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Cellectis(CLLS) - 2021 Q4 - Earnings Call Transcript
2022-03-04 21:37
Cellectis S.A. (NASDAQ:CLLS) Q4 2021 Results Earnings Conference Call March 4, 2022 8:00 AM ET Company Participants Arthur Stril - Chief Business Officer Andre Choulika - Chief Executive Officer Carrie Brownstein - Chief Medical Officer Bing Wang - Chief Financial Officer David Sourdive - Executive Vice President, CMC and Manufacturing Steve Doares - Chief Regulatory and Compliance Officer Conference Call Participants Yigal Nochomovitz - Citigroup Gena Wang - Barclays Capital David Windley - Jefferies Raju ...
Cellectis(CLLS) - 2021 Q4 - Annual Report
2022-03-02 16:00
PART I [Key Information](index=7&type=section&id=Item%203.%20Key%20Information) The company details significant risks related to its business, product development, third-party reliance, and financial condition [Risk Factors](index=7&type=section&id=D.%20Risk%20Factors) The company faces operational, clinical, regulatory, and financial risks, including a limited history and reliance on novel technology - The company has a limited operating history focused on R&D and has incurred **significant operating losses** since inception, with an expectation of continued losses for the foreseeable future[25](index=25&type=chunk)[26](index=26&type=chunk)[43](index=43&type=chunk) - Product candidates are based on novel gene-editing technology, which faces **high risks of failure** in time-consuming and expensive clinical trials, potential for undesirable side effects, and complex, heavily regulated manufacturing processes[27](index=27&type=chunk)[46](index=46&type=chunk) - The company relies on strategic licensing relationships and third parties for aspects of discovery, development, and manufacturing, which poses risks if these partners fail to perform or devote sufficient resources[28](index=28&type=chunk)[90](index=90&type=chunk) - The majority-owned subsidiary, Calyxt, faces significant risks, including its ability to continue as a **going concern**, which depends on obtaining additional financing[38](index=38&type=chunk)[129](index=129&type=chunk) - As a foreign private issuer, the company is exempt from certain U.S. securities laws and Nasdaq governance standards, which may afford **less protection to shareholders**[36](index=36&type=chunk)[206](index=206&type=chunk) [Information on the Company](index=60&type=section&id=Item%204.%20Information%20on%20the%20Company) The company operates as a clinical-stage biotechnology firm developing immuno-oncology products using proprietary gene-editing technologies [History and Development of the Company](index=60&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) Founded in 2000, the company has increased capital expenditures for manufacturing facilities to support R&D programs Capital Expenditures (2019-2021) | Year | Capital Expenditures (in millions) | | :--- | :--- | | 2019 | $13.0 | | 2020 | $46.3 | | 2021 | $19.0 | [Business Overview](index=60&type=section&id=B.%20Business%20Overview) The company develops 'off-the-shelf' allogeneic CAR T-cell immunotherapies using its TALEN® gene-editing technology - Cellectis focuses on developing allogeneic (from healthy donors) CAR T-cell therapies, which it believes offer advantages over autologous treatments in **market access, cost-effectiveness, and scalable manufacturing**[219](index=219&type=chunk)[222](index=222&type=chunk) - The company's core technology is **TALEN®**, a proprietary gene-editing tool used to create its UCART product candidates that allows for precise gene modifications[222](index=222&type=chunk)[298](index=298&type=chunk) Cellectis Product Pipeline Overview | Product Candidate | Target(s) | Indication | Development Phase | Sponsor/Partner | | :--- | :--- | :--- | :--- | :--- | | **Wholly-Owned** | | | | | | UCART123 | CD123 | r/r AML | Phase 1 | Cellectis | | UCART22 | CD22 | r/r B-ALL | Phase 1 | Cellectis | | UCARTCS1 | CS1 | r/r MM | Phase 1 | Cellectis | | UCART20x22 | CD20xCD22 | NHL | Pre-clinical | Cellectis | | **Partnered** | | | | | | ALLO-501 / ALLO-501A | CD19 | r/r NHL | Phase 1/2 | Allogene/Servier | | ALLO-715 | BCMA | r/r MM | Phase 1 | Allogene | | ALLO-605 | BCMA | r/r MM | Phase 1 | Allogene | | ALLO-316 | CD70 | RCC | Phase 1 | Allogene | - Cellectis has established two in-house manufacturing facilities: an **~80,000 sq ft plant in Raleigh, NC** for clinical and commercial UCART production, and a **~14,000 sq ft plant in Paris, France** for raw and starting materials[317](index=317&type=chunk) - Cellectis owns **56.1% of Calyxt** (as of Feb 23, 2022), a plant-based synthetic biology company that engineers plant metabolism to produce high-value chemistries[219](index=219&type=chunk)[319](index=319&type=chunk) [Organizational Structure](index=114&type=section&id=C.%20Organizational%20Structure) The company is a French société anonyme with key subsidiaries in the United States, including Calyxt, Inc Group Structure as of December 31, 2021 | Subsidiary Name | Jurisdiction of Incorporation | Ownership & Voting Interest Held By Cellectis S.A. | | :--- | :--- | :--- | | Calyxt, Inc. | Delaware | 61.8% (held directly) | | Cellectis, Inc. | Delaware | 100% (held directly) | | Cellectis Biologics, Inc. | Delaware | 100% (held indirectly through Cellectis, Inc.) | [Property, Plant and Equipment](index=114&type=section&id=D.