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Cellectis develops immunotherapy treatments for cancer using gene-edited allogeneic CAR T cells. Its products rely on donor-derived T cells that are edited to remove T cell receptor activity and engineered to express a chimeric antigen receptor (CAR) that targets cancer cells. The goal is to create off-the-shelf CAR T therapies that are available quickly and at a lower cost than patient-specific (autologous) CAR T treatments. Cellectis works through research and development, clinical trials, and partnerships with other pharma companies, such as Sanofi, and generates revenue from licensing, milestone payments, and potential future product sales. The company differentiates itself by offering off-the-shelf solutions rather than custom-made therapies, aiming to broaden access to advanced cancer treatment.
Industries
Biotechnology
Healthcare
Company Size
201-500
Company Stage
IPO
Headquarters
Paris, France
Founded
2000
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Total Funding
$515.8M
Above
Industry Average
Funded Over
11 Rounds
Professional Development Budget
Flexible Work Hours
LB Pharmaceuticals appoints Christopher Zergebel as Senior Vice President, Clinical Operations. NEW YORK, June 30, 2026 (GLOBE NEWSWIRE) - LB Pharmaceuticals Inc ("LB Pharmaceuticals" or the "Company") (Nasdaq: LBRX), a late-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, adjunctive treatment of major depressive disorder, and other neuropsychiatric diseases, today announced the appointment of Christopher Zergebel as Senior Vice President, Clinical Operations. Mr. Zergebel, a seasoned biotechnology executive with more than 25 years of global development operations experience, brings deep expertise in growing and leading cross-functional teams including clinical operations, data management, and project and portfolio management. "We are pleased to welcome Chris to the LB team as we focus on the execution of multiple clinical programs and indications for LB-102," said Heather Turner, Chief Executive Officer. "With the Phase 3 trial in schizophrenia and Phase 2 trial in bipolar depression underway, and the expected initiation early next year of a Phase 2 trial in adjunctive major depressive disorder, his deep operational expertise and ability to align strategy with execution will be instrumental as we advance LB-102 and continue to scale our organization." Prior to joining LB Pharmaceuticals, Mr. Zergebel served as Vice President, Development Operations at Cellectis Biologics, where he led global clinical development strategy and operations from early stage through post approval trials. Prior to Cellectis, Mr. Zergebel held senior leadership roles where he was responsible for establishing and optimizing development operations functions, overseeing R&D budgets, and successfully executing clinical programs. He has successfully led clinical operations for programs resulting in regulatory submissions and approvals and has built global project management and clinical infrastructure capabilities. Mr. Zergebel holds a B.A. in Biology from Boston University. "I am delighted to join LB at this exciting time," said Christopher Zergebel, Senior Vice President, Clinical Operations. "LB-102 is a unique molecule with the potential to meaningfully address a range of unmet needs for patients with both psychosis and mood disorders. With three late-stage clinical programs now active or planned, I look forward to drawing on my experience and working closely with the team to ensure rigorous and efficient execution across our pipeline." About LB Pharmaceuticals LB Pharmaceuticals is a late-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, adjunctive treatment of major depressive disorder and other neuropsychiatric diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of a broad range of neuropsychiatric diseases. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102; the design, objectives, initiation, timing, progress and results of clinical trials of LB-102, including the pivotal Phase 3 NOVA-2 trial in acute schizophrenia, the Phase 2 ILLUMINATE-1 trial in bipolar 1 depression and the Phase 2 trial for the adjunctive treatment of MDD; the continuing advancement of LB-102 and the Company's portfolio and its ability to address a range of unmet needs for patients with both psychosis and mood disorders. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the Company's limited operating history and historical losses; the Company's ability to raise additional funding to complete the development and any commercialization of LB-102; the Company's dependence on the success of its lead product candidate, LB-102; the Company's ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company's lead product candidate, LB-102; any undesirable side effects or other properties of the Company's product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company's ability to obtain, maintain and protect its intellectual property; and the Company's dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in the section titled "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
