Cemacabtagene ansegedleucel

The biopharma industry is facing a reckoning; Will the market ever fully accept cell therapy? This story is the first part in a four-part series about cell therapy, created by the Fierce Biotech team. Gabrielle Masson, Helen Floersh, James Waldron and Max Bayer contributed reporting to this series.   Cell therapy has been slashed by a thousand cuts over the past few years, from the failure of autologous CAR-T to live up to expectations, to market challenges to manufacturing woes. And now, the focus has shifted to autoimmune conditions. The biopharma industry is now facing a reckoning; Will the market ever fully accept these treatments? “We've lost our luster in cell therapies,” said Eric Schmidt Ph.D., biotech analyst for Cantor Fitzgerald, in an interview. “It's honestly been a pretty depressing last 12 months or so.” Sami Corwin, Ph.D., a research analyst at William Blair, calls this moment in time for cell therapy “a pivot.” Big Pharmas like Sanofi and Bristol Myers Squibb have begun pulling back from the cell therapy space, confronted with manufacturing challenges and the reality of marketing a personalized therapy. BMS shut down a California research center that was focused on the tumor microenvironment in April as part of a major restructuring. “The changes in our Cell Therapy Organization will streamline and focus efforts on the most promising areas, enabling us to maximize our inline assets, while building the foundation necessary to deliver on our best-in-class pipeline,” a spokesperson for BMS said at the time. Days later, BMS signed a $65 million upfront deal with Repertoire to work on tolerizing vaccines for autoimmune diseases, underscoring the pharma's interest in autoimmune but not cell therapy.  Also undergoing a pipeline reorganization, Sanofi shuttered legacy business Kiadis, which had been working on developing next-gen, ‘off-the-shelf,’ natural killer cell therapies. All of this has led to a muddled present, in which biotechs are walking away from oncology with uncertain partnership opportunities for the near future. “I guess in part, you can blame capacity and in part you can probably blame the complexity of the therapy. Or maybe you blame the competition as well,” Schmidt said. Even as cell therapies have put out strong data in oncology, the modality has been overshadowed by bispecifics, which have grown quickly in cancer care and surpassed sales for approved cell therapies in the myeloma space, specifically. “From a commercial standpoint, the autologous products … just haven't really knocked the cover off the ball the way that people might have been hopeful, given how strong the clinical data were,” Schmidt said, speaking specifically to CD19 cell therapies, which include Gilead’s Tecartus, Yescarta and Kymriah and Bristol Myers Squibb’s Breyanzi. Gilead has achieved the greatest success with Yescarta, which generated $380 million in net sales for the first quarter. Schmidt calls this the one “shining, positive example” in the field of approved therapies. The remaining approved cell therapies are all at or below $157 million. https://public.flourish.studio/visualisation/17948038/ But these products have not lived up to the hype elsewhere. “And that’s a real problem,” Schmidt said. “I don't know why. And I’m kind of hard-pressed to think it's just about supply and complexity and delivery.” Companies have also made slow progress in moving cell therapies into solid tumors, although some progress has been made including the approval of Iovance Biotherapeutics' Amtagvi in melanoma. Mustang Bio and City of Hope also recently showed in an early-stage trial that  CAR-T therapy may have a future in the difficult brain cancer glioblastoma.  For Allogene’s Zachary Roberts, M.D., Ph.D., the problems that have dogged cell therapy are simply because the tech wasn’t quite ready when all of these treatments rushed into the clinic. “I'm fond of saying that autologous products probably would not have been the first cell therapies approved, had we had the advanced gene editing tools that we have today,” said Roberts, EVP of R&D and chief medical officer. “So autologous products, as transformational as they have been, I believe, are essentially a stepping stone to the more cutting-edge allogeneic products like ours, and I'm excited by the in vivo CAR field, although they're still years away, and watching those data develop.” Cindy Perettie, global head of Gilead’s Kite Pharma unit, said that preclinical data does not translate as well into humans, so there is a huge amount of risk