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Cellectis S.A.

Cellectis S.A.CLLS财报

Nasdaq · 医疗保健 · 生物制品（不含诊断物质）

Cellectis is a French biopharmaceutical company. It develops genome-edited chimeric antigen receptor T-cell technologies for cancer immunotherapy. It has offices in Paris, New York City, and Raleigh, North Carolina.

What changed in Cellectis S.A.'s 20-F — 2023 vs 2024

Top changes in Cellectis S.A.'s 2024 20-F

696 paragraphs added · 767 removed · 561 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

134 edited+23 added−19 removed588 unchanged
Risks Related to Our Reliance on Third Parties: • We rely on third parties for certain aspects of our discovery, development, manufacturing and commercialization, if any, of our product candidates and issues relating to such third parties, or their activities, which could result in additional costs and delays and hinder our research, development and commercialization prospects. • License relationships may not be successful, including as a result of failures by our licensees or partners to perform satisfactorily or to devote resources to advance product candidates under our arrangements with them. • Servier’s discontinuation of its involvement in the development of CD19 Products and related disagreements may have adverse consequences • We rely on a third party for the supply of alemtuzumab that is used in certain of our clinical trials as part of the lymphodepletion regimen, and issues relating to such third party may impact the clinical development and commercialization of our products.
Risks Related to Our Reliance on Third Parties: • We rely on third parties for certain aspects of our discovery, development, manufacturing and commercialization, if any, of our product candidates and issues relating to such third parties, or their activities, which could result in additional costs and delays and hinder our research, development and commercialization prospects. • License relationships may not be successful, including as a result of failures by our licensees or partners to perform satisfactorily or to devote resources to advance product candidates under our arrangements with them. • Servier’s discontinuation of its involvement in the development of CD19 Products and related disagreements may have adverse consequences • We rely on a third party for the supply of alemtuzumab that is used in certain of our clinical trials as part of the lymphodepletion regimen, and issues relating to such third party may impact the clinical development and commercialization, if any, of our products.
An unfavorable outcome in one or more of our or our licensees’ or partners’ clinical trials would be a major setback for our product candidates and for us and may require us or our licensees or partners' to delay, reduce or re-define the scope of, or eliminate one or more product candidate development programs, any of which could have a material adverse effect on our business, financial condition and prospects.
An unfavorable outcome in one or more of our or our licensees’ clinical trials would be a major setback for our product candidates and for us and may require us or our licensees or partners' to delay, reduce or re-define the scope of, or eliminate one or more product candidate development programs, any of which could have a material adverse effect on our business, financial condition and prospects.
We are dependent on third parties for the supply of various of materials, including certain biological materials, that are necessary to produce our product candidates. The supply of these materials could be reduced or interrupted at any time. In such case, we may not be able to find other acceptable suppliers or on acceptable terms.
We are dependent on third parties for the supply of various materials, including certain biological materials, that are necessary to produce our product candidates. The supply of these materials could be reduced or interrupted at any time. In such case, we may not be able to find other acceptable suppliers or on acceptable terms.
Our ability to obtain patent protection for our product candidates is uncertain due to a number of factors, including: • we or our licensors may not have been the first to invent the technology covered by our or their pending patent applications or issued patents; 30 • we cannot be certain that we or our licensors were the first to file patent applications covering our product candidates, including their compositions or methods of use, as patent applications in the United States and most other countries are confidential for a period of time after filing; • others may independently develop identical, similar or alternative products or compositions or methods of use thereof; • the disclosures in our or our licensors’ patent applications may not be sufficient to meet the statutory requirements for patentability and the plausibility case law requirements that may exist in certain jurisdictions; • any or all of our or our licensors’ pending patent applications may not result in issued patents; • we or our licensors may not seek or obtain patent protection in countries or jurisdictions that may eventually provide us a significant business opportunity; • any patents issued to us or our licensors may not provide a basis for commercially viable products, may not provide any competitive advantages, or may be successfully challenged by third parties, which may result in our or our licensors’ patent claims being narrowed, invalidated or held unenforceable; • our compositions and methods may not be patentable; • others may design around our or our licensors’ patent claims to produce competitive products that fall outside of the scope of our or our licensors’ patents; and • others may identify prior art or other bases upon which to challenge and ultimately invalidate our or our licensors’ patents or otherwise render them unenforceable.
Our ability to obtain patent protection for our product candidates is uncertain due to a number of factors, including: • we or our licensors may not have been the first to invent the technology covered by our or their pending patent applications or issued patents; • we cannot be certain that we or our licensors were the first to file patent applications covering our product candidates, including their compositions or methods of use, as patent applications in the United States and most other countries are confidential for a period of time after filing; • others may independently develop identical, similar or alternative products or compositions or methods of use thereof; • the disclosures in our or our licensors’ patent applications may not be sufficient to meet the statutory requirements for patentability and the plausibility case law requirements that may exist in certain jurisdictions; 30 • any or all of our or our licensors’ pending patent applications may not result in issued patents; • we or our licensors may not seek or obtain patent protection in countries or jurisdictions that may eventually provide us a significant business opportunity; • any patents issued to us or our licensors may not provide a basis for commercially viable products, may not provide any competitive advantages, or may be successfully challenged by third parties, which may result in our or our licensors’ patent claims being narrowed, invalidated or held unenforceable; • our compositions and methods may not be patentable; • others may design around our or our licensors’ patent claims to produce competitive products that fall outside of the scope of our or our licensors’ patents; and • others may identify prior art or other bases upon which to challenge and ultimately invalidate our or our licensors’ patents or otherwise render them unenforceable.
The rights of shareholders and the responsibilities of members of our board of directors are in many ways different from the rights and obligations of shareholders in companies governed by the laws of U.S. jurisdictions.
The rights of shareholders and the responsibilities of members of our board of directors are in many ways different from the rights and obligations of shareholders in companies governed by the laws of U.S. jurisdictions.
Restrictions under applicable federal, state and foreign healthcare laws and regulations include but are not limited to the following: • The federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase or lease, order or recommendation of, any item, good, facility or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid. • The federal civil and criminal false claims laws and civil monetary penalties laws, which impose criminal and civil penalties, including those from civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government. • The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters. • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which impose certain requirements on covered entities and their business associates, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. • The federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that require applicable manufacturers of covered drugs, devices, biologics and medical supplies to track and annually report to CMS payments and other transfers of value provided to physicians and teaching hospitals and certain ownership and investment interests held by physicians or their immediate family members. • Analogous laws and regulations in various U.S. states, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state marketing and/or transparency laws applicable to manufacturers that may be broader in scope than U.S. federal requirements, state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. government, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA.
Restrictions under applicable federal, state and foreign healthcare laws and regulations include but are not limited to the following: 28 • The federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase or lease, order or recommendation of, any item, good, facility or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid. • The federal civil and criminal false claims laws and civil monetary penalties laws, which impose criminal and civil penalties, including those from civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government. • The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters. • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which impose certain requirements on covered entities and their business associates, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. • The federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that require applicable manufacturers of covered drugs, devices, biologics and medical supplies to track and annually report to CMS payments and other transfers of value provided to physicians and teaching hospitals and certain ownership and investment interests held by physicians or their immediate family members. • Analogous laws and regulations in various U.S. states, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state marketing and/or transparency laws applicable to manufacturers that may be broader in scope than U.S. federal requirements, state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. government, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA.
These provisions include the following: • a merger (i.e., in a French law context, a stock-for-stock exchange after which our company would be dissolved without being liquidated into the acquiring entity and our shareholders would become shareholders of the acquiring entity) of our company into a company incorporated in the European Union would require the approval of our board of directors as well as a two-thirds majority of the votes cast of the shareholders present, represented by proxy or voting by mail at the relevant meeting; • a merger of our company into a company incorporated outside of the European Union would require the unanimous approval of our shareholders; • under French law, a cash merger is treated as a share purchase and would require the consent of each participating shareholder; • our shareholders have granted and may in the future grant to our board of directors broad authorizations to increase our share capital or to issue additional ordinary shares or other securities (for example, warrants) to our shareholders, the public or qualified investors, which could be used as a possible defense following the launching of a tender offer for our shares; • our shareholders have preferential subscription rights proportional to their shareholding in our company on the issuance by us of any additional shares or securities giving the right, immediately or in the future, to new shares for cash or a set-off of cash debts, which rights may only be waived by the extraordinary general meeting (by a two-thirds majority vote) of our shareholders or on an individual basis by each shareholder; • our board of directors has the right to appoint directors to fill a vacancy created by the resignation or death of a director, subject to the ratification by the shareholders of such appointment at the next shareholders’ meeting, which prevents shareholders from having the sole right to fill vacancies on our board of directors; • our board of directors can only be convened by its chairman (and our managing director, if different from the chairman, may request the chairman to convene the board) or, when no board meeting has been held for more than two consecutive months, by directors representing at least one-third of the total number of directors; • our board of directors meetings can only be regularly held if at least half of the directors attend either physically or by way of videoconference or teleconference enabling the directors’ identification and ensuring their effective participation in the board of directors’ decisions; • our shares take the form of bearer securities or registered securities, if applicable legislation so permits, according to the shareholder’s choice.
These provisions include the following: 35 • a merger (i.e., in a French law context, a stock-for-stock exchange after which our company would be dissolved without being liquidated into the acquiring entity and our shareholders would become shareholders of the acquiring entity) of our company into a company incorporated in the European Union would require the approval of our board of directors as well as a two-thirds majority of the votes cast of the shareholders present, represented by proxy or voting by mail at the relevant meeting; • a merger of our company into a company incorporated outside of the European Union would require the unanimous approval of our shareholders; • under French law, a cash merger is treated as a share purchase and would require the consent of each participating shareholder; • our shareholders have granted and may in the future grant to our board of directors broad authorizations to increase our share capital or to issue additional ordinary shares or other securities (for example, warrants) to our shareholders, the public or qualified investors, which could be used as a possible defense following the launching of a tender offer for our shares; • our shareholders have preferential subscription rights proportional to their shareholding in our company on the issuance by us of any additional shares or securities giving the right, immediately or in the future, to new shares for cash or a set-off of cash debts, which rights may only be waived by the extraordinary general meeting (by a two-thirds majority vote) of our shareholders or on an individual basis by each shareholder; • our board of directors has the right to appoint directors to fill a vacancy created by the resignation or death of a director, subject to the ratification by the shareholders of such appointment at the next shareholders’ meeting, which prevents shareholders from having the sole right to fill vacancies on our board of directors; • our board of directors can only be convened by its chairman (and our managing director, if different from the chairman, may request the chairman to convene the board) or, when no board meeting has been held for more than two consecutive months, by directors representing at least one-third of the total number of directors; • our board of directors meetings can only be regularly held if at least half of the directors attend either physically or by way of videoconference or teleconference enabling the directors’ identification and ensuring their effective participation in the board of directors’ decisions; • our shares take the form of bearer securities or registered securities, if applicable legislation so permits, according to the shareholder’s choice.
In addition, in the future, we may not be able to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product or other legal or administrative liability claims by us or our partners, licensees or subcontractors, which could prevent or inhibit the commercial production and sale of any of our 20 product candidates that receive regulatory approval, which could adversely affect our business.
In addition, in the future, we may not be able to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product or other legal or administrative liability claims by us or our partners, licensees or subcontractors, which could prevent or inhibit the commercial production and sale of any of our product candidates that receive regulatory approval, which could adversely affect our business.
In connection with the preparation of our audited financial statements for the year ended December 31, 2023, we identified a material weakness in our internal controls over financial reporting related to a lack of formality of accounting processes and controls 22 over significant non-routine transactions and a design and operating deficiency associated with a lack of sufficient qualified resources with sufficient technical knowledge to identify and timely resolve complex accounting matters.
For example, in connection with the preparation of our audited financial statements for the year ended December 31, 2023, we identified a material weakness in our internal controls over financial reporting related to a lack of formality of accounting processes and controls over significant non-routine transactions and a design and operating deficiency associated with a lack of sufficient qualified resources with sufficient technical knowledge to identify 22 and timely resolve complex accounting matters.
Failure to comply with any of these laws and regulations could result in enforcement action against us, including fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects.
Failure to comply with any of these laws and regulations could result in enforcement action against us, including fines, imprisonment of company officials and public 21 censure, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects.
The overall ten-year market exclusivity period can be 25 extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are deemed to bring a significant clinical benefit in comparison with existing therapies.
The overall ten-year market exclusivity period can be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are deemed to bring a significant clinical benefit in comparison with existing therapies.
In the currently ongoing UCART product candidate clinical studies, the most common severe or life-threatening adverse events include CRS, cytopenia and infections. As reported, there have been patient deaths in the AMELI-01 Study and the now discontinued MELANI-01 Study as well as in clinical trials conducted by our licensees or partners, including deaths attributable to UCART immuno-therapy.
In the currently ongoing UCART product candidate clinical studies, the most common severe or life-threatening adverse events include CRS, cytopenia and infections. As reported, there have been patient deaths in the deprioritized AMELI-01 Study and the now discontinued MELANI-01 Study as well as in clinical trials conducted by our licensees or partners, including deaths attributable to UCART immuno-therapy.
Accordingly, our and our licensors’ efforts to enforce intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we own or license. Similarly, if our trade secrets are disclosed in a foreign jurisdiction, competitors worldwide could have access to our proprietary information and we may be without satisfactory recourse.
Accordingly, our and our licensors’ efforts to enforce intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we own or license. Similarly, if our trade secrets are disclosed in a foreign jurisdiction, competitors worldwide could have access to our proprietary information and we may be without satisfactory 32 recourse.
We will lose our foreign private issuer status if, as of the relevant determination date, more than 50% of our securities are held by U.S. residents and (i) more than 50% of our executive officers or more than 50% of the members of our board of directors are residents or citizens of the United States, (ii) more than 50% of our assets are located in the United States, or (iii) our business is principally administered within the United States we could lose our foreign private issuer status.
We will lose our foreign private issuer status if, as of the relevant determination date, more than 50% of our securities are held by U.S. residents and (i) more than 50% of our executive officers or more than 50% of the members of our board of directors are residents or citizens of the United States, (ii) more than 50% of our assets are located in the United States, or (iii) our business is principally administered within the United States.
Following this extensive regulatory process, the 11 manufacturing and marketing of our product candidates will be subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to pursue commercialization. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays.
Following this extensive regulatory process, the manufacturing and marketing of our product candidates will be subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to pursue commercialization. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays.
Such potential conflicts of interest and the appearance of conflicts, 23 even if such conflicts do not materialize, might adversely affect the public’s perception of us, as well as our relationship with other companies and our ability to enter into new relationships in the future, including with competitors of such related parties, which could harm our business and results of operations.
Such potential conflicts of interest and the appearance of conflicts, even if such conflicts do not materialize, might adversely affect the public’s perception of us, as well as our relationship with other companies and our ability to enter into new relationships in the future, including with competitors of such related parties, which could harm our business and results of operations.
Depending on the results of clinical trials and the process for obtaining regulatory approvals in other countries, we or our licensees or partners may decide to first seek regulatory approvals of a product candidate in countries other than the United States, or we or our licensees or partners may simultaneously seek regulatory approvals in the United States and other countries, in which case we or our licensees or partners will be subject to the regulatory requirements of health authorities in each country in which we seek approvals.
Depending on the results of clinical trials and the process for obtaining regulatory approvals in other countries, we or our licensees or partners may decide to first seek regulatory approvals of a product candidate in countries other than the United States, or we or our licensees or partners may simultaneously seek regulatory approvals in the United States and other countries, in which case we or our 27 licensees or partners will be subject to the regulatory requirements of health authorities in each country in which we seek approvals.
We may enter into agreements with third parties to sell, distribute and/or market any of the products candidates we develop for which we obtain regulatory approval, which may adversely affect our ability to generate revenues. As a company, we have no experience in sales, marketing and distribution of biopharmaceutical products.
We may enter into agreements with third parties to sell, distribute and/or market any of the product candidates we develop for which we obtain regulatory approval, which may adversely affect our ability to generate revenues. As a company, we have no experience in sales, marketing and distribution of biopharmaceutical products.
Our insurance policies may also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may use hazardous chemicals and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.
Our insurance policies may also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. 20 We may use hazardous chemicals and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.
Our failure to maintain certain tax benefits applicable to French technology companies may adversely affect our results of operations. As a French technology company, we have benefited from certain tax advantages, including the French research tax credit (Crédit d’Impôt Recherche), or CIR. The CIR is a French tax credit aimed at stimulating research and development.
Our failure to maintain certain tax benefits applicable to French technology companies may adversely affect our results of operations. 36 As a French technology company, we have benefited from certain tax advantages, including the French research tax credit (Crédit d’Impôt Recherche), or CIR. The CIR is a French tax credit aimed at stimulating research and development.
We are currently sponsoring three clinical studies, preparing regulatory filings to commence new clinical studies and/or to add additional investigational sites for ongoing studies, advancing pre-clinical testing for additional product candidates, and conducting manufacturing at our in-house manufacturing facilities. Accordingly, we expect our operational expenses to increase in connection with our ongoing activities.
We are currently sponsoring three clinical studies, preparing regulatory filings to potentially commence new clinical studies and/or to add additional investigational sites for ongoing studies, advancing pre-clinical testing for additional product candidates, and conducting manufacturing at our in-house manufacturing facilities. Accordingly, we expect our operational expenses to increase in connection with our ongoing activities.
Monitoring and managing toxicities in patients receiving our product candidates is challenging, which could adversely affect our ability to obtain regulatory approval and commercialize. For our clinical trials of our product candidates, we contract or will contract with academic medical centers and hospitals experienced in the assessment and management of toxicities arising during clinical trials.
Monitoring and managing toxicities in patients receiving our product candidates is challenging, which could adversely affect our ability to obtain regulatory approval and commercialize. 12 For our clinical trials of our product candidates, we contract or will contract with academic medical centers and hospitals experienced in the assessment and management of toxicities arising during clinical trials.
Such side effects could also result in the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities, or could lead to a more restrictive label for our product candidates. 13 Results of our clinical trials could reveal a high and unacceptable incidence and severity of side effects or unexpected characteristics.
Such side effects could also result in the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities, or could lead to a more restrictive label for our product candidates. Results of our clinical trials could reveal a high and unacceptable incidence and severity of side effects or unexpected characteristics.
Even with respect to more established products that fit into the categories of gene therapies or cell therapies, the regulatory landscape is still developing, and requirements have changed frequently and may continue to change in the future. Moreover, there is substantial, and sometimes uncoordinated, overlap in oversight responsibilities of gene therapy products and cell therapy products.
Even with respect to more established products that fit into the categories of gene therapies or cell therapies, the regulatory landscape is still developing, and requirements have changed frequently 23 and may continue to change in the future. Moreover, there is substantial, and sometimes uncoordinated, overlap in oversight responsibilities of gene therapy products and cell therapy products.
Some of the discussions among our licensees or partners and relevant regulatory agencies could generate additional unexpected requirements from regulatory agencies that may apply to our wholly-controlled UCART product candidates, including UCART123, UCART22 and UCART 20x22 and could lead to potential delays or additional requirements, such as additional studies or modifications to our controlled clinical studies.
Some of the discussions among our licensees or partners and relevant regulatory agencies could generate additional unexpected requirements from regulatory agencies that may apply to our wholly-controlled UCART product candidates, including UCART22 and UCART 20x22 and could lead to potential delays or additional requirements, such as additional studies or modifications to our controlled clinical studies.
Furthermore, our proprietary information may be independently developed or lawfully reverse-engineered by others in a manner that could prevent legal recourse by us. 31 We cannot guarantee that our trade secrets and other proprietary and confidential information will not be disclosed or that competitors will not otherwise gain access to our trade secrets.
Furthermore, our proprietary information may be independently developed or lawfully reverse-engineered by others in a manner that could prevent legal recourse by us. We cannot guarantee that our trade secrets and other proprietary and confidential information will not be disclosed or that competitors will not otherwise gain access to our trade secrets.
All of these milestones are based on a variety of assumptions, including assumptions regarding capital resources and constraints, progress of development activities, and the receipt of key regulatory approvals or actions, any of which may cause the timing of achievement of the milestones to vary considerably from our estimates.
All 14 of these milestones are based on a variety of assumptions, including assumptions regarding capital resources and constraints, progress of development activities, and the receipt of key regulatory approvals or actions, any of which may cause the timing of achievement of the milestones to vary considerably from our estimates.
We have entered into licensing or collaboration agreements with partners, such as Allogene, Servier and AstraZeneca under which our partners have or have the right to obtain exclusive development and commercialization rights with respect to certain product candidates. We may in the future enter into additional similar relationships.
We have entered into licensing or collaboration agreements with partners, such as Allogene, Servier and AstraZeneca under which our partners have or have the right to obtain exclusive development and commercialization rights with respect to certain product 17 candidates. We may in the future enter into additional similar relationships.
These rules, together with the detailed EU Guidelines on cGMP that are laid down in EudraLex—Volume 4, provide guidance on, inter alia, quality management, personnel, premises, documentation, production operations, quality control, outsources activities, complaints and product recall and self-inspection.
These rules, together with the detailed EU Guidelines on cGMP that are laid down in EudraLex—Volume 4, provide guidance on, inter alia, 29 quality management, personnel, premises, documentation, production operations, quality control, outsources activities, complaints and product recall and self-inspection.
Under French law, our share capital generally may be increased with the approval of a two-thirds majority of the votes cast of the shareholders present, represented by proxy, or voting by mail at an extraordinary general shareholders’ meeting following the 35 recommendation of our board of directors.
Under French law, our share capital generally may be increased with the approval of a two-thirds majority of the votes cast of the shareholders present, represented by proxy, or voting by mail at an extraordinary general shareholders’ meeting following the recommendation of our board of directors.
As a result, many companies have encountered significant problems in protecting and defending intellectual property rights in 32 certain foreign jurisdictions. Such issues may make it difficult for us to stop the infringement, misappropriation or other violation of our intellectual property rights.
As a result, many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions. Such issues may make it difficult for us to stop the infringement, misappropriation or other violation of our intellectual property rights.
Although we do not make speculative investments in third-party companies’ securities, from time to time, we have entered into licensing or other commercial agreements for which we have agreed to accept company securities as 37 consideration. Currently, we have entered into such arrangements with Primera Therapeutics, Inc.
Although we do not make speculative investments in third-party companies’ securities, from time to time, we have entered into licensing or other commercial agreements for which we have agreed to accept company securities as consideration. Currently, we have entered into such arrangements with Primera Therapeutics, Inc.
Also, while we expect reduced variability in our products candidates compared to autologous products, we do not have significant clinical data supporting any benefit of lower variability and the use of healthy donor material may create separate variability challenges for us.
Also, while we expect reduced variability in our product candidates compared to autologous products, we do not have significant clinical data supporting any benefit of lower variability and the use of healthy donor material may create separate variability challenges for us.
The approval processes are typically expensive, and the time required to obtain approval by the FDA, the EC and comparable foreign authorities is inherently unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the discretion of the regulatory authorities.
The approval processes are typically expensive, and the time required to obtain approval by the FDA, the EC and comparable foreign authorities is inherently unpredictable but typically takes many years following 25 the commencement of clinical trials and depends upon numerous factors, including the discretion of the regulatory authorities.
In addition, the regulatory authorities may, at any time, inspect a manufacturing facility involved with the preparation and/or control of 29 our product candidates as well as the associated quality systems for compliance with the regulations applicable to the activities being conducted.
In addition, the regulatory authorities may, at any time, inspect a manufacturing facility involved with the preparation and/or control of our product candidates as well as the associated quality systems for compliance with the regulations applicable to the activities being conducted.
If we are unable to partner with a third party that has adequate sales, marketing, and distribution capabilities, we may have difficulty commercializing our product candidates, which would adversely affect our business, financial condition, and ability to generate product revenues.
If we are unable to partner with a third party that has adequate sales, marketing, 19 and distribution capabilities, we may have difficulty commercializing our product candidates, which would adversely affect our business, financial condition, and ability to generate product revenues.
Products receiving orphan designation in the EU can receive ten years of market exclusivity from the date on which they are granted a market authorization in the EU, during which time no similar medicinal 26 product for the same indication may be placed on the market.
Products receiving orphan designation in the EU can receive ten years of market exclusivity from the date on which they are granted a market authorization in the EU, during which time no similar medicinal product for the same indication may be placed on the market.
These changes can cause allogeneic CAR T cells to cause additional adverse events. The allogeneic nature of our CAR T cell product candidates may also cause unique adverse events related to the differences between the donor material used to manufacture the product candidates and patients, such as GvHD.
These changes can cause allogeneic CAR T cells to cause additional adverse events. 13 The allogeneic nature of our CAR T cell product candidates may also cause unique adverse events related to the differences between the donor material used to manufacture the product candidates and patients, such as GvHD.
Adequate coverage and reimbursement from third-party payors are critical to new product acceptance. The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if government and other third-party payors fail to provide coverage and adequate reimbursement.
Adequate coverage and reimbursement from third-party payors are critical to new product acceptance. The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if 15 government and other third-party payors fail to provide coverage and adequate reimbursement.
Product candidates in these development phases undergo testing in animal studies, and the results from these animal studies may not be sufficiently compelling to warrant further advancement. Moreover, even if results from animal studies are positive, such results are not necessarily predictive of positive results in clinical studies.
Product candidates in these development phases undergo testing in animal studies, and the results from these animal studies may not be 9 sufficiently compelling to warrant further advancement. Moreover, even if results from animal studies are positive, such results are not necessarily predictive of positive results in clinical studies.
Any undesirable side effects could cause us, our licensees or partners or regulatory authorities to interrupt, delay, halt or terminate clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities.
Any undesirable side effects could cause us, our licensees or regulatory authorities to interrupt, delay, halt or terminate clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities.
If we are unable to maintain technological advancements consistent with industry standards, our operations and financial condition may be adversely affected. 9 Our therapeutic product candidate development programs are in various phases of development and may be unsuccessful. Our therapeutic product candidates are in various phases of development.
If we are unable to maintain technological advancements consistent with industry standards, our operations and financial condition may be adversely affected. Our therapeutic product candidate development programs are in various phases of development and may be unsuccessful. Our therapeutic product candidates are in various phases of development.
Advertising and promotional materials must comply with FDA rules and are subject to FDA review, in addition to other potentially applicable federal and state laws. 24 Similarly, in the EU any promotion of medicinal products is highly regulated.
Advertising and promotional materials must comply with FDA rules and are subject to FDA review, in addition to other potentially applicable federal and state laws. Similarly, in the EU any promotion of medicinal products is highly regulated.
French law provides that a shareholder, or a group of shareholders, may initiate a legal action to seek 38 indemnification from the directors of a company in the company’s interest if it fails to bring such legal action itself.
French law provides that a shareholder, or a group of shareholders, may initiate a legal action to seek indemnification from the directors of a company in the company’s interest if it fails to bring such legal action itself.
The deposit agreement among us, the depositary and purchasers of ADSs in the U.S. offering, as an ADS holder, and all other persons directly and indirectly holding ADSs, sets out ADS holder rights, as well as the rights and obligations of us and the depositary.
The 38 deposit agreement among us, the depositary and purchasers of ADSs in the U.S. offering, as an ADS holder, and all other persons directly and indirectly holding ADSs, sets out ADS holder rights, as well as the rights and obligations of us and the depositary.
In many countries, a product candidate 27 must be approved for reimbursement before it can be approved for sale in that country. In some cases, the intended price for the product is also subject to approval.
In many countries, a product candidate must be approved for reimbursement before it can be approved for sale in that country. In some cases, the intended price for the product is also subject to approval.
Therefore, holders of our ordinary shares and ADSs are not likely to receive any dividends for the foreseeable future and any increase in value will depend solely upon any future 36 appreciation.
Therefore, holders of our ordinary shares and ADSs are not likely to receive any dividends for the foreseeable future and any increase in value will depend solely upon any future appreciation.
Because we are developing novel CAR T-cell immunotherapy product candidates that are unique biological entities, the regulatory requirements that we will be subject to are not entirely clear.
Because we are developing novel allogeneic CAR T-cell immunotherapy product candidates that are unique biological entities, the regulatory requirements that we will be subject to are not entirely clear.
In light of such ownership, AstraZeneca may be in a position to exercise significant influence over matters affecting shareholders or requiring shareholder approval, including the election of the board of directors of the Company, amendments to our By-laws, and any delegation to the board of directors of the power to issue new shares or other equity securities.
