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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 — 2024 vs 2025

Top changes in Cellectis S.A.'s 2025 20-F

606 paragraphs added · 677 removed · 524 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

143 edited+26 added−18 removed584 unchanged
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.
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; 10 • 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 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.
Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate, with substantial evidence gathered in well-controlled clinical trials and to the satisfaction regulatory authorities (including the FDA in the United States and the EMA in the EU) that the product candidate is safe and effective for use in each target indication.
Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate, with substantial evidence gathered in well-controlled clinical trials and to the satisfaction of regulatory authorities (including the FDA in the United States and the EMA in the EU) that the product candidate is safe and effective for use in each target indication.
However, the 10-year market exclusivity may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, i.e. the prevalence of the condition has increased above the orphan designation threshold or it is judged that the product is sufficiently profitable so as not to justify maintenance of market exclusivity.
However, the 10-year market exclusivity may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, i.e. the prevalence of the condition has increased above the orphan designation threshold or it is judged that the product is sufficiently profitable so as not to justify maintenance of orphan exclusivity.
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: 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.
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.
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.
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.
Issued shares are registered in individual accounts opened by us or any authorized intermediary (depending on the form of such shares), in the name of each shareholder and kept according to the terms and conditions laid down by the legal and regulatory provisions; • under French law, a non-French resident as well as any French entity controlled by non-French residents may have to file a declaration for statistical purposes with the Bank of France (Banque de France) following the date of certain direct or indirect investments in us; see the section of this Annual Report titled “Ownership of Shares and ADSs by Non-French Persons”; • approval of at least a majority of the votes cast of the shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove directors with or without cause; • advance notice is required for nominations to the board of directors or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a director can be proposed at any shareholders’ meeting without notice; • transfers of shares shall comply with applicable insider trading rules; • in the event where certain ownership thresholds would be crossed, a number of disclosures should be made by the relevant shareholder in addition to other certain obligations; see the section of this Annual Report titled “Declaration of Crossing of Ownership Thresholds”; and • pursuant to French law, the sections of the By-laws relating to the number of directors and election and removal of a director from office may only be modified by a resolution adopted by a two-thirds majority of the votes cast of our shareholders present, represented by a proxy or voting by mail at the meeting.
Issued shares are registered in individual accounts opened by us or any authorized intermediary (depending on the form of such shares), in the name of each shareholder and kept according to the terms and conditions laid down by the legal and regulatory provisions; • under French law, a non-French resident as well as any French entity controlled by non-French residents may have to file a declaration for statistical purposes with the Bank of France (Banque de France) following the date of certain direct or indirect investments in us; see the section of this Annual Report titled “Ownership of Shares and ADSs by Non-French Persons”; • approval of at least a majority of the votes cast of the shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove directors with or without cause; • advance notice is required for nominations to the board of directors or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a director can be proposed at any shareholders’ meeting without notice; • transfers of shares shall comply with applicable insider trading rules; • in the event where certain ownership thresholds would be crossed, a number of disclosures should be made by the relevant shareholder in addition to other certain obligations; see the section of this Annual Report titled “Declaration of Crossing of Ownership Thresholds”; and 36 • pursuant to French law, the sections of the By-laws relating to the number of directors and election and removal of a director from office may only be modified by a resolution adopted by a two-thirds majority of the votes cast of our shareholders present, represented by a proxy or voting by mail at the meeting.
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.
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; • 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.
Commercialization of our product candidates in various markets could subject us to additional risks and uncertainties related to operating in foreign countries, including: • obtaining, on a country-by-country basis, the applicable marketing authorization from the competent regulatory authority; • the burden of complying with complex and changing regulatory, tax, accounting and legal requirements in each jurisdiction that we pursue; • differing medical practices and customs affecting acceptance in the marketplace; • import or export licensing requirements; • increased difficulties in managing the logistics and transportation of storing and shipping product candidates; • country specific requirements related to the cells used as starting material for manufacturing; • language barriers for technical training, healthcare professionals and patients documents; • reduced protection of intellectual property rights in some foreign countries; • foreign currency exchange rate fluctuations; • potential imposition of governmental controls; • economic weakness, including inflation, or political instability in foreign economies and markets; • difficulties staffing and managing foreign operations and workforces; and • business interruptions resulting from natural or man-made disasters, including earthquakes, tsunamis, fires, epidemics or pandemics, or geo-political actions, including war and terrorism.
Commercialization of our product candidates in various markets could subject us to additional risks and uncertainties related to operating in foreign countries, including: • obtaining, on a country-by-country basis, the applicable marketing authorization from the competent regulatory authority; • the burden of complying with complex and changing regulatory, tax, accounting and legal requirements in each jurisdiction that we pursue; • differing medical practices and customs affecting acceptance in the marketplace; • import or export licensing requirements; • increased difficulties in managing the logistics and transportation of storing and shipping product candidates; • country specific requirements related to the cells used as starting material for manufacturing; • language barriers for technical training, healthcare professionals and patients documents; • reduced protection of intellectual property rights in some foreign countries; • foreign currency exchange rate fluctuations; • potential imposition of governmental controls; • economic weakness, including inflation, or political instability in foreign economies and markets; • difficulties staffing and managing foreign operations and workforces; and 16 • business interruptions resulting from natural or man-made disasters, including earthquakes, tsunamis, fires, epidemics or pandemics, or geo-political actions, including war and terrorism.
Reliance on such third-parties entails additional risks to which we would not be subject if we conducted the above-mentioned activities ourselves, including: • that we may be unable to negotiate agreements with third parties under reasonable terms or that termination or non-renewal of an agreement occurs in a manner or time that is costly or damaging to us; • that such third-parties may have limited experience with our or comparable products and may require significant support from us in order to implement and maintain the infrastructure and processes required to manufacture, test or distribute our product candidates; • that such third parties may not perform as agreed or in compliance with applicable laws and requirements, or may not devote sufficient resources to our products; 16 • that we may not have sufficient rights or access to the intellectual property or know how relating to improvements or developments made by our third-party service providers in the course of their providing services to us; • that regulators object to or disallow the performance of specific tasks by certain third parties or disallow data provided by such third parties; • that such third parties may experience business disruptions, such as bankruptcy or acquisition, or failures or deficiencies in their supply chains, that disrupt their ability to perform their obligations to us.
Reliance on such third-parties entails additional risks to which we would not be subject if we conducted the above-mentioned activities ourselves, including: • that we may be unable to negotiate agreements with third parties under reasonable terms or that termination or non-renewal of an agreement occurs in a manner or time that is costly or damaging to us; • that such third-parties may have limited experience with our or comparable products and may require significant support from us in order to implement and maintain the infrastructure and processes required to manufacture, test or distribute our product candidates; • that such third parties may not perform as agreed or in compliance with applicable laws and requirements, or may not devote sufficient resources to our products; • that we may not have sufficient rights or access to the intellectual property or know how relating to improvements or developments made by our third-party service providers in the course of their providing services to us; • that regulators object to or disallow the performance of specific tasks by certain third parties or disallow data provided by such third parties; • that such third parties may experience business disruptions, such as bankruptcy or acquisition, or failures or deficiencies in their supply chains, that disrupt their ability to perform their obligations to us.
Additional factors that may influence whether our product candidates are accepted in the market, include: • the clinical indications for which product candidates are approved; • the potential and perceived advantages and risks of our product candidates relative to alternative treatments; • the prevalence and severity of side effects; • the demonstration of the clinical efficacy and safety of the product; • the approved labeling for the product and any required limitations or warnings; • the timing of market introduction of the product candidate as well as of competing products; • the effectiveness of educational outreach to the medical community about the product; • the coverage and reimbursement policies of government and commercial third-party payors pertaining to the product; and • the market price of the product relative to competing treatments.
Additional factors that may influence whether our product candidates are accepted in the market, include: • the clinical indications for which product candidates are approved; • the potential and perceived advantages and risks of our product candidates relative to alternative treatments; • the prevalence and severity of side effects; 15 • the demonstration of the clinical efficacy and safety of the product; • the approved labeling for the product and any required limitations or warnings; • the timing of market introduction of the product candidate as well as of competing products; • the effectiveness of educational outreach to the medical community about the product; • the coverage and reimbursement policies of government and commercial third-party payors pertaining to the product; and • the market price of the product relative to competing treatments.
The FDA or other regulatory authority, as applicable, may delay, limit or deny approval of our product candidates for many reasons, including disagreement with clinical trial design or implementation, determinations that a product candidate is not sufficiently safe or efficacious, objections to the statistical significance of data or our interpretation of data, objections to the production, formulation or labeling of our product candidates, and any other discretionary factors such regulators deem relevant.
The FDA or other regulatory authority, as applicable, may delay, limit or deny approval of our product candidate applications for many reasons, including disagreement with clinical trial design or implementation, determinations that a product candidate is not sufficiently safe or efficacious, objections to the statistical significance of data or our interpretation of data, objections to the production, formulation or labeling of our product candidates, and any other discretionary factors such regulators deem relevant.
Each U.S. holder is strongly urged to consult its tax advisor regarding these issues and any available elections to mitigate such tax consequences. See the section titled “Taxation—Material U.S. Federal Income Tax Considerations” in this Annual Report. We may have to take undesirable actions to avoid being deemed an investment company under the US Investment Company Act of 1940.
Each U.S. holder is strongly urged to consult its tax advisor regarding these issues and any available elections to mitigate such tax consequences. See the section titled “Taxation—Material U.S. Federal Income Tax Considerations” in this Annual Report. 37 We may have to take undesirable actions to avoid being deemed an investment company under the US Investment Company Act of 1940.
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.
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 and timely resolve complex accounting matters.
For example, on February 2022, following an opposition before the European Patent Office, the EP3004349 patent entitled “a method for producing precise DNA cleavage using CAS9 double nickase activity” was revoked. In addition, such interference, reexamination, post-grant review, inter partes review, opposition proceedings and other administrative proceedings may be costly and involve the diversion of significant management time.
For example, in February 2022, following an opposition before the European Patent Office, the EP3004349 patent entitled “a method for producing precise DNA cleavage using CAS9 double nickase activity” was revoked. In addition, such interference, reexamination, post-grant review, inter partes review, opposition proceedings and other administrative proceedings may be costly and involve the diversion of significant management time.
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.
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.
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.
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 25 to bring a significant clinical benefit in comparison with existing therapies.
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.
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.
Orphan designation is lost if it is established that the product no longer meets the orphan criteria before market authorization is granted. In EU, orphan medicinal products are eligible for financial incentives such as reduction of fees or fee waivers and applicants can benefit from specific regulatory assistance and scientific advice.
Orphan designation is lost if it is established that the product no longer meets the orphan criteria before market authorization is granted. 26 In the EU, orphan medicinal products are eligible for financial incentives such as reduction of fees or fee waivers and applicants can benefit from specific regulatory assistance and scientific advice.
The failure to attract, integrate, motivate, and retain additional skilled and qualified personnel, or to find suitable replacements upon departures, could have a material adverse effect on our business. We compete for such personnel against numerous companies, including larger, more established companies with significantly greater financial resources than we possess.
The failure to attract, integrate, motivate, and retain additional skilled and qualified personnel, or to 35 find suitable replacements upon departures, could have a material adverse effect on our business. We compete for such personnel against numerous companies, including larger, more established companies with significantly greater financial resources than we possess.
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.
Such potential conflicts of interest and the appearance of conflicts, even if such conflicts do not materialize, might adversely affect the 23 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 27 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 licensees or partners will be subject to the regulatory requirements of health authorities in each country in which we seek approvals.
While Allogene reported that its investigation concluded that gene editing was not responsible for the chromosomal abnormality and the hold was resolved, we or our licensees may discover future abnormalities caused by gene editing or other factors that would impact our development plans. In addition, the field of gene-editing is rapidly developing.
While Allogene reported that its investigation concluded that gene editing was not responsible for the chromosomal abnormality and the hold was resolved, we or our licensees may discover future abnormalities caused by gene editing or other factors that would impact our development plans. 9 In addition, the field of gene-editing is rapidly developing.
To the extent our licensees or partners do not aggressively and effectively pursue product candidates for which we are entitled to such payments, we will not realize these significant revenue streams, which may slow our overall development progress and could have an adverse effect on our business and future prospects.
To the extent our licensees or partners do not aggressively and effectively pursue product candidates for which we are 18 entitled to such payments, we will not realize these significant revenue streams, which may slow our overall development progress and could have an adverse effect on our business and future prospects.
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 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.
Pursuant to the Joint Research and Collaboration Agreement with AZ Ireland dated November 1, 2023 (the"AZ JRCA") with AZ Ireland 25 genetic targets have been exclusively reserved for AZ Ireland, from which up to 10 candidate products could be explored for development, and AZ Ireland will have an option for a worldwide exclusive license on the candidate products.
Pursuant to the Joint Research and Collaboration Agreement with AZ Ireland dated November 1, 2023 (the "AZ JRCA"), 25 genetic targets have been exclusively reserved for AZ Ireland, from which up to 10 candidate products could be explored for development, and AZ Ireland will have an option for a worldwide exclusive license on these candidate products.
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.
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.
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.
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 the licensed CD19 Products 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.
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.
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 2025 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.
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.
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.
We may be unable to detect vulnerabilities in our information technology systems because such threats and techniques change frequently, are often sophisticated in nature, and may not be detected until after a security incident has occurred. Despite our efforts to identify and remediate exploitable critical vulnerabilities, if any, in our information technology systems, our efforts may not be successful.
We may be unable to detect vulnerabilities in our information technology systems because such threats and techniques change frequently, are often sophisticated in nature, and may not be detected until after a security incident has occurred. Despite our efforts to 21 identify and remediate exploitable critical vulnerabilities, if any, in our information technology systems, our efforts may not be successful.
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.
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.
If we do not obtain orphan exclusivity for our products that do not have broad patent protection or if despite obtaining orphan drug designation (such as for UCART22 and CLLS52), we subsequently lose orphan drug exclusivity, our competitors may sell the same drug to treat the same condition and our revenues will be reduced.
If we do not obtain orphan exclusivity for our products that do not have broad patent protection or if despite obtaining orphan drug designation (such as for UCART22 and CLLS52), we subsequently lose orphan drug exclusivity, our competitors may sell the same drug to treat the same condition and our revenues will be significantly reduced.
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.
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.
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.
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.
Cost containment measures that healthcare payors and providers are instituting and the effect of further healthcare reform could significantly reduce potential revenues from the sale of any of our product candidates approved in the future, and could cause an increase in our compliance, manufacturing, or other operating expenses.
Cost containment measures that healthcare payors and providers are instituting and the effect of further healthcare 28 reform could significantly reduce potential revenues from the sale of any of our product candidates approved in the future, and could cause an increase in our compliance, manufacturing, or other operating expenses.
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.
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.
If significant events, such as significant GvHD or chromosomal abnormality events, are observed with the administration of our or our licensees’ product candidates, or if any of the product candidates is viewed as less safe or effective than autologous therapies, our ability to develop other allogeneic therapies may be significantly harmed.
If significant events, such as significant GvHD or chromosomal abnormality events, are observed with the administration of our or our licensees’ product candidates, or if any of the product candidates is viewed as less safe or effective than autologous therapies, our ability to develop other allogeneic therapies may be significantly 11 harmed.
Each of these risks could delay our clinical trials, the approval, if any of our product candidates by the FDA or the commercialization of our product candidates or result in higher costs or deprive us of potential product revenue. Third parties on whom we rely may not perform satisfactorily.
