ALLO-715

First r/r ALL patient dosed in Europe with Cellectis’ UCART22 product candidate manufactured in-house Cellectis implements CLLS52 for the first time in the clinic with Sanofi’s alemtuzumab Cellectis stops enrollment and treatment of patients in the MELANI-01 clinical trial evaluating UCARTCS1 product candidate in r/r MM Encouraging preclinical data on TALEN®-edited MUC1 CAR T-cells presented at the AACR 2023 annual meeting Two abstracts accepted for oral and poster presentations at the upcoming ASGCT annual meeting Cash position1 of 88$ million as of March 31, 2023 Conference call scheduled for 8AM ET/2PM CET on May 5, 2023 NEW YORK, May 04, 2023 (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 a business update and announced its results for the three-month period ending March 31, 2023. “Cellectis took a notable step forward this quarter with the first patient being dosed in France with our in-house manufactured product candidate UCART22 in the BALLI-01 clinical study. UCART22 is currently the most advanced allogeneic CAR T-cell product in development for relapsed or refractory B-cell acute lymphoblastic leukemia. We believe that our off-the-shelf treatment approach, coupled with our ability to manufacture UCART product candidates entirely in-house, gives us a main advantage on the market: it potentially maximizes the chances for eligible patients to be treated without delay,” said André Choulika, Ph.D., CEO of Cellectis. “Cellectis also announced last month that it implemented the use of Sanofi’s alemtuzumab as a Cellectis Investigational Medicinal Product, coded as CLLS52, as part of the lymphodepletion regimen for UCART22 in the BALLI-01 clinical trial, for UCART123 in the AMELI-01 clinical trial, and for UCART20x22 in the NATHALI-01 clinical trial. This follows the partnership and supply agreements we entered with Sanofi regarding alemtuzumab. “This quarter, Cellectis announced the closing of the global offering of 25 million dollars of its Depository Shares, launched in February – the net proceeds of the global offering and option of the Company is 22.8 million dollars – and in April, the drawdown of the 20 million euros under the Finance Contract for up to 40 million euros credit facility made with the European Investment Bank in December 2022. Cellectis plans to use the net proceeds of the funds to focus on the development of its pipeline of allogeneic CAR T-cell product candidates UCART22, UCART20x22 and UCART123, the Company decided to stop enrollment and treatment of patients with UCARTCS1. Indeed, to accelerate the speed of enrollment of patients in the MELANI-01 study, evaluating UCARTCS1, the Company would have had to invest meaningful amount of resources. To optimize its resources, Cellectis decided to focus its development efforts on the BALLI-01, AMELI-01 and NATHALI-01 studies. “We are excited about the drive in our clinical trials, building on the momentum of our lead product candidates in our pipeline, and the upcoming milestones for 2023.” Pipeline Highlights UCART Clinical Developments 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 targeting CD22 and is being evaluated in patients with r/r B-ALL in the BALLI-01 Phase 1/2a clinical study. On April 11, Cellectis announced that the first patient in Europe was dosed in France with its in-house manufactured product candidate UCART22 and completed the 28-day Dose Limiting Toxicity period. UCART22 is currently the most advanced allogeneic CAR T-cell product in development for relapsed or refractory B-cell acute lymphoblastic leukemia. Last December, Cellectis presented updated clinical data on its BALLI-01 clinical trial at a Live Webcast. The BALLI-01 study is now enrolling patients after FCA (fludarabine, cyclophosphamide and alemtuzumab) lymphodepletion. NATHALI-01 (evaluating UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL) UCART20x22 is Cellectis’ first allogeneic dual CAR T-cell product candidate targeting both CD20 and CD22 and is being evaluated in patients with r/r NHL in the NATHALI-01 Phase 1/2a clinical study. The NATHALI-01 study is now enrolling patients. 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 r/r AML in the AMELI-01 Phase 1 dose-escalation clinical study. On May 17, Cellectis will present clinical data on the AMELI-01 clinical trial in an oral presentation at the American Society of Gene and Cell Therapy (ASGCT) 2023 Annual Meeting. These data were presented in an oral presentation at the 64th American Society of Hematology (ASH) annual meeting last December. Details from the presentation will be available following the event on the Cellectis website at: The AMELI-01 study is now enrolling patients after FCA (fludarabine, cyclophosphamide and alemtuzumab) lymphodepletion in a two-dose regimen arm. 