moving things into the clinic. “Having that phase one bake-off or horse race is really critical in these,” she said. Nevertheless, biotechs remain committed to cell therapy. Companies in the space are now going to have to find a way to justify the continued push and bring investors back around. “We have no idea as an investment community where the bar will be drawn,” Schmidt said. “As you go forward over the next 12 months, there will be a ton of cards to turn over, a ton of learnings.” https://omny.fm/shows/the-top-line/fulfilling-the-promise-of-cell-gene-therapies-thro   Finding the spotlight The definition of cell therapy is vast and each specific technology has its challenges. Gene-edited cell therapies, for instance, are about to get a huge market test with the recent approval of sickle cell treatments Casgevy (Vertex Pharma and CRISPR Therapeutics) and Lyfgenia (bluebird bio). Both had huge price tags slapped on them and will need to confront the realities of a payer environment that might not be ready for them. That’s another story, however. Other types of cell therapy include CAR natural killer (NK) cells or T cell receptor (TCR) modified T cells. According to Schmidt, the biotechs working on NK cells have all “pretty much given up,” turning as well to autoimmune and “hoping that the bar is lower.” “Everyone who's got a platform has repositioned itself to autoimmune disease, more on hope than on any data,” he said. It’s CAR-T cell therapy that has made the greatest splash in the clinic, only to be sucked back out to sea with reports of relapse among patients. One of the first major corrections in CAR-T, which is sometimes referred to as cell-based gene therapy, was when autologous candidates were swapped out for so-called “off the shelf” allogeneic therapies that used donated cells rather than a patient’s own. This was said to ease the manufacturing and patient burden and speed turnaround time. Many first-gen allogenic biotechs emerged around 2018 with great promise, only to stutter, according to Corwin and Schmidt. “Outside the autologous products there’s been nothing to cheer about from a clinical standpoint,” Schmidt said. “The allogeneic therapies have, for the most part, taken a step backward.” Allogene stopped two trials of a CAR-T candidate in advanced lymphoma to focus on minimal residual disease in January. The move will slide cemacabtagene ansegedleucel (cema-cel) to the seventh line of treatment, where a potential market could exist as doctors tend to monitor sixth-line patients for the 30% who relapse. Caribou Biosciences, after being dogged by relapses among patients, repositioned itself with a partially matched allogeneic product—not the same as an off-the-shelf option, according to Schmidt. He said the company, which was co-founded by Nobel laureate Jennifer Doudna, Ph.D., is “on thin ice.” While the bulk of Caribou's pipeline remains focused on cancer, the company was just approved to test CB-010 in autoimmune, too. The trial will cover two types of lupus, lupus nephritis and extra renal lupus. "We're very encouraged by the initial safety and efficacy data that we've seen with CB-010 in oncology and that really motivated us to choose to also invest in developing it in parallel in lupus," Caribou CEO Rachel Haurwitz told investors at the BofA Securities 2024 Healthcare Conference earlier this month. The chief executive remains confident in the oncology side of CB-010's development program as well, with the company poised to unveil data at the upcoming American Society of Clinical Oncology meeting this week.  Not ready to give up on its CAR NK technology, Nkarta was cleared by the FDA last fall to test a candidate called NKX019 in lupus, a move that investors cheered. The allogeneic, CD19-directed CAR NK cell therapy was already in clinical testing for B-cell malignancies. Data from the oncology trial revealed in March showed sharply falling response rates, compared to an earlier cohort.  