In light of such ownership and voting power, AstraZeneca may be in a position to exercise significant influence over matters affecting shareholders or requiring shareholder approval, including the election of the board of directors of the Company, amendments to our By-laws, and any delegation to the board of directors of the power to issue new shares or other equity.
Risks Relating to Our Status as a Foreign Private Issuer and a French Company: • The rights of shareholders in companies subject to French corporate law differ in material respects from the rights of shareholders of corporations incorporated in the United States. • Our By-laws and French corporate law contain provisions that may delay or discourage a takeover attempt. • Our international operations may be exposed to foreign exchange risks, U.S. federal income tax risks, and additional risks, which may adversely affect our financial condition, results of operations and cash flows. • If we are classified as a PFIC for 2023 or any future taxable year, there may be adverse U.S. federal income tax consequences to U.S. holders. • As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and the Nasdaq’s corporate governance standards.
Risks Relating to Our Status as a Foreign Private Issuer and a French Company: • The rights of shareholders in companies subject to French corporate law differ in material respects from the rights of shareholders of corporations incorporated in the United States. • Our By-laws and French corporate law contain provisions that may delay or discourage a takeover attempt. • Our international operations may be exposed to foreign exchange risks, U.S. federal income tax risks, and additional risks, which may adversely affect our financial condition, results of operations and cash flows. • If we are classified as a PFIC for 2024 or any future taxable years, there may be adverse U.S. federal income tax consequences to U.S. holders. • As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and the Nasdaq’s corporate governance standards.
However, the anti-CD52 antibody may not have the benefits that we anticipate and could result in adverse effects or confounding other adverse effects.
However, the anti-CD52 antibody may not have the benefits that we anticipate and could result in adverse effects or confounding effects.
Cellectis’ equity interest in Calyxt was reduced to 2.9% after the closing of the Merger, which resulted in Cellectis losing control of Calyxt. Calyxt is therefore no longer consolidated since June 1, 2023 and continue to be presented as the results of discontinued operations until that date .
Cellectis’ equity interest in Calyxt was reduced to 2.9% upon the closing of the Merger, which resulted in Cellectis losing control of Calyxt. Calyxt is therefore no longer consolidated since June 1, 2023 and continue to be presented as the results of discontinued operations until that date .
Our business and future success depends on our ability to successfully develop, obtain regulatory approval for, and successfully commercialize our most advanced product candidates, UCART123, UCART22 and UCART20x22, our ability to develop and manufacture products candidates for AstraZeneca, and the ability of our licensees or partners to advance the product candidates that they are developing pursuant to licenses from us.
Our business and future success depends on our ability to successfully develop, obtain regulatory approval for, and successfully commercialize our most advanced product candidates UCART22 and UCART20x22, our ability to develop and manufacture product candidates for AstraZeneca, and the ability of our licensees or partners to advance the product candidates that they are developing pursuant to licenses from us.
Our competitors may introduce new technologies that render our technology obsolete, uneconomical or less attractive. Similarly, our licensees may improve upon our technology in ways that makes our underlying technology, without such improvements, less attractive. New technology could emerge at any point in the development cycle of our product candidates.
Our competitors may introduce new technologies that render our technologies obsolete, uneconomical or less attractive. Similarly, our licensees may improve upon our technologies in ways that make our underlying technology, without such improvements, less attractive. New technology could emerge at any point in the development cycle of our product candidates.
Other parties may allege that our or our collaborators’ products or product candidates or the use of our or our collaborators’ technologies infringe, misappropriate or otherwise violate patent claims or other intellectual property rights held by them or that we or our collaborators’ are employing their proprietary technology without authorization.
Other parties may allege that our or our collaborators’ products or product candidates or 33 the use of our or our collaborators’ technologies infringe, misappropriate or otherwise violate patent claims or other intellectual property rights held by them or that we or our licensees are employing their proprietary technology without authorization.
However, due to the potential amount of the payment obligation and the uncertainty about Cibus' ability to make payments under or indemnify us in connection with the lease and guaranty, this indemnification may not be sufficient to cover the possible payment obligation arising out of this guaranty.
However, due to the potential amount of the payment obligation and the uncertainty about Cibus's ability to make payments under or indemnify us in connection with the lease and guaranty, this indemnification may not be sufficient to cover the possible payment obligation arising out of this guaranty.
Based on our determination made on June 30, 2023 (the last business day of our most recently completed second fiscal quarter), we currently qualify as a foreign private issuer. The next determination will be made with respect to us on June 30, 2024.
Based on our determination made on June 30, 2024 (the last business day of our most recently completed second fiscal quarter), we currently qualify as a foreign private issuer. The next determination will be made with respect to us on June 30, 2025.
We are also exploring various dosing strategies for lymphodepletion in our clinical trials, which may increase the risk of serious adverse events. As more patients are included in our and our licensee’s clinical trials, previously less common, side effects and adverse events may also emerge.
We are also exploring various dosing strategies for lymphodepletion in our clinical trials, which may increase the risk of serious adverse events. As more patients are included in our and our licensees’ clinical trials, previously less common, side effects and adverse events may also emerge.
Pursuant to the voting agreement, at such time that the annual revenues of Calyxt Inc. equals $25.0 million or more for two consecutive 12-month periods after the closing of the Merger, Cibus will use commercially reasonable efforts to terminate our guaranty of Calyxt’s lease agreement with respect to its headquarters, which we provided in favor of the landlord of that property.
Pursuant to the voting agreement, at such time that the annual revenues of Cibus, Inc. equals $25.0 million or more for two consecutive 12-month periods after the closing of the Merger, Cibus will use commercially reasonable efforts to terminate our guaranty of Cibus’ lease agreement with respect to its headquarters, which we provided in favor of the landlord of that property.
In addition, a number of events, including any of the following, could delay clinical trials, negatively impact the ability to obtain regulatory approval for, and to market and sell, a particular product candidate, or result in suspension or termination of a clinical trial: conditions imposed by the FDA or any foreign regulatory authority regarding the scope or design of clinical trials; • delays in obtaining, or the inability to obtain, regulatory agency approval for the conduct of the clinical trials or required approvals from institutional review boards, or IRBs, or other reviewing entities at clinical sites selected for participation in our clinical trials; • the identification of flaws in the design of a clinical trial; • changes in regulatory requirements and guidance that necessitate amendments to clinical trial protocols; • delays in sufficiently developing, characterizing or controlling manufacturing processes suitable for clinical trials; • insufficient supply or deficient quality of the product candidates or other materials necessary to conduct the clinical trials; • difficulty in sourcing healthy donor material of sufficient quality and in sufficient quantity to meet our development needs; 10 • lower-than-anticipated enrollment and retention rate of subjects in clinical trials for a variety of reasons, including size of patient population, site selection, nature of trial protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications and competition from approved products; • delays in reaching agreement on acceptable terms with prospective contract research organizations (CROs) and clinical study sites and obtaining required institutional review board (IRB) approval at each clinical study site; • the placing of a clinical hold on our licensees’ or partners' clinical trials —for example, clinical holds were placed on our AMELI-01 Study in September 2018 and on our now discontinued MELANI-01 Study in July 2020 and on all of our licensee Allogene’s AlloCAR T clinical trials in October 2021 and remained in place until the FDA permitted these trials to restart in November 2018, November 2020 and January 2022, respectively; • unfavorable interpretations by FDA or similar foreign regulatory authorities of interim data; • determinations by the FDA or similar foreign regulatory authorities that a clinical trial protocol is deficient in design to meet its stated objectives; • failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; • serious safety issues, including drug-related side effects experienced by patients in clinical trials—for example, following patient safety issues, including patient death, related to cytokine release syndrome, or CRS, patient recruitment for our AMELI-01 Study and for our NaThaLi-01 Study were paused, in accordance with their respective protocols, pending the implementation of modified protocol treatment strategies, and commenced in October 2022 and in August 2023, respectively; • failure of our or our licensees’ or partners' third-party contractors to meet their contractual obligations in a timely manner; or • lack of, or failure to, demonstrate efficacy of our products candidate.
In addition, a number of events, including any of the following, could delay clinical trials, negatively impact the ability to obtain regulatory approval for, and to market and sell, a particular product candidate, or result in suspension or termination of a clinical trial: conditions imposed by the FDA or any foreign regulatory authority regarding the scope or design of clinical trials; • delays in obtaining, or the inability to obtain, regulatory agency approval for the conduct of the clinical trials or required approvals from institutional review boards, or IRBs, or other reviewing entities at clinical sites selected for participation in our clinical trials; • the identification of flaws in the design of a clinical trial; • changes in regulatory requirements and guidance that necessitate amendments to clinical trial protocols; • delays in sufficiently developing, characterizing or controlling manufacturing processes suitable for clinical trials; • insufficient supply or deficient quality of the product candidates or other materials necessary to conduct the clinical trials; • difficulty in sourcing healthy donor material of sufficient quality and in sufficient quantity to meet our development needs; • lower-than-anticipated enrollment and retention rate of subjects in clinical trials for a variety of reasons, including size of patient population, site selection, nature of trial protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications and competition from approved products; • delays in reaching agreement on acceptable terms with prospective contract research organizations (CROs) and clinical study sites and obtaining required institutional review board (IRB) approval at each clinical study site; • the placing of a clinical hold on our or our licensees’ clinical trials by the FDA or other similar foreign regulatory authorities, or the placing of a halt of our or our's licensees' clinical trials as per the applicable protocol rules —for example, clinical holds were placed on our deprioritized AMELI-01 Study in September 2018 and on our now discontinued MELANI-01 10 Study in July 2020 and on all of our licensee Allogene’s AlloCAR T clinical trials in October 2021 and remained in place until the FDA permitted these trials to restart in November 2018, November 2020 and January 2022, respectively; • unfavorable interpretations by FDA or similar foreign regulatory authorities of interim data; • determinations by the FDA or similar foreign regulatory authorities that a clinical trial protocol is deficient in design to meet its stated objectives; • failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; • serious safety issues, including drug-related side effects experienced by patients in clinical trials—for example, following patient safety issues, including patient death, related to cytokine release syndrome, or CRS, patient recruitment for certain of our Studies were paused, in accordance with their respective protocols, pending the implementation of modified protocol treatment strategies; • failure of our or our licensees' third-party contractors to meet their contractual obligations in a timely manner; or • lack of, or failure to, demonstrate safety or efficacy of our products candidate.
As we or our licensees or partners advance product candidates, we and they will be required to consult with these regulatory groups and comply with all applicable guidelines, rules and regulations. Because the UCART19 studies are being sponsored by Servier and Allogene, they are directly interacting with the relevant regulatory agencies and we are not able to direct such interactions.
As we or our licensees or partners advance product candidates, we and they will be required to consult with these regulatory groups and comply with all applicable guidelines, rules and regulations. Because the UCART19 studies are being sponsored by Allogene, it is directly interacting with the relevant regulatory agencies and we are not able to direct such interactions.
Our or our licensors’ issued patents and pending patent applications will expire on dates ranging from 2024 to 2042, subject to any patent extensions that may be available for such patents.
Our or our licensors’ issued patents and pending patent applications will expire on dates ranging from 2025 to 2042, subject to any patent extensions that may be available for such patents.
For instance, because the regimen will cause a transient and sometimes prolonged immune suppression, patients will have an increased risk of infection, such as to COVID-19, that may be unable to be cleared by the patient and ultimately lead to other serious adverse events or death. Our lymphodepletion regimen has caused and may also cause prolonged cytopenia.
For instance, because the regimen will cause a transient and sometimes prolonged immune suppression, patients will have an increased risk of infection that may be unable to be cleared by the patient and ultimately lead to other serious adverse events or death. Our lymphodepletion regimen has caused and may also cause prolonged cytopenia.
Risks Related to Operational Compliance and Risk Management: • We may encounter difficulties in managing our development and expansion, including challenges associated with recruiting additional employees, managing our internal development efforts and improving our operational, financial and management controls. • The risk of product liability claims is inherent in the development and commercialization of therapeutic products, and product liability or other lawsuits could divert management and financial resources, result in substantial liabilities and reduce the commercial potential of our product candidates. • The buy-out mechanism in our collaboration agreement with Servier may prevent or delay a takeover attempt. • We identified a material weakness in our internal control over financial reporting.
Risks Related to Operational Compliance and Risk Management: • We may encounter difficulties in managing our development and expansion, including challenges associated with recruiting additional employees, managing our internal development efforts and improving our operational, financial and management controls. • The risk of product liability claims is inherent in the development and commercialization of therapeutic products, and product liability or other lawsuits could divert management and financial resources, result in substantial liabilities and reduce the commercial potential of our product candidates. • The buy-out mechanism in our collaboration agreement with Servier may prevent or delay a takeover attempt.
If we fail to remediate our material weakness and to maintain effective internal control over financial reporting adequate to meet the requirements of the Sarbanes-Oxley Act, investors may lose confidence in our financial reporting, the price of our ordinary shares and ADSs could decline and our access to the capital markets could be restricted, and our business and reputation may be harmed.
If we fail to establish and maintain effective internal control over financial reporting adequate to meet the requirements of the Sarbanes-Oxley Act, investors may lose confidence in our financial reporting, the price of our ordinary shares and ADSs could decline and our access to the capital markets could be restricted, and our business and reputation may be harmed.
Risks Related to Operational Compliance and Risk Management We will need to develop and expand our company, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations. As of December 31, 2023, we had 216 full-time employees.
Risks Related to Operational Compliance and Risk Management We will need to develop and expand our company, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations. As of December 31, 2024, we had 222 full-time employees.
We operate two in-house manufacturing facilities—a facility in Paris, France, which is dedicated to the manufacturing of certain raw and starting material for our investigational products, and a facility in Raleigh, North Carolina, which is dedicated to the production of our investigational products.
We operate two in-house manufacturing facilities—a facility in Paris, France, which is dedicated to the manufacturing of certain raw and starting material for our investigational products, and a facility in Raleigh, North Carolina, which is dedicated to the production of our investigational products. Both facilities are fully operational.
We do not expect any of the product candidates we or our licensees or partners develop to be commercially available for many years and some or all may never become commercially available. The size of the initial market for our product candidates may be limited.
We do not expect any of the product candidates we or our licensees or partners develop to be commercially available for many years and some or all may never become commercially available.
As of June 30, 2023, approximately 22.4% of our securities were held by persons who were U.S. residents. The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic public company would be significantly more than the costs we currently incur as a foreign private issuer.
As of June 30, 2024, approximately 16.7% of our securities were held by persons who were U.S. residents. The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic public company would be significantly more than the costs we currently incur as a foreign private issuer.
Our TALEN technology involves a relatively new approach to gene editing, using sequence-specific deoxyribonucleic acid (DNA)-cutting enzymes, or nucleases, to perform precise and stable modifications in the DNA of living-cells and organisms.
Our gene-editing technologies, including notably the TALEN technology, involve a relatively new approach to gene editing, using sequence-specific deoxyribonucleic acid (DNA)-cutting enzymes, or nucleases, to perform precise and stable modifications in the DNA of living-cells and organisms.
Servier’s discontinuation of its involvement in the development of CD19 Products and related disagreements may have adverse consequences, Under the License, Development and Commercialization Agreement dated March 6, 2019, between us and Les Laboratoires Servier SAS and Institut de Recherches Internationales Servier SAS (collectively, “Servier”), as amended on March 4, 2020 (as so amended, the “Servier License Agreement”), Servier currently holds an exclusive worldwide license to develop and commercialize gene-edited allogeneic CAR T-cell products targeting CD19, including UCART19, ALLO-501 and ALLO-501A, in the field of anti-tumor adoptive immunotherapy (collectively, “CD19 Products”).
Under the License, Development and Commercialization Agreement dated March 6, 2019, between us and Les Laboratoires Servier SAS and Institut de Recherches Internationales Servier SAS (collectively, “Servier”), as amended on March 4, 2020 (as so amended, the “Servier License Agreement”), Servier currently holds an exclusive worldwide license to develop and commercialize gene-edited allogeneic CAR T-cell products targeting CD19, including UCART19, ALLO-501 and ALLO-501A, in the field of anti-tumor adoptive immunotherapy (collectively, “CD19 Products”).
We could also be subject to other adverse consequences as a result thereof. As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than a U.S. company. This may limit the information available to holders of ADSs.
We could also be subject to other adverse consequences as a result thereof. As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than a U.S. company.
In addition, holders of our ADSs may not be able to cancel such ADSs and withdraw the underlying ordinary shares when such holders owe money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities.
In addition, holders of our ADSs may not be able to cancel such ADSs and withdraw the underlying ordinary shares when such holders owe money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities. 39 The market price for our ADSs may be volatile or may decline regardless of our operating performance.
These clinical studies are currently conducted at specialized centers that are experienced at managing patients with advanced malignancies as well as toxicities associated with immunomodulatory therapies. We will monitor the safety profile of CLLS52 and ensure our pharmacovigilance reporting responsibilities as sponsor.
These clinical studies are currently conducted at specialized centers that are experienced at managing patients with advanced malignancies as well as toxicities associated with immunomodulatory therapies. We are monitoring the safety profile of CLLS52 and carrying out our pharmacovigilance reporting responsibilities as sponsor.
Similarly in EU, a biosimilar is typically defined as a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’).
Similarly in EU, a biosimilar is typically defined as a biological medicine highly similar to another already approved biological medicine.
Our executive officers, directors, current 5% or greater shareholders and affiliated entities beneficially own approximately 42.35% of our ordinary shares outstanding (including those underlying our ADSs, but excluding shares that may be acquired upon exercise of stock options or warrants) as of December 31, 2023.
Our executive officers, directors, current 5% or greater shareholders and affiliated entities beneficially own approximately 52.35% of our ordinary shares outstanding (including those underlying our ADSs, but excluding shares that may be acquired upon exercise of stock options or warrants, or upon the conversion of preferred shares) as of December 31, 2024.
Following this agreement, we are implementing the use of alementuzumab as a Cellectis investigational medicinal product, coded as CLLS52, in the clinical protocols AMELI-01, BALLI-01, and NaThaLi-01 in the United States and in the relevant European Union member states.
Following this agreement, we are implementing the use of alementuzumab as a Cellectis investigational medicinal product, coded as CLLS52, in our sponsored clinical protocols in the United States and in the relevant European Union member states.
As of December 31, 2023, our lease guaranty represents a liability in the amount of $22.9 million over the remaining 14-year lease period. Cibus, however, will not be required to replace us as guarantor or pay any fees in connection with termination of the guaranty.
As of December 31, 2024, our lease guaranty represents a liability in the amount of $21.4 million over the remaining 13-year lease period. Cibus, however, will not be required to replace us as guarantor or pay any fees in connection with termination of the guaranty.
In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Global financial markets have been negatively impacted as a result of global pandemics such as COVID-19 and military and regional conflicts, such as the invasion of Ukraine by Russia and the Middle East conflict.
In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. In recent years, global financial markets have experienced volatility as a result of military and regional conflicts, such as the invasion of Ukraine by Russia and the Middle East conflict.
The Research tax credit receivables as of December 31, 2023 include the accrual for a French research tax credit related to 2022 for $5.6 million and research tax credit related to previous periods for $15 million. The CIR is calculated based on our claimed amount of eligible research and development expenditures in France.
The Research tax credit receivables as of December 31, 2024 include the accrual for a French research tax credit related to 2024 for $6.2 million and research tax credit related to previous periods for $19.9 million. The CIR is calculated based on our claimed amount of eligible research and development expenditures in France.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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(Boston, Massachusetts), Hôpital Saint-Louis AP-HP (Paris, France), Hôpital Robert Debré AP-HP (Paris, France), CHU de Nantes (Nantes, France), and CHU de Rennes (Rennes, France), Sarah Cannon Research Institute, LLC and TriStar Bone Marrow Transplant, LLC (Nashville, Tennessee), Sarah Cannon Research Institute, LLC and HCA-HealthONE, LLC d/b/a Presbyterian/St.
(Boston, Massachusetts), Hôpital Saint-Louis AP-HP (Paris, France), Hôpital Robert Debré AP-HP (Paris, France), CHU de Nantes (Nantes, France), CHU de Rennes (Rennes, France), Sarah Cannon Research Institute, LLC and TriStar Bone Marrow Transplant, LLC (Nashville, Tennessee), Sarah Cannon Research Institute, LLC and HCA-HealthONE, LLC d/b/a Presbyterian/St.
Iovance licensed our TALEN technology in order to develop tumor infiltrating lymphocytes (TIL) that have been genetically edited to create more potent cancer therapeutics. The worldwide exclusive license enables Iovance to use TALEN® technology to address multiple gene targets to modify TIL for therapeutic use in several cancer indications.
Iovance licensed our TALEN technology in order to develop tumor infiltrating lymphocytes (TIL) that have been genetically edited to create more potent cancer therapeutics. The worldwide exclusive license enables Iovance to use our TALEN technology to address multiple gene targets to modify TIL for therapeutic use in several cancer indications.
Gene Editing to Inactivate Genes, such as the TCRα and CD52 We use our PulseAgile electroporation technology to introduce specific TALEN mRNA into the T-cells to inactivate a number of genes that are naturally present in the genome of these T-cells.
Gene Editing to Inactivate Genes, such as the TCRα and CD52 We use our PulseAgile electroporation technology to introduce specific mRNA, such as TALEN mRNA, into the T-cells to inactivate a number of genes that are naturally present in the genome of these T-cells.
Among the ACA’s provisions of importance to the pharmaceutical and biotechnology industries, in addition to those otherwise described above, are the following: • an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs; • an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and a cap on the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP; • a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D; • extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; • expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability; • expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; and • a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
Among the ACA’s provisions of importance to the pharmaceutical and biotechnology industries, in addition to those otherwise described above, are the following: • an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs; • an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and a cap on the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP; • a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D; • extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; • expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability; 72 • expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; and • a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
The initial PSP must include, among other things, an outline of the pediatric study or 68 studies that the sponsor plans to conduct, including to the extent practicable study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information.
The initial PSP must include, among other things, an outline of the pediatric study or studies that the sponsor plans to conduct, including to the extent practicable study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information.
Concurrent with this upfront payment, Pfizer also made a €25.8 million equity investment in our company. On April 3, 2018, Pfizer and Allogene Therapeutic, Inc. (“Allogene”) announced that they entered into an asset contribution agreement, pursuant to which Allogene purchased Pfizer’s portfolio of assets related to allogeneic CAR T-cell therapy (the “Asset 51 Contribution Transaction”).
Concurrent with this upfront payment, Pfizer also made a €25.8 million equity investment in our company. On April 3, 2018, Pfizer and Allogene Therapeutic, Inc. (“Allogene”) announced that they entered into an asset contribution agreement, pursuant to which Allogene purchased Pfizer’s portfolio of assets related to allogeneic CAR T-cell therapy (the “Asset Contribution Transaction”).
Several states have enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practices.
Several states have enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, 71 marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practices.
One patient who failed five prior lines of therapy experienced a durable minimal residual disease (MRD) negative complete response (CR) with full count recovery at Day 56 that continued beyond one year as of December 22, 2022, and one patient with stable disease achieved greater than 90% bone marrow blast reduction (60% to 5%) at Day 28.
One patient who failed five prior lines of therapy experienced a durable minimal residual disease (MRD) negative complete 47 response (CR) with full count recovery at Day 56 that continued beyond one year as of December 22, 2022, and one patient with stable disease achieved greater than 90% bone marrow blast reduction (60% to 5%) at Day 28.
Such signals may induce tumor cell killing, cytokine secretion and CAR T-cell multiplication. The following diagram shows the mechanism by which a CAR T-cell is believed to attack a tumor cell: Recent immuno-oncology advancements have supported the potential to cure certain cancers by harnessing the body’s immune system to fight cancer cells (see “Competition” section for more details).
Such signals may induce tumor cell killing, cytokine secretion and CAR T-cell multiplication. 55 The following diagram shows the mechanism by which a CAR T-cell is believed to attack a tumor cell: Recent immuno-oncology advancements have supported the potential to cure certain cancers by harnessing the body’s immune system to fight cancer cells (see “Competition” section for more details).
The longest CRs at this time was 18+ months with ALLO-501 and 15+ months with ALLO-501A. Patients received lymphodepletion containing fludarabine, cyclophosphamide and ALLO-647 (an anti-CD52 antibody) followed by escalating doses of ALLO-501 or ALLO-501A. In consolidation, patients with stable disease or better at Day 28 received a chemotherapy-free lymphodepletion (ALLO-647 only) and AlloCAR T cell infusion.
The longest CRs at this time was 18+ months with ALLO-501 and 15+ months with ALLO-501A. Patients received lymphodepletion containing fludarabine, cyclophosphamide and 49 ALLO-647 (an anti-CD52 antibody) followed by escalating doses of ALLO-501 or ALLO-501A. In consolidation, patients with stable disease or better at Day 28 received a chemotherapy-free lymphodepletion (ALLO-647 only) and AlloCAR T cell infusion.
Autologous CAR T-cell immunotherapies modify a patient’s own T-cells to target specific antigens that are located on cancer cells. This type of therapy requires an individualized immunotherapy product for each patient and is currently being tested in clinical trials by several academic institutions, and biotechnology and pharmaceutical companies.
Autologous CAR T-cell immunotherapies modify a patient’s own T-cells to target specific antigens that are located on cancer cells. This type of therapy requires an individualized immunotherapy product for each patient and is currently being tested in 40 clinical trials by several academic institutions, and biotechnology and pharmaceutical companies.
They play a particularly significant role if they are 55 tailored to target tumors, and potentially even more so if their genes are edited to overcome tumor defenses, to make T-cells compatible with other anti-cancer drugs that can be combined with them, and to prevent GvHD, which would allow the use of allogeneic T-cells.
They play a particularly significant role if they are tailored to target tumors, and potentially even more so if their genes are edited to overcome tumor defenses, to make T-cells compatible with other anti-cancer drugs that can be combined with them, and to prevent GvHD, which would allow the use of allogeneic T-cells.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the biological product has been associated with unexpected serious harm to patients. Human immunotherapy products and gene therapy products are a new category of therapeutics.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not 66 being conducted in accordance with the IRB’s requirements or if the biological product has been associated with unexpected serious harm to patients. Human immunotherapy products and gene therapy products are a new category of therapeutics.
Our UCART approach goes one step further in engineering and also in moving the CAR concept from a patient-by-patient therapeutic procedure to an off-the-shelf widely available pharmaceutical compound. 60 The manufacturing process of our allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, allogeneic, engineered CAR T-cells.
Our UCART approach goes one step further in engineering and also in moving the CAR concept from a patient-by-patient therapeutic procedure to an off-the-shelf widely available pharmaceutical compound. The manufacturing process of our allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, allogeneic, engineered CAR T-cells.
This property includes, our approximately 14,000 sq. ft. in-house manufacturing facility, which is dedicated to the production of certain raw and starting material for clinical supply, with the potential to supply commercial raw and starting material. Cellectis, Inc. leases a 24,375 square feet facility in New York, New York for administrative and research and development activities.
This property includes, our approximately 14,000 sq. ft. in-house manufacturing facility, which is dedicated to the production of certain raw and starting material for clinical supply, with the potential to supply commercial raw and starting material. 76 Cellectis, Inc. leases a 24,375 square feet facility in New York, New York for administrative and research and development activities.
In October 2022, Allogene announced the initiation of the “potentially” pivotal Phase 2 clinical trial of ALPHA2 trial in patients with relapsed or refractory large B-cell lymphoma. Allogene also announced that it was in the process of initiating the EXPAND trial, which is a separate potentially registration trial for ALLO-647—Allogene’s anti-CD52 monoclonal antibody.
In October 2022, Allogene announced the initiation of the pivotal Phase 2 clinical trial of ALPHA2 trial in patients with relapsed or refractory large B-cell lymphoma. Allogene also announced that it was in the process of initiating the EXPAND trial, which is a separate potentially registration trial for ALLO-647—Allogene’s anti-CD52 monoclonal antibody.
TCRs at the surface of T-cells allow them to recognize cells that express foreign, non-self, antigens (for example, cells infected by a virus or cells coming from another individual). Non-modified allogeneic T-cells bear functional TCRs and, if injected into a patient, 58 can potentially recognize non-self on that patient’s tissues and start attacking them.
TCRs at the surface of T-cells allow them to recognize cells that express foreign, non-self, antigens (for example, cells infected by a virus or cells coming from another individual). Non-modified allogeneic T-cells bear functional TCRs and, if injected into a patient, can potentially recognize non-self on that patient’s tissues and start attacking them.
