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Cellectis(CLLS) - 2023 Q1 - Earnings Call Transcript
2023-05-05 17:15
Financial Data and Key Metrics Changes - The net loss attributable to shareholders of Cellectis was $30 million, or $0.58 per share in Q1 2023, compared to a loss of $32 million, or $0.70 per share in Q1 2022, reflecting a $2 million decrease in net loss [33] - The cash position, excluding Calyxt, as of March 31, 2023, was $88 million, down from $95 million as of December 31, 2022, primarily due to cash outflows totaling $30 million [22][23] Business Line Data and Key Metrics Changes - Cellectis announced the dosing of the first patient in Europe with UCART22, an allogeneic CAR-T cell product candidate targeting CD22, evaluated in the BALLI-01 clinical study [19][26] - The company decided to stop enrollment and treatment of patients in the MELANI-01 study evaluating UCARTCS1 to focus on the development of UCART22, UCART20x22, and UCART123 [20][28] Market Data and Key Metrics Changes - Cellectis is actively enrolling patients in the NATHALI-01 trial for UCART20x22, which targets both CD20 and CD22, providing a dual antigen approach [31] - The company has presented encouraging preclinical data on TALEN edited MUC1 CART-T cell for treating triple-negative breast cancer, indicating potential market opportunities [4] Company Strategy and Development Direction - Cellectis aims to leverage its in-house manufacturing capabilities as a competitive advantage, allowing for timely treatment of eligible patients [26] - The company is focused on advancing its clinical trials and plans to present data at the American Society of Cell and Gene Therapy Annual Meeting [27] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the progress in clinical trials and the upcoming milestones for 2023, emphasizing the importance of gene editing technologies [35] - The company anticipates its cash runway to extend into the third quarter of 2024, indicating a stable financial outlook [18] Other Important Information - Cellectis closed a global offering of $25 million in February 2023, with net proceeds of approximately $22.8 million [17] - The company received the first tranche of €20 million from the European Investment Bank in April 2023, which will support the development of its pipeline [5][34] Q&A Session Summary Question: What new data will be presented for UCART123 at ASGCT? - The upcoming presentation will be an encore of the ASH presentation, with no new data expected [49] Question: What is the plan for dosing the next patient in the UCART22 trial? - There is a 28-day dose-limiting toxicity waiting period between the first and second patient, but subsequent patients can be enrolled simultaneously [37] Question: Why was the MELANI-01 study halted? - The decision was influenced by competition with BCMA bispecific therapies, making enrollment challenging [42] Question: What is the expected cash burn for the upcoming quarters? - The company expects a largely flat quarter-over-quarter cash burn for the rest of the year [50] Question: Will there be any adjustments to the dose level based on patients' disease burden? - The current trial is structured as a single-dose regimen, but the company will continue to evaluate this as they move forward [77]
Cellectis(CLLS) - 2023 Q2 - Quarterly Report
2023-05-03 16:00
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].
Cellectis(CLLS) - 2022 Q4 - Annual Report
2023-03-13 16:00
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]
Cellectis(CLLS) - 2022 Q4 - Annual Report
2023-03-13 16:00
(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 ...
Cellectis(CLLS) - 2022 Q4 - Earnings Call Transcript
2023-03-09 16:08
Cellectis S.A. (NASDAQ:CLLS) Q4 2022 Earnings Conference Call March 9, 2023 8:00 AM ET Company Participants Arthur Stril - Chief Business Officer Andre Choulika - Chief Executive Officer Bing Wang - Chief Financial Officer Mark Frattini - Chief Medical Officer Conference Call Participants Dev Prasad - Jefferies Gena Wang - Barclays Andrea Tan - Goldman Sachs Jack Allen - Baird Hartaj Singh - Oppenheimer & Company David Dai - SMBC Yanan Zhu - Wells Fargo Securities Brooke Schuster - William Blair Silvan Tuer ...
