MUC1 x CD19

Highlighted significant research, preclinical advances and platform technology progress at third annual R&D Day Appointed Kristin Yarema, Ph.D., as President, Cell Therapy, adding extensive oncology and allogeneic T cell immunotherapy experience to the Company's leadership team SAN DIEGO, May 9, 2023 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced updates and financial results for the first quarter ended March 31, 2023. "In the first quarter, we continued to advance our clinical and research stage efforts as well as enhanced our leadership with the recent appointment of Kristin Yarema, Ph.D., as President, Cell Therapy," said Mark Gergen, Chief Executive Officer of the Company. "In our allogeneic CAR-T portfolio, we are actively enrolling patients in the Phase 1 studies for P-MUC1C-ALLO1 and P-BCMA-ALLO1 and remain on track for an IND for P-CD19CD20-ALLO1 mid-year. These initial allogeneic clinical programs are designed to evaluate many aspects of our unique high-TSCM allogeneic platform including dosing strategies, pre-conditioning regimens, potential biomarkers and many other factors. In our gene therapy portfolio, we are in discussions with Takeda about our collaboration following the news that they have made some strategic decisions in their research priorities and will update when appropriate. In the meantime, we remain excited about the strong progress made on all gene therapy programs and look forward to giving six preclinical presentations at the American Society of Gene and Cell Therapy annual meeting next week." Program Updates CAR-T Programs In cell therapy, the Company is focused on three allogeneic CAR-T programs with two programs currently progressing in Phase 1 clinical trials and one expected IND during the year: MUC1-C Program P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers. The Company is currently evaluating P-MUC1C-ALLO1 in a Phase 1 clinical trial and presented early clinical data in December 2022 at the European Society for Medical Oncology Immuno-Oncology 2022 Annual Congress (ESMO I-O) in Geneva, Switzerland. The Company currently expects to present further clinical updates for the program at a medical meeting in 2023. BCMA Program P-BCMA-ALLO1 is an allogeneic CAR-T product candidate being developed to target relapsed/refractory multiple myeloma (R/R MM) in partnership with Roche. The Company is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and shared early clinical data from the program at ESMO I-O in December 2022. The Company currently expects to present further clinical updates for the program at a medical meeting in 2023, subject to clearance with Roche. CD19CD20 Program P-CD19CD20-ALLO1 is a preclinical allogeneic CAR-T product being developed to target B-cell malignancies in partnership with Roche. P-CD19CD20-ALLO1 is the Company's first dual CAR program and contains two fully functional CAR molecules to target cells that express either CD19 or CD20. The Company believes that by targeting both CD19 and CD20, there is potential to overcome potential antigen escape that has been observed by others. The Company expects to file an IND for P-CD19CD20-ALLO1 in mid-2023. Gene Therapy Programs The Company is advancing multiple preclinical gene therapy programs in liver-directed diseases: OTC Program P-OTC-101 is an in vivo program for the treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene. The Company is developing the P-OTC-101 program utilizing a hybrid delivery system and working on an updated timeline for the program. The Company presented data at its R&D Day in February 2023, highlighting continued advancements in preclinical models leading towards a potential functional cure of OTC Deficiency. FVIII Program The Company is advancing its P-FVIII-101 preclinical program partnered with Takeda, which is in development for the in vivo treatment of Hemophilia A. P-FVIII-101 utilizes piggyBac gene modification delivered via lipid nanoparticle that has demonstrated stable and sustained Factor VIII expression in animal models. The Company is presenting preclinical data from this program at the upcoming American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting being held in Los Angeles on May 16-20, 2023. PAH Program Announced at the Company's R&D Day in February 2023, P-PAH-101 is a liver-directed gene therapy partnered with Takeda to treat Phenylketonuria (PKU), an inherited genetic disorder caused by mutations in the phenylalanine hydroxylase (PAH) gene resulting in buildup of phenylalanine in the body. If left untreated, PKU can affect a person's cognitive development. P-PAH-101 utilizes piggyBac technology combined with its hybrid adeno-associated virus (AAV) and nanoparticle delivery system. The Company's preclinical data has demonstrated the potential to resolve phenylalanine to normal levels following a single treatment in juvenile and adult mice. P-PAH-101 is currently in preclinical development. Leadership Updates Kristin Yarema, Ph.D., Appointed President, Cell Therapy In April 2023, the Company announced the appointment of Kristin Yarema, Ph.D., as President, Cell Therapy, to lead the Company's drug development programs in cell therapy, including its collaboration with Roche. She joined the Company after most recently serving as Chief Commercial Officer at Atara Biotherapeutics, where she led the commercialization of EBVALLO™, which became the world's first marketed allogeneic T cell therapy after receiving regulatory approval in Europe for the treatment of a rare lymphoma. Prior to Atara, she held a series of U.S. and global commercial leadership roles at Amgen and Novartis in hematology-oncology among other therapeutic areas. Rafael G. Amado, M.D., Appointed to Board of Directors In April 2023, Rafael G. Amado, M.D., was appointed to the Company's Board of Directors. Dr. Amado is currently President, Head of Global Oncology Research and Development at Zai Lab, a public biopharmaceutical company. Prior to Zai Lab, Dr. Amado served as Executive Vice President, Head of Research and Development and Chief Medical Officer from September 2019 to December 2022 at Allogene Therapeutics, Inc. and President of Research and Development from August 2018 to August 2019 and Chief Medical Officer from March 2015 to August 2018 at Adaptimmune, LLC. Financial Results for the First Quarter 2023 "We continue to be disciplined on spend and evaluate plans and options to help us further manage our cash burn rate," said Johanna Mylet, Chief Financial Officer at Poseida. "We have been operating at the low end of our guided cash utilization range and our current base plan should allow us to preserve our runway into at least mid-2024, and possibly further depending on other decisions, including business development opportunities." Revenues Revenues were $10.3 million for the first quarter ended March 31, 2023, compared to $1.4 million for the same period in 2022. The increase of revenues was primarily due to revenues earned from the collaboration and license