The engineering steps for transduction and electroporation can take place one before another (and several times), depending on the product. We aim to continuously improve our manufacturing processes for better safety and robustness of our product lines. Towards manufacturing autonomy with two state-of-the-art plants In order to enhance our manufacturing autonomy, we have established two manufacturing facilities.
The engineering steps for transduction and electroporation can take place one before another (and several times), depending on the product. We aim to continuously improve our manufacturing processes for better safety and robustness of our product lines. 60 Towards manufacturing autonomy with two state-of-the-art plants In order to enhance our manufacturing autonomy, we have established two manufacturing facilities.
Raw Materials We are currently dependent on specialized third parties, who are subject to stringent manufacturing requirements and regulations, for the supply of various critical and biological materials – such as cells, chemicals, water, cytokines, vectors, nucleic acids, antibodies, medium, serum, buffers —that are necessary to produce our product candidates.
Raw Materials We are currently dependent on specialized third parties, who are subject to stringent manufacturing requirements and regulations, for the supply of various critical and biological materials – such as cells, chemicals, water, cytokines, vectors, nucleic acids, antibodies, biological reagents, medium, serum, buffers —that are necessary to produce our product candidates.
Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be 71 evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances.
Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances.
Among our main patents EP2997141, EP3189073, EP3126390, EP3004349 and EP3116902 are under opposition before the European Patent Office. UCART19 In addition to the patent portfolio relating to our platform and technologies, described above, our patent portfolio relating specifically to UCART19 includes granted patents and pending patent applications from the patent family WO2014184143 (CD19 Specific Chimeric Antigen Receptor and Uses Thereof).
Among our main patents EP2997141, EP3189073, EP3126390 and EP3004349 are under opposition before the European Patent Office. UCART19 In addition to the patent portfolio relating to our platform and technologies, described above, our patent portfolio relating specifically to UCART19 includes granted patents and pending patent applications from the patent family WO2014184143 (CD19 Specific Chimeric Antigen Receptor and Uses Thereof).
Under the Fast Track program, the FDA may consider the review of sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the 69 submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.
Under the Fast Track program, the FDA may consider the review of sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.
The median time from enrollment to the start of therapy was five days. In the ongoing dose escalation phase of the TRAVERSE trial, patients will receive lymphodepletion followed by ALLO-316 at one of 50 four cell dose levels (DL1= 40M cells, DL2= 80M cells, DL3=120M cells, DL4= 240M cells).
The median time from enrollment to the start of therapy was five days. In the ongoing dose escalation phase of the TRAVERSE trial, patients will receive lymphodepletion followed by ALLO-316 at one of four cell dose levels (DL1= 40M cells, DL2= 80M cells, DL3=120M cells, DL4= 240M cells).
The Centralized Procedure is also mandatory for ATMPs, which comprise gene therapy, somatic cell therapy and tissue engineered products. In this regard, on May 28, 2014, the EMA issued a recommendation that Cellectis’ UCART19 be considered a 74 gene therapy product under Regulation (EC) No 1394/2007 on ATMPs.
The Centralized Procedure is also mandatory for ATMPs, which comprise gene therapy, somatic cell therapy and tissue engineered products. In this regard, on May 28, 2014, the EMA issued a recommendation that Cellectis’ UCART19 be considered a gene therapy product under Regulation (EC) No 1394/2007 on ATMPs.
Our gene-editing expertise also enables us to develop product candidates that feature certain safety and efficacy attributes, including control 40 properties designed to prevent them from attacking healthy tissues, to enable them to tolerate standard oncology treatments, and to equip them to resist mechanisms that inhibit immune-system activity.
Our gene-editing expertise also enables us to develop product candidates that feature certain safety and efficacy attributes, including control properties designed to prevent them from attacking healthy tissues, to enable them to tolerate standard oncology treatments, and to equip them to resist mechanisms that inhibit immune-system activity.
This six-month exclusivity, which attaches to and runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued “Written Request” for such a trial. Other U.S.
This six-month 70 exclusivity, which attaches to and runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued “Written Request” for such a trial. Other U.S.
Under the CTR, NCAs may order the temporary halt or permanent discontinuation of a clinical trial at any time or impose other sanctions if they believe that the clinical trial is not being conducted in accordance with applicable requirements or presents an unacceptable risk to the clinical trial patients.
Under the CTR, NCAs may order the temporary halt or permanent discontinuation of a clinical trial at any time or impose other sanctions if they believe that the clinical trial is not being conducted in accordance with applicable requirements or presents an 73 unacceptable risk to the clinical trial patients.
Furthermore, approved products may be marketed only for the approved indications and in accordance with the provisions of the approved label. Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, may require a submission to and approval by the European Commission, or by the NCA, as applicable.
Furthermore, approved products may be marketed only for the approved indications and in accordance with the provisions of the approved label. Changes to some of the conditions 74 established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, may require a submission to and approval by the European Commission, or by the NCA, as applicable.
Between June 2016 and October 2018, seven children and 14 adults were enrolled in the two studies and received UCART19. Cytokine release syndrome, or CRS, was the most common adverse event and was observed in 19 patients (91%); three (14%) of whom had grade 3 or 4 CRS.
Between June 2016 and October 2018, seven children and fourteen adults were enrolled in the two studies and received UCART19. Cytokine release syndrome, or CRS, was the most common adverse event and was observed in 19 patients (91%); three (14%) of whom had grade 3 or 4 CRS.
Second, in Paris, France, we have completed construction of an approximately 14,000 sq. ft. in-house manufacturing facility, which is dedicated to the production of certain critical raw and starting material for clinical supply, with the potential to supply commercial raw and starting materials. The Paris facility commenced production of raw and starting materials in 2020.
Second, in Paris, France, we have completed construction of an approximately 14,000 sq. ft. in-house manufacturing facility, which is dedicated to the production of certain critical raw and starting material for clinical supply, with the potential to supply such materials for commercial production. The Paris facility commenced production of such raw and starting materials in 2020.
EU Supplementary Protection Certificates In the EU, Supplementary Protection Certificates (SCPs) are available to extend a patent term for up to five years to compensate patent protection lost during regulatory review. Although all EU Member States must provide SPCs, SPCs must currently be applied for and granted on a country-by-country basis.
EU Supplementary Protection Certificates In the EU, Supplementary Protection Certificates (SCPs) are available to extend a patent term for up to five years to compensate patent protection lost during regulatory review. Although all EU Member States must provide SPCs, SPCs must currently be applied for 75 and granted on a country-by-country basis.
These fusion proteins serve as readily targetable “DNA scissors” for genome engineering applications that enable us to perform targeted genome modifications such as sequence insertion, deletion, repair and replacement in living cells. The following diagram shows the structure of a TALEN.
These fusion proteins serve as readily targetable “DNA scissors” for genome engineering applications that enable us to perform targeted genome modifications such as sequence insertion, deletion, repair and replacement in living cells. 56 The following diagram shows the structure of a TALEN.
On March 8, 2019, we and Allogene agreed to terminate the Collaboration and License Agreement and entered into a new license agreement (the “Allogene License Agreement”) to reflect the relationship between us and Allogene following the Asset Contribution Transaction. The Allogene License Agreement establishes the rights and obligations of Cellectis and Allogene with respect to their collaboration program.
On March 8, 2019, we and Allogene agreed to terminate the Collaboration and License Agreement and entered into a new license agreement (the “Allogene License Agreement”) to reflect the relationship between us and Allogene following the Asset Contribution 51 Transaction. The Allogene License Agreement establishes the rights and obligations of Cellectis and Allogene with respect to their collaboration program.
Congress may also consider 73 subsequent legislation to replace elements of the ACA that are repealed or to enhance the coverage and operation of the ACA. As a result, the full impact of the ACA, any law repealing and/or replacing elements of it, and the political uncertainty surrounding any repeal or replacement legislation remains unclear.
Congress may also consider subsequent legislation to replace elements of the ACA that are repealed or to enhance the coverage and operation of the ACA. As a result, the full impact of the ACA, any law repealing and/or replacing elements of it, and the political uncertainty surrounding any repeal or replacement legislation remains unclear.
Since PD-1 and CD25 are known to be upregulated upon T-cell activation, inserting certain cytokine coding sequence under the control of PD-1 or CD25 genetic regulatory elements allows secretion of that certain cytokine only upon activation of the CAR T-cells and enhances antitumor activity.
Since PD-1 and CD25 are known to be upregulated upon T-cell activation, inserting certain cytokine coding sequence under the control of 59 PD-1 or CD25 genetic regulatory elements allows secretion of that certain cytokine only upon activation of the CAR T-cells and enhances antitumor activity.
Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market or make our development more complicated.
Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market or make our 64 development more complicated.
Historically, pharmaceutical companies have been the target of anti-corruption and similar investigations, as well as of wide media attention, sometimes resulting in significant penalties, image and other costs for such companies. 75 Finally, very stringent data privacy requirements apply in the EU.
Historically, pharmaceutical companies have been the target of anti-corruption and similar investigations, as well as of wide media attention, sometimes resulting in significant penalties, image and other costs for such companies. Finally, very stringent data privacy requirements apply in the EU.
The agreement will expire, unless earlier terminated in accordance with its terms, upon the expiration of the last to expire of the patents covering a product licensed pursuant to the agreement. The parties may terminate the Servier License Agreement at any time by 52 mutual consent.
The agreement will expire, unless earlier terminated in accordance with its terms, upon the expiration of the last to expire of the patents covering a product licensed pursuant to the agreement. The parties may terminate the Servier License Agreement at any time by mutual consent.
The FDA also may perform 70 certain confirmatory tests on lots of some products before releasing the lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, potency, and effectiveness of biological products.
The FDA also may perform certain confirmatory tests on lots of some products before releasing the lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, potency, and effectiveness of biological products.
The optimal lymphodepletion regimen prior to the administration of CAR-T product candidates 46 remains an area of investigation in the field of CAR T-cell therapy. In December 2021, the BALLI-01 Study was approved in France by the French drug agency, the ANSM.
The optimal lymphodepletion regimen prior to the administration of CAR-T product candidates remains an area of investigation in the field of CAR T-cell therapy. In December 2021, the BALLI-01 Study was approved in France by the French drug agency, the ANSM.
We have shown on human and mouse cell models that ß2M inactivation improves 59 allogeneic cell survival in the presence of alloreactive T-cells, and we are pursuing the ß2M inactivation approach for some of our preclinical candidates.
We have shown on human and mouse cell models that ß2M inactivation improves allogeneic cell survival in the presence of alloreactive T-cells, and we are pursuing the ß2M inactivation approach for some of our preclinical candidates.
Third-party payors may limit 72 coverage to specific drug products on an approved list, also known as a formulary, which might not include all of the approved drugs for a particular indication.
Third-party payors may limit coverage to specific drug products on an approved list, also known as a formulary, which might not include all of the approved drugs for a particular indication.
Other adverse events were grade 1 or 2 neurotoxicity in eight patients (38%), grade 1 acute skin graft-versus-host disease, or GvHD, in two patients (10%), and grade 4 prolonged cytopenia in six patients (32%).
Other adverse events were grade 1 or 2 neurotoxicity in eight patients (38%), grade 1 acute skin graft-versus-host disease, or GvHD, in two 48 patients (10%), and grade 4 prolonged cytopenia in six patients (32%).
The IND must become effective before clinical trials may begin. The IND is automatically effective 30 days after receipt by the FDA, unless during that time 66 the FDA raises concerns or questions regarding the proposed clinical trials.
The IND must become effective before clinical trials may begin. The IND is automatically effective 30 days after receipt by the FDA, unless during that time the FDA raises concerns or questions regarding the proposed clinical trials.
The outcome in older patients who are unable to receive intensive chemotherapy without unacceptable side effects remains dismal, with a median survival of 44 only 5 to 10 months.
The outcome in older patients who are unable to receive intensive chemotherapy without unacceptable side effects remains dismal, with a median survival of only 5 to 10 months.
Allogeneic TRCαß2M double knock-out CAR T-cells infused into a patient are expected not to be recognized by the patient’s own cytotoxicT-cells and therefore to potentially show prolonged survival after patients’ T-cells recover following lymphodepletion. We have developed several ß2M-specific TALEN allowing high efficiency of gene inactivation in combination with TRCα-specific TALEN (up to 88% double knock-out).
Allogeneic TRCαß2M double knock-out CAR T-cells infused into a patient are expected not to be recognized by the patient’s own cytotoxic T-cells and therefore to potentially show prolonged survival after patients’ T-cells recover following lymphodepletion. We have developed several ß2M-specific TALEN allowing high efficiency of gene inactivation in combination with TRCα-specific TALEN (up to 88% double knock-out).
To help reduce the risk of the introduction of 67 adventitious agents with use of biological products, the PHSA emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined.
To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHSA emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined.
Luke’s Medical Center (Nashville, Tennessee and Denver, Colorado), Sarah Cannon Research Institute, LLC and St. David’s Healthcare Partnership, L.P., LLP d/b/a St.
Luke’s Medical 45 Center (Nashville, Tennessee and Denver, Colorado), Sarah Cannon Research Institute, LLC and St. David’s Healthcare Partnership, L.P., LLP d/b/a St.
The FDA may impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a REMS, or otherwise limit the scope of any approval.
The FDA may impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a REMS, or otherwise 67 limit the scope of any approval.
Cellectis also granted AZ Ireland an exclusive option, on a candidate product by candidate product basis, to receive a worldwide, exclusive, royalty-bearing, sublicenseable (under certain conditions) license under the Licensed Technology to exploit (to make, have made, import, use, sell, or offer for sale) the relevant candidate product (any candidate product for which AZ Ireland exercises this option, a “Licensed Product”).
Cellectis also granted AZ Ireland an exclusive option, on a candidate product by candidate product basis, to receive a worldwide, exclusive, royalty-bearing, sublicensable (under certain conditions) license under the Licensed Technology to exploit (to make, have made, import, use, sell, or offer for sale) the relevant candidate product (any candidate product for which AZ Ireland exercises this option, a “Licensed Product”).
We also face competition from non-cell based treatments offered by companies such as Amgen Inc., AstraZeneca plc, Bristol-Myers Squibb Company, Incyte Corporation, Merck & Co., Inc., Novartis AG and F. Hoffman-La Roche AG. Immunotherapy is further being pursued by several biotech companies as well as by large-cap pharmaceuticals.
We also face competition from non-cell based treatments offered by companies such as Amgen Inc., AstraZeneca plc, Bristol-Myers Squibb Company, Incyte Corporation, Merck & Co., Inc., Novartis AG and F. Hoffman-La Roche AG, amongst others. Immunotherapy is further being pursued by several biotech companies as well as by large-cap pharmaceuticals.
These initiatives recently culminated in the enactment of the Inflation Reduction Act, or IRA, in August 2022, which, among other things, will allow the U.S.
These initiatives culminated in the enactment of the Inflation Reduction Act, or IRA, in August 2022, which, among other things, will allow the U.S.
CARs are constructed by assembling components, or domains, from different proteins, including: • In the extracellular space, one or more target binding domains, coming from ligands, such as antibodies or receptors, that can recognize their targets on the outside of the T-cell; • A hinge that helps position the target binding domains relative to their targets; • Trans-membrane domains that anchor the CAR at the T-cell’s surface relative to the T-cells; and • A set of activating or signaling domains, which are located within the T-cell’s interior, that deliver appropriate signals to the T-cells leading to T-cell activation or repression according to the T-cell environment.
CARs are constructed by assembling components, or domains, from different proteins, including: • In the extracellular space, one or more target binding domains, coming from ligands, such as antibodies or receptors, that can recognize their targets on the outside of the T-cell; • A hinge that helps position the target binding domains relative to their targets; • Transmembrane domains that anchor the CAR at the T-cell’s surface relative to the T-cells; and • A set of activating or signaling domains, which are located within the T-cell’s interior, that deliver appropriate signals to the T-cells leading to T-cell activation or repression according to the T-cell environment.
(Tampa, Florida), Dana Farber/ Partners Cancer Care, Inc (Boston, Massachusetts), Cornell University for and on behalf of its Joan and 45 Sanford I.
(Tampa, Florida), Dana Farber/ Partners Cancer Care, Inc (Boston, Massachusetts), Cornell University for and on behalf of its Joan and Sanford I.
CLLS52 (alemtuzumab) as anti-CD52 monoclonal antibody Following the execution of the supply agreement we entered into with Genzyme relating to the supply of alemtuzumab, we are implementing the use of alementuzumab as a Cellectis investigational medicinal product, coded as CLLS52, in the clinical protocols AMELI-01, BALLI-01, and NaThaLi-01 in the United States and in the relevant European Union member states.
CLLS52 (alemtuzumab) as anti-CD52 monoclonal antibody Following the execution of the supply agreement we entered into with Genzyme relating to the supply of alemtuzumab, we are implementing the use of alemtuzumab as a Cellectis investigational medicinal product, coded as CLLS52, in the clinical protocols BALLI-01 and NATHALI-01 in the United States and in the relevant European Union member states.
Current Intellectual Property Portfolio As a result of the licensing opportunities described above and our continuing research and development efforts, our intellectual property estate now contains patent applications that cover our products, including claims that cover: • methods central to genome engineering and gene editing of blood cells, including gene targeting, replacement, insertions and/or knock-out by using TALE-nucleases; • the main products we use in the manufacturing process, including nucleases; • manufacturing steps, including cell electroporation, transformation and genetic modifications; • resulting engineered cells; • single-chain and multi-subunit CARs expressed at the surface of T-cells; • specific gene inactivation and “suicide switch” gene expression; • allogeneic and autologous treatment strategies using our T-cell products; and • plant traits and methods for gene editing plant cells.
Current Intellectual Property Portfolio As a result of the licensing opportunities described above and our continuing research and development efforts, our intellectual property estate now contains patent applications that cover our products, including claims that cover: • methods central to genome engineering and gene editing of blood cells, including gene targeting, replacement, insertions and/or knock-out by using TALE-nucleases; • the main products we use in the manufacturing process, including nucleases; • manufacturing steps, including cell electroporation, transformation and genetic modifications; • resulting engineered cells; 61 • single-chain and multi-subunit CARs expressed at the surface of T-cells; • specific gene inactivation and “suicide switch” gene expression; and • allogeneic and autologous treatment strategies using our T-cell products.
Group Structure as of December 31, 2023 Subsidiary Name Jurisdiction of Incorporation Ownership & Voting Interest Held By Cellectis S.A. Cellectis, Inc. Delaware 100% (held directly) Cellectis Biologics, Inc. Delaware 100% (held indirectly through Cellectis, Inc.) See “Item 7. Major Shareholders and Related Party Transactions—B. Related Party Transactions—Transactions with subsidiaries D.
Group Structure as of December 31, 2024 Subsidiary Name Jurisdiction of Incorporation Ownership & Voting Interest Held By Cellectis S.A. Cellectis, Inc. Delaware 100% (held directly) Cellectis Biologics, Inc. Delaware 100% (held indirectly through Cellectis, Inc.) See “Item 7. Major Shareholders and Related Party Transactions—B. Related Party Transactions—Transactions with subsidiaries D.
During the period in which research activities are being conducted, Cellectis grants to AZ Ireland and its affiliates a non-exclusive, royalty-free, sublicenseable (under certain conditions) license to certain know-how and patents of Cellectis that are necessary for AZ Ireland to perform its research activities (the “Licensed Technology”).
During the period in which research activities are being conducted, Cellectis grants to AZ Ireland and its affiliates a non-exclusive, royalty-free, sublicensable (under certain conditions) license to certain know-how and patents of Cellectis that are necessary for AZ Ireland to perform its research activities (the “Licensed Technology”).
Business Overview—Our Licensing Relationships." Historical Overview – Product Candidates Being Developed Pursuant to Licenses AstraZeneca Under the AZ JRCA, AZ Ireland has an exclusive right to pursue the development and commercialization of products for a total of 10 selected candidate products.
Business Overview—Our Licensing Relationships." 41 Historical Overview – Product Candidates Being Developed Pursuant to Licenses AstraZeneca Under the AZ JRCA, AZ Ireland has an exclusive right to pursue the development and commercialization of products for a total of up to 10 selected candidate products.
Amongst other things, the proposal aims to revise, and potentially reduce, the duration of the data and market exclusivity, revise the marketing authorization procedure, broaden the possible post-authorization conditions, extend the reasons for a refusal of a marketing authorization, introduce more restrictive PIP waivers, increase the possible PIP obligations, etc.
Amongst other things, the proposal aims to revise, and potentially reduce, the duration of the data and market exclusivity, revise the marketing authorization procedure, broaden the possible post-authorization conditions, extend the reasons for a refusal of a marketing authorization, introduce more restrictive PIP waivers, increase the possible PIP obligations, among other things.
We expect our capital expenditures to increase in absolute terms in the near term as we continue to advance our research and development programs and grow our operations. We anticipate our capital expenditure in 2024 to be financed from our cash and cash equivalents on hand.
We expect our capital expenditures to increase in absolute terms in the near term as we continue to advance our research and development programs and grow our operations. We anticipate our capital expenditure in 2025 to be financed from our cash and cash equivalents on hand.
The process required by the FDA before a biologic may be marketed in the United States generally involves the following: • completion of extensive nonclinical, sometimes referred to as pre-clinical laboratory tests, pre-clinical animal studies and formulation studies in accordance with applicable regulations, including the FDA’s GLP regulations; • production and testing of clinical products according to the current Good Manufacturing Practices, or cGMP, and possible FDA product specific requirements; • submission to the FDA of an IND, which must become effective before clinical trials may begin and must be updated at least annually; • performance of adequate and well-controlled clinical trials in accordance with applicable IND and other clinical trial-related regulations, sometimes referred to as Good Clinical Practices, or GCPs, to establish the safety and efficacy of the proposed product candidate for each proposed indication; • submission to the FDA of a BLA; • satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the active pharmaceutical ingredient, or API, and finished product are manufactured to assess compliance with the IND/BLA and FDA’s cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality, purity and potency; • FDA review and approval of the BLA prior to any commercial marketing or sale of the product in the United States.
The process required by the FDA before a biologic may be marketed in the United States generally involves the following: • completion of extensive nonclinical, sometimes referred to as pre-clinical laboratory tests, pre-clinical animal studies and formulation studies in accordance with applicable regulations, including the FDA’s GLP regulations; • production and testing of clinical products according to the current Good Manufacturing Practices, or cGMP, and possible FDA product specific requirements; • submission to the FDA of an IND, which must become effective before clinical trials may begin and must be updated at least annually; • performance of adequate and well-controlled clinical trials in accordance with applicable IND and other clinical trial-related regulations, sometimes referred to as Good Clinical Practices, or GCPs, to establish the safety and efficacy of the proposed product candidate for each proposed indication; • submission to the FDA of a BLA; • satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the active pharmaceutical ingredient, or API, and finished product are manufactured to assess compliance with the IND/BLA and FDA’s cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality, purity and potency; • FDA review and approval of the BLA prior to any commercial marketing or sale of the product in the United States. 65 The data required to support a BLA is generated in three development segments: manufacturing, pre-clinical and clinical.
Our platform relies on precisely chosen protein families that can specifically recognize unique DNA sequences and can be tailored to target such sequences in any chosen gene or genetic region. Our allogeneic CAR T-cell therapy approach is based on our technology platform which combines CARs, TALEN and PulseAgile, our electroporation device.
Our platform relies on precisely chosen protein families that can specifically recognize unique DNA sequences and can be tailored to target such sequences in any chosen gene or genetic region. Our allogeneic CAR T-cell therapy approach is based on our technology platform which combines CARs, gene editing tools including TALEN, and PulseAgile, our electroporation device.
The following diagram shows the key stages in our engineering of UCARTCS1: Next-Generation Products – Inactivate Additional Genes, such as ß2M and PD-1 The allogeneic CAR T-cell approach developed by Cellectis aims at increasing accessibility to treatment for patients by using healthy donor cells to manufacture CAR T-cells.
The following diagram shows the key stages in our engineering of UCART: 58 Next-Generation Products – Inactivate Additional Genes, such as ß2M and PD-1 The allogeneic CAR T-cell approach developed by Cellectis aims at increasing accessibility to treatment for patients by using healthy donor cells to manufacture CAR T-cells.
The most fundamental challenge of gene editing is the need to specifically and efficiently target a precise DNA sequence within a gene. Our proprietary nuclease-based gene-editing technologies, combined with over 20 years of genome engineering experience, allow us to edit any gene with highly precise insertion, deletion, repair and replacement of DNA sequences.
The most fundamental challenge of gene editing is the need to specifically and efficiently target a precise DNA sequence within a gene. Our proprietary nuclease-based gene-editing technologies, combined with 25 years of genome engineering experience, allow us to edit any gene with highly precise insertion, deletion, repair and replacement of DNA sequences.
We believe these patent applications, which if issued, would expire in 2038, include claim directed to the composition of matter of UCART22, methods of manufacture of UCART22, and methods to use UCART22 in cancer treatment.
We believe these patent applications, which if issued, would expire in 2039, include claim directed to the composition of matter of UCART22, methods of manufacture of UCART22, and methods to use UCART22 in cancer treatment.
UCARTs are meant to be readily available CAR T-cells for a large patient population. The specificity of those allogeneic therapies is that T-cells from healthy donors are genetically edited with our proprietary technology, TALEN ® , to seek and destroy cancer cells.
UCARTs are meant to be readily available CAR T-cells for a large patient population. The specificity of those allogeneic product candidates is that T-cells from healthy donors are genetically edited with our proprietary technology, TALEN, to seek and destroy cancer cells.
Our approach aims to deliver off-the-shelf products with the following benefits: • Market access. Enable products to be shipped globally, thereby reducing deployment obstacles and providing accessibility to a broad patient population; 56 • Cost-effectiveness and Scalable Manufacturing. Streamlined manufacturing process has the potential to reduce costs, with potentially hundreds of doses per batch; • Novel Features.
Our approach aims to deliver off-the-shelf products with the following benefits: • Market access. Enable products to be shipped globally, thereby reducing deployment obstacles and providing accessibility to a broad patient population; • Cost-effectiveness and Scalable Manufacturing. Streamlined manufacturing process has the potential to reduce costs, with potentially hundreds of doses per batch; • Safety.
The optimal lymphodepletion regimen prior to the administration of CAR-T product candidates remains an area of investigation in the field of CAR T-cell therapy. The AMELI-01 Study is currently open for patient recruitment at University of Texas, MD Anderson Cancer Center (Houston, Texas), H. Lee Moffitt Cancer Center & Research Institute Hospital Inc.
The optimal lymphodepletion regimen prior to the administration of CAR-T product candidates remains an area of investigation in the field of CAR T-cell therapy. In 2024, the AMELI-01 Study was open for patient recruitment at University of Texas, MD Anderson Cancer Center (Houston, Texas), H. Lee Moffitt Cancer Center & Research Institute Hospital Inc.
The exclusive rights for the development and commercialization of UCART19 in the United States have been sublicensed by Servier to Allogene. For more information about these licensing relationships, see "Item 4. Information on the Company—B.
The exclusive rights for the development and commercialization of UCART19 in the United States, European Union and United Kingdom have been sublicensed by Servier to Allogene. For more information about these licensing relationships, see "Item 4. Information on the Company—B.
These preliminary data show that adding alemtuzumab to the FC lymphodepletion regimen was associated with sustained lymphodepletion and significantly higher UCART123 cell expansion, which correlated with improved anti-tumor activity. As of the date of this Annual Report, the AMELI-01 Study is currently enrolling patients.
These preliminary data show that adding alemtuzumab to the FC lymphodepletion regimen was associated with sustained lymphodepletion and significantly higher UCART123 cell expansion, which correlated with improved anti-tumor activity. As of the date of this Annual Report, the AMELI-01 Study is deprioritized.
Pursuant to this agreement, as amended in 2012, 2014, 2015 and 2022 we and our affiliates were granted an exclusive, worldwide, royalty-bearing, sublicensable license, under certain patents and patent applications owned by UMN, to make, use, sell, import, and otherwise 63 dispose of products covered by the licensed patents, for all fields of use.
Pursuant to this agreement, as amended in 2012, 2014, 2015 and 2022 we and our affiliates were granted an exclusive, worldwide, royalty-bearing, sublicensable license, under certain patents and patent applications owned by UMN, to make, use, sell, import, and otherwise dispose of products covered by the licensed patents, for all fields of use. These licensed patents relate to TALEN technology.