Cellectis(CLLS) - 2023 Q1 - Quarterly Report
2023-03-07 16:00
Allogene is developing ALLO-647, its proprietary anti-CD52 monoclonal antibody intended to enable expansion and persistence of AlloCAR T product candidates, including ALLO-501A. Allogene expects that the EXPAND trial, which is intended to demonstrate the contribution of ALLO-647 to the lymphodepletion regimen, will be open to enrollment early in the second quarter. ALLO-316, Allogene's first AlloCAR T candidate for solid tumors, targets CD70, an antigen expressed on clear cell renal cell carcinoma (RCC) and ...
Cellectis(CLLS) - 2022 Q3 - Earnings Call Transcript
2022-11-04 18:29
Cellectis S.A. (NASDAQ:CLLS) Q3 2022 Earnings Conference Call November 4, 2022 8:00 AM ET Operator Company Participants | --- | |------------------------------------------| | | | Arthur Stril - Chief Business Officer | | Andre Choulika - Chief Executive Officer | | Mark Frattini - Chief Medical Officer | | Bing Wang - Chief Financial Officer | | Conference Call Participants | | Gena Wang - Barclays | | Jack Allen - Baird | | Yigal Nochomovitz - Citigroup | | Salveen Richter - Goldman Sachs | | David Dai - S ...
Cellectis(CLLS) - 2022 Q3 - Quarterly Report
2022-11-02 16:00
Exhibit 99.1 PRELIMINARY NOTE The unaudited condensed Consolidated Financial Statements for the three and nine-month period ended September 30, 2022, included herein, have been prepared in accordance with International Accounting Standard 34 ("IAS 34")– Interim Financial Reporting as issued by the International Accounting Standards Board ("IASB"). The consolidated financial statements are presented in U.S. dollars. All references in this interim report to "$" and "U.S. dollars mean U.S. dollars and all refe ...
Cellectis(CLLS) - 2022 Q2 - Earnings Call Transcript
2022-08-05 18:36
Cellectis S.A. (NASDAQ:CLLS) Q2 2022 Earnings Conference Call August 5, 2022 8:00 AM ET Company Participants Arthur Stril - Chief Business Officer Andre Choulika - Chief Executive Officer Bing Wang - Chief Financial Officer Conference Call Participants Gena Wang - Barclays Ashiq Mubarack - Citi Hartaj Singh - Oppenheimer Jack Allen - Baird David Dai - SMBC Silvan Tuerkcan - JMP Securities Nicolas Abbott - Wells Fargo Operator Good morning, everyone, and welcome to the Cellectis Second Quarter 2020 Earnings ...
Cellectis(CLLS) - 2022 Q2 - Quarterly Report
2022-08-03 16:00
[Preliminary Note](index=1&type=section&id=PRELIMINARY%20NOTE) This section provides preliminary information regarding accounting standards and forward-looking statements [Accounting Standards and Forward-Looking Statements](index=1&type=section&id=Accounting%20Standards%20and%20Forward-Looking%20Statements) Unaudited financial statements follow **IAS 34** and **U.S. dollar** presentation, with a disclaimer on forward-looking statements - Financial statements are prepared in accordance with **International Accounting Standard 34 (IAS 34)** and presented in **U.S. dollars**[3](index=3&type=chunk) - The report contains forward-looking statements subject to **numerous risks and uncertainties**, including clinical trial outcomes, regulatory approvals, competition, manufacturing issues, and capital market dislocations[4](index=4&type=chunk) [PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This part presents unaudited interim consolidated financial statements, notes, and management's discussion and analysis [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents unaudited condensed consolidated financial statements, including position, operations, comprehensive income, cash flow, and equity [Condensed Consolidated Statements of Financial Position](index=3&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20FINANCIAL%20POSITION) Total assets and shareholders' equity decreased from **December 31, 2021** to **June 30, 2022**, driven by reduced cash Consolidated Statements of Financial Position (in thousands) | ASSETS / LIABILITIES & EQUITY | Dec 31, 2021 | Jun 30, 2022 | | :---------------------------- | :----------- | :----------- | | **Total