Each of these risks could delay our 17 clinical trials, the approval, if any of our product candidates by the FDA or the commercialization of our product candidates or result in higher costs or deprive us of potential product revenue. Third parties on whom we rely may not perform satisfactorily.
In any event, the receipt of RMAT designation, breakthrough therapy designation or PRIME support for a product candidate may not result in a faster development process, review or approval compared to products considered for approval under conventional regulatory procedures and does not assure ultimate regulatory approval.
In any event, the receipt of RMAT designation, breakthrough therapy designation or PRIME support for a product candidate may not result in a faster development process, review or approval compared to products considered for approval under conventional regulatory procedures and does not assure ultimate 27 regulatory approval.
Because our programs may involve additional product candidates or improved formulations of existing product candidates that may require the use of intellectual property or proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license or use such intellectual property and proprietary rights.
Because our programs may involve additional product candidates or improved formulations of existing product candidates that may require the use of intellectual property or proprietary rights held by third parties, the growth of our business may 34 depend in part on our ability to acquire, in-license or use such intellectual property and proprietary rights.
Further, if U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process, and certain matters of procedure would still be governed by the law of the jurisdiction in which the foreign court resides.
Further, if U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly 38 process, and certain matters of procedure would still be governed by the law of the jurisdiction in which the foreign court resides.
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.
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.
Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our product candidates. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products.
Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact 33 our ability to develop and market our product candidates. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products.
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.
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 licensees are employing their proprietary technology without authorization.
We may also experience delays in fully or effectively deploying a sustainable, reproducible and scalable manufacturing process at our new manufacturing facilities, which may prevent us from completing our clinical studies or commercializing our products on a timely or profitable basis, if at all.
We may also experience delays in fully or effectively deploying a sustainable, reproducible and scalable manufacturing process at our manufacturing facilities, which may prevent us from completing our clinical studies or commercializing our products on a timely or profitable basis, if at all.
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.
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.
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.
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.
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.
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.
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.
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.
Pursuant to this amendment, the parties to the amendment and settlement agreement putatively extended the licensed territory to the European Union and the United Kingdom and Allogene has putatively been granted an option to extend its licensed territory to China and Japan subject to certain conditions.
Pursuant to this amendment, the parties to the amendment and settlement agreement extended the licensed territory to the European Union and the United Kingdom and Allogene has been granted an option to extend its licensed territory to China and Japan subject to certain conditions.
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.
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.
Any legal action against us or our collaborators could lead to: • payment of damages, potentially including treble or punitive damages if we are found to have willfully infringed a party’s patent rights; • injunctive or other equitable relief that may effectively block our ability to further develop, commercialize, and sell products; • our or our collaborators being required to obtain a license under third-party intellectual property, and such license may not be available on an exclusive basis, on commercially acceptable terms, or at all; or • extensive discovery in which our confidential information could be compromised.
Any legal action against us or our collaborators could lead to: • payment of damages to the plaintiff, potentially including treble or punitive damages if we are found to have willfully infringed a party’s patent rights; • payment of damages to our licensees, • injunctive or other equitable relief that may effectively block our ability to further develop, commercialize, and sell products; • our or our collaborators being required to obtain a license under third-party intellectual property, and such license may not be available on an exclusive basis, on commercially acceptable terms, or at all; or • extensive discovery in which our confidential information could be compromised.
In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States.
In addition, the laws of some foreign countries do not 32 protect intellectual property rights to the same extent as federal and state laws in the United States.
Moreover, Cibus's most recent financial statements included in its quarterly report on Form 10-Q for the quarter ended September 30, 2024 note that there is substantial doubt about Cibus's ability to continue as a going-concern for at least one year from the date of issuance of those financial statements.
Moreover, Cibus's most recent financial statements included in its quarterly 30 report on Form 10-Q for the quarter ended September 30, 2025 note that there is substantial doubt about Cibus's ability to continue as a going-concern for at least one year from the date of issuance of those financial statements.
In addition, our competitors may have greater financial, technical and personnel resources that allow them to enjoy technological advantages and may in the future allow them to implement new technologies before we can. We cannot be certain that we will be able to implement technologies on a timely basis or at a cost that is acceptable to us.
In addition, many of our competitors have greater financial, technical and personnel resources that may allow them to enjoy technological advantages and may in the future allow them to implement new technologies before we can. We cannot be certain that we will be able to implement technologies on a timely basis or at a cost that is acceptable to us.
Also, in order to obtain reimbursement for our products in some countries, we may be required to conduct clinical trials that compare the cost-effectiveness of our products to other available therapies. Moreover, this political and legislative uncertainty could harm our and our licensees or partners’ ability to market any products and generate revenues.
Also, in order to obtain reimbursement for our products in some countries, we may be required to conduct clinical studies that compare the cost-effectiveness of our products to other available therapies. Moreover, this political and legislative uncertainty could harm our and our licensees or partners’ ability to market any products and generate revenues.
Any regulatory approvals received for the product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product.
Any regulatory approvals received for the product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical studies, and surveillance to monitor the safety and efficacy of the product.
Although we intend to seek orphan product designation for some or all of our product candidates, we may never receive such designations.
Although we intend to seek orphan product designation for some or all of our product candidates, we may never receive such designations for requested product candidates.
Although the material weakness has been fully remediated, despite our focus on maintaining effective internal controls, there can be no assurance that we will not experience additional material weaknesses in the future. Risks Relating to our Relationships with AstraZeneca AstraZeneca has significant influence over us.
Although the material weakness has been fully remediated, despite our focus on maintaining effective internal controls, there can be no assurance that we will not experience additional material weaknesses in the future. Risks Relating to our Relationship with AstraZeneca AstraZeneca has significant influence over us.
Risks Related to the Discovery, Development and Commercialization of Our Therapeutic Product Candidates: • Our product candidates must undergo clinical trials that are time-consuming and expensive, the outcomes of which are unpredictable, and for which there is a high risk of failure, and which are susceptible under a variety of circumstances to additional costs, delays, suspensions and terminations. • Initial, interim and preliminary data from our clinical trials may change as more data becomes available, and subsequent data may not bear out promising early results. • Because we anticipate that our product candidates may initially receive regulatory approval as treatments for advanced disease or rare diseases, the size of the initial market for our product candidates may be limited. • Our manufacturing process, which is highly complex and heavily regulated, may be difficult to efficiently and effectively operate and scale to the level required for advanced clinical trials or commercialization. • Our manufacturing facilities may not obtain or maintain the required regulatory authorizations to supply commercial products. • Acceptance and adoption of gene-editing and enrollment in our trials may be adversely affected by undesirable side effects, negative perceptions among the public or the medical community, or the inadequacy of payor coverage. • Our future profitability depends, in part, on our ability to penetrate global markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
Risks Related to the Discovery, Development and Commercialization of Our Therapeutic Product Candidates: • Because our product candidates all apply novel gene-editing technology, we are heavily dependent on the successful development of this technology. • Our product candidates must undergo clinical trials that are time-consuming and expensive, the outcomes of which are unpredictable, and for which there is a high risk of failure, and which are susceptible under a variety of circumstances to additional costs, delays, suspensions and terminations. • Initial, interim and preliminary data from our clinical trials may change as more data becomes available, and subsequent data may not bear out promising early results. • Because we anticipate that our product candidates may initially receive regulatory approval as treatments for advanced disease or rare diseases, the size of the initial market for our product candidates may be limited. • Our manufacturing process, which is highly complex and heavily regulated, may be difficult to efficiently and effectively operate and scale to the level required for advanced clinical trials or commercialization. • Our manufacturing facilities may not obtain or maintain the required regulatory authorizations to supply commercial products. • Acceptance and adoption of gene-editing and enrollment in our trials may be adversely affected by undesirable side effects, negative perceptions among the public or the medical community, or the inadequacy of payor coverage. • Our future profitability depends, in part, on our ability to penetrate global markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
As of December 31, 2024, considering the ordinary shares held by AZ Holdings and giving effect to the conversion of all Class A Preferred Shares and Class B Preferred Shares without regarding for when they may first be converted, AZ Holdings would beneficially own approximately 44% of our ordinary shares.
As of December 31, 2025, considering the ordinary shares held by AZ Holdings and giving effect to the conversion of all Class A Preferred Shares and Class B Preferred Shares without regarding for when they may first be converted, AZ Holdings would beneficially own approximately 44% of our ordinary shares.
In particular, AZ Holdings is our single largest shareholder. As of December 31, 2024, considering the ordinary shares held by AZ Holdings as well as all Class A Preferred Shares, which AZ Holdings has the right to acquire within the next 60 days, AZ Holdings, AZ Holdings beneficially owns approximately 32% of our ordinary shares.
In particular, AZ Holdings is our single largest shareholder. As of December 31, 2025, considering the ordinary shares held by AZ Holdings as well as all Class A Preferred Shares, which AZ Holdings has the right to acquire within the next 60 days, AZ Holdings, AZ Holdings beneficially owns approximately 32% of our ordinary shares.
As of December 31, 2024, considering the ordinary shares held by AZ Holdings and giving effect to the conversion of all Class A Preferred Shares and Class B Preferred Shares without regarding for when they may first be converted, AZ Holdings would beneficially own approximately 44% of our ordinary shares.
As of December 31, 2025, considering the ordinary shares held by AZ Holdings and giving effect to the conversion of all Class A Preferred Shares and Class B Preferred Shares without regarding for when they may first be converted, AZ Holdings would beneficially own approximately 44% of our ordinary shares.
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.
Our gene-editing technologies, including in particular our 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.
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.
Based on our determination made on June 30, 2025 (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, 2026.
If we do not receive anticipated payments, our development of product candidates could be delayed and we may need additional resources to develop our product candidates. Servier’s discontinuation of its involvement in the development of CD19 Products and related disagreements may have adverse consequences.
If we do not receive anticipated payments, our development of product candidates could be delayed and we may need additional resources to develop our product candidates. Servier’s discontinuation of its involvement in the development of CD19 Products may have adverse consequences.
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.
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 Minnesota offices, which we provided in favor of the landlord of that property.
As of December 31, 2024, considering the ordinary shares held by AZ Holdings as well as all Class A Preferred Shares, which AZ Holdings has the right to acquire within the next 60 days, AZ Holdings beneficially owns approximately 32% of our ordinary shares.
As of December 31, 2025, considering the ordinary shares held by AZ Holdings as well as all Class A Preferred Shares, which AZ Holdings has the right to acquire within the next 60 days, AZ Holdings beneficially owns approximately 32% of our ordinary shares.
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.
Our executive officers, directors, current 5% or greater shareholders and affiliated entities beneficially own approximately 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, 2025.
Risks Related to Intellectual Property. • Because our commercial success depends, in part, on obtaining and maintaining proprietary rights to our and our licensors’ intellectual property, our ability to compete may decline if we fail to obtain protection for our products, product candidates, processes and technologies or do not adequately protect our intellectual property. • Our competitive position may be adversely impacted as a result of a variety of factors, including potentially adverse determinations of complex legal and factual questions involved in patents and patent applications or insufficiently long patent lifespans in one or more jurisdictions where we obtain intellectual property protection. • Because it is cost prohibitive to seek intellectual property protection on a global basis, our intellectual property protection in certain jurisdictions many not be as robust as in the United States, which may adversely impact our competitive position. • Third parties may assert rights to inventions we develop or otherwise regard as our own. • A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business.
Risks Related to Intellectual Property. • Because our commercial success depends, in part, on obtaining and maintaining proprietary rights to our and our licensors’ intellectual property, our ability to compete may decline if we fail to obtain protection for our products, product candidates, processes and technologies or do not adequately protect our intellectual property. • Our competitive position may be adversely impacted as a result of a variety of factors, including potentially adverse determinations of complex legal and factual questions involved in patents and patent applications or insufficiently long patent lifespans in one or more jurisdictions where we obtain intellectual property protection. • Because it is cost prohibitive to seek intellectual property protection on a global basis, our intellectual property protection in certain jurisdictions may not be as robust as in the United States, which may adversely impact our competitive position. • Other third parties may assert rights to inventions we develop or otherwise regard as our own. • Any dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could interfere with the development and commercialization of our products and our licensees' products or otherwise harm our business.
The incorporation of an anti-CD52 monoclonal antibody as part of our lymphodepletion regimen prior to administration of UCART product candidates may increase the risk of adverse side effects. In certain of our clinical trials, we utilize an anti-CD52 monoclonal antibody as part of a lymphodepletion regimen to be infused prior to infusing patients with our product candidates.
The incorporation of an anti-CD52 monoclonal antibody as part of our lymphodepletion regimen prior to administration of UCART product candidates may increase the risk of adverse side effects. In our on-going clinical trials, we utilize an anti-CD52 monoclonal antibody as part of a lymphodepletion regimen to be infused prior to infusing patients with our product candidates.
Orphan drug designation must be requested at any time before submitting a BLA. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers.
Orphan drug designation must be requested before submitting a BLA. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers.
Similarly, in the EU, Directive 2003/94/EC, Regulation (EU) No 1252/2014 and Regulation (EU) 2017/1569 lay down the principles and guidelines of cGMP in respect of active substances for medicinal products for human use as well as investigational and medicinal products for human use and require that products are consistently produced and controlled in accordance with the applicable quality standards.
Similarly, in the EU, Directive (EU) 2017/1572, Regulation (EU) No 1252/2014 and Regulation (EU) 2017/1569 lay down the principles and guidelines of cGMP in respect of active substances for medicinal products for human use as well as investigational and medicinal products for human use and require that products are consistently produced and controlled in accordance with the applicable quality standards.
In addition, on October 7, 2021, the FDA placed a clinical hold on all of our licensee Allogene Therapeutics’ clinical trials following a chromosomal abnormality detected in ALLO-501A, which hold was removed by the FDA in January 2022.
In addition, on October 7, 2021, the FDA placed a clinical hold on all of our licensee Allogene’s clinical trials following a chromosomal abnormality detected in ALLO-501A, which hold was removed by the FDA in January 2022.
The ACA expanded health care coverage through Medicaid expansion and the implementation of a tax penalty for individuals who do not maintain mandated health insurance coverage (the so-called ‘individual mandate’). The ACA also contains a number of provisions that affect coverage and reimbursement of drug products. Uncertainty remains regarding the implementation and impact of the ACA.
The ACA expanded health care coverage through Medicaid expansion and the implementation of a tax penalty for individuals who do not maintain mandated health insurance coverage (the so-called ‘individual mandate’). The ACA also contains a number of provisions that affect coverage and reimbursement of drug products.
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.
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, 2025, we had 229 full-time employees.
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 (subject to the arbitral tribunal's decision) worldwide license to develop and commercialize gene-edited allogeneic CAR T-cell products targeting CD19, including ALLO-501A, in the field of anti-tumor adoptive immunotherapy (collectively, excluding the UCART19 V1, “CD19 Products”).
As of December 31, 2024, AZ Holdings may exercise voting power with respect to approximately 30% of the voting rights outstanding with respect to our share capital (inclusive of (i) the ordinary shares held by AZ Holdings and (ii) the voting rights of the Class A Preferred Shares, which vote together with our ordinary shares).
As of December 31, 2025, AZ Holdings may exercise voting power with respect to approximately 40% of the voting rights outstanding with respect to our share capital (inclusive of (i) the ordinary shares held by AZ Holdings and (ii) the voting rights of the Class A Preferred Shares, which vote together with our ordinary shares).
As of December 31, 2024, AZ Holdings may exercise voting power with respect to approximately 30% of the voting rights outstanding with respect to our share capital (inclusive of (i) the ordinary shares held by AZ Holdings, and (ii) the voting rights of the Class A Preferred Shares, which vote together with our ordinary shares).