Cellectis presents final Phase 1 results of lasme-cel and preliminary results on eti-cel at EHA 2026 Congress. Published on June 11, 2026. New York, NY - June 11, 2026 - 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, presents final Phase 1 data from the BALLI-01 clinical trial evaluating lasme-cel, a CD22 directed allogeneic CAR-T therapy, in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), and preliminary data from the NATHALI-01 study evaluating eti-cel, a dual CD20 and CD22 directed CAR-T in relapsed/refractory B-cell non Hodgkin lymphoma (r/r B-NHL), at the European Hematology Association (EHA) 2026 Annual Congress. BALLI-01 clinical trial evaluating lasme-cel in r/r B-ALL - Oral Presentation The BALLI-01 final Phase 1 data will be presented as an oral presentation by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at the University of Texas MD Anderson Cancer Center in Houston, TX. 45 patients in third line and beyond (3L+) were treated in the BALLI-01 study. 15 patients were treated at the recommended Phase 2 dose and 7 in the target Phase 2 population. Patients were heavily pretreated with those in the target Phase 2 population receiving a median of 5 prior lines of therapy (Range 2-11). Almost all patients were previously treated with blinatumumab (82%) and were also heavily exposed to CD19 CAR-T (53%), CD22-directed antibody-drug conjugate (ADC) (56%) and many had a prior hematopoietic stem cell transplantation (HSCT) (47%). Final Phase 1 data In the target Phase 2 population An overall response rate (ORR) of 100% (7/7) was achieved with a complete remission/complete remission with incomplete count recovery (CR/CRi) rate of 57% (4/7). Of these, 75% achieved minimal residual disease negative (MRD-ve) status. All patients subsequently proceeded to HSCT. Lasme-cel demonstrated a manageable safety profile * Cytokine release syndrome (CRS) >= grade 3 occurred in 4% of patients. * Immune effector cell-associated neurotoxicity syndrome (ICANS) >= grade 3 occurred in 4% of patients. * Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) >= grade 3 occurred in 2% of patients. All CRS, ICANS, and IEC-HS resolved. "These final Phase 1 results are particularly meaningful for a patient population that has very limited treatment options" said Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at UT MD Anderson. "Being able to achieve deep remissions in these patients and allowing them to subsequently receive an HSCT is promising. We look forward to accelerating accrual into the ongoing Pivotal Phase 2 study and bringing this treatment to patients." The Pivotal Phase 2 BALLI-01 trial is open for recruitment. Eligible patients and treating physicians are encouraged to visit BALLI-01 (NCT04150497) or contact Cellectis at [email protected] for information and participating sites. The first interim analysis is expected in Q4 2026. Oral Presentation: Safety and efficacy of UCART22 in heavily pretreated patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (B-ALL): results of the Phase 1 BALLI-01 trial Date/Time: Saturday, June 13 at 5:15 - 6:30pm, local time Session Title: Advances in the treatment of lymphoblastic leukemia Session Room: K1 Abstract Number: 4689 Note: presentation slides will be uploaded to Cellectis' website concurrently with the live presentation. NATHALI-01 clinical trial evaluating eti-cel in r/r B-NHL - Poster Presentation The NATHALI-01 preliminary data on the role of alemtuzumab in optimizing responses will be presented as a poster by Professor Emmanuel Bachy, M.D., Ph.D., Department of Hematology, Hospices Civils de Lyon, France. Eti-cel is a highly differentiated product being the first allogeneic dual CAR-T targeting both CD20 and CD22, for patients with r/r B-NHL. As of the February 2026 data cutoff, 14 patients with r/r B-NHL had been treated across three dose levels, in a heavily pre-treated population with a median of 3 prior lines of therapy, 93% of whom had received prior CD19-directed CAR-T therapy, and all of whom presented with stage IV disease at baseline. In the optimal dose cohort, ORR and complete response (CR) were 88% and 63%, respectively. The analysis identified a positive correlation between alemtuzumab exposure and clinical outcomes: higher alemtuzumab exposure created a favorable lower inflammatory homeostatic milieu prior to eti-cel infusion and was associated with enhanced eti-cel expansion and higher response rates. Additionally, responders maintained sustained low-level interleukin 2 (IL-2) secretion when compared to non-responders. These findings provide a scientific rationale for the implementation of a weight-based alemtuzumab dosing regimen, currently under investigation to optimize lymphodepletion. Additionally, subcutaneous low-dose IL-2 is being investigated to further enhance eti-cel expansion and treatment response. "These encouraging data demonstrate that not only can eti-cel drive responses in a very difficult-to-treat population, but that by optimizing exposure to alemtuzumab we may be able to create a favorable environment for CAR-T expansion and persistence." said Professor Emmanuel Bachy, M.D., Ph.D., Department of Hematology, Hospices Civils de Lyon, France. The NATHALI-01 study is open for recruitment with the full Phase 1 clinical data expected in Q4 2026. Poster Presentation: Alemtuzumab exposure and sustained IL-2 drive UCART20x22 expansion and clinical response in adults with relapsed or refractory B-cell non-Hodgkin lymphoma: NATHALI-01 study Date/Time: Saturday, June 13 at 6:45 - 7:45pm, local time Session: Poster Session 2 Poster Number: 4758 Note: poster presentation will be uploaded to Cellectis' website at the opening of the poster session.