Assets** | **382,076** | **320,883** | | **Total Shareholders' Equity**| **236,474** | **180,522** | | **Total Liabilities** | **145,602** | **140,361** | [Condensed Consolidated Statements of Operations (Unaudited) - Six-month period](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20(UNAUDITED)%20-%20Six-month%20period) Total revenues and other income significantly decreased, leading to increased operating loss despite a substantial net financial gain Consolidated Statements of Operations (Six-month period, in thousands, except per share) | Metric | Jun 30, 2021 | Jun 30, 2022 | | :---------------------------- | :----------- | :----------- | | Total revenues and other income | **42,581** | **6,596** | | Operating income (loss) | (**57,387**) | (**69,324**) | | Net Financial gain (loss) | **431** | **15,113** | | Net income (loss) | (**56,956**) | (**54,211**) | | Basic net income (loss) per share | (**1.17**) | (**1.12**) | [Condensed Consolidated Statements of Comprehensive Income (Loss) - Six-month period](index=5&type=section&id=CONDENSED%20COSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20INCOME%20(LOSS)%20-%20Six-month%20period) Total comprehensive loss increased due to a larger currency translation adjustment Consolidated Statements of Comprehensive Income (Loss) (Six-month period, in thousands) | Metric | Jun 30, 2021 | Jun 30, 2022 | | :---------------------------- | :----------- | :----------- |\n| Net income (loss) | (**56,956**) | (**54,211**) | | Currency translation adjustment | (**6,969**) | (**11,978**) | | Total Comprehensive income (loss) | (**63,348**) | (**64,971**) | [Condensed Consolidated Statements of Operations (Unaudited) - Three-month period](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20(UNAUDITED)%20-%20Three-month%20period) Net loss significantly reduced due to substantial financial gain and lower operating expenses, despite sharp revenue decline Consolidated Statements of Operations (Three-month period, in thousands, except per share) | Metric | Jun 30, 2021 | Jun 30, 2022 | | :---------------------------- | :----------- | :----------- |\n| Total revenues and other income | **14,615** | **2,765** | | Operating income (loss) | (**37,481**) | (**34,077**) | | Financial gain (loss) | (**4,129**) | **14,623** | | Net income (loss) | (**41,610**) | (**19,454**) | | Basic net income (loss) per share | (**0.88**) | (**0.42**) | [Condensed Consolidated Statements of Comprehensive Income (Loss) - Three-month period](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20INCOME%20(LOSS)%20-%20Three-month%20period) Total comprehensive loss decreased due to lower net loss, partially offset by negative currency translation adjustment Consolidated Statements of Comprehensive Income (Loss) (Three-month period, in thousands) | Metric | Jun 30, 2021 | Jun 30, 2022 | | :---------------------------- | :----------- | :----------- |\n| Net income (loss) | (**41,610**) | (**19,454**) | | Currency translation adjustment | **2,714** | (**8,870**) | | Total Comprehensive income (loss) | (**38,759**) | (**27,533**) | [Condensed Consolidated Statements of Cash Flow](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOW) Cash usage in operating activities increased, investing shifted to cash used, and financing activities decreased significantly Consolidated Statements of Cash Flow (Six-month period, in thousands) | Cash Flow Activity | Jun 30, 2021 | Jun 30, 2022 | | :---------------------------- | :----------- | :----------- |\n| Operating activities | (**53,054**) | (**60,181**) | | Investing activities | **9,941** | (**2,537**) | | Financing activities | **52,630** | **10,307** | | (Decrease) increase in cash and cash equivalents | **9,518** | (**52,411**) | | Cash and cash equivalents at end of period | **248,226** | **129,440** | [Condensed Consolidated Statements of Changes in Shareholders' Equity](index=9&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CHANGES%20IN%20SHAREHOLDERS'%20EQUITY) Total shareholders' equity decreased due to net loss and currency translation