Patent and Trademark Office in granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier-filed patent. Our issued patents will expire on dates ranging from 2024 to 2038. If patents are issued on our pending patent applications, the resulting patents are projected to expire on dates ranging from 2024 to 2041.
Patent and Trademark Office in granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier-filed patent. Our issued patents will expire on dates ranging from 2025 to 2041. If patents are issued on our pending patent applications, the resulting patents are projected to expire on dates ranging from 2025 to 2045.
These cells interfere with normal hematopoiesis, thus contributing to the bone marrow failure which is the most common underlying cause of death. AML is the most common type of acute leukemia in adults with an age-adjusted incidence rate in the United States of 4.1 per 100,000 individuals per year, with approximately 20,050 new cases and 11,540 deaths estimated in 2022.
These cells interfere with normal hematopoiesis, thus contributing to the bone marrow failure which is the most common underlying cause of death. AML is the most common type of acute leukemia in adults with an age-adjusted incidence rate in the United States of 4.1 per 100,000 individuals per year, with approximately 20,800 new cases and 11,200 deaths estimated in 2024.
Cellectis’ equity interest in Cibus was reduced to 2.9% as of June 1, 2023, after the closing of the Merger, which resulted in Cellectis losing control of Cibus. Our Strategy Our strategy is to leverage the transformative potential of our unique gene-editing technologies and expertise through our cell therapy platform.
Cellectis’ equity interest in Cibus was reduced to 2.9% as of June 1, 2023, after the closing of the Merger, which resulted in Cellectis losing control of Cibus. Subsequently, Cellectis sold in full its remaining equity in Cibus. Our Strategy Our strategy is to leverage the transformative potential of our unique gene-editing technologies and expertise through our cell therapy platform.
Our UCART product candidates rely for each product candidate upon one or more patent rights protecting various aspects of the technologies, including rights relating to: • the genetic editing of T-cells, using TALEN technology, covered by approximately twelve Cellectis-owned patent families and three in-licensed patent families; • the insertion of transgenes into T-cells using electroporation of mRNA, covered by approximately five Cellectis-owned patent families; • the appending of attributes to T-cells, covered by approximately eight Cellectis-owned patent families and one in-licensed patent family; • the molecular structure of CARs, covered by approximately six Cellectis-owned patent families; and • specific CARs that target selected antigen markers are covered by approximately fifteen Cellectis-owned patent applications and one in-licensed patent family. 62 For additional information, see “—Gene-Editing Platform” below.
Our UCART product candidates rely for each product candidate upon one or more patent rights protecting various aspects of the technologies, including rights relating to: • the genetic editing of T-cells, using TALEN technology, covered by approximately twelve Cellectis-owned patent families and three in-licensed patent families; • the insertion of transgenes into T-cells using electroporation of mRNA, covered by approximately five Cellectis-owned patent families; • the appending of attributes to T-cells, covered by approximately eight Cellectis-owned patent families and one in-licensed patent family; • the molecular structure of CARs, covered by approximately six Cellectis-owned patent families; and • specific CARs that target selected antigen markers are covered by approximately fifteen Cellectis-owned patent applications and one in-licensed patent family.
Develop products with new properties, such as becoming, through PD1 or TGFBR2 inactivation, refractory to tumor- deployed T-cell inhibition mechanisms; or such as boosting CAR T-cell activity by controlled expression of immunomodulatory molecules, through targeted gene insertion at specific chosen loci.
Develop products with new properties, such as becoming, through PD1 or TGFBR2 inactivation, refractory to tumor-deployed T-cell inhibition mechanisms; or such as boosting CAR T-cell activity by controlled expression of immunomodulatory molecules, through targeted gene insertion at specific chosen loci. • New strategies to fight against solid tumors.
Business Overview We are a clinical stage biotechnological company, employing our core proprietary technologies to develop products based on gene-editing, with a portfolio of allogeneic Chimeric Antigen Receptor T-cells, or UCART, product candidates in the field of immuno-oncology and gene-edited hematopoietic stem and progenitor cells, or HSPC, product candidates in other therapeutic indications.
Business Overview We are a clinical stage biotechnological company, employing our core proprietary technologies to develop products based on gene-editing, with a portfolio of allogeneic Chimeric Antigen Receptor T-cells, or UCART, product candidates in the field of immuno-oncology and gene therapy product candidates in other therapeutic indications.
Certain of these issued patents and pending patent applications, which expire between 2031 and 2041, cover product claims or process claims relevant to each of our product candidates, including UCART19, UCART123, UCART22, UCARTCS1 and UCART20x22. Our gene-editing platform and each of our UCART product candidates benefits from the protections conferred by several patents and patent applications in our patent portfolio.
Certain of these issued patents and pending patent applications, which expire between 2031 and 2041, cover product claims or process claims relevant to each of our product candidates. Our gene-editing platform and each of our UCART product candidates benefits from the protections conferred by several patents and patent applications in our patent portfolio.
We may rely, in some circumstances, on trade secrets to protect our technology. However, trade secrets can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors.
However, trade secrets can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to: • the initiation, progress, timing, costs and results of pre-clinical and clinic studies for our product candidates; • the capacity of manufacturing our products in France and in the United States; • the outcome, timing and cost of regulatory approvals by U.S. and non-U.S. regulatory authorities, including the possibility that regulatory authorities will require that we perform more studies than those that we currently expect; • the ability of our product candidates to progress through clinical development successfully; • the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; • our need to expand our research and development activities; • our need and ability to hire additional personnel; 91 • our need to implement additional infrastructure and internal systems, including manufacturing processes for our product candidates; • the effect of competing technological and market developments; and • the cost of establishing sales, marketing and distribution capabilities for any products for which we may receive regulatory approval.
Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to: • the initiation, progress, timing, costs and results of pre-clinical and clinic studies for our product candidates; • the capacity of manufacturing our products in France and in the United States; • the outcome, timing and cost of regulatory approvals by U.S. and non-U.S. regulatory authorities, including the possibility that regulatory authorities will require that we perform more studies than those that we currently expect; • the ability of our product candidates to progress through clinical development successfully; • the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; • our need to expand our research and development activities; • our need and ability to hire additional personnel; • our need to implement additional infrastructure and internal systems, including manufacturing processes for our product candidates; • the effect of competing technological and market developments; and • the cost of establishing sales, marketing and distribution capabilities for any products for which we may receive regulatory approval.
The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors, including: • the scope, rate of progress and expense of our ongoing as well as any additional pre-clinical studies, clinical trials and other research and development activities; • clinical trial and early-stage results; • the terms and timing of regulatory approvals; • the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; • the ability to market, commercialize and achieve market acceptance for any product candidate that we may develop in the future; and Selling, General and Administrative Expenses 82 Selling, general and administrative expenses consist primarily of employee-related expenses for executive, business development, intellectual property, finance, legal and human resources functions.
The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors, including: • the scope, rate of progress and expense of our ongoing as well as any additional pre-clinical studies, clinical trials and other research and development activities; • clinical trial and early-stage results; • the terms and timing of regulatory approvals; • the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; • the ability to market, commercialize and achieve market acceptance for any product candidate that we may develop in the future; and Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of employee-related expenses for executive, business development, finance, legal and human resources functions.
Our net cash provided by financing activities reflects mainly the net proceeds of $10.5 million from Calyxt’s follow-on offering and proceeds under Calyxt’s ATM equity program, after $0.8 million transaction costs and the payment of $5.8 million received in respect of the 2021 research tax credit pre-financing, partially offset by the payments of lease debts for $12.8 million and of the “PGE” loan for $1.3 million, $0.6 million of transaction costs related to the Cellectis ATM program and the follow-on offering of Cellectis, each launched in 2023, as well as $0.4 million of interest paid on the “PGE” loan along with interests and capital paid on a loan with our landlord in New-York.
Our net cash provided by financing activities reflects mainly the net proceeds of $10.5 million from Calyxt’s follow-on offering and proceeds under Calyxt’s ATM equity program, after $0.8 million transaction costs and the payment of $5.8 million received in respect of the 2021 research tax credit pre-financing, partially offset by the payments of lease debts for $12.8 million and of the “PGE” loan for $1.3 million, $0.6 million of transaction costs related to the Cellectis ATM program and the follow-on offering of Cellectis, 88 each launched in 2023, as well as $0.4 million of interest paid on the “PGE” loan along with interests and capital paid on a loan with our landlord in New-York.
On February 7, 2023, Cellectis has announced the exercise by the underwriters, Jefferies LLC and Barclays Capital Inc., of their option (the “Option”) to purchase an additional 1,107,800 ordinary shares (the “Additional Ordinary Shares”) of the Company to be delivered in the form of an aggregate of 1,107,800 ADSs The total number of ordinary shares issued in the form of ADSs amounted to 9,907,800 with gross proceed of $24.8 million and the aggregate net proceeds to the Company, after deducting underwriting commissions and estimated offering expenses of approximately $22.8 million.
On February 7, 2023, Cellectis announced the exercise by the underwriters, Jefferies LLC and Barclays Capital Inc., of their option (the “Option”) to purchase an additional 1,107,800 ordinary shares (the “Additional Ordinary Shares”) of the Company to be delivered in the form of an aggregate of 1,107,800 ADSs The total number of ordinary shares issued in the form of ADSs amounted to 9,907,800 with gross proceed of $24.8 million and the aggregate net proceeds to the Company, after deducting underwriting commissions and estimated offering expenses of approximately $22.8 million.
Any of these events could significantly harm our business, financial condition and prospects. EIB Finance Contract On December 28, 2022, we entered into a Finance Contract with the EIB for up to €40.0 million in loans to support research and development activities to advance our pipeline of gene-edited allogeneic cell therapy candidate products for oncology indications (the “R&D Activities”).
Any of these events could significantly harm our business, financial condition and prospects. 89 EIB Finance Contract On December 28, 2022, we entered into a Finance Contract with the EIB for up to €40.0 million in loans to support research and development activities to advance our pipeline of gene-edited allogeneic cell therapy candidate products for oncology indications (the “R&D Activities”).
ATM Program On January 4, 2023, we entered into an amendment to the Sales Agreement, dated as of March 29, 2021, with Jefferies LLC with respect to an equity offering program under which we may offer and sell ADS having an aggregate offering price of up to $60.0 million from time to time following January 4, 2023, through Jefferies as our sales agent.
ATM Program On January 4, 2023, we entered into an amendment to the Sales Agreement, dated as of March 29, 2021, with Jefferies LLC with respect to an equity offering program under which we may offer and sell ADS having an aggregate offering price of up to $60.0 million 91 from time to time following January 4, 2023, through Jefferies as our sales agent.
Indeed, if a company meets certain criteria in terms of sales, headcount or assets to be considered a small/middle size company, such company can request immediate refund of the remaining tax credit, without application of the three-year period. As from January 2021, Cellectis S.A. no longer meets such criteria.
If a company meets certain criteria in terms of sales, headcount or assets to be considered a small/middle size company, such company can request immediate refund of the remaining tax credit, without application of the three-year period. As from January 2021, Cellectis S.A. no longer meets such criteria.
Until the parties are able to terminate our lease guaranty, Cibus. may not renew or extend Cibus’s lease or enter into any amendment that would increase our liability under the lease guaranty. Further, Cibus, from and after the closing of the Merger, agrees to indemnify us and our affiliates in connection with the Cibus lease and our guaranty thereof. C.
Until the parties are able to terminate our lease guaranty, Cibus. may not renew or extend Cibus’s lease or enter into any amendment that would increase our liability under the lease guaranty. Further, Cibus, from and after the closing of the Merger, agrees to indemnify us and our affiliates in connection with the Cibus lease and our guaranty thereof.
The lease has a term of twenty years with four options to extend its term for five years each subject to there being no default under the lease terms beyond any cure period and Calyxt occupying the property at the time of extension. 95 The lease commenced in May 2018.
The lease has a term of twenty years with four options to extend its term for five years each subject to there being no default under the lease terms beyond any cure period and Calyxt occupying the property at the time of extension. The lease commenced in May 2018.
We do not expect to generate material revenues from sales of our therapeutic product candidates unless and until we successfully complete development of, and obtain marketing approval for, one or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty.
We do not expect to generate material revenues from sales of our product candidates unless and until we successfully complete development of, and obtain marketing approval for, one or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty.
Under the Servier License Agreement, we are eligible to receive flat low double-digit royalties based on annual net sales of commercialized products as well as a low double-digit royalty on certain development milestone payments received by Servier.
Under the Servier License Agreement, we are eligible to receive flat low double-digit royalties based on annual net sales of commercialized products as well as a low double-digit royalty on certain development milestone payments received by Servier under sublicenses.
As of December 31, 2023, we were eligible to receive payments pursuant to the AZ JRCA of an option exercise fee and development, regulatory and sales-related milestone payments, ranging from $70 million up to $220 million, per each of the 10 candidate products covered by the AZ JRCA, plus tiered royalties, which may range from mid-single to low-double digits, based on the sale of Licensed Products.
As of December 31, 2024, we were eligible to receive payments pursuant to the AZ JRCA of an option exercise fee and development, regulatory and sales-related milestone payments, ranging from $70 million up to $220 million, per each of the 10 candidate products covered by the AZ JRCA, plus tiered royalties, which may range from mid-single to low-double digits, based on the sale of Licensed Products.
Our audited consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB.
Our audited consolidated financial statements have been prepared in accordance with IFRS Accounting standards, as issued by the International Accounting Standards Board, or IASB.
Trend Information For a discussion of trends, see “Item 4.B—Business Overview,” “Item 5.A—Operating Results” and “Item 5.B—Liquidity and Capital Resources.” Other than as disclosed in these sections, we are not aware of any trends, uncertainties, demands, commitments or events since December 31, 2023 that are reasonably likely to have a material adverse effect on our revenues, income, profitability, liquidity or capital resources, or that would cause the disclosed financial information to be not necessarily indicative of future operating results or financial condition.
Trend Information For a discussion of trends, see “Item 4.B—Business Overview,” “Item 5.A—Operating Results” and “Item 5.B—Liquidity and Capital Resources.” Other than as disclosed in these sections, we are not aware of any trends, uncertainties, demands, commitments or events since December 31, 2024 that are reasonably likely to have a material adverse effect on our revenues, income, profitability, liquidity or capital resources, or that would cause the disclosed financial information to be not necessarily indicative of future operating results or financial condition. 93
We use judgement to determine the fair value of share-based awards at the grant date. Fair value is estimated using the Black-Scholes valuation model for stock options valuation. The determination of the fair value using an option-pricing model is affected by assumptions and variables including the expected term, expected volatility, risk-free interest rates and expected dividends.
We use judgment to determine the fair value of share-based awards at the grant date. Fair value is estimated using the Black-Scholes valuation model for stock options valuation. The determination of the fair value using an option-pricing model is affected by assumptions and variables including the expected term, expected volatility, risk-free interest rates and expected dividends.
We do not expect the impact of a potential discrepancy between the management calculation and the actual amount collected to have a material impact on our Consolidated Financial Statements. • Share-Based Compensation (Note 17) We account for share-based compensation in accordance with IFRS 2 Share-based payment.
We do not expect the impact of a potential discrepancy between the management calculation and the actual amount collected to have a material impact on our Consolidated Financial Statements. • Share-Based Compensation (Note 18 of the Consolidated Financial Statements) We account for share-based compensation in accordance with IFRS 2 Share-based payment.
The Finance Contract provides for funding in three tranches as follows: (i) an initial tranche of €20.0 million (“Tranche A”); (ii) a second tranche of €15.0 million (“Tranche B”); and (iii) a third tranche of €5.0 million (“Tranche C,” and each of Tranche A, Tranche B, and Tranche C, a “Tranche”), each issuable only in full.
The Finance Contract provided for funding in three tranches as follows: (i) an initial tranche of €20.0 million (“Tranche A”); (ii) a second tranche of €15.0 million (“Tranche B”); and (iii) a third tranche of €5.0 million (“Tranche C,” and each of Tranche A, Tranche B, and Tranche C, a “Tranche”), each issuable only in full.
When a specific research and development program is put on hold, as agreed by our customer as part of a joint executive committee decision, the revenue recognition continues to be deferred until research and development efforts resume. If the joint decision is to abandon the project, deferred revenue is fully recognized.
When a specific research and development program is put on hold, as agreed by our partner as part of a joint executive committee decision, the revenue recognition continues to be deferred until research and development efforts resume. If the joint decision is to abandon the project, deferred revenue is fully recognized.
Financial Overview The following selected statements of consolidated operations data for the years ended December 31, 2021, 2022 and 2023 and the selected statement of consolidated financial position data as of December 31, 2022 and 2023 have been derived from our audited consolidated financial statements included elsewhere in this Annual Report.
Financial Overview The following selected statements of consolidated operations data for the years ended December 31, 2022, 2023 and 2024 and the selected statement of consolidated financial position data as of December 31, 2023 and 2024 have been derived from our audited consolidated financial statements included elsewhere in this Annual Report.
The increase in financial expenses of $22.8 million between the years ended December 31, 2022 and 2023 is mainly attributable to the loss in fair value on our retained investment in Cibus since Calyxt's deconsolidation for $5.9 million, the $5.7 million loss in fair value of the derivative instrument on the Subsequent Investment Agreement with AstraZeneca (see following paragraph), a $11.9 million increase in foreign exchange loss (from a $1.5 million loss in 2022 to a $13.4 million loss in 2023), a $2.4 million loss on change in fair value of the EIB warrants, an interest expense on EIB loan of $1.5 million, and a BPI research tax credit prefinancing interest expense of $0.4 million, partially offset by a $4.4 million decrease in the financial loss related to Cytovia's receivable ($7.8 million loss in 2023 compared with a $12.1 million loss in 2022) and a $0.4 million decrease of interest expense on lease liabilities.
The increase in financial expenses of $22.8 million between the years ended December 31, 2022 and 2023 is mainly attributable to the loss in fair value on our retained investment in Cibus since Calyxt's deconsolidation for $5.9 million, the $5.7 million loss in fair value of the derivative instrument on the SIA with AstraZeneca, a $11.9 million increase in foreign exchange loss (from a $1.5 million loss in 2022 to a $13.4 million loss in 2023), a $2.4 million loss on change in fair value of the EIB warrants, an interest expense on EIB loan of $1.5 million, and a BPI research tax credit prefinancing interest expense of $0.4 million, partially offset by a $4.4 million decrease in the financial loss related to Cytovia's receivable ($7.8 million loss in 2023 compared with a $12.1 million loss in 2022) and a $0.4 million decrease of interest expense on lease liabilities.
Our current research and development focuses primarily on our CAR T-cell immunotherapy and HSPC product candidates, including conducting the pre-clinical activities, and preparing to conduct clinical studies of our UCART product candidates, providing general and administrative support for these operations and protecting our intellectual property.
Our current research and development focuses primarily on our CAR T-cell immunotherapy and gene therapy product candidates, including conducting the pre-clinical activities, and preparing to conduct clinical studies of our UCART product candidates, providing general and administrative support for these operations and protecting our intellectual property.
Our consolidated financial statements for 2021, 2022 and 2023 have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. 80 Financial Operations Overview Revenues and Other Income Collaboration agreements and licenses We derive substantially all of our therapeutics revenues from milestone payments and royalties on licensed technologies.
Our consolidated financial statements for 2022, 2023 and 2024 have been prepared in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board, or IASB. 80 Financial Operations Overview Revenues and Other Income Collaboration agreements and licenses We derive substantially all of our therapeutics revenues from milestone payments, services and royalties on licensed technologies and collaboration agreements.
Year Ended December 31, 2023 Our net cash flows used in operating activities of $24.7 million are mainly due to cash payments from Cellectis to suppliers of $47.7 million, Cellectis’ wages and social expenses paid of $39.7 million and Calyxt’s operating payments of $3.6 million, offset mainly by the $35.7 million of the proceeds from the Initial Investment Agreement with AstraZeneca reallocated to the AZ JRCA and therefore classified within operating activities, $25.0 million of upfront payment from the Joint Research and Collaboration Agreement with AstraZeneca, $2.0 million of cash-in from licensing revenue of Cellectis, $1.0 million of cash-in on from tax refund related to stock-options and $3.6 million of cash-in from income on financial investments.
Year Ended December 31, 2023 Our net cash flows used in operating activities of $24.7 million are mainly due to cash payments from Cellectis to suppliers of $47.7 million, Cellectis’ wages and social expenses paid of $39.7 million and Calyxt’s operating payments of $3.6 million, offset mainly by the $35.7 million of the proceeds from the IIA with AstraZeneca reallocated to the AZ JRCA and therefore classified within operating activities, $25.0 million of upfront payment from the AZ JRCA, $2.0 million of cash-in from licensing revenue of Cellectis, $1.0 million of cash-in on from tax refund related to stock-options and $3.6 million of cash-in from income on financial investments.
Information on the Company—B. Business Overview—UCART Pipeline.” For a discussion of our operating capital requirements and funding sources, please see “Liquidity and Capital Resources” below. Financial Operations Overview We have incurred net losses in nearly each year since our inception.
Information on the Company-B.Business Overview-Our Strategy." For a discussion of our operating capital requirements and funding sources, please see “Liquidity and Capital Resources” below. Financial Operations Overview We have incurred net losses in nearly each year since our inception.
Each of our material subsidiaries guarantees our obligations under the Finance Contract. References to our subsidiaries exclude Calyxt, Inc. The disbursement of each Tranche is conditioned upon certain documentary conditions, including the execution of a warrant agreement with respect to the EIB Warrants (as defined below). Each Tranche is subject to additional specific conditions precedent.
Each of our material subsidiaries guarantees our obligations under the Finance Contract. References to our subsidiaries exclude Calyxt, Inc. The disbursement of each Tranche is conditioned upon certain documentary conditions, including the execution of a warrant agreement with respect to the EIB Warrants (as defined below).
Cellectis decided to discontinue the ATM. 94 Joint Research Collaboration Agreement and Investment Agreements with AstraZeneca In addition to an upfront payment of $25 million made by AZ Ireland to Cellectis, under the AZ JRCA, AZ Ireland will reimburse Cellectis for its budgeted research costs associated with targets identified under the AZ JRCA.
Joint Research Collaboration Agreement and Investment Agreements with AstraZeneca In addition to an upfront payment of $25 million made by AZ Ireland to Cellectis, under the AZ JRCA, AZ Ireland will reimburse Cellectis for its budgeted research costs associated with targets identified under the AZ JRCA.
All tables referring to the year-end period ended December 31, 2023 present Calyxt’s results over a five-month period from January 1, 2023 to May 31, 2023.
All tables referring to the years ended December 31, 2023 present Calyxt’s results over a five-month period from January 1, 2023 to May 31, 2023.
See "Note Regarding Use of Non-IFRS Financial Measures" for important information. Overview We are a clinical stage biotechnological company, employing our core proprietary technologies to develop products based on gene-editing with a portfolio of allogeneic UCART product candidates in the field of immuno-oncology, gene-edited hematopoietic stem and progenitor cells (“HSPC”) product candidates in other therapeutic indications.
See "Note Regarding Use of Non-IFRS Financial Measures" for important information. Overview We are a clinical stage biotechnological company, employing our core proprietary technologies to develop products based on gene-editing with a portfolio of allogeneic UCART product candidates in the field of immuno-oncology and gene therapy product candidates in other therapeutic indications.
Financial Gain (Loss) Financial gain (loss) mainly consists of interest income related to our savings accounts and bank deposits, exchange gains and losses associated with transactions in foreign currencies and fair value of our financial assets, derivative instruments and interests associated with lease debts and financial liabilities.
Financial Gain (Loss) Financial gain (loss) mainly consists of (i) interest income related to our savings accounts and bank deposits, (ii) exchange gains and losses associated with transactions in foreign currencies, (iii) changes in the fair value of our financial assets and derivative instruments, and (iv) interests associated with lease debts and financial liabilities.
The audited consolidated financial statements for the years, and as of, December 31, 2021, 2022 and 2023 are presented in U.S. dollars, which differs from the functional currency of Cellectis S.A., which is the Euro.
The audited consolidated financial statements as of December 31, 2023 and 2024 and for the years ended December 31, 2022, 2023 and 2024 are presented in US dollars, which differs from the functional currency of Cellectis S.A., which is the Euro.
This former segment was only related to assets held for sale until May 31, 2023. This segment is presented as assets held for sale as of December 31, 2022 and discontinued operations for the year-end periods ended December 31, 2023 and 2022. For more information on our reportable segments, see Note 4.5 to our consolidated financial statements.
This former segment was only related to assets held for sale until May 31, 2023. This segment is presented as assets held for sale and discontinued operations for the year ended December 31, 2023. For more 83 information on our reportable segments, see Note 4.3 to our consolidated financial statements.
We anticipate that such expenses will increase substantially if and as we: • progress our sponsored clinical trials AMELI-01, BALLI-01, and NATALI-01 and initiate additional clinical trials for other self-owned product candidates; • continue to advance the research and development of our current and future immuno-oncology product candidates; advance research and development efforts for our HSPC product candidates; • further develop and refine the manufacturing process for our immuno-oncology product candidates; • maintain our manufacturing facilities in Paris (France) and Raleigh (North Carolina, USA), continue production at our in-house manufacturing facilities and change or add additional manufacturers or suppliers of biological materials to support our in-house manufacturing capabilities; • seek regulatory and marketing approvals for our product candidates, if any, that successfully complete development; • establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval; • support our licensees and partners in accordance with applicable license and collaboration agreements; • seek to identify and validate additional product candidates; • acquire or in-license other product candidates, technologies or biological material; • make milestone or other payments under any in-license agreements; • maintain, protect and expand our intellectual property portfolio; • seek to attract and retain new and existing skilled personnel; • create additional infrastructure to support our operations as a public company; and • experience any delays or encounter issues with any of the above.
We anticipate that such expenses will increase substantially if and as we: • progress our clinical studies BALLI-01 and NATHALI-01; • continue to advance the research and development of our current and future immuno-oncology product candidates; advance research and development efforts for our gene therapy product candidates; • further develop and refine the manufacturing process for our immuno-oncology product candidates; • maintain our manufacturing facilities in Paris (France) and Raleigh (North Carolina, USA), continue production at our in-house manufacturing facilities and change or add additional manufacturers or suppliers of biological materials to support our in-house manufacturing capabilities; • seek regulatory and marketing approvals for our product candidates, if any, that successfully complete development; • establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval; • seek to identify and validate additional product candidates; • acquire or in-license other product candidates, technologies or biological material; • make milestone or other payments under any in-license agreements; • maintain, protect and expand our intellectual property portfolio; • seek to attract and retain new and existing skilled personnel; • experience any delays or encounter issues with any of the above.
Upfront payments for research and development programs are deferred as a contract liability and recognized when the performance obligation is satisfied, as the customer receives the benefits of the services.
All considerations payments for research and development programs are deferred as a contract liability and recognized when the performance obligation is satisfied, as the partner receives the benefits of the services.
Any outstanding EIB Warrants will become exercisable upon the earliest to occur of (i) a change of control event, (ii) the maturity date of Tranche A, (iii) a public take-over bid approved by the Company’s board of directors, (iv) a sale of all or substantially all of the assets of Cellectis and its subsidiaries, (v) a debt repayment event—i.e., any mandatory repayment pursuant to the Finance Contract or any voluntary payment of more than 75% of any Tranche—in respect of one or more Tranches, or (vi) the receipt of a written demand for repayment from EIB in connection with an event of default under the Finance Contract (each an “Exercise Event”). 93 Following any Exercise Event and until expiration of the applicable EIB Warrants, the EIB may exercise a put option by which the EIB may request the Company to repurchase all or part of such then-exercisable EIB Warrants.
Any outstanding EIB Warrants will become exercisable upon the earliest to occur of (i) a change of control event, (ii) the maturity date of Tranche A, (iii) a public take-over bid approved by the Company’s board of directors, (iv) a sale of all or substantially all of the assets of Cellectis and its subsidiaries, (v) a debt repayment event—i.e., any mandatory repayment pursuant to the Finance Contract or any voluntary payment of more than 75% of any Tranche—in respect of one or more Tranches, or (vi) the receipt of a written demand for repayment from EIB in connection with an event of default under the Finance Contract (each an “Exercise Event”).
Concurrent with entering the lease, Cellectis guaranteed the lease agreement for Calyxt’s headquarters. However, Calyxt previously agreed to indemnify Cellectis for any obligations under this guaranty, effective upon Cellectis’ ownership falling to 50 percent or less of Calyxt’s outstanding common stock. Accordingly, Calyxt’s indemnification obligation was triggered in October 2022.