%20Property,%20Plant%20and%20Equipment) The company leases key administrative, R&D, and manufacturing facilities in Paris, New York, and Raleigh - Cellectis leases an **82,783 sq ft facility in Raleigh, North Carolina**, for its clinical and commercial UCART product manufacturing[390](index=390&type=chunk) - The company leases a **5,846 sq-meter facility in Paris**, which includes its corporate offices, R&D labs, and a manufacturing facility for raw and starting materials[390](index=390&type=chunk) [Operating and Financial Review and Prospects](index=115&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) The company's financial performance reflects reliance on collaboration revenues, rising R&D expenses, and challenges at its subsidiary Calyxt [Operating Results](index=126&type=section&id=A.%20Operating%20Results) The company's operating loss widened in 2021 due to decreased collaboration revenue and increased R&D expenses Consolidated Statement of Operations (2019-2021) | ($ in thousands) | 2019 | 2020 | 2021 | | :--- | :--- | :--- | :--- | | **Total revenues and other income** | **22,990** | **82,456** | **67,071** | | Cost of revenue | (11,392) | (36,275) | (31,360) | | Research and development expenses | (92,042) | (86,950) | (129,030) | | Selling, general and administrative expenses | (43,017) | (44,201) | (37,869) | | **Operating income (loss)** | **(123,552)** | **(85,437)** | **(130,677)** | | Net Financial gain (loss) | 8,340 | (12,046) | 5,570 | | **Net income (loss)** | **(115,212)** | **(97,483)** | **(125,107)** | | Attributable to shareholders of Cellectis | (102,091) | (81,074) | (114,197) | | Attributable to non-controlling interests | (13,121) | (16,409) | (10,910) | - **Revenues decreased by 22.5% in 2021**, primarily due to a $18.9 million decrease in collaboration agreement revenue[423](index=423&type=chunk) - **Research and development expenses increased by 48.4%** to $129.0 million in 2021, driven by higher personnel and external expenses for the therapeutic segment[428](index=428&type=chunk) - **Selling, general and administrative expenses decreased by 14.3%** to $37.9 million in 2021, mainly due to a $6.4 million decrease in non-cash stock-based compensation expense[430](index=430&type=chunk) [Liquidity and Capital Resources](index=134&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) The company's cash position is expected to fund therapeutic operations into early 2024, though its subsidiary faces going concern risks Cash and Cash Equivalents Position | As of | Amount (in millions) | | :--- | :--- | | Dec 31, 2021 | $186.1 | - Cellectis, excluding its subsidiary Calyxt, anticipates that its cash position will be sufficient to fund its therapeutic operations **into early 2024**[456](index=456&type=chunk) - Calyxt's management has concluded there is **substantial doubt regarding its ability to continue as a going concern**, as its cash is only sufficient to fund operations into late 2022[459](index=459&type=chunk) Summary of Cash Flows (Year Ended Dec 31, 2021) | Cash Flow Activity | Amount (in thousands) | | :--- | :--- | | Net cash used in operating activities | $(104,562) | | Net cash provided by investing activities | $7,279 | | Net cash provided by financing activities | $47,525 | [Directors, Senior Management and Employees](index=141&type=section&id=Item%206.%20Directors,%20Senior%20Management%20and%20Employees) The company's leadership consists of an experienced board and management team, with a workforce primarily focused on R&D - The aggregate cash compensation paid to current executive officers and directors for the year ended December 31, 2021, was **$6.6 million**[482](index=482&type=chunk) - As of December 31, 2021, Cellectis had 300 employees (excluding Calyxt), with **245 (82%) engaged in research and development activities**[511](index=511&type=chunk) - The company has a change of control plan for its executive committee members, providing a severance package equal to **24 months of compensation plus a bonus**[485](index=485&type=chunk)[487](index=487&type=chunk) - The Board of Directors consists of nine members and one observer, with a **majority determined to be independent**[500](index=500&type=chunk)[502](index=502&type=chunk) [Major Shareholders and Related Party Transactions](index=154&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) Ownership is distributed among institutional investors and insiders, with significant related-party agreements involving its subsidiary Calyxt Major Shareholders (as of Feb 14, 2022) | Shareholder | Ownership Percentage | | :--- | :--- | | Baillie Gifford & Co. | 9.53% | | Bpifrance Participations | 8.10% | | ARK Investment Management LLC | 6.47% | | Pfizer, Inc. | 6.13% | - All directors and executive officers as a group beneficially owned approximately **18.38% of the company's ordinary shares** as of February 14, 2022[516](index=516&type=chunk) - Cellectis has a Stockholders Agreement with Calyxt that grants it **significant contractual approval rights** as long as it owns at least 50% of Calyxt's common stock[527](index=527&type=chunk) [Financial Information](index=164&type=section&id=Item%208.