Even CRISPR Tx, which is one of few companies to have a cell therapy approved with the Vertex-partnered Casgevy, pivoted its pipeline in December 2023 toward autoimmune. Some companies are continuing to try and prove autologous therapies can thrive, bolstered by the regulatory approvals that have come. BioNTech has been working on its manufacturing process to prepare the CAR-T BNT211 for pivotal trials. The German biotech signed a $250 million upfront deal with Autolus Therapeutics in February to use the company’s manufacturing technology. In return, BioNTech is supporting Autolus’ autologous CD19 CAR-T called obe-cel, which is currently awaiting an FDA decision for B-cell acute lymphoblastic leukemia. “I am a huge believer in cell therapy. And I think that we are still very much in the first chapter ... And I think what we're doing right now as a field is looking for ways to accelerate and simplify what we have to do with cell therapy to bring approvals in quicker and in interesting ways,” Allogene’s Roberts said. But now, thanks to some key studies out of Germany, the science on cell therapy has improved and the ability to address larger markets could be within reach. Corwin believes companies that are onto next-gen allogenic may “come back into the spotlight now.” Editor's Note: This story is part of a series on cell therapy. The second part will be published on May 30. This story was updated on May 29 at 3:23 p.m. ET, to include comments from Caribou CEO Rachel Haurwitz.

• Cellectis announced completion of the additional equity investment of $140M by AstraZeneca • Cash position of $143 million as of March 31, 20241; cash runway projection into 20262 • Conference call and webcast scheduled for tomorrow, May 29, 2024 at 8:00AM ET / 2:00PM CET NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, today provided business updates and reported financial results for the three-month period ending March 31, 2024. “We are thrilled to have announced the closing of the additional equity investment of $140 million by AstraZeneca. This followed AstraZeneca’s initial payment of $105 million, composed of a $80 million equity investment and a $25 million upfront payment under our research collaboration. “Following AstraZeneca’s additional investment, we expect our cash runway to fund operations into 2026. We will continue to focus our efforts and expenses on advancing its core clinical trials BALLI-01, NATHALI-01 and AMELI-01, which remain wholly owned assets, while building, within our owned preclinical pipeline and in collaboration with AstraZeneca, the next generation of medicines to address areas of high unmet patient needs. “We strongly believe that gene edited cell and gene therapy products are revolutionizing medicine across a number of therapeutic areas and will become a large part of molecular medicine of the future,” said André Choulika, Ph.D., Chief Executive Officer at Cellectis. __________________ 1 Cash position includes cash, cash equivalents, restricted cash and fixed-term deposits classified as current -financial assets. Restricted cash was $5 million as of March 31, 2024. Fixed-term deposits classified as current-financial assets was $15 million as of March 31, 2024. 2 Cash runway includes the additional investment by AstraZeneca of $140 million, completed on May 3, 2024. Pipeline Highlights UCART Clinical Programs Cellectis continues to focus on the enrollment of patients in the BALLI-01 study (evaluating UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), in the NATHALI-01 study (evaluating UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL), and in the AMELI-01 study (evaluating UCART123) in relapsed or refractory acute myeloid leukemia (r/r AML). We expect to provide updates in the advancements of BALLI-01 and NATHALI-01 by year-end 2024. Partnerships Licensed Allogeneic CAR T-cell Development Programs Anti-CD19 program Allogene’s investigational oncology products utilize Cellectis technologies. Servier, which has an exclusive license to the anti-CD19 investigational products from Cellectis, has granted Allogene an exclusive sublicense to these products in the U.S., European Union and the United Kingdom. Allogene announced the execution with Servier of an amendment to the sublicense to expand the licensed territory to the European Union and the United Kingdom. Allogene announced that it continues to focus on the development of its investigational product cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A), as part of the first line (1L) treatment plan for LBCL patients who are at risk of relapse following 1L chemoimmunotherapy. Allogene announced that start-up activities for the ALPHA3 trial are ongoing with a planned study initiation in mid-2024. Allogene further announced that enrollment is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel. Anti-CD70 program The anti-CD70 program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this program. Allogene announced that a Phase 1 data update of the ongoing TRAVERSE trial with ALLO-316 in RCC from approximately 20 patients with CD70 positive RCC is planned by YE 2024. Corporate Updates Collaboration and Investment Agreements with AstraZeneca