As of December 31, 2025, AZ Holdings may exercise voting power with respect to approximately 40% of the voting rights outstanding with respect to our share capital (inclusive of (i) the ordinary shares held by AZ Holdings, and (ii) the voting rights of the Class A Preferred Shares, which vote together with our ordinary shares).

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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In accordance with this amendment, the licensed territory has been putatively extended to the European Union and the United Kingdom and Allogene has putatively been granted an option to extend its licensed territory to China and Japan subject to certain conditions.
In accordance with this amendment, the licensed territory has been putatively extended to the European Union and the United Kingdom and Allogene has been granted an option to extend its licensed territory to China and Japan subject to certain conditions.
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.
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.
The approved autologous CAR-T cell programs are: • tisagenlecleucel (Kymriah®) commercialized by Novartis AG, first approved by the FDA in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse; • axicabtagene ciloleucel (Yescarta®) commercialized by Kite Pharma, a subsidiary of Gilead Sciences, first approved by the FDA in October 2017 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy; • brexucabtagene autoleucel (Tecartus™) commercialized by Kite Pharma, a subsidiary of Gilead Sciences, first approved by the FDA in July 2020 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma; • lisocabtagene maraleucel (Breyanzi™) commercialized by Bristol Myers Squibb, first approved by the FDA in February 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy; • idecabtagene vicleucel (Abecma™) commercialized by Bristol Myers Squibb and bluebird bio, first approved by the FDA in March 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody; and • ciltacabtagene autoleucel (Carvykti™) commercialized by Janssen Biotech, Inc. and Legend Biotech Corp., first approved by the FDA in February 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. • obecabtagene autoleucel (Aucatzyl™) commercialized by Autolus Inc., first approved by the FDA in November 2024 for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) after two or more prior lines of systemic therapy or after allogeneic stem cell transplantation.
The approved autologous CAR-T cell programs are: • tisagenlecleucel (Kymriah®) commercialized by Novartis AG, first approved by the FDA in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse; • axicabtagene ciloleucel (Yescarta®) commercialized by Kite Pharma, a subsidiary of Gilead Sciences, first approved by the FDA in October 2017 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy; • brexucabtagene autoleucel (Tecartus™) commercialized by Kite Pharma, a subsidiary of Gilead Sciences, first approved by the FDA in July 2020 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma; 60 • lisocabtagene maraleucel (Breyanzi™) commercialized by Bristol Myers Squibb, first approved by the FDA in February 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy; • idecabtagene vicleucel (Abecma™) commercialized by Bristol Myers Squibb and bluebird bio, first approved by the FDA in March 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody; and • ciltacabtagene autoleucel (Carvykti™) commercialized by Janssen Biotech, Inc. and Legend Biotech Corp., first approved by the FDA in February 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. • obecabtagene autoleucel (Aucatzyl™) commercialized by Autolus Inc., first approved by the FDA in November 2024 for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) after two or more prior lines of systemic therapy or after allogeneic stem cell transplantation.
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.
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; and • allogeneic and autologous treatment strategies using our T-cell products.
Obtaining the pharmaceutical establishment license, either as distributor, operator, importer or as manufacturer, requires the submission of a request file specific to each of the mentioned qualifications with the Agence nationale de sécurité du médicament et des produits de santé (ANSM), which only grants it after review of this file and evaluation, usually after verification that the company has adequate premises, the necessary personnel and an adapted structure with satisfactory procedures for carrying out the proposed pharmaceutical activities.
Obtaining the pharmaceutical establishment license, either as distributor, operator, importer, exporter or as manufacturer, requires the submission of a request file specific to each of the mentioned qualifications with the Agence nationale de sécurité du médicament et des produits de santé (ANSM), which only grants it after review of this file and evaluation, usually after verification that the company has adequate premises, the necessary personnel and an adapted structure with satisfactory procedures for carrying out the proposed pharmaceutical activities.
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.
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 58 • specific CARs that target selected antigen markers are covered by approximately fifteen Cellectis-owned patent applications and one in-licensed patent family.
The first biological product submitted under the abbreviated approval pathway that is approved as interchangeable with the reference product has exclusivity against other biologics submitting applications under the abbreviated approval pathway for the lesser of (1) one year after the first commercial marketing, (2) 18 months after approval if there is no legal challenge, (3) 18 months after the resolution in the applicant’s favor of a lawsuit challenging the reference biologic’s patents if an application has been submitted, or (4) 42 months after the application has been approved if a lawsuit is ongoing within the 42-month period.
Under the BPCIA, the first biological product submitted under the abbreviated approval pathway that is approved as interchangeable with the reference product has exclusivity against other biologics submitting applications under the abbreviated approval pathway for the lesser of (1) one year after the first commercial marketing, (2) 18 months after approval if there is no legal challenge, (3) 18 months after the resolution in the applicant’s favor of a lawsuit challenging the reference biologic’s patents if an application has been submitted, or (4) 42 months after the application has been approved if a lawsuit is ongoing within the 42-month period.
Orphan Drug Designation Under the Orphan Drug Act, a sponsor may request and the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making available in the United States drug or biologic for this type of disease or condition will be recovered from sales in the United States for that product.
Orphan Drug Designation Under the Orphan Drug Act, a sponsor may request and the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making available in the United States drug or biologic for this type of disease or condition will be recovered from sales in the United 64 States for that product.
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.
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.
The key elements of our strategy are to: • Advance our self-owned allogeneic UCART portfolio of product candidates up to the Biologics License Application (BLA) and commercialize them; • Continue to utilize our self-owned manufacturing network to produce commercial-grade UCART products for clinical use, as well as critical raw and starting materials of the UCART product candidates; • Structure a commercial launch plan for our self-owned product candidates; • Continue the research and development of our gene therapy programs.
The key elements of our strategy are to: • Advance our self-owned allogeneic UCART portfolio of product candidates up to the Biologics License Application (BLA) and commercialize them; • Continue to utilize our self-owned manufacturing network to produce commercial-grade UCART products for clinical use, as well as critical raw and starting materials of the UCART product candidates; 43 • Structure a commercial launch plan for our self-owned product candidates; • Continue the research and development of our gene therapy programs.
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.
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.
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.
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.
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.
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.
Cell expansion in patients with CD70 positive disease was robust, and there was a trend toward greater tumor shrinkage in patients with the highest levels of CD70 expression Allogene reported that ALLO-316 demonstrated a generally manageable safety profile with no GvHD. One dose limiting toxicity of liver enzyme elevation occurred in the second dose level.
Cell expansion in patients with CD70 positive disease was robust, and there was a trend toward greater tumor shrinkage in patients with the highest levels of CD70 expression Allogene reported that ALLO-316 demonstrated a generally manageable safety profile with no GvHD. One dose limiting toxicity of liver enzyme 48 elevation occurred in the second dose level.
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.
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. 56 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. 76 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. Cellectis, Inc. leases a 24,375 square feet facility in New York, New York for administrative and research and development activities.
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.
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 five-year survival rate for patients with advanced kidney cancer is less than 15%.Systemic therapy (including immunotherapy and molecularly targeted agents), surgery, and radiation therapy all may have a role in the treatment paradigm depending on the extent of disease, sites of involvement, and patient-specific factors.
The five-year survival rate for patients with advanced kidney cancer is less than 15%. Systemic therapy (including immunotherapy and molecularly targeted agents), surgery, and radiation therapy all may have a role in the treatment paradigm depending on the extent of disease, sites 44 of involvement, and patient-specific factors.
Key Advantage of allogeneic delivery was established with >97% of patients treated with a median time from enrollment to initiation of treatment of five days for ALLO-501 and two days for ALLO-501A. In November 2022, Allogene presented an update on clinical data for the Phase 1 ALPHA Studies.
Key Advantage of allogeneic delivery was established with >97% of patients treated with a median time from enrollment to initiation of treatment of five days for ALLO-501 and two days for ALLO-501A. 47 In November 2022, Allogene presented an update on clinical data for the Phase 1 ALPHA Studies.
Recently, several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of the product for unapproved, and thus non-reimbursable, uses.
Recently, several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies 67 have been prosecuted for causing false claims to be submitted because of the companies’ marketing of the product for unapproved, and thus non-reimbursable, uses.
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.
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.
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.
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.
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.
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.
Post-approval clinical trials, sometimes referred to as “Phase 4” clinical trials, may be conducted after initial marketing approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up.
Post-approval clinical studies, sometimes referred to as “Phase 4” clinical trials, may be conducted after initial marketing approval. These clinical studies are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up.
To achieve this goal, several approaches are envisaged including for example identifying small populations with severe disease where a medicine’s benefit-risk balance could be favorable or making more use of real-world data where appropriate to support clinical trial data.
To achieve this goal, several approaches are envisaged including for example identifying small populations with severe 70 disease where a medicine’s benefit-risk balance could be favorable or making more use of real-world data where appropriate to support clinical trial data.
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.
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.
Federal and state agencies, congressional committees and foreign governments have expressed interest in further regulating biotechnology. More restrictive regulations or claims that our products are unsafe or pose a hazard could prevent us from commercializing any products in one or more jurisdictions.
Federal and state agencies, congressional committees and 61 foreign governments have expressed interest in further regulating biotechnology. More restrictive regulations or claims that our products are unsafe or pose a hazard could prevent us from commercializing any products in one or more jurisdictions.
In addition, gene editing requires only a transient presence of TALEN, thus preserving the integrity and functionality of the T-cell’s genome. • Efficiency. A large percentage of cells treated by the nuclease bear the desired genomic modification after treatment is completed.
In addition, gene editing requires only a transient presence of TALEN, thus preserving the integrity and functionality of the T-cell’s genome. 54 • Efficiency. A large percentage of cells treated by the nuclease bear the desired genomic modification after treatment is completed.
We are also required to pay UMN milestone payments up to a total of $290,000 in the aggregate upon the occurrence of specified events and to pay certain patent-related expenses incurred under the agreement for prosecuting and maintaining the licensed patents.
We are also 59 required to pay UMN milestone payments up to a total of $290,000 in the aggregate upon the occurrence of specified events and to pay certain patent-related expenses incurred under the agreement for prosecuting and maintaining the licensed patents.
Under this program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” designation may qualify for a pediatric priority review voucher (pPRV) that can be redeemed to receive a priority review of a subsequent marketing application for a different product.
Under this program, a sponsor who receives an 65 approval for a drug or biologic for a “rare pediatric disease” designation may qualify for a pediatric priority review voucher (pPRV) that can be redeemed to receive a priority review of a subsequent marketing application for a different product.
Decreases in third-party reimbursement for our product candidate or a decision by a third-party payor to not cover our product candidate could reduce physician usage of the product candidate and have a material adverse effect on our sales, results of operations and financial condition.
Decreases in third-party reimbursement for our product candidate or a decision by a third-party payor to not 68 cover our product candidate could reduce physician usage of the product candidate and have a material adverse effect on our sales, results of operations and financial condition.
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%).
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%).
Pursuant to this amendment, the licensed territory has putatively been extended to the European Union and the United Kingdom and Allogene has putatively been granted an option to extend its licensed territory to China and Japan subject to certain conditions.
Pursuant to this amendment, the licensed territory has been extended to the European Union and the United Kingdom and Allogene has been granted an option to extend its licensed territory to China and Japan subject to certain conditions.
The March Servier License Agreement superseded and replaced the Prior Servier Agreement in order to modify the targets covered by our license to Servier, to establish the terms of our and Servier’s collaboration and to reflect the status of products in development.
The Servier License Agreement superseded and replaced the Prior Servier Agreement in order to modify the targets covered by our license to Servier, to establish the terms of our and Servier’s collaboration and to reflect the status of products in development.
Each UCART product candidate is designed to target a selected antigen expressed on tumor cells and bears specific engineered attributes, such as inhibition of alloreactivity and compatibility with specific medical regimens that cancer patients may undergo. UCART is the first therapeutic product line that we are developing with our gene-editing platform to address unmet medical needs in oncology.
Each UCART product candidate is designed to target selected antigen(s) expressed on tumor cells and bears specific engineered attributes, such as inhibition of alloreactivity and compatibility with specific medical regimens that cancer patients may undergo. UCART is the first therapeutic product line that we are developing with our gene-editing platform to address unmet medical needs in oncology.
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).
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: 53 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).
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.
We also face competition from non-cell based treatments offered by companies such as Amgen Inc., AstraZeneca plc, Bristol-Myers Squibb Company, Incyte Corporation, Johnson & Johnson, Merck & Co., Inc., Novartis AG, Pfizer, Inc., and F. Hoffman-La Roche AG, amongst others. Immunotherapy is further being pursued by several biotech companies as well as by large-cap pharmaceuticals.
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.
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.
In December 2023, we presented updated data of the Phase I BALLI-01 clinical trial at the American Society of Hematology Annual Meeting, including the following data: • In vitro comparability studies suggested that the new process used by Cellectis to manufacture in-house UCART22 ("UCART22 P2") is more potent than the process used by external CDMO to manufacture UCART22 ("UCART22 P1").
In December 2023, we presented updated data of the Phase I BALLI-01 clinical trial at the American Society of Hematology Annual Meeting, including the following data: • In vitro comparability studies suggested that the new process used by Cellectis to manufacture in-house lasme-cel ("UCART22 P2") is more potent than the process used by external CDMO to manufacture lasme-cel ("UCART22 P1").
As a result, Allogene announced it will deprioritize the currently enrolling third line (3L) LBCL ALPHA2 and EXPAND trials. Furthermore, Allogene announced a new Phase 1b ALPHA2 cohort of up to 40 relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients to be treated with the investigational product cema-cel.
As a result, Allogene announced it will deprioritize the then enrolling third line (3L) LBCL ALPHA2 and EXPAND trials. Furthermore, Allogene announced a new Phase 1b ALPHA2 cohort of up to 40 relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients to be treated with the investigational product cema-cel.
In 2011, we entered into an exclusive license agreement with the Regents of the University of Minnesota (UMN) pursuant to which we in-licensed one patent family related to customized rare-cutting endonucleases, in connection with which we have registered the trademark TALEN in certain jurisdictions. This patent portfolio comprises ten patents in the United States and two European patents.
In 2011, we entered into an exclusive license agreement with the Regents of the University of Minnesota (UMN) pursuant to which we in-licensed one patent family related to customized rare-cutting endonucleases, in connection with which we have registered the trademark TALEN in certain jurisdictions. This patent portfolio comprises ten patents in the United States and three European patents.
The lease, which commenced in April 2019 has a term that expires on December 31, 2034. We completed construction of our manufacturing facility at this property in 2021, which is dedicated to the production of clinical and commercial UCART products. ITEM 4A. UNRESOLVE D STAFF COMMENTS Not applicable. 77
The lease, which commenced in April 2019 has a term that expires on December 31, 2034. We completed construction of our manufacturing facility at this property in 2021, which is dedicated to the production of clinical and commercial UCART products. ITEM 4A. UNRESOLVE D STAFF COMMENTS Not applicable. 73
Analogously as to the U.S., clinical trials that are deployed to support marketing authorization application are typically conducted in three sequential phases, but the phases may overlap or be combined. On January 31, 2022, Regulation EU No 536/2014 (CTR) became fully applicable in the EU.
Analogously as to the U.S., clinical trials that are deployed to support marketing authorization application are typically conducted in three sequential phases, but the phases may overlap or be combined. On January 31, 2022, Regulation EU No 536/2014 (CTR) became fully effective in the EU.
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.