%20Financial%20Information) The company has no history of paying dividends and notes a significant subsequent equity offering by its subsidiary Calyxt - The company has **never declared or paid cash dividends** and does not intend to do so in the foreseeable future, planning to reinvest any future earnings into growth[198](index=198&type=chunk)[537](index=537&type=chunk) - Subsequent to year-end, subsidiary Calyxt completed an offering resulting in approximately **$10.9 million in gross proceeds**, which could dilute Cellectis's ownership to below 50%[538](index=538&type=chunk)[798](index=798&type=chunk) [Additional Information](index=165&type=section&id=Item%2010.%20Additional%20Information) The company's governance is subject to French corporate law, with potential U.S. tax implications for ADS holders - Under French law and the company's by-laws, shares held in registered form for more than two years are granted **double voting rights**[549](index=549&type=chunk) - The company does not believe it was a **Passive Foreign Investment Company (PFIC)** for the 2021 tax year, but classification could result in adverse U.S. tax consequences for U.S. holders[203](index=203&type=chunk)[571](index=571&type=chunk) - Dividends paid by the company to U.S. Holders are generally subject to **French withholding tax**, which may be reduced under the U.S.-France tax treaty[589](index=589&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=183&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure relates to foreign currency fluctuations between the U.S. dollar and the Euro - The company faces significant **foreign currency exchange risk** due to a mismatch between U.S. dollar-denominated revenues and Euro-denominated expenses[595](index=595&type=chunk)[721](index=721&type=chunk) - The net foreign exchange result for fiscal year 2021 was a **gain of $9.9 million**[596](index=596&type=chunk) - **Commodity price risk** related to Calyxt's soybean product line has been eliminated following the wind-down of those operations[599](index=599&type=chunk) PART II [Controls and Procedures](index=187&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective - Management concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2021[607](index=607&type=chunk) - Based on the COSO framework, management concluded that the company's **internal control over financial reporting was effective** as of December 31, 2021, and received an unqualified audit opinion[607](index=607&type=chunk) [Corporate Governance and Other Information](index=187&type=section&id=Item%2016.%20Corporate%20Governance%20and%20Other%20Information) The company adheres to a Code of Conduct and follows certain French home country governance practices - The board of directors has identified Pierre Bastid, Laurent Arthaud, and Hervé Hoppenot as **independent audit committee financial experts**[608](index=608&type=chunk) Principal Accountant Fees (2020-2021) | Fee Type ($ in thousands) | 2020 | 2021 | | :--- | :--- | :--- | | Audit Fees | 676 | 838 | | Audit-Related Fees | — | — | | Tax Fees | — | — | | Other Fees | — | — | | **Total** | **676** | **838** | - As a foreign private issuer, the company follows **French home country practices** for certain governance matters, such as board committee composition and quorum requirements[616](index=616&type=chunk) PART III [Financial Statements](index=190&type=section&id=Item%2018.%20Financial%20Statements) The audited consolidated financial statements received an unqualified opinion, with a critical audit matter in revenue recognition - The independent auditor, Ernst & Young et Autres, issued an **unqualified opinion** on the consolidated financial statements, stating they present fairly in accordance with IFRS[628](index=628&type=chunk) - A **critical audit matter** was identified related to revenue recognition from collaboration and license agreements, requiring a high degree of auditor judgment[630](index=630&type=chunk)[632](index=632&type=chunk) Consolidated Financial Position (in thousands) | | As of Dec 31, 2020 | As of Dec 31, 2021 | | :--- | :--- | :--- | | **Total Assets** | **$469,471** | **$382,076** | | Total Liabilities | $160,625 | $145,602 | | **Total Shareholders' Equity** | **$308,846** | **$236,474** |
Cellectis(CLLS) - 2021 Q4 - Annual Report
2022-03-02 16:00
EXHIBIT 99.1 Cellectis Provides Business Update and Reports 4th Quarter and Full Year 2021 Financial Results Encouraging preliminary results from BALLI-01 study (evaluating UCART22) in relapsed/refractory B-cell Acute Lymphoblastic Leukemia presented at ASH 2021 annual meeting; BALLI-01 currently enrolling at DL3 On track for planned 2022 IND submission for UCART20x22, our first allogeneic dual CAR T-cell product candidate, in B-cell non-Hodgkin's Lymphoma Two manufacturing sites are now fully operational; ...