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 r/r MM in the MELANI-01 Phase 1 dose-escalation clinical study. To accelerate the speed of enrollment of patients in the MELANI-01 study, the Company would have had to invest meaningful amount of resources. To optimize its resources, the Company decided to focus its development efforts on the BALLI-01, AMELI-01 and NATHALI-01 studies and therefore to stop enrollment and treatment of patients in the MELANI-01 study. Research Data & Preclinical Programs TALEN®-edited MUC1 CAR T-cells On April 17, Cellectis released preclinical data on TALEN®-edited MUC1 CAR T-cells at the American Association for Cancer Research (AACR) Annual Meeting 2023. The preclinical data presented in a poster showed the capability of armored allogeneic MUC1 CAR T-cells to excel in the immune suppressive tumor micro-environment suggesting that they could be an effective option in treating relapsed and refractory triple negative breast cancer (TNBC) patients with limited therapeutic options. Poster of the presentation is available on Cellectis’ website: Multiplex engineering for superior generation of efficient CAR T-cells On May 17, 2023, Cellectis will present preclinical data on multiplex engineering for superior generation of CAR T-cells, at the American Society of Gene and Cell Therapy (ASGCT) 2023 Annual Meeting. Details from the presentation will be available following the event on the Cellectis website at: Licensed Allogeneic CAR T-cell Development Programs Servier and Allogene: anti-CD19 programs  Allogene continues to enroll patients in the industry’s first potentially pivotal Phase 2 allogeneic CAR T clinical trial with ALLO-501A. Allogene announced that the single-arm ALPHA2 trial will enroll approximately 100 r/r large B cell lymphoma (LBCL) patients who have received at least two prior lines of therapy and have not received prior anti-CD19 therapy. Allogene expects to complete enrollment in H1 2024.After the close of the quarter, Allogene announced that pooled data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A, in r/r LBCL would be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting June 2 – 6, 2023 in Chicago, Illinois. Allogene: anti-BCMA and anti-CD70 programs Allogene presented interim data from its Phase 1 TRAVERSE trial of ALLO-316, its first investigational product candidate for solid tumors, during an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting in April. The ongoing dose escalation study is enrolling patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed on standard therapies that included an immune checkpoint inhibitor and a VEGF-targeting therapy. The data reported to date is primarily from the DL1 and DL2 cohorts. Anti-tumor activity was primarily observed in patients with tumors confirmed to express CD70 (N=10). Among 18 patients evaluable for efficacy, the disease control rate (DCR) was 89%. In the 10 patients whose tumors were known to express CD70, the disease control rate was 100%, which included three patients who achieved partial remission (two confirmed, one unconfirmed). The longest response lasted until month eight. There was a trend toward greater tumor shrinkage in patients with higher levels of CD70 expression. In patients evaluable for safety (N=19), ALLO-316 demonstrated an adverse event pro consistent with autologous CAR T therapies. Dose escalation in the TRAVERSE trial is expected to be completed in 2023. During the quarter, data from the Phase 1 UNIVERSAL trial with ALLO-715 for the treatment of r/r multiple myeloma (MM) was published in Nature Medicine. UNIVERSAL is the first allogeneic anti-BCMA CAR T to demonstrate proof-of-concept in MM with response rates that are similar to an approved autologous CAR T therapy. Allogene is evaluating manufacturing processes improvements across its BCMA candidates to achieve optimal performance. Partnerships Cytovia Therapeutics, Inc. (“Cytovia”) On January 20, Cellectis announced that it has amended certain financial terms of the $20 million convertible note issued by its partner, Cytovia Therapeutics, in payment of the upfront collaboration consideration provided for pursuant to the research collaboration and non-exclusive license agreement between Cellectis and Cytovia. The amended and restated note provides for automatic conversion into common stock of Cytovia in the case of certain fundamental transactions pursuant to which Cytovia becomes a public reporting company and for conversion at Cellectis’ option in connection with certain financing transactions, upon a company sale and at final maturity. In each case such conversion is subject to a 9.9% ownership cap, with the balance issuable in the form of pre-funded warrants. Among other changes, the amended and restated note increases the applicable interest rate of the note to 10% per annum, subject to a 10% step up upon the occurrence and continuation of an event of default, provides for the repayment of 50% of the outstanding amount on April 30, 2023 and extends the final maturity date for the repayment of the remaining outstanding amount to June 30, 2023. Corporate Updates Global offering and American Depositary Shares (ADS) On January 4, 2023, Cellectis established an At-The-Market (ATM) Program on Nasdaq. Cellectis has filed a prospectus supplement with the Securities and Exchange Commission (“SEC”), pursuant to which