This novel editing approach might unlock new strategies for the treatment of metabolic and neurological diseasesNon-viral circular ssDNA delivery associated to TALEN® gene editing allows high levels of gene insertion in long-term repopulating HSPCs NEW YORK, April 22, 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, will present first ...

NEW YORK, April 10, 2024 (GLOBE NEWSWIRE) -- Cellectis (the "Company") (NASDAQ:CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, announced today the publication of a new research paper in Molecular Therapy, demonstrating that TALEN-mediated intron editing of hematopoietic stem and progenitor cells (HSPCs) enables transgene expression restricted to the myeloid lineage. This approach could unlock new therapeutic avenues for ...

Cellectis SA (NASDAQ:CLLS) Q3 2023 Earnings Conference Call November 7, 2023 8:00 AM ET Company Participants Arthur Stril - Chief Business Officer Andre Choulika - Co-founder, CEO& Director Mark Frattini - Chief Medical Officer Bing Wang - CFO Conference Call Participants Dev Prasad - Jefferies Hartaj Singh - Oppenheimer Jack Allen - Robert W. Baird & Co. Silvan Tuerkcan - JMP Securities Whitney Watson - Goldman Sachs Operator Good morning, everyone, and welcome to the Cellectis Third Quarter 2023 Earnings ...

Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts, money market funds, and fixed bank deposits, in each case primarily in France. The portion of cash and cash equivalents denominated in U.S. dollars is $44.5 million as of September 30, 2023. Historical Changes in Cash Flows The table below summarizes our sources and uses of cash For the ...