adjustments, despite share capital increase Consolidated Statements of Changes in Shareholders' Equity (in thousands) | Metric | Jan 1, 2021 | Jun 30, 2021 | Jan 1, 2022 | Jun 30, 2022 | | :---------------------------- | :---------- | :----------- | :---------- | :----------- |\n| Total Shareholders' Equity | **308,845** | **302,323** | **236,474** | **180,522** | - **Calyxt** completed a **follow-on offering** on **February 23, 2022**, issuing **common stock and warrants**, generating net proceeds of **$10.0 million** and impacting equity by **$2.7 million**[23](index=23&type=chunk) - Shareholders approved the absorption of **$372.7 million** of **retained earnings into share premium** on **June 28, 2022**, with no impact on **total equity**, **comprehensive income (loss)**, **assets, or liabilities**[23](index=23&type=chunk) [Notes to the Interim Consolidated Financial Statements](index=11&type=section&id=NOTES%20TO%20THE%20INTERIM%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) This section provides detailed notes to the interim consolidated financial statements, covering company information, accounting principles, and financial details [Note 1. The Company](index=11&type=section&id=Note%201.%20The%20Company) **Cellectis** is a clinical-stage biotech company focused on gene-editing for immuno-oncology and genetic diseases, holding a majority stake in **Calyxt** - **Cellectis** is a **clinical-stage biotechnology company** developing **allogeneic Chimeric Antigen Receptor T-cells (UCART)** for immuno-oncology and **gene-edited hematopoietic stem cells (HSC)** for genetic diseases[27](index=27&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) - As of **June 30, 2022**, **Cellectis S.A.** owns **51.3%** of **Calyxt, Inc.**, its plant-based synthetic biology subsidiary, which leverages its **PlantSpring technology platform**[30](index=30&type=chunk) - The **COVID-19 pandemic** has slowed patient enrollment in **Cellectis' AMELI-01, BALLI-01, and MELANI-01 clinical trials** but did not have a material impact on **Calyxt's** operations during the first six months of **2022**[32](index=32&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk) [Note 2. Accounting principles](index=12&type=section&id=Note%202.%20Accounting%20principles) Interim consolidated financial statements are prepared in **U.S. dollars** under **IAS 34**, with consistent policies and no significant new standard impact - Interim Consolidated Financial Statements are presented in **U.S. dollars** and prepared in accordance with **IAS 34**[37](index=37&type=chunk)[43](index=43&type=chunk) - No significant impact from new or amended accounting standards adopted from **January 1, 2022**[40](index=40&type=chunk) - **Cellectis S.A.** controls and consolidates **Cellectis, Inc.**, **Cellectis Biologics, Inc.**, and approximately **51.3%** of **Calyxt's** outstanding common stock as of **June 30, 2022**[51](index=51&type=chunk)[54](index=54&type=chunk) [Note 3. Information concerning the Group's Consolidated Operations](index=16&type=section&id=Note%203.%20Information%20concerning%20the%20Group's%20Consolidated%20Operations) This note details Group revenues, other income, and operating expenses by segment; revenues and operating expenses significantly decreased [Revenues and other income](index=16&type=section&id=3.1%20Revenues%20and%20other%20income) Total revenues and other income significantly decreased due to lower collaboration revenues and **Calyxt's** business model shift Revenues and Other Income (Six-month period, in thousands) | Metric | Jun 30, 2021 | Jun 30, 2022 | % Change | | :---------------------------- | :----------- | :----------- | :------- |\n| Revenues | **36,777** | **3,045** | **-91.7%** | | Other income | **5,804** | **3,551** | **-38.8%** | | Total revenues and other income | **42,581** | **6,596** | **-84.5%** | - The decrease in revenues is mainly due to the recognition of a **$15.0 million** upfront payment from **Cytovia** and a **$5.1 million** milestone from **Allogene** in **H1 2021**, which did not recur