it may offer and sell to eligible investors a maximum gross amount of up to $60.0 million of American Depositary Shares (“ADS”), each representing one ordinary share of Cellectis, nominal value €0.05 per share, from time to time in sales deemed to be an “at the market offering” pursuant to the terms of a sales agreement with Jefferies LLC (“Jefferies”), acting as sales agent. The timing of any sales will depend on a variety of factors. On February 2, 2023 Cellectis announced the launch of the Cellectis Follow-on Offering in which it offered $22 million of its ADS. Jefferies LLC and Barclays Capital Inc. (the “Underwriters”) acted as joint book-running managers for the Global Offering. Pricing occurred on February 2, 2023, at $2.50 per ADS for 8,800,800 ADSs. On February 7, 2023, Cellectis has announced the exercise by the Underwriters of their option (the “Option”) to purchase an additional 1,107,800 ordinary shares (the “Additional Ordinary Shares”) of the Company to be delivered in the form of an aggregate of 1,107,800 ADSs (the “Additional ADSs”). As a consequence, the total number of ordinary shares issued in the form of ADSs amounted to 9,907,800 for the base offering plus the Option exercise bringing the gross proceed to $24.8 million. The aggregate net proceeds to the Company, after deducting underwriting commissions and estimated offering expenses, amounted to approximately $22.8 million. The Company plans to use approximately $17.0 million (€15.6 million) of the net proceeds of the Global Offering to fund the continued clinical development of UCART 123, UCART22 and UCART20x22 and any remainder for working capital and other general corporate purposes. Calyxt and Cibus Merger Agreement On January 13, 2023, Calyxt and Cibus, and the other parties thereto entered into the definitive Merger Agreement under which Calyxt and Cibus will merge in an all-stock transaction. Under the terms of the Merger Agreement, Calyxt will issue shares of its common stock to Cibus shareholders in an exchange ratio such that upon completion of the merger, Calyxt shareholders are expected to own approximately 5% of the combined company, subject to adjustments permitted by the Merger Agreement. The Boards of Directors of both companies unanimously approved the Calyxt Merger. Concurrent with the execution of the merger agreement, certain officers of Calyxt, all of Calyxt’s directors, and Cellectis executed support agreements in favor of the Calyxt Merger. On March 1, 2023, as stated in the Merger Agreement, Calyxy’s Board authorized the grant of 3,487,503 RSUs to all employees. These awards will vest upon completion of the Transactions, and accordingly, the expense associated with these awards will be recognized over the period from the date of grant to the estimated closing date of the Transactions. Consequently, after the completion of the Transaction, and subject to the issuance of some or all of such RSUs, Cellectis will own approximately 2.4% of Calyxt. Cellectis currently holds a 48.2 % equity interest in Calyxt. Following the closing of the merger, Cellectis is expected to own approximately 2.4% of the equity interests of the combined company. Warrant agreement with the European Investment Bank On April 4, Cellectis announced it entered into the warrant agreement (the “Warrant Agreement”) and finalized the related ancillary documents required under the credit facility with the European Investment Bank (“EIB”) for up to €40 million previously announced on December 28, 2022. The Company also announced the drawdown of the first tranche of €20 million (“Tranche A”) under the Finance Contract, that has been disbursed by the EIB in early April 2023. Cellectis plans to use the proceeds of Tranche A towards the development of its pipeline of allogeneic CAR T-cell product candidates: UCART22, UCART20x22, UCART123. Financial results The interim condensed consolidated financial statements of Cellectis, which consolidate the results of Calyxt, Inc. of which Cellectis owned approximately 48.2% of outstanding shares of common stock (as of March 31, 2023), 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 Q1 2023 financial results press release. On January 13, 2023, Calyxt, Cibus Global LLC (Cibus) and certain other parties named therein, entered into an Agreement and Plan of Merger (the “Merger Agreement”), pursuant to which, subject to the terms and conditions thereof, Calyxt and Cibus will merge in an all-stock transaction (the “Calyxt Merger”). As a consequence of the foregoing, Calyxt meets the “held-for-sale" criteria specified in IFRS 5 and has been classified as a discontinued operation. Cash: As of March 31, 2023, Cellectis, excluding Calyxt, had $88 million in consolidated cash, cash equivalents, and restricted cash. This compares to $95 million in consolidated cash, cash equivalents and restricted cash as of December 31, 2022. This difference mainly reflects $30 million of cash out, which include $6 million of payments for R&D expenses, $4 million for SG&A suppliers, $15 million for staff costs, $4 million for rents and