agreement with Roche, which became effective in the third quarter of 2022. Research and Development Expenses Research and development expenses were $38.1 million for the first quarter ended March 31, 2023, compared to $48.9 million for the same period in 2022. The decrease was primarily driven by the wind-down of the Company's clinical development activities associated with our autologous programs and related contract termination expense in the prior year and the transition of manufacturing to the Company's internal pilot plant for P-BCMA-ALLO1, partially offset by increases in the number of ongoing clinical trials, including enrollment and manufacturing for the P-MUC1C-ALLO1 and P-BCMA-ALLO1 Phase 1 clinical trials, and increases related to the Company's preclinical stage programs due to an increase in research collaboration activity and personnel and facilities expenses as a result of increased headcount. General and Administrative Expenses General and administrative expenses for the first quarter ended March 31, 2023 were $11.8 million compared to $9.5 million for the same period in 2022. The increase was primarily related to an increase in stock-based compensation expense due to a one-time modification associated with the retirement of the Company's former Executive Chairman. Net Loss Net loss was $38.8 million for the first quarter ended March 31, 2023, compared to $58.1 million for the same period of 2022. Cash Position As of March 31, 2023, the Company's cash, cash equivalents and short-term investments balance was $247.2 million. The Company expects that its cash, cash equivalents and short-term investments together with the remaining near-term milestones and other payments from Roche will continue to be sufficient to fund operations into at least mid-2024. About Poseida Therapeutics, Inc. Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated cell and gene therapies with the capacity to cure certain cancers and rare diseases. The Company's pipeline includes allogeneic CAR-T cell therapy product candidates for both solid and liquid tumors as well as in vivo gene therapy product candidates that address patient populations with high unmet medical need. The Company's approach to cell and gene therapies is based on its proprietary genetic editing platforms, including its non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System and nanoparticle and hybrid gene delivery technologies. The Company has formed global strategic collaborations with Roche and Takeda to unlock the promise of cell and gene therapies for patients. Learn more at and connect with Poseida on Twitter and LinkedIn. 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. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials, including timing of regulatory submissions and approvals and clinical data updates; potential fees, milestones and other payments that the Company may receive pursuant to its collaboration agreements; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's technology platforms and product candidates; estimates of the Company's cash balance, expenses, capital requirements, any future revenue, and need for additional financing; the Company's ability to attract and/or retain new and existing collaborators with relevant expertise and its expectations regarding the potential benefits to be derived from any such collaborations; and the Company's plans and strategy with respect to developing its technologies and product candidates. 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 forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the Company's reliance on third parties for various aspects of its business; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; the fact that the Company will have limited control over the efforts and resources that its strategic partners devote to advancing development programs under their respective collaboration agreements and the Company may not receive the potential fees and payments under the collaboration agreements and the ability of its strategic partners to early terminate the collaborations, such that the Company may not fully realize the benefits of such collaborations; and the other risks described in the Company's filings with 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. 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, except as required by law. SOURCE Poseida Therapeutics, Inc.

Presented early data from Phase 1 trials of P-MUC1C-ALLO1 and P-BCMA-ALLO1 allogeneic CAR-T cell therapy programs at the European Society for Medical Oncology Immuno-Oncology 2022 Annual Congress (ESMO I-O) Highlighted preclinical data from P-FVIII-101 gene therapy program at the 64th American Society of Hematology Annual Meeting & Exposition (ASH) SAN DIEGO, March 9, 2023 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced updates and financial results for the fourth quarter and full year ended December 31, 2022. "For Poseida, 2022 was a year of execution, progress and validation for our proprietary technology and programs in both cell and gene therapy. In cell therapy, we advanced two fully allogeneic CAR-T programs into the clinic and presented early clinical data for both programs at ESMO I-O in December 2022. We also established a strategic partnership with Roche, a global leader in oncology, focused on our allogeneic CAR-T platform in hematological indications," said Mark Gergen, Chief Executive Officer of the Company. "In gene therapy, our Takeda-partnered in vivo gene therapy program in Hemophilia A continued to demonstrate promise as a potential functional cure with proof of principle data presented at ASH. Along with the rest of the industry, we continue to manage through headwinds as we deal with macro-economic issues and conditions that can impact multiple aspects of our business. We remain focused on advancing our business and continuing to drive innovation as reflected at our recent R&D Day." Program Updates CAR-T Programs In cell therapy, the Company is focused on three allogeneic CAR-T programs with two programs currently progressing in Phase 1 clinical trials and one expected IND during the year: MUC1-C Program P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers. The Company is currently evaluating P-MUC1C-ALLO1 in a Phase 1 clinical trial and presented early clinical data in December 2022 at ESMO I-O in Geneva, Switzerland. Data highlighted at the meeting showed that P-MUC1C-ALLO1 was well tolerated, with no dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), graft vs host disease (GVHD) or immune effector cell-associated neurotoxicity syndrome (ICANS). In addition, P-MUC1C-ALLO1 showed encouraging clinical activity, including an objective partial response in a breast cancer patient at the lowest dose. The Company expects to present further clinical data updates for the program at a medical meeting in 2023. BCMA Program P-BCMA-ALLO1 is an allogeneic CAR-T product candidate being developed to target relapsed/refractory multiple myeloma (R/R MM) in partnership