Cellectis(CLLS)
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Cellectis(CLLS) - 2025 Q4 - Earnings Call Transcript
2026-03-20 13:02
Financial Data and Key Metrics Changes - As of December 31, 2025, cash equivalents, restricted cash, and fixed-term deposits amounted to $211 million, a decrease of $53 million from $264 million as of December 31, 2024, primarily due to cash payments and operational expenses [20][21] - The company reported a consolidated net loss attributable to shareholders for the twelve months ended December 31, 2025, with specific figures available in the press release [21] Business Line Data and Key Metrics Changes - The allogeneic CAR-T candidate lasme-cel achieved a 100% overall response rate in the target phase 2 population, converting all patients to transplant-eligible candidates [6][13] - The dual CAR-T candidate eti-cel demonstrated an 88% overall response rate and a 63% complete response rate in heavily pre-treated patients [9][16] Market Data and Key Metrics Changes - Cellectis is advancing its pivotal phase 2 trial for lasme-cel, with site openings in North America and Europe expected to continue into 2026 [8] - The company is also collaborating with partners like Servier and Allogene, with key milestones anticipated in 2026 [19] Company Strategy and Development Direction - Cellectis aims to transform into a late-stage development organization, focusing on delivering clinical results for patients with no therapeutic solutions [4][11] - The company is committed to internalizing its manufacturing capabilities, which has shown improved efficacy compared to external manufacturing [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position to fund operations into the second half of 2027, allowing for continued development of lasme-cel and eti-cel [18] - The management highlighted the importance of their allogeneic CAR-T products in addressing unmet medical needs in oncology, particularly for patients with aggressive diseases [4][6] Other Important Information - The anticipated BLA submission for lasme-cel is planned for the second half of 2028, while eti-cel is expected to progress to pivotal phase 2 in 2027 with a BLA submission in H2 2029 [16] - The company is actively engaging in partnerships to enhance its gene editing platform and expand its product offerings [10][11] Q&A Session Summary Question: Update on lasme-cel and BALLI-01 enrollment - Management confirmed that recruitment is on track and expects to complete data analysis by the end of the year for the first 40 patients [24] Question: Expectations for dose optimization in the pivotal study - Management indicated that they anticipate being able to differentiate between the two dose levels of alemtuzumab based on efficacy and safety [25] Question: Details on Servier arbitration and its impact - The arbitration ruling allowed Cellectis to regain rights to UCART19, while remaining eligible for milestones related to cema-cel [30] Question: Importance of alemtuzumab in lymphodepletion - Management emphasized that alemtuzumab is critical for optimizing lymphodepletion and achieving better patient outcomes [33] Question: Update on esiCell and patient follow-up - Management provided a top-line update indicating strong complete remission rates and plans for further data sharing by the end of the year [37] Question: Application of lymphodepletion in outpatient settings - Management noted that regulatory requirements currently necessitate inpatient delivery, but there is potential for future outpatient use [58] Question: AstraZeneca partnership updates - Management expressed satisfaction with the collaboration but indicated that updates would be limited at AstraZeneca's request due to competitive considerations [60]
Cellectis(CLLS) - 2025 Q4 - Earnings Call Transcript
2026-03-20 13:00
Financial Data and Key Metrics Changes - As of December 31, 2025, Cellectis reported cash equivalents, restricted cash, and fixed-term deposits amounting to $211 million, a decrease of $53 million from $264 million as of December 31, 2024, primarily due to cash payments and operational expenses [19][20] - The company managed its cash with discipline, focusing on the development of lasme-cel and eti-cel, and believes its current cash position is sufficient to fund operations into the second half of 2027 [18][19] Business Line Data and Key Metrics Changes - Lasme-cel achieved a 100% overall response rate in the target phase 2 population, with 80% of patients achieving minimal residual disease (MRD) negative status [5][12] - Eti-cel demonstrated an 88% overall response rate and a 63% complete response rate in heavily pre-treated patients during phase 1 trials [8][16] Market Data and Key Metrics Changes - Cellectis is advancing its pivotal phase 2 trial for lasme-cel, with site openings in North America and Europe expected to continue into 2026 [7][12] - The