On May 6, 2024, Cellectis announced the completion of the subsequent investment of $140M in Cellectis by AstraZeneca (LSE/STO/Nasdaq: AZN). AstraZeneca subscribed for 10,000,000 “class A” convertible preferred shares and 18,000,000 “class B” convertible preferred shares, in each case at a price of $5.00 per convertible preferred share, issued by the board of directors of Cellectis. AstraZeneca owns approximately 44% of the share capital and 30% of the voting rights of the Company (based on the number of voting rights currently outstanding). Appointment On May 2, 2024, Cellectis announced the appointment of Mr. Arthur Stril as Interim Chief Financial Officer, following the resignation of Bing Wang, Ph.D. The appointment of Mr. Marc Dunoyer and Dr. Tyrell Rivers as members of the board of directors of Cellectis, decided by the extraordinary general meeting of the shareholders of Cellectis held on December 22, 2023, is effective as from May 3, 2024. Financial Results The interim condensed consolidated financial statements of Cellectis have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board (“IFRS”). As from June 1, 2023 and the deconsolidation of Calyxt, which corresponded to the Plants operating segment, we view our operations and manage our business in a single operating and reportable segment corresponding to the Therapeutics segment. For this reason, we are no longer presenting financial measures broken down between our two reportable segments – Therapeutics and Plants. In the appendices of this Q1 2024 financial results press release, Calyxt's results are isolated under "Income (loss) from discontinued operations" for the 3-month period ended March 31, 2023, and are no longer included for the 3-month period ended March 31, 2024, due to the deconsolidation. Cash: As of March 31, 2024, Cellectis had $143 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current-financial assets. This compares to $156 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current-financial assets as of December 31, 2023. This $13 million decrease is mainly due to cash payments from Cellectis to suppliers of $13 million, including $9 million to R&D suppliers and $4 million to SG&A suppliers, wages, bonuses and social expenses paid of $15 million, the payments of lease debts of $3 million and the repayment of the “PGE” loan of $1 million, partially offset by the $16 million cash received from EIB pursuant to the disbursement of the €15 million Tranche B and $2 million of cash-in from our financial investments. With cash and cash equivalents of $123 million and a $15 million term deposit maturing in May 2024 classified as a current financial asset as of March 31, 2024, and taking into account the $140 million equity investment received on May 3, 2024 from AstraZeneca pursuant to the Subsequent Investment Agreement, the Company believes its cash and cash equivalents will be sufficient to fund its operations into 2026 and therefore for at least twelve months following the unaudited interim condensed consolidated financial statements' publication. Revenues and Other Income: Consolidated revenues and other income were $6.5 million for the three months ended March 31, 2024 compared to $3.6 million for the three months ended March 31, 2023. This $2.9 million increase between the three months ended March 31, 2023 and 2024 was mainly attributable to (i) recognition of a $4.4 million revenue in 2024 based on the progress of our performance obligation rendered under the first Research Plan of the JRCA with AZ Ireland while revenues recognized for the three months ended March 31, 2023 was immaterial, (ii) a decrease of research tax credit of $1.2 million due to a decrease of eligible expenses, and (iii) the recognition in the three-month periods ended March 31, 2023 of $0.3 million representing the portion of an initial payments from BPI corresponding to a grant pursuant to our grant and repayable advance agreement with BPI signed in March 2023. R&D Expenses: Consolidated R&D expenses were $22.3 million for the three months ended March 31, 2024, compared to $21.1 million for the three months ended March 31, 2023. R&D personnel expenses decreased by $0.3 million from $10.3 million in 2023 to $10.0 million in 2024 primarily due to a decrease in the average unit fair value of stock options and free share awards vesting between the two periods. R&D purchases, external expenses and other increased by $0.9 million (from $11.1 million in 2023 to $12.3 million in 2024) mainly related to increase in manufacturing activities to support our R&D