with Roche. The Company is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and shared early clinical data from the program at ESMO I-O in December 2022. P-BCMA-ALLO1 was well tolerated, with no DLTs, CRS, GVHD or ICANS. P-BCMA-ALLO1 demonstrated responses in heavily pre-treated patients with R/R MM at the lowest dose, including in patients who had previously received BCMA-targeted therapy and patients with high-risk disease. In the fourth quarter of 2022, the Company also successfully added the ability to manufacture P-BCMA-ALLO1 at its internal GMP pilot plant in San Diego. The Company expects to present further clinical updates for the program at a medical meeting in 2023, subject to clearance with Roche. CD19CD20 Program P-CD19CD20-ALL01 is a preclinical allogeneic CAR-T product being developed to target B-cell malignancies in partnership with Roche. P-CD19CD20-ALL01 is the Company's first dual CAR program and contains two fully functional CAR molecules to target cells that express either CD19 or CD20. The Company believes that by targeting both CD19 and CD20, there is potential to overcome some of the issues of earlier generation CD19 CAR-T products where antigen escape has been observed. The Company expects to file an IND for P-CD19CD20-ALLO1 in mid-2023. Gene Therapy Programs The Company is advancing multiple preclinical gene therapy programs in liver-directed diseases: OTC Program P-OTC-101 is an in vivo program for the treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene. The Company is developing the P-OTC-101 program utilizing a hybrid delivery system and working on an updated timeline for the program. The Company presented data at its R&D Day in February 2023, highlighting continued advancements in preclinical models leading towards a potential functional cure of OTC Deficiency. FVIII Program The Company is advancing its P-FVIII-101 preclinical program partnered with Takeda, which is in development for the in vivo treatment of Hemophilia A. P-FVIII-101 utilizes piggyBac gene modification delivered via lipid nanoparticle that has demonstrated stable and sustained Factor VIII expression in animal models. The Company presented preclinical data from this program at the ASH annual meeting in New Orleans in December 2022, which showed that P-FVIII-101 achieved and sustained normalized (>50%) human Factor VIII activity following a single dose and delivered therapeutic Factor VIII activity in mice following single and repeat doses, indicating the potential for dose titration. The data support that, with the Company's piggyBac delivery system, the therapeutic transgene expression cassette can be stably integrated into the genome of liver cells and provide consistent and durable therapeutic activity. PAH Program Announced at the Company's R&D Day in February 2023, P-PAH-101 is a liver-directed gene therapy to treat Phenylketonuria (PKU), an inherited genetic disorder caused by mutations in the phenylalanine hydroxylase (PAH) gene resulting in buildup of phenylalanine in the body. If left untreated, PKU can affect a person's cognitive development. P-PAH-101 utilizes piggyBac technology combined with its hybrid adeno-associated virus (AAV) and nanoparticle delivery system. The Company's preclinical data has demonstrated the potential to resolve phenylalanine to normal levels following a single treatment in juvenile and adult mice. P-PAH-101 is partnered with Takeda and currently in preclinical development. Expansion of Gene Therapy Scientific Advisory Board In 2022 the Company announced the formation of its Gene Therapy Scientific Advisory Board (SAB), chaired by George M. Church, Ph.D. In March 2023, the Company announced the appointment of five new members to its Gene Therapy SAB to provide counsel on the Company's gene therapy programs in development. Financial Results for the Fourth Quarter and Full Year 2022 Revenues Revenues were $10.1 million and $130.5 million for the fourth quarter and the full year ended December 31, 2022, compared to $31.2 million for both the fourth quarter and the full year ended December 31, 2021. The increase of revenues was primarily due to revenues earned from the collaboration and license agreement with Roche, which became effective in the third quarter of 2022, and the Takeda collaboration and license agreement, which became effective in the fourth quarter of 2021. Research and Development Expenses Research and development expenses were $33.9 million for the fourth quarter ended December 31, 2022, compared to $39.1 million for the same period in 2021. The decrease was primarily driven by the wind-down of the Company's P-BCMA-101 and P-PSMA-101 autologous programs as the Company transitioned to an allogeneic platform, offset by an increase in personnel expenses as a result of increased headcount, which included an increase in stock-based compensation expense. For the full year ended December 31, 2022, research and development expenses were $152.9 million, compared to $136.7 million for the same period in 2021. The increase was primarily due to an increase in personnel expenses as a result of increased headcount, which included an increase in stock-based compensation expense, and an increase in overall active clinical programs offset by the wind-down of the Company's P-BCMA-101 autologous program as the Company transitioned to the allogeneic program. General and Administrative Expenses General and administrative expenses for the fourth quarter ended December 31, 2022 and 2021, were $9.4 million and $9.6 million, respectively. The decrease was primarily related to a decrease in insurance expense, offset by an increase in personnel expenses due to an increase in headcount. For the full year ended December 31, 2022 and 2021, general and administrative expenses were $37.5 million and $35.9 million, respectively. The increase was primarily related to an increase in personnel expenses due to an increase in headcount, which included an increase in stock-based compensation expense. Net Income (Loss) Net loss was $33.3 million for the fourth quarter ended December 31, 2022, compared to a net income of $1.5 million for the same period of 2021. Net loss for the full year ended December 31, 2022 and 2021, were $64.0 million and $125.0 million, respectively. Cash Position As of December 31, 2022, the Company's cash, cash equivalents and short-term investments balance was $282.5 million. The Company expects that its cash, cash equivalents and short-term investments together with the remaining near-term milestones and other payments from Roche will be sufficient to fund operations into at least mid-2024. About Poseida Therapeutics, Inc. Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated cell and gene therapies with the capacity to cure certain cancers and rare diseases. The Company's pipeline includes allogeneic CAR-T cell therapy product candidates for both solid and liquid tumors as well as in vivo gene therapy product candidates that address patient populations with high unmet medical need. The Company's approach to cell and gene therapies is based on its proprietary genetic editing platforms, including its non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System and nanoparticle and hybrid gene delivery technologies. The Company has formed global strategic collaborations with Roche and Takeda to unlock the promise of cell and gene therapies for patients. Learn more at and connect with Poseida on Twitter and LinkedIn. 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. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials, including timing of regulatory submissions and approvals and clinical data updates; potential fees, milestones and other payments that the Company may receive pursuant to its collaboration agreements; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's technology platforms and product candidates; and the Company's plans and strategy with respect to developing its technologies and product candidates. 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 forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the Company's reliance on third parties for various aspects of its business; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; the fact that the Company will have limited control over the efforts and resources that its strategic partners devote to advancing development programs under their respective collaboration agreements and the Company may not receive the potential fees and payments under the collaboration agreements and the ability of its strategic partners to early terminate the collaborations, such that the Company may not fully realize the benefits of such collaborations; and the other risks described in the Company's filings with 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. 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, except as required by law. SOURCE Poseida Therapeutics, Inc.

ASH 2022 sponsored programs – UCART123 abstract selected for oral presentation & preclinical data on UCARTCS1 selected for poster presentation, in collaboration with the Amsterdam University Medical Center Preclinical data on TALEN®-edited smart CAR T-cells to be presented at SITC 2022 Partner Allogene Therapeutics announced having initiated industry’s first allogeneic CAR T Phase 2 trial Iovance Biotherapeutics, Inc. announced having dosed the first patient and completed safety observation period in its IOV-GM1-201 clinical trial Mark Frattini, M.D., Ph.D., appointed Chief Medical Officer Cash position1 of $103 million as of September 30, 2022 Conference call scheduled for 8AM ET/2PM CET on November 4, 2022 NEW YORK, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop potentially life-saving cell and gene therapies, announced its results for the three-month and nine-month periods ending September 30, 2022. “2022 has been a productive year thus far for Cellectis. Today, we were proud to announce that our UCART123 abstract was accepted for an oral presentation at the American Society of Hematology Annual Meeting. Acute myeloid leukemia presents a huge unmet medical need with a lack of cell therapy options, and these encouraging preliminary clinical data are a great step for patients with this condition,” said André Choulika, Ph.D., Chief Executive Officer of Cellectis. “We continue to enroll patients in our three Cellectis-sponsored Phase 1 dose escalation clinical trials and are very excited to initiate the dosing of patients with our product candidates UCART22 and UCART20x22 that have been fully manufactured in-house. This quarter, our partnerships continued to be a highlight for Cellectis, as several of our licensed partners disclosed exciting milestones. Our licensed partner, Allogene Therapeutics, announced that it was entering into the potentially pivotal Phase 2 trial, for patients with large B-cell lymphoma. Iovance Biotherapeutics announced that the first patient was dosed and completed the safety observation period in the IOV-GM1-201 clinical trial of Iovance’s first genetically modified TALEN®-edited TIL therapy for the treatment of previously treated advanced melanoma or metastatic NSCLC. These achievements showcase once more that TALEN® is a technology of choice for leading cell and gene therapy companies, and that we are continuing to deliver on our promise of constant innovation in order to advance the efforts of both our and our partner’s clinical trials. Cellectis remains steadfast in its mission to develop innovative cancer therapy product candidates, and I am proud of the progress we have made in our journey this year.” Pipeline highlights UCART Clinical Development Programs BALLI-01 (evaluating UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) UCART22 is an allogeneic CAR T-cell product candidate that targets CD22 and is being evaluated in the BALLI-01 clinical study, a Phase 1/2a open-label dose-escalation study designed to evaluate the safety and clinical activity of the product candidate in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)BALLI-01 is currently enrolling patients at dose level 3 (DL3) (5 × 106 cells/kg) with fludarabine, cyclophosphamide and alemtuzumab (FCA) preconditioning regimen.Cellectis plans to initiate dosing patients with UCART22 product candidate manufactured fully in-house. AMELI-01 (evaluating UCART123) in relapsed or refractory acute myeloid leukemia (r/r AML) UCART123 is an allogeneic CAR T-cell product candidate targeting CD123 and is being evaluated in patients with relapsed or refractory acute myeloid leukemia (r/r AML) in the AMELI-01 Phase 1 dose-escalation clinical study. Today, Cellectis announced the release of an abstract, which was accepted for oral presentation at the American Society of Hematology (ASH) 2022 Annual Meeting. The abstract includes preliminary clinical data from the Phase I, open-label, dose-escalation AMELI-01 study in patients with r/r AML, showing that adding alemtuzumab to the fludarabine and cyclophosphamide lymphodepletion regimen was associated with improved lymphodepletion and significantly higher UCART123 cell expansion, which correlated with improved activity. These encouraging data support the continued enrollment into the study. Oral presentation will occur on December 12 at 5:00PM; Ernest N. Morial Convention Center, Hall E Link to abstract here. MELANI-01 (evaluating UCARTCS1) in relapsed or refractory multiple myeloma (r/r MM) UCARTCS1 is an allogeneic CAR T-cell product candidate targeting CS1 and is being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the MELANI-01 Phase 1 dose-escalation clinical study. Cellectis is currently enrolling patients at dose level 1 (DL1) (1 × 106 cells/kg) with fludarabine and cyclophosphamide preconditioning regimen. NatHaLi-01 (evaluating UCART20x22) in relapsed or refractory Non-Hogdkin Lymphoma (r/r NHL) UCART20x22 is Cellectis’ first allogeneic dual CAR T-cell product candidate being developed for patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL). UCART20x22 is Cellectis’ first product candidate fully