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Cellectis(CLLS) - 2020 Q1 - Earnings Call Transcript
2020-05-09 08:51
Financial Data and Key Metrics Changes - Cellectis reported a cash position of $304 million as of March 31, 2020, unchanged from December 31, 2019, reflecting $28 million of proceeds and $5 million VAT received from Servier, offset by $29 million of net cash flows used in operations and $4 million unfavorable Forex impact [18] - The consolidated cash position, including Calyxt, was $351 million as of March 31, 2020, down from $364 million as of December 31, 2019, primarily due to $13 million of net cash flows used in operating and capital expenditures activities of Calyxt [19] - Selective stand-alone net income attributable to shareholders was $27 million in Q1 2020, compared to a net loss of $10 million in Q1 2019, driven by a significant increase in revenues and other income of $46 million [21] - Consolidated net income attributable to shareholders, including Calyxt, was $20 million or $0.47 income per share in Q1 2020, compared to a loss of $15 million or $0.36 loss per share in Q1 2019 [22] Business Line Data and Key Metrics Changes - Cellectis is progressing with three proprietary allogenic CAR-T cell product candidates in clinical development, with ongoing trials for UCART22, UCARTCS1, and UCART123 [7][10] - All three Phase 1 trials remain on track, with plans to share interim clinical data by the end of the year, contingent on COVID-19 impacts [12] Market Data and Key Metrics Changes - The company is focused on developing its deep pipeline of product candidates and completing the construction of its manufacturing facilities in Paris and Raleigh [23] Company Strategy and Development Direction - Cellectis aims to strengthen its position as a leader in gene-edited cell therapy, with plans to advance next-generation products into clinical development in the coming years [25] - The company is on track with its clinical development schedule and manufacturing site construction, which is designed to deliver full independence and internal know-how in gene editing and cell therapy [24] Management's Comments on Operating Environment and Future Outlook - Management expressed gratitude to healthcare workers and emphasized the company's commitment to advancing cancer treatments during the COVID-19 pandemic [6] - The company remains focused on its clinical programs and manufacturing capabilities, with a strong cash position to fund operations into 2022 [18][23] Other Important Information - Cellectis has amended its agreement with Servier, granting an expanded exclusive worldwide license for next-generation allogeneic CAR T-cell products targeting CD19, which includes rights to UCART19, ALLO-501, and ALLO-501A [20] Q&A Session Summary Question: Can you discuss how you will evaluate the dose for expansion after dose escalation? - Management indicated that optimal safety, translational data, and activity of the cells will be considered for determining the dose for expansion [27][28] Question: What are the criteria for the BALLI and AMELI studies to move into dose expansion? - The criteria include evaluating activity, safety, and combined translational data to determine the optimal dose for moving forward [33][34] Question: Can you provide insights on the ALLO-501A study readout at ASCO? - Management noted that the differences between ALLO-647 and alemtuzumab dosing would be evaluated, and they are looking to optimize lymphodepletion regimens [38][40] Question: How far into the dose escalation are you in each of the three studies? - All three programs are in lockstep, having cleared the first dose level and now exploring the second dose level [59] Question: What are your thoughts on the recent patent for CRISPR-edited T-cell therapies? - Management expressed confidence in the enforceability of the patent and highlighted the company's early adoption of CRISPR technology in T-cells [66][67]
Cellectis(CLLS) - 2019 Q4 - Earnings Call Transcript
2020-03-06 04:12