However, Calyxt previously agreed to indemnify Cellectis for any obligations under this guaranty, effective upon Cellectis’ ownership falling to 50 percent or less of Calyxt’s outstanding common stock. Accordingly, Calyxt’s indemnification obligation was triggered in October 2022.
Furthermore, in the case of any public take-over bid from a third party or a sale of all outstanding shares of the Company to any person or group of persons acting in concert, in the context of a group of specified Company shareholders acting in concert, the Company shall be entitled to repurchase all, but not less than all, of the EIB Warrants at a price equal to the greater of (a) 0.3 times the amount disbursed under the Finance Contract divided by the aggregate number of EIB Warrants issued (reduced by the number of exercised EIB Warrants) and (b) the fair market value of the EIB Warrants.
The exercise of such put options would be at the fair market value of the EIB Warrants, subject to a cap equal to the aggregate principal amount disbursed by EIB pursuant to the Finance Contract, reduced by certain repaid amounts, at the time of exercise of the put option. 90 Furthermore, in the case of any public take-over bid from a third party or a sale of all outstanding shares of the Company to any person or group of persons acting in concert, in the context of a group of specified Company shareholders acting in concert, the Company shall be entitled to repurchase all, but not less than all, of the EIB Warrants at a price equal to the greater of (a) 0.3 times the amount disbursed under the Finance Contract divided by the aggregate number of EIB Warrants issued (reduced by the number of exercised EIB Warrants) and (b) the fair market value of the EIB Warrants.
State Guaranteed Loan (“PGE”) We received the PGE loan on July 2020 of $18.5 million (including interest) (or $20.4 million using exchange rate as of December 31, 2023) of which $14.1 million remains outstanding, from a bank syndicate formed with HSBC, Société Générale, Banque Palatine and BPI.
State Guaranteed Loan (“PGE”) We received the PGE loan on July 2020 of €18.5 million (or $19.2 million using exchange rate as of December 31,2024) of which €8.1 million remains outstanding, from a bank syndicate formed with HSBC, Société Générale, Banque Palatine and BPI.
Companies demonstrating that they have research expenditures that meet the required CIR criteria receive a tax credit that may be used for the payment of their income tax due for the fiscal year in which the expenditures were incurred and during the next three fiscal years.
Companies demonstrating that they have research expenditures that meet the required CIR criteria receive a tax credit that may be used for the payment of their income tax due for the fiscal year in which the expenditures were incurred and during the next three fiscal years. Any unused portion of the tax credit is then refunded by the French treasury.
Under the lease, Calyxt pays an annual base rent of eight percent of the total project cost with scheduled increases in rent of 7.5 percent on the sixth, eleventh, and sixteenth anniversaries of the start of the lease commencement as well as on the first day of each renewal term.
Under the lease, Calyxt pays an annual base rent of eight percent of the total project cost with scheduled increases in rent of 7.5 percent on the sixth, eleventh, and sixteenth anniversaries of the start of the lease commencement as well as on the first day of each renewal term. 92 Concurrent with entering the lease, Cellectis guaranteed the lease agreement for Calyxt’s headquarters.
Personnel expenses decreased by $0.3 million from $7.7 million in 2022 to $7.4 million in 2023 primarily due to a $0.7 million decrease in non-cash stock-based compensation expense mainly consecutive to the probable non achievement of certain performance obligations .
Between the years ended December 31, 2022 and 2023, selling, general and administrative expenses decreased by $0.7 million. Personnel expenses decreased by $0.3 million from $7.7 million in 2022 to $7.4 million in 2023 primarily due to a $0.7 million decrease in non-cash stock-based compensation expense mainly consecutive to the probable non achievement of certain performance obligations.
The decrease in net loss attributable to non-controlling interests of $0.5 million is mainly due to the deconsolidation of Calyxt on June 1, 2023, partially offset by the increase of Calyxt's net loss over the first five months of 2023 compared to the same period in 2022 During the year ended December 31, 2022, we recorded $7.9 million in loss attributable to non-controlling interests.
The decrease in net loss attributable to non-controlling interests of $0.5 million is mainly due to the deconsolidation of Calyxt on June 1, 2023, partially offset by the increase of Calyxt's net loss over the first five months of 2023 compared to the same period in 2022. B.
The former Plants segment corresponded to the activity of Calyxt. As from June 1, 2023 and the deconsolidation of Calyxt, we view our operations and manage our business in a single operating and reportable segment corresponding to the Therapeutics segment. As of May 31, 2023, immediately prior the consummation of the Merger, we owned a 48.0% equity interest in Calyxt.
Operating Results Preliminary Note Regarding Calyxt Since June 1, 2023 and the deconsolidation of Calyxt, we view our operations and manage our business in a single operating and reportable segment corresponding to the Therapeutics segment. As of May 31, 2023, immediately prior the consummation of the Merger, we owned a 48.0% equity interest in Calyxt.
The fair value of the loan on October 6, 2023 was $1.0 million, resulting in a grant of $0.9 million.We therefore recognized a $1.4 million grant in profit and loss for the year ended December 31, 2023, in addition to the $0.3 million contractual grant, as the subsidized expenses have been incurred and the contractual conditions for obtaining the subsidy have been met.
On October 10, 2023, we received an additional payment of $1.9 million, with a fair value of the loan amounting to $1.0 million, resulting in a grant of $0.9 million.We therefore recognized a $1.4 million grant in profit and loss for the year ended December 31, 2023, in addition to the $0.3 million contractual grant, as the subsidized expenses have been incurred and the contractual conditions for obtaining the subsidy have been met. 84 Cost of revenue.
For the twelve-month period ended December 31, 2023, we mainly derived our Therapeutics revenues from the research collaboration and exclusive license agreement with Iovance, and from other license agreements for the use of our TALEN technology. On September 15, 2022, Servier sent to us and Allogene a notice of discontinuation of its involvement in the development of the CD19 Products.
For the twelve-month period ended December 31, 2024, we mainly derived our Therapeutics revenues from the JRCA with AstraZeneca, and from other license agreements for the use of our gene editing technology. On September 15, 2022, Servier sent to us and Allogene a notice of discontinuation of its involvement in the development of the CD19 Products.
Research and development expenses consist primarily of: • personnel costs, including salaries, related benefits and share-based compensation, for our employees engaged in scientific research and development functions; • cost of third-party contractors such as contract research organizations, or CROs, and academic institutions involved in pre-clinical or clinical trials that we may conduct, or third-party contractors involved in field trials; • purchases and manufacturing of biological materials, real-estate leasing costs as well as conferences and travel costs; • costs to write and support the research for filing patents and; • certain other expenses, such as expenses for use of laboratories and facilities for our research and development activities.
Research and Development Expenses We engage in substantial research and development efforts to develop innovative CAR T-cell immunotherapy. 81 Research and development expenses consist primarily of: • personnel costs, including salaries, related benefits and share-based compensation, for our employees engaged in scientific research and development functions; • cost of third-party contractors such as contract research organizations, or CROs, and academic institutions involved in pre-clinical or clinical trials that we may conduct, or third-party contractors involved in field trials; • purchases and manufacturing of biological materials, real-estate leasing costs as well as conferences and travel costs; • costs to write and support the research for filing patents and; • expenses related to several license agreements we have entered into to obtain access to technology that we use in our product development efforts. • certain other expenses, such as expenses for use of laboratories and facilities for our research and development activities.
As of the date of this Annual Report, we have not sold any ADS under the amended program subsequent to such date.
As of the date of this Annual Report, we have not sold any ADS under the amended program subsequent to such date. In 2024, Cellectis decided to discontinue the ATM.
We have funded our operations since inception primarily through private and public offerings of our equity securities, grant revenues, payments received under patent licenses, reimbursements of research tax credit claims and payments under our licensing agreements with Allogene and Servier.
We have funded our operations since inception primarily through private and public offerings of our equity securities, grant revenues (including payments of research tax credits), and payments received under collaboration and licensing agreements with Allogene, Servier and AstraZeneca.
As of December 31, 2023, our lease guaranty represents a liability in the amount of $22.9 million over the remaining 14 years lease period. Cibus, however, will not be required to replace us as guarantor or pay any fees in connection with termination of the guaranty.
As of December 31, 2024, our lease guaranty represents a potential obligation in the amount of $21.4 million over the remaining 13 years lease period. Cibus, however, will not be required to replace us as guarantor or pay any fees in connection with termination of the guaranty.
Bpifrance Participations, Baillie Gifford & Co. and Long Focus Capital Management LLC, existing shareholders of the Company, were allocated in the aggregate more than half of the ADS sold in the global offering.
Pricing occurred on February 2, 2023, at $2.50 per ADS . Bpifrance Participations, Baillie Gifford & Co. and Long Focus Capital Management LLC, existing shareholders of the Company, were allocated in the aggregate more than half of the ADS sold in the global offering.
We classify personnel and other costs related to information technology, human resources, business development, legal, intellectual property and general management in research and development expense based on the time that employees spent contributing to research and development activities versus general and administrative activities.
We classify personnel and other costs related to information technology, human resources, business development, legal, intellectual property and general management in research and development expense based on the contribution of each of these departments to research and development activities versus general and administrative activities.
Purchases, external expenses and other decreased by $4.4 million (from $54.9 million in 2022 to $50.5 million in 2023) mainly relating to lower consumables purchases and subcontracting expenses due to continuing internalization of our manufacturing and quality activities to support our R&D pipeline. Between the years ended December 31, 2021 and 2022, research and development expenses decreased by $20.4 million.
Purchases, external expenses and other decreased by $4.4 million (from $54.9 million in 2022 to $50.5 million in 2023) mainly relating to lower consumables purchases and subcontracting expenses due to continuing internalization of our manufacturing and quality activities to support our R&D pipeline. Selling, general and administrative expenses.
For the year ended December 31, 2021 2022 2023 $ in thousands Revenues and other income 38,597 25,725 9,193 Operating expenses Cost of revenue (1,844 ) (1,772 ) (737 ) Research and development expenses (117,840 ) (97,501 ) (87,646 ) Selling, general and administrative expenses (22,882 ) (17,494 ) (16,812 ) Other operating income and expenses 488 1,377 (1,300 ) Operating income (loss) (103,481 ) (89,666 ) (97,302 ) Financial gain (loss) 6,731 - (8,935 ) - (19,163 ) Income tax - (87 ) (371 ) Income (loss) from continuing operations (96,749 ) (98,688 ) (116,835 ) Income (loss) from discontinued operations (28,358 ) (15,345 ) 8,392 Net income (loss) (125,107 ) (114,034 ) (108,443 ) Attributable to shareholders of Cellectis (114,197 ) (106,139 ) (101,059 ) Attributable to non-controlling interests (10,910 ) (7,894 ) (7,384 ) Earnings per share attributable to shareholders of Cellectis (1) Basic and diluted (2) (2.55 ) (2.33 ) (1.77 ) Number of shares used for computing Basic and diluted (1) 44,820,279 45,547,359 57,012,815 Other operating data Adjusted Net Income (Loss) attributable to shareholders of Cellectis (3) (101,700 ) (98,069 ) (93,973 ) (1) See Note 18 to our consolidated financial statements for further details on the calculation of basic and diluted loss per ordinary share.
For the year ended December 31, 2022 2023 2024 $ in thousands Revenues and other income 25,725 9,193 49,217 Operating expenses Cost of revenue (1,772 ) (737 ) - Research and development expenses (97,501 ) (87,646 ) (90,536 ) Selling, general and administrative expenses (17,494 ) (16,812 ) (19,085 ) Other operating income and expenses 1,377 (1,300 ) 849 Operating income (loss) (89,666 ) (97,302 ) (59,554 ) Financial gain (loss) (8,935 ) - (19,163 ) - 22,793 Income tax (87 ) (371 ) (0 ) Income (loss) from continuing operations (98,688 ) (116,835 ) (36,761 ) Income (loss) from discontinued operations (15,345 ) 8,392 - Net income (loss) (114,034 ) (108,443 ) (36,761 ) Attributable to shareholders of Cellectis (106,139 ) (101,059 ) (36,761 ) Attributable to non-controlling interests (7,894 ) (7,384 ) - Earnings per share attributable to shareholders of Cellectis (1) Basic and diluted (2) (2.33 ) (1.77 ) (0.41 ) Number of shares used for computing Basic and diluted (1) 45,547,359 57,012,815 90,566,346 Other operating data Adjusted Net Income (Loss) attributable to shareholders of Cellectis (3) (98,069 ) (93,973 ) (33,594 ) (1) See Note 19 to our consolidated financial statements for further details on the calculation of basic and diluted loss per ordinary share.
For the year ended December 31, % change 2021 2022 2023 2023 vs 2022 Other operating income (expenses) 488 1,377 (1,300 ) -194.4 % The increase in other operating expenses between the years ended December 31, 2022 and 2023 amounted to $2.7 million and is mainly related to the recognition of costs related to a commercial litigation for $0.5 million and the unfavorable outcome of the litigation with the French administration which led to the reimbursement of $0.7million of research tax credit and the provision for risk of $0.5 million related to 2015 and 2016 research tax credit and the favorable outcome of a claim with the French social tax authorities regarding tax on stock options for $1.0 million that was a one-time item recognized in 2022.
Other operating income and expenses For the year ended December 31, % change 2022 2023 2024 2024 vs 2023 Other operating income (expenses) 1,377 (1,300 ) 849 -165.3 % The decrease in other operating income (expenses) between the years ended December 31, 2023 and 2024 amounted to $2.0 million and is primarily related to non-recurring expenses recorded in 2023 in connection with (i) a research tax credit litigation for which $0.7 million were paid in 2023 and $0.5 million were accrued in 2023 and settled in 2024, and (ii) a commercial litigation accrued in 2023 for $0.5 million and not yet settled as of December 31, 2024. 85 The increase in other operating expenses between the years ended December 31, 2022 and 2023 amounted to $2.7 million and is mainly related to the recognition of costs related to a commercial litigation for $0.5 million and the unfavorable outcome of the litigation with the French administration which led to the reimbursement of $0.7 million of research tax credit and the provision for risk of $0.5 million related to 2015 and 2016 research tax credit and the favorable outcome of a claim with the French social tax authorities regarding tax on stock options for $1.0 million that was a one-time item recognized in 2022.
See “Note Regarding Use of Non-IFRS Financial Measures. 78 Statement of Consolidated Financial Position Data As of December 31, 2021 2022 2023 $ in thousands Current financial assets and Cash and cash equivalents 186,135 97,697 203,815 Other assets 195,941 163,519 130,456 Total assets 382,076 261,216 334,270 Shareholders' equity 236,474 125,941 84,695 Non current liabilities 96,254 72,279 94,431 Current liabilities 49,348 62,996 155,144 Total shareholders' equity and liabilities 382,076 261,216 334,270 Reconciliation of Adjusted Net Income (Loss) attributable to shareholders of Cellectis to Net Income (Loss) attributable to shareholders of Cellectis For the year ended December 31, 2021 2022 2023 $ in thousands Net Income (Loss) attributable to shareholders of Cellectis (114,197 ) (106,139 ) (101,059 ) Adjustment of non-cash stock-based compensation expense from continued operations: Research and development expenses 9,381 4,098 3,952 Selling, general and administrative expenses 2,113 1,945 1,281 Total non-cash stock-based compensation expense from continued operations 11,493 6,043 5,233 Adjustment of non-cash stock-based compensation expense from discontinued operations 1,625 4,132 3,859 Non-cash stock-based compensation expense attributable to non controlling interests (621 ) (2,105 ) (2,006 ) Adjusted Net Income (Loss) attributable to shareholders of Cellectis ** (101,700 ) (98,069 ) (93,973 ) ** Non-IFRS financial measure.
See “Note Regarding Use of Non-IFRS Financial Measures. 78 Statement of Consolidated Financial Position Data As of December 31, 2022 2023 2024 $ in thousands Current financial assets and Cash and cash equivalents 97,697 203,815 260,306 Other assets 163,519 130,456 123,238 Total assets 261,216 334,270 383,544 Shareholders' equity 125,941 84,695 131,033 Non current liabilities 72,279 94,431 86,241 Current liabilities 62,996 155,144 166,269 Total shareholders' equity and liabilities 261,216 334,270 383,544 Reconciliation of Adjusted Net Income (Loss) attributable to shareholders of Cellectis to Net Income (Loss) attributable to shareholders of Cellectis For the year ended December 31, 2022 2023 2024 $ in thousands Net Income (Loss) attributable to shareholders of Cellectis (106,139 ) (101,059 ) (36,761 ) Adjustment of non-cash stock-based compensation expense from continued operations: Research and development expenses 4,098 3,952 2,028 Selling, general and administrative expenses 1,945 1,281 1,139 Total non-cash stock-based compensation expense from continued operations 6,043 5,233 3,167 Adjustment of non-cash stock-based compensation expense from discontinued operations 4,132 3,859 0 Non-cash stock-based compensation expense attributable to non controlling interests (2,105 ) (2,006 ) 0 Adjusted Net Income (Loss) attributable to shareholders of Cellectis * (98,069 ) (93,973 ) (33,594 ) ** Non-IFRS financial measure.
Administrative expenses also include facility-related costs and service fees, other professional services and recruiting fees. We classify personnel and other costs related to information technology, human resources, business development, legal, intellectual property and general management in research and development expense based on the time that employees spent contributing to research and development activities versus general and administrative activities.
Administrative expenses also include facility-related costs and service fees, other professional services and recruiting fees. We classify personnel and other costs related to information technology, human resources, business development, legal and general management in general and administrative expenses based on the contribution of each of these departments to general and administrative activities versus research and development activities.
Critical Accounting Policies and Estimates Some of the accounting methods and policies used in preparing our financial statements under IFRS are based on complex and subjective assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the circumstances concerned.
Differences arising on settlement or translation of monetary items are recognized as financial income or expenses in profit or loss. 82 Critical Accounting Policies and Estimates Some of the accounting methods and policies used in preparing our financial statements under IFRS Accounting Standards are based on complex and subjective assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the circumstances concerned.
The Warrant Agreement contains certain customary representations and warranties by the Company and is governed by French law. Drawdowns under the Finance Contract – Tranches A and B On March 30, 2023, the Company announced the drawdown of the first tranche under the Finance Contract in the amount of €20 million (“Tranche A”), disbursed by the EIB in April 2023.
Drawdowns under the Finance Contract – Tranches A, B and C On March 30, 2023, the Company announced the drawdown of the first tranche under the Finance Contract in the amount of €20 million (“Tranche A”), disbursed by the EIB in April 2023.
Our research and development efforts are focused on our existing product candidates, (i) UCART123 product candidate evaluated in the AMELI-01 Study since February 2017, (ii) UCART22 product candidate evaluated in the BALLI-01 Study since November 2019, (iii) UCART20x22 product candidate evaluated in the NaThaLi-01 Study since August 2022 and (v) other product candidates which are in the pre-clinical development phases.
Our research and development efforts are focused on our product candidates (i) UCART123, previously evaluated in the AMELI-01 Study (until November 2024), (ii) UCART22, currently evaluated in the BALLI-01 Study, (ii) UCART20x22, currently evaluated in the NATHALI-01 Study and (iii) other product candidates which are in the pre-clinical development phases.
For the year ended December 31, 2021 2022 2023 $ in thousands Net cash flows provided by (used in) operating activities (104,562 ) (87,444 ) (24,746 ) Net cash flows provided by (used in) investing activities 7,279 (2,761 ) (15,510 ) Net cash flows provided by (used in) financing activities 47,525 1,145 82,865 Total (49,758 ) (89,060 ) 42,608 Effect of exchange rate changes on cash (5,754 ) (3,360 ) 884 With respect to Calyxt, see Note 3 to our consolidated financial statements for more information on our scope of consolidation and non-consolidated entities, and Note 5 to our consolidated financial statements for more information on discontinued operations.
Cash flows from Calyxt, which is classified as discontinued operations in the financial statements as of December 31, 2023 and as of December 31, 2022, are included in the figures presented below. 87 For the year ended December 31, 2022 2023 2024 $ in thousands Net cash flows provided by (used in) operating activities (87,444 ) (24,746 ) 22,989 Net cash flows provided by (used in) investing activities (2,761 ) (15,510 ) (102,808 ) Net cash flows provided by (used in) financing activities 1,145 82,865 89,113 Total (89,060 ) 42,608 9,295 Effect of exchange rate changes on cash (3,360 ) 884 (2,752 ) With respect to Calyxt, see Note 3 to our consolidated financial statements for more information on our scope of consolidation and non-consolidated entities, and Note 5 to our consolidated financial statements for more information on discontinued operations.
Financial income and expenses For the year ended December 31, % change 2021 2022 2023 2023 vs 2022 Financial income 13,218 8,880 21,479 141.9 % Financial expenses (6,486 ) (17,815 ) (40,642 ) 128.1 % Net Financial gain (loss) 6,731 (8,935 ) (19,163 ) 114.5 % 86 The increase in financial income of $12.6 million between the year periods ended December 31, 2022 and 2023 is mainly attributable to an increase in gain from our financial investments of $2.5 million and a $0.2 million gain on money market funds fair value measurement, an increase in the foreign exchange gain of $10.1 million (from a $7.5 million gain in 2022 to a $17.6 million gain in 2023, of which $8.0 million are reclassified from other comprehensive income pursuant to Calyxt’s deconsolidation).
The increase in financial income of $12.6 million between the year periods ended December 31, 2022 and 2023 is mainly attributable to an increase in gain from our financial investments of $2.5 million and a $0.2 million gain on money market funds fair value measurement, an increase in the foreign exchange gain of $10.1 million (from a $7.5 million gain in 2022 to a $17.6 million gain in 2023, of which $8.0 million are reclassified from other comprehensive income pursuant to Calyxt’s deconsolidation).
For the year ended December 31, % change 2021 2022 2023 2023 vs 2022 Net income (loss) (125,107 ) (114,034 ) (108,443 ) -4.9 % Net income includes net income from discontinued operations.
For the year ended December 31, % change 2022 2023 2024 2024 vs 2023 Net income (loss) (114,034 ) (108,443 ) (36,761 ) -66.1 % Net income includes net income from discontinued operations.
As of December 31, 2023, we were eligible to receive potential development and commercial milestone payments pursuant to (i) the License, Development and Commercialization Agreement dated March 6, 2019 between Servier and Cellectis, as amended on March 79 4, 2020 (the “Servier License Agreement”) of up to $410 million and (ii) the License Agreement dated March 8, 2019 between Allogene and Cellectis (the “Allogene License Agreement”) of up to $2.8 billion.
As of December 31, 2024, we were eligible to receive potential development and commercial milestone payments pursuant to (i) the License, Development and Commercialization Agreement dated March 6, 2019 between Servier and Cellectis, as amended on March 4, 2020 (the “Servier License Agreement”), initially estimated of up to $410 million and (ii) the License Agreement dated March 8, 2019 between Allogene and Cellectis (the “Allogene License Agreement”) in a per target aggregate amount of up to $185.0 million, 79 with aggregate milestone payments received as of the date of this Annual Report of $15.0 million.
For the year ended December 31, % change 2021 2022 2023 2023 vs 2022 Income tax 0 (87 ) (371 ) 326.0 % The income tax expense of the year ended December 31, 2023 amounting to $0.4 million corresponds to the cumulated income tax expense of Cellectis Inc. and Cellectis Biologics Inc., both entities filing a consolidated tax return.
For the year ended December 31, % change 2022 2023 2024 2024 vs 2023 Income tax (87 ) (371 ) (0 ) -100.0 % The income tax expense of the year ended December 31, 2024 is nil and corresponds to the cumulated current income tax expense of Cellectis Inc. and Cellectis Biologics Inc. for $0.5 million, both entities filing a consolidated tax return , offset by the partial capitalization of deferred tax assets.
Purchases, external expenses and other decreased by $0.4 million (from $9.8 million in 2022 to $9.4 million in 2023) mainly explained by less subcontracting expenses due to reprioritization of activities. Between the years ended December 31, 2021 and 2022, selling, general and administrative expenses decreased by $5.4 million.
Purchases, external expenses, depreciation and amortization expenses and other decreased by $0.4 million (from $9.8 million in 2022 to $9.4 million in 2023) mainly explained by less subcontracting expenses due to reprioritization of activities.
If any of the assumptions change significantly, share-based compensation for future awards may differ materially compared with the awards granted previously We use judgement to determine the expected outcome and timing of realization of non-market performance obligations related to free shares awards A potential discrepancy between the Company’s estimate and the actual realization of the non-market performance conditions could have a material impact on our Consolidated Financial Statements. • Provisions for risks and charges (Note 19) A provision is recognized if, as a result of a past event, we have a present legal or constructive obligation that can be estimated reliably, and it is probable that an outflow of economic benefits will be required to settle the obligation.
A potential discrepancy between the Company’s estimate and the actual realization of the non-market performance conditions could have a material impact on our Consolidated Financial Statements. • Provisions (Note 20 of the Consolidated Financial Statements) A provision is recognized if, as a result of a past event, we have a present legal or constructive obligation that can be estimated reliably, and it is probable that an outflow of economic benefits will be required to settle the obligation.
Cellectis’ Contractual Obligations and Commitments As of December 31, 2023, Cellectis had the following contractual obligations: As of December 31, 2023 Total Less than 1 year 1 - 3 years 3 - 5 years More than 5 years $ in thousands Lease agreement 63,349 11,107 19,647 15,046 17,548 License and collaboration agreements 13,480 1,400 2,800 2,800 6,480 Clinical & Research and Development agreements 71 71 - - - IT licensing agreements 319 233 86 - - State Guaranteed loan « PGE » 14,057 5,107 8,950 - - EIB loan 22,100 - - - 22,100 Bpifrance's advance 1,910 - - 433 1,477 Total contractual obligations 115,286 17,918 31,483 18,279 47,606 Cellectis’ short-term and long-term material requirements are reflected in the table above and mainly relate to: • Lease agreements regarding Cellectis’ corporate headquarter in Paris, France, its administrative and research and development facility in New York, New York, and its manufacturing facilities in Paris, France, and Raleigh, North Carolina, as well as leased equipment for $63.3 million, of which $11.1 million are payable in 2024. • License and collaboration agreements with third parties that subject the Company to certain fixed license fees, as well as fees based on future events, such as research and sales milestones for $13.5 million, of which $1.4 million are payable in 2024. • IT licensing agreements for $0.3 million, of which $0.2 million are payable in 2024. • A State Guaranteed loan “PGE” of $14.1 million, of which $5.1 million is payable in 2024. • A long term loan with the EIB of $22.1 million • A long term advance with Bpifrance of $1.9 million An analysis as to Cellectis’ ability to meet these requirements is provided under the caption “Operating capital requirements – Cellectis S.A.”, discussed above Calyxt Lease Guaranty In September 2017, Calyxt entered into a lease agreement with a third party for its corporate headquarters and laboratory facilities in Roseville, Minnesota, which encompasses approximately 44,000 square feet including office and research and development space.
Cellectis’ Contractual Obligations and Commitments As of December 31, 2024, Cellectis had the following contractual obligations: As of December 31, 2024 Total Less than 1 year 1 - 3 years 3 - 5 years More than 5 years $ in thousands Lease agreement 51,996 10,557 16,495 12,162 12,782 License and collaboration agreements 1,280 200 400 400 280 Clinical & Research and Development agreements 67 67 - - - IT licensing agreements 1,177 288 889 State Guaranteed loan « PGE » 8,547 4,901 3,646 EIB loan 63,727 32,972 30,755 Bpifrance's advance 5,584 2,994 2,590 Research Tax Credit financings 11,626 11,626 - - - Total contractual obligations 144,004 27,638 21,431 48,528 46,408 Cellectis’ short-term and long-term material requirements are reflected in the table above and mainly relate to: • Lease agreements regarding Cellectis’ corporate headquarter in Paris, France, its administrative and research and development facility in New York, New York, and its manufacturing facilities in Paris, France, and Raleigh, North Carolina, as well as leased equipment for $52.0 million, of which $10.6 million are payable in 2025. • License and collaboration agreements with third parties that subject the Company to certain fixed license fees, as well as fees based on future events, of which $0.2 million are payable in 2025. • IT licensing agreements for $1.2 million, of which $0.3 million are payable in 2025. • A State Guaranteed loan “PGE” of $8.5 million, of which $4.9 million is payable in 2025. • Research Tax Credit financing of $11.6 million, payable in 2025. • A long term loan with the EIB of $63.7 million • A long term advance with Bpifrance of $5.6 million An analysis as to Cellectis’ ability to meet these requirements is provided under the caption “Operating capital requirements – Cellectis S.A.”, discussed above Calyxt Lease Guaranty In September 2017, Calyxt entered into a lease agreement with a third party for its corporate headquarters and laboratory facilities in Roseville, Minnesota, which encompasses approximately 44,000 square feet including office and research and development space.