designed, developed and manufactured in-house, showcasing the Company’s transformation into an end-to-end cell and gene therapy platform spanning discovery, product development, manufacturing of starting materials used for genomic engineering and final cell therapy product candidates, in addition to clinical development. On August 1st, the U.S. Food and Drug Administration (FDA) allowed Cellectis’ IND to proceed with UCART20x22 in clinical development for patients with r/r NHL. Research Data & Preclinical Programs UCARTCS1 Today, Cellectis in collaboration with the Amsterdam University Medical Center (VUmc) announced the release of an abstract on product candidate UCARTCS1, which was accepted for poster presentation at the ASH 2022 Annual Meeting. The abstract includes preclinical data evaluating in vitro activity of UCARTCS1 against multiple myeloma (MM) cell lines and bone marrow samples from MM patients, as well as in vivo activity in a MM mouse model. The potential impact of previous therapy and tumor characteristics on the in vitro efficacy of UCARTCS1 was also investigated. The preclinical data that will be presented demonstrate anti-tumor activity in vitro and in vivo supporting the potential benefit of our UCARTCS1 first in-human study, MELANI-01, a Phase 1, open-label, dose-escalation trial for patients with r/r MM. Presentation will occur on Saturday, December 10, 2022; 5:30 PM - 7:30 PM; Ernest N. Morial Convention Center, Hall D Link to abstract here. TALEN®-edited smart CAR T-cells On October 5, Cellectis announced that preclinical data on TALEN®-edited smart CAR T-cells supporting improved solid tumor targeting will be presented at the Society for Immunotherapy of Cancer’s (SITC) Annual meeting, to be held on November 8-12, 2022 in Boston. Cellectis will present two posters: A poster on TALEN®-edited smart CAR T-cells targeting MUC1-expressing solid tumors. MUC1 is a tumor-associated antigen that is overexpressed in a number of solid tumor malignancies including triple-negative breast cancer (TNBC).A poster on innovative T-cell engineering strategies designed to increase the activity of CAR T-cells for solid tumors while mitigating toxicity risks. Presentations will occur on November 10, from 9:00AM until 9:00PM ET, Hall C. TALEN®-based gene therapy preclinical programs On October 11, at the European Society of Gene and Cell Therapy (ESGCT), Cellectis presented pre-clinical data that leverages TALEN® gene editing technology to develop a hematopoietic stem and progenitor cell (HSPCs)-based gene therapy for the treatment of sickle cell disease, and a TALEN®-based gene editing approach that reprograms HSPCs to secrete alpha-L-iduronidase (IDUA), a therapeutic enzyme missing in Mucopolysaccharidosis type I (MPS-I). The pre-clinical data presented at ESGCT further demonstrate our ability to leverage TALEN® gene editing technology to potentially address genetic diseases, namely sickle cell disease and lysosomal storage diseases. By correcting a mutation or inserting a corrected gene at the HSPC level, Cellectis aims to provide a lifelong supply of healthy cells in a single intervention. Click here to access the presentations and abstracts. Licensed Allogeneic CAR T-cell Development ProgramsAllogene Therapeutics, Inc.’s CAR T programs utilize Cellectis technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier (the “Servier Agreement”). Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S. while Servier retains exclusive rights for all other countries. In September 2022, Servier communicated that it was discontinuing its involvement in the development of in-licensed CD19 products and purporting to provide Allogene with the ability to elect to obtain a license to the CD19 Products outside of the United States. We are evaluating all available options and contractual remedies to address the foregoing matters and other performance issues, which we believe may involve material breaches of the Servier Agreement by Servier. Allogene’s anti-BCMA and anti-CD70 programs are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these programs. Servier and Allogene: anti-CD19 programs On October 6, 2022, Allogene announced it has initiated potentially pivotal allogeneic CAR T Phase 2 clinical trial of ALLO-501A (ALPHA2 trial) in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). Allogene expects that the ALPHA2 trial will enroll approximately 100 patients who have received at least two prior lines of therapy and have not received prior anti-CD19 therapy. Allogene announced that updated clinical data from the CD19 program will be provided at Allogene’s R&D Showcase on November 29, 2022. Allogene: anti-BCMA program On November 2, 2022, Allogene announced that the Phase 1 portion of the UNIVERSAL trial on ALLO-715 continues enrolling patients with r/r multiple myeloma (MM). Allogene also announced it will provide a clinical update from UNIVERSAL focused on a single dose ALLO-715 and discuss next steps for the program at the R&D Showcase. Allogene: solid tumor program On November 2, 2022, Allogene stated that ALLO-316, which targets CD70, its first AlloCAR T candidate for solid tumors, is being studied in patients with advanced or metastatic clear cell renal cell carcinoma (RCC) in the Phase 1 TRAVERSE trial. Gene Editing Partnerships Iovance Biotherapeutics, Inc. (“Iovance”) On October 10, 2022, Iovance announced that the first patient was dosed and completed the safety observation period in the IOV-GM1-201 clinical trial of Iovance’s first genetically modified TIL therapy in development, IOV-4001, for the treatment of previously treated advanced melanoma or metastatic NSCLC. To inactivate the gene coding for the PD-1 protein, IOV-4001 utilizes the gene-editing TALEN® technology licensed from Cellectis. This single genetic modification in IOV-4001 has the potential to enhance the antitumor activity of the TIL mechanism to directly target and kill tumor cells. Dosing the first patient with IOV-4001 is an important first step in providing proof-of-concept for delivering genetically modified TIL therapy to solid tumor patients with significant unmet needs and few treatment options. Cytovia Therapeutics Cytovia announced it will present new preclinical data on TALEN® gene-edited, induced pluripotent stem cells (iPSC)-derived Natural Killer (NK) cells at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting. The abstract, entitled “TALEN®-Based Gene-Edited iPSC-Derived NK (iNK) Cells Demonstrate Enhanced Antitumor Activity”, was accepted for poster presentation. These data highlight the progress of Cellectis’ research and development collaboration with Cytovia to develop TALEN®-edited iPSC NK and CAR-NK cells. Cellectis has developed custom TALEN® which Cytovia is using to edit iPSCs in a safe and effective manner. The poster presentation will occur on November 11, from 9:00AM until 9:00PM ET, Poster Hall. Corporate Updates Appointment On September 28, 2022, Cellectis announced the appointment of Mark Frattini, M.D., Ph.D., as Chief