Financial Data and Key Metrics Changes - Cellectis reported a consolidated cash position of $364 million as of December 31, 2019, with a net loss attributable to shareholders of $102 million, or $2.41 per share, representing an increase of $23 million over 2018 [29][28] - Revenues and other income for 2019 were $16 million, with $3 million reported in Q4 2019 [28] - R&D expenses increased by $12 million to $18 million for the year 2019 compared to 2018, while SG&A expenses decreased by $9 million to $17 million for the same period [28] Business Line Data and Key Metrics Changes - Cellectis is advancing three wholly controlled allogeneic CAR-T cell product candidates: UCARTCS1, UCART22, and UCART123, all currently in Phase I dose escalation trials [6][15] - The company has entered into two licensing agreements for its allogeneic CAR-T cell platform, including an expanded exclusive worldwide license with Servier for CD19-targeting products [8][9] Market Data and Key Metrics Changes - The company is focusing on the clinical development of its CAR-T cell product candidates, which are designed to address significant unmet medical needs in various hematological malignancies [6][15] - Cellectis is also expanding its manufacturing capabilities with a new facility in Raleigh, North Carolina, expected to be operational next year, alongside a facility in Paris [12] Company Strategy and Development Direction - Cellectis aims to establish itself as a leader in gene-edited cell therapy, with a focus on developing its proprietary gene editing platform and expanding its clinical pipeline [30][31] - The company is integrating its manufacturing expertise as a strategic asset to achieve full manufacturing independence [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of clinical trials and the potential for proof-of-concept data in 2020 [30] - The company is optimistic about the advancements in its R&D efforts and the potential for new patents to strengthen its competitive position in the gene-editing space [31] Other Important Information - Cellectis has made a selective decision to partner with Iovance Biotherapeutics to develop gene-edited tumor infiltrating lymphocytes for cancer therapeutics [10] - The company is monitoring the on-target and off-target interactions of its CAR-T cell therapies closely as it progresses through various dose cohorts [16] Q&A Session Summary Question: What is the ideal balance of the immune system for CAR-T cell therapy? - Management noted that determining the ideal immune system balance for CAR-T treatment is complex and will be informed by data from ongoing studies [34][35] Question: What are the implications of the upheld patent by the European Patent Office? - The upheld patent relates to CRISPR-related technologies for gene editing in T-cells, reinforcing Cellectis' early position in this technology [42][43] Question: Can you provide details on the UCART22 trial design? - The UCART22 trial is focused on adult patients with relapsed/refractory B-ALL, with specific enrollment criteria based on CD22 expression [75] Question: What is the plan for the alemtuzumab cohort? - The initial approach will use a single dose of alemtuzumab, with potential for future studies to explore different dosing strategies [68][69] Question: How many patients are needed to determine the Phase II dose? - The number of patients per cohort may range from 2 to 4, with a systematic approach to determine the optimal dose for each product [65][66]
Cellectis(CLLS) - 2019 Q4 - Earnings Call Presentation
2020-03-05 16:18
cellectis EDITING LIFE COMMITMENT TO A CURE | --- | --- | --- | --- | |-------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...
Cellectis(CLLS) - 2019 Q4 - Annual Report
2020-03-04 22:47
[PART I](index=7&type=section&id=PART%20I) This section provides an overview of Cellectis's key financial data, operational risks, business model, and corporate structure [Key Information](index=7&type=section&id=Item%203.%20Key%20Information) This section presents selected consolidated financial data and a detailed breakdown of significant risks facing the company [Selected Financial Data](index=7&type=section&id=A.