Group Structure as of December 31, 2025 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.
As of December 31, 2024, considering the ordinary shares held by AZ Holdings and giving effect to the conversion of all Class A Preferred Shares and Class B Preferred Shares without regarding for when they may first be converted, AZ Holdings would beneficially own approximately 44% of our ordinary shares.
As of December 31, 2025, considering the ordinary shares held by AZ Holdings and giving effect to the conversion of all Class A Preferred Shares and Class B Preferred Shares without regarding for when they may first be converted, AZ Holdings would beneficially own approximately 44% of our ordinary shares.
Immunotherapy: Turning the Immune System into “Smart Drugs” The immune system has evolved to protect the body from invading pathogens or external harmful materials by identifying these foreign bodies through “non-self” antigens, which are molecular signatures that they carry and are foreign to the body.
Immunotherapy: Turning the Immune System into “Smart Drugs" The immune system has evolved to protect the body from invading pathogens or external harmful materials by identifying these foreign bodies through “non-self” antigens, which are molecular signatures that they carry and are foreign to the body.
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.
Certain of these issued patents and pending patent applications, which expire between 2030 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.
Evidence of UCART22 anti-tumor activity was observed in 60% (n=3) of the five patients at: (i) a patient experienced a durable minimal residual disease (MRD) negative complete response with incomplete count recovery (CRi) that continued beyond 6 months as of December 2022, (ii) a patient experienced an MRD negative complete response (CR) that continued beyond Day 56 as of December 2022, and (iii) patient experienced a morphologic leukemia-free state (MLFS) that continued beyond Day 84.
Evidence of lasme-cel anti-tumor activity was observed in 60% (n=3) of the five patients at: (i) a patient experienced a durable minimal residual disease (MRD) negative complete response with incomplete count recovery (CRi) that continued beyond 6 months as of December 2022, (ii) a patient experienced an MRD negative complete response (CR) that continued beyond Day 56 as of December 2022, and (iii) patient experienced a morphologic leukemia-free state (MLFS) that continued beyond Day 84.
Either party may terminate the agreement in the event of the other party’s bankruptcy or insolvency. 52 On September 15, 2022, Servier sent to us and Allogene a notice of discontinuation of its involvement in the development of the CD19 Products.
Either party may terminate the agreement in the event of the other party’s bankruptcy or insolvency. 50 On September 15, 2022, Servier sent to us and Allogene a notice of discontinuation of its involvement in the development of the CD19 Products.
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.
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 2026 to be financed from our cash and cash equivalents on hand.
As of December 31, 2024, considering the ordinary shares held by AZ Holdings as well as all Class A Preferred Shares, which AZ Holdings has the right to acquire within the next 60 days, AZ Holdings beneficially owns approximately 32% of our ordinary shares.
As of December 31, 2025, considering the ordinary shares held by AZ Holdings as well as all Class A Preferred Shares, which AZ Holdings has the right to acquire within the next 60 days, AZ Holdings beneficially owns approximately 32% of our ordinary shares.
The median age at diagnosis for ALL is 17 years with 53% of patients diagnosed at younger than 20 years of age. In contrast, 29.3% of cases are diagnosed at 45 years or older and only 14.1% of patients are diagnosed at 65 years or older.
The median age at diagnosis for ALL is 17 years with 53% of patients diagnosed at younger than 20 years of age. In contrast, 29% of cases are diagnosed at 45 years or older and only 14% of patients are diagnosed at 65 years or older.
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.
Documents on Display”. 40 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.
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.
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.
Clinical Findings In December 2022, we presented positive preliminary clinical data from the Phase 1 BALLI-01 Study at a Live Webcast during the American Society of Hematology annual meeting. These data were from five patients who received UCART22 at DL3 (5x10 6 cells/kg) after lymphodepletion with FCA.
Clinical Findings In December 2022, we presented positive preliminary clinical data from the Phase 1 BALLI-01 Study at a Live Webcast during the American Society of Hematology annual meeting. These data were from five patients who received lasme-cel at DL3 (5x10 6 cells/kg) after lymphodepletion with FCA.
In addition, in 2014, we entered into a series of agreements with Life Technologies Corporation (controlled by Thermo Fisher Scientific Inc.) pursuant to which we received a non-exclusive sublicense under certain patents and patent applications related to the research and therapeutic uses of TALE-nucleases and we granted certain rights to Life Technologies under our TALEN technology.
In addition, in 2014, we entered into a series of agreements with Life Technologies Corporation (controlled by Thermo Fisher Scientific Inc.) pursuant to which we received a non-exclusive sublicense under certain patents related to research and therapeutic uses of TALE-nucleases (the "LTC Agreements") and we granted certain rights to Life Technologies under our TALEN technology.
Within 60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.
Within 60 days following submission of the BLA, the FDA reviews the application to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the 63 time of submission and may request additional information.
Clinical Development Status The NATHALI-01 Study is an open-label, Phase 1/2a dose-finding and dose-expansion multicenter clinical trial designed to evaluate the safety, expansion, persistence, and clinical activity of UCART20x22 in patients with relapsed or refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL).
Clinical Development Status The NATHALI-01 Study is an open-label, Phase 1/2a dose-finding and dose-expansion multicenter clinical trial designed to evaluate the safety, expansion, persistence, and clinical activity of eti-cel in patients with relapsed or refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL).
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.
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.
See “Risk Factors— Risks Related to Our Reliance on Third Parties—Servier’s discontinuation of its involvement in the development of CD19 Products and related disagreements may have adverse consequences.”. Clinical Findings In December 2020, Servier published, in the Lancet journal, pooled results of the UCART19 Studies.
See 46 “Risk Factors— Risks Related to Our Reliance on Third Parties—Servier’s discontinuation of its involvement in the development of CD19 Products may have adverse consequences.”. Clinical Findings In December 2020, Servier published, in the Lancet journal, pooled results of the UCART19 Studies.
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.
Second, in Paris, France, we have developed 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.
Secondary objectives/endpoints include assessing the efficacy of UCART22 (rate of objective response) in relapsed or refractory B-ALL patients, and minimal residual disease (MRD)+ B-ALL patients; assessment of the duration of response, time to response, progression-free survival, and overall survival, MRD negative rate, and evaluating the pharmacokinetic and pharmacodynamic profile of alemtuzumab.
Secondary objectives/endpoints include assessing the efficacy of lasme-cel (rate of objective response) in relapsed or refractory B-ALL patients, and minimal residual disease (MRD)+ B-ALL patients; assessment of the duration of response, time to response, progression-free survival, and overall survival, MRD negative rate, and evaluating the pharmacokinetic and pharmacodynamic profile of alemtuzumab.
Our strategy is also to develop and obtain additional intellectual property covering innovative manufacturing processes and methods for genetically engineering T-cells expressing new constructs and for genetically engineering plants expressing new traits.
Our strategy is also to develop and obtain additional intellectual property covering innovative manufacturing processes and methods for genetically engineering T-cells expressing new constructs.
There can be no assurance that we will receive orphan drug designation for any product candidates in the United States, in the EU or in any other market.
There can be no assurance that we will receive and/or maintain orphan drug designation for any product candidates in the United States, in the EU or in any other market.
The CTR also established an EU Portal which is designed to act as a single entry point for submission of data and information relating to clinical trials. The CTD will continue to apply in parallel to the CTR until January 30, 2025 to certain trials only.
The CTR also established an EU Portal which is designed to act as a single entry point for submission of data and information relating to clinical trials. The CTD continued to apply in parallel to the CTR until January 30, 2025 to certain trials only.
In January 2022, Allogene announced that the FDA has removed the clinical hold on all of its AlloCAR T clinical trials. In March 2022, Allogene announced that the FDA has granted fast track designation to ALLO-316. In October 2024, Allogene announced having received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for ALLO-316.
In January 2022, Allogene announced that the FDA removed the clinical hold on all of its AlloCAR T clinical trials. In March 2022, Allogene announced that the FDA granted fast track designation to ALLO-316, and in October 2024, Allogene announced having received FDA Regenerative Medicine Advanced Therapy (RMAT) designation.
In March 2022, Allogene announced that the FDA has granted fast track designation to ALLO-316. 50 In October 2024, Allogene announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316.
In March 2022, Allogene announced that the FDA has granted fast track designation to ALLO-316, and in October 2024, Allogene announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316.
In addition, under the License, Development and Commercialization Agreement dated March 6, 2019, between Servier and us, and as amended on March 4, 2020 (as so amended, the “Servier License Agreement”), Servier has an exclusive worldwide license to develop and commercialize gene-edited allogeneic CAR T-cell products targeting CD19, including ALLO-501A, in the field of anti-tumor adoptive immunotherapy (Allogene’s product candidate developed pursuant to a sublicense by Servier to Allogene).
Under the License, Development and Commercialization Agreement dated March 6, 2019, between Servier and us, and as amended on March 4, 2020 (as so amended, the “Servier License Agreement”), Servier has an exclusive (subject to the arbitral tribunal's decision) worldwide license to develop and commercialize gene-edited allogeneic CAR T-cell products targeting CD19, including ALLO-501A, in the field of anti-tumor adoptive immunotherapy (Allogene’s product candidate developed pursuant to a sublicense by Servier to Allogene).
Such designation can be requested in the case of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition and either (a) such condition affects no more than five in 10,000 persons in the EU when the application is made, or (b) the product, without the benefits derived from orphan status, would unlikely generate sufficient return in the EU to justify the necessary investment.
In the EU, the designation as an “orphan medicinal product” can be requested in the case of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition and either (a) such condition affects no more than five in 10,000 persons in the EU when the application is made, or (b) the product, without the benefits derived from orphan status, would unlikely generate sufficient return in the EU to justify the necessary investment.
In February 2021, Allogene announced that the FDA had granted fast track designation to ALLO-501A for relapsed or refractory diffuse large B cell lymphoma (LCBL). In June 2022, Allogene announced that the FDA granted Regenerative Medicine Advance Therapy (RMAT) designation to ALLO-501A in relapsed or refractory large B cell lymphoma (LBCL).
In February 2021, Allogene announced that the FDA had granted fast track designation to ALLO-501A for relapsed or refractory (r/r) diffuse large B cell lymphoma (LBCL), and in June 2022, Allogene announced that the FDA granted Regenerative Medicine Advance Therapy (RMAT) designation to ALLO-501A in r/r LBCL.
Cellectis is also eligible to receive an option exercise fee and development, regulatory and sales-related milestone payments, ranging from approximately $70 million up to $220 million, per each of the 10 candidate products, plus tiered royalties, which may range from mid-single to low-double digits, based on the sale of Licensed Products.
Cellectis is also eligible to receive an option exercise fee and development, regulatory and sales-related milestone payments, ranging from approximately $80 million up to $253 million, per each of the 10 candidate products, plus tiered royalties, which may range from mid-single to low-double digits, based on the sale of Licensed Products.
The primary endpoints are to assess the safety and tolerability of Universal Chimeric Antigen Receptor (UCAR) T-cells targeting CD22 (UCART22) administered to patients with r/r B-ALL and to determine the MTD and/or Recommended Phase 2 Dose (RP2D) of UCART22 in patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL).
The primary endpoints are to assess the safety and tolerability of Universal Chimeric Antigen Receptor T-cells targeting CD22 administered to patients with r/r B-ALL and to determine the MTD and/or Recommended Phase 2 Dose (RP2D) of lasme-cel in patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL).
We believe that targeting both CD20 and CD22 is more likely to prevent tumor escape and is an alternative to approved autologous CAR-T products targeting CD19. As all our UCART product candidates, UCART20x22 lacks the TCR and is intended to be used in an allogeneic context.
We believe that targeting both CD20 and CD22 is more likely to prevent tumor escape and is an alternative to approved autologous CAR-T products targeting CD19. As with all our UCART product candidates, eti-cel lacks the TCR and is intended to be used in an allogeneic context.
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.
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 2026 to 2041. If patents are issued on our pending patent applications, the resulting patents are projected to expire on dates ranging from 2026 to 2046.
For so long as the agreement remains in effect, we are restricted from researching, developing, or commercializing any product directed against a CD19 target that is used for the same purpose as it is used with a product candidate developed under the agreement.
Except for UCART19 V1, and for so long as the agreement remains in effect, we are restricted from researching, developing, or commercializing any product directed against a CD19 target that is used for the same purpose as it is used with a product candidate developed under the agreement.
As of December 31, 2024, AZ Holdings may exercise voting power with respect to approximately 30% of the voting rights outstanding with respect to our share capital (inclusive of (i) the ordinary shares held by AZ Holdings and (i) the voting rights of the Class A Preferred Shares, which vote together with our ordinary shares).
As of December 31, 2025, AZ Holdings may exercise voting power with respect to approximately 40% of the voting rights outstanding with respect to our share capital (inclusive of (i) the ordinary shares held by AZ Holdings and (i) the voting rights of the Class A Preferred Shares, which vote together with our ordinary shares).
Pursuant to the Allogene License Agreement, we granted to Allogene an exclusive, worldwide, royalty-bearing, license, on a target-by-target basis, with sublicensing rights under certain conditions, under certain of our intellectual property, including our TALEN and electroporation technology, to make, use, sell, import, and otherwise exploit and commercialize chimeric antigen receptor (CAR) T cells products directed at a total of 15 selected targets, including BCMA, FLT3, DLL3 and CD70, for human oncologic therapeutic, diagnostic, prophylactic and prognostic purposes.
The Allogene License Agreement establishes the rights and obligations of Cellectis and Allogene with respect to their collaboration program. 49 Pursuant to the Allogene License Agreement, we granted to Allogene an exclusive, worldwide, royalty-bearing, license, on a target-by-target basis, with sublicensing rights under certain conditions, under certain of our intellectual property, including our TALEN and electroporation technology, to make, use, sell, import, and otherwise exploit and commercialize chimeric antigen receptor (CAR) T cells products directed at a total of 15 selected targets, including BCMA, FLT3, DLL3 and CD70, for human oncologic therapeutic, diagnostic, prophylactic and prognostic purposes.
Under the Servier License Agreement, Cellectis grants to Servier, an exclusive worldwide, royalty bearing license with sublicensing rights under certain conditions, under certain of our patents and know-how to develop, manufacture and commercialize gene-edited allogeneic CAR T-cell products targeting CD19 and gene edited exclusively by Cellectis’ TALEN, in the field of anti-tumor adoptive immunotherapy.
Under the Servier License Agreement, Cellectis granted to Servier, an exclusive (subject to the arbitral tribunal's decision) worldwide, royalty bearing license with sublicensing rights under certain conditions, under certain of our patents and know-how to develop, manufacture and commercialize gene-edited allogeneic CAR T-cell products targeting CD19 and gene edited exclusively by Cellectis’ TALEN, in the field of anti-tumor adoptive immunotherapy.
The FDA and the European Commission have granted Orphan Drug Designation (ODD) status to UCART22 for the treatment of ALL and the FDA has granted Rare Pediatric Disease Designation (RPDD) status to UCART22.
The FDA and the European Commission have granted Orphan Drug Designation (ODD) status to lasme-cel for the treatment of ALL and the FDA has granted Rare Pediatric Disease Designation (RPDD) status to lasme-cel.
Extramedullary accumulations of lymphoblasts may occur in various sites, especially the meninges, gonads, thymus, liver, spleen, or lymph nodes. Data from the Surveillance, Epidemiology, and End Results (SEER) database have shown an age-adjusted incidence rate of ALL in the United States of 1.8 per 100,000 individuals per year, with approximately 6.550 new cases and 1.330 deaths estimated in 2024.