The fair value of the loan on June 19, 2023 was $0.4 million, resulting in a grant of $0.5 million.
On June 19, 2023 we received a $0.9 million payment from BPI, with a fair value of the loan amounting to $0.4 million, resulting in a grant of $0.5 million.
The income tax expense of the year ended December 31, 2022 amounting to $0.1 million corresponds to the cumulated income tax expense of Cellectis Inc. and Cellectis Biologics Inc., both entities filing a consolidated tax return. 87 Net Income / loss.
The income tax expense of the years ended December 31, 2023 and December 31, 2022 amounting respectively to $0.4 million and $0.1 million corresponds to the cumulated income tax expense of Cellectis Inc. and Cellectis Biologics Inc. 86 Net Income / loss.
Other income For the year ended December 31, % change 2021 2022 2023 2023 vs 2022 Research tax credit 8,239 6,546 6,582 0.5 % Other income 11 7 1,856 26473.2 % Other income 8,250 6,553 8,438 28.8 % The increase in other income of $1.9 million between the years ended December 31, 2022 and 2023 is mainly related to the recognition of a $1.4 million income related to the achievement of two milestones under the grant and refundable advance agreement signed with Bpifrance (“BPI”) to partially support a R&D program related to Cellectis’ UCART 20x22.
Other income For the year ended December 31, % change 2022 2023 2024 2024 vs 2023 Research tax credit 6,546 6,582 6,447 -2.0 % Other income 7 1,856 1,265 -31.8 % Other income 6,553 8,438 7,712 -8.6 % The decrease in other income of $0.7 million between the years ended December 31, 2023 and 2024 mainly due to a decrease in a government grant received from Bpifrance ("BPI") under the grant and refundable advance agreement signed with BPI (the "BPI Grant and Advance Agreement") to partially support a R&D program related to Cellectis' UCART20x22 signed in March 2023.
Business Overview—Our Licensing Relationships.” Income (loss) from discontinued operations For the year ended December 31, % change 2021 2022 2023 2023 vs 2022 Income (loss) from discontinued operations (28,358 ) (15,345 ) 8,392 -154.7 % Income loss from discontinued operations include Calyxt loss until deconsolidation.
Income (loss) from discontinued operations For the year ended December 31, % change 2022 2023 2024 2024 vs 2023 Income (loss) from discontinued operations (15,345 ) 8,392 0 -100.0 % Income loss from discontinued operations include Calyxt loss until deconsolidation.
We also granted certain information and inspection rights to the EIB in connection with the Finance Contract. The Finance Contract contains certain customary representations and warranties by us and is governed by French law. The Warrant Agreement On March 30, 2023, the Company and EIB entered into a Subscription Agreement for Warrants to be Issued by Cellectis S.A.
We also granted certain information and inspection rights to the EIB in connection with the Finance Contract. The Finance Contract contains certain customary representations and warranties by us and is governed by French law.
As from June 1, 2023 and the deconsolidation of Calyxt, we view our operations and manage our business in a single operating and reportable segment corresponding to the Therapeutics segment. Our Therapeutics segment is focused on the development of products in the field of immuno-oncology and monogenic diseases.
Together with our focus on immuno-oncology, we are developing gene therapy product candidates in other therapeutic indications. As from June 1, 2023 and the deconsolidation of Calyxt, we view our operations and manage our business in a single operating and reportable segment corresponding to the Therapeutics segment.
In the event of such a cancellation by the EIB prior to the expiration of a period of three years after disbursement of Tranche A.
In the event of such a cancellation by the EIB prior to the expiration of a period of three years after disbursement of Tranche A. On January 16, 2024, Cellectis drew down on the second tranche of €15 million under the Finance Contract.
Gain/Loss attributable to non-controlling interests. For the year ended December 31, % change 2021 2022 2023 2023 vs 2022 Gain (loss) attributable to non-controlling interests (10,910 ) (7,894 ) (7,384 ) -6.5 % During the year ended December 31, 2023, we recorded $7.4 million in loss attributable to non-controlling interests.
Gain/Loss attributable to non-controlling interests. For the year ended December 31, % change 2022 2023 2024 2024 vs 2023 Gain (loss) attributable to non-controlling interests (7,894 ) (7,384 ) 0 -100.0 % During the year ended December 31, 2024, no gain or loss attributable to non-controlling interests has been recorded.
Cost of revenue For the year ended December 31, % change 2021 2022 2023 2023 vs 2022 Cost of goods sold 0 0.00 - -100.0 % Royalty expenses (1,844 ) (1,772 ) (737 ) -58.4 % Cost of revenue (1,844 ) (1,772 ) (737 ) -58.4 % The decrease in cost of revenues between the years ended December 31, 2022 and 2023 is the direct consequence of the decrease in milestones revenues.
For the year ended December 31, % change 2022 2023 2024 2024 vs 2023 Royalty expenses (1,772 ) (737 ) - -100.0 % Cost of revenue (1,772 ) (737 ) 0 -100.0 % The decrease in cost of revenues between the years ended December 31, 2024 and 2023 is the consequence of the reclassification in R&D expenses of our license-related expenses as a result of a change in business model.
Research and Development, Patents and Licenses, etc. Our research and development teams utilize our deep expertise to contribute to the growth of our business. As of December 31, 2023, we had 169 employees engaged in research and development activities.
Our research and development teams utilize our deep expertise to contribute to the growth of our business. As of December 31, 2024, we had 180 employees engaged in research and development activities. In the years ended December 31, 2022, 2023 and 2024 we spent $97.5 million, $87.6 million and $90.5 million respectively, on research and development.
Each Tranche B Warrant allows the EIB to subscribe for one ordinary share of the Company, at a price of €2.53, corresponding to 99% of the volume-weighted average price of the Company’s ordinary shares over the last 3 trading days preceding the decision of the board of directors of the Company to issue the Tranche B Warrants.
In connection with the drawdown of Tranche B, the Company issued 1,460,053 Tranche B Warrants to the EIB, representing approximately 2.0% of the Company's outstanding share capital at their issuance date, with an exercise price of €2.53 (corresponding to 99% of the volume-weighted average price of the Company’s ordinary shares over the last 3 trading days preceding the decision of the board of directors of the Company to issue the Tranche B Warrants).
Our ordinary shares have been traded on the Euronext Growth market of Euronext in Paris since February 7, 2007 and our ADSs have traded on the Nasdaq Global Market in New York since March 30, 2015. 89 Liquidity management As of December 31, 2023, we had cash, cash equivalents, fixed-term deposits classified as current financial assets of $151.7 million comprising cash and cash equivalents of $136.7 million.
Our ordinary shares have been traded on the Euronext Growth market of Euronext in Paris since February 7, 2007 and our ADSs have traded on the Nasdaq Global Market in New York since March 30, 2015.
Operating Results The following table sets forth our selected consolidated statement of income data: For the year ended December 31, 2021 2022 2023 $ in thousands Revenues and other income Revenues 30,347 19,171 755 Other income 8,250 6,553 8,438 Total revenues and other income 38,597 25,725 9,193 Operating expenses Cost of revenue (1,844 ) (1,772 ) (737 ) Research and development expenses (117,840 ) (97,501 ) (87,646 ) Selling, general and administrative expenses (22,882 ) (17,494 ) (16,812 ) Other operating income (expenses) 488 1,377 (1,300 ) Total operating expenses (142,077 ) (115,390 ) (106,495 ) Operating income (loss) (103,480 ) (89,666 ) (97,302 ) Financial income 13,218 8,880 21,479 Financial expenses (6,486 ) (17,815 ) (40,642 ) Net Financial gain (loss) 6,731 (8,935 ) (19,163 ) Income tax - (87 ) (371 ) Income (loss) from continuing operations (96,749 ) (98,688 ) (116,835 ) Income (loss) from discontinued operations (28,358 ) (15,345 ) 8,392 Net income (loss) (125,107 ) (114,034 ) (108,443 ) Attributable to shareholders of Cellectis (114,197 ) (106,139 ) (101,059 ) Attributable to non-controlling interests (10,910 ) (7,894 ) (7,384 ) 84 Revenues.
Operating Results The following table sets forth our selected consolidated statement of income data: For the year ended December 31, 2022 2023 2024 $ in thousands Revenues and other income Revenues 19,171 755 41,505 Other income 6,553 8,438 7,712 Total revenues and other income 25,725 9,193 49,217 Operating expenses Cost of revenue (1,772 ) (737 ) - Research and development expenses (97,501 ) (87,646 ) (90,536 ) Selling, general and administrative expenses (17,494 ) (16,812 ) (19,085 ) Other operating income (expenses) 1,377 (1,300 ) 849 Total operating expenses (115,390 ) (106,495 ) (108,771 ) Operating income (loss) (89,666 ) (97,302 ) (59,554 ) Financial income 8,880 21,479 44,407 Financial expenses (17,815 ) (40,642 ) (21,614 ) Net Financial gain (loss) (8,935 ) (19,163 ) 22,793 Income tax (87 ) (371 ) (0 ) Income (loss) from continuing operations (98,688 ) (116,835 ) (36,761 ) Income (loss) from discontinued operations (15,345 ) 8,392 - Net income (loss) (114,034 ) (108,443 ) (36,761 ) Attributable to shareholders of Cellectis (106,139 ) (101,059 ) (36,761 ) Attributable to non-controlling interests (7,894 ) (7,384 ) - Revenues For the year ended December 31, % change 2022 2023 2024 2024 vs 2023 Collaboration agreements 18,230 0 40,898 100.0 % Other revenues 941 755 608 -19.50 % Revenues 19,171 755 41,505 5397.7 % The increase in revenues of $40.8 million between the years ended December 31, 2023 and 2024 mainly reflects (i) the recognition of $35.5 million recognized in 2024 in connection with our performance obligation rendered pursuant to three Research Plans adopted under the AZ JRCA, and (ii) the recognition of a $5.4 million milestone paid by Servier pursuant to the Servier License Agreement.
Recognition of revenues for the year ended December 31, 2023 is mainly related to research collaboration and exclusive license agreement with Iovance. The decrease in revenues of $11.2 million or 36.8%, between the years ended December 31, 2021 and 2022 primarily reflects a decrease of revenue pursuant to our collaboration agreements.
Recognition of revenues for the year ended December 31, 2023 is mainly related to research collaboration and exclusive license agreement with Iovance.

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The duties specifically assigned to the audit and finance committee by our board of directors include, but are not limited to: with regard to our financial statements: • review on a preliminary basis and express its opinion on the draft annual and quarterly financial statements prior to the board of directors officially receiving the financial statements; • examine the critical accounting policies and practices of the Company, including their relevance and consistency used for the preparation of the Company’s consolidated financial statements and rectify any failure to comply with these policies and practices; • monitor the scope of consolidation and review, where necessary, any explanations in connection thereto; • interview, when necessary, the statutory auditors, the chairman of the board of directors, the chief executive officer, the chief financial officer, the employees in charge of our internal controls or any other management personnel; these discussions may take place, where required, without the presence of the chairman of our board of directors and the chief executive officer; and • examine—prior to their publication—the draft annual and interim financial statements, the draft annual report and any other draft financial statements (including projected financial statements) prepared for the needs of upcoming material transactions together with the related press releases; with regard to internal controls: • assess the efficiency and quality of internal control systems and procedures within the consolidated Company; • examine, with the persons in charge of the internal audit, and, if necessary, outside of the presence of the chairman of the board of directors and the chief executive officer, the contingency and action plans with respect to internal audit, the findings following the implementation of these actions and the recommendations and follow-up actions in connection therewith; and • entrust the internal audit department with any mission which the committee deems necessary; with regard to external controls: • examine any question relating to the appointment, renewal or dismissal of our statutory auditors and their fees regarding the performance of their control review functions; • oversee the rules relating to the use of the statutory auditors for assignments other than the audit of the financial statements and, more generally, ensure that we comply with the principles guaranteeing the statutory auditors’ independence; • at least annually, review and discuss the information provided by management and the auditors relating to the independence of the audit firm; • pre-approve any services entrusted to the statutory auditors which is outside of the scope of the annual audit; • review every year with the statutory auditors all fees paid to by the Company and its subsidiaries to any networks to which the auditors belong, their work plan, their findings and recommendations, as well as actions taken by us following such recommendations; • review and discuss with the statutory auditors their comments on internal controls over financial reporting and any matters that have come to the attention of the statutory auditors that lead them to believe that modification to our disclosures about changes in internal control over financial reporting is necessary for management’s certifications pursuant to Section 302 of the Sarbanes-Oxley Act; • discuss if necessary any points of disagreement between the statutory auditors and the officers of the Company that may arise within the scope of these operations; and • review and discuss with the statutory auditors the plans for, and the scope of, the annual audit and other examinations; and with regard to risks: • review on a regular basis the financial situation, the cash position and the material risks and undertakings of the Company and its subsidiaries; and • review the risk management policy and the process implemented to evaluate and manage these risks.
The duties specifically assigned to the audit and finance committee by our board of directors include, but are not limited to: with regard to our financial statements: • review on a preliminary basis and express its opinion on the draft annual and quarterly financial statements prior to the board of directors officially receiving the financial statements; • examine the critical accounting policies and practices of the Company, including their relevance and consistency used for the preparation of the Company’s consolidated financial statements and rectify any failure to comply with these policies and practices; 101 • monitor the scope of consolidation and review, where necessary, any explanations in connection thereto; • interview, when necessary, the statutory auditors, the chairman of the board of directors, the chief executive officer, the chief financial officer, the employees in charge of our internal controls or any other management personnel; these discussions may take place, where required, without the presence of the chairman of our board of directors and the chief executive officer; and • examine—prior to their publication—the draft annual and interim financial statements, the draft annual report and any other draft financial statements (including projected financial statements) prepared for the needs of upcoming material transactions together with the related press releases; with regard to internal controls: • assess the efficiency and quality of internal control systems and procedures within the consolidated Company; • examine, with the persons in charge of the internal audit, and, if necessary, outside of the presence of the chairman of the board of directors and the chief executive officer, the contingency and action plans with respect to internal audit, the findings following the implementation of these actions and the recommendations and follow-up actions in connection therewith; and • entrust the internal audit department with any mission which the committee deems necessary; with regard to external controls: • examine any question relating to the appointment, renewal or dismissal of our statutory auditors and their fees regarding the performance of their work; • oversee the rules relating to the use of the statutory auditors for assignments other than the audit of the financial statements and, more generally, ensure that we comply with the principles guaranteeing the statutory auditors’ independence; • at least annually, review and discuss the information provided by management and the auditors relating to the independence of the audit firm; • pre-approve any services entrusted to the statutory auditors which is outside of the scope of the annual audit; • review every year with the statutory auditors all fees paid to by the Company and its subsidiaries to any networks to which the auditors belong, their work plan, their findings and recommendations, as well as actions taken by us following such recommendations; • review and discuss with the statutory auditors their comments on internal controls over financial reporting and any matters that have come to the attention of the statutory auditors that lead them to believe that modification to our disclosures about changes in internal control over financial reporting is necessary for management’s certifications pursuant to Section 302 of the Sarbanes-Oxley Act; • discuss if necessary any points of disagreement between the statutory auditors and the officers of the Company that may arise within the scope of these operations; and • review and discuss with the statutory auditors the plans for, and the scope of, the annual audit and other examinations; and with regard to risks: • review on a regular basis the financial situation, the cash position and the material risks and undertakings of the Company and its subsidiaries; and • review the risk management policy and the process implemented to evaluate and manage these risks.
The principal duties and responsibilities of our compensation committee include, but are not limited to: • review the compensation of our employees and managers of the Company and its subsidiaries (fixed and variable compensations, bonus, etc.) and make any recommendation to our board of directors in connection therewith; 105 • review equity incentive plans (non-employee warrants, stock options, restricted (free) shares, etc.) and make recommendations to our board of directors in connection therewith; • make recommendations to our board of directors regarding the compensation, pension and insurance plans, benefits in kind and other various pecuniary rights, of officers, as well as the allocation of equity incentive instruments granted to executive officers and directors of the Company; • evaluate and make recommendations on the compensation policies and programs of executive officers and on the compensation of directors; • recommend the approval, adoption and amendment of all cash- and equity-based incentive compensation plans in which any of our executive officers or directors participate and all other equity-based plans; • review any proposed employment agreement with, and any proposed severance or retention plans or agreements applicable to, any of our executive officers; • review, at least annually, corporate goals and objectives relevant to the compensation of our executive officers; and • evaluate the performance of the executive officers in light of corporate goals and objectives and recommend compensation levels for these executive officers based on those evaluations and any other factors the compensation committee deems appropriate.
The principal duties and responsibilities of our compensation committee include, but are not limited to: • review the compensation of our employees and managers of the Company and its subsidiaries (fixed and variable compensations, bonus, etc.) and make any recommendation to our board of directors in connection therewith; • review equity incentive plans (non-employee warrants, stock options, restricted (free) shares, etc.) and make recommendations to our board of directors in connection therewith; • make recommendations to our board of directors regarding the compensation, pension and insurance plans, benefits in kind and other various pecuniary rights, of officers, as well as the allocation of equity incentive instruments granted to executive officers and directors of the Company; • evaluate and make recommendations on the compensation policies and programs of executive officers and on the compensation of directors; • recommend the approval, adoption and amendment of all cash- and equity-based incentive compensation plans in which any of our executive officers or directors participate and all other equity-based plans; • review any proposed employment agreement with, and any proposed severance or retention plans or agreements applicable to, any of our executive officers; • review, at least annually, corporate goals and objectives relevant to the compensation of our executive officers; and • evaluate the performance of the executive officers in light of corporate goals and objectives and recommend compensation levels for these executive officers based on those evaluations and any other factors the compensation committee deems appropriate.
For the 2021, 2022 and 2023 Free Share Plans, our shareholders have determined that the vesting period must be at least three years from the date of grant with no holding period applicable, and that the vesting of free shares granted to our corporate officer and members of our executive committee are subject to performance conditions.
For the 2021, 2022, 2023 and 2024 Free Share Plans, our shareholders have determined that the vesting period must be at least three years from the date of grant with no holding period applicable, and that the vesting of free shares granted to our corporate officer and members of our executive committee are subject to performance conditions.
She received her bachelor’s degree in marketing from New York University Stern School of Business and MS in human resources management / organization development from the New School of Social Research. Stephan Reynier , MSc, joined Cellectis in April 2011. He serves as Chief Regulatory and Pharmaceutical Compliance Officer. Mr.
She received her bachelor’s degree in marketing from New York University Stern School of Business and MS in human resources management and organization development from the New School of Social Research. 94 Stephan Reynier , MSc, joined Cellectis in April 2011. He serves as Chief Regulatory and Pharmaceutical Compliance Officer. Mr.
Reynier has extensive experience, from his previous positions as Senior Director at Voisin Consulting Life Sciences and European Associate Director Medical Affairs at Gilead Sciences, in the design and implementation of regulatory strategies for the development 97 of drugs and biologics, with a strong focus on cell and gene therapy.
Reynier has extensive experience, from his previous positions as Senior Director at Voisin Consulting Life Sciences and European Associate Director Medical Affairs at Gilead Sciences, in the design and implementation of regulatory strategies for the development of drugs and biologics, with a strong focus on cell and gene therapy.
Disclosure of Actions to Recover Erroneously Awarded Compensation Because no annual period presented in this Annual Report on Form 20-F is being restated, we are not required to check the box on the cover page hereof regarding the correction of an error to previously issued financial statements.
Disclosure of Actions to Recover Erroneously Awarded Compensation Because no annual period presented in this Annual Report on Form 20-F is being restated, we are not required to check the box on the cover page hereof regarding the correction of an error to previously issued financial statements. Not applicable.
Our board of 102 directors is not required to grant stock options with vesting and exercise terms that are the same for every participant. The term of each stock option granted under the Stock Option Plans will generally be ten years from the date of grant.
Our board of directors is not required to grant stock options with vesting and exercise terms that are the same for every participant. The term of each stock option granted under the Stock Option Plans will generally be ten years from the date of grant.
The composition and functioning of 104 all of our committees will comply with all applicable requirements of the French Commercial Code, the Exchange Act, Nasdaq, and the rules and regulations of the SEC. In accordance with French law, committees of our board of directors will only have an advisory role and can only make recommendations to our board of directors.
The composition and functioning of all of our committees will comply with all applicable requirements of the French Commercial Code, the Exchange Act, Nasdaq, and the rules and regulations of the SEC. In accordance with French law, committees of our board of directors will only have an advisory role and can only make recommendations to our board of directors.
Free Shares Under our 2012, 2013, 2014, 2015, 2018, Second 2018, 2021, 2022 and 2023 Free Share Plans, or collectively the Free Shares Plans, we have granted free shares to certain of our employees and officers.
Free Shares Under our 2012, 2013, 2014, 2015, 2018, Second 2018, 2021, 2022, 2023 and 2024 Free Share Plans, or collectively the Free Shares Plans, we have granted free shares to certain of our employees and officers.
Stock Options Under our 2015, 2016, 2017, 2018, 2021, 2022 and 2023 Stock Options Plans, or collectively the Stock Options Plans, we have granted stock options to certain of our employees, officers and chairman of the board of directors.
Stock Options Under our 2015, 2016, 2017, 2018, 2021, 2022, 2023 and 2024 Stock Options Plans, or collectively the Stock Options Plans, we have granted stock options to certain of our employees, officers and chairman of the board of directors.
In the event the board would be composed of less than three directors as a result of a vacancy, the remaining directors shall immediately convene a shareholders’ general meeting to elect one or several new directors so there are at least three directors serving on the board, in accordance with French law. We currently have nine directors.
In the event the board would be composed of less than three directors as a result of a vacancy, the remaining directors shall immediately convene a shareholders’ general meeting to elect one or several new directors so there are at least three directors serving on the board, in accordance with French law. We currently have eleven directors.
Limitations on Liability and Indemnification Matters 100 Under French law, provisions of By-laws that limit the liability of directors and officers are prohibited.
Limitations on Liability and Indemnification Matters Under French law, provisions of By-laws that limit the liability of directors and officers are prohibited.
Boehm served on the board of directors of Nordic Nanoverctor SA from July 2018 to April 2022, and of Humanigen Inc from February 2018 to February 2024. Mr. Boehm spent 29 years at Novartis, working locally, regionally and globally in various senior management roles, after building his career in Marketing & Sales and Medical Affairs.
Boehm served on the board of directors of Nordic Nanoverctor SA, and of Humanigen Inc from 2018 to February 2024. Mr. Boehm spent 29 years at Novartis, working locally, regionally and globally in various senior management roles, after building his career in Marketing & Sales and Medical Affairs.
The following table sets forth the names of our directors, the years of their initial appointment as directors and the expiration dates of their current term. Name Current Position Year of Initial Appointment Term Expiration Year Jean-Pierre Garnier, M.D. Chairman and Director 2020 2026 André Choulika, Ph.D. Director and CEO 1999 2024 David Sourdive, Ph.D.
The following table sets forth the names of our directors, the years of their initial appointment as directors and the expiration dates of their current term. 100 Name Current Position Year of Initial Appointment Term Expiration Year Jean-Pierre Garnier, M.D. Chairman and Director 2020 2026 André Choulika, Ph.D. Director and CEO 1999 2027 David Sourdive, Ph.D.
Mr Reynier graduated as Agro-Engineer in France and received a Master of Science in Chemical Engineering from the University of Toronto, Canada. David Sourdive , Ph.D., is a co-founder of Cellectis and holds the position of Executive Vice President, Technical Operations since 2017. Prior to that date, Dr. Sourdive served as Executive Vice President, Corporate Development since 2008. Dr.
Mr Reynier graduated as Agro-Engineer in France and received a Master of Science in Chemical Engineering from the University of Toronto, Canada. David Sourdive , Ph.D., is a co-founder of Cellectis and holds the position of Executive Vice President, CMC and Manufacturing since 2017. Prior to that date, Dr. Sourdive served as Executive Vice President, Corporate Development since 2008. Dr.
She also held various human resource leadership roles for Pfizer’s business units, divisions, and functions with regional and global accountabilities. In addition to her experience in biotech/biopharma, Ms. Nam-Wortman has 14 years of experience in the consulting industry focused on strategic and organization change management from Delta Consulting Group and IBM.
She also held various human resource leadership roles for Pfizer’s business units, divisions, and functions with regional and global accountabilities. In addition to her experience in biotech/biopharma, Ms. Nam-Wortman has significant experience in the consulting industry focused on strategic and organization change management from Delta Consulting Group and IBM.
In addition, Mr. Boehm is the founder and owner of Rainer Boehm GmbH and is currently serving on the board of directors of BioCopy AG since February 2020, Berlin Cure AG since January 2022, and Omega Therapeutics since September 2022. From July 2018 to 2022, Mr.
Boehm is the founder and owner of Rainer Boehm GmbH and is currently serving on the board of directors of BioCopy AG since February 2020, Berlin Cure AG since January 2022, and Omega Therapeutics since September 2022. From 2018 to 2022, Mr.
Bergstrom , M.D., Ph.D., serves as a member of our board of directors since June 2022, after having served as observer of our board of directors since November 2021. Dr. Bergstrom, currently serves as Executive Vice President, Head of Research and Development at Relay Therapeutics, Inc., a public clinical-stage precision medicines company.
Bergstrom , M.D., Ph.D., serves as a member of our board of directors since 2022, after having served as observer of our board of directors since November 2021. Dr. Bergstrom, currently serves as President, Research and Development at Relay Therapeutics, Inc., a public clinical-stage precision medicines company.
Bergstrom Director 2022 2025 Pursuant to French regulations, any company having more than 50 employees must, implement a Comité Social et Économique or Social and Economic Committee, which replaces and regroups the former various employee representative bodies, including the Délégation Unique du Personnel initially in place at Cellectis.
Director 2024 2027 Pursuant to French regulations, any company having more than 50 employees must, implement a Comité Social et Économique or Social and Economic Committee, which replaces and regroups the former various employee representative bodies, including the Délégation Unique du Personnel initially in place at Cellectis.
We proceeded with the re-election, for a two-year term, of this Social and Economic Committee on September 14, 2022. 103 Director Independence As a foreign private issuer, under the listing requirements and rules of Nasdaq, we are not required to have independent directors on our board of directors, except with respect to our audit and finance committee.
We proceeded with the re-election, for a two-year term, of this Social and Economic Committee on September 19, 2024. Director Independence As a foreign private issuer, under the listing requirements and rules of Nasdaq, we are not required to have independent directors on our board of directors, except with respect to our audit and finance committee.
Garnier was Chairman of Idorsia, a public bio-technology company based in Switzerland and listed on the Swiss Stock Exchange (SIX), which was spun off of Actelion LTD with a billion-dollar investment from Johnson & Johnson (J&J).
From 2018 to 2020, Dr. Garnier was Chairman of Idorsia, a public bio-technology company based in Switzerland and listed on the Swiss Stock Exchange (SIX), which was spun off of Actelion LTD with a billion-dollar investment from Johnson & Johnson (J&J).
Prior to Mersana, he was Global Head of Translational and Experimental Medicine at Sanofi Oncology. At Sanofi, Dr. Bergstrom held roles of increasing responsibility at Merck Research Laboratories, culminating in his role as Oncology Franchise Lead, Experimental Medicine. Since April 2021, Dr. Bergstrom served on the board of directors at Fusion Pharmaceuticals, a public biotechnologies company. Dr.
Prior to Mersana, he was Global Head of Translational and Experimental Medicine at Sanofi Oncology. At Sanofi, Dr. Bergstrom held roles of increasing responsibility at Merck Research Laboratories, culminating in his role as Oncology Franchise Lead, Experimental Medicine. From 2021 to June 2024, Dr. Bergstrom has served on the board of directors at Fusion Pharmaceuticals, a public biotechnologies company. Dr.
Since September 2019, he serves on the board of directors of Exeliom S.A.S., since February 2021, he serves on the board of directors of Cell-Easy S.A.S, from June 2023 he has served on the board of directors of hema.to GmbH, and from October 2023, he serves at the board of directors of Aqemia SAS.