%20Selected%20Financial%20Data) The company's selected financial data from 2015 to 2019 reveals increasing operating losses and a net loss attributable to shareholders Selected Consolidated Operations Data ($ in thousands) | Indicator | 2017 | 2018 | 2019 | | :--- | :--- | :--- | :--- | | **Revenues and other income** | **33,715** | **21,432** | **22,990** | | Operating income (loss) | (92,650) | (105,091) | (123,552) | | Net income (loss) | (103,683) | (88,333) | (115,212) | | Attributable to shareholders of Cellectis | (99,368) | (78,693) | (102,091) | | Basic and diluted EPS ($) | (2.78) | (1.93) | (2.41) | | Adjusted Net Loss attributable to shareholders | (50,443) | (44,130) | (78,849) | Selected Consolidated Financial Position Data ($ in thousands) | Indicator | As of Dec 31, 2018 | As of Dec 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | 451,889 | 360,907 | | Total assets | 500,840 | 467,469 | | Total shareholders' equity | 450,272 | 355,470 | | Total current liabilities | 46,869 | 62,604 | - The company adopted IFRS 15 (Revenue from Contracts with Customers) retrospectively from January 1, 2018, and IFRS 16 (Leases) using the modified retrospective method from January 1, 2019. Financial statements for periods prior to 2019 were not restated for the adoption of IFRS 16[31](index=31&type=chunk)[37](index=37&type=chunk) [Risk Factors](index=9&type=section&id=D.%20Risk%20Factors) The company identifies numerous significant risks across its operations, including limited operating history, development, third-party reliance, and intellectual property - The company has a limited operating history, has incurred significant losses since inception, and anticipates continued losses. As of December 31, 2019, **cash and equivalents of $360.9 million** are expected to fund Cellectis' operations into 2022 and its subsidiary Calyxt's operations through mid-2021[41](index=41&type=chunk)[44](index=44&type=chunk)[51](index=51&type=chunk) - Development of therapeutic product candidates is in early stages and may be unsuccessful. The company's gene-editing and CAR T-cell technologies are new and unproven, with several candidates in pre-clinical stages and **three self-sponsored clinical studies (UCART123, UCART22, UCARTCS1) ongoing**[42](index=42&type=chunk)[57](index=57&type=chunk) - The company faces a complex and uncertain regulatory environment for its novel CAR T-cell therapies in both the U.S. (FDA) and EU (EMA), which could lead to delays, increased costs, or prevent approval[74](index=74&type=chunk)[75](index=75&type=chunk) - Cellectis relies on third-party CMOs for manufacturing, which is a complex and highly regulated process subject to multiple risks including contamination, equipment failure, and supply disruptions. The company is establishing its own manufacturing facilities in Raleigh, NC, and Paris, France, but has no prior experience in this area[100](index=100&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) - The company's majority-owned subsidiary, Calyxt, faces significant competition in the plant-based technology market, risks from public perception of gene-edited products, and susceptibility to commodity price changes and adverse weather conditions[205](index=205&type=chunk)[234](index=234&type=chunk)[256](index=256&type=chunk) - The company's commercial success depends on obtaining and maintaining proprietary rights for its intellectual property. There are risks related to patentability, challenges from third parties, and the potential for technology to be rendered obsolete[288](index=288&type=chunk)[293](index=293&type=chunk) - As a foreign private issuer, Cellectis is exempt from certain U.S. securities rules and follows French home country practices in some corporate governance matters, which may afford less protection to shareholders than U.S. domestic issuers[408](index=408&type=chunk)[410](index=410&type=chunk) [Information on the Company](index=59&type=section&id=Item%204.%20Information%20on%20the%20Company) This section details Cellectis's history, business operations, corporate structure, and regulatory environment [History and Development of the Company](index=59&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) Cellectis S.A. was incorporated in France in 2000, with increasing capital expenditures for new manufacturing facilities - Capital expenditures rose to **$13.0 million in 2019**, up from **$4.9 million in 2018** and **$2.7 million in 2017**[425](index=425&type=chunk) - The company is building two new manufacturing facilities: an **82,000 sq. ft. facility in Raleigh, North Carolina** for clinical and commercial UCART product production, and a **14,000 sq. ft. facility in Paris, France** for producing starting materials[426](index=426&type=chunk) [Business Overview](index=59&type=section&id=B.%20Business%20Overview) Cellectis is a clinical-stage biotechnology company developing allogeneic CAR T-cell immunotherapies using its proprietary TALEN® gene-editing technology - Cellectis is a clinical-stage company focused on developing allogeneic (off-the-shelf) CAR T-cell immunotherapies using its proprietary TALEN® gene-editing technology[428](index=428&type=chunk) - The company's internal pipeline includes **UCART123 (for AML), UCART22 (for B-ALL), and UCARTCS1 (for MM)**, all of which are in Phase 1 clinical trials in the U.S.