taxes, $1 million of reimbursement of the “PGE” loan and a $23 million net cash inflow from the capital raise closed in February. Based on the current operating plan, Cellectis (excluding Calyxt) anticipates that the cash and cash equivalents as of March 31, 2023 will fund Cellectis’ operations into the third quarter of 2024. Revenues and Other Income: Consolidated revenues and other income were $3.6 million for the three months ended March 31, 2023 compared to $3.8 million for the three months ended March 31, 2022. The slight decrease of $0.2 million between the three months ended March 31, 2023, and 2022 reflects the recognition of two milestones related to Cellectis’ agreement with Cytovia for $1.5 million in 2022 while recognition of revenues in 2023 is not material and was almost fully offset by an increase of the research tax credit for $1.0 million in addition to the recognition of a BPI R&D grant of $0.3 million. R&D Expenses: Consolidated R&D expenses were $21.1 million three months ended March 31, 2023 compared to $26.6 million for the three months ended March 31, 2022. The $5.5 million decrease was primarily attributable to (i) a $2.6 million decrease in personal expenses due to departures not replaced (ii) a $3.0 million decrease in purchases, external expenses and other (from $13.8 million in 2022 to $10.8 million in 2023) mainly explained by internalization of our manufacturing and quality activities to support our R&D pipeline. SG&A Expenses: Consolidated SG&A expenses were $5.0 million for the three months ended March 31, 2023 compared to $6.1 million for the three months ended March 31, 2022. The $1.1 million decrease primarily reflects (i) a $0.9 million decrease in purchases, external expenses and other (from $3.7 million in 2022 to $2.9 million in 2023) mainly explained by the implementation of our new enterprise resource planning (ERP) software in 2022 (ii) a $0.2 million decrease in personal expenses. Net income (loss) from discontinued operations: The $1.7 million decrease of net loss from discontinued operations between the three-month period ended March 31, 2022 and 2023 is primarily driven by (i) the decrease of $2.6 million of R&D expenses (from $3.2 million in 2022 to $1.3 in 2023) and SG&A expenses (from $2.9 million in 2022 to $2.2 million in 2023) partially offset by (i) the increase of $0.7 million of net financial loss and (ii) the increase of $0.2 million of other operating expenses. Net Income (loss) Attributable to Shareholders of Cellectis including Calyxt: The consolidated net loss attributable to shareholders of Cellectis was $30.1 million (or $0.58 per share) for the three months ended March 31, 2023, of which $27.8 million was attributed to Cellectis continuing operations, compared to $31.9 million (or $0.70 per share) for the three months ended March 31, 2022, of which $28.3 million was attributed to Cellectis continuing operations. This $1.8 million decrease in net loss between the three months of 2023 and 2022 was primarily driven by (i) a $5.3 million decrease of research and development, (ii) a decrease of $1.7 million of loss from discontinued operations, (iii) a $1.3 million decrease of SG&A expenses partially offset by (i) an increase in net financial loss of $5.3 million primarily due to the decrease of the fair value of Cytovia’s convertible note on March 31, 2023 of $4.6 million compared to a $7.9 million on December 31, 2022, (ii) a decrease of $0.2 million of revenues and other income, (iii) an increase of other operating expenses of $0.6 million, (iv) a decrease of $0.4 million in loss attributable to non-controlling interests due to the decrease in Calyxt’s net loss. Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: The consolidated adjusted net loss attributable to shareholders of Cellectis was $28.1 million (or $0.55 per share) for the three months ended March 31, 2023, of which $26.2 million is attributed to Cellectis, compared to a net loss of $29.3 million (or $0.64 per share) for the three months ended March 31, 2022, of which $26.0 million was attributed to Cellectis. Please see “Note Regarding Use of Non-IFRS Financial Measures” for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis. We currently foresee focusing our cash spending at Cellectis for 2023 in the following areas: Supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of UCART123, UCART22, UCART 20x22 and potential new product candidates, and Operating our state-of-the-art manufacturing capabilities in Paris (France), and Raleigh (North Carolina, USA); and Continuing strengthening our manufacturing and clinical departments. CELLECTIS S.A. (unaudited) STATEMENT OF CONSOLIDATED FINANCIAL POSITION ($ in thousands, except per share data) As of December 31, 2022 March 31, 2023 ASSETS Non-current assets Intangible assets 718 713 Property, plant, and equipment 63,621 61,708 Right-of-use assets 44,275 43,436 Non-current financial assets 8,791 8,185 Total non-current assets 117,406 114,042 Current assets Trade receivables 772 1,120 Subsidies receivables 14,496 18,245 Other current assets 9,078 