Since September 2019, he serves on the board of directors of Exeliom S.A.S., since February 2021, he serves on the board of directors of Cell-Easy S.A.S, from June 2023 he serves on the board of directors of hema.to GmbH, from October 2023, he serves at the board of directors of Aqemia SAS, and from September 2024, he serves on the board of Hephaistos S.A.S.
Environmental and Social Committee. Our environmental and social committee assists our board in reviewing the environmental and social matters within the Company. Currently, our environmental and social committee, which is included in the Audit and Finance Committee, is comprised of three members of the board of directors: Mr. Malkomes, Mr. Bastid and Don Bergstrom.
Environmental and Social Committee. Our environmental and social committee assists our board in reviewing the environmental and social matters within the Company. Currently, our environmental and social committee, which is a subcommittee of the Audit and 102 Finance Committee, is comprised of three members of the board of directors: Mr. Malkomes, Mr. Bastid and Don Bergstrom.
His work there was focused on immunological T-cell memory. Dr. Sourdive graduated from the École Polytechnique and received his PhD in molecular virology at the Institut Pasteur. He also has management training from the HEC (Challenge +). Arthur Stril joined Cellectis in July 2018 as Vice President, Corporate Development, and was appointed Chief Business Officer in 2020. Mr.
His work there was focused on immunological T-cell memory. Dr. Sourdive graduated from the École Polytechnique and received his PhD in molecular virology at the Institut Pasteur. He also has management training from the HEC (Challenge +). Arthur Stril joined Cellectis in 2018 as Vice President, Corporate Development.
He is co-inventor of numerous patents in the field of nucleases and genome engineering and co-author on more than 50 scientific publications and co-editor of one book entitled “Site-directed Insertion of Transgenes.” As head of Cellectis’s Research department since 2004, he helped to the development of the key Cellectis technologies. Mark Frattini , M.D., Ph.D., joined Cellectis in August 2020.
He is co-inventor of numerous patents in the field of nucleases and genome engineering and co-author on more than 50 scientific publications and co-editor of one book entitled “Site-directed Insertion of Transgenes.” As head of Cellectis’s Research department since 2004, he helped to the development of the key Cellectis technologies.
Our current plan, the 2023 Free Share Plan, was adopted by 101 our board of directors on August 3, 2023 according to the authorization granted by the combined ordinary and extraordinary shareholders’ general meeting dated June 27, 2023. Free shares may be granted to any individual employed by us or by any affiliated company.
Our current plan, the 2024 Free Share Plan, was adopted by our board of directors on August 6, 2024 according to the authorization granted by the combined ordinary and extraordinary shareholders’ general meeting dated June 28, 2024. Free shares may be granted to any individual employed by us or by any affiliated company.
Garnier has served as director of the board of directors of Radius Therapuetic, and from 2018 to 2022, he served as Chairman of the board of directors of Carmat, a public company based in France. From 2018 to 2020, Dr.
Garnier has served as director of the board of directors of Carrier Global Corp., a public company. From 2015 to 2022, Dr. Garnier has served as director of the board of directors of Radius Therapuetic, and from 2018 to 2022, he served as Chairman of the board of directors of Carmat, a public company based in France.
As of December 31, 2023, 137 of our employees were located in France and 84 of our employees were located in the United States. None of our employees is subject to a collective bargaining agreement. We consider our relationship with our employees to be good. E.
As of December 31, 2024, 147 of our employees were located in France and 75 of our employees were located in the United States. None of our employees is subject to a collective bargaining agreement. We consider our relationship with our employees to be good. E.
From 2006 to 2012, Mr. Arthaud held the position of Deputy CEO at CDC Entreprises. Since 2009 Mr. Arthaud has also directed InnoBio, an investment fund managed by Bpifrance Investissement as part of the FSI France Investissement program.
He served on the board of directors of Adocia from 2009 to 2022. From 2006 to 2012, Mr. Arthaud held the position of Deputy CEO at CDC Entreprises. Since 2009 Mr. Arthaud has also directed InnoBio, an investment fund managed by Bpifrance Investissement as part of the FSI France Investissement program.
Mark Frattini (Chief Medical Officer), Dr. Steve Doares (Senior Vice President, US Manufacturing and Site Head), Dr. Phillippe Duchateau (Chief Scientific Officer), Ms. Kyung Nam-Wortman (Executive Vice President, Chief Human Resources Officer), Mr. Stephan Reynier (Chief Regulatory and Compliance Officer), Dr. David Sourdive (Executive Vice President CMC and Manufacturing, and Director), Mr. Arthur Stril (Chief Business Officer), Dr.
Adrian Kilcoyne (Chief Medical Officer), Dr. Steve Doares (Senior Vice President, US Manufacturing and Site Head), Dr. Phillippe Duchateau (Chief Scientific Officer), Ms. Kyung Nam-Wortman (Executive Vice President, Chief Human Resources Officer), Mr. Stephan Reynier (Chief Regulatory and Compliance Officer), Dr. David Sourdive (Executive Vice President CMC and Manufacturing, and Director), Mr.
The authority of our board of directors to grant equity incentives may be extended or increased only by extraordinary shareholders’ meetings. As a result, we typically request that our shareholders authorize new pools of equity incentive instruments at every annual shareholders’ meeting and cancel the unallocated portions of the previous pools.
The authority of our board of directors to grant equity incentives may be extended or increased only by extraordinary shareholders’ meetings. As a result, we typically request that our shareholders authorize new pools of equity incentive instruments at every annual shareholders’ meeting and cancel the unallocated portions of the previous pools. Non-employee warrants are usually granted under similar terms.
Malkomes currently serves as chief financial officer of Cardior Pharmaceuticals GmbH, a biopharmaceutical company based in Germany. Prior to joining Cardior Pharmaceuticals GmbH, Mr. Malkomes was Chief Financial Officer and Chief Business Officer at Medigene AG until March 31, 2022.
Malkomes was Chief Financial Officer at Cardior Pharmaceuticals GmbH, a biopharmaceutical company based in Germany from November 2022. Prior to joining Cardior Pharmaceuticals GmbH, Mr. Malkomes was Chief Financial Officer and Chief Business Officer at Medigene AG until March 31, 2022.
Under the change of control plan, the severance package shall be equal to 24 months of compensation increased by an amount equal to the annual performance bonus to which the senior managers or executive officers concerned may be entitled for the year of their departure (or for Dr.
Under the change of control plan, the severance package shall be equal to 24 months of compensation increased by an amount equal to 1.5 times the annual performance bonus to which the senior managers or executive officers concerned may be entitled for the year of their departure (or for Dr. Choulika only, two times such target bonus).
Pursuant to the shareholders authorization dated June 27, 2023, the maximum aggregate number of ordinary shares, which may be issued is 2,779,188, provided that our board of directors may decide of new grant of free shares only under our current 2023 Free Share Plan and within the overall limit on the amount of issuance made to grant free shares and upon exercise of stock options, which is 2,779,188.
Pursuant to the shareholders authorization dated June 28, 2024, the maximum aggregate number of ordinary shares, which may be issued is 6,307,288, provided that our board of directors may decide of new grant of free shares only under our current 2024 Free Share Plan and within the overall limit on the amount of issuance made to grant free shares and upon exercise of stock options, which is 6,307,288.
Pursuant to the shareholders authorization dated June 27, 2023, the maximum aggregate number of ordinary shares, which may be is 2,779,188, provided that our board of directors may decide of new grant of stock options only under our current 2023 Stock Option Plan, and within the overall limit on the amount of issuance made to grant free shares and upon exercise of stock options, which is 2,779,188.
Pursuant to the shareholders authorization dated June 28, 2024, the maximum aggregate number of ordinary shares, which may be is 6,307,288, provided that our board of directors may decide of new grant of stock options only under our current 2024 Stock Option Plan, and within the overall limit on the amount of issuance made to grant free shares and upon exercise of stock options, which is 6,307,288.
These are: • employee warrants (otherwise known as bons de souscription de parts de créateur d’entreprise or BSPCE), granted only to employees of Cellectis; • non-employee warrants (otherwise known as bons de souscription d’actions or BSA), granted only to non-employee directors and other service providers or consultants not eligible for employee warrants; • restricted, or free, shares (otherwise known as actions gratuites); and • stock options (otherwise known as options de souscription d’actions).
These are: • non-employee warrants (otherwise known as bons de souscription d’actions or BSA), granted only to non-employee directors and other service providers or consultants not eligible for employee warrants; • restricted, or free, shares (otherwise known as actions gratuites); and • stock options (otherwise known as options de souscription d’actions).
Bergstrom holds an M.D. from the University of Washington, Seattle, and a Ph.D. from the Fred Hutchinson Cancer Research Center, where he also completed his post-doctoral training. He was a resident in clinical pathology at the University of Washington. Axel-Sven Malkomes serves as a member of our board of directors since June 2022. Mr.
Bergstrom holds an M.D. from the University of Washington, Seattle, and a Ph.D. from the Fred Hutchinson Cancer Research Center, where he also completed his post-doctoral training. He was a resident in clinical pathology at the University of Washington. Cécile Chartier serves as a member of our board of directors since 2023.
Non-Employee Warrants (BSA ) Non-employee warrants are granted by our board of directors to third-party service providers, consultants and non-employee directors of the Company.
Non-Employee Warrants (BSA ) Non-employee warrants are granted by our board of directors to EIB (pursuant to the terms of the Finance Contract), third-party service providers, consultants and non-employee directors of the Company.
Our board of directors has determined that, applying the applicable rules and regulations of the SEC and the Nasdaq listing standards, all of our directors, except Drs. Choulika and Sourdive and Mr. Arthaud, qualify as “independent directors”.
Our board of directors has determined that, applying the applicable rules and regulations of the SEC and the Nasdaq listing standards, all of our directors, except Dr. Choulika, Dr. Sourdive, Mr. Marc Dunoyer and Mr. Tyrell Rivers, qualify as “independent directors”.
Employees As of December 31, 2023, we had 221 employees, 216 of whom were full-time, 57 of whom hold M.D, Ph.D. or Pharm.D. degrees, 169 of whom were engaged in research and development activities and 52 of whom are engaged in business development, commercial, legal, finance, information systems, human resources or administrative support.
Employees As of December 31, 2024, we had 222 employees, 216 of whom were full-time, 53 of whom hold M.D, Ph.D. or Pharm.D. degrees, 180 of whom were engaged in research and development activities and 42 of whom are engaged in business development, commercial, legal, finance, information systems, human resources or administrative support.
Pursuant to delegations granted at our annual shareholders’ meeting, our board of directors determines the recipients, dates of grant and exercise price of non-employee warrants, the number of non-employee warrants to be granted and the terms and conditions thereof, including their vesting schedule. The term of each non-employee warrant is generally 10 years from the date of grant.
Pursuant to delegations granted at our annual shareholders’ meeting, our board of directors determines the recipients, dates of grant and exercise price of non-employee warrants, the number of non-employee warrants to be granted and the terms and conditions thereof, including their vesting schedule.
Our current plan, the 2022 Stock Option Plan, was adopted by our board of directors on September 15, 2022 according to the authorization granted by the combined ordinary and extraordinary shareholders’ general meeting dated June 27, 2023. The Stock Options Plans follow the same rules.
Our current plan, the 2024 Stock Option Plan, was adopted by our board of directors on August 6, 2024, according to the authorization granted by the combined ordinary and extraordinary shareholders’ general meeting dated June 28, 2024. The Stock Options Plans follow the same rules.
Directors and Senior Management The following table sets forth information regarding our executive officers and directors as of the date of this Annual Report: Name Age Position(s) Executive Officers: André Choulika, Ph.D. 59 Director, Chief Executive Officer and Co-Founder Mark Frattini, MD 58 Chief Medical Officer Steven Doares, Ph.D. 64 Senior Vice President of US Manufacturing Philippe Duchateau, Ph.D. 61 Chief Scientific Officer Kyung Nam-Wortman 54 Chief Human Resources Officer Stephan Reynier 54 Chief Regulatory & Pharmaceutical Compliance Officer David Sourdive, Ph.D. 57 Director, Deputy Chief Executive Officer, Executive Vice President, CMC and Manufacturing Arthur Stril 35 Chief Business Officer Marie-Bleuenn Terrier 42 General Counsel Bing Wang, Ph.D. 48 Chief Financial Officer Non-Employee Directors: Jean-Pierre Garnier, Ph.D. 76 Chairman of the Board and Director Laurent Arthaud 61 Director Pierre Bastid 69 Director Rainer Boehm 63 Director Axel-Sven Malkomes 57 Director Cécile Chartier, Ph.D. 57 Director Donald A.
Directors and Senior Management The following table sets forth information regarding our executive officers and directors as of the date of this Annual Report: Name Age Position(s) Executive Officers: André Choulika, Ph.D. 60 Director, Chief Executive Officer and Co-Founder Adrian Kilcoyne, M.D, MPH 55 Chief Medical Officer Steven Doares, Ph.D. 65 Senior Vice President of US Manufacturing Philippe Duchateau, Ph.D. 62 Chief Scientific Officer Kyung Nam-Wortman 55 Chief Human Resources Officer Stephan Reynier 55 Chief Regulatory & Pharmaceutical Compliance Officer David Sourdive, Ph.D. 58 Director, Deputy Chief Executive Officer, Executive Vice President, CMC and Manufacturing Arthur Stril 36 Chief Financial Officer & Chief Business Officer Marie-Bleuenn Terrier 43 General Counsel Non-Employee Directors: Jean-Pierre Garnier, Ph.D. 77 Chairman of the Board and Director Laurent Arthaud 62 Director Pierre Bastid 70 Director Rainer Boehm 64 Director Axel-Sven Malkomes 58 Director Cécile Chartier, Ph.D. 58 Director Donald A.
Director and Deputy CEO 2000 2024 Pierre Bastid Director 2011 2026 Laurent Arthaud Director 2011 2026 Cécile Chartier Director 2023 2026 Axel-Sven Malkomes Director 2022 2025 Rainer Boehm Director 2017 2026 Donald A.
Director and Deputy CEO 2000 2027 Pierre Bastid Director 2011 2026 Laurent Arthaud Director 2011 2026 Cécile Chartier Director 2023 2026 Axel-Sven Malkomes Director 2022 2025 Rainer Boehm Director 2017 2026 Donald A. Bergstrom Director 2022 2025 Marc Dunoyer Director 2024 2027 Tyrell Rivers, Ph.D.
Laurent Poirot), a severance package shall be paid if, within the 36-month period following a change of control of Cellectis S.A., the following triggering event occurs, without the agreement of such employee: termination (including by non-renewal) of such person’s employment other than for gross misconduct (faute lourde).
Pursuant to the change of control plan applicable to certain of our senior managers, a severance package shall be paid if, within the 24-month period following a change of control of Cellectis S.A., the following triggering event occurs, without the agreement of such employee: termination (including by non-renewal) of such person’s employment other than for gross misconduct (faute lourde).
Nam-Wortman was Senior Vice President, Head of Human Resources, Head of Information Technology, Facilities and Internal Communications at Achillion (recently acquired by Alexion in January 2020) since October 2014. Prior to her tenure at Achillion, Ms.
Kyung Nam-Wortman , joined Cellectis in November 2020 as Executive Vice President, Chief Human Resources Officer. Before joining Cellectis, Ms. Nam-Wortman was Senior Vice President, Head of Human Resources, Head of Information Technology, Facilities and Internal Communications at Achillion (acquired by Alexion in January 2020) since October 2014. Prior to her tenure at Achillion, Ms.
As of the date of this Annual Report, 448,262 ordinary shares remain available for issuance under the 2023 Free Share Plan and 2023 Stock Option Plan.
As of the date of this Annual Report, 2,314,830 ordinary shares remain available for issuance under the 2024 Free Share Plan and 2024 Stock Option Plan.
Board Committees Our board of directors has established an audit and finance committee, a compensation committee and an environmental and social committee, each of which operates pursuant to a separate charter adopted by our board of directors.
See "Item 16.G - Corporate Governance" for additional information. Board Committees Our board of directors has established an audit and finance committee, a compensation committee and an environmental and social committee, each of which operates pursuant to a separate charter adopted by our board of directors.
Choulika and Ms. Terrier are domestic partners. B. Compensation Compensation of Directors and Executive Officers The aggregate cash compensation paid and benefits in kind granted by us to our current executive officers and directors, for the year ended December 31, 2023, was $5.6 million.
Compensation Compensation of Directors and Executive Officers The aggregate cash compensation paid and benefits in kind granted by us to our current executive officers and directors, for the year ended December 31, 2024, was $5.5 million.
As of December 31, 2023, there were no service agreements between the Company or any of its subsidiaries and any director providing for benefits upon termination of employment.
Rivers — — — — * The conversion rate used is the average rate of the period Service Agreements As of December 31, 2024, there were no service agreements between the Company or any of its subsidiaries and any director providing for benefits upon termination of employment.
He subsequently earned his MBA at Stanford University, California, as a Fulbright Scholar. He was recently promoted from Chevalier to Officier de la Légion d’Honneur of France. Laurent Arthaud serves as a member of our board of directors since October 28, 2011. Mr.
He subsequently earned his MBA at Stanford University, California, as a Fulbright Scholar. He was recently promoted from Chevalier to Officier de la Légion d’Honneur of France. Laurent Arthaud serves as a member of our board of directors since 2011. Mr. Arthaud is the Managing Director of Life Sciences and Ecotechnologies for Bpifrance Investissement since 2012.
From June 2015 to December 2019, he has served on the board of directors of Eukarÿs SAS. From 1998 to 2000, he directed the biotechnologies laboratory of the Centre d’Etudes du Bouchet for the French Ministry of Defense. From 1997 to 1998, Dr. Sourdive worked at one of the leading laboratories in viral immunology at Emory University in Atlanta, Georgia.
Sourdive served on the Board of Omics SAS. Before his tenure at Cellectis, Dr. Sourdive directed the biotechnologies laboratory of the Centre d’Etudes du Bouchet for the French Ministry of Defense. From 1997 to 1998, Dr. Sourdive worked at one of the leading laboratories in viral immunology at Emory University in Atlanta, Georgia.
In general, employee warrants (BSPCE) and non-employee warrants (BSA) no longer continue to vest following termination of the employment, office or service of the holder and all vested shares must be exercised within post-termination exercise periods set forth in the applicable equity award grant documents.
They expire ten years after the date of grant if not exercised earlier according to their vesting schedule (see below). In general, non-employee warrants (BSA) no longer continue to vest following termination of the office or service of the holder and all vested shares must be exercised within post-termination exercise periods set forth in the applicable equity award grant documents.
The total amount set aside or accrued to provide pension, retirement or similar benefits was $0.6 million for the year ended December 31, 2023. 99 Directors Compensation (Gross Salary+Bonus)* Board fees* Out-of- pocket expenses* Equity awards granted in 2023 A. Choulika 874,938 — 1,659 250,000 SO D. Sourdive 557,755 — 83 100,000 SO J.P.
The total amount set aside or accrued to provide pension, retirement or similar benefits was $0.4 million for the year ended December 31, 2024. 96 Directors Compensation (Gross Salary+Bonus)* Board fees* Out-of- pocket expenses* Equity awards granted in 2024 A. Choulika 937,539 — — 350,000 SO D. Sourdive 593,156 — — 175,000 SO J.P.
Dr Chartier serves as Chief Scientific Officer at NextVivo, Inc. since November 2022, a position she also held from July through December 2021.Dr Chartier also serves at the Scientific Board of Advisors of CTRL Therapeutics. Prior to her tenure at NextVivo, Dr.
Dr Chartier serves as at the Scientific Board of Advisors of CTRL Therapeutics. From 2022 until December 2024, she was Chief Scientific Officer at NextVivo, Inc. Prior to her tenure at NextVivo, Dr.
The vesting period of the stock options granted to our employees is four years, and to our officers is over three years and is subject to performance conditions; • 55,690 stock options have been granted to certain employees in June 2023 under the 2022 Stock Option Plan and are under a vesting period of four years. C.
The vesting period of the stock options granted to our executive officers and chairman is over three years and is subject to performance conditions; • 643,450 stock options have been granted to certain employees in May 2024 under the 2023 Stock Option Plan.
From 2021 to December 2023, he served on the board of directors of Mablink S.A.S. From December 2018 to December 2021, he served on the board of directors of Enobraq SAS. From October 2017 to May 2020, Dr. Sourdive served on the Board of Omics SAS.
From February 2014 to April 2024, he served on the board of directors of Mediterranean Institute for Life Sciences (MEDILS). From 2021 to December 2023, he served on the board of directors of Mablink S.A.S. From December 2018 to December 2021, he served on the board of directors of Enobraq SAS. From October 2017 to May 2020, Dr.
For the 2021, 2022 and 2023 Stock Options Plans, our shareholders have determined that the vesting period must be at least three years from the date of grant, and that the vesting of stock options granted to our corporate officer and members of our executive committee are subject to performance conditions.
As of the date of this Annual Report 2,314,830 ordinary shares remain available for issuance under the 2024 Stock Option Plan and 2024 Free Share Plan. 99 For the 2021, 2022, 2023 and 2024 Stock Options Plans, our shareholders have determined that the vesting period must be at least over three years from the date of grant, and that the vesting of stock options granted to our corporate officer and members of our executive committee are subject to performance conditions.
Doares is responsible for the deployment of Cellectis’ manufacturing facility in Raleigh, for clinical and commercial supplies of the Cellectis’ current immuno-oncology UCART product candidates. Prior joining Cellectis, Dr.
Steven Doares , Ph.D. joined Cellectis in July 2020 as Senior Vice President, US Manufacturing and Site Head of the Raleigh, North Carolina manufacturing facility. Dr. Doares is responsible for the deployment of Cellectis’ manufacturing facility in Raleigh, for clinical and commercial supplies of the Cellectis’ current immuno-oncology UCART product candidates. Prior joining Cellectis, Dr.
Our non-employee warrants are generally granted subject to a three-year vesting, subject to continued service. As of December 31, 2023, 3,118,063 non-employee warrants exercisable for an aggregate of 3,118,063 ordinary shares at a weighted average exercise price of €4.61 per share, were outstanding.
The term of each non-employee warrant is generally 10 years from the date of grant. 98 Our non-employee warrants are generally granted subject to a three-year vesting, subject to continued service. As of December 31, 2024, 5,189,542 non-employee warrants exercisable for an aggregate of 5,209,875 ordinary shares at a weighted average exercise price of €3.68 per share, were outstanding.
Prior to his tenure at Medigene, he served as Vice Chairman and Managing Director of the Life Sciences Practice for Barclays PLC, in Europe. Cécile Chartier serves as a member of our board of directors since June 2023.
Prior to his tenure at Medigene, he served as Vice Chairman and Managing Director of the Life Sciences Practice for Barclays PLC, in Europe. Tyrell Rivers , PhD, serves as a member of our board of directors since May 2024. Since May 2024, Mr. Rivers has served as Executive Director within AstraZeneca's Corporate Development Group. Prior to this role, Dr.
He is CEO and Chairman of Cellectis, Inc. since December 2014 and Cellectis Biologics, Inc. since January 2019. From 1997 to 1999, Dr.
He served as Chairman of our board of directors from 2011 to November 2020 and Chairman of the board of directors of Calyxt from August 2010 to July 2020. He is CEO and Chairman of Cellectis, Inc. since December 2014 and Cellectis Biologics, Inc. since January 2019. From 1997 to 1999, Dr.
Incentive stock options and non-qualified stock options may be granted under the Stock Option Plans, except for the 2021, 2022 and 2023 Stock Options under which only non-qualified stock options are available. As of the date of this Annual Report 411,120 ordinary shares remain available for issuance under the 2023 Stock Option Plan and 2023 Free Share Plan.
Incentive stock options and non-qualified stock options may be granted under the Stock Option Plans, except for the 2021, 2022, 2023 and 2024 Stock Options under which only non-qualified stock options are available.
For the year ended December 31, 2023, 260,000 stock options with an exercise price of €1.80 per ordinary share, and 1,239,821 stock options with an exercise price of €3.17 per ordinary share were issued to executive officers as compensation under the 2022 Stock Option Plan.
For the year ended December 31, 2024, 1,412,476 stock options with an exercise price of €2.60 per ordinary share, and 205,500 stock options with an exercise price of €2.07 per ordinary share were granted to executive officers as compensation under the 2023 Stock Option Plan, and 100,000 stock options with an exercise price of €1.90 were granted to one of our executive officer under the 2024 Stock Option Plan.
Arthaud served at the board of directors of Calyxt from 2020 to May 2023, serving as a director designated by Cellectis. He previously served at the Calyxt’s board of directors from July 2017 to May 2019. He served on the board of directors of TxCell from 2012 to 2018, on the board of directors of Adocia from 2009 to 2022.
He currently serves on the boards of directors of Kurma Life Sciences, Sparingvision, Aledia, Ribogenics, Inc., Enyo Pharma and Argobio. Mr. Arthaud served at the board of directors of Calyxt from 2020 to May 2023, serving as a director designated by Cellectis. He previously served at the Calyxt’s board of directors from July 2017 to May 2019.
Bergstrom, Ph.D. 52 Director Executive Officers André Choulika , Ph.D., is one of the founders of Cellectis and served as Chief Executive Officer since the Company’s inception in 1999. He served as Chairman of our board of directors from 2011 to November 2020 and Chairman of the board of directors of Calyxt from August 2010 to July 2020.
Bergstrom, Ph.D. 53 Director Marc Dunoyer 72 Director Tyrell Rivers, Ph.D. 52 Director Executive Officers André Choulika , Ph.D., is one of the founders of Cellectis and served as Chief Executive Officer since the Company’s inception in 1999.
Bastid is currently serving on the board of directors of Pharnext (a biotechnology company), Carmat S.A., DCTV Center New-York, and of a series of his owned investment and private equity companies and was Chairman of Z Nautic SAS from November 2019 to January 2020. 98 Rainer Boehm serves as a member of Cellectis’ board of directors since 2017.
Bastid is currently serving as chairman on the board of directors of Carmat S.A., and he serves as the board of directors of DCTV Center New-York, Nepteam S.A.S, and of a series of his owned investment and private equity companies. Mr.
Chartier also founded CHartier consulting in 2022. Dr Chartier obtained her Ph.D. in molecular biology from the Université Louis Pasteur in Strasbourg, France and completed post-doctoral training at Harvard Medical School. Board Diversity The table below provides certain information regarding the diversity of our board of directors as of the date of this Annual Report.
Chartier also founded Chartier Consulting in 2022. Dr Chartier obtained her Ph.D. in molecular biology from the Université Louis Pasteur in Strasbourg, France and completed post-doctoral training at Harvard Medical School. Marc Dunoyer serves as a member of our board of directors since May 2024. Mr. Dunoyer serves as Chief Executive Officer of Alexion, AstraZeneca Rare Disease, since August 2021.
The vesting period of the stock options granted to our employees is four years, and to our officers is over three years and is subject to performance conditions; • 2,150 free shares have been granted to a new employee in March 2023 under the 2022 Free Share Plan and are under a vesting period of three years; • 4,300 stock options have been granted a new employee in March 2023 under the 2022 Stock Option Plan and are under a vesting period of four years; • 358,100 stock options have been granted to certain employees and officers in May 2023 under the 2022 Stock Option Plan, out of which 260,000 were granted to certain of our officers.
The vesting period of the stock options granted to our employees is four years, and to our officers is over three years and is subject to performance conditions; • 100,000 stock options have been granted to one of our executive officer in August 2024 under the 2024 Stock Option Plan and are under a vesting period over three years and is subject to performance conditions; • 21,000 stock options have been granted to certain of our employees in September 2024 under the 2024 Stock Option Plan and are under a vesting period over four years; • 19,675 stock options have been granted to certain of our employees in November 2024 under the 2024 Stock Option Plan and are under a vesting period over four years.
Stril graduated from the École Normale Supérieure, Paris & Cambridge University, and holds a diploma in Immunotherapy from the Université Paris-Descartes. Mr. Stril is also a member of the French Corps des Mines. Marie-Bleuenn Terrier joined Cellectis as Legal Counsel in 2008, and was appointed General Counsel in 2013.
Stril is also a member of the French Corps des Mines and is a member of the advisory board of Life Science Cares, a not-for profit organisation. Marie-Bleuenn Terrier joined Cellectis as Legal Counsel in 2008, and was appointed General Counsel in 2013.
Non-employee Directors Jean-Pierre Garnier , M.D., has served as a member and Chairman of our board of directors since November 2020. Since 2019, he served as director of the board of directors of Carrier Global Corp., a public company. From 2015 to 2022, Dr.