Extramedullary accumulations of lymphoblasts may occur in various sites, especially the meninges, gonads, thymus, liver, spleen, or lymph nodes. Data from the Surveillance, Epidemiology, and End Results (SEER) database have shown an age-adjusted incidence rate of ALL in the United States of 1.9 per 100,000 individuals per year, with approximately 6,100 new cases and 1,400 deaths estimated in 2025.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

79 edited+15 added−18 removed116 unchanged
At issuance date and at the end of each reporting period, the warrants (including related put and call options) are measured at fair value, with changes in fair value recorded as gains or losses in consolidated our statement of operations in accordance with IFRS 9 and IFRS 13.
At issuance date and at the end of each reporting period, the warrants (including related put and call options) are measured at fair value, with changes in fair value recorded as gains or losses in our consolidated statement of operations in accordance with IFRS 9 and IFRS 13.
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.
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; 84 • 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.
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”).
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”).
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.
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 (the "ATM") 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.
On March 3, 2023, the Company and the EIB entered into a Subscription Agreement for Warrants to be issued by Cellectis S.A. (the "Warrant Agreement") in satisfaction of the foregoing condition. Borrowings under the Finance Contract will mature with respect to each Tranche six years from the respective disbursement date for such Tranche.
On March 3, 2023, the Company and the EIB entered into a Subscription Agreement for Warrants to be issued by Cellectis S.A. (the "Warrant Agreement") in satisfaction of the foregoing condition. Borrowings under the Finance Contract mature with respect to each Tranche six years from the respective disbursement date for such Tranche.
The actual value of our assets, liabilities and shareholders’ equity and of our losses could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted. We believe that the most significant management judgments and assumptions in the preparation of our financial statements are named below.
The actual value of our assets, liabilities and shareholders’ equity and of 78 our losses could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted. We believe that the most significant management judgments and assumptions in the preparation of our financial statements are named below.
Sales of products and services Revenues on sales of products are recognized once the control over the delivered products is transferred to the customer. Sales include shipping and handling charges if billed to the customer and are reported net of trade promotion and other costs, including estimated allowances for returns, unsalable product and prompt pay discounts.
Sales of products and services Revenues on sales of products are recognized once the control over the delivered products is transferred to the customer. Sales include shipping and handling charges if billed to the customer and are reported net of trade promotion and other costs, including estimated allowances for returns, unsalable products and prompt pay discounts.
Upon the occurrence of an event of default, EIB may demand immediate repayment by us of all or part of the outstanding funds, together with accrued interest, and all other accrued or outstanding amounts under the Finance Contract. In connection with the Finance Contract, we agreed to certain customary affirmative and negative undertakings.
Upon the occurrence of an event of default, EIB may demand immediate repayment by us of all or part of the outstanding funds, together with accrued interest, and all other accrued or outstanding amounts under the Finance Contract. 85 In connection with the Finance Contract, we agreed to certain customary affirmative and negative undertakings.
Our net cash flows provided by financing activities of $82.9 million reflect mainly a $44.9 million inflow from AZ Holdings' $80.0 million initial investment after reallocation of $35.7 million to operating activities, the $25.0 million gross proceeds from Cellectis' follow-on offering in February 2023, the $21.2 million cash received from EIB pursuant to the disbursement of the Tranche A net of transaction costs, the $5.7 million received in respect of the 2022 research tax credit pre-financing, the $2.8 million refundable advance received from BPI, $2.5 million of Interim Funding received by Calyxt from Cibus, partially offset by transaction costs related to AZ Holdings' initial investment of $0.6 million and to Cellectis' follow-on offering of $1.5 million, the payments of lease debts of $11.8 million and the repayment of the “PGE” loan of $5.0 million.
Our net cash flows provided by financing activities of $82.9 million reflect mainly a $44.9 million inflow from AZ Holdings' $80.0 million initial investment after reallocation of $35.7 million to operating activities, the $25.0 million gross proceeds from Cellectis' follow-on offering in February 2023, the $21.2 million cash received from EIB pursuant to the disbursement of the Tranche A net of transaction costs, the $5.7 million received in respect of the 2022 research tax credit pre-financing, the $2.8 million refundable advance received from BPI, $2.5 million of Interim Funding received by Calyxt from Cibus, partially offset by transaction costs related to AZ Holdings' initial investment of $0.6 million and to Cellectis' follow-on offering of $1.5 million, the payments of lease debts of $11.8 million and the repayment of the PGE loan of $5.0 million.
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.
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.
We use a Longstaff Schwartz model to estimate the fair value of ther EIB warrants which is affected by assumptions and variables including the expected term, the expected volatility, the Company's stock price, risk-free rates, put option cap and expected dividends.
We use a Longstaff Schwartz model to estimate the fair value of the EIB warrants which is affected by assumptions and variables including the expected term, the expected volatility, the Company's stock price, risk-free rates, put option cap and expected dividends.
Year Ended December 31, 2024 Our net cash flows provided by operating activities of $23.0 million mainly come from $42.8 million of cash received from our license and collaboration agreements, $57.0 million of cash proceeds upon closing of the Subsequent Investment with AstraZeneca allocated to operating activities (out of a total of $139.8 million net cash proceeds - see Note 2.6 of our Consolidated Financial Statements), $6.4 million of interests received on our financial investments, $1.0 million of government grants received pursuant to the BPI Grant and Advance Agreement, $1.8 million of cash-in from value-added tax reimbursement, and $0.7 million of sublease revenue related to our premises in New York, partially offset by payments to suppliers for $47.0 million, wages, bonuses and social social expenses paid for $39.6 million, and a reimbursement of the fiscal years 2017 and 2018 French research tax credit for $0.7 million pursuant to Paris Administrative Court's decision .
Year Ended December 31, 2024 Our net cash flows provided by operating activities of $23.0 million mainly come from $42.8 million of cash received from our license and collaboration agreements, $57.0 million of cash proceeds upon closing of the Subsequent Investment with AstraZeneca allocated to 83 operating activities (out of a total of $139.8 million net cash proceeds - see Note 2.6 of our Consolidated Financial Statements), $6.4 million of interest received on our financial investments, $1.0 million of government grants received pursuant to the BPI Grant and Advance Agreement, $1.8 million of cash-in from value-added tax reimbursement, and $0.7 million of sublease revenue related to our premises in New York, partially offset by payments to suppliers for $47.0 million, wages, bonuses and social expenses paid for $39.6 million, and a reimbursement of the fiscal years 2017 and 2018 French research tax credit for $0.7 million pursuant to Paris Administrative Court's decision .
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.
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. 86 On January 16, 2024, Cellectis drew down on the second tranche of €15 million under the Finance Contract.
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.
This former segment was only related to assets held for sale until May 31, 2023. This segment is presented as discontinued operations for the year ended December 31, 2023. For more information on our reportable segments, see Note 4.3 to our consolidated financial statements.
Tranche B will mature six years from its disbursement date and will accrue interest at a rate of 7% per annum capitalized annually and payable at maturity. On December 10, 2024, Cellectis drew down the third tranche of €5 million under the Finance Contract.
Tranche B matures six years from its disbursement date and will accrue interest at a rate of 7% per annum capitalized annually and payable at maturity. On December 10, 2024, Cellectis drew down the third tranche of €5 million under the Finance Contract.
Our net cash flows used in investing activities of $102.8 million were primarily driven by $99.0 million used for purchases of current financial assets (net of maturities), $1.2 millions related to the acquisition of a right to licence certain patents accounted as an intangible asset, $1.7 million of investments in R&D equipment and building fittings under construction in France and $1.0 million in the United States.
Our net cash flows used in investing activities of $102.8 million were primarily driven by $99.0 million used for purchases of current financial assets (net of maturities), $1.2 million related to the acquisition of a right to license certain patents accounted as an intangible asset, $1.7 million of investments in R&D equipment and building fittings under construction in France and $1.0 million in the United States.
Our net cash flows provided by financing activities of $89.2 million were mainly driven by the closing of the SIA with AstraZeneca which resulted in net cash proceeds of $139.8 million cash, of which $57.0 million were recorded as cash-flows from operating activities and $82.8 million as financing activities (see Note 2.6 of the Consolidated Financial Statements), $21.6 million cash received from EIB pursuant to the disbursement of the Tranche B and C, $1.7 million refundable advance and grant received from BPI, partially offset by the payments of lease debts for $11.1 million, the repayment of the “PGE” loans for $5.0 million, and $0.8 million of interest paid on our borrowings.
Our net cash flows provided by financing activities of $89.2 million were mainly driven by the closing of the SIA with AstraZeneca which resulted in net cash proceeds of $139.8 million cash, of which $57.0 million were recorded as cash-flows from operating activities and $82.8 million as financing activities (see Note 2.6 of the Consolidated Financial Statements), $21.6 million cash received from EIB pursuant to the disbursement of the Tranche B and C, $1.7 million refundable advance and grant received from BPI, partially offset by the payments of lease debts for $11.1 million, the repayment of the PGE loan for $5.0 million, and $0.8 million of interest paid on our borrowings.
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.
Financial Overview The following selected statements of consolidated operations data for the years ended December 31, 2023, 2024 and 2025 and the selected statement of consolidated financial position data as of December 31, 2024 and 2025 have been derived from our audited consolidated financial statements included elsewhere in this Annual Report.
(2) Potential ordinary shares resulting from the exercise of share warrants and employee warrants are antidilutive. (3) Adjusted Net Income (Loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS.
(2) Potential ordinary shares resulting from the exercise of share warrants and employee warrants are antidilutive. (3) Adjusted Net Income (Loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS® Accounting Standards.
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
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, 2025 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. 88
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.
The audited consolidated financial statements as of December 31, 2024 and 2025 and for the years ended December 31, 2023, 2024 and 2025 are presented in US dollars, which differs from the functional currency of Cellectis S.A., which is the Euro.
Please refer below for a reconciliation of Adjusted Net Income (Loss) attributable to shareholders of Cellectis to Net Income (Loss) attributable to shareholders of Cellectis, which is the most directly comparable financial measure calculated in accordance with IFRS.
Please refer below for a reconciliation of Adjusted Net Income (Loss) attributable to shareholders of Cellectis to Net Income (Loss) attributable to shareholders of Cellectis, which is the most directly comparable financial measure calculated in accordance with IFRS Accounting Standards.
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.
All consideration 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.
Cibus' most recent financial statements included in its quarterly report on Form 10-Q for the quarter ended September 31, 2024 note that there is substantial doubt about Cibus' ability to conteinue as a going concern for at least one year from the date of issuance of those financial statements. C. Research and Development, Patents and Licenses, etc.
Cibus' most recent financial statements included in its quarterly report on Form 10-Q for the quarter ended September 31, 2025 note that there is substantial doubt about Cibus' ability to continue as a going concern for at least one year from the date of issuance of those financial statements. C. Research and Development, Patents and Licenses, etc.
For the year ended December 31, 2024, substantially all of our revenues were derived from the AZ JRCA and from other license agreements for the use of our gene editing technology.
For the year ended December 31, 2025, substantially all of our revenues were derived from the AZ JRCA and from other license agreements for the use of our gene editing technology.
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 of our material subsidiaries guarantees our obligations under the Finance Contract. References to our subsidiaries in this discussion of the EIB Finance Contract 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).
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.
Our consolidated financial statements for 2023, 2024 and 2025 have been prepared in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board, or IASB. 76 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.
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.
In 2024, Cellectis discontinued the ATM. 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.
Tranche A will mature six years from the disbursement date and interest on Tranche A shall be paid in kind, shall be capitalized annually by increasing the principal amount of Tranche A, and shall accrue at a rate equal to 8.0% per annum.
Tranche A matures six years from the disbursement date and interest on Tranche A shall be paid in kind, shall be capitalized annually by increasing the principal amount of Tranche A, and shall accrue at a rate equal to 8.0% per annum.
Our Therapeutics segment is focused on the development of products in the field of immuno-oncology and monogenic diseases. Our former Plants segment is presented as assets held for sale and discontinued operations for the year-end period ended December 31, 2023.
Our Therapeutics segment is focused on the development of products in the field of immuno-oncology and monogenic diseases. Our former Plants segment is presented as discontinued operations for the year-end period ended December 31, 2023.
See Note 13 to our consolidated financial statements for more information about the amounts outstanding under the PGE loan.
See Note 14 to our consolidated financial statements for more information about the amounts outstanding under the PGE loan.
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.
As of December 31, 2025, 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 $80 million up to $253 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 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.
As of December 31, 2025, 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”), estimated of up to $340 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, with aggregate 75 milestone payments received as of the date of this Annual Report of $15.0 million.
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.
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; 77 • 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; • expenses related to several license agreements we have entered into to obtain access to technology that we use in our product development efforts; and • certain other expenses, such as expenses for use of laboratories and facilities for our research and development activities.
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.
Cost of revenue For the year ended December 31, % change 2023 2024 2025 2025 vs 2024 Royalty expenses (737 ) - - - Cost of revenue (737 ) 0 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.
Pursuant to this amendment, the parties to the to the amendment and settlement agreement putatively extended the licensed territory to the European Union and the United Kingdom and Allogene has putatively been granted an option to extend its licensed territory to China and Japan subject to certain conditions.
Pursuant to this amendment, the licensed territory has been extended to the European Union and the United Kingdom and Allogene has been granted an option to extend its licensed territory to China and Japan subject to certain conditions.
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.
Our research and development teams utilize our deep expertise to contribute to the growth of our business. As of December 31, 2025, we had 186 employees engaged in research and development activities. In the years ended December 31, 2023, 2024 and 2025 we spent $87.6 million, $90.5 million and $93.5 million respectively, on research and development.
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.
As of December 31, 2025, our lease guaranty represents a potential obligation in the amount of $19.9 million over the remaining 12 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.
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.
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.
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.
Gain/Loss attributable to non-controlling interests For the year ended December 31, % change 2023 2024 2025 2025 vs 2024 Gain (loss) attributable to non-controlling interests (7,384 ) 0 0 - 82 During the year ended December 31, 2024 and 2025, no gain or loss attributable to non-controlling interests has been recorded.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The income tax expense of the year ended December 31, 2024 is nil and corresponds to the 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.
The decrease in net loss attributable to non-controlling interests of $7.4 million is due to the deconsolidation of Calyxt. During the year ended December 31, 2023, we recorded $7.4 million in loss attributable to non-controlling interests.
The decrease in net loss attributable to non-controlling interests of $7.4 million as of December 31, 2024 compared to the year ended December 31, 2023 is due to the deconsolidation of Calyxt. B.
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.
Income (loss) from discontinued operations For the year ended December 31, % change 2023 2024 2025 2025 vs 2024 Income (loss) from discontinued operations 8,392 0 0 - Income (loss) from discontinued operations includes Calyxt loss until deconsolidation.
Tranche C will mature six years from its disbursement date and will accrue interest at a rate of 6% per annum capitalized annually and payable at maturity. With the drawdown of Tranche C, the Company has drawn the full €40 million available under the Finance Contract. Tranche C is expected to be disbursed by the EIB by December 18, 2024.
Tranche C matures six years from its disbursement date and will accrue interest at a rate of 6% per annum capitalized annually and payable at maturity. With the drawdown of Tranche C, the Company has drawn the full €40 million available under the Finance Contract.
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.
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.
Cellectis is also eligible to receive 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, plus tiered royalties, which may range from mid-single to low-double digits, based on the sale of Licensed Products.
Cellectis is also eligible to receive an option exercise fee and development, regulatory and sales-related milestone payments, ranging from $80 million up to $253 million, per each of the 10 candidate products, plus tiered royalties based on the sale of Licensed Products.