pipeline. SG&A Expenses: Consolidated SG&A expenses were $5.1 million for the three months ended March 31, 2024 compared to $5.0 million for the three months ended March 31, 2023. SG&A personnel expenses are stable (from $2.1 million in 2023 to $2.1 million in 2024), with a $0.2 million increase in salaries being offset by a $0.2 million decrease in stock-based compensation expenses. SG&A purchases, external expenses and other increased by $0.1 million (from $2.9 million in 2023 to $3.0 million in 2024). Other operating income and expenses: Other operating income and expenses were a $0.0 million net income for the three months ended March 31, 2024 compared to a $0.6 million net expense for the three months ended March 31, 2023. Other operating income and expenses included costs related to a commercial litigation for $0.5 million in 2023, whereas no significant item was recognized in 2024. Net financial gain (loss): We had a consolidated net financial gain of $26.3 million for the three months ended March 31, 2024, compared to a $4.4 million loss for the three months ended March 31, 2023. This $30.7 million difference reflects mainly (i) a $21.3 million gain in change in fair value of the Subsequent Investment Agreement derivative instrument, (ii) a $1.4 million increase in gain from our financial investments, (iii) a $1.4 million gain in change in fair value of our investment in Cibus, (iv) a $1.3 million gain in change in fair value of EIB warrants tranche A and B, (v) an increase in our net foreign exchange gain of $3.2 million and (vi) the loss in fair value measurement on Cytovia convertible note recognized in the three months period ended March 31, 2023 of $3.3 million, partially offset by a $0.8 million interest expense on EIB Tranche A and Tranche B loans. Net income (loss) from discontinued operations: Net loss from discontinued operations of $4.7 million for the three months ended March 31, 2023 corresponded to Calyxt’s results. Since Calyxt has been deconsolidated since June 1, 2023, there is no longer any "Income (loss) from discontinued operations" for the three months ended March 31, 2024. Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net income attributable to shareholders of Cellectis was $5.6 million (or a $0.08 income per share) for the three months ended March 31, 2024, compared to a $30.1 million loss (or a $0.58 loss per share) for the three months ended March 31, 2023, of which $27.8 million was attributed to Cellectis continuing operations. This $38.2 million difference was primarily driven by (i) an increase in revenues and other income of $2.9 million, (ii) a decrease of $0.7 million in non-cash stock based compensation expense, (iii) a $30.7 million change from a net financial loss of $4.4 million to a net financial gain of $26.3 million and (iv) a decrease in net other operating expense of $0.6 million, and (v) a $2.5 million decrease in net loss from discontinued operations attributable to shareholders of Cellectis, partially offset by (i) an increase of $1.3 million in purchases, external expenses and other and (ii) an increase of $0.4 million in wages. Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net income attributable to shareholders of Cellectis was $6.5 million (or a $0.09 income per share) for the three months ended March 31, 2024, compared to a net loss of $28.1 million (or a $0.55 loss per share) for the three months ended March 31, 2023. Please see "Note Regarding Use of Non-IFRS Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis. We currently foresee focusing our cash spending at Cellectis for 2024 in the following areas: Supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of UCART22, UCART20x22, UCART123 and potential new product candidates, and Operating our state-of-the-art manufacturing capabilities in Paris (France), and Raleigh (North Carolina, USA); and Continuing strengthening our manufacturing and clinical departments. CELLECTIS S.A. STATEMENT OF CONSOLIDATED FINANCIAL POSITION (unaudited) ($ in thousands) As of December 31, 2023 March 31, 2024 ASSETS Non-current assets Intangible assets 671 677 Property, plant, and equipment 54,681 52,051 Right-of-use assets 38,060 35,787 Non-current financial assets 7,853 7,870 Total non-current assets 101,265 96,386 Current assets Trade receivables 569 16,036 Subsidies receivables 20,900 23,100 Other current assets 7,722 5,429 Current deferred tax assets 409 Cash and cash equivalent and Current financial assets 203,815 213,099 Total current assets 233,005 258,073 TOTAL ASSETS 334,270 354,459 LIABILITIES Shareholders’ equity Share capital 4,365 4,376 Premiums related to the share capital 522,785 523,596 Currency translation adjustment (36,690 ) (37,243 ) Retained earnings (304,707 ) (405,808 ) Net income (loss) (101,059 ) 5,643 Total shareholders’ equity - Group Share 84,695 90,566 Non-controlling interests 0 0 Total shareholders’ equity 84,695 90,566 Non-current liabilities Non-current financial liabilities 49,125 62,618 Non-current lease debts 42,948 40,587 Non-current provisions 2,200 2,241 Non-current deferred tax liabilities 158 0 Total non-current liabilities 94,431 105,446 Current liabilities Current financial liabilities 5,289 5,174 Current lease debts 8,502 8,404 Trade payables 19,069 16,051 Deferred revenues and deferred income 110,325 120,556 Current provisions 1,740 960 Current deferred tax liabilities 137 Other current liabilities 10,219 7,165 Total current liabilities 155,144 158,447 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 334,270 354,459 Cellectis S.A. UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS ($ in thousands, except per share amounts) For the three-month period ended March 31, 2023 2024 Revenues and other income Revenues 139 4,528 Other income 3,420 1,970 Total revenues and other income 3,559 6,498 Operating expenses Research and development expenses (21,415 ) (22,324 ) Selling, general and administrative expenses (4,964 ) (5,104 ) Other operating income (expenses) (611 ) 35 Total operating expenses (26,990 ) (27,791 ) Operating income (loss) (23,431 ) (21,293 ) Financial gain (loss) (4,402 ) 26,275 Income tax 0 262 Income (loss) from continuing operations (27,833 ) 5,643 Income (loss) from discontinued operations (4,691 ) 0 Net income (loss) (32,525 ) 5,643 Attributable to shareholders of Cellectis (30,074 ) 5,643 Attributable to non-controlling interests (2,450 ) 0 Basic net income (loss) attributable to shareholders of Cellectis, per share ($/share) (0.58 ) 0.08 Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) (0.58 ) (0.15 ) Basic net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) (0.04 ) 0.00 Diluted net income (loss) attributable to shareholders of Cellectis from discontinued operations, per share ($ /share) (0.04 ) 0.00 Number of shares used for computing Basic 51,452,348 71,810,231 Diluted 51,452,348 103,093,741 Note Regarding Use of Non-IFRS Financial Measures Cellectis 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 (unaudited) ($ in thousands, except per share data) For the three-month period ended March 31, 2023 2024 Net income (loss) attributable to shareholders of Cellectis (30,074 ) 5,643 Adjustment: Non-cash stock-based compensation expense attributable to shareholders of Cellectis 1,979 887 Adjusted net income (loss) attributable to shareholders of Cellectis (28,095 ) 6,530 Basic adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (0.55 ) 0.09 Basic adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($ /share) (0.10 ) 0.00 Weighted average number of outstanding shares, basic (units) 51,452,348 71,810,231 Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (0.55 ) (0.14) Diluted adjusted net income (loss) attributable to shareholders of Cellectis from discontinued operations ($/share) (0.10 ) 0.00 Weighted average number of outstanding shares, diluted (units) 51,452,348 103,093,741 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 24 years of experience and 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. 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). Forward-looking Statements  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 “expect,” “will,” “believe,” and “may”, or the negative of these and similar expressions. These forward-looking statements 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 the advancement, timing and progress of clinical trials, the timing of our presentation of clinical data, the potential of our clinical and preclinical programs, and the sufficiency of cash to fund operations. 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 candidates 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, 2023 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. For further information on Cellectis, please contact: Media contacts: Pascalyne Wilson, Director, Communications, +33 (0)7 76 99 14 33, media@cellectis.com Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93 Investor Relation contacts: Arthur Stril, Interim Chief Financial Officer, +1 (347) 809 5980, investors@cellectis.com Ashley R. Robinson, LifeSci Advisors, +1 617 430 7577 Attachment 20240528_Q1 earnings press release_ENGLISH.pdf