[442](index=442&type=chunk)[445](index=445&type=chunk)[446](index=446&type=chunk) - Cellectis has strategic alliances with Allogene and Servier, which include potential milestone payments of up to **$3.7 billion** and future royalties. Allogene has exclusive rights to **15 targets**, while Servier has an exclusive worldwide license for CD19-targeted products[433](index=433&type=chunk)[434](index=434&type=chunk)[435](index=435&type=chunk) - The company is building its own manufacturing facilities in Raleigh, NC (for UCART products) and Paris, France (for starting materials) to enhance manufacturing autonomy, complementing its existing reliance on CMOs[563](index=563&type=chunk) - Through its **68.9% ownership in Calyxt**, Cellectis is also developing plant-based products using gene-editing. Calyxt commercialized its first product, high oleic soybean oil, in Q1 2019[447](index=447&type=chunk)[568](index=568&type=chunk) [Organizational Structure](index=106&type=section&id=C.%20Organizational%20Structure) Cellectis S.A. is a French société anonyme with key subsidiaries including Calyxt, Inc. and Cellectis, Inc Group Structure as of December 31, 2019 | Subsidiary Name | Jurisdiction of Incorporation | Ownership & Voting Interest Held By Cellectis S.A. | | :--- | :--- | :--- | | Calyxt, Inc. | Delaware | 68.9% (held directly) | | Cellectis, Inc. | Delaware | 100% (held directly) | | Cellectis Biologics, Inc. | Delaware | 100% (held indirectly through Cellectis, Inc.) | [Property, Plant and Equipment](index=106&type=section&id=D.%20Property,%20Plant%20and%20Equipment) Cellectis leases several key facilities for its operations, including administrative, R&D, and new manufacturing sites - Key leased facilities include administrative and R&D sites in Paris, France (**4,679 sq-m**) and New York, NY (**15,532 sq-ft**)[760](index=760&type=chunk)[761](index=761&type=chunk) - A new **82,000 sq-ft facility** is being constructed in Raleigh, NC, for commercial manufacturing of UCART products, with completion expected in 2020 and commissioning in 2021[762](index=762&type=chunk) - Subsidiary Calyxt, Inc. occupies a **40,000 sq-ft headquarters** in Roseville, MN, through a sale-leaseback transaction guaranteed by Cellectis S.A.[763](index=763&type=chunk) [Operating and Financial Review and Prospects](index=107&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) This section provides a detailed analysis of Cellectis's financial performance, liquidity, and critical accounting policies [Operating Results](index=113&type=section&id=A.%20Operating%20Results) For 2019, Cellectis reported a widened operating loss of $(123.6) million, driven by increased R&D and cost of revenue Consolidated Operations Data ($ in thousands) | | 2017 | 2018 | 2019 | |:---|---:|---:|---:| | **Total revenues and other income** | **33,715** | **21,432** | **22,990** | | Cost of revenue | (2,620) | (2,739) | (11,392) | | Research and development expenses | (79,227) | (76,567) | (92,042) | | Selling, general and administrative expenses | (44,750) | (47,248) | (43,017) | | **Operating income (loss)** | **(92,650)** | **(105,091)** | **(123,552)** | | Financial gain (loss) | (11,032) | 16,758 | 8,340 | | **Net income (loss)** | **(103,683)** | **(88,333)** | **(115,212)** | | Attributable to shareholders of Cellectis | (99,368) | (78,693) | (102,091) | - Revenues increased by **19.3% in 2019**, primarily due to a **$7.3 million increase in Calyxt's product sales**, which was partially offset by a **$4.4 million decrease in collaboration agreement revenues**[810](index=810&type=chunk) - R&D expenses increased by **20.2% to $92.0 million in 2019** from **$76.6 million in 2018**, mainly due to increased spending on advancing clinical programs[817](index=817&type=chunk)[818](index=818&type=chunk) - Cost of revenue surged to **$11.4 million in 2019** from **$2.7 million in 2018**, driven by a **$9.3 million cost of goods sold** related to the commercial launch of Calyxt's products[815](index=815&type=chunk) [Liquidity and Capital Resources](index=120&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) As of December 31, 2019, Cellectis had $360.9 million in cash, expected