With cash and cash equivalents of $143.3 million and a fixed-term deposit of $115.8 million as of December 31, 2024, the Company believes such amounts will be sufficient to fund its operations into 2027 and therefore for at least twelve months following the consolidated financial statements’ publication.
With cash and cash equivalents of $61.5 million and fixed-term deposits of $144.8 million as of December 31, 2025, the Company believes such amounts will be sufficient to fund its operations into the second half of 2027 and therefore for at least twelve months following the consolidated financial statements’ publication.
Financial income and expenses For the year ended December 31, % change 2022 2023 2024 2024 vs 2023 Financial income 8,880 21,479 44,407 106.7 % Financial expenses (17,815 ) (40,642 ) (21,614 ) -46.8 % Net Financial gain (loss) (8,935 ) (19,163 ) 22,793 -218.9 % The increase in financial income of $22.9 million between the year periods ended December 31, 2023 and 2024 was mainly attributable to (i) an increase in income from cash, cash equivalents and financial assets of $7.7 million, (ii) a $14.3 million gain in change in fair value of SIA derivative instrument (compared to a loss in 2023, see below), (iii) a $5.7 million gain in change in fair value of European Investment Bank ("EIB") Tranches A and B warrants (compared to a loss in 2023, see below) partially offset by (iv) a decrease in the foreign exchange gain of $4.5 million (from a $17.6 million gain in 2023 to a $13.1 million gain in 2024).
The increase in financial income of $22.9 million between the year ended December 31, 2023 and 2024 was mainly attributable to (i) an increase in income from cash, cash equivalents and financial assets of $7.7 million, (ii) a $14.3 million gain in change in fair value of SIA derivative instrument (compared to a loss in 2023, see below), (iii) a $5.7 million gain in change in fair value of European Investment Bank ("EIB") Tranches A and B warrants (compared to a loss in 2023, see below) partially offset by (iv) a decrease in the foreign exchange gain of $4.5 million (from a $17.6 million gain in 2023 to a $13.1 million gain in 2024).
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, 2023 2024 2025 $ in thousands Revenues and other income 9,193 49,217 79,592 Operating expenses Cost of revenue (737 ) - - Research and development expenses (87,646 ) (90,536 ) (93,517 ) Selling, general and administrative expenses (16,812 ) (19,085 ) (19,790 ) Other operating income and expenses (1,300 ) 849 638 Operating income (loss) (97,302 ) (59,554 ) (33,076 ) Financial gain (loss) (19,163 ) - 22,793 - (34,940 ) Income tax (371 ) (0 ) 423 Income (loss) from continuing operations (116,835 ) (36,761 ) (67,593 ) Income (loss) from discontinued operations 8,392 - - Net income (loss) (108,443 ) (36,761 ) (67,593 ) Attributable to shareholders of Cellectis (101,059 ) (36,761 ) (67,593 ) Attributable to non-controlling interests (7,384 ) - - Earnings per share attributable to shareholders of Cellectis (1) Basic and diluted (2) (1.77 ) (0.41 ) (0.67 ) Number of shares used for computing Basic and diluted (1) 57,012,815 90,566,346 100,279,276 Other operating data Adjusted Net Income (Loss) attributable to shareholders of Cellectis (3) (93,973 ) (33,594 ) (61,483 ) (1) See Note 19 to our consolidated financial statements for further details on the calculation of basic and diluted loss per ordinary share.
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.
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.
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.
For the year ended December 31, 2023 2024 2025 $ in thousands Net cash flows provided by (used in) operating activities (24,746 ) 22,989 (39,401 ) Net cash flows provided by (used in) investing activities (15,510 ) (102,808 ) (29,484 ) Net cash flows provided by (used in) financing activities 82,865 89,113 (16,761 ) Total 42,608 9,295 (85,647 ) Effect of exchange rate changes on cash 884 (2,752 ) 3,928 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.
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.
See “Note Regarding Use of Non-IFRS Financial Measures. 74 Statement of Consolidated Financial Position Data As of December 31, 2023 2024 2025 $ in thousands Current financial assets and Cash and cash equivalents 203,815 260,306 208,663 Other assets 130,456 123,238 116,057 Total assets 334,270 383,544 324,720 Shareholders' equity 84,695 131,033 75,901 Non current liabilities 94,431 86,241 103,067 Current liabilities 155,144 166,269 145,752 Total shareholders' equity and liabilities 334,270 383,545 324,720 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, 2023 2024 2025 $ in thousands Net Income (Loss) attributable to shareholders of Cellectis (101,059 ) (36,761 ) (67,593 ) Adjustment of non-cash stock-based compensation expense from continued operations: Research and development expenses 3,952 2,028 4,142 Selling, general and administrative expenses 1,281 1,139 1,968 Total non-cash stock-based compensation expense from continued operations 5,233 3,167 6,110 Adjustment of non-cash stock-based compensation expense from discontinued operations 3,859 0 0 Non-cash stock-based compensation expense attributable to non controlling interests (2,006 ) 0 0 Adjusted Net Income (Loss) attributable to shareholders of Cellectis * (93,973 ) (33,594 ) (61,483 ) ** Non-IFRS financial measure.
For the year ended December 31, % change 2022 2023 2024 2024 vs 2023 Personnel expenses (7,674 ) (7,381 ) (7,493 ) 1.5 % Purchases, external expenses (6,712 ) (6,682 ) (9,182 ) 37.4 % Depreciation and amortization expenses (incl. right of use amortization) (1,887 ) (2,012 ) (1,483 ) -26.3 % Other (1,221 ) (738 ) (927 ) 25.7 % Selling, general and administrative expenses (17,494 ) (16,812 ) (19,085 ) 13.5 % Between the years ended December 31, 2023 and 2024, selling, general and administrative expenses increased by $2.3 million mainly due to a $2.5 million increase in purchases and external expenses (from $6.7 million in 2023 to $9.2 million in 2024) primarily related to legal and finance external support.
Selling, general and administrative expenses For the year ended December 31, % change 2023 2024 2025 2025 vs 2024 Personnel expenses (7,381 ) (7,493 ) (7,681 ) 2.5 % Purchases, external expenses (6,682 ) (9,182 ) (9,797 ) 6.7 % Depreciation and amortization expenses (incl. right of use amortization) (2,012 ) (1,483 ) (1,397 ) -5.8 % Other (738 ) (927 ) (915 ) -1.3 % Selling, general and administrative expenses (16,812 ) (19,085 ) (19,790 ) 3.7 % Selling, general and administrative expenses increased by $0.7 million between the years ended December 31, 2024 and 2025 mainly due to a $0.6 million increase in purchases and external expenses (from $9.2 million in 2024 to $9.8 million in 2025).
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.
The income tax expense of the year ended December 31, 2023 amounting to $0.4 million corresponds to the income tax expense of Cellectis Inc. and Cellectis Biologics Inc.
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.
Net Income / loss For the year ended December 31, % change 2023 2024 2025 2025 vs 2024 Net income (loss) (108,443 ) (36,761 ) (67,593 ) 83.9 % Net income includes net income from discontinued operations.
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.
Our research and development efforts are focused as of the date of this report on our product candidates: (i) lasme-cel (previously known as UCART22), currently evaluated in the BALLI-01 Study, (ii) eti-cel (previously known as UCART20x22), currently evaluated in the NATHALI-01 Study and (iii) other product candidates which are in the pre-clinical development phases.
The decrease in stock-based compensation expense is primarily due to the lower fair value of the instruments under vesting in 2024 compared to 2023, as well as higher than expected forfeitures in 2024 due to employee terminations. Between the years ended December 31, 2022 and 2023, research and development expenses decreased by $9.9 million.
The decrease in stock-based compensation expense is primarily due to the lower fair value of the instruments under vesting in 2024 compared to 2023, as well as higher than expected forfeitures in 2024 due to employee terminations.
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.
The decrease in other income of $0.7 million between the years ended December 31, 2023 and 2024 is 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.
For the year ended December 31, % change 2022 2023 2024 2024 vs 2023 Personnel expenses (42,610 ) (37,158 ) (34,253 ) -7.8 % Purchases, external expenses (37,736 ) (32,996 ) (36,611 ) 11.0 % Depreciation and amortization expenses (incl. right of use amortization) (16,579 ) (16,511 ) (18,391 ) 11.4 % Other (575 ) (981 ) (1,281 ) 30.6 % Research and development expenses (97,501 ) (87,646 ) (90,536 ) 3.3 % Starting the year ended December 31, 2024, the license-in costs were presented in research and development expenses.
Research and development expenses 80 For the year ended December 31, % change 2023 2024 2025 2025 vs 2024 Personnel expenses (37,158 ) (34,253 ) (38,466 ) 12.3 % Purchases, external expenses (32,996 ) (36,611 ) (35,083 ) -4.2 % Depreciation and amortization expenses (incl. right of use amortization) (16,511 ) (18,391 ) (18,665 ) 1.5 % Other (981 ) (1,281 ) (1,301 ) 1.6 % Research and development expenses (87,646 ) (90,536 ) (93,517 ) 3.3 % Starting the year ended December 31, 2024, the license-in costs were presented in research and development expenses.
Liquidity management As of December 31, 2024, we had cash and cash equivalents of $143.3 million and a fix-term deposit (classified as current financial assets) of $115.8 million classified. Long term restricted cash amounts to $4.6 million and is classified in Other non-current financial assets.
Liquidity management As of December 31, 2025, we had cash and cash equivalents of $61.5 million and fix-term deposits (classified as current financial assets) of $144.8 million. Restricted cash amounts to $4.4 million and is classified in current and non-current financial assets.
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.
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.
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.
For the twelve-month period ended December 31, 2025, we mainly derived our Therapeutics revenues from the JRCA with AstraZeneca, and from other license agreements for the use of our gene editing technology.
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.
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. 79 Operating Results The following table sets forth our selected consolidated statement of income data: For the year ended December 31, 2023 2024 2025 $ in thousands Revenues and other income Revenues 755 41,505 72,949 Other income 8,438 7,712 6,644 Total revenues and other income 9,193 49,217 79,592 Operating expenses Cost of revenue (737 ) - - Research and development expenses (87,646 ) (90,536 ) (93,517 ) Selling, general and administrative expenses (16,812 ) (19,085 ) (19,790 ) Other operating income (expenses) (1,300 ) 849 638 Total operating expenses and other operating income (106,495 ) (108,771 ) (112,669 ) Operating income (loss) (97,302 ) (59,554 ) (33,076 ) Financial income 21,479 44,407 16,124 Financial expenses (40,642 ) (21,614 ) (51,064 ) Net Financial gain (loss) (19,163 ) 22,793 (34,940 ) Income tax (371 ) (0 ) 423 Income (loss) from continuing operations (116,835 ) (36,761 ) (67,593 ) Income (loss) from discontinued operations 8,392 - - Net income (loss) (108,443 ) (36,761 ) (67,593 ) Attributable to shareholders of Cellectis (101,059 ) (36,761 ) (67,593 ) Attributable to non-controlling interests (7,384 ) - - Revenues For the year ended December 31, % change 2023 2024 2025 2025 vs 2024 Collaboration agreements 0 40,898 72,074 43.3 % Other revenues 755 608 875 43.90 % Revenues 755 41,505 72,949 75.8 % The increase in revenues of $31.4 million between the years ended December 31, 2024 and 2025 is mainly driven by the evolution of activities performed in connection with the Research Plans and the fulfillment of our performance obligations under the AstraZeneca Joint Research and Collaboration Agreement.
The Company plans to use the proceeds of Tranche C towards the development of its pipeline of allogeneic CAR T-cell product candidates: UCART22 and UCART20x22. Follow-on offering On February 7, 2023, Cellectis launched of a follow-on offering of $22 million of its ADS for which Jefferies LLC and Barclays Capital Inc. acted as joint book-running managers for the Global Offering.
Follow-on offering On February 7, 2023, Cellectis launched of a follow-on offering of $22 million of its ADS for which Jefferies LLC and Barclays Capital Inc. acted as joint book-running managers for the Global Offering. Pricing occurred on February 2, 2023, at $2.50 per ADS.
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.
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.
Operating Expenses Our operating expenses consist primarily of research and development expenses and selling, general and administrative expenses.
Operating Expenses Our operating expenses consist primarily of research and development expenses and selling, general and administrative expenses. Research and Development Expenses We engage in substantial research and development efforts to develop innovative CAR T-cell immunotherapy.
The portion of cash and cash equivalents denominated in U.S. dollars is $110.8 million as of December 31, 2024. Current financial assets denominated in U.S. dollars amounted to $107.5 million as of December 31, 2024. Historical Changes in Cash Flows The table below summarizes our sources and uses of cash for the years ended December 31, 2022, 2023 and 2024.
The portion of cash and cash equivalents denominated in U.S. dollars is $31.2 million as of December 31, 2025. Current financial assets, excluding restricted cash, denominated in U.S. dollars amounted to $138.9 million as of December 31, 2025.
See “Risk Factors— Risks Related to Our Reliance on Third Parties—Servier’s discontinuation of its involvement in the development of CD19 Products and related disagreements may have adverse consequences.” In May 2024, Allogene announced the execution of an amendment and settlement agreement which amended the sublicense agreement between Servier and Allogene on CD19 Products.
On September 15, 2022, Servier sent to us and Allogene a notice of discontinuation of its involvement in the development of the CD19 Products (including notably UCART19 V1 and cema-cel) and in May 2024, Allogene announced the signature of an amendment and settlement agreement which amended the license agreement between Servier and Allogene.
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.
Between the years ended December 31, 2023 and 2024, selling, general and administrative expenses increased by $2.3 million mainly due to a $2.5 million increase in purchases and external expenses (from $6.7 million in 2023 to $9.2 million in 2024) primarily related to legal and finance external support.
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.
Cellectis’ Contractual Obligations and Commitments As of December 31, 2025, Cellectis had the following contractual obligations: As of December 31, 2025 Total Less than 1 year 1 - 3 years 3 - 5 years More than 5 years $ in thousands Lease agreements 43,438 10,151 15,739 9,667 7,881 IT licensing agreements 2,812 1,081 1,731 - - State Guaranteed loan « PGE » 4,129 4,129 - - EIB loan 72,076 - - 72,076 - Conditional advances 6,316 - 1,612 4,703 - Research Tax Credit financing and others 7,443 6,593 408 408 34 Total contractual obligations 136,212 21,954 19,489 86,854 7,915 87 Cellectis’ short-term and long-term material requirements are reflected in the table above and mainly relate to: • lease agreements regarding Cellectis’ corporate headquarters 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 a total of $43.4 million, of which $10.2 million are payable in 2026; • IT licensing agreements for $2.8 million, of which $1.1 million is payable in 2026; • a State Guaranteed loan “PGE” of $4.1 million, payable in 2026; • Research Tax Credit financing of $6.4 million, payable in 2026; • a long-term loan with the EIB of $72.1 million; • long-term conditional advances with Bpifrance of $6.3 million.
The decrease in net loss of $5.6 million between the years ended December 31, 2022 and 2023 was mainly due to (i) a decrease of $1.0 million in cost of revenue, (ii) a decrease of $4.8 million in purchases, external expenses and other, (iii) a decrease of €5.3 million in wages, (iv) a $0.8 million decrease in non-cash stock-based compensation expense and (v) a $23.7 million decrease in net loss of discontinued operations, partially offset by (i) a $16.5 million decrease in revenues and other income, (ii) a $2.7 million decrease of net other operating income, (iii) a $0.3 million increase in social charges on stock option grants expenses, (iv) a $0.3 million increase in income tax expense and (v) an increase of net financial loss of $10.2 million.