company is also investigating eti-cel's potential impact with low-dose interleukin-2 support to enhance CAR-T efficacy without increasing toxicity [8][16] Company Strategy and Development Direction - Cellectis aims to transform into a late-stage development organization, with 2026 expected to be a year of significant milestones and data readouts [10][17] - The company is focused on delivering clinical results for patients with no therapeutic solutions, emphasizing the importance of its allogeneic CAR-T approach [4][5] Management's Comments on Operating Environment and Future Outlook - Management highlighted the challenges faced by biotechnology companies in recent years but emphasized Cellectis's commitment to advancing its clinical programs [4][5] - The management expressed confidence in the potential of lasme-cel and eti-cel to provide significant therapeutic options for patients with difficult-to-treat cancers [6][8] Other Important Information - Cellectis's gene editing platform is becoming the backbone of a broader allogeneic CAR-T ecosystem, with partnerships with Servier and Iovance advancing their respective programs [9][10] - The company anticipates presenting full phase 1 data for eti-cel later this year and expects to submit a Biologics License Application (BLA) for lasme-cel in the second half of 2028 [17][19] Q&A Session Summary Question: Update on lasme-cel and BALLI-01 enrollment - Management confirmed that recruitment is on track and expects to complete data analysis by the end of the year for the first 40 patients [23][24] Question: Expectations for dose optimization in the pivotal study - Management indicated that they have a strong analysis plan to differentiate between the two alemtuzumab dose levels, focusing on efficacy and safety [25][26] Question: Details on Servier arbitration and its impact - Management clarified that the arbitration ruling allows Cellectis to develop UCART19 independently while remaining eligible for milestones related to cema-cel [28][30] Question: Safety of CD52 preconditioning - Management emphasized the importance of alemtuzumab in optimizing lymphodepletion and achieving better outcomes [32][33] Question: Update on esiCell and patient follow-up - Management provided a top-line update on esiCell, indicating strong complete remission rates and plans for further data on IL-2 cohorts [35][36] Question: Competitive landscape regarding CD19 therapies - Management noted that their focus is on CD22, differentiating their product from others targeting CD19, and emphasized the need for alternative therapies for patients [41][42] Question: Expectations for EHA updates - Management indicated that they will present an updated dataset at EHA, including additional patients and insights on optimal lymphodepletion [50][52] Question: Outpatient setting for lymphodepletion procedures - Management stated that regulatory requirements currently necessitate inpatient delivery, but there is potential for outpatient use in the future [56][57] Question: AstraZeneca partnership updates - Management expressed satisfaction with the collaboration and indicated that updates will be provided when appropriate [58][60]
Cellectis Reports Full Year 2025 Financial Results and Provides a Business Update
Globenewswire· 2026-03-19 23:21
Pivotal Phase 2 with lasme-cel in r/r B-ALL (BALLI-01 trial) ongoing Phase 1: 83% ORR at RP2D and 100% ORR in the target Phase 2 populationIn target Phase 2 population: 100% of patients became eligible to transplantPivotal Phase 2 first interim analysis expected in Q4 2026BLA submission anticipated in 2028 Phase 1 with eti-cel in r/r NHL (NATHALI-01 trial) ongoing Best-in-class dual allogeneic CAR-T cell product targeting CD20 & CD22At current dose level, 88% ORR; 63% CR rate after 2+ prior lines of therap ...
Cellectis to Report Fourth Quarter and Full Year 2025 Financial Results on March 19, 2026
Globenewswire· 2026-03-12 20:30
Core Insights - Cellectis will report its financial results for Q4 and full year 2025 on March 19, 2026, after the US market closes [1] - An investor conference call and webcast will take place on March 20, 2026, at 8:00 AM ET, to discuss the financial results and business updates [2] Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing life-saving cell and gene therapies using a pioneering gene-editing platform [3] - The company employs an allogeneic approach for CAR T immunotherapies, aiming to provide off-the-shelf, ready-to-use gene-edited CAR T-cells for cancer treatment [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 [3] Company Locations and Listings - Cellectis is headquartered in Paris, France, with additional locations in New York and Raleigh, NC [4] - The company is listed on the Nasdaq Global Market under the ticker CLLS and on Euronext Growth under the ticker ALCLS [4]
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]