in **H1 2022**. **H1 2022** revenues included **$1.5 million** from **Cytovia** milestones and **$1.0 million** from a licensee change of control[60](index=60&type=chunk) - Products and services revenues decreased significantly due to the wind-down of **Calyxt's** soybean product line in late **2021**, with **H1 2022** revenues solely from **Calyxt's** palm oil alternative development agreement[62](index=62&type=chunk) [Operating expenses](index=18&type=section&id=3.2%20Operating%20expenses) Total operating expenses decreased due to significant reduction in cost of goods sold from **Calyxt's** business model change and decreased **R&D** Operating Expenses (Six-month period, in thousands) | Metric | Jun 30, 2021 | Jun 30, 2022 | % Change | | :----------------------------------- | :----------- | :----------- | :------- |\n| Cost of revenue | (**19,899**) | (**714**) | **-96.4%** | | Research and development expenses | (**62,338**) | (**58,527**) | **-6.1%** | | Selling, general and administrative expenses | (**18,219**) | (**17,695**) | **-2.9%** | | Total operating expenses | (**99,968**) | (**75,920**) | **-24.1%** | - **Cost of goods sold** decreased by **$18.7 million** (**100%**) due to **Calyxt's** shift from soybean product sales to its **PlantSpring Technology and BioFactory model**[68](index=68&type=chunk) - **Research and development expenses** decreased by **$3.8 million**, mainly due to lower purchases, external expenses, and non-cash stock-based compensation, partially offset by increased wages and salaries in the **therapeutic segment**[204](index=204&type=chunk) [Reportable segments](index=20&type=section&id=3.3%20Reportable%20segments) The Group operates in **Therapeutics** and **Plants** segments; **CODM** uses segment-specific financial indicators for performance and resource allocation - The Group's two operating and reportable segments are **Therapeutics** (focused on gene-edited **UCART** and **HSC** product candidates) and **Plants** (**Calyxt's** plant-based synthetic biology solutions)[74](index=74&type=chunk) - The **CODM**, composed of key executives, evaluates segment performance based on revenues, operating expenses, and adjusted net income (loss), but not asset or liability information[73](index=73&type=chunk)[79](index=79&type=chunk) Key Performance Indicators by Reportable Segment (Six-month period, in thousands) | Metric | Plants 2021 | Therapeutics 2021 | Total 2021 | Plants 2022 | Therapeutics 2022 | Total 2022 | | :----------------------------------- | :---------- | :---------------- | :--------- | :---------- | :---------------- | :--------- |\n| External revenues and other income | **18,244** | **24,337** | **42,581** | **73** | **6,523** | **6,596** | | Total operating expenses | (**32,063**) | (**67,905**) | (**99,968**) | (**12,856**) | (**63,064**) | (**75,920**) | | Operating income (loss) before tax | (**13,818**) | (**43,569**) | (**57,387**) | (**12,783**) | (**56,541**) | (**69,324**) | | Net income (loss) attributable to shareholders of Cellectis | (**9,233**) | (**42,554**) | (**51,787**) | (**3,531**) | (**47,328**) | (**50,858**) | [Note 4. Impairment tests](index=24&type=section&id=Note%204.%20Impairment%20tests) No impairment indicators were identified for intangible or tangible assets in **Therapeutics** and **Plants CGUs** - No impairment indicators were identified for intangible or tangible assets in the **Therapeutics** and **Plants CGUs** for the six-month period ended **June 30, 2022**[86](index=86&type=chunk) [Note 5. Right-of-use assets](index=24&type=section&id=Note%205.%20Right-of-use%20assets) Net book value of right-of-use assets decreased due to depreciation and disposals from New York premises sublease Right-of-use Assets (in thousands) | Metric | Jan 1, 2022 | Jun 30, 2022 | | :----------------------------------- | :---------- | :----------- |\n| Net book value | **69,423** | **61,086** | | Additions | **793** | | | Disposal of right-of-use asset | (**2,743**) | | | Depreciation expense | (**4,917**) | | | Translation adjustments | (**1,