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Unaudited financial statements for H1 2023 show decreased total assets and an improved net loss, driven by Calyxt deconsolidation and reduced operating expenses [Condensed Consolidated Statements of Financial Position](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Financial%20Position) As of June 30, 2023, total assets decreased to $227.7 million, primarily due to Calyxt's deconsolidation, while total liabilities increased and shareholders' equity declined Condensed Consolidated Statements of Financial Position ($ in thousands) | Account | As of December 31, 2022 | As of June 30, 2023 | | :--- | :--- | :--- | | **Total Assets** | **261,216** | **227,674** | | Total current assets | 122,043 | 113,285 | | Total non-current assets | 117,406 | 114,389 | | Total assets held for sale | 21,768 | — | | **Total Liabilities** | **135,275** | **131,115** | | Total current liabilities | 48,131 | 42,047 | | Total non-current liabilities | 72,279 | 89,068 | | Total liabilities related to asset held for sale | 14,864 | — | | **Total Shareholders' Equity** | **125,941** | **96,558** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the six months ended June 30, 2023, revenues significantly decreased, but a lower operating loss and a substantial financial gain from Calyxt deconsolidation led to an improved net loss Six-Month Statement of Operations Highlights ($ in thousands, except per share amounts) | Metric | For the six-month period ended June 30, 2022 | For the six-month period ended June 30, 2023 | | :--- | :--- | :--- | | Revenues | 2,972 | 317 | | Total operating expenses | (63,064) | (52,612) | | Operating income (loss) | (56,541) | (47,053) | | Net Financial gain (loss) | 9,213 | 11,580 | | Income (loss) from continuing operations | (47,328) | (35,731) | | Income (loss) from discontinued operations | (6,883) | (10,377) | | **Net income (loss)** | **(54,211)** | **(46,108)** | | Net loss attributable to shareholders | (50,858) | (40,715) | | **Basic/Diluted net loss per share ($)** | **(1.12)** | **(0.76)** | Three-Month Statement of Operations Highlights ($ in thousands, except per share amounts) | Metric | For the three-month period ended June 30, 2022 | For the three-month period ended June 30, 2023 | | :--- | :--- | :--- | | Revenues | 1,307 | 178 | | Operating income (loss) | (27,313) | (23,659) | | Net Financial gain (loss) | 8,301 | 15,982 | | **Net income (loss)** | **(19,454)** | **(13,583)** | | Net loss attributable to shareholders | (18,946) | (10,648) | | **Basic/Diluted net loss per share ($)** | **(0.42)** | **(0.19)** | [Unaudited Interim Statements of Consolidated Cash Flows](index=8&type=section&id=Unaudited%20Interim%20Statements%20of%20Consolidated%20Cash%20Flows) For the six months ended June 30, 2023, net cash used in operating activities improved, significantly offset by cash provided by financing activities, resulting in a net decrease in cash and cash equivalents Consolidated Cash Flows ($ in thousands) | Cash Flow Activity | For the six-month period ended June 30, 2022 | For the six-month period ended June 30, 2023 | | :--- | :--- | :--- | | Net cash flows used in operating activities | (60,181) | (47,369) | | Net cash flows used in investment activities | (2,537) | (1,558) | | Net cash flows provided by financing activities | 10,307 | 39,597 | | **(Decrease) increase in cash and cash equivalents** | **(52,411)** | **(9,329)** | | **Cash and cash equivalents at end of period** | **129,440** | **84,386** | [Notes to the Interim Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20the%20Interim%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies and events, including Calyxt's deconsolidation, new financing, and the impairment of a note receivable, alongside segment reporting and share-based compensation - The company is a clinical-stage biotechnology firm focused on developing allogeneic CAR T-cell (UCART) product candidates for immuno-oncology and gene-edited hematopoietic stem cell (HSPC) candidates for genetic diseases using its proprietary technologies[34](index=34&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk) - On May 31, 2023, Calyxt, Inc. merged with Cibus Global, reducing Cellectis' equity interest to **2.9%** and resulting in a loss of control. Consequently, Calyxt was deconsolidated from June 1, 2023, and is treated as a discontinued operation for all periods presented[59](index=59&type=chunk)[76](index=76&type=chunk)[102](index=102&type=chunk) - The company's ability to continue as a going concern is based on its cash and cash equivalents of **$84.4 million** as of June 30, 2023, which management believes is sufficient to fund operations for at least the next twelve months[64](index=64&type=chunk)[65](index=65&type=chunk) [Management's Discussion & Analysis of Financial Condition and Results of Operations](index=52&type=section&id=Item%202.%20Management's%20Discussion%20%26%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage UCART programs, financial performance showing reduced expenses and an improved net loss, and new financing extending the cash runway into Q3 2024 - The company is advancing three proprietary clinical studies: **AMELI-01** for r/r AML, **BALLI-01** for r/r ALL, and **NATHALI-01** for r/r B-NHL. To optimize resources, the company stopped enrollment in the **MELANI-01** study[190](index=190&type=chunk)[330](index=330&type=chunk) - Key financing events in H1 2023 include a follow-on offering raising gross proceeds of **$24.8 million** and the drawdown of the first **€20 million** tranche of a **€40 million** loan facility from the European Investment Bank (EIB)[315](index=315&type=chunk) - The company's cash and cash equivalents of **$84.4 million**, combined with other financial assets and anticipated funding, are expected to be sufficient to fund operations into the **third quarter of 2024**[398](index=398&type=chunk) Comparison of Results for the Six-Month Periods Ended June 30 ($ in thousands) | Metric | 2022 | 2023 | % Change | | :--- | :--- | :--- | :--- | | Revenues | 2,972 | 317 | -89.3% | | Other income | 3,551 | 5,242 | 47.6% | | R&D expenses | (52,231) | (43,225) | -17.2% | | SG&A expenses | (10,893) | (8,914) | -18.2% | | Net Financial gain (loss) | 9,213 | 11,580 | 25.7% | | Income (loss) from discontinued operations | (6,883) | (10,377) | 50.8% | | **Net income (loss)** | **(54,211)** | **(46,108)** | **-14.9%** | [Quantitative and Qualitative Disclosures About Market Risks](index=68&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) No material changes in quantitative and qualitative market risk disclosures were reported from the prior fiscal year-end - There have been **no material changes** in quantitative and qualitative disclosures about market risk from the end of the preceding fiscal year[372](index=372&type=chunk) [Controls and Procedures](index=68&type=section&id=Item%204.%20Controls%20and%20Procedures) No material changes to the company's internal control over financial reporting occurred during the six-month period ended June 30, 2023 - **No changes** occurred during the six-month period ended June 30, 2023, that materially affected or are likely to materially affect the Company's internal control over financial reporting[373](index=373&type=chunk) [PART II – OTHER INFORMATION](index=69&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=69&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business - The company is **not currently involved** in any legal proceedings expected to have a material adverse effect on its business[374](index=374&type=chunk) [Risk Factors](index=69&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors from the Annual Report on Form 20-F for the year ended December 31, 2022, have been reported - **No material changes** to the risk factors from the Annual Report on Form 20-F for the year ended December 31, 2022, have been reported[375](index=375&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=69&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - **None reported**[402](index=402&type=chunk)

Cellectis SA (NASDAQ:CLLS) Q2 2023 Earnings Conference Call August 5, 2023 8:00 AM ET Company Participants Arthur Stril - Chief Business Officer Andre Choulika - Co-Founder, CEO & Director Mark Frattini - SVP, Clinical Sciences & Chief Medical Officer Bing Wang - CFO Conference Call Participants Yigal Nochomovitz - Citigroup Gena Wang - Barclays Bank Yanan Zhu - Wells Fargo Anoumid Vaziri - Goldman Sachs Group Dev Prasad - Jefferies Hartaj Singh - Oppenheimer Jack Allen - Robert W. Baird Silvan Tuerkcan - J ...