9,703 Cash and cash equivalent and Current financial assets 97,697 88,162 Total current assets 122,043 117,231 Total assets held for sale 21,768 20,135 TOTAL ASSETS 261,216 251,408 LIABILITIES Shareholders’ equity Share capital 2,955 3,487 Premiums related to the share capital 583,122 608,086 Currency translation adjustment (28,605 ) (28,542 ) Retained earnings (333,365 ) (439,220 ) Net income (loss) (106,139 ) (30,074 ) Total shareholders’ equity - Group Share 117,968 113,735 Non-controlling interests 7,973 6,754 Total shareholders’ equity 125,941 120,489 Non-current liabilities Non-current financial liabilities 20,531 19,625 Non-current lease debts 49,358 48,285 Non-current provisions 2,390 2,540 Total non-current liabilities 72,279 70,450 Current liabilities Current financial liabilities 5,088 5,188 Current lease debts 7,872 8,181 Trade payables 21,456 22,324 Deferred revenues and deferred income 59 342 Current provisions 477 1,011 Other current liabilities 13,179 6,094 Total current liabilities 48,131 43,140 Total liabilities related to asset held for sale 14,864 17,328 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 261,216 251,408 CELLECTIS S.A. STATEMENT OF CONSOLIDATED OPERATIONS – First three months (unaudited) ($ in thousands, except per share data) For the three-month period ended March 31, 2022 * 2023 Revenues and other income Revenues 1,665 139 Other income 2,135 3,420 Total revenues and other income 3,800 3,559 Operating expenses Cost of revenue (385 ) (334 ) Research and development expenses (26,601 ) (21,081 ) Selling, general and administrative expenses (6,063 ) (4,964 ) Other operating income (expenses) 21 (611 ) Total operating expenses (33,028 ) (26,990 ) Operating income (loss) (29,228 ) (23,431 ) Financial gain (loss) 912 (4,402 ) Income (loss) from continuing operations (28,316 ) (27,833 ) Income (loss) from discontinued operations (6,441 ) (4,691 ) Net income (loss) (34,757 ) (32,525 ) Attributable to shareholders of Cellectis (31,911 ) (30,074 ) Attributable to non-controlling interests (2,846 ) (2,450 ) Basic net income (loss) attributable to shareholders of Cellectis per share ($/share) (0.70 ) (0.58 ) Diluted net income (loss) attributable to shareholders of Cellectis per share ($/share) (0.70 ) (0.58 ) Basic net income (loss) attributable to shareholders of Cellectis per share ($ /share) from discontinued operations (0.08 ) (0.04 ) Diluted net income (loss) attributable to shareholders of Cellectis per share ($ /share) from discontinued operations (0.08 ) (0.04 ) * These amounts reflect adjustments made in connection with the presentation of the discontinued operation CELLECTIS S.A. DETAILS OF KEY PERFORMANCE INDICATORS BY REPORTABLE First three months (unaudited) For the three-month period ended March 31, 2022 For the three-month period ended March 31, 2023 $ in thousands Plants (discontinued operations) Therapeutics Total reportable segments Plants (discontinued operations) Therapeutics Total reportable segments External revenues 32 1,665 1,697 42 139 180 External other income - 2,135 2,135 - 3,420 3,420 External revenues and other income 32 3,800 3,832 42 3,559 3,600 Cost of revenue (0 ) (385 ) (385 ) - (334 ) (334 ) Research and development expenses (2,878 ) (26,601 ) (29,479 ) (2,165 ) (21,081 ) (23,246 ) Selling, general and administrative expenses (3,216 ) (6,063 ) (9,279 ) (1,336 ) (4,964 ) (6,300 ) Other operating income and expenses 43 21 65 (139 ) (611 ) (750 ) Total operating expenses (6,050 ) (33,028 ) (39,078 ) (3,640 ) (26,990 ) (30,630 ) Operating income (loss) before tax (6,019 ) (29,228 ) (35,247 ) (3,598 ) (23,431 ) (27,029 ) Net financial gain (loss) (422 ) 912 490 (1,093 ) (4,402 ) (5,495 ) Net income (loss) from discontinued operations (6,441 ) (6,441 ) (4,691 ) (4,691 ) Net income (loss) (6,441 ) (28,316 ) (34,757 ) (4,691 ) (27,833 ) (32,525 ) Non-controlling interests 2,846 - 2,846 2,450 - 2,450 Net income (loss) attributable to shareholders of Cellectis (3,595 ) (28,316 ) (31,911 ) (2,241 ) (27,833 ) (30,074 ) R&D non-cash stock-based expense attributable to shareholder of Cellectis (11 ) 1,680 1,669 85 1,103 1,188 SG&A non-cash stock-based expense attributable to shareholder of Cellectis 342 636 979 274 517 791 Adjustment of share-based compensation attributable to shareholders of Cellectis 332 2,316 2,648 359 1,620 1,979 Adjusted net income (loss) attributable to shareholders of Cellectis (3,263 ) (26,000 ) (29,263 ) (1,882 ) (26,213 ) (28,095 ) Depreciation and amortization (708 ) (4,934 ) (5,641 ) 6 (4,456 ) (4,450 ) Additions to tangible and intangible assets 363 581 945 - 245 245 NoteRegardingUseofNon-IFRSFinancialMeasures 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 – First Quarter (unaudited) ($ in thousands, except per share data) For the three-month period ended March 31, 2022 * 2023 Net income (loss) attributable to shareholders of Cellectis (31,911 ) (30,074 ) Adjustment: Non-cash stock-based compensation expense attributable to shareholders of Cellectis 2,648 1,979 Adjusted net income (loss) attributable to shareholders of Cellectis (29,263 ) (28,095 ) Basic Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (0.64 ) (0.55 ) Basic adjusted earnings from discontinued operations attributable to shareholders of Cellectis ($ /share) (0.07 ) (0.04 ) Weighted average number of outstanding shares, basic (units) 45,486,477 51,452,348 Diluted Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) (0.64 ) (0.55 ) Diluted Adjusted net income (loss) attributable to shareholders of Cellectis ($/share) from discontinued operations (0.07 ) (0.04 ) Weighted average number of outstanding shares, diluted (units) 45,486,477 51,452,348 *These amounts reflect adjustments made in connection with the presentation of the discontinued operation 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 23 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). For more information, visit . Follow Cellectis on social media: @cellectis, LinkedIn and YouTube  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 “anticipate,” “believe,” “intend”, “expect,” “plan,” “scheduled,” “could,” “would” 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 clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of data and submission of regulatory filings, the adequacy of our supply of clinical vials, the operational capabilities at our manufacturing facilities, the sufficiency of cash to fund operations, the adequacy and continuity of supply of clinical supply and alemtuzumab, the ability of an anti-CD52 as alemtuzumab to improve any efficacy and the potential benefit of UCART 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, 2022 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. Media contact: Pascalyne Wilson, Director, Communications, +33 (0)7 76 99 14 33, media@cellectis.com Investor Relation contacts: Arthur Stril, Chief Business Officer, +1 (347) 809 5980, investors@cellectis.com  Ashley R. Robinson, LifeSci Advisors, +1 617 430 7577 1 Cash position includes cash, cash equivalents and restricted cash. Restricted cash was $5 million as of March 31, 2023. Attachment Q1 2023 PR(1)

Enrollment Ongoing in Industry’s First Potentially Pivotal Phase 2 Allogeneic CAR T Trial, ALPHA2, in Relapsed/Refractory Large B Cell LymphomaInitiated Phase 2 EXPAND Trial to Support Licensure of ALLO-647 as a Lymphodepleting Agent for ALLO-501AAnnounced American Society of Clinical Oncology (ASCO) Annual Meeting Presentation of Phase 1 Data from the ALLO-501/501A TrialsPresented Interim Phase 1 Data on ALLO-316 in Renal Cell Carcinoma at the American Association of Cancer Research (AACR) Annual Meeting Data Provide Proof-of-Concept for an Allogeneic CAR T in Solid TumorsThree of 10 Patients Achieved a Partial Response Following a Single Infusion of ALLO-316; Patients Had Previously Progressed on Standard Therapies that Included an Immune Checkpoint Inhibitor and a VEGF-Targeting Therapy Appointed Cell Therapy Pioneer Timothy Moore as Chief Technical OfficerEnded Q1 2023 with $514 Million in Cash, Cash Equivalents and Investments; Cash Runway Projected Into Q2 2025Conference Call and Webcast Scheduled for Today at 2:00 PM PT/5:00 PM ET SOUTH SAN FRANCISCO, Calif., May 03, 2023 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today provided a corporate update and reported financial results for the quarter ended March 31, 2023. “Our first quarter progress continues to establish Allogene as the leader in the development of allogeneic CAR T product candidates,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “Our success across multiple clinical programs, ability to attract top tier talent, and financial stewardship to weather the challenging external market environment paves the way toward to bringing a new generation of CAR T products to patients.” Pipeline Updates ALLO-501A: Anti-CD19 AlloCAR T Program The Company continues to enroll patients in the industry’s first potentially pivotal Phase 2 allogeneic CAR T clinical trial with ALLO-501A. The single-arm ALPHA2 trial is enrolling patients with relapsed/refractory (R/R) large B cell lymphoma (LBCL) and utilizes a single dose of ALLO-501A (120 million CAR+ cells) following lymphodepletion with FCA90 (fludarabine, 30 mg/m2; cyclophosphamide 300 mg/m2; and ALLO-647 30 mg, daily for 3 days). This trial will enroll approximately 100 patients who have received at least two prior lines of therapy and have not received prior anti-CD19 therapy. The primary endpoint is overall response rate (ORR), and the key secondary endpoint is duration of response (DoR). Patients may receive treatment as an outpatient at the investigator’s discretion. The Company expects to complete enrollment in 1H 2024. During the first quarter, the Company initiated the EXPAND trial to support licensure of ALLO-647. The Company is developing ALLO-647, an anti-CD52 monoclonal antibody, to permit the use of standard low-dose FC (fludarabine, 30 mg/m2 and cyclophosphamide 300 mg/m2, daily for 3 days) lymphodepletion regimens across our portfolio. This proprietary regimen is intended to prevent premature rejection, thereby enabling expansion and persistence of AlloCAR T cells