She holds a Master’s degree in Law from the Panthéon La Sorbonne University in Paris. Non-employee Directors Jean-Pierre Garnier , M.D., serves as a member and Chairman of our board of directors since November 2020. Since September 2024, he has served as chairman of the board of directors of BioAge Therapeutics, Inc. From 2019 to 2024, Dr.
Bing Wang (Chief Financial Officer), and Ms. Marie-Bleuenn Terrier (General Counsel). The change of control plan also applies to Ms. Delphine Jay (Human Resources Director), and Dr. Laurent Poirot (Senior Vice President Immunology).
Arthur Stril (Chief Financial Officer & Chief Business Officer), and Ms. Marie-Bleuenn Terrier (General Counsel). The change of control plan also applies to two of our senior managers.
Stril serves on the board of directors of Primera Therapeutics, Inc. since May 2023, serving as a director designated by Cellectis Mr. Stril began his career at the European Commission’s Directorate-General for Competition, controlling global pharmaceutical mergers. He later became Head of the Hospital Financing Unit at the French Ministry of Health. Mr.
Stril began his career at the European Commission’s Directorate-General for Competition, controlling global pharmaceutical mergers. He later became Head of the Hospital Financing Unit at the French Ministry of Health. Mr. Stril graduated from the École Normale Supérieure, Paris and Cambridge University, and holds a diploma in Immunotherapy from the Université Paris-Descartes. Mr.
During the year ended December 31, 2023: • 340,750 free shares have been granted to certain employees in January 2023 under the 2022 Free Share Plan. The vesting period of the free shares granted to our employees is three years; • 1,417,321 stock options have been granted in January 2023 under the 2022 Stock Option Plan.
During the year ended December 31, 2024: • 1,682,476 stock options have been granted in January 2024 under the 2023 Stock Option Plan. These stock option have been granted to our executive officers and our chairman.
As of December 31, 2023, 228,875 of the 3,118,963 warrants are held by certain of our directors and some of our consultants and exercisable, and 2,779,188 he 3,118,963 warrants are held by the EIB.
As of December 31, 2024, 338,875 of the 5,189,542 warrants are held by certain of our directors and some of our consultants and exercisable for an aggregate of 359,208 ordinary shares, and 4,850,667 of the 5,189,542 warrants are held by the EIB.
Sourdive has also been a member of our board of directors since 2000. Since February 2014, Dr. Sourdive also served on the board of directors of Mediterranean Institute for Life Sciences (MEDILS).
Sourdive is also a member of our board of directors since 2000.
These stock option have been granted to a certain number of employees and officers, out of which 1,239,821 were granted to our officers.
The vesting period of the stock options granted to our employees is four years; • 587,562 stock options have been granted to certain employees and executive officers in June 2024 under the 2023 Stock Option Plan, out of which 225,000 were granted to certain of our executive officers.
Garnier — 97,344 16,634 89,821 SO L. Arthaud — — — — P. Bastid — 97,344 — — R. Boehm — 99,597 — — D. Bergstrom — 102,751 — — H. Hoppenot — 51,376 — — A. Schwebig — 48,672 — — A-S Malkomes — 102,752 — — C.
Garnier — 97,389 9,237 105,416 SO L. Arthaud — — — — P. Bastid — 97,389 — — R. Boehm — 102,800 — — D. Bergstrom — 97,389 — — A-S Malkomes — 102,800 — — C. Chartier — 97,389 — — M. Dunoyer — — — — T.
Removed
André Choulika was awarded Chevalier of the Légion d’Honneur in France. Steven Doares , Ph.D. joined Cellectis in July 2020 as Senior Vice President, US Manufacturing and Site Head of the Raleigh, North Carolina manufacturing facility. Dr.

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Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Related-Party Transactions Policy We have adopted a related-party transaction policy that sets forth our procedures for the identification, review, consideration and approval or ratification of related-party transactions. The policy became effective immediately upon the completion of our initial public 109 offering.
Related-Party Transactions Policy We have adopted a related-party transaction policy that sets forth our procedures for the identification, review, consideration and approval or ratification of related-party transactions. The policy became effective immediately upon the completion of our initial public offering.
Beneficial ownership is determined in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities and include ordinary shares that can be acquired within 60 days of February 15, 2024.
Beneficial ownership is determined in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities and include ordinary shares that can be acquired within 60 days of February 15, 2025.
Pursuant to this agreement and according to market standards, BPI advanced 5,456,000 € over the period from June 15, 2022 to June 15, 2023, with a commitment fee to be charged to Cellectis of 0.40%. The agreement was amended to extend the period to June, 15, 2024.
Pursuant to this agreement and according to market standards, BPI advanced 5,456,000 € over the period from June 15, 2022 to June 15, 2023, with a commitment fee to be charged to Cellectis of 0.40%. The agreement was amended to extend the period to October, 15, 2025.
In computing the number of ordinary shares beneficially owned by a person and the percentage ownership of that person, we deemed outstanding ordinary shares subject to options and warrants held by that person that are immediately exercisable or exercisable 106 within 60 days of February 15, 2024.
In computing the number of ordinary shares beneficially owned by a person and the percentage ownership of that person, we deemed outstanding ordinary shares subject to options and warrants held by that person that are immediately exercisable or exercisable within 60 days of February 15, 2025.
Pursuant to this agreement and according to market standards, Bpifrance advances 5,284,000 € over the period from July 15, 2023 to July 15, 2024, with a commitment fee to be charged to Cellectis of 0.40%.
Pursuant to this agreement and according to market standards, Bpifrance advances 5,284,000 € over the period from July 15, 2023 to October 15, 2025, with a commitment fee to be charged to Cellectis of 0.40%.
Long Focus Capital Management LLC, Long Focus Capital Master Ltd. and Condagua LLC’s address is 207 Calle Del Parque, A&M Tower, 8th Floor San Juan, PR 00912. (4) Includes 219,173 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 200,000 ordinary shares that Mr.
Long Focus Capital Management LLC, Long Focus Capital Master Ltd. and Condagua LLC’s address is 207 Calle Del Parque, A&M Tower, 8th Floor San Juan, PR 00912. (4) Includes 232,323 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 212,000 ordinary shares that Mr.
The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of February 14, 2024 for: • each beneficial owner of more than 5% of our outstanding ordinary shares; • each of our directors and executive officers; and • all of our directors and executive officers as a group.
The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of February 15, 2025 for: • each beneficial owner of more than 5% of our outstanding ordinary shares; • each of our directors and executive officers; and • all of our directors and executive officers as a group.
Indemnification Agreements See “Item. 6B—Limitations on Liability and Indemnification Matters.” Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling us pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
See “Item. 7A—Major Shareholders” for information regarding equity awards to certain of our executive officers. 106 Indemnification Agreements See “Item. 6B—Limitations on Liability and Indemnification Matters.” Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling us pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
Helmers may be deemed to beneficially own the 2,415,996 ordinary shares held by Long Focus Capital Master, Ltd. and the 2,071,297 ordinary shares held by Condagua, LLC as the SEC registered investment adviser and the principal of LFCM, respectively. A. Glenn Helmers is the beneficial owner of the 2,071,297 ordinary shares held by Condagua, LLC.
Helmers may be deemed to beneficially own the 2,510,101 ordinary shares held by Long Focus Capital Master, Ltd. and the 2,107,192 ordinary shares held by Condagua, LLC as the SEC registered investment adviser and the principal of LFCM, respectively. A. Glenn Helmers is the beneficial owner of the 2,107,192 ordinary shares held by Condagua, LLC.
Other than as stated above, none of our principal shareholders has voting rights different than our other shareholders. Shareholders in the United States As of June 30, 2023 and December 31, 2023, we estimate that approximately 22.4% and 27.9%, respectively, of our outstanding ordinary shares were held in the United States. B.
Other than as stated above, none of our principal shareholders has voting rights different than our other shareholders. Shareholders in the United States As of June 30, 2024 and December 31, 2024, we estimate that approximately 16.7% and 22.6%, respectively, of our outstanding ordinary shares were held in the United States. B.
As reported on the Schedule 13G, Long Focus Capital Master, Ltd. is the beneficial owner of record of 2,415,996 shares of ordinary shares. Condagua, LLC is the beneficial owner of record of 2,071,297 ordinary shares. Long Focus Capital Management, LLC (“LFCM”) and John B.
As reported on the Schedule 13G, Long Focus Capital Master, Ltd. is the beneficial owner of record of 2,510,101 ordinary shares, Condagua, LLC is the beneficial owner of record of 2,107,192 ordinary shares, Long Focus Capital Management, LLC (“LFCM”) and John B.
Choulika has the right to acquire pursuant to stock options granted in September 2015 governed by the 2015 Stock Option Plan, 160,701 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 226,477 ordinary shares that Mr.
Choulika has the right to acquire pursuant to stock options granted in September 2015 governed by the 2015 Stock Option Plan, 170,343 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 240,065 ordinary shares that Mr.
Choulika has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 135,000 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 140,000 ordinary shares that Mr.
Choulika has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 143,100 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 148,400 ordinary shares that Mr.
Choulika has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 116,250 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 90,750 ordinary shares that Mr.
Choulika has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 164,300 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 153,912 ordinary shares that Mr.
Duchateau has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 70,000 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 25,500 ordinary shares that Dr.
Duchateau has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 74,200 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 36,040 ordinary shares that Dr.
Duchateau has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan and 22,000 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 1,650 ordinary shares that Dr.
Duchateau has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan and 37,312 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 3,551ordinary shares that Dr.
Reynier has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 70,000 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 25,500 ordinary shares that Mr.
Reynier has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 74,200 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 36,040 ordinary shares that Mr.
Garnier has the right to acquire pursuant to stock options granted in 108 March 2022 under the 2021 Stock Option Plan and 19,761 ordinary shares that Mr. Garnier has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan.
Garnier has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 53,317 ordinary shares that Mr. Garnier has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 36,874 ordinary shares that Mr.
Duchateau has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 169,858 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 30,000 ordinary shares that Dr.
Duchateau has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 180,049 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 31,800 ordinary shares that Dr.
Reynier has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 67,609 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 40,000 ordinary shares that Mr.
Reynier has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 71,665 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 42,400 ordinary shares that Mr.
Reynier has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 6,875 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in May 2021 under the 2018 Stock Option Plan, 22,000 ordinary shares that Mr.
Reynier has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 9,937 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in May 2021 under the 2018 Stock Option Plan, 37,312 ordinary shares that Mr.
Reynier has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 40,000 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in September 2015 under the 2015 Stock Option Plan, 58,856 ordinary shares that Mr.
Reynier has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 42,400 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in September 2015 under the 2015 Stock Option Plan, 62,387 ordinary shares that Mr.
Sourdive has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 175,000 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in September 2015 governed by the 2015 Stock Option Plan, 140,614 ordinary shares that Mr.
Sourdive has the right to acquire pursuant to stock options granted in September 2015 governed by the 2015 Stock Option Plan, 149,050 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 210,058 ordinary shares that Mr.
Pursuant to the AZ JRCA, Cellectis’ research costs under the collaboration will be funded by AZ Ireland and Cellectis has received an upfront payment of $25 million in November 2023. For more information, see “Item 4. Information on the Company—B.
Pursuant to the AZ JRCA, Cellectis’ research costs under the collaboration are funded by AZ Ireland. Cellectis also received upfront payments of $25.0 million in November 2023, and milestone payments in an aggregate amount of $22.0 million in 2024. For more information, see “Item 4. Information on the Company—B.
Reynier has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 1,650 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan and 22,000 ordinary shares that Mr.
Reynier has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 3,551 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 59,360 ordinary shares that Mr.
Doares has the right to acquire pursuant to stock options granted in May 2021 under the 2018 Stock Option Plan, 22,000 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 1,650 ordinary shares that Mr.
Doares has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 14,906 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in May 2021 under the 2018 Stock Option Plan, 37,312 ordinary shares that Mr.
Choulika has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan and 55,000 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan. (5) Includes 175,343 ordinary shares that Mr.
Choulika has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 148,400 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, and 122,430 ordinary shares that Mr.
Duchateau has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 150,000 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in September 2015 governed by the 2015 Stock Option Plan, 120,526 ordinary shares that Dr.
(6) Includes 139,398 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 159,000 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in September 2015 governed by the 2015 Stock Option Plan, 127,757 ordinary shares that Dr.
Terrier has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 90,000 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in September 2015 under the 2015 Stock Option Plan, 140,614 ordinary shares that Mrs.
Terrier has the right to acquire pursuant to stock options granted in September 2015 under the 2015 Stock Option Plan, 149,050 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 210,058 ordinary shares that Mrs.
(2) Amounts beneficially owned were reported pursuant to a Schedule 13D amendment filed with the SEC on November 6, 2023.
(1) Amounts beneficially owned were reported pursuant to a Schedule 13D amendment filed with the SEC on January 1, 2025.
Terrier has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan and 22,000 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan. (8) Includes 39,452 ordinary shares that Mr.
Terrier has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, and 47,223 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan. (8) Includes 41,819 ordinary shares that Mr.
BPI, has signed a grant and refundable advance to partially support a R&D program related to Cellectis UCART 20x22 for up to €6.4 million subject to specific conditions. In 2023, Cellectis received $3.1 million pursuant to this advance.
We entered into the BPI Grant and Advance Agreement to partially support a R&D program related to Cellectis UCART 20x22 for up to €6.4 million subject to specific conditions. In 2023 and 2024, Cellectis received respectively $3.1 million and $2.7 million pursuant to the BPI Grant and Advance Agreement.
Stril has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 25,500 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 22,000 ordinary shares that Mr.
Sourdive has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 36,040 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 37,312 ordinary shares that Mr.
The percentage ownership information shown in the table is based upon 71,751,201 ordinary shares outstanding as of February 15, 2024.
The percentage ownership information shown in the table is based upon 72,093,873 ordinary shares outstanding as of February 15, 2025.
Sourdive has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 22,000 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 1,650 ordinary shares that Mr.
Stril has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 37,312 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 3,551 ordinary shares that Mr.
Terrier has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 22,000 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 1,650 ordinary shares that Mrs.
Terrier has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 3,551 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 59,360 ordinary shares that Mrs.
Duchateau has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan and 22,000 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan. (7) Includes 87,671 ordinary shares that Mrs.
Duchateau has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 59,360 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, and 47,223 ordinary shares that Mr.
Nam-Wortman has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 1,650 ordinary shares that Mrs. Nam-Wortman has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan and 22,000 ordinary shares that Mrs.
Nam-Wortman has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 37,312 ordinary shares that Mrs. Nam-Wortman has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 3,551 ordinary shares that Mrs.
Stril has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan. (13) Includes 55,000 ordinary shares that Mr. Wang has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan and 22,000 ordinary shares that Mr.
Stril has the right to acquire pursuant to stock options granted in May 2023 under the 2022 Stock Option Plan, and 51,441 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan. (12) Includes 53,000 ordinary shares that Mr.
Doares has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan and 22,000 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan. (11) Includes 16,656 ordinary shares that Mrs.
Nam-Wortman has the right to acquire pursuant to stock options granted in May 2023 under the 2022 Stock Option Plan, and 47,223 ordinary shares that Mrs. Nam-Wortman has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan. (11) Includes 5,300 ordinary shares that Mr.
Sourdive has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 70,000 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 25,500 ordinary shares that Mr.
Stril has the right to acquire pursuant to stock options granted in October 2018 under the 2018 Stock Option Plan, 15,370 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 36,040 ordinary shares that Mr.
Stril has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 1,650 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan and 22,000 ordinary shares that Mr.
Doares has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 3,551 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 59,360 ordinary shares that Mr.
Transactions with Our Principal Shareholders, Directors and Executive Officers BPI, which is a shareholder of Cellectis, participated in a bank syndicate that granted to Cellectis the PGE loan. Since January 1, 2023, we have made payments of $1.6 million in principal and $0.2 million in interest pursuant to the PGE loan.
Transactions with Our Principal Shareholders, Directors and Executive Officers BPI, which is a shareholder of Cellectis, participated in a bank syndicate that granted to Cellectis the PGE loan.
Voting Rights A double voting right is attached to each registered share which is held in the name of the same shareholder for at least two years. Any of our principal shareholders who have held our ordinary shares in registered form for at least two years have this double voting rights.
Any of our principal shareholders who have held our ordinary shares in registered form for at least two years have this double voting rights.
Sourdive has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 198,168 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 80,000 ordinary shares that Mr.
Sourdive has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 84,800 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 74,200 ordinary shares that Mr.
Terrier has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 198,168 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 80,000 ordinary shares that Mrs.
Terrier has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 84,800 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 74,200 ordinary shares that Mrs.
Terrier has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 70,000 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 25,500 ordinary shares that Mrs.
Terrier has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan, 36,040 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 37,312 ordinary shares that Mrs.
Sourdive has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 22,000 ordinary shares that Mr. Sourdive has 107 the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan and 703,041 shares held by Viveoo SARL. (6) Includes 131,508 ordinary shares that Dr.
Sourdive has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 47,223 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan, 288,041 shares held by Viveoo SARL, and 415,000 shares held by SGBT LUX VIVEOO.
Until they convert into ordinary shares, the "class A" convertible preferred shares would have single voting rights and would not carry any double voting right at any moment, and the "class B" would carry no voting rights except on any distribution of dividends or reserves.
Until they convert into ordinary shares, the "class A" convertible preferred shares have single voting rights, and will not be eligible for double voting right under any circumstances, and the "class B" have no voting rights for a period of 74 years, except with respect to any distribution of dividends or reserves.
Consists of 6,913,153 ordinary shares (corresponding to 9,792,653 voting rights) beneficially owned by Caisse des dépôts et consignations, which includes 5,873,247 ordinary shares (corresponding to 8,752,747 voting rights) beneficially owned by each of Bpifrance Participations S.A., EPIC Bpifrance and Bpifrance S.A and 1,039,906 ordinary shares (corresponding to 1,039,906 voting rights) beneficially owned by CDC Croissance S.A.Bpifrance Participations S.A., EPIC Bpifrance and Bpifrance S.A.'s address is 27-31, avenue du Général Leclerc, 94710 Maisons-Alfort Cedex, France.
Consists of 6,913,153 ordinary shares (corresponding to 10,292,653 voting rights) beneficially owned by Caisse des Dépôts, which includes 5,873,247 ordinary shares (corresponding to 9,252,747 voting rights) beneficially owned by each of Bpifrance Participations S.A., EPIC Bpifrance and Bpifrance S.A and 1,039,906 ordinary shares (corresponding to 1,039,906 voting rights) beneficially owned by CDC Croissance S.A.
Name of Beneficial Owner Ordinary Shares Beneficially Owned Number Percentage 5% Shareholders: AstraZeneca (1) 16,000,000 22.24% Bpifrance Participations (2) 6,913,153 9.61% Long Focus Capital Management LLC (3) 4,615,293 6.41% Directors and Executive Officers: André Choulika, Ph.D. (4) 2,361,168 3.28% David Sourdive, Ph.D. (5) 1,897,930 2.64% Philippe Duchateau, Ph.D.
Name of Beneficial Owner Ordinary Shares Beneficially Owned Number Percentage 5% Shareholders: AstraZeneca PLC (1) 26,000,000 31.67% Bpifrance Participations SA (2) 6,913,153 9.59% Long Focus Capital Management LLC (3) 4,617,293 6,40% Directors and Executive Officers: André Choulika, Ph.D. [(4) 2,790,186 3.78% David Sourdive, Ph.D. (5) 2,069,622 2.83% Philippe Duchateau, Ph.D.
We did not deem these shares outstanding, however, for the purpose of computing the percentage ownership of any other person. Beneficial ownership representing less than 1% is denoted with an asterisk (*). The information in the table below is based on information known to us or ascertained by us from public filings made by the shareholders in France.
We did not deem these shares outstanding, however, for the purpose of computing the percentage ownership of any other person. Beneficial ownership representing less than 1% is denoted with an asterisk (*).
Frattini has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 3,960 ordinary shares that Dr. Frattini has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 23,100 ordinary shares that Dr.
Sourdive has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 3,551 ordinary shares that Mr. Sourdive has the right to acquire 104 pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 59,360 ordinary shares that Mr.
Frattini has the right to acquire pursuant to stock options granted in November 2022 and 22,000 ordinary shares that Dr. Frattini has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan. (10) Includes 17,000 ordinary shares that Mr.
Reynier has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 27,984 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in May 2023 under the 2022 Stock Option Plan, and 47,223 ordinary shares that Mr.
Reynier has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan. (9) Includes 45,000 ordinary shares that Dr. Frattini has the right to acquire pursuant to stock options granted in September 2020 under the 2018 Stock Option Plan, 11,625 ordinary shares that Dr.
Reynier has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan. (9) Includes 18,020 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in July 2020 under the 2018 Stock Option Plan, 36,040 ordinary shares that Mr.
Nam-Wortman has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan. (12) Includes 5,000 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in October 2018 under the 2018 Stock Option Plan, 14,500 ordinary shares that Mr.
Choulika has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan. (5) Includes 185,863 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 185,500 ordinary shares that Mr.
Equity Awards Since January 1, 2023, we have granted equity awards to certain of our directors and executive officers: • On January 24, 2023, we granted 1,417,321 stock options to our executive officers and the chairman of our board of directors, with a vesting over three years and subject to performance conditions. • On May 4, 2023, we granted 260,000 stock options to certain of our executive officers, with a vesting over three years and subject to performance conditions.
Equity Awards Since January 1, 2024, we have granted equity awards to certain of our directors and executive officers: • On January 25, 2024, we granted 1,682,476 stock options (of which 270,000 stock options were forfeited) to our executive officers and the chairman of our board of directors, with a vesting over three years and subject to performance conditions. • On June 26, 2024, we granted 225,000 stock options (of which 20,000 stock options expired) to certain of our executive officers, with a vesting over three years and subject to performance conditions. • On August 7, 2024, we granted 100,000 stock options to one of our executive officers, with a vesting over three years and subject to performance conditions.
(15) The ordinary shares include 40,000 non-employee warrants which are exercisable since October 11, 2018. (16) Includes 24,032 ordinary shares that Mr. Garnier has the right to acquire pursuant to stock options granted in April 2021 under the 2018 Stock Option Plan, 24,291 ordinary shares that Mr.
Boehm has the right to acquire pursuant to non-employee warrants granted in October 2017. (14) Includes 28,051 ordinary shares that Mr. Garnier has the right to acquire pursuant to stock options granted in April 2021 under the 2018 Stock Option Plan, 41,197 ordinary shares that Mr.
Nam-Wortman has the right to acquire pursuant to stock options granted in November 2020 under the 2018 Stock Option Plan, 25,500 ordinary shares that Mrs. Nam-Wortman has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan and 22,000 ordinary shares that Mrs.
Doares has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan. (10) Includes 21,730 ordinary shares that Mrs. Nam-Wortman has the right to acquire pursuant to stock options granted in November 2020 under the 2018 Stock Option Plan, 36,040 ordinary shares that Mrs.
Doares has the right to acquire pursuant to stock options granted in July 2020 under the 2018 Stock Option Plan, 25,500 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 10,313 ordinary shares that Mr.
Doares has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 20,988 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in May 2023 under the 2022 Stock Option Plan, and 47,223 ordinary shares that Mr.
Caisse des Dépôts' address is 56, rue de Lille, 75007 Paris, France. (3) Amounts beneficially owned include 4,615,293 ordinary shares reported on December 31, 2023, according to the shareholder records provided by Nasdaq as of such date, and include the 4,487,293 ordinary shares reported pursuant to a Schedule 13G amendment filed with the SEC on February 14, 2024.
Bpifrance Participations S.A., EPIC Bpifrance and Bpifrance S.A.'s address is 27-31, avenue du Général Leclerc, 94710 Maisons-Alfort Cedex, France. Caisse des Dépôts' address is 56, rue de Lille, 75007 Paris, France. (3) Amounts beneficially owned were reported pursuant to a Schedule 13G amendment filed with the SEC on February 11, 2025.
Ordinary shares beneficially owned by AZ Holdings. in the total amount of 16,000,000, were acquired on November 2nd, 2023 in the context of the Initial Investment. As reported on the Schedule 13D filed with the SEC on November 9, 2023, AstraZeneca PLC may be deemed to beneficially own the ordinary shares.
As reported on the Schedule 13D filed with the SEC on January 1, 2025, AstraZeneca PLC may be deemed to beneficially own the ordinary shares. (2) Amounts beneficially owned were reported pursuant to a Schedule 13D amendment filed with the SEC on January 30, 2025.
Bergstrom — * Axel-Sven Malkomes — * Cécile Chartier — * All directors and executive officers as a group (17 persons) 8,860,725 12.31% * Represents beneficial ownership of less than one per cent. (1) The address of AstraZeneca PLC is 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge CB2 0AA, England.
Bergstrom — * Axel-Sven Malkomes — * Cécile Chartier — * Marc Dunoyer — * Tyrell Rivers — * All directors and executive officers as a group (18 persons) 10,316,133 13.16% * Represents beneficial ownership of less than one per cent.
Wang has the right to acquire pursuant to stock options in January 2023 under the 2022 Stock Option Plan (14) The ordinary shares include 50,000 non-employee warrants which are exercisable since March 27, 2016, 50,000 non-employee warrants, which are exercisable since September 8, 2016, 40,175 non-employee warrants, which are exercisable since March 14, 2017, 40,000 non-employee warrants, which are exercisable since October 28, 2017, 40,000 non-employee warrants, which are exercisable since October 11, 2018, 55,900 shares personally held and 1,743,678 shares held by Lohas SARL.
Bastid has the right to acquire pursuant to non-employee warrants granted in October 2016, 42,400 ordinary shares that Mr. Bastid has the right to acquire pursuant to non-employee warrants granted in October 2017, 55,900 shares personally held and 1,743,678 shares held by Lohas SARL. (13) Includes 42,400 ordinary shares that Mr.
(6) 786,296 1.09% Marie-Bleuenn Terrier (7) 768,211 1.07% Stephan Reynier (8) 413,686 * Mark Frattini (9) 122,700 * Steven Doares (10) 110,956 * Kyung Nam-Wortman (11) 99,426 * Arthur Stril (12) 99,230 * Bing Wang, PhD(13) 77,000 * Pierre Bastid (14) 2,019,753 2.81% Laurent Arthaud — * Rainer Boehm (15) 40,000 * Jean-Pierre Garnier (16) 64,369 * Donald A.
(6) 947,954 1.30% Marie-Bleuenn Terrier (7) 929,543 1.27% Stephan Reynier (8) 588,530 * Adrian Kilcoyne — * Steven Doares (9) 261,710 * Kyung Nam-Wortman (10) 246,834 * Arthur Stril (11) 246,952 * Pierre Bastid (12) 2,032,963 2.81% Laurent Arthaud — * Rainer Boehm (13) 42,400 * Jean-Pierre Garnier (14) 159,439 * Donald A.
Removed
See “Item. 7A—Major Shareholders” for information regarding equity awards to certain of our executive officers.
Added
Our By-Laws provide that all ordinary shares held in registered form (actions nominatives) in the name of the same shareholder for at least two years will be entitled to a double voting right. 103 The information in the table below is based on information known to us or ascertained by us from public filings made by the shareholders in France.
Added
Consists of 16,000,000 ordinary shares (corresponding to 16,000,000 voting rights) and 10,000,000 shares of Class A Preferred Shares (corresponding to 16,000,000 voting rights), which are convertible at any time by AZ Holdings and which vote together with the Company's ordinary shares. The address of AstraZeneca PLC is 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge CB2 0AA, England.
Added
Duchateau has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan. (7) Includes 92,931 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 95,400 ordinary shares that Mrs.
Added
Nam-Wortman has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 59,360 ordinary shares that Mrs. Nam-Wortman has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 20,988 ordinary shares that Mrs.
Added
Stril has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 59,360 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 20,988 ordinary shares that Mr.
Added
Bastid has the right to acquire pursuant to non-employee warrants granted in March 2015, 53,000 ordinary shares that Mr. Bastid has the right to acquire pursuant to non-employee warrants granted in September 105 2015, 42,585 ordinary shares that Mr. Bastid has the right to acquire pursuant to non-employee warrants granted in March 2016, 42,400 ordinary shares that Mr.
Added
Garnier has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan. Voting Rights A double voting right is attached to each registered share which is held in the name of the same shareholder for at least two years.
Added
During the fiscal years ended 2023 and 2024, we have made payments of $1.6 million in principal each year and respectively $0.2 million and $0.1 million in interest pursuant to the PGE loan.

Other CLLS 10-K year-over-year comparisons