Cellectis SA (NASDAQ:CLLS) Q1 2023 Earnings Conference Call May 5, 2023 8:00 AM ET Company Participants Arthur Stril - Chief Business Officer Andre Choulika - Co-Founder, CEO & Director Mark Frattini - SVP, Clinical Sciences & Chief Medical Officer Bing Wang - CFO Conference Call Participants Gena Wang - Barclays Bank Yigal Nochomovitz - Citigroup Anoumid Vaziri - Goldman Sachs Group Dev Prasad - Jefferies Hartaj Singh - Oppenheimer Jack Allen - Robert W. Baird & Co. Ingrid Gafanhao - Kempen Silvan Tuerkcan ...

Financial Performance - For the three-month period ended March 31, 2023, the net loss was $32.5 million, compared to a net loss of $34.8 million for the same period in 2022, representing a 6.5% improvement [9]. - Total comprehensive loss for the three-month period ended March 31, 2023, was $31.4 million, compared to a total comprehensive loss of $37.4 million for the same period in 2022, indicating a 16.5% reduction [9]. - Calyxt incurred a net loss of $5.4 million for the three months ended March 31, 2023, and used $2.0 million of cash for operating activities during the same period [338]. Cash Flow and Liquidity - Net cash flows used in operating activities for the three-month period ended March 31, 2023, were $28.3 million, an improvement from $36.6 million used in the same period in 2022, reflecting a 22.5% decrease in cash outflow [331]. - As of March 31, 2023, Cellectis, excluding Calyxt, had cash and cash equivalents of $83.5 million, sufficient to continue operations for at least twelve months [336]. - Cellectis expects cash flow from operations, government funding, and a €40.0 million finance contract with the European Investment Bank to support operations into the third quarter of 2024 [336]. - Calyxt has received $1.0 million of Interim Funding from Cibus as of March 31, 2023, with an additional $0.5 million received subsequently [340]. Going Concern and Regulatory Approval - Cellectis faces substantial doubt regarding Calyxt's ability to continue as a going concern for a period of 12 months or more from the filing date of its quarterly report [342]. - The company anticipates that it will not generate significant revenues from product sales until regulatory approval is obtained for its therapeutic product candidates [335]. Financial Reporting Adjustments - The company has made adjustments in its financial reporting to reflect discontinued operations, impacting the overall financial results presented [8].

Product Development - Cellectis will present updated preclinical data on its product candidate UCARTMUC1 for solid tumors at the AACR 2023, highlighting its potential for patients with high unmet medical needs[3] - The company developed multiplexed gene editing using TALEN® technology to enhance CAR T-cell efficacy while maintaining safety in hostile tumor microenvironments[4] - Cellectis is pioneering off-the-shelf, ready-to-use gene-edited CAR T-cells, leveraging over 22 years of experience in gene editing[5] - The therapeutic target MUC1 is overexpressed in a significant number of triple-negative breast cancer (TNBC) patients, making it a promising target for CAR T-cell therapy[8] - The presentation will explore the benefits of variable delivery routes and molecular armoring to improve the efficacy of MUC1-CAR T-cells[9] - Cellectis utilizes an allogeneic approach for CAR-T immunotherapies, aiming to address the challenges posed by the tumor microenvironment[5] - The company is committed to developing life-changing product candidates to treat diseases with unmet medical needs[5] Company Information - Cellectis' headquarters are located in Paris, France, with additional locations in New York and Raleigh, North Carolina[5] - The company is listed on both the Nasdaq Global Market (ticker: CLLS) and Euronext Growth (ticker: ALCLS)[5] Risks and Uncertainties - Forward-looking statements indicate potential risks and uncertainties related to product development and cash runway[6]

(Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) or (g) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 Date of event requiring this shell company report France (Jurisdiction of incorporation or organization) * Not for trading, but only in connection with the registration of the American Depositary Shares. Indicate the number of outstanding shares of common stock as of the close of the period covered by the annual report. Indicate by check mark whether the reg ...