Cellectis(CLLS) - 2021 Q3 - Earnings Call Transcript
2021-11-05 16:04
Cellectis S.A. (NASDAQ:CLLS) Q3 2021 Results Conference Call November 5, 2021 8:00 AM ET Company Participants Andre Choulika - Chief Executive Officer Eric Dutang - Chief Financial Officer Carrie Brownstein - Chief Medical Officer Conference Call Participants Yigal Nochomovitz - Citigroup Gena Wang - Barclays Kelsey Goodwin - Guggenheim Kelly Shi - Jeffries Hartaj Singh - Oppenheimer & Co Jack Allen - Baird Raju Prasad - William Blair Nick Abbott - Wells Fargo Ingrid Gafanhão - Kempen & Co Operator Greeting ...
Cellectis(CLLS) - 2021 Q2 - Earnings Call Transcript
2021-08-06 19:33
Financial Data and Key Metrics Changes - Cellectis reported a cash position of $238 million as of August 6, 2021, down from $244 million at the end of 2020, primarily due to $59 million in net sales proceeds and $46 million in net equity proceeds raised [22][23] - The net loss attributable to shareholders, excluding Calyxt, was $43 million in the first half of 2021, compared to a net income of $3 million in 2020, driven by a decrease in revenues and an increase in R&D expenses [24][25] - The consolidated net loss attributable to shareholders, including Calyxt, was $52 million or $1.17 per share in the first half of 2021, compared to $12 million or $0.29 per share in 2020 [25] Business Line Data and Key Metrics Changes - Cellectis has made significant progress in its clinical trials, including enrolling patients in three Phase 1 dose-escalation trials for UCART22, BALLI-01, and UCARTCS1 [9][10] - The company presented preliminary data for UCARTCS1 at a major conference, validating CS1 as a target for CAR T-cell therapy in multiple myeloma [10] Market Data and Key Metrics Changes - Cellectis has entered into a partnership with Sanofi for the supply of alemtuzumab, which will be used in certain UCART clinical trials, indicating a strategic move to enhance clinical trial support [16] - The company is also focused on expanding its pipeline with new product candidates targeting various cancers, including solid tumors [12][13] Company Strategy and Development Direction - Cellectis aims to leverage its gene editing platform to develop novel proprietary medicines for serious diseases, focusing on hematologic malignancies and solid tumors [27] - The company plans to file INDs for new product candidates in 2022, including UCART20x22 and UCART mesothelin [13][15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about entering a new phase of development, emphasizing clinical execution and internal product manufacturing capabilities [8][27] - The company is focused on developing its pipeline while maintaining efficient cash management to support operations into early 2023 [22][26] Other Important Information - Cellectis has successfully completed two UCART training runs in its Raleigh GMP manufacturing facility, marking a key milestone in its manufacturing capabilities [18] - The company is preparing to organize a live visit of its manufacturing facility for investors, showcasing its state-of-the-art capabilities [83] Q&A Session Summary Question: Will data for UCART22 be presented at ASH? - Management aims to present data at ASH, with some cohorts expected by the end of the year [31] Question: Thoughts on moving HEAL technology to in-vivo systems? - The focus is currently on ex-vivo systems, with plans to transition to in-vivo once safety and efficacy are established [34] Question: Long-term partnering strategy? - Cellectis remains open to partnerships to accelerate clinical execution, considering past collaborations as beneficial [39][40] Question: Update on UCARTCS1 trial progress? - The trial is progressing well, but specific enrollment numbers are not disclosed due to safety monitoring requirements [70] Question: IP perspective on UCART MK1? - Cellectis believes it has a strong IP position in gene editing, having filed patents long before competitors [60] Question: Solid tumor strategy and first targets? - The first target for solid tumors is likely to be mesothelin CAR-T, focusing on indications like mesothelioma and pancreatic cancer [65]
Cellectis(CLLS) - 2020 Q4 - Earnings Call Transcript
2021-03-05 20:15
Cellectis S.A. (NASDAQ:CLLS) Q4 2020 Earnings Conference Call March 5, 2021 8:00 AM ET Company Participants Simon Harnest - Senior Vice President, Corporate Strategy and Finance André Choulika - Chief Executive Officer Carrie Brownstein - Chief Medical Officer Eric Dutang - Chief Financial Officer Conference Call Participants Michael Schmidt - Guggenheim Securities, LLC Gena Wang - Barclays Salveen Richter - Goldman Sachs Hartaj Singh - Oppenheimer & Company Yigal Nochomovitz - Citigroup Wangzhi Li - Ladenb ...
