indicating improved liquidity[11]. - Cash and cash equivalents stood at $159.1 million, with an additional deposit of $100.3 million, providing sufficient funds to support operations into 2027[20]. Research and Development - Research and development expenses for the nine-month period ended September 30, 2024, were $69,670,000, up from $62,690,000 in 2023, indicating an increase of approximately 11.5%[7]. - Research and development expenses increased to $69.7 million for the nine-month period ended September 30, 2024, up from $62.7 million in 2023, reflecting a rise of approximately 11.9%[48]. - Research and development expenses for the three-month period ended September 30, 2023, were $19,075 thousand, increasing to $23,829 thousand in 2024, indicating a rise in investment in innovation[9]. - The total research and development expenses for Q3 2024 were $23,829 million, reflecting a significant investment in innovation and product development[52]. Assets and Liabilities - Total assets increased to $395,876,000 as of September 30, 2024, compared to $334,270,000 as of December 31, 2023, showing a growth of approximately 18.4%[6]. - Total current liabilities increased to $165,650,000 as of September 30, 2024, from $155,144,000 as of December 31, 2023, representing a rise of about 6.5%[6]. - Non-current financial liabilities increased to $61,575,000 as of September 30, 2024, from $49,125,000 as of December 31, 2023, reflecting an increase of about 25.3%[6]. - Total financial liabilities increased from $135,151 thousand as of December 31, 2023 to $141,003 thousand as of September 30, 2024[91]. - Total deferred revenues and contract liabilities increased by $11.7 million to $122.0 million from $110.3 million as of December 31, 2023, primarily due to additional invoicing related to three Research Plans[108]. Shareholder Equity - Total shareholders' equity increased to $129,424,000 as of September 30, 2024, from $84,695,000 as of December 31, 2023, indicating a growth of approximately 52.7%[6]. - As of September 30, 2024, Cellectis reported total shareholders' equity of $129.424 million, an increase from $76.123 million as of September 30, 2023[13]. - The share capital increased to $5.9 million as of September 30, 2024, from $4.4 million as of January 1, 2024, following a capital increase involving the issuance of 28 million shares for $140.0 million[110]. - Cellectis' share capital increased to 100,093,873 shares as of September 30, 2024, up from 55,583,768 shares as of September 30, 2023[13]. Collaboration and Agreements - Cellectis entered into a Joint Research and Collaboration Agreement with AstraZeneca, aiming to develop up to 10 novel cell and gene therapy products[27]. - AstraZeneca made an initial equity investment of $80 million, acquiring approximately 22% of Cellectis' share capital[28]. - Cellectis received an upfront payment of $25 million under the Joint Research Collaboration Agreement, with potential milestone payments ranging from $70 million to $220 million for each candidate product[28]. - The total upfront payments allocated to Research Plans amount to $109.1 million, including $25 million from the AZ JRCA and $48.4 million from the Subsequent Investment Agreement[36]. Financial Income and Expenses - The company reported a financial income of $29,727,000 for the nine-month period ended September 30, 2024, compared to $16,133,000 for the same period in 2023, marking an increase of approximately 84.5%[7]. - Financial income for the nine-month period ended September 30, 2024 was $29,727 million, up from $16,133 million in the same period of 2023, marking an increase of 84.5%[58]. - Financial expenses increased from $23,085 million in the nine-month period ended September 30, 2023 to $24,049 million in 2024, a rise of 4.2%[58]. - The company reported a foreign exchange gain of $12,424 million in the nine-month period ended September 30, 2023, which decreased to $3,811 million in 2024, a decline of 69.4%[58]. Stock Options and Compensation - The weighted-average fair value of stock options granted decreased to €1.41 in 2024 from €1.65 in 2023, with expected volatility remaining high at 64.6%-65.2%[113]. - Share-based compensation expense related to stock option awards was $1.8 million for the nine-month period ended September 30, 2024, compared to $2.0 million for the same period in 2023[115]. - The total number of shares outstanding increased to 100,093,873 as of September 30, 2024, reflecting the issuance of shares related to capital increases and employee stock options[110]. - The balance of non-employee warrants as of September 30, 2024, was 359,207, with a weighted-average exercise price of €26.69 and a remaining average useful life of 1.7 years[120].

UCART22 and UCART20x22: enrollment ongoing, Phase 1 dataset and late-stage development strategy to be presented in 2025AstraZeneca partnership: R&D activities are 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 disorderAppointed Adrian Kilcoyne, M.D., MPH, MBA, an industry leader in the advancement of cell therapy treatment, as Chief Medical OfficerCash position of $264 million as of September ...