to fund operations into 2022, but additional capital will be needed Historical Cash Flows ($ in thousands) | | 2017 | 2018 | 2019 | |:---|---:|---:|---:| | Net cash flows used in operating activities | (52,327) | (68,137) | (69,142) | | Net cash flows from (used in) investing activities | 1,784 | 35,623 | (35,872) | | Net cash flows from (used in) financing activities | 41,266 | 236,494 | (3,862) | - As of December 31, 2019, the company held **$360.9 million in cash, cash equivalents, and current financial assets**[859](index=859&type=chunk) - Management believes current cash resources are sufficient to fund operations into 2022. However, additional capital will be required for further development and commercialization efforts[875](index=875&type=chunk) [Tabular Disclosure of Contractual Obligations](index=123&type=section&id=F.%20Tabular%20Disclosure%20of%20Contractual%20Obligations) As of December 31, 2019, Cellectis had total contractual obligations of $190.7 million, primarily for leases, other agreements, and construction Contractual Obligations as of December 31, 2019 ($ in thousands) | Obligation Type | Total | Less than 1 year | 1 - 3 years | 3 - 5 years | More than 5 years | | :--- | :--- | :--- | :--- | :--- | :--- | | Lease agreements | 73,181 | 4,014 | 18,886 | 9,764 | 40,516 | | License agreements | 18,607 | 1,389 | 2,778 | 2,778 | 11,662 | | Manufacturing agreements | 6,218 | 6,218 | — | — | — | | Clinical & R&D agreements | 2,086 | 1,424 | 662 | — | — | | Construction agreements | 39,741 | 39,741 | — | — | — | | Other agreements | 50,896 | 30,851 | 20,045 | — | — | | **Total** | **190,728** | **83,637** | **42,371** | **12,542** | **52,179** | [Directors, Senior Management and Employees](index=124&type=section&id=Item%206.%20Directors,%20Senior%20Management%20and%20Employees) This section details the company's leadership, compensation practices, board structure, and employee base [Directors and Senior Management](index=124&type=section&id=A.%20Directors%20and%20Senior%20Management) The company is led by co-founder Dr. André Choulika, with an experienced senior management team and diverse Board of Directors - Dr. André Choulika, a co-founder and pioneer in nuclease-based genome editing, leads the company as Chairman and CEO[885](index=885&type=chunk) - The executive team includes Dr. Philippe Duchateau (CSO), Eric Dutang (CFO), and Dr. David Sourdive (Co-founder and EVP, Strategic Initiatives)[885](index=885&type=chunk) [Compensation](index=127&type=section&id=B.%20Compensation) In 2019, aggregate cash compensation for executive officers and directors was $5.2 million, supplemented by various equity incentive plans - Aggregate cash compensation for executive officers and directors in 2019 was **$5.2 million**[904](index=904&type=chunk) - The company has a change of control plan that provides a severance package equal to **24 months of compensation plus a bonus amount** for key executives if their employment is terminated within **36 months** following a change of control[907](index=907&type=chunk)[908](index=908&type=chunk)[909](index=909&type=chunk) - Equity incentives are a key part of compensation, with various plans for employee warrants (BSPCE), non-employee warrants (BSA), free shares, and stock options. As of Dec 31, 2019, **9,672,382 stock options** were outstanding[916](index=916&type=chunk)[936](index=936&type=chunk) [Board Practices](index=131&type=section&id=C.%20Board%20Practices) The Board of Directors consists of eight members, with six independent, and follows French governance practices as a foreign private issuer - The Board of Directors consists of **eight members**, with **six qualifying as independent directors**[947](index=947&type=chunk)[950](index=950&type=chunk) - As a foreign private issuer, Cellectis follows French home country practices for certain governance matters, such as not requiring a majority-independent board or a nominations committee, and having different quorum requirements for shareholder meetings[952](index=952&type=chunk)[955](index=955&type=chunk) - The Board has two primary committees: an Audit and Finance Committee and a Compensation Committee. In line with French law, these committees have an advisory role to the full board[957](index=957&type=chunk)[958](index=958&type=chunk) [Employees](index=135&type=section&id=D.