and supporting improved clinical performance of product candidates. In the EXPAND trial, approximately 70 patients with R/R LBCL will be randomized to be lymphodepleted with FCA90 (which includes 90 mg of ALLO-647) versus FC alone before receiving a single 120 million cell dose of ALLO-501A. The study is designed to demonstrate the superiority of FCA90 over FC as measured by progression free survival (PFS). After the close of the quarter, the Company announced that pooled data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A, in R/R LBCL would be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting June 2 – 6, 2023 in Chicago, Illinois. ALLO-316: Anti-CD70 AlloCAR T ProgramThe Company presented interim data from its Phase 1 TRAVERSE trial of ALLO-316, the Company’s first AlloCAR T investigational product candidate for solid tumors, during an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting in April. The ongoing dose escalation study is enrolling patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed on standard therapies that included an immune checkpoint inhibitor and a VEGF-targeting therapy. Emerging data from this trial have demonstrated the potential of an allogeneic CAR T product to treat CD70 expressing RCC. In this trial, ALLO-316 showed early anti-tumor activity with deepening responses over time. The data reported to date is primarily from the DL1 and DL2 cohorts. Anti-tumor activity was primarily observed in patients with tumors confirmed to express CD70 (N=10). Among 18 patients evaluable for efficacy, the disease control rate (DCR) was 89%. In the 10 patients whose tumors were known to express CD70, the disease control rate was 100%, which included three patients who achieved partial remission (two confirmed, one unconfirmed). The longest response lasted until month eight. There was a trend toward greater tumor shrinkage in patients with higher levels of CD70 expression. In patients evaluable for safety (N=19), ALLO-316 demonstrated an adverse event profile generally consistent with autologous CAR T therapies. One dose-limiting toxicity of Grade 3 autoimmune hepatitis occurred in the second dose level. Cytokine release syndrome (CRS) was all low-grade with the exception of one Grade 3. Neurotoxicity, which is now defined more broadly, was generally low grade and reversible with most events being fatigue or headache. There were no cases of immune effector cell-associated neurotoxicity syndrome (ICANS). Infections occurred in eight patients of which four were Grade 3+ including one Grade 5 respiratory failure due to Covid-19 infection deemed unrelated to study treatment. Grade 3+ prolonged cytopenia was observed in three patients (16%). There were no cases of graft-versus-host disease (GvHD). The Dagger™ technology, which is a feature of ALLO-316, is designed to resist rejection of AlloCAR T cells by the host immune cells, thereby supporting expansion and enabling a prolonged window of persistence during which AlloCAR T cells can target and destroy cancer cells. Initial translational data from the TRAVERSE trial demonstrates the suppression of CD70 positive, alloreactive host T cells and marked peak expansion of ALLO-316 despite the relatively low cell doses tested. The Company plans to deploy Dagger technology to potentially enhance the persistence and activity of next generation AlloCAR T products, including those that target other hematological and solid tumors. The Company has deployed a new investigational in vitro companion diagnostic (IVD) assay designed to prospectively assess CD70 expression levels to enhance patient selection. Dose escalation in the TRAVERSE trial is expected to be completed in 2023. ALLO-715: Anti-BCMA AlloCAR T Program During the quarter, data from the Phase 1 UNIVERSAL trial with ALLO-715 for the treatment of r/r multiple myeloma (MM) was published in Nature Medicine. UNIVERSAL is the first allogeneic anti-BCMA CAR T to demonstrate proof-of-concept in MM with response rates that are similar to an approved autologous CAR T therapy. The Company is evaluating manufacturing processes improvements across its BCMA candidates to achieve optimal performance. Corporate UpdatesIn April, it was announced that Timothy Moore had been appointed as Executive Vice President, Chief Technical Officer. The appointment of Mr. Moore, an industry pioneer responsible for the global development of two of the most commercially successful autologous CAR T manufacturing processes, reinforces the Company’s focus on being the first to bring an AlloCAR T product to market. First Quarter Financial Results Research and development expenses were $80.2 million for the first quarter of 2023, which includes $9.2 million of non-cash stock-based compensation expense.General and administrative expenses were $18.9 million for the first quarter of 2023, which includes $9.6 million of non-cash stock-based compensation expense.Net loss for the first quarter of 2023 was $98.7 million, or $0.68 per share, including non-cash stock-based compensation expense of $18.8 million.The Company had $514 million in cash, cash equivalents, and investments as of March 31, 2023. 