Cellectis(CLLS) - 2020 Q4 - Annual Report
2021-03-03 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) or (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...
Cellectis(CLLS) - 2020 Q3 - Earnings Call Transcript
2020-11-06 19:45
Cellectis S.A. (NASDAQ:CLLS) Q3 2020 Earnings Conference Call November 6, 2020 8:00 AM ET Company Participants Simon Harnest – Senior Vice President, Corporate Strategy and Finance André Choulika – Chief Executive Officer Carrie Brownstein – Chief Medical Officer Eric Dutang – Chief Financial Officer Conference Call Participants Gena Wang – Barclays Yigal Nochomovitz – Citigroup Jim Birchenough – Wells Fargo Kelsey Goodwin – Guggenheim Salveen Richter – Goldman Sachs Hartaj Singh – Oppenheimer & Company Wan ...
Cellectis (CLLS) Investor Presentation - Slideshow
2020-09-11 14:54
Company Overview and Pipeline - Cellectis is committed to developing allogeneic CAR T-cells, with over 20 years of expertise in gene editing and 8 years in allogeneic CAR-T manufacturing[2] - The company has 6 ongoing clinical trials as of 2020, with 3 Cellectis-sponsored and 3 partnered[2] - Cellectis' pipeline includes innovative cancer therapies for unmet needs, such as UCART123 for Acute Myeloid Leukemia, UCART22 for Acute Lymphoblastic Leukemia, and UCARTCS1 for Multiple Myeloma[8] - Cellectis is constructing two in-house manufacturing plants, one in Paris, France, for raw material supply, and another in Raleigh, North Carolina, for GMP commercial-scale UCART manufacturing[29] Partnerships and Licensing - Cellectis has partnerships with industry leaders, with up to $3.2 billion in potential milestone payments plus royalties[5] - The company granted Servier an exclusive worldwide license to develop and commercialize all next-generation gene-edited allogeneic CAR T-cell products targeting CD19, including rights to ALLO-501[11] - Cellectis granted Allogene an exclusive license to 15 allogeneic CAR T-Cell targets including UCARTBCMA / ALLO-715, with up to $2.8 billion in development & sales milestones plus high single-digit royalties on sales[5] Clinical Trial Data and Efficacy - In a Phase 1 dose escalation study of ALLO-501 in R/R Non-Hodgkin Lymphoma, the overall response rate was 63%, and the complete response rate was 37%[11] - In a Phase 1 dose escalation study of UCART19 in R/R ALL, the CR/CRi rate with optimal lymphodepletion was 82%[13] - CD123 is expressed in >90% on malignant cells in AML[14] - CD22 is expressed in >95% B-ALL cells[16]
Cellectis(CLLS) - 2020 Q2 - Earnings Call Transcript
2020-08-06 23:32
Cellectis S.A. (NASDAQ:CLLS) Q2 2020 Earnings Conference Call August 6, 2020 7:30 AM ET Company Participants Simon Harnest - Vice President-Corporate Strategy & Finance André Choulika - Chairman & Chief Executive Officer Carrie Brownstein - Chief Medical Officer Eric Dutang - Chief Financial Officer Conference Call Participants Jim Birchenough - Wells Fargo Michael Schmidt - Guggenheim Gena Wang - Barclays Biren Amin - Jefferies Wangzhi Li - Ladenburg Thalmann Salveen Richter - Goldman Sachs Hartaj Singh - ...