Cellectis receives RMAT status from FDA for lasmé-cel, the first allogeneic CAR-T therapy in a pivotal trial for patients with relapsed or refractory B-ALL. NEW YORK, June 09, 2026 (GLOBE NEWSWIRE) - Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering genome editing platform to develop cell and gene therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasmé-cel), its allogeneic CAR-T cell therapy candidate targeting the CD22 antigen, for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). The granting of RMAT status reflects the FDA's recognition of lasmé-cel's potential to address the unmet medical need of patients with relapsed or refractory B-ALL. This RMAT designation is supported by phase 1 data from the BALLI-01 clinical trial, which demonstrate promising efficacy with a manageable safety profile. Final results of the phase 1 BALLI-01 trial will be presented as an oral presentation this Saturday, June 13, from 5:15 pm to 6:30 pm (Paris/CEST) at the 2026 European Hematology Association (EHA) Congress by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at MD Anderson Cancer Center in Houston. "As a pioneer in allogeneic CAR-T technologies, we see the attainment of RMAT status for lasmé-cel as strong recognition of the importance of offering off-the-shelf CAR-T options to patients with relapsed or refractory B-ALL who cannot afford to wait. This status strengthens our interactions with the FDA as we advance lasmé-cel in its pivotal program," said Dr. André Choulika, co-founder and chief executive officer of Cellectis. The phase 2 pivotal BALLI-01 trial is currently open for enrollment. Information on eligible patients and participating clinical centers is available on clinicaltrials.gov: BALLI-01 (NCT04150497). About Cellectis Cellectis is a clinical-stage biotechnology company using its pioneering genome editing platform to develop innovative cell and gene therapies for the treatment of serious diseases. Cellectis is developing the first allogeneic immunotherapy products based on CAR-T cells, inventing the concept of off-the-shelf, ready-to-use engineered CAR T cells for the treatment of cancer patients, and a gene therapy development platform in other therapeutic indications. With its fully internalized manufacturing capabilities, Cellectis is one of the few companies in genome editing to control the end-to-end cell and gene therapy value chain. Cellectis's headquarters is located in Paris. Cellectis also has offices in New York and Raleigh in the United States. Cellectis is listed on the Euronext Growth market (code: ALCLS) and on the Nasdaq Global Market (code: CLLS). To learn more, visit our website: www.cellectis.com and follow Cellectis on LinkedIn and X. Cautionary Statement This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "would" or "potential" or the negative of these terms and other similar expressions. These forward-looking statements include statements regarding the potential of the Company's clinical trials to become a registration phase (including notably the phase 2 of the BALLI-01 study), the advancement, timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the expected timing for the presentation of our data, the sufficiency of cash to fund operations, the potential benefits of our product candidates and technologies. There are also risks of loss of RMAT designation if it is established that the product no longer meets the required criteria, and that this designation may not result in faster development or a faster regulatory review or approval process. In addition, many other important risk factors, including those described in our annual report on Form 20-F as amended and in our annual financial report (including the management report) for the year ended December 31, 2024 and subsequent documents filed by Cellectis with the Securities Exchange Commission, available on the SEC's website at www.sec.gov, as well as other known and unknown risks and uncertainties, may adversely affect these forward-looking statements and cause our actual results, performance or achievements to differ materially from those expressed or implied in the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. For more information about Cellectis, please contact: Media contacts: Pascalyne Wilson, Director, Communications, +33 (0)7 76 99 14 33, [email protected] Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93, Investor relations contact: Arthur Stril, Chief Financial Officer & Chief Business Officer, [email protected] Attachment
Cellectis, a clinical-stage biotechnology company developing gene-edited cell therapies, reported first quarter 2026 results with cash reserves of $188 million, providing runway into Q4 2027. The company expects pivotal Phase 2 interim data for lasme-cel in relapsed/refractory B-cell acute lymphoblastic leukaemia in Q4 2026, with a biologics licence application anticipated in 2028. Full Phase 1 data for eti-cel in non-Hodgkin lymphoma is also expected in Q4 2026. Partner Allogene reported interim pivotal data from the ALPHA3 trial of cema-cel, originally developed by Cellectis as UCART19, showing 58.3% of patients achieved MRD negativity versus 16.7% in the observation arm, with a favourable safety profile. Consolidated net loss attributable to shareholders was $17.8 million for Q1 2026, compared to $18.1 million for Q1 2025.
Cellectis SA is set to release its Q4 2025 earnings on 20 March 2026. Analysts expect revenue of $14.90 million and losses of $0.24 per share for the quarter. Full-year 2025 revenue is forecast at $58.42 million with losses of $0.73 per share. Over the past 90 days, revenue estimates for 2025 have increased from $55.17 million to $58.42 million, whilst earnings estimates improved from losses of $0.87 per share to $0.73 per share. However, 2026 revenue estimates have declined from $69.51 million to $53.66 million. In Q3 2025, Cellectis exceeded expectations with revenue of $32.37 million against estimates of $6.01 million. The average analyst price target suggests 113% upside from the current price of $3.08.
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Industries
Biotechnology
Healthcare
Company Size
201-500
Company Stage
IPO
Headquarters
Paris, France
Founded
2000
Find jobs on Simplify and start your career today