%20Employees) As of December 31, 2019, Cellectis had 264 employees, with 171 engaged in research and development activities - The company had **264 employees** as of December 31, 2019[966](index=966&type=chunk) - **171 employees (65% of the workforce)** are engaged in research and development activities[966](index=966&type=chunk) - The employee base is located in France (**110 employees**) and the United States (**154 employees**)[966](index=966&type=chunk) [Major Shareholders and Related Party Transactions](index=135&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) This section outlines the company's ownership structure and its transactions with related parties, including major shareholders and subsidiary agreements [Major Shareholders](index=135&type=section&id=A.%20Major%20Shareholders) As of February 29, 2020, major shareholders include FMR LLC, Bpifrance Participations, Pfizer, and Capital International Investors Major Shareholders (as of Feb 29, 2020) | Name of Beneficial Owner | Percentage Ownership | | :--- | :--- | | FMR LLC | 7.50% | | Bpifrance Participations | 6.78% | | Pfizer, Inc. | 6.57% | | Capital International Investors | 5.93% | | Pierre Bastid (Director) | 8.39% | - All directors and executive officers as a group beneficially own **22.39%** of the company's ordinary shares[972](index=972&type=chunk) [Related Party Transactions](index=138&type=section&id=B.%20Related%20Party%20Transactions) Cellectis has key related-party transactions, including collaborations with Pfizer/Allogene and various agreements with its subsidiary Calyxt - The collaboration with Pfizer, a major shareholder, generated revenues of **$19.7 million in 2017** and **$7.4 million in 2018**. This agreement was subsequently transferred to Allogene[977](index=977&type=chunk) - Cellectis has a Management Services Agreement with its subsidiary Calyxt, under which it provides administrative, financial, and legal services. In 2019, Calyxt paid Cellectis **$1.4 million** for these services[986](index=986&type=chunk)[988](index=988&type=chunk) - A Stockholders Agreement with Calyxt grants Cellectis significant approval rights over Calyxt's major corporate decisions as long as it owns at least **50%** of Calyxt's stock, and certain rights (like board nomination) as long as it owns at least **15%**[989](index=989&type=chunk)[990](index=990&type=chunk) - Cellectis has granted Calyxt an exclusive, worldwide license to its intellectual property for use in the agricultural and food product fields, in exchange for royalties on net sales and a share of sublicensing revenue[996](index=996&type=chunk)[997](index=997&type=chunk) [Financial Information](index=143&type=section&id=Item%208.%20Financial%20Information) This section confirms the inclusion of consolidated financial statements, absence of material legal proceedings, and French dividend distribution rules - The company's consolidated financial statements are included at the end of the Annual Report, starting on page F-1[1005](index=1005&type=chunk) - The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business[1006](index=1006&type=chunk) - Under French law, dividends can only be distributed from 'distributable profits' and require shareholder approval. The company has not historically paid dividends and may be restricted from doing so if net assets fall below a certain threshold[1007](index=1007&type=chunk)[1008](index=1008&type=chunk) [The Offer and Listing](index=144&type=section&id=Item%209.%20The%20Offer%20and%20Listing) This section details the trading markets for Cellectis's securities, including Nasdaq Global Market and Euronext Growth - Cellectis ADSs are listed on the Nasdaq Global Market under the symbol "CLLS" since **March 24, 2015**[1016](index=1016&type=chunk) - The company's ordinary shares are listed on the Euronext Growth market of Euronext in Paris under the symbol "ALCLS" since **February 7, 2007**[1016](index=1016&type=chunk) [Additional Information](index=144&type=section&id=Item%2010.%20Additional%20Information) This section covers key corporate and legal information, including By-laws, shareholder rights, and U.S. and French tax considerations [Memorandum and Articles of Association](index=144&type=section&id=B.