The increase in net loss of $30.8 million between the years ended December 31, 2024 and 2025 was mainly due to (i) a $30.4 million increase in revenues and other income, offset by (ii) a $3.0 million increase in research and development expenses and (iii) a net financial loss of $34.9 million in the year ended December 31, 2025, compared to a net financial gain of 22.8 million in the year ended December 31, 2024.
The decrease in revenue of $18.4 million or 96.1% between the years ended December 31, 2022 and 2023 mainly reflects (i) the recognition of a $15.8 million milestone from Servier in connection with the first patient dosed in the Allogene ALPHA2 Study in 2022, (ii) the recognition of two milestones under the collaboration and license with Cytovia Therapeutics, Inc.
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.
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.
The increase in financial expenses of $29.5 million between the year ended December 31, 2024 and 2025 is mainly attributable to a (i) $22.2 million increase in foreign exchange loss over the period due to the devaluation of the USD against the EUR which resulted in foreign exchange losses on our cash, cash equivalents and financial assets, (ii) a $6.7 million increase in loss on fair value measurement mainly explained by a $14.7 million loss on the fair value measurement of the Tranches A, B and C warrants issued to the EIB partly offset by a $7.8 million decrease in the loss on fair value measurement of our investment in shares of Cibus which was entirely sold in the first quarter of 2025, and (iii) a $0.7 million increase in interest on our financial and lease liabilities.
The increase in other income of $1.9 million between the years ended December 31, 2022 and 2023 is mainly related to the BPI Grant and Advance Agreement. This refundable advance is accounted for as a government loan as defined by IAS 20.
Other income For the year ended December 31, % change 2023 2024 2025 2025 vs 2024 Research tax credit 6,582 6,447 6,644 3.1 % Other income 1,856 1,265 - -100.0 % Other income 8,438 7,712 6,644 -13.9 % The decrease in other income of $1.1 million between the years ended December 31, 2024 and 2025 is mainly due to a decrease in a government grant received from Bpifrance ("BPI").
In 2024, we were sponsoring clinical studies with respect to three proprietary Cellectis UCART product candidates at seven (7) sites for the AMELI-01 Study, at sixteen (16) sites for the BALLI-01 Study, and at twelve (12) sites for the NatHaLi-01 Study. For more information, see "Item 4.
See “Risk Factors— Risks Related to Our Reliance on Third Parties—Servier’s discontinuation of its involvement in the development of CD19 Products may have adverse consequences.” As of the date of this Annual Report, we are sponsoring clinical studies with respect to two proprietary Cellectis UCART product candidates: the BALLI-01 Study and the NATHALI-01 Study. For more information, see “Item 4.
Removed
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.

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Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

61 edited+5 added−7 removed102 unchanged
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 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 work; 96 • oversee the rules relating to the use of the statutory auditors for assignments other than the audit of the financial statements and of internal control over financial reporting 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 are 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.
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.
We proceeded with the re-election, for a two-year term, of this Social and Economic Committee on September 19, 2024. 95 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.
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.
For the 2021, 2022, 2023, 2024 and 2025 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 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.
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. 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 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 89 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.
At Novartis, he led all emerging markets regions as well as the United States and Canada, either for Oncology or the Pharmaceuticals division. His most recent assignments were Chief Commercial and Medical Affairs Officer globally for Novartis Pharma from 2010 to 2017, as well as ad interim Chief Executive Officer and Division Head Pharma.
At Novartis, he led all emerging markets regions as well as the United States and 90 Canada, either for Oncology or the Pharmaceuticals division. His most recent assignments were Chief Commercial and Medical Affairs Officer globally for Novartis Pharma from 2010 to 2017, as well as ad interim Chief Executive Officer and Division Head Pharma.
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.
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 2027 David Sourdive, Ph.D.
Criminal liability cannot be indemnified under French law, whether directly by the company or through liability insurance. We maintain customary liability insurance coverage for our directors and executive officers, including insurance against liability under the Securities Act.
Criminal liability cannot be indemnified under French law, whether directly by the company or through liability insurance. 92 We maintain customary liability insurance coverage for our directors and executive officers, including insurance against liability under the Securities Act.
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.
Free Shares Under our 2012, 2013, 2014, 2015, 2018, Second 2018, 2021, 2022, 2023, 2024 and 2025 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, 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.
Stock Options Under our 2015, 2016, 2017, 2018, 2021, 2022, 2023, 2024 and 2025 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 eleven 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 ten directors.
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.
Garnier has served as director of the board of directors of Carrier Global Corp., a public company. From 2016 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.
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.
Arthur Stril (Chief Financial Officer & Chief Business Officer), and Ms. Marie-Bleuenn Terrier (General Counsel). The change of control plan also applies to one of our senior managers.
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.
Rivers — — — — * The conversion rate used is the average rate of the period 91 Service Agreements As of December 31, 2025, there were no service agreements between the Company or any of its subsidiaries and any director providing for benefits upon termination of employment.
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.
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, 2025, was $5.6 million.
Our audit and finance committee reviews our internal accounting procedures, consults with and reviews the services provided by our independent registered public accountants and assists our board of directors in its oversight of our corporate accounting and financial reporting. Currently, our audit and finance committee is comprised of three members of the board of directors: Messrs. Malkomes, Bastid, and Bergstrom.
Our audit and finance committee reviews our internal accounting procedures, consults with and reviews the services provided by our independent registered public accountants and assists our board of directors in its oversight of our corporate accounting and financial reporting. Currently, our audit and finance committee is comprised of three members of the board of directors: Messrs. Muller, Bergstrom, and Boehm.
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.
She holds a Master’s degree in Law from the Panthéon La Sorbonne University in Paris. Non-employee Directors Jean-Pierre Garnier , Ph.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 Labs, Inc. From 2019, Dr.
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.
He currently serves on the boards of directors of Kurma Life Sciences, Sparingvision, Aledia, and Enyo Pharma. 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. From 2018 to 2025, Mr.
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.
Pursuant to the shareholders authorization dated June 26, 2025, the maximum aggregate number of ordinary shares, which may be is 6,017,473, 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 6,017,473.
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.
Our current plan, the 2025 Free Share Plan, was adopted by our board of directors on August 4, 2025 according to the authorization granted by the combined ordinary and extraordinary shareholders’ general meeting dated June 26, 2025. Free shares may be granted to any individual employed by us or by any affiliated company.
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.
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, and Berlin Cure AG since January 2022. From Septembr 2022 to March 2025, Mr. Boehm served on the board of directors of Omega Therapeutics. From 2018 to 2022, Mr.
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 26, 2025, the maximum aggregate number of ordinary shares, which may be issued is 6,017,473, provided that our board of directors may decide of new grant of free shares only under our current 2025 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 6,017,473.
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.
Our current plan, the 2025 Stock Option Plan, was adopted by our board of directors on August 4, 2025, according to the authorization granted by the combined ordinary and extraordinary shareholders’ general meeting dated June 26, 2025. The Stock Options Plans follow the same rules.
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.
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 Finance Committee, is comprised of three members of the board of directors: Mr. Muller, Mr. Bergstrom, and Mr. Boehm.
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.
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.
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.
As of December 31, 2025, 151 of our employees were located in France and 78 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. 97 E.
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.
Director and Deputy CEO 2000 2027 Laurent Arthaud Director 2011 2026 Donald A. Bergstrom Director 2022 2028 Rainer Boehm Director 2017 2026 Cécile Chartier Director 2023 2026 Marc Dunoyer Director 2024 2027 André Muller Director 2025 2028 Tyrell Rivers, Ph.D.
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.
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.
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.
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. Rainer Boehm serves as a member of Cellectis’ board of directors since 2017. In addition, Mr.
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.
As of the date of this Annual Report, 2,701,060 ordinary shares remain available for issuance under the 2025 Free Share Plan and 2025 Stock Option Plan.
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.
The vesting period of the stock options granted to our executive officers and chairman is over three years and is subject to performance conditions; • 1,866,150 stock options have been granted to certain employees in March 2025 under the 2024 Stock Option Plan.
Under the 2024 employees change of control plan, the severance package shall be between 3 and 12 months of compensation, according to the job level of the covered employee. 97 The severance package required under applicable laws and regulations, including the amount negotiated by the Comité Social et Economique (if any) in respect of French employees, will take precedence in the event of any conflict with the Company's plans, provided however such severance package cannot be lower than the severance package determined under the applicable change in control plan established by the Company.
The severance package required under applicable laws and regulations, including the amount negotiated by the Comité Social et Economique (if any) in respect of French employees, will take precedence in the event of any conflict with the Company's plans, provided however such severance package cannot be lower than the severance package determined under the applicable change in control plan established by the Company.
Rainer launched and oversaw the commercialization of many brands during his career, amongst them Femara, Zometa and Glivec, as well as Cosentyx and Entresto. Rainer has a medical degree from the University of Ulm in Germany, and a Master of Business Administration from Schiller University in France. Donald A.
Rainer launched and oversaw the commercialization of many brands during his career, amongst them Femara, Zometa and Glivec, as well as Cosentyx and Entresto. Rainer has a medical degree from the University of Ulm in Germany, and a Master of Business Administration from Schiller University in France. Cécile Chartier serves as a member of our board of directors since 2023.
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.
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. 61 Director, Chief Executive Officer and Co-Founder Adrian Kilcoyne, M.D, MPH 56 Chief Medical Officer Steven Doares, Ph.D. 66 Senior Vice President of US Manufacturing Philippe Duchateau, Ph.D. 63 Chief Scientific Officer Kyung Nam-Wortman 56 Chief Human Resources Officer Stephan Reynier 56 Chief Regulatory & Pharmaceutical Compliance Officer David Sourdive, Ph.D. 59 Director, Deputy Chief Executive Officer, Executive Vice President, CMC and Manufacturing Arthur Stril 37 Chief Financial Officer & Chief Business Officer Marie-Bleuenn Terrier 44 General Counsel Non-Employee Directors: Jean-Pierre Garnier, Ph.D. 78 Chairman of the Board and Director Laurent Arthaud 63 Director Donald A.
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.
During the year ended December 31, 2025: • 3,851,783 stock options have been granted in January 2025 under the 2024 Stock Option Plan. These stock option have been granted to our executive officers and our chairman.
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.
Employees As of December 31, 2025, we had 229 employees, 224 of whom were full-time, 58 of whom hold M.D, Ph.D. or Pharm.D. degrees, 185 of whom were engaged in research and development activities and 44 of whom are engaged in business development, commercial, legal, finance, information systems, human resources or administrative support.
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.
The vesting period of the stock options granted to our employees is four years; • 476,100 stock options have been granted to certain employees and executive officers in June 2025 under the 2024 Stock Option Plan, out of which 270,500 were granted to certain of our executive officers.
Under the 2015, 2016, 2018, and 2021 Stock Options Plans, in the event of a voluntary retirement of the beneficiary, the beneficiary will continue to benefit from the stock options which may be exercised according to the vesting schedule decided by the board of directors during the grant of the corresponding stock options until their expiration date.
Under the 2015, 2016, 2018, and 2021 Stock Options Plans, in the event of a voluntary retirement of the beneficiary, the beneficiary will continue to benefit from the stock options which may be exercised according to the vesting schedule decided by the board of directors during the grant of the corresponding stock options until their expiration date. 94 The board of directors has the authority to modify awards outstanding under our Stock Option Plans, subject to the written consent of the beneficiary for any modification adverse to such beneficiary.
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.
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.
Prior to his tenure at Relay Therapeutics, from January 2014 to March 2018, Dr. Bergstrom was Chief Medical Officer at Mersana Therapeutics, where he led the advancement of two products based on Mersana’s proprietary antibody-drug conjugate platform through non-clinical development and into Phase 1 clinical trials.
Bergstrom was Chief Medical Officer at Mersana Therapeutics, where he led the advancement of two products based on Mersana’s proprietary antibody-drug conjugate platform through non-clinical development and into Phase 1 clinical trials. Prior to Mersana, he was Global Head of Translational and Experimental Medicine at Sanofi Oncology. At Sanofi, Dr.
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.
Bergstrom, Ph.D. 54 Director Rainer Boehm 65 Director Cécile Chartier, Ph.D. 59 Director Marc Dunoyer 73 Director André Muller 62 Director Tyrell Rivers, Ph.D. 53 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.
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.
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. • 132,000 stock options have been granted to certain of our employees in November 2025 under the 2025 Stock Option Plan and are under a vesting period over four years; • 20,000 stock options have been granted to certain of our employees in December 2025 under the 2025 Stock Option Plan and are under a vesting period over four years.
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.
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. His work there was focused on immunological T-cell memory. Dr.
Stock Options granted under the Stock Option Plans generally may not be sold, transferred or pledged in any manner other than by will or by the laws of descent or distribution.
For example, the board has the authority to extend a post-termination exercise period. Stock Options granted under the Stock Option Plans generally may not be sold, transferred or pledged in any manner other than by will or by the laws of descent or distribution.
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.
For the 2021, 2022, 2023, 2024 and 2025 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.
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.
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 was appointed Chief Business Officer in 2020 and Chief Business Officer and Interim Chief Financial Officer in 2024.
Free shares may also be granted to our Chief Executive Officer. However, no free share may be granted to a beneficiary holding more than 10% of our share capital or to a beneficiary who would hold more than 10% of our share capital as a result of such grant.
However, no free share may be granted to a beneficiary holding more than 10% of our share capital or to a beneficiary who would hold more than 10% of our share capital as a result of such grant. 93 Our board of directors has the authority to administer the Free Share Plans.
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.
Sourdive is also a member of our board of directors since 2000. Since June 2023 Dr. Sourdive 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.
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.
The total amount set aside or accrued to provide pension, retirement or similar benefits was $0.4 million for the year ended December 31, 2025. Directors Compensation (Gross Salary+Bonus)* Board fees* Out-of-pocket expenses* Equity awards granted in 2025 A. Choulika 943,894 — 38,979 880,000 D. Sourdive 620,729 — 15,545 352,500 J.P. Garnier — 101,698 18,114 171,783 L.
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.
From September 2019 to October 2025, he served on the board of directors of Exeloim S.A.S. From February 2021 to September 2025, he served on the board of directors of Cell-Easy S.A.S. From February 2014 to April 2024, he served on the board of directors of Mediterranean Institute for Life Sciences (MEDILS).
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.
For the year ended December 31, 2025, 3,851,783 stock options with an exercise price of €1.56 per ordinary share, and 270,500 stock options with an exercise price of €1,28 per ordinary share were granted to directors and executive officers as compensation under the 2024 Stock Option Plan..
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.
As of December 31, 2025, 169,500 of the 5,020,167 warrants were held by certain of our directors and some of our consultants for an aggregate of 175,170 ordinary shares, and 4,850,667 of the 5,020,167 warrants were held by the EIB. As of December 31, 2025, 117,938 of the 5,020,167 warrants were exercisable.
He was appointed Chief Business Officer in 2020 and Chief Business Officer and Interim Chief Financial Officer in 2024. He currently serves as Chief Financial Officer and Chief Business Officer since January 2025. Mr. Stril serves on the board of directors of Primera Therapeutics, Inc. since May 2023, serving as a director designated by Cellectis Mr.
He currently serves as Chief Financial Officer and Chief Business Officer since January 2025. Mr. Stril serves on the board of directors of Primera Therapeutics, Inc. since 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.
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.