Medical Officer. Dr Frattini joined Cellectis in August 2020 as Senior Vice President of Clinical Sciences and has been responsible for Cellectis’ clinical leadership including the clinical development strategy of the Company’s current immune-oncology UCART product candidates. He has also been serving as a core member of the senior clinical team and has been managing a team of physicians and clinical scientists. As Chief Medical Officer, Dr. Frattini oversees clinical research and development for Cellectis’ UCART clinical trial programs. He remains based in Cellectis’ New York office and has joined the Company’s executive committee. Financial Results The interim condensed consolidated financial statements of Cellectis, which consolidate the results of Calyxt, Inc. of which Cellectis owned approximately 51.2% of outstanding shares of common stock (as of September 30, 2022), have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board (“IFRS”).We present certain financial metrics broken out between our two reportable segments – Therapeutics and Plants – in the appendices of this Q3 2022 financial results press release. Cash: As of September 30, 2022, Cellectis, including Calyxt, had $103 million in consolidated cash, cash equivalents, and restricted cash of which $95 million are attributable to Cellectis on a stand-alone basis. This compares to $191 million in consolidated cash, cash equivalents and restricted cash as of December 31, 2021, of which $177 million was attributable to Cellectis on a stand-alone basis. This net decrease of $88 million primarily reflects (i) $81 million of net cash flows used in operating, investing and lease financing activities of Cellectis, (ii) $17 million of net cash flows used in operating, capital expenditures and lease financing activities of Calyxt, and (iii) a $10 million unfavorable foreign exchange (FOREX) impact which was partially offset by (i) $10 million of net proceeds from capital raised at Calyxt in February 2022, (ii) $6 million of cash received related to research tax credit prefinancing and (iii) $3 million of cash received related to licenses and milestone payments. Based on the current operating plan, Cellectis excluding Calyxt anticipates that the cash, cash equivalents, and restricted cash as of September 30, 2022 will fund Cellectis’ operations into early 2024.Revenues and Other Income: Consolidated revenues and other income were $9 million for the nine months ended September 30, 2022 compared to $53 million for the nine months ended September 30, 2021. 99% of consolidated revenues and other income was attributable to Cellectis in the first nine months of 2022. This decrease between the nine months ended September 30, 2022 and 2021 was mainly attributable to (i) a decrease of revenue pursuant to the recognition of a $15 million convertible note obtained as consideration for a “right-to-use” license granted to Cytovia and a $5 million Allogene milestone during the nine-month period ended September 30, 2021, while revenue related to collaboration agreements for the nine months of 2022 consists of the recognition of two milestones related to Cellectis’ agreement with Cytovia for $2 million and the recognition of $1 million related to a change of control of a licensee pursuant to the terms of its license agreement with Cellectis and the amendment to the license agreement (extension of the option term) (ii) a decrease in other revenues of $24 million relating to a change in Calyxt’s business model for its PlantSpring technology and BioFactory, in which no significant revenue was yet recognized.Cost of Revenues: Consolidated cost of revenues were $1 million for the nine months ended September 30, 2022 compared to $29 million for the nine months ended September 30, 2021. This decrease is driven by the change in Calyxt’s business model for its PlantSpring and BioFactory. R&D Expenses: Consolidated R&D expenses were $85 million for the nine months ended September 30, 2022 compared to $97 million for the nine months ended September 30, 2021. 89% of consolidated R&D expenses was attributable to Cellectis in the first nine months of 2022. The $11 million decrease between the first nine months of 2022 and 2021 was primarily attributable to (i) a decrease of purchases, external expenses and other by $10 million (from $57 million in 2021 to $47 million in 2022) due to lower consumables, subcontracting costs and depreciation and amortization for the therapeutic segment, (ii) a $1 million decrease in social charges on stock option, and (iii) a $3 million decrease in non-cash stock-based compensation expense partially offset by an increase of $3 million in wages and salaries mainly driven by the increased R&D headcount in the therapeutic segment.SG&A Expenses: Consolidated SG&A expenses were $25 million for the nine months ended September 30, 2022 compared to $28 million for the nine months ended September 30, 2021. 62% of consolidated SG&A expenses was attributable to Cellectis in the first nine months of 2022. The $3 million decrease primarily reflects (i) a $3 million decrease in wages and salaries, (ii) a $1 million decrease in purchases, external expenses and other (from $14 million in 2021 to $12 million in 2022) partially offset by (i) a $3 million increase in non-cash stock-based compensation expense mainly explained by the favorable impact in 2021 of the recapture of non-cash stock-based compensation from the forfeiture of certain of Calyxt’s former CEO’s unvested stock options, restricted stock units, and performance stock units following his departure.Net Income (loss) Attributable to Shareholders of Cellectis: The consolidated net loss attributable to shareholders of Cellectis was $79 million (or $1.74 per share) for the nine months ended September 30, 2022, of which $73 million was attributed to Cellectis, compared to $89 million (or $2.00 per share) for the nine months ended September 30, 2021, of which $75 million was attributed to Cellectis. This $10 million decrease in net loss between first nine months 2022 and 2021 was primarily driven by (i) an increase in net financial gain of $14 million, (ii) a decrease of $28 million of cost of revenue, (iii) a $11 million decrease of research and development and, (iv) a $3 million decrease of SG&A expenses partially offset by a decrease in revenues and other income of $45 million.Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: The consolidated adjusted net loss attributable to shareholders of Cellectis was $72 million (or $1.58 per share) for the nine months ended September 30, 2022, of which $67 million is attributed to Cellectis, compared to a net loss of $80 million (or $1.79 per share) or the nine months ended September 30, 2021, of which $66 million was attributed to Cellectis. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis. We currently foresee focusing our cash spending at Cellectis for the Full Year of 2022 in the following areas: Supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of UCART123, UCART22, UCARTCS1, UCART 20x22 and new product candidates, andOperating our state-of-the-art manufacturing capabilities in Paris (France), and Raleigh (North Carolina, U.S.A); andContinuing strengthening our manufacturing and clinical departments. As of the date of this interim report, BALLI-01 (UCART22 Phase 1 open label Study) is currently enrolling patients at (i) dose level 3 (DL3) with an FCA preconditioning regimen and (ii) dose level 2 (DL2) using UCART22 batches manufactured from an upgraded Cellectis internal manufacturing Process 2 (P2) with an FCA preconditioning regimen. CELLECTIS S.A.(unaudited)CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION($ in thousands, except per share data) As of December 31, 2021 Unaudited September 30,2022 ASSETS Non-current assets Intangible assets 1,854 1,511 Property, plant, and equipment 78,846 70,759 Right-of-use assets 69,423 58,112 Non-current financial assets 6,524 8,926 Total non-current assets 156,647 139,307 Current assets Trade receivables 20,361 802 Subsidies receivables 9,268 12,152 Other current assets 9,665 8,311 Cash and cash equivalent and Current financial assets 186,135 119,008 Total current assets 225,429 140,272 TOTAL ASSETS 382,076 279,580 LIABILITIES Shareholders’ equity Share capital 2,945 2,949 Premiums related to the share capital 934,696 579,047 Currency translation adjustment (18,021) (35,434)Retained earnings (584,129) (330,595)Net income (loss) (114,197) (79,326)Total shareholders’ equity - Group Share 221,293 136,641 Non-controlling interests 15,181 8,971 Total shareholders’ equity 236,474 145,612 Non-current liabilities Non-current financial liabilities 20,030 14,699 Non-current lease debts 71,526 63,592 Non-current provisions 4,073 2,646 Other non-current liabilities 626 - Total non-current liabilities 96,254 80,937 Current liabilities Current financial liabilities 2,354 10,379 Current lease debts 8,329 7,971 Trade payables 23,762 22,353 Deferred revenues and deferred income 301 320 Current provisions 871 425 Other current liabilities 13,731 11,582 Total current liabilities 49,348 53,030 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 382,076 279,580 Cellectis S.A. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)For the three-month period ended September 30, 2022$ in thousands, except per share amounts For the three-month period ended September 30, 2021 2022 Revenues and other income Revenues 8,312 217 Other income 2,516 1,704 Total revenues and other income 10,827 1,921 Operating expenses Cost of revenue (9,213) (367)Research and development expenses (34,324) (26,667)Selling, general and administrative expenses (9,675) (7,641)Other operating income (expenses) 18 (408)Total operating expenses (53,195) (35,082) Operating income (loss) (42,368) (33,162) Financial gain (loss) 2,296 1,896 Net income (loss) (40,071) (31,265)Attributable to shareholders of Cellectis (37,413) (28,467)Attributable to non-controlling interests (2,658) (2,798) Basic net income (loss) attributable to shareholders of Cellectis per share ($/share) (0.82) (0.63) Diluted net income (loss) attributable to shareholders of Cellectis per share ($/share) (0.82) (0.63) Cellectis S.A. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) For the nine-month period ended September 30, 2022$ in thousands, except per share amounts For the nine-month period ended September 30, 2021 2022 Revenues and other income Revenues 45,088 3,262 Other income 8,320 5,255 Total revenues and other income 53,408 8,517 Operating expenses Cost of revenue (29,113) (1,081)Research and development expenses (96,663) (85,194)Selling, general and administrative expenses (27,894) (25,336)Other operating income (expenses) 506 608 Total operating expenses (153,163) (111,003) Operating income (loss) (99,755) (102,485) Financial gain (loss) 2,728 17,009 Net income (loss) (97,027) (85,476)Attributable to shareholders of Cellectis (89,201) (79,326)Attributable to non-controlling interests (7,827) (6,150)Basic net income (loss) attributable to shareholders of Cellectis per share ($/share) (2.00) (1.74) Diluted net income (loss) attributable to shareholders of Cellectis per share ($/share) (2.00) (1.74) CELLECTIS S.A. DETAILS OF KEY PERFORMANCE INDICATORS BY REPORTABLE SEGMENTS – Third Quarter(unaudited) - ($ in thousands) For the three-month period endedSeptember 30, 2021 For the three-month period endedSeptember 30, 2022$ in thousands PlantsTherapeuticsTotal reportable segments PlantsTherapeuticsTotal reportable segments External revenues 8,288 24 8,312 42 175 217 External other income 0 2,516 2,516 - 1,704 1,704 External revenues and other income 8,288 2,540 10,827 42 1,879 1,921 Cost of revenue (8,807)(407)(9,213) (0)(367)(367)Research and development expenses (2,523)(31,802)(34,324) (2,830)(23,837)(26,667)Selling, general and administrative expenses (3,992)(5,683)(9,675) (2,738)(4,903)(7,641)Other operating income and expenses 18 (1)18 (282)(125)(408)Total operating expenses (15,304)(37,892)(53,195) (5,850)(29,233)(35,082)Operating income (loss) before tax (7,016)(35,352)(42,368) (5,808)(27,353)(33,162)Financial gain (loss) (291)2,588 2,296 90 1,806 1,896 Net income (loss) (7,307)(32,764)(40,071) (5,718)(25,547)(31,265)Non controlling interests 2,658 - 2,658 2,798 - 2,798 Net income (loss) attributable to shareholders of Cellectis (4,650)(32,764)(37,413) (2,920)(25,547)(28,467)R&D non-cash stock-based expense attributable to shareholder of Cellectis 151 3,219 3,370 116 809 925 SG&A non-cash stock-based expense attributable to shareholder of Cellectis 707 986 1,693 434 521 955 Adjustment of share-based compensation attributable to shareholders of Cellectis 858 4,204 5,062 550 1,330 1,880 Adjusted net income (loss) attributable to shareholders of Cellectis (3,792)(28,560)(32,351) (2,370)(24,218)(26,587)Depreciation and amortization (615)(3,708)(4,323) (438)(4,305)(4,744)Additions to tangible and intangible assets 69 3,426 3,495 218 223 442 CELLECTIS S.A. DETAILS OF KEY PERFORMANCE INDICATORS BY REPORTABLE SEGMENTS – First nine-months(unaudited) - ($ in thousands) For the nine-month period endedSeptember 30, 2021 For the nine-month period endedSeptember 30, 2022$ in thousands PlantsTherapeuticsTotal reportable segments PlantsTherapeuticsTotal reportable segments External revenues 25,004 20,085 45,088 115 3,147 3,262 External other income 1,528 6,792 8,320 - 5,255 5,255 External revenues and other income 26,532 26,876 53,408 115 8,402 8,517 Cost of revenue (27,512)(1,601)(29,113) (0)(1,081)(1,081)Research and development expenses (8,358)(88,304)(96,663) (9,127)(76,067)(85,194)Selling, general and administrative expenses (11,520)(16,373)(27,894) (9,539)(15,797)(25,336)Other operating income and expenses 25 481 506 (40)649 608 Total operating expenses (47,366)(105,797)(153,163) (18,706)(92,297)(111,003)Operating income (loss) before tax (20,834)(78,921)(99,755) (18,591)(83,894)(102,485)Net financial gain (loss) (875)3,603 2,728 5,990 11,019 17,009 Net income (loss) (21,709)(75,318)(97,027) (12,601)(72,875)(85,476)Non-controlling