%20Memorandum%20and%20Articles%20of%20Association) This subsection summarizes key provisions of the company's By-laws and French corporate law, including director powers and shareholder rights - Under French law, directors are elected for **three-year terms**. Decisions are made by a majority vote, with the Chairman having a deciding vote in case of a tie[1025](index=1025&type=chunk)[1029](index=1029&type=chunk) - Shareholders have preferential subscription rights for new cash share issuances, which can only be waived by a **two-thirds majority vote** at an extraordinary general meeting[1077](index=1077&type=chunk)[1078](index=1078&type=chunk) - Shares held in registered form for more than **two years** are granted double voting rights[1038](index=1038&type=chunk) - Several provisions in the By-laws and French law could delay or prevent a change in control, including supermajority or unanimous shareholder approval for mergers and broad board authorization to issue new shares[1067](index=1067&type=chunk) [Taxation](index=153&type=section&id=E.%20Taxation) This subsection details material U.S. and French tax consequences for U.S. holders of ADSs, focusing on PFIC status, dividends, and capital gains - The company does not believe it was a Passive Foreign Investment Company (PFIC) for the **2019 taxable year**, but its status is determined annually and is not guaranteed for future years. PFIC status could result in adverse U.S. federal income tax consequences for U.S. holders[1102](index=1102&type=chunk)[1103](index=1103&type=chunk) - Dividends paid to U.S. holders are generally subject to French withholding tax, but the rate is typically reduced from **28% to 15%** under the U.S.-France tax treaty for eligible holders[1153](index=1153&type=chunk)[1154](index=1154&type=chunk) - The French Financial Transaction Tax (TFT) of **0.3%** does not currently apply to the company's securities as its market capitalization was below the **€1 billion threshold** as of the last determination date, but this could change in the future[1143](index=1143&type=chunk)[1144](index=1144&type=chunk) - U.S. holders are generally not subject to French tax on capital gains from the sale of ADSs, provided they do not hold more than **25%** of the company's dividend rights and are entitled to U.S.-France tax treaty benefits[1161](index=1161&type=chunk)[1163](index=1163&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=162&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to foreign currency exchange risk and commodity price risk through its subsidiary Calyxt - The company faces significant foreign currency exchange risk due to receiving revenues in U.S. dollars (e.g., from Allogene) while incurring most expenses in Euros. As of Dec 31, 2019, **$214.6 million in cash and cash equivalents** were denominated in U.S. dollars[1174](index=1174&type=chunk)[1176](index=1176&type=chunk) - The net foreign exchange result for fiscal year 2019 was a gain of **$3.8 million**[1177](index=1177&type=chunk) - Through its subsidiary Calyxt, the company is exposed to commodity price risk. A hypothetical **10% increase** in commodity futures prices would result in an **$880,000 decrease** in Calyxt's financial condition[1181](index=1181&type=chunk) - Interest rate risk and inflation risk are not considered to have a material effect on the business[1179](index=1179&type=chunk)[1180](index=1180&type=chunk) [PART II](index=165&type=section&id=PART%20II) This section details the use of proceeds from equity offerings, internal controls, audit committee expertise, and corporate governance practices [Material Modifications to the Rights of Security Holders and Use of Proceeds](index=165&type=section&id=Item%2014.%20Material%20Modifications%20to%20the%20Rights%20of%20Security%20Holders%20and%20Use%20of%20Proceeds.) This section details the use of proceeds from the company's major equity offerings in March 2015 and April/May 2018 - The March 2015 IPO generated net proceeds of approximately **$209.6 million**, used for developing immuno-oncology candidates, R&D, and general corporate purposes[1195](index=1195&type=chunk)[1196](index=1196&type=chunk) - A follow-on offering in April/May 2018 raised gross proceeds of approximately **$190.5 million ($175 million + $15.5 million)**[1197](index=1197&type=chunk) [Controls and Procedures](index=166&type=section&id=Item%2015.%20Controls%20and%20Procedures.) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2019 - Management concluded that the company's disclosure controls and procedures were effective as of **December 31, 2019**[1199](index=1199&type=chunk) - Based on the COSO framework, management concluded that the company's internal control over financial reporting was effective as of **December 31, 2019**[1199](index=1199&type=chunk) - The independent auditor, Ernst & Young et Autres, issued an unqualified opinion on the effectiveness of the company's internal control over financial reporting as of **December 31, 2019**[1199](index=1199&type=chunk) [Audit Committee Financial Expert](index=166&type=section&id=Item%2016A.%20AUDIT%20COMMITTEE%20FINANCIAL%20EXPERT) Three members of the audit and finance committee qualify as 'audit committee financial experts' and are independent - The board has identified Pierre Bastid, Laurent Arthaud, and Hervé Hoppenot as audit committee financial experts[1201](index=1201&type=chunk) - All three designated financial experts are independent under SEC and Nasdaq rules[1201](index=1201&type=chunk) [Principal Accountant Fees and Services](index=167&type=section&id=Item%2016C.%20PRINCIPAL%20ACCOUNTANT%20FEES%20AND%20SERVICES) Ernst & Young et Autres served as the independent auditor for 2018 and 2019, with total audit fees of $775 thousand in 2019 Principal Accountant Fees ($ in thousands) | Fee Type | 2018 | 2019 | | :--- | :--- | :--- | | Audit Fees | 847 | 775 | | Audit-Related Fees | — | — | | Tax Fees | — | — | | Other Fees | — | — | | **Total** | **847** | **775** | - The audit and finance committee has a policy to pre-approve all audit and non-audit services provided by the independent accounting firm[1208](index=1208&type=chunk) [Corporate Governance](index=168&type=section&id=Item%2016G.%20CORPORATE%20GOVERNANCE) As a French foreign private issuer, Cellectis adheres to French corporate governance practices, differing from some Nasdaq standards - Cellectis follows French home country corporate governance practices, which differ from Nasdaq standards, such as not requiring a majority of directors to be independent[1214](index=1214&type=chunk) - The company's audit committee complies with SEC Rule 10A-3, but its role is advisory, as French law requires shareholder approval for the appointment of statutory auditors[1215](index=1215&type=chunk) - Quorum requirements for shareholder meetings are governed by French law, which specifies different thresholds (**20% or 25%** depending on the meeting type) than the Nasdaq's **33 1/3% standard**[1216](index=1216&type=chunk) [PART III](index=171&type=section&id=PART%20III) This section contains the company's audited consolidated financial statements and an index of all exhibits filed with the annual report [Financial Statements](index=171&type=section&id=Item%2017.%20Financial%20Statements) This section contains the company's audited consolidated financial statements for 2017-2019, prepared in accordance with IFRS - The consolidated financial statements for the years ended **December 31, 2017, 2018, and 2019**, along with the independent auditor's report, are provided starting on page F-1[1227](index=1227&type=chunk)[1238](index=1238&type=chunk) [Exhibits](index=172&type=section&id=Item%2019.%20Exhibits) This section provides an index of all exhibits filed as part of the Annual Report, including key corporate and contractual documents - An index of exhibits filed with the annual report is provided, including key corporate documents and material contracts[1229](index=1229&type=chunk)
Cellectis (CLLS) Presents At 2019 Jefferies Global Healthcare Conference - Slideshow
2019-06-07 20:39
COMMITMENT TO A CURE cellectis.com | --- | --- | --- | |-------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...
Cellectis S.A. (CLLS) To Present At Oppenheimer 29th Annual Healthcare Conference - Slideshow
2019-03-21 16:20
COMMITMENT TO A CURE cellectis.co m | --- | --- | --- | --- | |-------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...
Cellectis (CLLS) Presents At Barclays Global Healthcare Conference - Slideshow
2019-03-14 18:26
| --- | --- | --- | --- | --- | --- | |-----------------------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | fert | | | | | | | ger | | | | | | | EDITING LIFE COMMITMENT TO A CURE | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | cellectis.com | --- | --- | --- | |-------|------------------------------------------------------------------------------------------------------------------------------------------------------------ ...
Cellectis(CLLS) - 2018 Q4 - Annual Report
2019-03-12 01:54
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, 2018 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 ...