Incentive stock options and non-qualified stock options may be granted under the Stock Option Plans, except for the 2021, 2022, 2023, 2024, and 2025 Stock Options under which only non-qualified stock options are available. As of the date of this Annual Report 2,701,060 ordinary shares remain available for issuance under the 2025 Stock Option Plan and 2025 Free Share Plan.
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.
Arthaud served on the board of directors of Ribogenics, Inc. 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.
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.
Tyrell Rivers , Ph.D., 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.
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.
Our non-employee warrants are generally granted subject to a three-year vesting, subject to continued service. As of December 31, 2025, 5,020,167 non-employee warrants were outstanding for an aggregate of 5,025,837 potential ordinary shares at a weighted average exercise price of €2.51 per share.
From 1999 to 2004 he served as Vice President of Aventis Capital, an investment subsidiary of the pharmaceuticals group Aventis, and as President of Pharmavent Partners from 2004 to 2006. Mr. Arthaud is a graduate of the École Polytechnique and the École Nationale de Statistique et d’Administration Économique.
Arthaud has also directed InnoBio, an investment fund managed by Bpifrance Investissement as part of the FSI France Investissement program. From 1999 to 2004 he served as Vice President of Aventis Capital, an investment subsidiary of the pharmaceuticals group Aventis, and as President of Pharmavent Partners from 2004 to 2006. Mr.
Dunoyer holds an MBA from HEC Paris and a Bachelor of Law degree from Paris University. Axel-Sven Malkomes serves as a member of our board of directors since June 2022. Since November 11, 2024, Mr. Malkomes has served as Chief Financial Officer of CureVac N.V. Prior to his tenure at CureVAc, Mr.
Dunoyer holds an MBA from HEC Paris and a Bachelor of Law degree from Paris University. André Muller serves as a member of our board of directors since June 2025. Mr. Muller serves as advisor to the board of directors and to the chief executive officer of Idorsia Pharmaceuticals Ltd., since 2025, and as director of Chiron Investment AG. Mr.
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.
Arthaud is a graduate of the École Polytechnique and the École Nationale de Statistique et d’Administration Économique. Donald A. 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.
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.
Arthaud — — — — R. Boehm — 112,998 7,947 — D. Bergstrom — 101,698 136 — C. Chartier — 101,698 — — M. Dunoyer — — — — A-S Malkomes — 53,674 272 — A. Muller — 53,674 — — T.
Removed
Sourdive is also a member of our board of directors since 2000.
Added
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. Before his tenure at Cellectis, Dr.
Removed
Pierre Bastid serves as a member of Cellectis’ board of directors since 2011. Mr. Bastid has 25 years of experience in turning around, developing and running technology businesses in Asia, Europe and the United States. In addition to Cellectis, Mr.
Added
Bergstrom, currently serves as President, Research and Development at Relay Therapeutics, Inc., a public clinical-stage precision medicines company. Prior to his tenure at Relay Therapeutics, from January 2014 to March 2018, Dr.
Removed
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.
Added
Muller previously served as chief executive officer of Idorsia Pharmaceuticals Ltd from June 2024 to June 2025 and was chief financial officer of Idorsia Pharmaceuticals Ltd from June 2017 to June 2024. Mr. Muller holds a master’s degree in business administration from EMLYON Business School, Lyon, France.
Removed
Bastid was Chairman of Z Nautic SAS from November 2019 to January 2020, and member of the board of directors of Pharnext S.A.S from 2017 to 2022. 95 Rainer Boehm serves as a member of Cellectis’ board of directors since 2017. In addition, Mr.
Added
Under the 2024 employees change of control plan, the severance package shall be between 3 and 12 months of compensation, according to the job level of the covered employee.
Removed
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.
Added
Free shares may also be granted to our Chief Executive Officer.
Removed
Our board of directors has the authority to administer the Free Share Plans.
Removed
The board of directors has the authority to modify awards outstanding under our Stock Option Plans, subject to the written consent of the beneficiary for any modification adverse to such beneficiary. For example, the board has the authority to extend a post-termination exercise period.

Item 7. Management's Discussion & Analysis

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

60 edited+4 added−6 removed25 unchanged
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.
Transactions with Our Principal Shareholders, Directors and Executive Officers BPI, which is a shareholder of Cellectis, participated in a bank syndicate that granted the PGE loan to Cellectis.
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.
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. 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.
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.
Consists of 16,000,000 ordinary shares (corresponding to 32,000,000 voting rights) and 10,000,000 shares of Class A Preferred 98 Shares (corresponding to 10,000,000 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.
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.
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, 2026.
(1) Amounts beneficially owned were reported pursuant to a Schedule 13D amendment filed with the SEC on January 1, 2025.
(1) Amounts beneficially owned were reported pursuant to a Schedule 13D amendment filed with the SEC on January 24, 2025.
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.
Garnier has the right to acquire pursuant to stock options granted in January 2025 under the 2024 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.
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.
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, 2026.
Related Party Transactions Since January 1, 2023, we have engaged in the following transactions with our directors, executive officers and holders of more than 5% of our outstanding voting securities and their affiliates, which we refer to as our related-parties.
Related Party Transactions Since January 1, 2024, we have engaged in the following transactions with our directors, executive officers and holders of more than 5% of our outstanding voting securities and their affiliates, which we refer to as our related-parties.
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.
The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of February 15, 2026 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.
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%.
Pursuant to this agreement and according to market standards, Bpifrance advances 5,284,000 € over the period from July 15, 2023 to October 15, 2026, with a commitment fee to be charged to Cellectis of 0.40%.
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.
As reported on the Schedule 13D filed with the SEC on January 24, 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 December 12, 2025.
Business Overview—Our Licensing Relationships.” Agreements with Our Directors and Executive Officers Director and Executive Officer Compensation See “Item 6.B—Compensation of Directors and Executive Officers” for information regarding compensation of directors and executive officers and service agreement with Director.
For more information, see “Item 4. Information on the Company—B. Business Overview—Our Licensing Relationships.” Agreements with Our Directors and Executive Officers Director and Executive Officer Compensation See “Item 6.B—Compensation of Directors and Executive Officers” for information regarding compensation of directors and executive officers and service agreement with Director.
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 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 2022 under the 2021 Stock Option Plan, 5,300 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.
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. Doares has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 5,300 ordinary shares that Mr.
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.
Consists of 6,913,153 ordinary shares (corresponding to 10,599,440 voting rights) beneficially owned by Caisse des Dépôts, which includes 5,873,247 ordinary shares (corresponding to 9,559,534 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.
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.
Sourdive has the right to acquire pursuant to stock options granted in June 2024 under the 2023 Stock Option Plan, 115,500 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in January 2025 under the 2024 Stock Option Plan, 288,041 shares held by Viveoo SARL, and 415,000 shares held by SGBT LUX VIVEOO.
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.
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.
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.
(5) Includes 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. 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 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.
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 37,312 ordinary shares that Dr.
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.
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. 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.
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.
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, 2025 and December 31, 2025, we estimate that approximately 15.1% and 17.0%, respectively, of our outstanding ordinary shares were held in the United States. B.
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 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 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 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 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 October 2017 under the 2017 Stock Option Plan, 74,200 ordinary shares that Mr.
The percentage ownership information shown in the table is based upon 72,093,873 ordinary shares outstanding as of February 15, 2025.
The percentage ownership information shown in the table is based upon 72,590,994 ordinary shares outstanding as of February 15, 2026.
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.
Pursuant to this agreement and according to market 100 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%. This advance has been fully repaid before October, 15, 2025, according to agreement term.
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.
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. Reynier has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 10,600 ordinary shares that Mr.
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.
Terrier has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 5,300 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 94,340 ordinary shares that Mrs.
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.
Choulika has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 235,850 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 248,570 ordinary shares that Mr.
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.
Nam-Wortman has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 42,612 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, 95,877 ordinary shares that Mrs.
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.
Sourdive has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 5,300 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 94,340 ordinary shares that Mr.
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.
Stril has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 42,612 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in May 2023 under the 2022 Stock Option Plan, 104,441 ordinary shares that Mr.
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.
During the fiscal years ended 2024 and 2025, we made principal repayments of $1.6 million and $1.7 million, respectively, as well as interest payments of $0.1 million in each of those years pursuant to the PGE loan.
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 May 2022 under the 2021 Stock Option Plan, 94,340 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 56,816 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.
Doares has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 94,340 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 42,612 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.
Stril has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 5,300 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 94,340 ordinary shares that Mr.
In considering related-party transactions, our board of directors, or to the extent permitted by applicable law an independent committee of our board of directors, will take into account the relevant available facts and circumstances including, but not limited to: • the benefits and perceived benefits to us; • the opportunity costs of alternative transactions; • the materiality and character of the related party’s interest; • the actual or apparent conflict of interest of the related party; and • the terms available to or from, as the case may be, unrelated third parties or to or from employees generally.
In considering related-party transactions, our board of directors, or to the extent permitted by applicable law an independent committee of our board of directors, will take into account the relevant available facts and circumstances including, but not limited to: • the benefits and perceived benefits to us; • the opportunity costs of alternative transactions; • the materiality and character of the related party’s interest; • the actual or apparent conflict of interest of the related party; and • the terms available to or from, as the case may be, unrelated third parties or to or from employees generally. 101 The policy requires that, in determining whether to approve, ratify or reject a related-party transaction, our board of directors, or if permitted by applicable law an independent committee of our board of directors, must consider, in light of known circumstances, whether the transaction is in, or is not inconsistent with, our best interests and those of our shareholders, as our board of directors, or if permitted by applicable law an independent committee of our board of directors, determines in the good faith exercise of its discretion.
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 June 2024 under the 2023 Stock Option Plan, and 115,500 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in January 2025 under the 2024 Stock Option Plan. (10) Includes 21,730 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.
Nam-Wortman has the right to acquire pursuant to stock options granted in January 2025 under the 2024 Stock Option Plan. (11) Includes 5,300 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.
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.
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. Doares has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, 15,900 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.
Garnier has the right to acquire pursuant to stock options granted in April 2021 under the 2018 Stock Option Plan, 41,196 ordinary shares that Mr. Garnier has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 84,736 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.
Terrier has the right to acquire pursuant to stock options granted in June 2024 under the 2023 Stock Option Plan, and 115,500 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in January 2025 under the 2024 Stock Option Plan. (7) Includes 71,665 ordinary shares that Mr.
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.
Terrier has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 95,877 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan, 11,550 ordinary shares that Mrs.
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.
Garnier has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 74,866 ordinary shares that Mr. Garnier has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan, and 56,688 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.
Reynier has the right to acquire pursuant to stock options granted in May 2023 under the 2022 Stock Option Plan, 95,877 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan, 11,550 ordinary shares that Mr.
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.
Name of beneficial owner Ordinary Shares Beneficially Owned Number Percentage 5% Shareholders: AstraZeneca PLC (1) 26,000,000 31.48 % Bpifrance Participations SA (2) 6,913,153 9.52 % Directors and Executive Officers: André Choulika, Ph.D. (3) 2,679,511 3.61 % David Sourdive, Ph.D. (4) 1,764,352 2.41 % Philippe Duchateau, Ph.D.
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.
Duchateau has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 5,300 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in May 2022 under the 2021 Stock Option Plan, 94,340 ordinary shares that Dr.
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.
Sourdive has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 95,877 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan, 13,200 ordinary shares that Mr.
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.
Duchateau has the right to acquire pursuant to stock options granted in January 2023 under the 2022 Stock Option Plan, 95,877 ordinary shares that Mr. Duchateau has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan, 11,550 ordinary shares that Mr.
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.
Bergstrom - * Cécile Chartier - * André Muller - * Marc Dunoyer - * Tyrell Rivers - * All directors and executive officers as a group (17 persons) 8,598,728 11.70 % * Represents beneficial ownership of less than one per cent.
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.
Equity Awards Since January 1, 2025, we have granted equity awards to certain of our directors and executive officers: • On January 30, 2025, we granted 3,851,783 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 June 23, 2025, we granted 270,500 stock options to certain of our executive officers, with a vesting over three years and subject to performance conditions.
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.
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) Includes 240,065 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.
Stril has the right to acquire pursuant to stock options granted in January 2025 under the 2024 Stock Option Plan. (12) Includes 42,400 ordinary shares that Mr. Boehm has the right to acquire pursuant to non-employee warrants granted in October 2017. (13) Includes 29,112 ordinary shares that Mr.
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.
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 is eligible for future milestone payments, plus tiered royalties based on the sale of Licensed Products (as defined in the AZ JRCA).
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.
Nam-Wortman has the right to acquire pursuant to stock options granted in March 2022 under the 2021 Stock Option Plan, 5,300 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, 94,340 ordinary shares that Mrs.
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.
Choulika has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan, and 290,400 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in January 2025 under the 2024 Stock Option Plan. (4) Includes 210,058 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.
Doares has the right to acquire pursuant to stock options granted in May 2023 under the 2022 Stock Option Plan, 95,877 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan, 6,600 ordinary shares that Mr.
(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.
(5) 735,292 1.00 % Marie-Bleuenn Terrier (6) 805,655 1.10 % Stephan Reynier (7) 684,913 * Adrian Kilcoyne (8) 148,500 * Steven Doares (9) 492,871 * Kyung Nam-Wortman (10) 477,001 * Arthur Stril (11) 481,631 * Laurent Arthaud - * Rainer Boehm (12) 42,400 * Jean-Pierre Garnier (13) 286,602 * Donald A.
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.
Stril has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan, 6,765 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in June 2024 under the 2023 Stock Option Plan, and 115,500 ordinary shares that Mr.
(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.
Duchateau has the right to acquire pursuant to stock options granted in June 2024 under the 2023 Stock Option Plan, and 115,500 ordinary shares that Mr. Duchateau has the right to acquire pursuant to stock options granted in January 2025 under the 2024 Stock Option Plan. (6) Includes 210,058 ordinary shares that Mrs.
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.
Nam-Wortman has the right to acquire pursuant to stock options granted in January 2024 under the 2023 Stock Option Plan, 6,600 ordinary shares that Mrs. Nam-Wortman has the right to acquire pursuant to stock options granted in June 2024 under the 2023 Stock Option Plan, and 115,500 ordinary shares that Mrs.
Removed
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.
Added
Reynier has the right to acquire pursuant to stock options granted in June 2024 under the 2023 Stock Option Plan, and 115,500 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in January 2025 under the 2024 Stock Option Plan. 99 (8) Includes 33,000 ordinary shares that Mr.
Removed
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.
Added
Kilcoyne has the right to acquire pursuant to stock options granted in August 2024 under the 2024 Stock Option Plan, and 115,500 ordinary shares that Mr. Kilcoyne has the right to acquire pursuant to stock options granted in January 2025 under the 2024 Stock Option Plan. (9) Includes 18,020 ordinary shares that Mr.
Removed
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.
Added
On November 17, 2025, AZ Ireland and Cellectis entered into an amendment to the JRCA to prospectively change the structure of the milestone payments, leading to an aggregate amount of up to $80 million to up to $253 million per each of the 10 candidate products (vs. up to $70 million to up to $220 million per candidate product previously).
Removed
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
See “Item. 7A—Major Shareholders” for information regarding equity awards to certain of our executive officers.
Removed
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.
Removed
The policy requires that, in determining whether to approve, ratify or reject a related-party transaction, our board of directors, or if permitted by applicable law an independent committee of our board of directors, must consider, in light of known circumstances, whether the transaction is in, or is not inconsistent with, our best interests and those of our shareholders, as our board of directors, or if permitted by applicable law an independent committee of our board of directors, determines in the good faith exercise of its discretion.

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