2023 Financial Guidance The Company now expects a decrease in cash, cash equivalents, and investments of approximately $230 million in 2023. Based on current expectation, the Company expects its cash runway to be sufficient to fund operations into Q2 2025. GAAP Operating Expenses are expected to be approximately $340 million, including estimated non-cash stock-based compensation expense of approximately $80 million. These estimates exclude any impact from potential business development activities. Conference Call and Webcast DetailsAllogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days. About Allogene TherapeuticsAllogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com and follow @AllogeneTx on Twitter and LinkedIn. Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," “projects,” "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: ALPHA2 being a potentially pivotal trial; expected enrollment and related timelines; the expected timing to complete dose escalation; the potential of an allogeneic CAR T product to treat CD70 express RCC based on emerging data; study design; the timing and ability to progress the ALPHA2 and TRAVERSE trials; clinical outcomes, which may materially change as more patient data become available; ; the ability to achieve optimal clinical performance through manufacturing processes improvements; the design and potential benefits of our Dagger technology, including its ability to resist rejection of AlloCAR T cells by the host immune cells and the expected benefits therefrom, and our plans to deploy Dagger technology; the potential for our product candidates to be approved; the potential benefits of AlloCAR T products and 2023 financial guidance. Various factors may cause material differences between Allogene’s expectations and actual results, including, risks and uncertainties related to: our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; Servier’s discontinuation of its involvement in the development of all CD19 products pursuant to our Exclusive License and Collaboration Agreement and our disputes with Servier may have adverse consequences; the limited nature of our Phase 1 data from our clinical trials and the extent to which such data may or may not be validated in any future clinical trial; our ability to maintain intellectual property rights necessary for the continued development of our product candidates, including pursuant to our license agreements; our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or limit their commercial potential; the extent to which COVID-19 adversely impacts our business, including our preclinical studies and clinical trials; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; challenges with manufacturing or optimizing manufacturing of our product candidates; and our ability to obtain additional financing to develop our products and implement our operating plans. These and other risks are discussed in greater detail in Allogene’s filings with the SEC, including without limitation under the “Risk Factors” heading in its Annual Report on Form 10-K for the year ended December 31, 2022, and in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, being filed with the SEC today. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Caution should be exercised regarding statements comparing autologous CAR T data. There are differences in the clinical trial design, patient populations, published data, follow-up times and the product candidates themselves, and the results from the clinical trials of autologous products may have no interpretative value on our existing or future results. AlloCAR T™ and Dagger™ are trademarks of Allogene Therapeutics, Inc. Allogene’s AlloCAR 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. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S. The anti-BCMA and anti-CD70 AlloCAR T programs are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these AlloCAR T programs. ALLOGENE THERAPEUTICS, INC.SELECTED FINANCIAL DATA (unaudited; in thousands, except share and per share data) STATEMENTS OF OPERATIONS Three Months Ended March 31, 2023 2022Collaboration revenue - related party$ 52 $ 61Operating expenses: Research and development$ 80,238 $ 60,156General and administrative 18,884 19,897Total operating expenses 99,122 80,053Loss from operations (99,070) (79,992)Other income (expense), net: Interest and other income, net 2,059 492Other expenses (1,693) (350)Total other income (expense), net 366 142Net loss (98,704) (79,850)Net loss per share, basic and diluted$ (0.68) $ (0.56)Weighted-average number of shares used in computing net loss per share, basic and diluted 144,563,829 141,356,306 SELECTED BALANCE SHEET DATA As of March 31, 2023 As of December 31, 2022Cash, cash equivalents and investments$ 514,012 $ 576,471Total assets 746,871 817,079Total liabilities 154,609 151,209Total stockholders’ equity 592,262 665,870 Allogene Media/Investor Contact:Christine CassianoChief Communications Officer(714) 552-0326Christine.Cassiano@allogene.com