interests 7,827 - 7,827 6,150 - 6,150 Net income (loss) attributable to shareholders of Cellectis (13,883)(75,318)(89,201) (6,451)(72,875)(79,326)R&D non-cash stock-based expense attributable to shareholder of Cellectis 682 6,922 7,604 332 3,943 4,274 SG&A non-cash stock-based expense attributable to shareholder of Cellectis (208)1,901 1,693 1,224 1,713 2,937 Adjustment of share-based compensation attributable to shareholders of Cellectis 474 8,823 9,297 1,555 5,656 7,211 Adjusted net income (loss) attributable to shareholders of Cellectis (13,409)(66,495)(79,904) (4,896)(67,219)(72,114)Depreciation and amortization (1,834)(9,651)(11,485) (1,754)(13,739)(15,493)Additions to tangible and intangible assets 377 14,446 14,822 890 1,675 2,565 Note Regarding Use of Non-IFRS Financial MeasuresCellectis S.A. presents adjusted net income (loss) attributable to shareholders of Cellectis in this press release. Adjusted net income (loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. We have included in this press release a reconciliation of this figure to net income (loss) attributable to shareholders of Cellectis, which is the most directly comparable financial measure calculated in accordance with IFRS. Because adjusted net income (loss) attributable to shareholders of Cellectis excludes Non-cash stock-based compensation expense—a non-cash expense, we believe that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure. In particular, we believe that the elimination of Non-cash stock-based expenses from Net income (loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of adjusted net income (loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under IFRS. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of Non-cash stock- based compensation expense differently; and (b) other companies may report adjusted net income (loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider adjusted net income (loss) attributable to shareholders of Cellectis alongside our IFRS financial results, including Net income (loss) attributable to shareholders of Cellectis. RECONCILIATION OF IFRS TO NON-IFRS NET INCOME – Third Quarter(unaudited)($ in thousands, except per share data) For the three-month period ended September 30, 2021 2022 Net income (loss) attributable to shareholders of Cellectis (37,413) (28,467)Adjustment: 5,062 1,880 Non-cash stock-based compensation expense attributable to shareholders of Cellectis Adjusted net income (loss) attributable to shareholders of Cellectis (32,351) (26,587) Basic Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (0.71) (0.58) Weighted average number of outstanding shares, basic (units) (1) 45,471,977 45,540,315 Diluted Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) (0.71) (0.58) Weighted average number of outstanding shares, diluted (units) (1) 45,471,977 45,540,315 When we have adjusted net loss, in accordance with IFRS, we use the Weighted average number of outstanding shares, basic to compute the Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share). When we have adjusted net income, in accordance with IFRS, we use the Weighted average number of outstanding shares, diluted to compute the Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) RECONCILIATION OF IFRS TO NON-IFRS NET INCOME – First nine-months(unaudited)($ in thousands, except per share data) For the nine-month period ended September 30, 2021 2022 Net income (loss) attributable to shareholders of Cellectis (89,201) (79,326)Adjustment: 9,297 7,211 Non-cash stock-based compensation expense attributable to shareholders of Cellectis Adjusted net income (loss) attributable to shareholders of Cellectis (79,904) (72,114) Basic Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1.79) (1.58) Weighted average number of outstanding shares, basic (units) (1) 44,599,935 45,511,626 Diluted Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (1) (1.79) (1.58) Weighted average number of outstanding shares, diluted (units) (1) 44,599,935 45,511,626 (1) When we have adjusted net loss, in accordance with IFRS, we use the Weighted average number of outstanding shares, basic to compute the Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share). When we have adjusted net income, in accordance with IFRS, we use the Weighted average number of outstanding shares, diluted to compute the Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) About Cellectis Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with over 22 years of expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to treat diseases with unmet medical needs. As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing lifesaving UCART product candidates for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) and multiple myeloma (MM). .HEAL is a new platform focusing on hemopoietic stem cells to treat blood disorders, immunodeficiencies and lysosomal storage diseases. Cellectis’ headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). AlloCAR T™ is a trademark of Allogene Therapeutics, Inc. For more information, visit www.cellectis.comFollow Cellectis on social media: @cellectis, LinkedIn and YouTube. For further information, please contact: Media contacts: Pascalyne Wilson, Director, Communications, +33776991433, media@cellectis.comMargaret Gandolfo, Senior Manager, Communications, +1 (646) 628 0300 Investor Relation contact: Arthur Stril, Chief Business Officer, +1 (347) 809 5980, investors@cellectis.comAshley R. Robinson, LifeSci Advisors, +1 (617) 430 7577 Forward-looking StatementsThis 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 “anticipate,” “believe,” “intend”, “expect,” “plan,” “scheduled,” “could,” “may” and “will,” or the negative of these and similar expressions. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our licensed partners. Forward-looking statements include statements about advancement, timing and progress of our and our partners’ clinical trials (including with respect to patient enrollment and follow-up), the timing of presentation of data, the operational capabilities at our manufacturing facilities and the sufficiency of cash to fund operations. the potential of our preclinical programs and product candidates. These forward-looking statements are made in light of information currently available to us and are subject to numerous risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development. With respect to our cash runway, our operating plans, including product development plans, may change as a result of various factors, including factors currently unknown to us. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F and the financial report (including the management report) for the year ended December 31, 2021 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by 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. 1 Cash position includes cash, cash equivalent, current financial assets and restricted cash. Restricted cash was $5million as of September 30, 2022. Attachment Q3-2022-EarningsPR-English-PW (2)